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Public Health Service (PHS) Policies on Research Misconduct – 42 CFR Part 93 – June 2005

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[Federal Register: May 17, 2005 (Volume 70, Number 94)]
[Rules and Regulations]               
[Page 28369-28400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my05-16]                         


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Part III

Department of Health and Human Services


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42 CFR Parts 50 and 93


Public Health Service Policies on Research Misconduct; Final Rule


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Parts 50 and 93

RIN 0940-AA04


Public Health Service Policies on Research Misconduct

AGENCY: U.S. Department of Health and Human Services (HHS). 

ACTION: Final rule. 

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SUMMARY: This final rule removes 42 CFR part 50, subpart A, 
"Responsibilities of Awardee and Applicant Institutions for Dealing 
With and Reporting Possible Misconduct in Science," and replaces it 
with a new, more comprehensive part 93, "Public Health Service 
Policies on Research Misconduct." The proposed part 93 was published 
for public comment on April 16, 2004. The final rule reflects both 
substantive and non-substantive amendments in response to public 
comments and to correct errors and improve clarity, but the general 
approach of the NPRM is retained. The purpose of the final rule is to 
implement legislative and policy changes applicable to research 
misconduct that occurred over the last several years, including the 
common Federal policies and procedures on research misconduct issued by 
the Office of Science and Technology Policy on December 6, 2000.

DATES: This final rule will become effective June 16, 2005.

ADDRESSES: Address any comments or questions regarding this final rule 
to: Chris B. Pascal, J.D., Director, Office of Research Integrity, 1101 
Wootton Parkway, Suite 750, Rockville, MD 20852. Some commonly asked 
questions and answers to them will be posted on the Office of Research 
Integrity Web site prior to the effective date of the regulation. The 
URL for the ORI Web site is: http://ori.hhs.gov.

    You may submit comments and questions on this final rule by sending 
electronic mail (e-mail) to research@osophs.dhhs.gov. Submit electronic 
comments as either a WordPerfect file, version 9.1 or higher, or a 
Microsoft Word 97 or 2000 file format. You may also submit comments or 
questions as an ASCII file avoiding the use of special characters and 
any form of encryption.

FOR FURTHER INFORMATION CONTACT: Brenda Harrington, (301) 443-3400. 
(This is not a toll-free number).

SUPPLEMENTARY INFORMATION: 

I. Public Comments--General

    The Notice of Proposed Rulemaking (NPRM) proposing to remove 42 CFR 
part 50, subpart A and replace it with a new part 93 was published in 
the Federal Register on April 16, 2004 (69 FR 20778). Comments were 
requested on or before June 15, 2004. In addition to this invitation 
for public comment on any aspect of the proposed rulemaking, the NPRM 
requested comment on specific aspects of the proposed rule including: 
(A) Whether there should be any limitation on the ability of 
institutions to conduct a research misconduct proceeding through a 
consortium or other entity qualified by practice and experience to 
conduct research misconduct proceedings (Sec.  93.306); (B) the use of 
Administrative Law Judges (ALJs) to conduct HHS research misconduct 
hearings rather than a panel of three decisionmakers (Sec.  93.502); 
(C) treating the decision of the ALJ as a recommended decision to the 
Assistant Secretary for Health (ASH) as opposed to the current practice 
in which the decision of the panel on the merits of the HHS findings of 
misconduct and administrative actions, other than debarment, 
constitutes final agency action (Sec. Sec.  93.500(d) and 93.523(c)); 
(D) authorizing the ALJ to appoint a scientific expert (that 
appointment is required if requested by either party) to advise the ALJ 
on scientific issues, but not provide testimony for the record (Sec.  
93.502(b)); (E) consistent with current practice, permitting HHS to 
amend its findings of research misconduct up to 30 days before the 
scheduled hearing (Sec.  93.514); (F) extending the period for 
retaining records of the research misconduct proceeding, including 
inquiries, from 3 to 7 years (Sec.  93.317); (G) imposing a 120-day 
deadline for the completion of any institutional appeal from a finding 
of research misconduct (Sec.  93.314); and (H) whether the HHS 
estimates on the potential burden of information collection 
requirements are accurate and whether those requirements are necessary 
for the proper performance of HHS functions.
    Twenty-eight documents commenting on the NPRM were submitted to HHS 
by mail or e-mail. Most of the documents addressed multiple sections of 
the proposed rule. A number of the commentators made general positive 
comments such as that: the proposed rule is well drafted, provides 
valuable guidance for researchers and institutions and is much improved 
over the current regulation; the detail and transparency of the 
procedures will result in a better focus on the merits of a case rather 
than procedural complications; the proposal recognizes the importance 
of primary reliance on the institutions to respond to allegations of 
research misconduct; and the clarification and harmonization of 
definitions, standards, and procedures are appreciated.
    Most of the commentators endorsed the changes in the definition of 
research misconduct and the incorporation of the three elements 
necessary for a finding of research misconduct in conformity with the 
Federal Policy on Research Misconduct issued by the Office of Science 
and Technology Policy (OSTP). Some expressed support for the PHS 
practice of excluding coverage of authorship disputes in the absence of 
a clear allegation of plagiarism. There were expressions of support for 
the coverage of PHS intramural programs and PHS contractors, the 
coverage of the plagiarism of a PHS supported research record, even if 
the respondent does not receive such support, the clarification of the 
role of the complainant, the adoption of a six-year limitation on the 
pursuit of misconduct allegations, separation of adjudication and 
appeal from the inquiry and investigation stages, setting a time limit 
on the investigation by the institution, and the inclusion of ALJs in 
the hearing process. These and other supportive comments may be 
discussed in the consideration of specific changes to the proposed rule 
that follows.
    There were also general, negative comments on the proposed rule, 
some of which were in direct opposition to positive comments. Some 
commentators feel that the proposal is overly detailed and thus 
contrary to the OSTP goal of a more uniform Federal-wide approach. 
Another criticizes the continuation in the proposed rule of a trend 
toward legalization of scientific disputes by immediately casting 
parties into adversarial roles. Other commentators object to the change 
from a hearing conducted by a three-member panel to one conducted by an 
ALJ, stating that there has not been any showing of a need to change 
the current practice. One commentator felt that HHS should be 
responsible for investigating allegations of misconduct at institutions 
that have repeatedly failed to properly investigate research 
misconduct. These and other critical comments may be discussed in the 
consideration of specific changes that follow.
    Some letters of comment repeated comments that had been made in 
response to the OSTP proposal for a government-wide Federal policy on 
research misconduct. Because OSTP considered those comments prior to

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issuing its final policy and this final rule is consistent with the 
aspects of the OSTP policy addressed in the comments, those comments 
will not be further discussed here.
    Comments on specific sections of the regulation are addressed below 
under headings based on the general issue raised by the comments. If 
that issue encompasses more than one section of the regulation, all 
those sections will be discussed under that heading.

II. Changes Made in Response to Comments

A. Applicability, Secs. 93.100(b) and 93.102(b)

    A number of commentators concluded that the applicability section, 
93.102, and the descriptions of applicability in other sections 
unreasonably extend HHS jurisdiction beyond PHS supported biomedical or 
behavioral research and research training. One commentator recommended 
that descriptions of applicability be uniform throughout the 
regulation. There were specific objections to: (1) The statement in 
Sec. 93.100(b) that covered institutions must comply with the 
regulation with respect to allegations of misconduct ``occurring at or 
involving research or research training projects or staff of the 
institution''; (2) the coverage, in Sec. 93.102(a) and other sections 
describing applicability, of ``activities related to that research or 
research training;'' and (3) the extension of coverage in Sec. 
93.102(a) to allegations of misconduct involving any research record 
generated from covered research, research training, or activities 
related to that research or training, regardless of whether the user or 
reviewer receives PHS support or whether an application resulted in any 
PHS support.
    Several clarifying changes have been made in response to these 
comments, but these changes do not change the intended substance of the 
provisions in the NPRM. The current regulation, 42 CFR 50.101, covers 
each entity that applies for a ``research, research-training or 
research-related grant or cooperative agreement'' under the PHS Act. 
Such an entity must establish policies and procedures for investigating 
and reporting instances of alleged misconduct involving ``research or 
research training or related research activities that are supported 
with funds available under the PHS Act.'' Thus, applicability to 
research-related activities is not new. The NPRM was not intended to 
change the applicability to those activities as it is expressed in the 
current regulation and has been applied in practice under that 
regulation.
    This rulemaking establishes the necessary HHS jurisdiction to 
implement the new term ``reviewing research'' in the OSTP definition of 
research misconduct. In ORI's experience, plagiarism can occur during 
the review process when a manuscript is submitted for publication. In 
the great majority of cases where an allegation arises that a PHS 
supported research record was plagiarized, we expect that the reviewers 
will be current recipients of PHS research funds because the reviewers 
are selected based on their subject matter expertise and the research 
in question is PHS funded biomedical and behavioral research. In cases 
where the respondent is PHS supported or affiliated with a PHS 
supported institution, we would expect the misconduct allegation to be 
pursued by the PHS supported institution. In those cases where the 
reviewer who is alleged to have committed plagiarism is solely funded 
by another Federal agency, ORI would refer the allegation to that 
agency. In addition, jurisdiction does not attach to allegations of 
plagiarism where there is no PHS support for the research record in 
question. Thus, we have removed the phrase ``regardless of whether the 
user or reviewer currently receives PHS support'' from Sec. 93.102.
    To eliminate redundancy and clarify the general policy and 
applicability provisions, Secs. 93.100 and 93.102, we have: (1) Moved 
the statement of applicability to institutions from Sec. 93.100(b) to 
Sec. 93.102(b) and rewritten it to be more concise; and (2) moved 
paragraph (c) of Sec. 93.100 to paragraph (a) of that section and 
combined the proposed paragraphs (a) and (d) into a new paragraph (b).
    The provision setting forth the types of allegations to which the 
regulation applies has been moved from Sec. 93.102(a) to paragraph (b) 
of that section and has been amended to clarify that the regulation 
applies to allegations of research misconduct involving: (i) 
Applications or proposals for PHS support for biomedical or behavioral 
extramural or intramural research, research training, or activities 
related to that research or research training, such as the operation of 
tissue or data banks or the dissemination of research information; (ii) 
PHS supported biomedical or behavioral extramural or intramural 
research; (iii) PHS supported biomedical or behavioral extramural or 
intramural research training programs; (iv) PHS supported extramural or 
intramural activities that are related to biomedical or behavioral 
research or research training, such as the operation of tissue and data 
banks or the dissemination of research information; and (v) plagiarism 
of research records produced in the course of PHS supported research, 
research training, or PHS supported activities related to that research 
or research training. The examples of activities that are related to 
research or research training are intended to be illustrative, not 
exhaustive. They are intended to convey the concept that under its 
research and research training authorities, PHS funds many activities 
that are closely related to research and research training, but might 
not be considered to be within the common understanding of what 
constitutes research or research training. Consistent with the intent 
of, and practice under the current regulation, allegations of research 
misconduct involving those funded activities, or applications for the 
funding of those activities, are covered.
    In each section that refers to the applicability of the regulation 
we have referenced the applicability section or repeated the 
applicability of the regulation to PHS supported research, research 
training, and activities related to that research or research training.

B. Subsequent Use Exception to Six Year Limitation on Misconduct 
Allegations, Sec. 93.105(b)(1)

    In response to a comment requesting clarification, we have amended 
paragraph (b)(1) of Sec. 93.105. The amendment clarifies that even 
though HHS or an institution does not receive an allegation of research 
misconduct within six years of when the misconduct is alleged to have 
occurred, the regulation would apply if, within six years of when the 
allegation is received, the respondent has cited, republished, or 
otherwise used for his or her potential benefit the research record 
that is the subject of the allegation of misconduct.

C. Rebuttable Presumption of Misconduct in the Absence of Records, 
Secs. 93.106(a)(1) and 93.516(b)

    Commentators raised several concerns about proposed Sec. 
93.106(a)(1) and Sec. 93.516(b) under which the absence of, or 
respondent's failure to provide research records adequately documenting 
the questioned research establishes a presumption of research 
misconduct that can be rebutted by credible evidence corroborating the 
research or providing a reasonable explanation for the absence of, or 
respondent's failure to provide the research records. The concerns 
included: (1) Retroactive application of the provision where there was 
no previous requirement for the retention

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of the records; (2) holding the respondent responsible for the 
retention of records over which he/she may have no control; and (3) 
there is no guidance on what would be a ``reasonable explanation'' for 
the absence of records.
    In response to these comments, we have eliminated the rebuttable 
presumption of research misconduct. Sections 93.106 and 93.516 have 
been changed to state that the destruction, absence of, or respondent's 
failure to provide records adequately documenting the questioned 
research is evidence of research misconduct where the institution or 
HHS establishes by a preponderance of the evidence that the respondent 
intentionally, knowingly, or recklessly had research records and 
destroyed them, had the opportunity to maintain the records but failed 
to do so, or maintained the records, but failed to produce them in a 
timely manner, and that respondent's conduct constitutes a significant 
departure from accepted practices of the relevant research community. 
This is in keeping with the definition of falsification to include 
omitting data or results such that the research is not accurately 
represented in the research record (Sec. 93.103(b)) and with the 
requirements for a finding of research misconduct in Sec. 93.104. This 
answers the concerns about retroactive application and that the 
respondent may not have had control over the records by holding the 
respondent to the accepted practices of his/her research community. The 
weight to be accorded the evidence of research misconduct under these 
circumstances must be determined by the trier of fact in each case.

D. Respondent's Burden To Prove Honest Error or Difference of Opinion, 
Secs. 93.106(a)(2) and 93.516(b)

    As proposed, Sec. 93.106(a)(2) provided that once the institution 
or HHS makes a prima facie showing of research misconduct the 
respondent has the burden of proving any affirmative defenses raised, 
including honest error or difference of opinion. There were a number of 
objections to that section on the grounds that shifting the burden of 
proving honest error or difference of opinion to the respondent 
effectively shifts the burden of the institution and HHS to prove each 
element of research misconduct or, at the least, creates confusion. 
Some of the commentators opined that the institution and the HHS have 
the burden of proving the absence of honest error or difference of 
opinion.
    As stated in the preamble of the Federal Register notice 
promulgating the final OSTP Research Misconduct Policy (65 FR 76260, 
Dec. 6, 2000), the exclusion of honest error or difference of opinion 
from the definition of research misconduct does not create a separate 
element of proof; institutions and agencies are not required to 
disprove possible honest error or difference of opinion. Given that 
guidance, this final rule retains honest error or difference of opinion 
as an affirmative defense that the respondent has the burden of proving 
by a preponderance of the evidence.
    However, we recognize that there is an overlap between the 
responsibility of respondents to prove this affirmative defense and the 
burden of institutions and HHS to prove that research misconduct was 
committed intentionally, knowingly, or recklessly. Accordingly, 
consistent with the opinion of the United States Supreme Court in 
Martin v. Ohio, 480 U.S. 228, 107 S. Ct. 1098 (1987), we have amended 
Sec. 93.106 to require consideration of admissible, credible evidence 
respondent submits to prove honest error or difference of opinion in 
determining whether the institution and HHS have carried their burden 
of proving by a preponderance of the evidence that the alleged research 
misconduct was committed intentionally, knowingly, or recklessly. This 
consideration would be required, regardless of whether respondent 
carries his/her burden of proving honest error or difference of opinion 
by a preponderance of the evidence.
    In light of this change, we have removed the reference to the 
institution or HHS making a prima facie showing of research misconduct 
as unnecessary and confusing. Because this is the only use of prima 
facie in the regulation, we have removed the definition of that term.

E. Coordination With Other Agencies, Sec. 93.109

    Some commentators pointed out that Sec. 93.109(a), as proposed, is 
not consistent with the statement in the OSTP Policy that a lead agency 
should be designated when more than one agency has jurisdiction. We 
have amended paragraph (a) to state that if more than one agency of the 
Federal government has jurisdiction, HHS will cooperate with the other 
agencies in designating a lead agency. We have added a sentence 
clarifying that where HHS is not the lead agency, it may, in 
consultation with the lead agency, take action to protect the health 
and safety of the public, promote the integrity of the PHS supported 
research and research process, or to conserve public funds.

F. Definition of Research Record, Sec. 93.224

    One commentator recommended that the research record include the 
comments of the complainant and respondent on the inquiry and 
investigation reports. We agree that documents and materials provided 
by the respondent as part of his/her comments on the inquiry and 
investigation reports, or at any other stage of the research misconduct 
proceeding do not differ significantly from those provided in response 
to questions regarding the research. Only the latter were included in 
the proposed definition of research record. Accordingly, we have 
amended Sec. 93.224 (formerly Sec. 93.226) so that the definition of 
research record includes documents and materials that embody the facts 
resulting from the research that are provided by the respondent at any 
point in the course of the research misconduct proceeding. The purpose 
of including documents provided by respondent in the research record is 
to hold the respondent responsible for the integrity of those research 
documents regardless of when they were prepared or furnished to the 
institution or HHS.
    Because the complainant is not being held responsible for the 
record of data or results that embodies the facts resulting from the 
research at issue, we are not including comments provided by the 
complainant during the research misconduct proceeding in the definition 
of the term ``research record.'' Those comments may be considered by 
the institution and/or HHS and they may be admitted as evidence in any 
hearing, but they are not part of the research record. If the 
complainant possesses documents that embody the facts resulting from 
the research that is the subject of the research misconduct proceeding, 
those documents are research records and the institution is responsible 
for maintaining and securing those documents in the same manner as 
other research records. Those documents are distinct from analyses of 
research records or results that a complainant may prepare prior to or 
in the course of a research misconduct proceeding to support his or her 
allegation of misconduct. Any such documents may be considered evidence 
pertinent to the allegation, but they are not part of the research 
record.

G. Reporting Inquiries to ORI, Sec. 93.300(a)

    Several commentators interpreted the general language in proposed 
Sec. 93.300(a), requiring institutions to have policies and procedures 
for ``reporting

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inquiries and investigations of alleged research misconduct in 
compliance with this part,'' to require the reporting of all inquiries 
to ORI, contrary to the requirement in Sec. 93.309 for reporting only 
those inquiries resulting in a finding that an investigation is 
warranted. We have amended Sec. 93.300(a) to clarify that the 
institution's policies and procedures must comply with the requirements 
of the regulation for addressing allegations of research misconduct. 
This includes the requirements of Sec. 93.309.
    It was also recommended that this section be amended to require 
that the institution's written policies and procedures be provided to 
the complainant and other interested parties on request. We have added 
a requirement that the policies and procedures be provided to members 
of the public upon request to Sec. 93.302(a)(1) because it addresses 
the availability of the institution's policies and procedures to HHS 
and ORI upon request.

H. Precautions To Protect Against Conflicts of Interest, Secs. 
93.300(b) and 93.304(b)

    In response to a general comment that the regulation should ensure 
that those conducting inquiries and investigations do not have 
conflicts of interest, we have amended Secs. 93.300(b) and 93.304(b) to 
require institutions to include precautions against conflicts of 
interest on the part of those involved in the inquiry or investigation. 
This expands upon the requirement in Sec. 93.310(f) that institutions 
take reasonable steps to ensure an impartial investigation, ``including 
participation of persons with appropriate scientific expertise who do 
not have unresolved personal, professional, or financial conflicts of 
interest with those involved with the inquiry or investigation.''

I. Reporting of Aggregated Information by Institutions, Sec. 93.302(c)

    Several commentators recommended deletion of proposed Sec. 
93.302(c) because its broad language would encompass research 
misconduct proceedings that are outside the jurisdiction of HHS. We 
agree with the intent of these comments and have amended this provision 
to refer to aggregated information on the institution's research 
misconduct proceedings covered by this part.

J. Responsibility for Securing Research Records and Evidence, Secs. 
93.305, 93.307(b) and 93.310(d)

    Several commentators recommended that Sec. 93.305 be amended to 
ensure that any securing of scientific instruments not interfere with 
ongoing research. Scientific instruments are included in the definition 
of ``research record'' in Sec. 93.224 to the extent they are, or 
contain physical or electronic records of data or results that embody 
the facts resulting from scientific inquiry. In response to these 
comments we have added language to paragraphs (a) and (c) of Sec. 
93.305, paragraph (b) of Sec. 93.307, and paragraph (d) of Sec. 93.310 
permitting institutions to secure copies of data or other research 
records on shared scientific instruments, so long as those copies are 
substantially equivalent in evidentiary value to the instruments 
themselves. It is expected that institutions will exercise discretion 
in determining whether copies of the data are substantially equivalent 
in evidentiary value to the instruments themselves, consulting with ORI 
as the institution determines necessary. The evidentiary value of 
scientific instruments will vary from case to case. In some cases their 
value may be dependent upon the manner in which they record data, 
rather than the data they contain. In those cases, it may be reasonable 
for the institution to permit continued use of the instrument, so long 
as it remains available for inspection by those conducting the inquiry 
and investigation.

K. Using a Consortium or Other Entity To Conduct Research Misconduct 
Proceedings, Sec. 93.306

    One commentator recommended that there should be greater detail 
regarding the kinds of practice and experience that would qualify an 
outside entity to conduct research misconduct proceedings, how possible 
conflicts of interest would be handled, and whose responsibility it 
would be to determine whether the outside entity is qualified.
    The proposed Sec. 93.306 contains a catchall phrase providing that 
an institution may use a consortium or other entity to conduct research 
misconduct proceedings, if the institution prefers not to conduct its 
own proceeding. In light of the incorporation of this broad discretion 
in the proposed section, we have simplified Sec. 93.306 to provide that 
an institution may use the services of a consortium or person that the 
institution reasonably determines to be qualified by practice and 
experience to conduct research misconduct proceedings. Thus, the 
institution may decide to use an outside consortium or person for any 
reason and it determines whether that outside consortium or person is 
qualified. We have substituted the defined term ``person'' for the term 
``entity.'' Any outside person conducting a research misconduct 
proceeding would be subject to the requirements for precautions against 
conflicts of interest in Secs. 93.300(b) and 93.304(b).

L. Standards for Investigation, Sec. 93.310(g) and (h)

    A number of commentators felt that the provisions of proposed Sec. 
93.310(g) and (h) establish a performance standard that cannot be met 
through the use of the terms ``any'' and ``all.'' We have amended 
paragraphs (g) and (h) to require, respectively, interviews of each 
person who has been reasonably identified as having information 
regarding relevant aspects of the investigation, and the pursuit of all 
significant issues and leads discovered that are determined relevant to 
the investigation. The institutions are responsible for making the 
relevancy determinations that are included in these paragraphs.

M. Opportunity To Comment on the Investigation Report and Review the 
Supporting Evidence, Sec. 93.312(a) and (b)

    One commentator proposed language clarifying the period for the 
respondent to comment on the investigation report. Another commentator 
felt that the institution should be required to give the respondent an 
opportunity to review all research records and evidence upon which the 
investigation report is based. We believe that clarification of the 30-
day period for comment by the respondent and for comment by the 
complainant, at the discretion of the institution, is needed. We have 
amended paragraphs (a) and (b) of Sec. 93.312 accordingly. In addition, 
we have amended paragraph (b) to make it clear that institutions have 
the discretion to provide the complete investigation report to the 
complainant for comment or relevant portions of it.
    The OSTP Guidelines for Fair and Timely Procedures, Section IV of 
the Uniform Federal Policy, provide that one of the safeguards for 
subjects of allegations is reasonable access to the data and other 
evidence supporting the allegations and the opportunity to respond to 
the allegations, the supporting evidence and the proposed findings of 
research misconduct, if any. Consistent with that guidance, we have 
amended Sec. 93.312(a) to require institutions to give the respondent, 
concurrently with the draft investigation report, a copy of, or 
supervised access to, the evidence on which the report is based.

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N. Institutional Appeals, Sec. 93.314(a)

    One commentator requested language clarifying that the 120-day 
period for completing institutional appeals applies only to appeals 
from the finding of misconduct, not appeals from personnel actions. We 
have implemented this comment through the addition of appropriate 
language to Sec. 93.314(a).

O. Completing the Research Misconduct Process, Sec. 93.316

    Several commentators objected to this provision because they 
interpreted it as requiring that ORI be notified when an inquiry ends 
in a finding of no misconduct. These commentators recommended that the 
regulation address the question of whether settlements based on an 
admission of misconduct are reportable. In response to these comments 
we have amended Sec. 93.316(a) to require that institutions notify ORI 
if they plan to close a case at the inquiry, investigation, or appeal 
stage on the basis that the respondent has admitted research 
misconduct, a settlement with the respondent has been reached, or for 
any other reason, except a determination at the inquiry stage that an 
investigation is not warranted, or a finding of no misconduct at the 
investigation stage, which must be reported to ORI under Sec. 93.315. 
We have also changed Sec. 93.316(b) to provide for ORI consultation 
with the institution on its basis for closing a case, rather than 
simply reviewing the institution's decision, and expanded the actions 
ORI may take to include approving or conditionally approving closure of 
the case and taking compliance action.

P. Retention and Custody of Records of the Research Misconduct 
Proceeding, Sec. 93.317

    There were several objections that the seven-year retention period: 
(1) Creates storage problems; (2) should not apply to scientific 
instruments; and (3) is contrary to the 3-year retention period for 
records relating to grants in OMB Circular A-110. One commentator 
recommended that the term ``records of research misconduct 
proceedings'' be defined to include a relevancy standard.
    In order to clarify what must be retained, we have added a new 
paragraph (a) to Sec. 93.317 defining records of research misconduct 
proceedings by referring to the sections of the regulation that 
describe what records institutions must prepare in the course of 
research misconduct proceedings. The definition includes a relevancy 
standard and requires that an institution document any determination 
that records are irrelevant. We have added two exceptions to the 
requirement for retention of the records for a period of 7 years that 
is now in paragraph (b) of Sec. 93.317. The institution is not 
responsible for maintaining the records if they have been transferred 
to HHS in accordance with paragraph (c), formerly (b), or ORI has 
advised the institution in writing that it no longer needs to retain 
the records.
    As stated in the preamble of the NPRM (69 FR at 20784) the 7-year 
retention period is based on concerns that the 3-year period for 
retaining inquiry records in the current regulation, 42 CFR 
50.103(d)(6) is too short to permit HHS or the Department of Justice to 
investigate potential civil or criminal fraud cases. While the 7-year 
retention period is potentially burdensome, that burden will fall on a 
limited number of institutions, 53 according to the Paperwork Reduction 
Act burden estimate in the preamble to the NPR, and the burden is 
mitigated by exceptions for transfer of custody to HHS and for a 
written notification from ORI that the records do not have to be 
retained by the institution. Upon the effective date of this final 
rule, the 7-year retention period for records of research misconduct 
proceedings will supercede the more general requirements for the 
retention of records relating to grants. We note that the 7-year 
retention period is consistent with the provision in the HHS general 
grants administration regulation, 45 CFR 74.53(b)(1) providing that if 
any review, claim, financial management review, or audit is started 
during the 3-year retention period, the pertinent records must be 
retained until all such matters have been resolved and final action 
taken.

Q. ORI Allegation Assessments, Sec. 93.402

    Several commentators recommended requiring that ORI notify the 
institution of any allegation received by ORI, regardless of how ORI 
disposes of the allegation. Consistent with this recommendation, we 
have amended paragraph (d) of Sec. 93.402 to provide that if ORI 
decides that an inquiry is not warranted, it will close the case and 
may forward the allegation in accordance with paragraph (e) which 
provides that allegations not covered by the regulation may be 
forwarded to the appropriate HHS component, Federal or State agency, 
institution or other appropriate entity. In deciding whether to forward 
a specific allegation to the institution, ORI will consider potential 
confidentiality issues for the complainant and others. We are open to 
further dialogue with the research community on this issue.

R. Standard for the Assistant Secretary for Health's Review of the 
ALJ's Decision, Secs. 93.500(d) and 93.523

    One commentator recommended that there be criteria for the 
Assistant Secretary for Health (ASH) to review the ALJ's decision, 
similar to the ``arbitrary and capricious, or clearly erroneous'' 
standard for the HHS debarring official to review the ALJ's decision 
(paragraph (e) of Sec. 93.500).
    In response to this comment, we have added to Sec. 93.523(b) a 
standard of review for the ASH's review of the decision of the ALJ. The 
standard of review for the ASH is the same ``arbitrary and capricious 
or clearly erroneous'' standard that applies to the debarring 
official's review where debarment or suspension is a recommended HHS 
administrative action. In addition, we have amended Secs. 93.500 and 
93.523 to establish a procedure for the ASH review, clarify the 
relationship between the ASH review and the debarring official's 
decision on recommended debarment or suspension actions, and identify 
what constitutes the final HHS action. The Assistant Secretary for 
Health notifies the parties of an intention to review the ALJ's 
recommended decision within 30 days after service of the recommended 
decision. Upon review, the ASH may modify or reject the decision in 
whole or in part after determining it, or the part modified or 
rejected, to be arbitrary and capricious or clearly erroneous. If the 
ASH does not notify the parties of an intent to review the recommended 
decision within the 30-day period, that decision becomes final and 
constitutes the final HHS action, unless debarment or suspension is an 
administrative action recommended in the decision. If debarment or 
suspension is a recommended HHS action either in a decision of the ALJ 
that the ASH does not review, or in the decision of the ASH after 
review, the decision constitutes proposed findings of fact to the HHS 
debarring official.
    As noted in the discussion of changes not based on comments, we 
have amended several sections to ensure that the Assistant Secretary 
for Health cannot be responsible both for making findings of research 
misconduct and for reviewing the ALJ's recommended decision on those 
findings, if respondent contests the findings by requesting a hearing. 
ORI will be responsible for making those findings, consistent with its 
responsibilities as the reviewer of institutional findings of

[[Page 28375]]

research misconduct and as a party to any hearing on those findings. 
This maintains the separation between investigation and adjudication, 
because any inquiry or investigation would be conducted by the 
institution, or if conducted by HHS, it would not be conducted by ORI 
(Sec. 93.400(a)(4)).

S. Extension for Good Cause To Supplement the Hearing Request, Sec. 
93.501(d)

    One commentator recommended that the 30-day limit for supplementing 
the hearing request be measured from notification of the appointment of 
the ALJ, rather than from receipt of the charge letter. The commentator 
notes that the ALJ may not be appointed within 30 days after receipt of 
the charge letter and recommends an amendment providing that the ALJ 
may grant an additional period of no more than 60 days from the 
respondent's receipt of notification of the appointment of the ALJ. 
This comment makes a good point, but 60 days from notice of the 
appointment of the ALJ is too long a period, given that there may be an 
additional 30 days for appointment of the ALJ after the request for a 
hearing is filed. Thus, we have amended paragraph (d) to provide that 
after receiving notification of the appointment of the ALJ, the 
respondent has 10 days to file with the ALJ a proposal for 
supplementation of the hearing request that includes a showing of good 
cause for supplementation. Note that this 10-day period is consistent 
with the period for responding to a motion in Sec. 93.510(c) and that 
in accordance with Sec. 93.509(d), the ALJ may modify the 10-day period 
for good cause shown.

T. Role of Scientific Expert Appointed by ALJ, Sec. 93.502

    It was recommended that advice of the scientific expert appointed 
to advise the ALJ be part of the record and available to both parties. 
It was further recommended that the scientific expert be available for 
questioning by the parties. Another commentator recommended specific 
guidance in the regulation to assist ALJs in retaining appropriate 
scientific expertise. Another commentator felt that the appointment of 
an expert to assist the ALJ should be mandatory in every case, while 
others felt such an appointment should be mandatory in those cases 
involving complex scientific, medical or technical issues. For the 
reasons explained below under the heading, ``Significant Comments Not 
Resulting in Changes,'' we are not requiring the appointment of an 
expert to assist the ALJ in every case.
    The proposed Sec. 93.502 provides some guidance on the selection of 
scientific and technical experts by requiring that they have 
appropriate expertise to assist the ALJ in evaluating scientific or 
technical issues related to the HHS findings of research misconduct. 
Furthermore, experts may not have real or apparent conflicts of 
interest, or as added in this final rule, bias or prejudice that might 
reasonably impair their objectivity in the proceeding.
    In paragraph (b)(1) of Sec. 93.502 of this final rule we are 
providing further guidance on the selection of an expert to advise the 
ALJ. Upon a motion by the ALJ or one of the parties to appoint an 
expert to advise the ALJ, the ALJ must permit the parties to submit 
nominations. If such a motion is made by a party, the ALJ must appoint 
an expert, either: (1) The expert, if any, who is agreeable to both 
parties and found to be qualified by the ALJ; or, (2) if the parties 
cannot agree upon an expert, the expert chosen by the ALJ.
    These provisions will ensure the selection of well-qualified 
experts, minimize disputes, speed the appointment process by providing 
precise procedural rules, and enhance fairness by providing for greater 
involvement of the parties in the process.
    Consistent with the greater involvement of the parties in the 
selection of the expert and with the comment recommending a more 
formalized process for the expert to provide advice, we are adding Sec. 
93.502((b)(2) to clarify the role of the expert appointed by the ALJ. 
The ALJ may seek advice from the appointed expert at any time during 
the discovery or hearing phase of the proceeding. Advice must be 
provided in the form of a written report, containing the expert's 
background and qualifications, which is served upon the parties. The 
report and the expert's qualifications and advice may be challenged by 
the parties in the form of a motion or through testimony of the 
parties' own experts, unless the ALJ determines such testimony to be 
inadmissible in accordance with Sec. 93.519, or that such testimony 
would unduly delay the proceeding. In this manner, the report and any 
comment on it would be part of the record. These procedures will 
greatly enhance the detail and quality of the expert advice available 
for consideration by the ALJ and provide greater transparency and 
confidence to the scientific community on the expertise provided to the 
ALJ.

II. Changes Not Based on Comments

A. Grandfather Exception to Six Year Limitation on Receipt of 
Misconduct Allegations, Sec. 93.105(b)(3)

    We have changed the condition for the grandfather exception from 
``had the allegation of research misconduct under review or 
investigation on the effective date of this regulation'' to ``had 
received the allegation of research misconduct before the effective 
date of this part.'' This makes the condition for the grandfather 
exception consistent with the event that tolls the running of the six-
year limitation: the receipt of the misconduct allegation by the 
institution or HHS.

B. Confidentiality, 93.108

    Consistent with longstanding practice and with Sec. 93.403, we have 
added a provision to clarify that ORI is within the category of those 
who need to know the identity of the respondent and complainant and 
that an institution may not invoke confidentiality to withhold that 
information from ORI as it conducts its review under Sec. 93.403.

C. Definition of Deciding Official, Sec. 93.207, and Authority of ORI, 
Sec. 93.400.

    To ensure that the Assistant Secretary for Health is not 
responsible for both making findings of research misconduct and for 
reviewing the recommended decision of the ALJ on those findings if 
respondent contests the findings by requesting a hearing, Sec. 93.400 
has been amended to give ORI the authority to make findings of research 
misconduct. That section and Sec. 93.404 have also been amended to 
clarify that ORI proposes administrative actions to HHS (defined as the 
Secretary or his delegate) and upon HHS approval, proceeds to implement 
those proposed actions in accordance with the procedures in the 
regulation. Accordingly, the definition of, and references to the term 
``deciding official'' have been deleted. Giving ORI the responsibility 
for making findings of research misconduct is consistent with its 
responsibilities for reviewing institutional findings of research 
misconduct and for defending those findings if the respondent 
challenges them. This change will maintain the separation between 
investigation and adjudication, because ORI will not conduct any 
inquiry or investigation on behalf of HHS.
    These changes have necessitated changing references to HHS and ORI 
and other clarifying changes in Secs. 93.403-406, 93.411, 93.500-501, 
93.503, and 93.516-517. As provided in Sec.

[[Page 28376]]

93.406, the ORI finding of research misconduct is the final HHS action 
only if the respondent does not contest the charge letter within the 
prescribed period. The administrative actions, proposed by ORI and 
approved by HHS, become final in the same manner, except that the 
debarring official's decision is the final HHS action on any debarment 
or suspension action.

C. Definition of Good Faith, Sec. 93.210

    Under Secs. 93.227 and 93.300(d), committee members are protected 
against retaliation for good faith cooperation with a research 
misconduct proceeding. As proposed, Sec. 93.211 (now Sec. 93.210) 
defined ``good faith'' for complainants and witnesses, but not for 
committee members. We have added such a definition, stating that a 
committee member acts in good faith if he/she cooperates with the 
research misconduct proceeding by carrying out the duties assigned 
impartially for the purpose of helping an institution meet its 
responsibilities under this regulation. A committee member does not act 
in good faith if his/her acts or omissions on the committee are 
dishonest or influenced by personal, professional, or financial 
conflicts of interest with those involved in the research misconduct 
proceeding.

D. Definition of Institutional Member, Sec. 93.214

    We have added more examples of institutional members.

E. Institutional Policies and Procedures--Reporting the Opening of an 
Investigation, Sec. 93.304(d)

    We have simplified the date for institutions to report the opening 
of investigations to ORI. This report must be made on or before the 
date on which the investigation begins. Institutions are encouraged to 
report the opening of an investigation to ORI as promptly as possible 
after the decision to open an investigation is made.

F. Taking Custody of and Securing Records at the Beginning of an 
Inquiry, Sec. 93.307(b)

    We have added a requirement that on or before the date on which the 
respondent is notified of the inquiry, or the inquiry begins, whichever 
is earlier, the institution must, to the extent it has not already done 
so, promptly take all reasonable and practical steps to obtain custody 
of all the research records and evidence needed to conduct the research 
misconduct proceeding, inventory the records and evidence and sequester 
them in a secure manner, except that where the research records or 
evidence encompass scientific instruments shared by a number of users, 
custody may be limited to copies of the data or evidence on such 
instruments, so long as those copies are substantially equivalent to 
the evidentiary value of the instruments. This is consistent with the 
identical requirements that become applicable when the institution 
notifies the respondent of the allegation and when the respondent is 
notified of an investigation. (Secs. 93.305(a) and 93.310(d)). These 
requirements are necessary because of the potential for the destruction 
or alteration of the research records. To minimize that potential, an 
institution should take custody of the records whenever it has reason 
to believe that the records may be subject to alteration or destruction 
because of an allegation or potential allegation of research 
misconduct. This may protect the respondent, as well as the 
institution.

G. Interaction With Other Offices, Sec. 93.401

    To accurately reflect ORI's authority and practices, we have 
expanded this section to authorize ORI to provide expertise and 
assistance to the Department of Justice, the HHS Inspector General, PHS 
and other Federal offices, and State or local offices involved in 
investigating or otherwise pursuing research misconduct allegations or 
related matters.

H. Procedures for Debarment or Suspension Actions Based on Misconduct 
Findings, Secs. 93.405, 93.500-501, 93.503 and 93.523.

    We have amended these sections to clarify the relationship between 
the regulations governing debarment and suspension and the procedures 
in subpart E for contesting ORI findings of research misconduct and 
proposed HHS administrative actions. Section 93.500(d) (comparable to 
Sec. 93.500(c) of the NPRM) explains that the procedures under subpart 
E provide the notification, opportunity to contest and fact finding 
required under the HHS regulation governing debarment and suspension. 
Consistent with that regulation, the debarring official provides 
notification of the proposed debarment or suspension as part of the 
charge letter (Sec. 93.405(a)) and makes the final decision on 
debarment and suspension actions whether that decision is based upon 
respondent's failure to contest the charge letter (Secs. 93.406, 
93.501(a) and 93.503(c)), the decision of the ALJ, or the decision of 
the ALJ as modified by the Assistant Secretary for Health (Secs. 
93.500(c) and 93.523(b) and (c)).

I. HHS Administrative Action--Recovery of Funds, Sec. 93.407(b)

    We have clarified what funds HHS may seek to recover in connection 
with a finding of research misconduct by amending Sec. 93.407(b) to 
refer to the potential recovery of PHS funds spent in support of 
activities that involved research misconduct.

J. Appointment of the ALJ--Description of Functions, Sec. 93.502(a)

    We have amended Sec. 93.502(a) to describe the functions of the ALJ 
more completely.

K. Limits on the Authority of the ALJ, Sec. 93.506(a) and (c)

    We have added references in Secs. 93.506(a) and (c) stating that 
the ALJ does not have the authority to find invalid or refuse to follow 
Federal statutes or regulations, Secretarial delegations of authority, 
or HHS policies. This is consistent with a similar provision in the 
regulation upon which the research misconduct hearing process is based, 
42 CFR part 1005, which governs the hearing process for OIG exclusion 
of health care providers.

L. Actions for Violating an Order or Disruptive Conduct, Sec. 
93.515(b)(6)

    We have changed ``taking a negative inference from the absence of 
research records, documents, or other information'' to ``drawing the 
inference that spoliated evidence was unfavorable to the party 
responsible for its spoliation.'' This change is intended to clarify 
the nature of the negative inference that may be reached by the ALJ and 
distinguish the spoliation of evidence during or in anticipation of the 
hearing, from the absence or destruction of records that may be 
evidence of research misconduct. In this context, spoliation has 
essentially the same meaning as is accepted by Federal courts, i.e., 
the destruction or significant alteration of evidence during or in 
anticipation of the hearing.

M. Corrections and Minor Changes

    In addition to the significant changes not based on comments 
described above, we have made changes to: (1) Correct errors, such as 
references to PHS rather than HHS, or to a hearing officer, rather than 
the ALJ; (2) use uniform language in describing the same condition or 
event in different sections of the regulation; (3) adding citations to 
other sections, where appropriate, to make cross-references more 
concise and

[[Page 28377]]

technically correct; and (4) use plain, and more precise language.

III. Significant Comments Not Resulting in Changes

A. Definition of Research Misconduct, Sec. 93.103

    Although most commentators supported the new definition of research 
misconduct, there were a number of comments recommending changes, 
including that: (1) The definition should be based on deception; (2) 
the definition of falsification is inadequate because it does not cover 
the nonexperimental manipulation of human or animal subjects with the 
goal of influencing research results, or bias in the coding of 
qualitative data; (3) the definition of plagiarism should expressly 
exclude authorship and credit disputes; and (4) the definition of 
misconduct should be expanded to include negligent and intentional 
mistreatment of animals.
    As explained in the preamble of the NPRM, the proposed definition 
of research misconduct, which is included in this final rule without 
change, includes OSTP's description of ``fabrication, falsification, 
and plagiarism.'' That description is clear and sufficiently concrete 
to provide the basis for reasonable determinations of whether research 
misconduct has occurred and whether the misconduct was intentional, 
knowing, or reckless. Given the careful consideration that has been 
given to this definition and the value of a uniform government-wide 
definition, we are adopting the definition as it was proposed. We note 
that the nonexperimental manipulation of human or animal subjects to 
influence the research results would appear to be a manipulation of 
research materials or processes within the intendment of the definition 
of falsification.

B. Confidentiality, Secs. 93.108, 93.300(e) and 93.304(a)

    Several commentators recommended including witnesses and committee 
members and strengthening the confidentiality protections to provide 
the same protections as the OSTP Policy. Other commentators recommended 
that: (1) The rule give examples of what disclosures are limited and 
state when an institution is free to announce the results of an 
investigation to scientific journals; (2) the identity of the 
complainant and his/her statement be disclosed to the respondent; and 
(3) that the sanctions for a violation of confidentiality be specified.
    We have not changed Sec. 93.108 or the other provisions requiring 
institutions to provide confidentiality to respondents, complainants, 
and research subjects who are identifiable from research records or 
evidence. We believe these provisions provide the same protections as 
the OSTP policy. Institutions have considerable discretion in 
implementing the confidentiality protections and are free to extend 
them to witnesses and committee members. However, consistent with the 
limitation of the OSTP confidentiality provision to complainants and 
respondents, we are not requiring that they do so.

C. Definition of Allegation--Inclusion of Oral Allegations, Sec. 93.201

    Several commentators objected to the inclusion of oral allegations 
in the definition of the term ``allegation.'' Although, the current PHS 
regulation at 42 CFR part 50, subpart A, does not define the term 
allegation, it has been longstanding ORI practice to accept oral 
allegations, including oral, anonymous allegations. Experience has 
shown that oral allegations may contain relatively complete 
information, but if they do not, they are often followed by more 
complete allegations, or lead to more complete information.
    The definition of allegation must be considered in the context of 
the criteria warranting an inquiry. Under Sec. 93.307(a), an inquiry is 
warranted if the allegation: (1) Falls within the definition of 
research misconduct; (2) involves PHS supported biomedical or 
behavioral research, research training, or activities related to that 
research or research training; and (3) is sufficiently credible and 
specific so that potential evidence of research misconduct may be 
identified. Information sufficient to make these determinations can be 
transmitted orally. If such information is not transmitted orally or by 
other means, the institution cannot initiate an inquiry based upon the 
oral allegation. Under Sec. 93.300(b), an institution is obligated to 
respond to each allegation of research misconduct involving PHS 
supported biomedical or behavioral research, research training or 
activities related to that research or research training. The response 
must consist of assessing the allegation to determine if the criteria 
for initiating an inquiry are met and should consist of reasonable 
efforts to obtain further information about the allegation. We do not 
believe these are unreasonable burdens in response to oral allegations, 
particularly since oral allegations can, and have conveyed information 
leading to findings of research misconduct that have protected the 
integrity of PHS supported research. We also note that the Offices of 
the Inspector General at various Federal agencies routinely accept oral 
and anonymous allegations in their pursuit of fraud, waste, and abuse.

D. Definition of Research Record, Sec. 93.226

    We did not make any changes in this section in response to comments 
that the inclusion of oral presentations will inhibit open scientific 
discourse and objections to the interpretation of ``data and results'' 
to include computers and scientific equipment. The definition of 
``research record'' is consistent with the definition of that term in 
the OSTP Policy. Oral presentations are a widely accepted method of 
conveying scientific information and research results. There is no 
logical reason why scientists should be permitted to falsify, 
fabricate, and plagiarize PHS supported biomedical and behavioral 
research, research training and activities related to that research and 
research training in oral presentations. The interpretation of the OSTP 
definition to include computers and scientific instruments is 
reasonable and consistent with the wording of the definition. 
Laboratory records, ``both physical and electronic,'' are covered in 
the OSTP definition. Computers and scientific instruments contain 
electronic records. As explained above, we have made changes to clarify 
that if those electronic records can be extracted from the computer or 
instrument without change and recorded for later use, the computer or 
instrument need not be retained as the repository of the record.

E. Definition of Retaliation, Sec. 93.226; Protection From Retaliation 
Secs. 93.300(d) and 93.304(l)

    One commentator recommended that the definition be amended to 
include retaliation against the respondent for his/her efforts to 
defend against the charges of research misconduct. The proposed 
definition would not include action resulting from research misconduct 
proceedings or personnel actions. It was also recommended that Secs. 
93.300(d) and 93.304(l) be amended to require institutions to protect 
respondents from retaliation by referring to ``all participants.''
    The purpose of the retaliation provision is to encourage 
researchers to come forward with good faith allegations of research 
misconduct and to encourage good faith cooperation with a research 
misconduct proceeding. In ORI's experience, there has been no showing 
of a need to protect

[[Page 28378]]

respondents from retaliation in order to ensure they will take steps to 
defend against an allegation of misconduct. In contrast, experience has 
shown a need to restore the reputations of respondents where there is a 
finding of no misconduct and Sec. 93.304(k) requires institutions to do 
that. If a need to protect respondents from retaliation is shown, 
institutions have broad discretion under the rule to address that 
situation on a case-by-case basis or adopt a policy to remedy the 
problem.

F. Responsibility of Institutions To Foster Responsible Conduct of 
Research, Sec. 93.300(c)

    Several commentators objected to the requirement that institutions 
foster a research environment that promotes the responsible conduct of 
research, arguing that it is beyond the scope of a regulation on 
research misconduct. One letter, signed by four separate organizations, 
stated: ``Though responsible conduct of research is clearly an 
imperative that our institutions embrace, the nature of the general 
research environment and the promotion of the responsible conduct of 
research are not tied only to research misconduct as ORI staff have 
asserted in many venues, and, as a consequence, should not be linked in 
this particular policy.''
    These commentators are reading too much into this provision. This 
is not a requirement for institutions to establish a new program for 
the responsible conduct of research. Rather, this provision 
appropriately updates the language of the current regulation requiring 
institutions to foster a research environment that discourages 
misconduct in all research and deals forthrightly with possible 
misconduct associated with research for which PHS funds have been 
provided or requested (42 CFR 50.105). The new provision recognizes the 
continuing importance of the responsible conduct of research to 
competent research that is free of any research misconduct. As stated 
by the Institute of Medicine (IOM) in its 2002 report, Integrity in 
Scientific Research: Creating an Environment That Promotes Responsible 
Conduct, ``instruction in the responsible conduct of research need not 
be driven by federal mandates, for it derives from a premise 
fundamental to doing science: the responsible conduct of research is 
not distinct from research; on the contrary, competency in research 
encompasses the responsible conduct of that research and the capacity 
for ethical decisionmaking.'' (Report at p. 9). In the context of this 
regulation, the directive in Sec. 93.300(c) to foster a research 
environment that promotes the responsible conduct of research means an 
environment that promotes competent, ethical research that is free of 
misconduct. This is directly related to the purposes of the regulation 
to establish the responsibilities of institutions in responding to 
research misconduct issues and to promote the integrity of PHS 
supported research and the research process (Sec. 93.101).

G. Responsibility for Maintenance of Research Records and Evidence, 
Sec. 93.305

    One commentator recommended that this section be amended to require 
the prompt return to the respondent of records that, upon inventory, 
are found not to be relevant to the misconduct proceeding. Paragraph 
(a) of Sec. 93.305 requires the institution to obtain custody of all 
records and evidence needed to conduct the research misconduct 
proceeding. That requirement would not extend to records that are 
reasonably determined by the institution not to be needed to conduct 
the proceeding. We believe the imposition of an affirmative duty to 
return records that are determined to be irrelevant could adversely 
affect inquiries and investigations, because experience has shown that 
research misconduct proceedings are better served by broadly securing 
all records thought to be relevant. The respondent is protected by 
paragraph (b) of Sec. 93.305 under which he/she may obtain copies of 
the records or reasonable, supervised access.

H. Institutional Inquiry--Consideration of Honest Error or Difference 
of Opinion, Sec. 93.307

    Several commentators recommended amending this section to impose an 
affirmative burden on institutions to assess whether honest error or 
difference of opinion exempts the allegation from consideration as 
research misconduct.
    As noted earlier in this supplementary information, we have 
concluded that honest error or difference of opinion is an affirmative 
defense based on the statement in the preamble of the OSTP final rule 
that institutions and agencies are not required to disprove possible 
honest error or difference of opinion in order to make a finding of 
research misconduct. However, because of the overlap between this 
affirmative defense and the responsibility of institutions and HHS to 
prove that the alleged research misconduct was committed intentionally, 
knowingly, or recklessly, evidence of honest error or difference of 
opinion is to be considered in determining whether the institutions and 
HHS have met their burden of proving that element, a prerequisite to a 
finding of research misconduct.
    Under Sec. 93.307(c), the purpose of an inquiry is to conduct an 
initial review of the evidence to determine if an investigation is 
warranted. An investigation is warranted under Sec. 93.307(d) if: (1) 
There is a reasonable basis for concluding that the allegation involves 
PHS supported research, research training, or activities related to 
that research or research training and falls within the definition of 
research misconduct, and (2) preliminary information-gathering and 
fact-finding from the inquiry indicates that the allegation may have 
substance. It is important to note that possible honest error or 
difference of opinion goes to the issue of whether the alleged research 
misconduct was committed intentionally, knowingly, or recklessly, not 
whether the allegation involves fabrication, falsification, or 
plagiarism. A finding that the research misconduct is conducted 
intentionally, knowingly, or reckless is necessary for a finding of 
research misconduct; a finding that is not made until the investigation 
is completed, absent an admission at an earlier stage.
    Given this fact, and the preliminary nature of the fact finding at 
the inquiry stage, it would be appropriate for the inquiry report to 
note if there is possible evidence of honest error or difference of 
opinion for consideration in the investigation, but it would be 
inappropriate for the inquiry report to conclude, on the basis of an 
initial review of the evidence of honest error or difference of 
opinion, that the allegation should be dismissed. The determination of 
whether the alleged misconduct is intentional, knowing, or reckless, 
including consideration of evidence of honest error or difference of 
opinion, should be made at the investigation stage, following a 
complete review of the evidence. As noted in the preamble of the OSTP 
final policy, institutions and HHS do not have the burden of disproving 
possible honest error or differences of opinion.

I. Institutional Investigation, Sec. 93.310 and Investigation Time 
Limits, Sec. 93.311

    Some commentators recommended that complainants be given a right to 
participate in the process. As explained in the preamble of the NPRM, 
complainants are witnesses in that they do not control or direct the 
process, do not have special access to evidence, except as determined 
by the institution

[[Page 28379]]

or ORI, and do not act as decision makers. This ensures that the 
institution will carry out its responsibility under Sec. 93.310(f) to 
conduct investigations that are fair.
    Other commentators felt that the respondent should have an explicit 
right to review and comment on evidence and cross-examine witnesses at 
the investigation stage, and the right to request an extension of time 
for conducting the investigation. The proposed regulation requires 
that: (1) Where appropriate, the respondent be given copies of, or 
reasonable, supervised access to the research records secured by the 
institution on or before the date it notifies the respondent of the 
allegation, inquiry or investigation (Sec. 93.305(b)); (2) the 
respondent be notified in writing of the allegations before the 
investigation begins (Sec. 93.310(c)); (3) the institution interview 
the respondent and any witnesses he/she identifies who may have 
substantive information regarding any relevant aspects of the 
investigation (Sec. 93.310(g)); and (4) the respondent be given 30 days 
to review and comment on the investigation report (Sec. 93.312). These 
provisions have been retained and, as noted above, we have added to 
this final rule a requirement that respondent be given copies of, or 
supervised access to the evidence supporting the investigation report, 
concurrent with the period for comment. We believe these requirements 
ensure that the respondent will have a fair opportunity to present 
relevant evidence during the research misconduct proceeding, 
particularly when viewed in the context of the respondent's right to 
contest any HHS findings of research misconduct and proposed 
administrative sanctions before an ALJ. It is important to note that 
the final rule does not prohibit institutions from giving respondents 
greater rights during the investigation, so long as they do not 
contravene HHS requirements; the rule establishes a floor for their 
participation.

J. Appointment of the ALJ and Scientific Expert, Sec. 93.502

    Two scientific societies objected to the ALJ provision, 
recommending that the current three member adjudication panel be 
retained. Another scientific society raised concerns about the extent 
to which scientists would be involved in the process, if they were not 
part of the adjudication panel (these concerns have been addressed 
through the changes in this section discussed above) and four 
associations supported the ALJ provision, provided that scientific or 
technical experts are required to participate in those cases involving 
complex scientific, medical or technical issues. As stated in the 
preamble of the NPRM, we believe that the change to a single 
decisionmaker will substantially improve and simplify the process for 
all parties. The change provides a process similar to Medicare and 
State health care program exclusion cases brought by the Office of the 
Inspector General (OIG), which have similar impacts on the reputations 
of the respondents. This process is also consistent with Recommendation 
92-7 of the Administrative Conference of the United States that ALJs 
should hear and decide cases involving the imposition of sanctions 
having a substantial economic effect. Use of an ALJ with ready access 
to scientific and technical expertise, rather than multiple decision 
makers, will streamline the process without compromising the quality of 
decisions that are dependent upon resolution of scientific, medical, or 
technical issues.
    In addition to the comments recommending mandatory appointment of 
an expert in complex cases, another commentator recommended that the 
ALJ be required to appoint a scientific or technical expert to assist 
the ALJ in every case, rather than the ALJ being authorized to appoint 
such an expert and being required to appoint such an expert upon the 
request of one of the parties, as proposed in the NPRM. We are not 
changing the provision to require the appointment of an expert in every 
case or in all cases involving complex issues. We believe that such a 
rigid requirement is not needed to ensure fairness. In complex cases, 
it will always be in the interest of at least one of the parties to 
ensure that the ALJ fully understands the issues by requesting the 
appointment of an expert. Upon such a request, the appointment of an 
expert is mandatory. Furthermore, the ALJ, who is in the best position 
to assess the complexity of the case in light of his/her own knowledge 
and training, may appoint an expert in the absence of any motion by a 
party. The self-interest of the parties and the duty of the ALJ to 
exercise his/her discretion to provide a fair hearing should ensure 
that an expert is appointed where necessary to ensure fairness. We will 
closely monitor the appointment of experts in future hearings and, if 
problems are apparent, consider amending the regulations to compel the 
appointment of an expert in order to ensure that the ALJ will have the 
benefit of expert advice in cases involving complex issues.

IV. General Issues and Requests for Clarification

    Several general comments and requests for clarification are 
addressed in the following question and answer format.
    Q. Is the detail in the final rule contrary to the goal of the OSTP 
Federal Policy on Research Misconduct to provide a more uniform 
Federal-wide approach?
    A. No, the final rule is consistent with the OSTP Federal Policy. 
As stated elsewhere in this Supplementary Information we have made some 
changes in order to adhere more closely to the Federal Policy and 
refused to make other changes that would have been inconsistent with 
the Federal Policy. The Supplementary Information section of the Notice 
of Proposed Rulemaking (69 FR 20778, 20780 (April 16, 2004)) explained 
that the proposed rule contained more detail than the existing rule 
because institutions had over the years asked for more detailed 
guidance and that detailed guidance would ensure thorough and fair 
inquiries and investigations and greater accountability on the part of 
all participants in research misconduct proceedings. Similarly, it was 
explained that the more detailed hearing process was being proposed in 
response to concerns that the current informal procedures lack the 
consistency and clarity provided by binding rules of procedure for 
other types of cases. Thus, the detail in the final rule is necessary 
to ensure more uniformity among the various institutions that will be 
conducting research misconduct proceedings and to ensure fair, uniform 
procedures for the benefit of respondents. The detail in the proposed 
rule, which is retained in this final rule, is entirely consistent with 
the goals of the OSTP Federal Policy to provide for fair and timely 
procedures and to strive for uniformity in implementation.
    Q. How should institutions deal with bad faith allegations?
    A. The final rule, Sec. 93.300(d), requires institutions to take 
all reasonable and practical steps to protect the positions and 
reputations of good faith complainants and protect them from 
retaliation by respondents and other institutional members. By negative 
implication, such steps are not required for bad faith complainants. 
Bad faith complainants are those who, under the definition of ``good 
faith'' in Sec. 93.210, do not have a belief in the truth of their 
allegation that a reasonable person in the complainant's position could 
have based on the information known to the complainant at the time.

[[Page 28380]]

We have determined there is no need for the final rule to further 
address bad faith allegations, given that institutions may have 
internal standards of conduct that address matters not addressed in the 
final rule (Sec. 93.319). However, the definition of ``good faith'' 
provides important guidance for institutions because it makes clear 
that an allegation can lack sufficient credibility and specificity so 
that potential evidence of research misconduct cannot be identified 
(Sec. 93.307(a)(3)), but still may not be a bad faith allegation. Thus, 
if institutions exercise their discretion to adopt procedures 
addressing bad faith allegations, we urge them to include fair 
procedures for determining whether there has been a bad faith 
allegation. ORI is prepared to work collaboratively with the research 
community to develop guidance in this area if research institutions and 
associations desire to do so.
    Q. Will the final rule apply retroactively?
    A. No, the final rule will become effective 30 days after the date 
it is published in the Federal Register and will apply prospectively. 
The effect of that prospective application will depend upon how the 
provisions of the rule interact with the activities of the institution 
and ORI. Upon the expiration of 30 days, the final rule will 
immediately apply to institutions that are receiving PHS support for 
research, research training or activities related to that research or 
research training. For institutions not receiving such PHS support, the 
regulation will not apply until they submit an application for that 
support.
    If an institution to which the final rule applies immediately has 
completed an inquiry or investigation and reports to ORI after the 
effective date of the final rule, ORI will take further action, make 
findings, and provide an opportunity for a hearing in accordance with 
the final rule. If a request for a hearing is received by the DAB Chair 
after the effective date of the final rule, the hearing will be 
conducted in accordance with the final rule. This will ensure that 
respondents have the benefit of the detailed, fair hearing procedures 
in the final rule. Because it is not possible to address every possible 
scenario relating to the prospective application of the final rule, 
institutions that have received allegations of misconduct, or have 
ongoing inquiries or investigations upon the effective date of this 
final rule should contact ORI to determine how the rule will apply to 
those ongoing activities. ORI will make every effort to minimize 
burdens and ensure that all parties are treated fairly. Generally, if 
an institution has a research misconduct proceeding pending at the time 
the new regulation becomes effective with respect to that institution, 
ORI would expect the new procedural requirements to be applicable to 
the institution's subsequent steps in that proceeding, unless the 
institution or respondent would be unduly burdened or treated unfairly. 
However, the definition of research misconduct that was in effect at 
the time the misconduct occurred would apply.
    Q. Should HHS take action to provide immunity from personal 
liability for institutions, committee members, and witnesses who 
participate in research misconduct proceedings?
    A. As the commentator who raised this issue implied, a Federal 
statute, rather than an HHS regulation, would be needed to provide this 
immunity. Earlier attempts by HHS to develop legislation providing 
immunity were unsuccessful. ORI does not currently have sufficient data 
to make the case for Federal legislation. Interested parties are 
encouraged to submit evidence that would help us in determining whether 
there is a need for Federal legislation to provide immunity for 
committee members and witnesses or to propose ways to provide such 
protection in the absence of such legislation.
    Q. Should HHS have primary responsibility for responding to 
allegations of research misconduct at institutions that have repeatedly 
failed to handle such allegations properly?
    A. Under the final rule, HHS has the discretion to take 
responsibility for responding to allegations of research misconduct at 
institutions that are failing to handle such allegations properly. 
Under Sec. 93.400, ORI may respond directly to any allegation of 
research misconduct at any time before, during, or after an 
institution's response to the matter. The ORI response may include, but 
is not limited to, reviewing an institution's findings and process and 
recommending that HHS perform an inquiry or investigation. In addition, 
ORI may make findings and impose HHS administrative actions related to 
an institution's compliance with the final rule. Where an institution 
has failed in the past to respond promptly or properly to allegations 
of research misconduct, ORI will monitor closely its subsequent 
responses to allegations of research misconduct. However, ORI would 
intervene only as it determines necessary and would first provide 
advice and assistance to the institution. ORI would exercise its 
discretion to respond directly to an allegation of research misconduct 
only if the institution disregarded that advice or assistance or 
otherwise continued to fail to properly carry out its responsibilities 
under the final rule.
    Q. Are sanctions required or available for imposition against those 
who violate the confidentiality requirements in the final rule?
    A. The final rule does not provide for specific sanctions against 
those who violate the confidentiality protections in Sec. 93.108, but 
an institution would be subject to the general sanctions for failure to 
comply with the final rule and its assurance if it fails to comply with 
Sec. 93.108. Section 93.300(e) requires institutions to provide 
confidentiality to the extent required by Sec. 93.108, and Sec. 93.304 
requires that an institution seeking an approved assurance have written 
policies and procedures that, consistent with Sec. 93.108, provide for 
protecting the confidentiality of respondents, complainants and 
research subjects. The final rule does not impose, or require 
institutions to impose sanctions against institutional members who 
violate the confidentiality provisions of Sec. 93.108, but institutions 
have the discretion to impose such sanctions by making compliance with 
those provisions a condition of employment. Institutions may also wish 
to develop specific policies addressing actions the institution may 
take when institutional members violate the confidentiality 
requirements.
    Q. Does a respondent have a right to continue his/her research 
after allegations of research misconduct have been made?
    A. The final rule does not directly address the issue of whether 
the respondent has a right to continue his/her research after an 
allegation of research misconduct has been made. Section 93.305 
requires the institution to: (1) promptly obtain custody of and 
sequester all research records and evidence needed to conduct the 
research misconduct proceeding; and (2) where appropriate, give the 
respondent copies of, or reasonable, supervised access to the research 
records. There are at least two reasons for providing such access: to 
enable the respondent to prepare a defense against the allegation, and/
or to continue the research.
    As proposed and adopted in this final rule, Sec. 93.305(b) requires 
the institution to provide the respondent copies of, or supervised 
access to the research records secured by the institution, unless that 
would be inappropriate. The determination of when it would be 
inappropriate to provide such copies or access is left to the 
discretion of the institution. In exercising this discretion, 
institutions

[[Page 28381]]

should consider separately the issues of whether the respondent should 
continue the research and whether and under what circumstances the 
respondent should be given copies of or access to the research records. 
In considering the former issue, institutions should weigh, among other 
factors, the special circumstances listed in Sec. 93.318, the 
importance of continuing the research, and whether the expertise of the 
respondent is unique. Institutions must also be cognizant of the 
interests of the PHS funding agency and the need to confer with that 
agency about suspension or discontinuation of the research or to obtain 
approval if the Principal Investigator is being replaced. If the 
respondent does not continue the research, it would be appropriate, 
absent special circumstances, to give him/her a copy of the records, or 
reasonable, supervised access to them for the purpose of preparing a 
defense to the allegations. In order to ensure that the respondent has 
this opportunity at the investigation stage, Sec. 93.312(a) requires 
the institution to give the respondent a copy of, or supervised access 
to the evidence upon which the draft investigation report is based 
concurrently with the provision of the draft report for comment by the 
respondent.
    Q. Does the 120-day time limit for completing an investigation 
include the 30-day period for respondent to review and comment on the 
draft report?
    A. Yes. Section 93.311 provides in pertinent part that an 
institution must complete all aspects of an investigation within 120 
days of beginning it, including providing the draft report for comment 
in accordance with Sec. 93.312, and sending the final report to ORI 
under Sec. 93.315. Under Sec. 93.313(g), the final report must include 
and consider any comments made by the respondent or complainant on the 
draft investigation report. If additional time is needed, the 
institution can request reasonable extensions for completion of the 
investigation.

Analysis of Impacts

    As discussed in greater detail below, we have examined the 
potential impact of this final rule as directed by Executive Orders 
12866 and 13132, the Unfunded Mandates Act of 1995, the Regulatory 
Flexibility Act, and the Paperwork Reduction Act of 1995.
    We have also determined that this final rule will not: (1) Have an 
impact on family well-being under section 654 of the Treasury and 
General Government Appropriations Act of 1999; nor (2) have a 
significant adverse effect on the supply, distribution, or use of 
energy sources under Executive Order 13211.

A. Executive Order 12866

    These final regulations have been drafted and reviewed in 
accordance with Executive Order 12866 (58 FR 51735), section 1(b), 
Principles of Regulation. The Department has determined that this final 
rule is a ``significant regulatory action'' under Executive Order 
12866, section 3(f), Regulatory Planning and Review because it will 
materially alter the obligations of recipients of PHS biomedical and 
behavioral research and research training grants. However, the final 
regulation is not economically significant as defined in section 
3(f)(1), because it will not have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities. Therefore, the information enumerated in 
section 6(a)(3)(C) of the Executive Order is not required. The final 
rule has been reviewed by the Office of Management and Budget (OMB) 
under the terms of the Executive Order.
    Recipients of PHS biomedical and behavioral research grants will 
have to comply with the reporting and record keeping requirements in 
the proposed regulation. As shown below in the Paperwork Reduction Act 
analysis, those burdens encompass essentially all of the activities of 
the institutions that are required under the proposed regulation. The 
estimated total annual burden is 19,727.5 hours. The U.S. Department of 
Labor, Bureau of Labor Statistics, sets the mean hourly wage for 
Educational Administrators, Postsecondary at $ 36.12. The mean hourly 
wage for lawyers is $ 51.56. The average hourly cost of benefits for 
all civilian workers would add $ 7.40 to these amounts. In order to 
ensure that all possible costs are included and to account for 
potentially higher rates at some institutions, we estimated the cost 
per burden hour at $ 100. This results in a total annual cost for all 
institutions of $ 1,972,750.

B. The Unfunded Mandates Reform Act of 1995

    Sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (2 
U.S.C. 1532 and 1535) require that agencies prepare several analytic 
statements before promulgating a rule that may result in annual 
expenditures of State, local, and tribal governments, or by the private 
sector, of $100 million or more in any one year. This final rule will 
not result in expenditures of this magnitude, and thus the Secretary 
certifies that such statements are not necessary.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601, et seq.) requires 
agencies to prepare a regulatory flexibility analysis describing the 
impact of the final rule on small entities, but also permits agency 
heads to certify that the final rule will not, if promulgated, have a 
significant economic impact on a substantial number of small entities. 
The primary effect of this rule is to require covered institutions to 
implement policies and procedures for responding to research misconduct 
cases. The Department certifies that this rule will not have a 
significant impact on a substantial number of small entities, as 
defined by the Regulatory Flexibility Act, based on the following 
facts.
    Approximately 47 percent (1862) of the 4000 institutions that 
currently have research misconduct assurances are small entities. The 
primary impact of the final rule on covered institutions results from 
the reporting and record keeping provisions which are analyzed in 
detail under the heading, ``The Paperwork Reduction Act.'' Significant 
annual burdens apply only if an institution learns of possible research 
misconduct and begins an inquiry, investigation, or both. In 2001, 86 
inquiries and 46 investigations were conducted among all the 
institutions. No investigations were conducted by a small entity and 
only one conducted an inquiry. Small entities would be able to avoid 
entirely the potential burden of conducting an inquiry or investigation 
by filing a Small Organization Statement under section 93.303. The 
burden of filing this Statement is .5 hour. Thus, the significant 
burden of conducting inquiries and investigations will not fall on a 
substantial number of small entities.
    A small organization that files the Small Organization Statement 
must report allegations of research misconduct to ORI and comply with 
all provisions of the proposed regulation other than those requiring 
the conduct of inquiries and investigations. The total annual average 
burden per response for creating written policies and procedures for 
addressing research misconduct is approximately 16 hours. However, 
approximately 99 percent of currently funded institutions already have 
these policies and procedures in place and spend approximately .5 hour 
updating

[[Page 28382]]

them. The most significant of the burdens that might fall on an entity 
filing a Small Organization Statement is taking custody of research 
records and evidence when there is an allegation of research 
misconduct. The average burden per response is 35 hours, but based on 
reports of research misconduct over the last three years, less than 5 
small entities would have to incur that burden in any year.
    Based on the forgoing analysis that was not commented upon when it 
appeared in the Notice of Proposed Rulemaking, the Department concludes 
that this final rule will not impose a significant burden on a 
substantial number of small entities.

D. Executive Order 13132: Federalism

    This final rule will not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with section 6 
of Executive Order 13132, we have determined that this rule does not 
have sufficient federalism implications to warrant the preparation of a 
federalism summary impact statement.

E. The Paperwork Reduction Act

    Sections 300-305, 307-311, 313-318, and 413 of the rule contain 
information collection requirements that are subject to review by the 
OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et 
seq.). The title, description, and respondent description of the 
information collection requirements are shown below with an estimate of 
the annual reporting burdens. Included in the estimates is the time for 
reviewing instructions, gathering and maintaining the data needed, and 
completing and reviewing the collection of information. Public comments 
on these estimates and other aspects of compliance with the Paperwork 
Reduction Act were invited in the NPRM.
    As indicated in the foregoing discussion of the comments, a number 
of them addressed reporting and recordkeeping burdens. In response to 
comments that the proposed reporting requirements in Secs. 93.300(a), 
93.302(c) and 93.316 were subject to an overly broad interpretation, we 
have made clarifying changes to limit their scope. This did not result 
in any change in the burden estimates, because those estimates were 
based upon a restrictive interpretation of the requirements. While 
changes were made to make it easier for institutions to meet the 
requirements in Secs. 93.305, 93.307, and 93.310 for securing records 
contained in scientific instruments we do not believe that those 
changes significantly affect the burden of the collection requirements.
    As explained above, the addition of a relevancy standard to Sec. 
93.317 and provisions for transferring the custody of records to HHS 
will lessen the overall burden of retaining records of research 
misconduct proceedings, although we have added a requirement that the 
institutions document any determination that records are irrelevant. In 
addition, we are adding an explanatory note to the burden estimate for 
Sec. 93.317. This note explains that not all of the 53 respondents that 
are expected to conduct research misconduct proceedings each year, on 
average, will have to to retain the records of those proceedings for a 
full seven years. If ORI determines that a thorough, complete 
investigation has been conducted and finds that there was no research 
misconduct or settles a case, it will notify the institution that it 
does not have to retain the records of the research misconduct 
proceeding, unless ORI is aware of an action by federal or state 
government to which the records may pertain. Historically, about 60 
percent of cases closed by ORI do not result in PHS misconduct findings 
or PHS administrative actions. Thus, it is expected that in the 
majority of cases ORI will notify the institutions that they do not 
have to retain the records for the full seven-year period.
    We have added a burden statement for the requirement in Sec. 
93.302(a)(1) that institutions provide their policies and procedures on 
research misconduct, upon request, to ORI, HHS, and members of the 
public (this third item was added in response to comments). Based on 
recent data, we have increased the number of respondents in the items 
relating to the conduct of investigations by institutions. In addition, 
we have made minor changes to account for the renumbering of sections 
and paragraphs and to correct errors. With these changes, the estimates 
published in the NPRM are adopted as the burden estimates of the final 
rule. The information collection requirements in the final rule have 
been submitted to OMB for review.
    Title: Public Health Service Policies on Research Misconduct.
    Description: This final rule revises the current regulation, 42 CFR 
50.101, et seq., in three significant ways and will supersede the 
current regulation. First, the proposed rule integrates the White House 
Office of Science and Technology Policy's (OSTP) December 6, 2000, 
government wide Federal Policy on Research Misconduct. Second, the 
proposed rule incorporates the recommendations of the HHS Review Group 
on Research Misconduct and Research Integrity that were approved by the 
Secretary of HHS on August 25, 1999. Third, the proposed rule 
integrates a decade's worth of experience and understanding since the 
agency's first regulations were promulgated.
    Description of Respondents: The ``respondents'' for the collection 
of information described in this regulation are institutions that apply 
for or receive PHS support through grants, contracts, or cooperative 
agreements for any project or program that involves the conduct of 
biomedical or behavioral research, biomedical or behavioral research 
training, or activities related to that research or training (see 
definition of ``Institution'' at Sec. 93.213).

Subpart C--Responsibilities of Institutions

Compliance and Assurances

Section 93.300(a)
    See Sec. 93.304 for burden statement.
Section 93.300(c)
    See Sec. 93.302(a)(2)(i) for burden statement.
Section 93.300(i)
    See Sec. 93.301(a) for burden statement.
Section 93.301(a)
    Covered institutions must provide ORI with an assurance either by 
submitting the initial certification (500 institutions) or by 
submitting an annual report (3500 institutions).
    Number of Respondents--4000.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--.5 hour.
    Total Annual Burden--2000 hours.
Section 93.302(a)(1)
    Covered institutions must, upon request, provide their policies and 
procedures on research misconduct to ORI, authorized HHS personnel, and 
members of the public.
    Number of Respondents--2000.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--.5 hour.
    Total Annual Burden--1000 hours.
Section 93.302(a)(2)(i)
    Each applicant institution must inform its research members

[[Page 28383]]

participating in or otherwise involved with PHS supported biomedical or 
behavioral research, research training or activities related to that 
research or research training, including those applying for PHS 
support, of the institution's policies and procedures and emphasize the 
importance of compliance with these policies and procedures.
    Number of Respondents--4000.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--.5 hour.
    Total Annual Burden--2000 hours.
Section 93.302(b)
    See Sec. 93.301(a) for burden statement.
Section 93.302(c)
    In addition to the annual report, covered institutions must submit 
aggregated information to ORI on request regarding research misconduct 
proceedings.
    Number of Respondents--100.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--100.
Section 93.303
    Covered institutions that, due to their small size, lack the 
resources to develop their own research misconduct policies and 
procedures may elect to file a ``Small Organization Statement'' with 
ORI.
    Number of Respondents--75.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--.5 hour.
    Total Annual Burden--37.5 hours.
Section 93.304
    Covered institutions with active assurances must have written 
policies and procedures for addressing research misconduct. 
Approximately 3500 institutions already have these policies and 
procedures in place in any given year and spend minimal time (.5 hour) 
updating them. Approximately 500 institutions each year spend an 
average of two days creating these policies and procedures for the 
first time.
    Number of Respondents--4000.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--2.5 hours.
    Total Annual Burden--10,000 hours.
Section 93.305(a), (c), and (d)
    When a covered institution learns of possible research misconduct, 
it must promptly take custody of all research records and evidence and 
then inventory and sequester them. Covered institutions must also take 
custody of additional research records or evidence discovered during 
the course of a research misconduct proceeding. Once the records are in 
custody, the institutions must maintain them until ORI requests them, 
HHS takes final action, or as required under Sec. 93.317.
    Number of Respondents--53.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--35 hours.
    Total Annual Burden--1855 hours.
Section 93.305(b)
    Where appropriate, covered institutions must give the respondent 
copies of or reasonable, supervised access to the research record.
    Number of Respondents--53.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--5 hours.
    Total Annual Burden--265 hours.

The Institutional Inquiry

Section 93.307(b)
    At the time of or before beginning an inquiry, covered institutions 
must notify the presumed respondent in writing.
    Number of Respondents--53.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--53 hours.
Section 93.307(e)
    See Sec. 93.309 for burden statement.
Section 93.307(f)
    Covered institutions must provide the respondent an opportunity to 
review and comment on the inquiry report and attach any comments to the 
report.
    Number of Respondents--53.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--53 hours.
Section 93.308(a)
    Covered institutions must notify the respondent whether the inquiry 
found that an investigation is warranted.
    Number of Respondents--53.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--.5 hour.
    Total Annual Burden--26.5 hours.
Section 93.309(a)
    When a covered institution issues an inquiry report in which it 
finds that an investigation is warranted, the institution must provide 
ORI with a specified list of information within 30 days of the inquiry 
report's issuance.
    Number of Respondents--20.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--16 hours.
    Total Annual Burden--320 hours.
Section 93.309(c)
    Covered institutions must keep sufficiently detailed documentation 
of inquiries to permit a later assessment by ORI of reasons why 
decision was made to forego an investigation.
    Number of Respondents--37.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--37 hours.

The Institutional Investigation

Section 93.310(b)
    See Sec. 93.309(a) for burden statement.
Section 93.310(c)
    Covered institutions must notify the respondent of allegations of 
research misconduct before beginning the investigation.
    Number of Respondents--20.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1.
    Total Annual Burden--20 hours.
Section 93.310(d)
    See Sec. 93.305(a), (c), and (d) for burden statement.
Section 93.310(g)
    Covered institutions must record or transcribe all witness 
interviews, provide the recording or transcript to the witness for 
correction, and include the recording or transcript in the record of 
the investigation.
    Number of Respondents--20.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--15 hours.
    Total Annual Burden--300 hours.
Section 93.311(b)
    If unable to complete the investigation in 120 days, covered 
institutions must submit a written request for an extension from ORI.
    Number of Respondents--16.

[[Page 28384]]

    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--16 hours.
Section 93.313
    See Sec. 93.315 for burden statement.
Section 93.314(b)
    If unable to complete any institutional appeals process relating to 
the institutional finding of misconduct within 120 days from the 
appeal's filing, covered institutions must request an extension in 
writing and provide an explanation.
    Number of Respondents--5.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--.5 hour.
    Total Annual Burden--2.5 hours.
Section 93.315
    At the conclusion of the institutional investigation process, 
covered institutions must submit four items to ORI: the investigation 
report (with attachments and appeals), final institutional actions, the 
institutional finding, and any institutional administrative actions.
    Number of Respondents--20.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--80 hours.
    Total Annual Burden--1600 hours.
Section 93.316(a)
    Covered institutions that plan to end an inquiry or investigation 
before completion for any reason must contact ORI before closing the 
case and submitting its final report.
    Number of Respondents--10.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--2 hours.
    Total Annual Burden--20 hours.

Other Institutional Responsibilities

Section 93.317(a) and (b)
    See Sec. 93.305(a), (c), and (d), for burden statement. It is 
expected that not all of the 53 respondents that learn of misconduct 
will have to retain the records of their research misconduct 
proceedings for seven years. If ORI determines that a thorough, 
complete investigation has been conducted and finds that there was no 
research misconduct, or settles the case, it will notify the 
institution that it does not have to retain the records of the research 
misconduct proceeding, unless ORI is aware of an action by federal or 
state government to which the records pertain.
Section 93.318
    Covered institutions must notify ORI immediately in the event of 
any of an enumerated list of exigent circumstances.
    Number of Respondents--2.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--1 hour.
    Total Annual Burden--2 hours.

Subpart D--Responsibilities of the U.S. Department of Health and Human 
Services Institutional Compliance Issues

Section 93.413(c)(6)
    ORI may require noncompliant institutions to adopt institutional 
integrity agreements.
    Number of Respondents--1.
    Number of Responses per Respondent--1.
    Annual Average Burden per Response--20 hours.
    Total Annual Burden--20 hours.
    The Department has submitted a copy of this final rule to OMB for 
its review of these information collection requirements under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Prior to the 
effective date of this final rule, HHS will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the information collection provisions in this final rule. An 
agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

List of Subjects

42 CFR Part 50

    Administrative practice and procedure, Science and technology, 
Reporting and recordkeeping requirements, Research, Government 
contracts, Grant programs.

42 CFR Part 93

    Administrative practice and procedure, Science and technology, 
Reporting and recordkeeping requirements, Research, Government 
contracts, Grant programs.

    Dated: January 14, 2005.
Cristina V. Beato,
Acting Assistant Secretary for Health.

    Dated: May 3, 2005.
Michael O. Leavitt,
Secretary of Health and Human Services.

0
Accordingly, under the authority of 42 U.S.C. 289b, HHS is amending 42 
CFR parts 50 and 93 as follows:

PART 50--POLICIES OF GENERAL APPLICABILITY

0
1. The authority citation for 42 CFR part 50 continues to as follows:

    Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42 
U.S.C. 216); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (42 
U.S.C. 300a-4), unless otherwise noted.

Subpart A [Removed]

0
2. Part 50, Subpart A (Sec. Sec.  50.101-50.105) is removed and 
reserved.
0
3. A new Part 93, with subparts A, B, C, D and E is added to read as 
follows:

PART 93--PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

Sec.
93.25 Organization of this part.
93.50 Special terms.
Subpart A--General
93.100 General policy.
93.101 Purpose.
93.102 Applicability.
93.103 Research misconduct.
93.104 Requirements for findings of research misconduct.
93.105 Time limitations.
93.106 Evidentiary standards.
93.107 Rule of interpretation.
93.108 Confidentiality.
93.109 Coordination with other agencies.
Subpart B--Definitions
93.200 Administrative action.
93.201 Allegation.
93.202 Charge letter.
93.203 Complainant.
93.204 Contract.
93.205 Debarment or suspension.
93.206 Debarring official.
93.207 Departmental Appeals Board or DAB.
93.208 Evidence.
93.209 Funding component.
93.210 Good faith.
93.211 Hearing.
93.212 Inquiry.
93.213 Institution.
93.214 Institutional member
93.215 Investigation.
93.216 Notice.
93.217 Office of Research Integrity or ORI.
93.218 Person.
93.219 Preponderance of the evidence.
93.220 Public Health Service or PHS.
93.221 PHS support.
93.222 Research.
93.223 Research misconduct proceeding.

[[Page 28385]]

93.224 Research record.
93.225 Respondent.
93.226 Retaliation.
93.227 Secretary or HHS.
Subpart C--Responsibilities of Institutions

Compliance and Assurances

93.300 General responsibilities for compliance.
93.301 Institutional assurances.
93.302 Institutional compliance with assurances.
93.303 Assurances for small institutions.
93.304 Institutional policies and procedures.
93.305 Responsibility for maintenance and custody of research 
records and evidence.
93.306 Using a consortium or person for research misconduct 
proceedings.

The Institutional Inquiry

93.307 Institutional inquiry.
93.308 Notice of the results of the inquiry.
93.309 Reporting to ORI on the decision to initiate an 
investigation.

The Institutional Investigation

93.310 Institutional investigation.
93.311 Investigation time limits.
93.312 Opportunity to comment on the investigation report.
93.313 Institutional investigation report.
93.314 Institutional appeals.
93.315 Notice to ORI of institutional findings and actions.
93.316 Completing the research misconduct process.

Other Institutional Responsibilities

93.317 Retention and custody of the research misconduct proceeding 
record.
93.318 Notifying ORI of special circumstances.
93.319 Institutional standards.
Subpart D--Responsibilities of the U.S. Department of Health and Human 
Services

General Information

93.400 General statement of ORI authority.
93.401 Interaction with other offices and interim actions.

Research Misconduct Issues

93.402 ORI allegation assessments.
93.403 ORI review of research misconduct proceedings.
93.404 Findings of research misconduct and proposed administrative 
actions.
93.405 Notifying the respondent of findings of research misconduct 
and HHS administrative actions.
93.406 Final HHS actions.
93.407 HHS administrative actions.
93.408 Mitigating and aggravating factors in HHS administrative 
actions.
93.409 Settlement of research misconduct proceedings.
93.410 Final HHS action with no settlement or finding of research 
misconduct.
93.411 Final HHS action with a settlement or finding of misconduct.

Institutional Compliance Issues

93.412 Making decisions on institutional noncompliance.
93.413 HHS compliance actions.

Disclosure of Information

93.414 Notice.
Subpart E--Opportunity to Contest ORI Findings of Research Misconduct 
and HHS Administrative Actions

General Information

93.500 General policy.
93.501 Opportunity to contest findings of research misconduct and 
administrative actions.

Hearing Process

93.502 Appointment of the Administrative Law Judge and scientific 
expert.
93.503 Grounds for granting a hearing request.
93.504 Grounds for dismissal of a hearing request.
93.505 Rights of the parties.
93.506 Authority of the Administrative Law Judge.
93.507 Ex parte communications.
93.508 Filing, forms, and service.
93.509 Computation of time.
93.510 Filing motions.
93.511 Prehearing conferences.
93.512 Discovery.
93.513 Submission of witness lists, witness statements, and 
exhibits.
93.514 Amendment to the charge letter.
93.515 Actions for violating an order or for disruptive conduct.
93.516 Standard and burden of proof.
93.517 The hearing.
93.518 Witnesses.
93.519 Admissibility of evidence.
93.520 The record.
93.521 Correction of the transcript.
93.522 Filing post-hearing briefs.
93.523 The Administrative Law Judge's ruling.

    Authority: 42 U.S.C. 216, 241, and 289b.


Sec.  93.25  Organization of this part.

    This part is subdivided into five subparts. Each subpart contains 
information related to a broad topic or specific audience with special 
responsibilities as shown in the following table.

------------------------------------------------------------------------
                                     You will find provisions related to
         In subpart . . .                           . . .
------------------------------------------------------------------------
A.................................  General information about this rule.
B.................................  Definitions of terms used in this
                                     part.
C.................................  Responsibilities of institutions
                                     with PHS support.
D.................................  Responsibilities of the U.S.
                                     Department of Health and Human
                                     Services and the Office of Research
                                     Integrity.
E.................................  Information on how to contest ORI
                                     research misconduct findings and
                                     HHS administrative actions.
------------------------------------------------------------------------

Sec.  93.50  Special terms.

    This part uses terms throughout the text that have special meaning. 
Those terms are defined in Subpart B of this part.

Subpart A--General


Sec.  93.100  General policy.

    (a) Research misconduct involving PHS support is contrary to the 
interests of the PHS and the Federal government and to the health and 
safety of the public, to the integrity of research, and to the 
conservation of public funds.
    (b) The U.S. Department of Health and Human Services (HHS) and 
institutions that apply for or receive Public Health Service (PHS) 
support for biomedical or behavioral research, biomedical or behavioral 
research training, or activities related to that research or research 
training share responsibility for the integrity of the research 
process. HHS has ultimate oversight authority for PHS supported 
research, and for taking other actions as appropriate or necessary, 
including the right to assess allegations and perform inquiries or 
investigations at any time. Institutions and institutional members have 
an affirmative duty to protect PHS funds from misuse by ensuring the 
integrity of all PHS supported work, and primary responsibility for 
responding to and reporting allegations of research misconduct, as 
provided in this part.


Sec.  93.101  Purpose.

    The purpose of this part is to--
    (a) Establish the responsibilities of HHS, PHS, the Office of 
Research Integrity (ORI), and institutions in responding to research 
misconduct issues;
    (b) Define what constitutes misconduct in PHS supported research;
    (c) Define the general types of administrative actions HHS and the 
PHS may take in response to research misconduct; and
    (d) Require institutions to develop and implement policies and 
procedures for--
    (1) Reporting and responding to allegations of research misconduct 
covered by this part;
    (2) Providing HHS with the assurances necessary to permit the 
institutions to participate in PHS supported research.
    (e) Protect the health and safety of the public, promote the 
integrity of PHS supported research and the research process, and 
conserve public funds.


Sec.  93.102  Applicability.

    (a) Each institution that applies for or receives PHS support for 
biomedical or

[[Page 28386]]

behavioral research, research training or activities related to that 
research or research training must comply with this part.
    (b)(1) This part applies to allegations of research misconduct and 
research misconduct involving:
    (i) Applications or proposals for PHS support for biomedical or 
behavioral extramural or intramural research, research training or 
activities related to that research or research training, such as the 
operation of tissue and data banks and the dissemination of research 
information;
    (ii) PHS supported biomedical or behavioral extramural or 
intramural research;
    (iii) PHS supported biomedical or behavioral extramural or 
intramural research training programs;
    (iv) PHS supported extramural or intramural activities that are 
related to biomedical or behavioral research or research training, such 
as the operation of tissue and data banks or the dissemination of 
research information; and
    (v) Plagiarism of research records produced in the course of PHS 
supported research, research training or activities related to that 
research or research training.
    (2) This includes any research proposed, performed, reviewed, or 
reported, or any research record generated from that research, 
regardless of whether an application or proposal for PHS funds resulted 
in a grant, contract, cooperative agreement, or other form of PHS 
support.
    (c) This part does not supersede or establish an alternative to any 
existing regulations or procedures for handling fiscal improprieties, 
the ethical treatment of human or animal subjects, criminal matters, 
personnel actions against Federal employees, or actions taken under the 
HHS debarment and suspension regulations at 45 CFR part 76 and 48 CFR 
subparts 9.4 and 309.4.
    (d) This part does not prohibit or otherwise limit how institutions 
handle allegations of misconduct that do not fall within this part's 
definition of research misconduct or that do not involve PHS support.


Sec.  93.103  Research misconduct.

    Research misconduct means fabrication, falsification, or plagiarism 
in proposing, performing, or reviewing research, or in reporting 
research results.
    (a) Fabrication is making up data or results and recording or 
reporting them.
    (b) Falsification is manipulating research materials, equipment, or 
processes, or changing or omitting data or results such that the 
research is not accurately represented in the research record.
    (c) Plagiarism is the appropriation of another person's ideas, 
processes, results, or words without giving appropriate credit.
    (d) Research misconduct does not include honest error or 
differences of opinion.


Sec.  93.104  Requirements for findings of research misconduct.

    A finding of research misconduct made under this part requires 
that--
    (a) There be a significant departure from accepted practices of the 
relevant research community; and
    (b) The misconduct be committed intentionally, knowingly, or 
recklessly; and
    (c) The allegation be proven by a preponderance of the evidence.


Sec.  93.105  Time limitations.

    (a) Six-year limitation. This part applies only to research 
misconduct occurring within six years of the date HHS or an institution 
receives an allegation of research misconduct.
    (b) Exceptions to the six-year limitation. Paragraph (a) of this 
section does not apply in the following instances:
    (1) Subsequent use exception. The respondent continues or renews 
any incident of alleged research misconduct that occurred before the 
six-year limitation through the citation, republication or other use 
for the potential benefit of the respondent of the research record that 
is alleged to have been fabricated, falsified, or plagiarized.
    (2) Health or safety of the public exception. If ORI or the 
institution, following consultation with ORI, determines that the 
alleged misconduct, if it occurred, would possibly have a substantial 
adverse effect on the health or safety of the public.
    (3) ``Grandfather'' exception. If HHS or an institution received 
the allegation of research misconduct before the effective date of this 
part.


Sec.  93.106  Evidentiary standards.

    The following evidentiary standards apply to findings made under 
this part.
    (a) Standard of proof. An institutional or HHS finding of research 
misconduct must be proved by a preponderance of the evidence.
    (b) Burden of proof. (1) The institution or HHS has the burden of 
proof for making a finding of research misconduct. The destruction, 
absence of, or respondent's failure to provide research records 
adequately documenting the questioned research is evidence of research 
misconduct where the institution or HHS establishes by a preponderance 
of the evidence that the respondent intentionally, knowingly, or 
recklessly had research records and destroyed them, had the opportunity 
to maintain the records but did not do so, or maintained the records 
and failed to produce them in a timely manner and that the respondent's 
conduct constitutes a significant departure from accepted practices of 
the relevant research community.
    (2) The respondent has the burden of going forward with and the 
burden of proving, by a preponderance of the evidence, any and all 
affirmative defenses raised. In determining whether HHS or the 
institution has carried the burden of proof imposed by this part, the 
finder of fact shall give due consideration to admissible, credible 
evidence of honest error or difference of opinion presented by the 
respondent.
    (3) The respondent has the burden of going forward with and proving 
by a preponderance of the evidence any mitigating factors that are 
relevant to a decision to impose administrative actions following a 
research misconduct proceeding.


Sec.  93.107  Rule of interpretation.

    Any interpretation of this part must further the policy and purpose 
of the HHS and the Federal government to protect the health and safety 
of the public, to promote the integrity of research, and to conserve 
public funds.


Sec.  93.108  Confidentiality.

    (a) Disclosure of the identity of respondents and complainants in 
research misconduct proceedings is limited, to the extent possible, to 
those who need to know, consistent with a thorough, competent, 
objective and fair research misconduct proceeding, and as allowed by 
law. Provided, however, that:
    (1) The institution must disclose the identity of respondents and 
complainants to ORI pursuant to an ORI review of research misconduct 
proceedings under Sec.  93.403.
    (2) Under Sec.  93.517(g), HHS administrative hearings must be open 
to the public.
    (b) Except as may otherwise be prescribed by applicable law, 
confidentiality must be maintained for any records or evidence from 
which research subjects might be identified. Disclosure is limited to 
those who have a need to know to carry out a research misconduct 
proceeding.

[[Page 28387]]

Sec.  93.109  Coordination with other agencies.

    (a) When more than one agency of the Federal government has 
jurisdiction of the subject misconduct allegation, HHS will cooperate 
in designating a lead agency to coordinate the response of the agencies 
to the allegation. Where HHS is not the lead agency, it may, in 
consultation with the lead agency, take appropriate action to protect 
the health and safety of the public, promote the integrity of the PHS 
supported research and research process and conserve public funds.
    (b) In cases involving more than one agency, HHS may refer to 
evidence or reports developed by that agency if HHS determines that the 
evidence or reports will assist in resolving HHS issues. In appropriate 
cases, HHS will seek to resolve allegations jointly with the other 
agency or agencies.

Subpart B--Definitions


Sec.  93.200  Administrative action.

    Administrative action means--
    (a) An HHS action in response to a research misconduct proceeding 
taken to protect the health and safety of the public, to promote the 
integrity of PHS supported biomedical or behavioral research, research 
training, or activities related to that research or research training 
and to conserve public funds; or
    (b) An HHS action in response either to a breach of a material 
provision of a settlement agreement in a research misconduct proceeding 
or to a breach of any HHS debarment or suspension.


Sec.  93.201  Allegation.

    Allegation means a disclosure of possible research misconduct 
through any means of communication. The disclosure may be by written or 
oral statement or other communication to an institutional or HHS 
official.


Sec.  93.202  Charge letter.

    Charge letter means the written notice, as well as any amendments 
to the notice, that are sent to the respondent stating the findings of 
research misconduct and any HHS administrative actions. If the charge 
letter includes a debarment or suspension action, it may be issued 
jointly by the ORI and the debarring official.


Sec.  93.203  Complainant.

    Complainant means a person who in good faith makes an allegation of 
research misconduct.


Sec.  93.204  Contract.

    Contract means an acquisition instrument awarded under the HHS 
Federal Acquisition Regulation (FAR), 48 CFR Chapter 1, excluding any 
small purchases awarded pursuant to FAR Part 13.


Sec.  93.205  Debarment or suspension.

    Debarment or suspension means the Government wide exclusion, 
whether temporary or for a set term, of a person from eligibility for 
Federal grants, contracts, and cooperative agreements under the HHS 
regulations at 45 CFR part 76 (nonprocurement) and 48 CFR subparts 9.4 
and 309.4 (procurement).


Sec.  93.206  Debarring official.

    Debarring official means an official authorized to impose debarment 
or suspension. The HHS debarring official is either--
    (a) The Secretary; or
    (b) An official designated by the Secretary.


Sec.  93.207  Departmental Appeals Board or DAB.

    Departmental Appeals Board or DAB means, depending on the context--
    (a) The organization, within the Office of the Secretary, 
established to conduct hearings and provide impartial review of 
disputed decisions made by HHS operating components; or
    (b) An Administrative Law Judge (ALJ) at the DAB.


Sec.  93.208  Evidence.

    Evidence means any document, tangible item, or testimony offered or 
obtained during a research misconduct proceeding that tends to prove or 
disprove the existence of an alleged fact.


Sec.  93.209  Funding component.

    Funding component means any organizational unit of the PHS 
authorized to award grants, contracts, or cooperative agreements for 
any activity that involves the conduct of biomedical or behavioral 
research, research training or activities related to that research or 
research training, e.g., agencies, bureaus, centers, institutes, 
divisions, or offices and other awarding units within the PHS.


Sec.  93.210  Good faith.

    Good faith as applied to a complainant or witness, means having a 
belief in the truth of one's allegation or testimony that a reasonable 
person in the complainant's or witness's position could have based on 
the information known to the complainant or witness at the time. An 
allegation or cooperation with a research misconduct proceeding is not 
in good faith if made with knowing or reckless disregard for 
information that would negate the allegation or testimony. Good faith 
as applied to a committee member means cooperating with the research 
misconduct proceeding by carrying out the duties assigned impartially 
for the purpose of helping an institution meet its responsibilities 
under this part. A committee member does not act in good faith if his/
her acts or omissions on the committee are dishonest or influenced by 
personal, professional, or financial conflicts of interest with those 
involved in the research misconduct proceeding.


Sec.  93.211  Hearing.

    Hearing means that part of the research misconduct proceeding from 
the time a respondent files a request for an administrative hearing to 
contest ORI findings of research misconduct and HHS administrative 
actions until the time the ALJ issues a recommended decision.


Sec.  93.212  Inquiry.

    Inquiry means preliminary information-gathering and preliminary 
fact-finding that meets the criteria and follows the procedures of 
Sec. Sec.  93.307-93.309.


Sec.  93.213  Institution.

    Institution means any individual or person that applies for or 
receives PHS support for any activity or program that involves the 
conduct of biomedical or behavioral research, biomedical or behavioral 
research training, or activities related to that research or training. 
This includes, but is not limited to colleges and universities, PHS 
intramural biomedical or behavioral research laboratories, research and 
development centers, national user facilities, industrial laboratories 
or other research institutes, small research institutions, and 
independent researchers.


Sec.  93.214  Institutional member.

    Institutional member or members means a person who is employed by, 
is an agent of, or is affiliated by contract or agreement with an 
institution. Institutional members may include, but are not limited to, 
officials, tenured and untenured faculty, teaching and support staff, 
researchers, research coordinators, clinical technicians, postdoctoral 
and other fellows, students, volunteers, agents, and contractors, 
subcontractors, and subawardees, and their employees.


Sec.  93.215  Investigation.

    Investigation means the formal development of a factual record and 
the examination of that record leading to a decision not to make a 
finding of research misconduct or to a recommendation for a finding of 
research misconduct which may include

[[Page 28388]]

a recommendation for other appropriate actions, including 
administrative actions.


Sec.  93.216  Notice.

    Notice means a written communication served in person, sent by mail 
or its equivalent to the last known street address, facsimile number or 
e-mail address of the addressee. Several sections of Subpart E of this 
part have special notice requirements.


Sec.  93.217  Office of Research Integrity or ORI.

    Office of Research Integrity or ORI means the office to which the 
HHS Secretary has delegated responsibility for addressing research 
integrity and misconduct issues related to PHS supported activities.


Sec.  93.218  Person.

    Person means any individual, corporation, partnership, institution, 
association, unit of government, or legal entity, however organized.


Sec.  93.219  Preponderance of the evidence.

    Preponderance of the evidence means proof by information that, 
compared with that opposing it, leads to the conclusion that the fact 
at issue is more probably true than not.


Sec.  93.220  Public Health Service or PHS.

    Public Health Service or PHS means the unit within the Department 
of Health and Human Services that includes the Office of Public Health 
and Science and the following Operating Divisions: Agency for 
Healthcare Research and Quality, Agency for Toxic Substances and 
Disease Registry, Centers for Disease Control and Prevention, Food and 
Drug Administration, Health Resources and Services Administration, 
Indian Health Service, National Institutes of Health, and the Substance 
Abuse and Mental Health Services Administration, and the offices of the 
Regional Health Administrators.


Sec.  93.221  PHS support.

    PHS support means PHS funding, or applications or proposals 
therefor, for biomedical or behavioral research, biomedical or 
behavioral research training, or activities related to that research or 
training, that may be provided through: Funding for PHS intramural 
research; PHS grants, cooperative agreements, or contracts or subgrants 
or subcontracts under those PHS funding instruments; or salary or other 
payments under PHS grants, cooperative agreements or contracts.


Sec.  93.222  Research.

    Research means a systematic experiment, study, evaluation, 
demonstration or survey designed to develop or contribute to general 
knowledge (basic research) or specific knowledge (applied research) 
relating broadly to public health by establishing, discovering, 
developing, elucidating or confirming information about, or the 
underlying mechanism relating to, biological causes, functions or 
effects, diseases, treatments, or related matters to be studied.


Sec.  93.223  Research misconduct proceeding.

    Research misconduct proceeding means any actions related to alleged 
research misconduct taken under this part, including but not limited 
to, allegation assessments, inquiries, investigations, ORI oversight 
reviews, hearings, and administrative appeals.


Sec.  93.224  Research record.

    Research record means the record of data or results that embody the 
facts resulting from scientific inquiry, including but not limited to, 
research proposals, laboratory records, both physical and electronic, 
progress reports, abstracts, theses, oral presentations, internal 
reports, journal articles, and any documents and materials provided to 
HHS or an institutional official by a respondent in the course of the 
research misconduct proceeding.


Sec.  93.225  Respondent.

    Respondent means the person against whom an allegation of research 
misconduct is directed or who is the subject of a research misconduct 
proceeding.


Sec.  93.226  Retaliation.

    Retaliation for the purpose of this part means an adverse action 
taken against a complainant, witness, or committee member by an 
institution or one of its members in response to--
    (a) A good faith allegation of research misconduct; or
    (b) Good faith cooperation with a research misconduct proceeding.


Sec.  93.227  Secretary or HHS.

    Secretary or HHS means the Secretary of HHS or any other officer or 
employee of the HHS to whom the Secretary delegates authority.

Subpart C--Responsibilities of Institutions

Compliance and Assurances


Sec.  93.300  General responsibilities for compliance.

    Institutions under this part must--
    (a) Have written policies and procedures for addressing allegations 
of research misconduct that meet the requirements of this part;
    (b) Respond to each allegation of research misconduct for which the 
institution is responsible under this part in a thorough, competent, 
objective and fair manner, including precautions to ensure that 
individuals responsible for carrying out any part of the research 
misconduct proceeding do not have unresolved personal, professional or 
financial conflicts of interest with the complainant, respondent or 
witnesses;
    (c) Foster a research environment that promotes the responsible 
conduct of research, research training, and activities related to that 
research or research training, discourages research misconduct, and 
deals promptly with allegations or evidence of possible research 
misconduct;
    (d) Take all reasonable and practical steps to protect the 
positions and reputations of good faith complainants, witnesses and 
committee members and protect them from retaliation by respondents and 
other institutional members;
    (e) Provide confidentiality to the extent required by Sec.  93.108 
to all respondents, complainants, and research subjects identifiable 
from research records or evidence;
    (f) Take all reasonable and practical steps to ensure the 
cooperation of respondents and other institutional members with 
research misconduct proceedings, including, but not limited to, their 
providing information, research records, and evidence;
    (g) Cooperate with HHS during any research misconduct proceeding or 
compliance review;
    (h) Assist in administering and enforcing any HHS administrative 
actions imposed on its institutional members; and
    (i) Have an active assurance of compliance.


Sec.  93.301  Institutional assurances.

    (a) General policy. An institution with PHS supported biomedical or 
behavioral research, research training or activities related to that 
research or research training must provide PHS with an assurance of 
compliance with this part, satisfactory to the Secretary. PHS funding 
components may authorize

[[Page 28389]]

funds for biomedical and behavioral research, research training, or 
activities related to that research or research training only to 
institutions that have approved assurances and required renewals on 
file with ORI.
    (b) Institutional Assurance. The responsible institutional official 
must assure on behalf of the institution that the institution--
    (1) Has written policies and procedures in compliance with this 
part for inquiring into and investigating allegations of research 
misconduct; and
    (2) Complies with its own policies and procedures and the 
requirements of this part.


Sec.  93.302  Institutional compliance with assurances.

    (a) Compliance with assurance. ORI considers an institution in 
compliance with its assurance if the institution--
    (1) Establishes policies and procedures according to this part, 
keeps them in compliance with this part, and upon request, provides 
them to ORI, other HHS personnel, and members of the public;
    (2) Takes all reasonable and practical specific steps to foster 
research integrity consistent with Sec.  93.300, including--
    (i) Informs the institution's research members participating in or 
otherwise involved with PHS supported biomedical or behavioral 
research, research training or activities related to that research or 
research training, including those applying for support from any PHS 
funding component, about its policies and procedures for responding to 
allegations of research misconduct, and the institution's commitment to 
compliance with the policies and procedures; and
    (ii) Complies with its policies and procedures and each specific 
provision of this part.
    (b) Annual report. An institution must file an annual report with 
ORI which contains information specified by ORI on the institution's 
compliance with this part.
    (c) Additional information. Along with its assurance or annual 
report, an institution must send ORI such other aggregated information 
as ORI may request on the institution's research misconduct proceedings 
covered by this part and the institution's compliance with the 
requirements of this part.


Sec.  93.303  Assurances for small institutions.

    (a) If an institution is too small to handle research misconduct 
proceedings, it may file a ``Small Organization Statement'' with ORI in 
place of the formal institutional policies and procedures required by 
Sec. Sec.  93.301 and 93.304.
    (b) By submitting a Small Organization Statement, the institution 
agrees to report all allegations of research misconduct to ORI. ORI or 
another appropriate HHS office will work with the institution to 
develop and implement a process for handling allegations of research 
misconduct consistent with this part.
    (c) The Small Organization Statement does not relieve the 
institution from complying with any other provision of this part.


Sec.  93.304  Institutional policies and procedures.

    Institutions seeking an approved assurance must have written 
policies and procedures for addressing research misconduct that include 
the following--
    (a) Consistent with Sec.  93.108, protection of the confidentiality 
of respondents, complainants, and research subjects identifiable from 
research records or evidence;
    (b) A thorough, competent, objective, and fair response to 
allegations of research misconduct consistent with and within the time 
limits of this part, including precautions to ensure that individuals 
responsible for carrying out any part of the research misconduct 
proceeding do not have unresolved personal, professional, or financial 
conflicts of interest with the complainant, respondent, or witnesses;
    (c) Notice to the respondent, consistent with and within the time 
limits of this part;
    (d) Written notice to ORI of any decision to open an investigation 
on or before the date on which the investigation begins;
    (e) Opportunity for the respondent to provide written comments on 
the institution's inquiry report;
    (f) Opportunity for the respondent to provide written comments on 
the draft report of the investigation, and provisions for the 
institutional investigation committee to consider and address the 
comments before issuing the final report;
    (g) Protocols for handling the research record and evidence, 
including the requirements of Sec.  93.305;
    (h) Appropriate interim institutional actions to protect public 
health, Federal funds and equipment, and the integrity of the PHS 
supported research process;
    (i) Notice to ORI under Sec.  93.318 and notice of any facts that 
may be relevant to protect public health, Federal funds and equipment, 
and the integrity of the PHS supported research process;
    (j) Institutional actions in response to final findings of research 
misconduct;
    (k) All reasonable and practical efforts, if requested and as 
appropriate, to protect or restore the reputation of persons alleged to 
have engaged in research misconduct but against whom no finding of 
research misconduct is made;
    (l) All reasonable and practical efforts to protect or restore the 
position and reputation of any complainant, witness, or committee 
member and to counter potential or actual retaliation against these 
complainants, witnesses, and committee members; and
    (m) Full and continuing cooperation with ORI during its oversight 
review under Subpart D of this part or any subsequent administrative 
hearings or appeals under Subpart E of this part. This includes 
providing all research records and evidence under the institution's 
control, custody, or possession and access to all persons within its 
authority necessary to develop a complete record of relevant evidence.


Sec.  93.305  Responsibility for maintenance and custody of research 
records and evidence.

    An institution, as the responsible legal entity for the PHS 
supported research, has a continuing obligation under this part to 
ensure that it maintains adequate records for a research misconduct 
proceeding. The institution must--
    (a) Either before or when the institution notifies the respondent 
of the allegation, inquiry or investigation, promptly take all 
reasonable and practical steps to obtain custody of all the research 
records and evidence needed to conduct the research misconduct 
proceeding, inventory the records and evidence, and sequester them in a 
secure manner, except that where the research records or evidence 
encompass scientific instruments shared by a number of users, custody 
may be limited to copies of the data or evidence on such instruments, 
so long as those copies are substantially equivalent to the evidentiary 
value of the instruments;
    (b) Where appropriate, give the respondent copies of, or 
reasonable, supervised access to the research records;
    (c) Undertake all reasonable and practical efforts to take custody 
of additional research records or evidence that is discovered during 
the course of a research misconduct proceeding, except that where the 
research records or evidence encompass scientific instruments shared by 
a number of users, custody may be limited to copies of the data or 
evidence on such instruments, so long as those copies are substantially 
equivalent to the

[[Page 28390]]

evidentiary value of the instruments; and
    (d) Maintain the research records and evidence as required by Sec.  
93.317.


Sec.  93.306  Using a consortium or other person for research 
misconduct proceedings.

    (a) An institution may use the services of a consortium or person 
that the institution reasonably determines to be qualified by practice 
and experience to conduct research misconduct proceedings.
    (b) A consortium may be a group of institutions, professional 
organizations, or mixed groups which will conduct research misconduct 
proceedings for other institutions.
    (c) A consortium or person acting on behalf of an institution must 
follow the requirements of this part in conducting research misconduct 
proceedings.

The Institutional Inquiry


Sec.  93.307  Institutional inquiry.

    (a) Criteria warranting an inquiry. An inquiry is warranted if the 
allegation--
    (1) Falls within the definition of research misconduct under this 
part;
    (2) Is within Sec.  93.102; and
    (3) Is sufficiently credible and specific so that potential 
evidence of research misconduct may be identified.
    (b) Notice to respondent and custody of research records. At the 
time of or before beginning an inquiry, an institution must make a good 
faith effort to notify in writing the presumed respondent, if any. If 
the inquiry subsequently identifies additional respondents, the 
institution must notify them. To the extent it has not already done so 
at the allegation stage, the institution must, on or before the date on 
which the respondent is notified or the inquiry begins, whichever is 
earlier, promptly take all reasonable and practical steps to obtain 
custody of all the research records and evidence needed to conduct the 
research misconduct proceeding, inventory the records and evidence, and 
sequester them in a secure manner, except that where the research 
records or evidence encompass scientific instruments shared by a number 
of users, custody may be limited to copies of the data or evidence on 
such instruments, so long as those copies are substantially equivalent 
to the evidentiary value of the instruments.
    (c) Review of evidence. The purpose of an inquiry is to conduct an 
initial review of the evidence to determine whether to conduct an 
investigation. Therefore, an inquiry does not require a full review of 
all the evidence related to the allegation.
    (d) Criteria warranting an investigation. An inquiry's purpose is 
to decide if an allegation warrants an investigation. An investigation 
is warranted if there is--
    (1) A reasonable basis for concluding that the allegation falls 
within the definition of research misconduct under this part and 
involves PHS supported biomedical or behavioral research, research 
training or activities related to that research or research training, 
as provided in Sec.  93.102; and
    (2) Preliminary information-gathering and preliminary fact-finding 
from the inquiry indicates that the allegation may have substance.
    (e) Inquiry report. The institution must prepare a written report 
that meets the requirements of this section and Sec.  93.309.
    (f) Opportunity to comment. The institution must provide the 
respondent an opportunity to review and comment on the inquiry report 
and attach any comments received to the report.
    (g) Time for completion. The institution must complete the inquiry 
within 60 calendar days of its initiation unless circumstances clearly 
warrant a longer period. If the inquiry takes longer than 60 days to 
complete, the inquiry record must include documentation of the reasons 
for exceeding the 60-day period.


Sec.  93.308  Notice of the results of the inquiry.

    (a) Notice to respondent. The institution must notify the 
respondent whether the inquiry found that an investigation is 
warranted. The notice must include a copy of the inquiry report and 
include a copy of or refer to this part and the institution's policies 
and procedures adopted under its assurance.
    (b) Notice to complainants. The institution may notify the 
complainant who made the allegation whether the inquiry found that an 
investigation is warranted. The institution may provide relevant 
portions of the report to the complainant for comment.


Sec.  93.309  Reporting to ORI on the decision to initiate an 
investigation.

    (a) Within 30 days of finding that an investigation is warranted, 
the institution must provide ORI with the written finding by the 
responsible institutional official and a copy of the inquiry report 
which includes the following information--
    (1) The name and position of the respondent;
    (2) A description of the allegations of research misconduct;
    (3) The PHS support, including, for example, grant numbers, grant 
applications, contracts, and publications listing PHS support;
    (4) The basis for recommending that the alleged actions warrant an 
investigation; and
    (5) Any comments on the report by the respondent or the 
complainant.
    (b) The institution must provide the following information to ORI 
on request--
    (1) The institutional policies and procedures under which the 
inquiry was conducted;
    (2) The research records and evidence reviewed, transcripts or 
recordings of any interviews, and copies of all relevant documents; and
    (3) The charges for the investigation to consider.
    (c) Documentation of decision not to investigate. Institutions must 
keep sufficiently detailed documentation of inquiries to permit a later 
assessment by ORI of the reasons why the institution decided not to 
conduct an investigation. Consistent with Sec.  93.317, institutions 
must keep these records in a secure manner for at least 7 years after 
the termination of the inquiry, and upon request, provide them to ORI 
or other authorized HHS personnel.
    (d) Notification of special circumstances. In accordance with Sec.  
93.318, institutions must notify ORI and other PHS agencies, as 
relevant, of any special circumstances that may exist.

The Institutional Investigation


Sec.  93.310  Institutional investigation.

    Institutions conducting research misconduct investigations must:
    (a) Time. Begin the investigation within 30 days after determining 
that an investigation is warranted.
    (b) Notice to ORI. Notify the ORI Director of the decision to begin 
an investigation on or before the date the investigation begins and 
provide an inquiry report that meets the requirements of Sec.  93.307 
and Sec.  93.309.
    (c) Notice to the respondent. Notify the respondent in writing of 
the allegations within a reasonable amount of time after determining 
that an investigation is warranted, but before the investigation 
begins. The institution must give the respondent written notice of any 
new allegations of research misconduct within a reasonable amount of 
time of deciding to pursue allegations not addressed during the inquiry 
or in the initial notice of investigation.
    (d) Custody of the records. To the extent they have not already 
done so at the allegation or inquiry stages, take all reasonable and 
practical steps to obtain custody of all the research records and

[[Page 28391]]

evidence needed to conduct the research misconduct proceeding, 
inventory the records and evidence, and sequester them in a secure 
manner, except that where the research records or evidence encompass 
scientific instruments shared by a number of users, custody may be 
limited to copies of the data or evidence on such instruments, so long 
as those copies are substantially equivalent to the evidentiary value 
of the instruments. Whenever possible, the institution must take 
custody of the records--
    (1) Before or at the time the institution notifies the respondent; 
and
    (2) Whenever additional items become known or relevant to the 
investigation.
    (e) Documentation. Use diligent efforts to ensure that the 
investigation is thorough and sufficiently documented and includes 
examination of all research records and evidence relevant to reaching a 
decision on the merits of the allegations.
    (f) Ensuring a fair investigation. Take reasonable steps to ensure 
an impartial and unbiased investigation to the maximum extent 
practicable, including participation of persons with appropriate 
scientific expertise who do not have unresolved personal, professional, 
or financial conflicts of interest with those involved with the inquiry 
or investigation.
    (g) Interviews. Interview each respondent, complainant, and any 
other available person who has been reasonably identified as having 
information regarding any relevant aspects of the investigation, 
including witnesses identified by the respondent, and record or 
transcribe each interview, provide the recording or transcript to the 
interviewee for correction, and include the recording or transcript in 
the record of the investigation.
    (h) Pursue leads. Pursue diligently all significant issues and 
leads discovered that are determined relevant to the investigation, 
including any evidence of additional instances of possible research 
misconduct, and continue the investigation to completion.


Sec.  93.311  Investigation time limits.

    (a) Time limit for completing an investigation. An institution must 
complete all aspects of an investigation within 120 days of beginning 
it, including conducting the investigation, preparing the report of 
findings, providing the draft report for comment in accordance with 
Sec.  93.312, and sending the final report to ORI under Sec.  93.315.
    (b) Extension of time limit. If unable to complete the 
investigation in 120 days, the institution must ask ORI for an 
extension in writing.
    (c) Progress reports. If ORI grants an extension, it may direct the 
institution to file periodic progress reports.


Sec.  93.312  Opportunity to comment on the investigation report.

    (a) The institution must give the respondent a copy of the draft 
investigation report and, concurrently, a copy of, or supervised access 
to, the evidence on which the report is based. The comments of the 
respondent on the draft report, if any, must be submitted within 30 
days of the date on which the respondent received the draft 
investigation report.
    (b) The institution may provide the complainant a copy of the draft 
investigation report or relevant portions of that report. The comments 
of the complainant, if any, must be submitted within 30 days of the 
date on which the complainant received the draft investigation report 
or relevant portions of it.


Sec.  93.313  Institutional investigation report.

    The final institutional investigation report must be in writing and 
include:
    (a) Allegations. Describe the nature of the allegations of research 
misconduct.
    (b) PHS support. Describe and document the PHS support, including, 
for example, any grant numbers, grant applications, contracts, and 
publications listing PHS support.
    (c) Institutional charge. Describe the specific allegations of 
research misconduct for consideration in the investigation.
    (d) Policies and procedures. If not already provided to ORI with 
the inquiry report, include the institutional policies and procedures 
under which the investigation was conducted.
    (e) Research records and evidence. Identify and summarize the 
research records and evidence reviewed, and identify any evidence taken 
into custody but not reviewed.
    (f) Statement of findings. For each separate allegation of research 
misconduct identified during the investigation, provide a finding as to 
whether research misconduct did or did not occur, and if so--
    (1) Identify whether the research misconduct was falsification, 
fabrication, or plagiarism, and if it was intentional, knowing, or in 
reckless disregard;
    (2) Summarize the facts and the analysis which support the 
conclusion and consider the merits of any reasonable explanation by the 
respondent;
    (3) Identify the specific PHS support;
    (4) Identify whether any publications need correction or 
retraction;
    (5) Identify the person(s) responsible for the misconduct; and
    (6) List any current support or known applications or proposals for 
support that the respondent has pending with non-PHS Federal agencies.
    (g) Comments. Include and consider any comments made by the 
respondent and complainant on the draft investigation report.
    (h) Maintain and provide records. Maintain and provide to ORI upon 
request all relevant research records and records of the institution's 
research misconduct proceeding, including results of all interviews and 
the transcripts or recordings of such interviews.


Sec.  93.314  Institutional appeals.

    (a) While not required by this part, if the institution's 
procedures provide for an appeal by the respondent that could result in 
a reversal or modification of the findings of research misconduct in 
the investigation report, the institution must complete any such appeal 
within 120 days of its filing. Appeals from personnel or similar 
actions that would not result in a reversal or modification of the 
findings of research misconduct are excluded from the 120-day limit.
    (b) If unable to complete any appeals within 120 days, the 
institution must ask ORI for an extension in writing and provide an 
explanation for the request.
    (c) ORI may grant requests for extension for good cause. If ORI 
grants an extension, it may direct the institution to file periodic 
progress reports.


Sec.  93.315  Notice to ORI of institutional findings and actions.

    The institution must give ORI the following:
    (a) Investigation Report. Include a copy of the report, all 
attachments, and any appeals.
    (b) Final institutional action. State whether the institution found 
research misconduct, and if so, who committed the misconduct.
    (c) Findings. State whether the institution accepts the 
investigation's findings.
    (d) Institutional administrative actions. Describe any pending or 
completed administrative actions against the respondent.


Sec.  93.316  Completing the research misconduct process.

    (a) ORI expects institutions to carry inquiries and investigations 
through to completion and to pursue diligently all significant issues. 
An institution must

[[Page 28392]]

notify ORI in advance if the institution plans to close a case at the 
inquiry, investigation, or appeal stage on the basis that the 
respondent has admitted guilt, a settlement with the respondent has 
been reached, or for any other reason, except the closing of a case at 
the inquiry stage on the basis that an investigation is not warranted 
or a finding of no misconduct at the investigation stage, which must be 
reported to ORI under Sec.  93.315.
    (b) After consulting with the institution on its basis for closing 
a case under paragraph (a) of this section, ORI may conduct an 
oversight review of the institution's handling of the case and take 
appropriate action including:
    (1) Approving or conditionally approving closure of the case;
    (2) Directing the institution to complete its process;
    (3) Referring the matter for further investigation by HHS; or,
    (4) Taking a compliance action.

Other Institutional Responsibilities


Sec.  93.317  Retention and custody of the research misconduct 
proceeding record.

    (a) Definition of records of research misconduct proceedings. As 
used in this section, the term ``records of research misconduct 
proceedings'' includes:
    (1) The records that the institution secures for the proceeding 
pursuant to Sec. Sec.  93.305, 93.307(b) and 93.310(d), except to the 
extent the institution subsequently determines and documents that those 
records are not relevant to the proceeding or that the records 
duplicate other records that are being retained;
    (2) The documentation of the determination of irrelevant or 
duplicate records; (3) The inquiry report and final documents (not 
drafts) produced in the course of preparing that report, including the 
documentation of any decision not to investigate as required by Sec.  
93.309(d);
    (4) The investigation report and all records (other than drafts of 
the report) in support of that report, including the recordings or 
transcriptions of each interview conducted pursuant to Sec.  93.310(g); 
and
    (5) The complete record of any institutional appeal covered by 
Sec.  93.314.
    (b) Maintenance of record. Unless custody has been transferred to 
HHS under paragraph (c) of this section, or ORI has advised the 
institution in writing that it no longer needs to retain the records, 
an institution must maintain records of research misconduct proceedings 
in a secure manner for 7 years after completion of the proceeding or 
the completion of any PHS proceeding involving the research misconduct 
allegation under subparts D and E of this part, whichever is later.
    (c) Provision for HHS custody. On request, institutions must 
transfer custody of or provide copies to HHS, of any institutional 
record relevant to a research misconduct allegation covered by this 
part, including the research records and evidence, to perform forensic 
or other analyses or as otherwise needed to conduct an HHS inquiry or 
investigation or for ORI to conduct its review or to present evidence 
in any proceeding under subparts D and E of this part.


Sec.  93.318  Notifying ORI of special circumstances.

    At any time during a research misconduct proceeding, as defined in 
Sec.  93.223, an institution must notify ORI immediately if it has 
reason to believe that any of the following conditions exist:
    (a) Health or safety of the public is at risk, including an 
immediate need to protect human or animal subjects.
    (b) HHS resources or interests are threatened.
    (c) Research activities should be suspended.
    (d) There is reasonable indication of possible violations of civil 
or criminal law.
    (e) Federal action is required to protect the interests of those 
involved in the research misconduct proceeding.
    (f) The research institution believes the research misconduct 
proceeding may be made public prematurely so that HHS may take 
appropriate steps to safeguard evidence and protect the rights of those 
involved.
    (g) The research community or public should be informed.


Sec.  93.319  Institutional standards.

    (a) Institutions may have internal standards of conduct different 
from the HHS standards for research misconduct under this part. 
Therefore, an institution may find conduct to be actionable under its 
standards even if the action does not meet this part's definition of 
research misconduct.
    (b) An HHS finding or settlement does not affect institutional 
findings or administrative actions based on an institution's internal 
standards of conduct.

Subpart D--Responsibilities of the U.S. Department of Health and 
Human Services

General Information


Sec.  93.400  General statement of ORI authority.

    (a) ORI review. ORI may respond directly to any allegation of 
research misconduct at any time before, during, or after an 
institution's response to the matter. The ORI response may include, but 
is not limited to--
    (1) Conducting allegation assessments;
    (2) Determining independently if jurisdiction exists under this 
part in any matter;
    (3) Forwarding allegations of research misconduct to the 
appropriate institution or HHS component for inquiry or investigation;
    (4) Recommending that HHS should perform an inquiry or 
investigation or issue findings and taking all appropriate actions in 
response to the inquiry, investigation, or findings;
    (5) Notifying or requesting assistance and information from PHS 
funding components or other affected Federal and state offices and 
agencies or institutions;
    (6) Reviewing an institution's findings and process;
    (7) Making a finding of research misconduct; and
    (8) Proposing administrative actions to HHS.
    (b) Requests for information. ORI may request clarification or 
additional information, documentation, research records, or evidence 
from an institution or its members or other persons or sources to carry 
out ORI's review.
    (c) HHS administrative actions. (1) In response to a research 
misconduct proceeding, ORI may propose administrative actions against 
any person to the HHS and, upon HHS approval and final action in 
accordance with this part, implement the actions.
    (2) ORI may propose to the HHS debarring official that a person be 
suspended or debarred from receiving Federal funds and may propose to 
other appropriate PHS components the implementation of HHS 
administrative actions within the components' authorities.
    (d) ORI assistance to institutions. At any time, ORI may provide 
information, technical assistance, and procedural advice to 
institutional officials as needed regarding an institution's 
participation in research misconduct proceedings.
    (e) Review of institutional assurances. ORI may review 
institutional assurances

[[Page 28393]]

and policies and procedures for compliance with this part.
    (f) Institutional compliance. ORI may make findings and impose HHS 
administrative actions related to an institution's compliance with this 
part and with its policies and procedures, including an institution's 
participation in research misconduct proceedings.


Sec.  93.401  Interaction with other offices and interim actions.

    (a) ORI may notify and consult with other offices at any time if it 
has reason to believe that a research misconduct proceeding may involve 
that office. If ORI believes that a criminal or civil fraud violation 
may have occurred, it shall promptly refer the matter to the Department 
of Justice (DOJ), the HHS Inspector General (OIG), or other appropriate 
investigative body. ORI may provide expertise and assistance to the 
DOJ, OIG, PHS offices, other Federal offices, and state or local 
offices involved in investigating or otherwise pursuing research 
misconduct allegations or related matters.
    (b) ORI may notify affected PHS offices and funding components at 
any time to permit them to make appropriate interim responses to 
protect the health and safety of the public, to promote the integrity 
of the PHS supported research and research process, and to conserve 
public funds.
    (c) The information provided will not be disclosed as part of the 
peer review and advisory committee review processes, but may be used by 
the Secretary in making decisions about the award or continuation of 
funding.

Research Misconduct Issues


Sec.  93.402  ORI allegation assessments.

    (a) When ORI receives an allegation of research misconduct directly 
or becomes aware of an allegation or apparent instance of research 
misconduct, it may conduct an initial assessment or refer the matter to 
the relevant institution for an assessment, inquiry, or other 
appropriate actions.
    (b) If ORI conducts an assessment, it considers whether the 
allegation of research misconduct appears to fall within the definition 
of research misconduct, appears to involve PHS supported biomedical or 
behavior research, research training or activities related to that 
research or research training, as provided in Sec.  93.102, and whether 
it is sufficiently specific so that potential evidence may be 
identified and sufficiently substantive to warrant an inquiry. ORI may 
review all readily accessible, relevant information related to the 
allegation.
    (c) If ORI decides that an inquiry is warranted, it forwards the 
matter to the appropriate institution or HHS component.
    (d) If ORI decides that an inquiry is not warranted it will close 
the case and forward the allegation in accordance with paragraph(e) of 
this section.
    (e) ORI may forward allegations that do not fall within the 
jurisdiction of this part to the appropriate HHS component, Federal or 
State agency, institution, or other appropriate entity.


Sec.  93.403  ORI review of research misconduct proceedings.

    ORI may conduct reviews of research misconduct proceedings. In 
conducting its review, ORI may--
    (a) Determine whether there is HHS jurisdiction under this part;
    (b) Consider any reports, institutional findings, research records, 
and evidence;
    (c) Determine if the institution conducted the proceedings in a 
timely and fair manner in accordance with this part with sufficient 
thoroughness, objectivity, and competence to support the conclusions;
    (d) Obtain additional information or materials from the 
institution, the respondent, complainants, or other persons or sources;
    (e) Conduct additional analyses and develop evidence;
    (f) Decide whether research misconduct occurred, and if so who 
committed it;
    (g) Make appropriate research misconduct findings and propose HHS 
administrative actions; and
    (h) Take any other actions necessary to complete HHS' review.


Sec.  93.404  Findings of research misconduct and proposed 
administrative actions.

    After completing its review, ORI either closes the case without a 
finding of research misconduct or--
    (a) Makes findings of research misconduct and proposes and obtains 
HHS approval of administrative actions based on the record of the 
research misconduct proceedings and any other information obtained by 
ORI during its review; or
    (b) Recommends that HHS seek to settle the case.


Sec.  93.405  Notifying the respondent of findings of research 
misconduct and HHS administrative actions.

    (a) When the ORI makes a finding of research misconduct or seeks to 
impose or enforce HHS administrative actions, other than debarment or 
suspension, it notifies the respondent in a charge letter. In cases 
involving a debarment or suspension action, the HHS debarring official 
issues a notice of proposed debarment or suspension to the respondent 
as part of the charge letter. The charge letter includes the ORI 
findings of research misconduct and the basis for them and any HHS 
administrative actions. The letter also advises the respondent of the 
opportunity to contest the findings and administrative actions under 
Subpart E of this part.
    (b) The ORI sends the charge letter by certified mail or a private 
delivery service to the last known address of the respondent or the 
last known principal place of business of the respondent's attorney.


Sec.  93.406  Final HHS actions.

    Unless the respondent contests the charge letter within the 30-day 
period prescribed in Sec.  93.501, the ORI finding of research 
misconduct is the final HHS action on the research misconduct issues 
and the HHS administrative actions become final and will be 
implemented, except that the debarring official's decision is the final 
HHS action on any debarment or suspension actions.


Sec.  93.407  HHS administrative actions.

    (a) In response to a research misconduct proceeding, HHS may impose 
HHS administrative actions that include but are not limited to:
    (1) Clarification, correction, or retraction of the research 
record.
    (2) Letters of reprimand.
    (3) Imposition of special certification or assurance requirements 
to ensure compliance with applicable regulations or terms of PHS 
grants, contracts, or cooperative agreements.
    (4) Suspension or termination of a PHS grant, contract, or 
cooperative agreement.
    (5) Restriction on specific activities or expenditures under an 
active PHS grant, contract, or cooperative agreement.
    (6) Special review of all requests for PHS funding.
    (7) Imposition of supervision requirements on a PHS grant, 
contract, or cooperative agreement.
    (8) Certification of attribution or authenticity in all requests 
for support and reports to the PHS.
    (9) No participation in any advisory capacity to the PHS.
    (10) Adverse personnel action if the respondent is a Federal 
employee, in compliance with relevant Federal personnel policies and 
laws.
    (11) Suspension or debarment under 45 CFR Part 76, 48 CFR Subparts 
9.4 and 309.4, or both.
    (b) In connection with findings of research misconduct, HHS also 
may

[[Page 28394]]

seek to recover PHS funds spent in support of the activities that 
involved research misconduct.
    (c) Any authorized HHS component may impose, administer, or enforce 
HHS administrative actions separately or in coordination with other HHS 
components, including, but not limited to ORI, the Office of Inspector 
General, the PHS funding component, and the debarring official.


Sec.  93.408  Mitigating and aggravating factors in HHS administrative 
actions.

    The purpose of HHS administrative actions is remedial. The 
appropriate administrative action is commensurate with the seriousness 
of the misconduct, and the need to protect the health and safety of the 
public, promote the integrity of the PHS supported research and 
research process, and conserve public funds. HHS considers aggravating 
and mitigating factors in determining appropriate HHS administrative 
actions and their terms. HHS may consider other factors as appropriate 
in each case. The existence or nonexistence of any factor is not 
determinative:
    (a) Knowing, intentional, or reckless. Were the respondent's 
actions knowing or intentional or was the conduct reckless?
    (b) Pattern. Was the research misconduct an isolated event or part 
of a continuing or prior pattern of dishonest conduct?
    (c) Impact. Did the misconduct have significant impact on the 
proposed or reported research record, research subjects, other 
researchers, institutions, or the public health or welfare?
    (d) Acceptance of responsibility. Has the respondent accepted 
responsibility for the misconduct by--
    (1) Admitting the conduct;
    (2) Cooperating with the research misconduct proceedings;
    (3) Demonstrating remorse and awareness of the significance and 
seriousness of the research misconduct; and
    (4) Taking steps to correct or prevent the recurrence of the 
research misconduct.
    (e) Failure to accept responsibility. Does the respondent blame 
others rather than accepting responsibility for the actions?
    (f) Retaliation. Did the respondent retaliate against complainants, 
witnesses, committee members, or other persons?
    (g) Present responsibility. Is the respondent presently responsible 
to conduct PHS supported research?
    (h) Other factors. Other factors appropriate to the circumstances 
of a particular case.


Sec.  93.409  Settlement of research misconduct proceedings.

    (a) HHS may settle a research misconduct proceeding at any time it 
concludes that settlement is in the best interests of the Federal 
government and the public health or welfare.
    (b) Settlement agreements are publicly available, regardless of 
whether the ORI made a finding of research misconduct.


Sec.  93.410  Final HHS action with no settlement or finding of 
research misconduct.

    When the final HHS action does not result in a settlement or 
finding of research misconduct, ORI may:
    (a) Provide written notice to the respondent, the relevant 
institution, the complainant, and HHS officials.
    (b) Take any other actions authorized by law.


Sec.  93.411  Final HHS action with settlement or finding of research 
misconduct.

    When a final HHS action results in a settlement or research 
misconduct finding, ORI may:
    (a) Provide final notification of any research misconduct findings 
and HHS administrative actions to the respondent, the relevant 
institution, the complainant, and HHS officials. The debarring official 
may provide a separate notice of final HHS action on any debarment or 
suspension actions.
    (b) Identify publications which require correction or retraction 
and prepare and send a notice to the relevant journal.
    (c) Publish notice of the research misconduct findings.
    (d) Notify the respondent's current employer.
    (e) Take any other actions authorized by law.

Institutional Compliance Issues


Sec.  93.412  Making decisions on institutional noncompliance.

    (a) Institutions must foster a research environment that 
discourages misconduct in all research and that deals forthrightly with 
possible misconduct associated with PHS supported research.
    (b) ORI may decide that an institution is not compliant with this 
part if the institution shows a disregard for, or inability or 
unwillingness to implement and follow the requirements of this part and 
its assurance. In making this decision, ORI may consider, but is not 
limited to the following factors--
    (1) Failure to establish and comply with policies and procedures 
under this part;
    (2) Failure to respond appropriately when allegations of research 
misconduct arise;
    (3) Failure to report to ORI all investigations and findings of 
research misconduct under this part;
    (4) Failure to cooperate with ORI's review of research misconduct 
proceedings; or
    (5) Other actions or omissions that have a material, adverse effect 
on reporting and responding to allegations of research misconduct.


Sec.  93.413  HHS compliance actions.

    (a) An institution's failure to comply with its assurance and the 
requirements of this part may result in enforcement action against the 
institution.
    (b) ORI may address institutional deficiencies through technical 
assistance if the deficiencies do not substantially affect compliance 
with this part.
    (c) If an institution fails to comply with its assurance and the 
requirements of this part, HHS may take some or all of the following 
compliance actions:
    (1) Issue a letter of reprimand.
    (2) Direct that research misconduct proceedings be handled by HHS.
    (3) Place the institution on special review status.
    (4) Place information on the institutional noncompliance on the ORI 
Web site.
    (5) Require the institution to take corrective actions.
    (6) Require the institution to adopt and implement an institutional 
integrity agreement.
    (7) Recommend that HHS debar or suspend the entity.
    (8) Any other action appropriate to the circumstances.
    (d) If the institution's actions constitute a substantial or 
recurrent failure to comply with this part, ORI may also revoke the 
institution's assurance under Sec. Sec.  93.301 or 93.303.
    (e) ORI may make public any findings of institutional noncompliance 
and HHS compliance actions.

Disclosure of Information


Sec.  93.414  Notice.

    (a) ORI may disclose information to other persons for the purpose 
of providing or obtaining information about research misconduct as 
permitted under the Privacy Act, 5 U.S.C. 552a.
    (b) ORI may publish a notice of final agency findings of research 
misconduct, settlements, and HHS administrative actions and release and 
withhold information as permitted by the Privacy Act and the Freedom of 
Information Act, 5 U.S.C. 552.

[[Page 28395]]

Subpart E--Opportunity To Contest ORI Findings of Research 
Misconduct and HHS Administrative Actions

General Information


Sec.  93.500  General policy.

    (a) This subpart provides a respondent an opportunity to contest 
ORI findings of research misconduct and HHS administrative actions, 
including debarment or suspension, arising under 42 U.S.C. 289b in 
connection with PHS supported biomedical and behavioral research, 
research training, or activities related to that research or research 
training.
    (b) A respondent has an opportunity to contest ORI research 
misconduct findings and HHS administrative actions under this part, 
including debarment or suspension, by requesting an administrative 
hearing before an Administrative Law Judge (ALJ) affiliated with the 
HHS DAB, when--
    (1) ORI has made a finding of research misconduct against a 
respondent; and
    (2) The respondent has been notified of those findings and any 
proposed HHS administrative actions, including debarment or suspension, 
in accordance with this part.
    (c) The ALJ's ruling on the merits of the ORI research misconduct 
findings and the HHS administrative actions is subject to review by the 
Assistant Secretary for Health in accordance with Sec.  93.523. The 
decision made under that section is the final HHS action, unless that 
decision results in a recommendation for debarment or suspension. In 
that case, the decision under Sec.  93.523 shall constitute findings of 
fact to the debarring official in accordance with 45 CFR 76.845(c).
    (d) Where a proposed debarment or suspension action is based upon 
an ORI finding of research misconduct, the procedures in this part 
provide the notification, opportunity to contest, and fact-finding 
required under the HHS debarment and suspension regulations at 45 CFR 
part 76, subparts H and G, respectively, and 48 CFR Subparts 9.4 and 
309.4.


Sec.  93.501  Opportunity to contest findings of research misconduct 
and administrative actions.

    (a) Opportunity to contest. A respondent may contest ORI findings 
of research misconduct and HHS administrative actions, including any 
debarment or suspension action, by requesting a hearing within 30 days 
of receipt of the charge letter or other written notice provided under 
Sec.  93.405.
    (b) Form of a request for hearing. The respondent's request for a 
hearing must be--
    (1) In writing;
    (2) Signed by the respondent or by the respondent's attorney; and
    (3) Sent by certified mail, or other equivalent (i.e., with a 
verified method of delivery), to the DAB Chair and ORI.
    (c) Contents of a request for hearing. The request for a hearing 
must--
    (1) Admit or deny each finding of research misconduct and each 
factual assertion made in support of the finding;
    (2) Accept or challenge each proposed HHS administrative action;
    (3) Provide detailed, substantive reasons for each denial or 
challenge;
    (4) Identify any legal issues or defenses that the respondent 
intends to raise during the proceeding; and
    (5) Identify any mitigating factors that the respondent intends to 
prove.
    (d) Extension for good cause to supplement the hearing request. (1) 
After receiving notification of the appointment of the ALJ, the 
respondent has 10 days to submit a written request to the ALJ for 
supplementation of the hearing request to comply fully with the 
requirements of paragraph (c) of this section. The written request must 
show good cause in accordance with paragraph (d)(2) of this section and 
set forth the proposed supplementation of the hearing request. The ALJ 
may permit the proposed supplementation of the hearing request in whole 
or in part upon a finding of good cause.
    (2) Good cause means circumstances beyond the control of the 
respondent or respondent's representative and not attributable to 
neglect or administrative inadequacy.

Hearing Process


Sec.  93.502  Appointment of the Administrative Law Judge and 
scientific expert.

    (a) Within 30 days of receiving a request for a hearing, the DAB 
Chair, in consultation with the Chief Administrative Law Judge, must 
designate an Administrative Law Judge (ALJ) to determine whether the 
hearing request should be granted and, if the hearing request is 
granted, to make recommended findings in the case after a hearing or 
review of the administrative record in accordance with this part.
    (b) The ALJ may retain one or more persons with appropriate 
scientific or technical expertise to assist the ALJ in evaluating 
scientific or technical issues related to the findings of research 
misconduct.
    (1) On the ALJ's or a party's motion to appoint an expert, the ALJ 
must give the parties an opportunity to submit nominations. If such a 
motion is made by a party, the ALJ must appoint an expert, either:
    (i) The expert, if any, who is agreed upon by both parties and 
found to be qualified by the ALJ; or,
    (ii) If the parties cannot agree upon an expert, the expert chosen 
by the ALJ.
    (2) The ALJ may seek advice from the expert(s) at any time during 
the discovery and hearing phases of the proceeding. The expert(s) shall 
provide advice to the ALJ in the form of a written report or reports 
that will be served upon the parties within 10 days of submission to 
the ALJ. That report must contain a statement of the expert's 
background and qualifications. Any comment on or response to a report 
by a party, which may include comments on the expert's qualifications, 
must be submitted to the ALJ in accordance with Sec.  93.510(c). The 
written reports and any comment on, or response to them are part of the 
record. Expert witnesses of the parties may testify on the reports and 
any comments or responses at the hearing, unless the ALJ determines 
such testimony to be inadmissible in accordance with Sec.  93.519, or 
that such testimony would unduly delay the proceeding.
    (c) No ALJ, or person hired or appointed to assist the ALJ, may 
serve in any proceeding under this subpart if he or she has any real or 
apparent conflict of interest, bias, or prejudice that might reasonably 
impair his or her objectivity in the proceeding.
    (d) Any party to the proceeding may request the ALJ or scientific 
expert to withdraw from the proceeding because of a real or apparent 
conflict of interest, bias, or prejudice under paragraph (c) of this 
section. The motion to disqualify must be timely and state with 
particularity the grounds for disqualification. The ALJ may rule upon 
the motion or certify it to the Chief ALJ for decision. If the ALJ 
rules upon the motion, either party may appeal the decision to the 
Chief ALJ.
    (e) An ALJ must withdraw from any proceeding for any reason found 
by the ALJ or Chief ALJ to be disqualifying.


Sec.  93.503  Grounds for granting a hearing request.

    (a) The ALJ must grant a respondent's hearing request if the ALJ 
determines there is a genuine dispute over facts material to the 
findings of research misconduct or proposed administrative actions, 
including any debarment or suspension action. The respondent's general 
denial or assertion of error for each finding of research misconduct, 
and any basis for the finding, or for the proposed HHS administrative 
actions in

[[Page 28396]]

the charge letter, is not sufficient to establish a genuine dispute.
    (b) The hearing request must specifically deny each finding of 
research misconduct in the charge letter, each basis for the finding 
and each HHS administrative action in the charge letter, or it is 
considered an admission by the respondent. If the hearing request does 
not specifically dispute the HHS administrative actions, including any 
debarment or suspension actions, they are considered accepted by the 
respondent.
    (c) If the respondent does not request a hearing within the 30-day 
time period prescribed in Sec.  93.501(a), the finding(s) and any 
administrative action(s), other than debarment or suspension actions, 
become final agency actions at the expiration of the 30-day period. 
Where there is a proposal for debarment or suspension, after the 
expiration of the 30-day time period the official record is closed and 
forwarded to the debarring official for a final decision.
    (d) If the ALJ grants the hearing request, the respondent may waive 
the opportunity for any in-person proceeding, and the ALJ may review 
and decide the case on the basis of the administrative record. The ALJ 
may grant a respondent's request that waiver of the in-person 
proceeding be conditioned upon the opportunity for respondent to file 
additional pleadings and documentation. ORI may also supplement the 
administrative record through pleadings, documents, in-person or 
telephonic testimony, and oral presentations.


Sec.  93.504  Grounds for dismissal of a hearing request.

    (a) The ALJ must dismiss a hearing request if the respondent--
    (1) Does not file the request within 30 days after receiving the 
charge letter;
    (2) Does not raise a genuine dispute over facts or law material to 
the findings of research misconduct and any administrative actions, 
including debarment and suspension actions, in the hearing request or 
in any extension to supplement granted by the ALJ under Sec.  
93.501(d);
    (3) Does not raise any issue which may properly be addressed in a 
hearing;
    (4) Withdraws or abandons the hearing request; or
    (b) The ALJ may dismiss a hearing request if the respondent fails 
to provide ORI with notice in the form and manner required by Sec.  
93.501.


Sec.  93.505  Rights of the parties.

    (a) The parties to the hearing are the respondent and ORI. The 
investigating institution is not a party to the case, unless it is a 
respondent.
    (b) Except as otherwise limited by this subpart, the parties may--
    (1) Be accompanied, represented, and advised by an attorney;
    (2) Participate in any case-related conference held by the ALJ;
    (3) Conduct discovery of documents and other tangible items;
    (4) Agree to stipulations of fact or law that must be made part of 
the record;
    (5) File motions in writing before the ALJ;
    (6) Present evidence relevant to the issues at the hearing;
    (7) Present and cross-examine witnesses;
    (8) Present oral arguments;
    (9) Submit written post-hearing briefs, proposed findings of fact 
and conclusions of law, and reply briefs within reasonable time frames 
agreed upon by the parties or established by the ALJ as provided in 
Sec.  93.522; and
    (10) Submit materials to the ALJ and other parties under seal, or 
in redacted form, when necessary, to protect the confidentiality of any 
information contained in them consistent with this part, the Privacy 
Act, the Freedom of Information Act, or other Federal law or 
regulation.


Sec.  93.506  Authority of the Administrative Law Judge.

    (a) The ALJ assigned to the case must conduct a fair and impartial 
hearing, avoid unnecessary delay, maintain order, and assure that a 
complete and accurate record of the proceeding is properly made. The 
ALJ is bound by all Federal statutes and regulations, Secretarial 
delegations of authority, and applicable HHS policies and may not 
refuse to follow them or find them invalid, as provided in paragraph 
(c)(4) of this section. The ALJ has the authorities set forth in this 
part.
    (b) Subject to review as provided elsewhere in this subpart, the 
ALJ may--
    (1) Set and change the date, time, schedule, and place of the 
hearing upon reasonable notice to the parties;
    (2) Continue or recess the hearing in whole or in part for a 
reasonable period of time;
    (3) Hold conferences with the parties to identify or simplify the 
issues, or to consider other matters that may aid in the prompt 
disposition of the proceeding;
    (4) Administer oaths and affirmations;
    (5) Require the attendance of witnesses at a hearing;
    (6) Rule on motions and other procedural matters;
    (7) Require the production of documents and regulate the scope and 
timing of documentary discovery as permitted by this part;
    (8) Require each party before the hearing to provide the other 
party and the ALJ with copies of any exhibits that the party intends to 
introduce into evidence;
    (9) Issue a ruling, after an in camera inspection if necessary, to 
address the disclosure of any evidence or portion of evidence for which 
confidentiality is requested under this part or other Federal law or 
regulation, or which a party submitted under seal;
    (10) Regulate the course of the hearing and the conduct of 
representatives, parties, and witnesses;
    (11) Examine witnesses and receive evidence presented at the 
hearing;
    (12) Admit, exclude, or limit evidence offered by a party;
    (13) Hear oral arguments on facts or law during or after the 
hearing;
    (14) Upon motion of a party, take judicial notice of facts;
    (15) Upon motion of a party, decide cases, in whole or in part, by 
summary judgment where there is no disputed issue of material fact;
    (16) Conduct any conference or oral argument in person, by 
telephone, or by audio-visual communication;
    (17) Take action against any party for failing to follow an order 
or procedure or for disruptive conduct.
    (c) The ALJ does not have the authority to--
    (1) Enter an order in the nature of a directed verdict;
    (2) Compel settlement negotiations;
    (3) Enjoin any act of the Secretary; or
    (4) Find invalid or refuse to follow Federal statutes or 
regulations, Secretarial delegations of authority, or HHS policies.


Sec.  93.507  Ex parte communications.

    (a) No party, attorney, or other party representative may 
communicate ex parte with the ALJ on any matter at issue in a case, 
unless both parties have notice and an opportunity to participate in 
the communication. However, a party, attorney, or other party 
representative may communicate with DAB staff about administrative or 
procedural matters.
    (b) If an ex parte communication occurs, the ALJ will disclose it 
to the other party and make it part of the record after the other party 
has an opportunity to comment.
    (c) The provisions of this section do not apply to communications 
between an employee or contractor of the DAB and the ALJ.


Sec.  93.508  Filing, forms, and service.

    (a) Filing. (1) Unless the ALJ provides otherwise, all submissions 
required or authorized to be filed in the proceeding must be filed with 
the ALJ.

[[Page 28397]]

    (2) Submissions are considered filed when they are placed in the 
mail, transmitted to a private delivery service for the purpose of 
delivering the item to the ALJ, or submitted in another manner 
authorized by the ALJ.
    (b) Forms. (1) Unless the ALJ provides otherwise, all submissions 
filed in the proceeding must include an original and two copies. The 
ALJ may designate the format for copies of nondocumentary materials 
such as videotapes, computer disks, or physical evidence. This 
provision does not apply to the charge letter or other written notice 
provided under Sec.  93.405.
    (2) Every submission filed in the proceeding must include the title 
of the case, the docket number, and a designation of the nature of the 
submission, such as a ``Motion to Compel the Production of Documents'' 
or ``Respondent's Proposed Exhibits.''
    (3) Every submission filed in the proceeding must be signed by and 
contain the address and telephone number of the party on whose behalf 
the document or paper was filed, or the attorney of record for the 
party.
    (c) Service. A party filing a submission with the ALJ must, at the 
time of filing, serve a copy on the other party. Service may be made 
either to the last known principal place of business of the party's 
attorney if the party is represented by an attorney, or, if not, to the 
party's last known address. Service may be made by--
    (1) Certified mail;
    (2) First-class postage prepaid U.S. Mail;
    (3) A private delivery service;
    (4) Hand-delivery; or
    (5) Facsimile or other electronic means if permitted by the ALJ.
    (d) Proof of service. Each party filing a document or paper with 
the ALJ must also provide proof of service at the time of the filing. 
Any of the following items may constitute proof of service:
    (1) A certified mail receipt returned by the postal service with a 
signature;
    (2) An official record of the postal service or private delivery 
service;
    (3) A certificate of service stating the method, place, date of 
service, and person served that is signed by an individual with 
personal knowledge of these facts; or
    (4) Other proof authorized by the ALJ.


Sec.  93.509  Computation of time.

    (a) In computing any period of time under this part for filing and 
service or for responding to an order issued by the ALJ, the 
computation begins with the day following the act or event, and 
includes the last day of the period unless that day is a Saturday, 
Sunday, or legal holiday observed by the Federal government, in which 
case it includes the next business day.
    (b) When the period of time allowed is less than 7 days, 
intermediate Saturdays, Sundays, and legal holidays observed by the 
Federal government must be excluded from the computation.
    (c) Where a document has been filed by placing it in the mail, an 
additional 5 days must be added to the time permitted for any response. 
This paragraph does not apply to a respondent's request for hearing 
under Sec.  93.501.
    (d) Except for the respondent's request for a hearing, the ALJ may 
modify the time for the filing of any document or paper required or 
authorized under the rules in this part to be filed for good cause 
shown. When time permits, notice of a party's request for extension of 
the time and an opportunity to respond must be provided to the other 
party.


Sec.  93.510  Filing motions.

    (a) Parties must file all motions and requests for an order or 
ruling with the ALJ, serve them on the other party, state the nature of 
the relief requested, provide the legal authority relied upon, and 
state the facts alleged.
    (b) All motions must be in writing except for those made during a 
prehearing conference or at the hearing.
    (c) Within 10 days after being served with a motion, or other time 
as set by the ALJ, a party may file a response to the motion. The 
moving party may not file a reply to the responsive pleading unless 
allowed by the ALJ.
    (d) The ALJ may not grant a motion before the time for filing a 
response has expired, except with the parties' consent or after a 
hearing on the motion. However, the ALJ may overrule or deny any motion 
without awaiting a response.
    (e) The ALJ must make a reasonable effort to dispose of all motions 
promptly, and, whenever possible, dispose of all outstanding motions 
before the hearing.


Sec.  93.511  Prehearing conferences.

    (a) The ALJ must schedule an initial prehearing conference with the 
parties within 30 days of the DAB Chair's assignment of the case.
    (b) The ALJ may use the initial prehearing conference to discuss--
    (1) Identification and simplification of the issues, specification 
of disputes of fact and their materiality to the ORI findings of 
research misconduct and any HHS administrative actions, and amendments 
to the pleadings, including any need for a more definite statement;
    (2) Stipulations and admissions of fact including the contents, 
relevancy, and authenticity of documents;
    (3) Respondent's waiver of an administrative hearing, if any, and 
submission of the case on the basis of the administrative record as 
provided in Sec.  93.503(d);
    (4) Identification of legal issues and any need for briefing before 
the hearing;
    (5) Identification of evidence, pleadings, and other materials, if 
any, that the parties should exchange before the hearing;
    (6) Identification of the parties' witnesses, the general nature of 
their testimony, and the limitation on the number of witnesses and the 
scope of their testimony;
    (7) Scheduling dates such as the filing of briefs on legal issues 
identified in the charge letter or the respondent's request for 
hearing, the exchange of witness lists, witness statements, proposed 
exhibits, requests for the production of documents, and objections to 
proposed witnesses and documents;
    (8) Scheduling the time, place, and anticipated length of the 
hearing; and
    (9) Other matters that may encourage the fair, just, and prompt 
disposition of the proceedings.
    (c) The ALJ may schedule additional prehearing conferences as 
appropriate, upon reasonable notice to or request of the parties.
    (d) All prehearing conferences will be audio-taped with copies 
provided to the parties upon request.
    (e) Whenever possible, the ALJ must memorialize in writing any oral 
rulings within 10 days after the prehearing conference.
    (f) By 15 days before the scheduled hearing date, the ALJ must hold 
a final prehearing conference to resolve to the maximum extent possible 
all outstanding issues about evidence, witnesses, stipulations, motions 
and all other matters that may encourage the fair, just, and prompt 
disposition of the proceedings.


Sec.  93.512  Discovery.

    (a) Request to provide documents. A party may only request another 
party to produce documents or other tangible items for inspection and 
copying that are relevant and material to the issues identified in the 
charge letter and in the respondent's request for hearing.
    (b) Meaning of documents. For purposes of this subpart, the term 
documents includes information, reports, answers, records, accounts, 
papers, tangible items, and other data and documentary evidence. This 
subpart does not require the creation of any document. However, 
requested data

[[Page 28398]]

stored in an electronic data storage system must be produced in a form 
reasonably accessible to the requesting party.
    (c) Nondisclosable items. This section does not authorize the 
disclosure of--
    (1) Interview reports or statements obtained by any party, or on 
behalf of any party, of persons whom the party will not call as witness 
in its case-in-chief;
    (2) Analyses and summaries prepared in conjunction with the 
inquiry, investigation, ORI oversight review, or litigation of the 
case; or
    (3) Any privileged documents, including but not limited to those 
protected by the attorney-client privilege, attorney-work product 
doctrine, or Federal law or regulation.
    (d) Responses to a discovery request. Within 30 days of receiving a 
request for the production of documents, a party must either fully 
respond to the request, submit a written objection to the discovery 
request, or seek a protective order from the ALJ. If a party objects to 
a request for the production of documents, the party must identify each 
document or item subject to the scope of the request and state the 
basis of the objection for each document, or any part that the party 
does not produce.
    (1) Within 30 days of receiving any objections, the party seeking 
production may file a motion to compel the production of the requested 
documents.
    (2) The ALJ may order a party to produce the requested documents 
for in camera inspection to evaluate the merits of a motion to compel 
or for a protective order.
    (3) The ALJ must compel the production of a requested document and 
deny a motion for a protective order, unless the requested document 
is--
    (i) Not relevant or material to the issues identified in the charge 
letter or the respondent's request for hearing;
    (ii) Unduly costly or burdensome to produce;
    (iii) Likely to unduly delay the proceeding or substantially 
prejudice a party;
    (iv) Privileged, including but not limited to documents protected 
by the attorney-client privilege, attorney-work product doctrine, or 
Federal law or regulation; or
    (v) Collateral to issues to be decided at the hearing.
    (4) If any part of a document is protected from disclosure under 
paragraph (d)(3) of this section, the ALJ must redact the protected 
portion of a document before giving it to the requesting party.
    (5) The party seeking discovery has the burden of showing that the 
ALJ should allow it.
    (e) Refusal to produce items. If a party refuses to provide 
requested documents when ordered by the ALJ, the ALJ may take 
corrective action, including but not limited to, ordering the 
noncompliant party to submit written answers under oath to written 
interrogatories posed by the other party or taking any of the actions 
at Sec.  93.515.


Sec.  93.513  Submission of witness lists, witness statements, and 
exhibits.

    (a) By 60 days before the scheduled hearing date, each party must 
give the ALJ a list of witnesses to be offered during the hearing and a 
statement describing the substance of their proposed testimony, copies 
of any prior written statements or transcribed testimony of proposed 
witnesses, a written report of each expert witness to be called to 
testify that meets the requirements of Federal Rule of Civil Procedure 
26(a)(2)(B), and copies of proposed hearing exhibits, including copies 
of any written statements that a party intends to offer instead of live 
direct testimony. If there are no prior written statements or 
transcribed testimony of a proffered witness, the party must submit a 
detailed factual affidavit of the proposed testimony.
    (b) A party may supplement its submission under paragraph (a) of 
this section until 30 days before the scheduled hearing date if the ALJ 
determines:
    (1) There are extraordinary circumstances; and
    (2) There is no substantial prejudice to the objecting party.
    (c) The parties must have an opportunity to object to the admission 
of evidence submitted under paragraph (a) of this section under a 
schedule set by the ALJ. However, the parties must file all objections 
before the final prehearing conference.
    (d) If a party tries to introduce evidence after the deadlines in 
paragraph (a) of this section, the ALJ must exclude the offered 
evidence from the party's case-in-chief unless the conditions of 
paragraph (b) of this section are met. If the ALJ admits evidence under 
paragraph (b) of this section, the objecting party may file a motion to 
postpone all or part of the hearing to allow sufficient time to prepare 
and respond to the evidence. The ALJ may not unreasonably deny that 
motion.
    (e) If a party fails to object within the time set by the ALJ and 
before the final prehearing conference, evidence exchanged under 
paragraph (a) of this section is considered authentic, relevant and 
material for the purpose of admissibility at the hearing.


Sec.  93.514  Amendment to the charge letter.

    (a) The ORI may amend the findings of research misconduct up to 30 
days before the scheduled hearing.
    (b) The ALJ may not unreasonably deny a respondent's motion to 
postpone all or part of the hearing to allow sufficient time to prepare 
and respond to the amended findings.


Sec.  93.515  Actions for violating an order or for disruptive conduct.

    (a) The ALJ may take action against any party in the proceeding for 
violating an order or procedure or for other conduct that interferes 
with the prompt, orderly, or fair conduct of the hearing. Any action 
imposed upon a party must reasonably relate to the severity and nature 
of the violation or disruptive conduct.
    (b) The actions may include--
    (1) Prohibiting a party from introducing certain evidence or 
otherwise supporting a particular claim or defense;
    (2) Striking pleadings, in whole or in part;
    (3) Staying the proceedings;
    (4) Entering a decision by default;
    (5) Refusing to consider any motion or other action not timely 
filed; or
    (6) Drawing the inference that spoliated evidence was unfavorable 
to the party responsible for its spoliation.


Sec.  93.516  Standard and burden of proof.

    (a) Standard of proof. The standard of proof is the preponderance 
of the evidence.
    (b) Burden of proof. (1) ORI bears the burden of proving the 
findings of research misconduct. The destruction, absence of, or 
respondent's failure to provide research records adequately documenting 
the questioned research is evidence of research misconduct where ORI 
establishes by a preponderance of the evidence that the respondent 
intentionally, knowingly, or recklessly had research records and 
destroyed them, had the opportunity to maintain the records but did not 
do so, or maintained the records and failed to produce them in a timely 
manner and the respondent's conduct constitutes a significant departure 
from accepted practices of the relevant research community.
    (2) The respondent has the burden of going forward with and the 
burden of proving, by a preponderance of the evidence, any and all 
affirmative defenses raised. In determining whether ORI has carried the 
burden of proof

[[Page 28399]]

imposed by this part, the ALJ shall give due consideration to 
admissible, credible evidence of honest error or difference of opinion 
presented by the respondent.
    (3) ORI bears the burden of proving that the proposed HHS 
administrative actions are reasonable under the circumstances of the 
case. The respondent has the burden of going forward with and proving 
by a preponderance of the evidence any mitigating factors that are 
relevant to a decision to impose HHS administrative actions following a 
research misconduct proceeding.


Sec.  93.517  The hearing.

    (a) The ALJ will conduct an in-person hearing to decide if the 
respondent committed research misconduct and if the HHS administrative 
actions, including any debarment or suspension actions, are 
appropriate.
    (b) The ALJ provides an independent de novo review of the ORI 
findings of research misconduct and the proposed HHS administrative 
actions. The ALJ does not review the institution's procedures or 
misconduct findings or ORI's research misconduct proceedings.
    (c) A hearing under this subpart is not limited to specific 
findings and evidence set forth in the charge letter or the 
respondent's request for hearing. Additional evidence and information 
may be offered by either party during its case-in-chief unless the 
offered evidence is--
    (1) Privileged, including but not limited to those protected by the 
attorney-client privilege, attorney-work product doctrine, or Federal 
law or regulation.
    (2) Otherwise inadmissible under Sec. Sec.  93.515 or 93.519.
    (3) Not offered within the times or terms of Sec. Sec.  93.512 and 
93.513.
    (d) ORI proceeds first in its presentation of evidence at the 
hearing.
    (e) After both parties have presented their cases-in-chief, the 
parties may offer rebuttal evidence even if not exchanged earlier under 
Sec. Sec.  93.512 and 93.513.
    (f) Except as provided in Sec.  93.518(c), the parties may appear 
at the hearing in person or by an attorney of record in the proceeding.
    (g) The hearing must be open to the public, unless the ALJ orders 
otherwise for good cause shown. However, even if the hearing is closed 
to the public, the ALJ may not exclude a party or party representative, 
persons whose presence a party shows to be essential to the 
presentation of its case, or expert witnesses.


Sec.  93.518  Witnesses.

    (a) Except as provided in paragraph (b) of this section, witnesses 
must give testimony at the hearing under oath or affirmation.
    (b) The ALJ may admit written testimony if the witness is available 
for cross-examination, including prior sworn testimony of witnesses 
that has been subject to cross-examination. These written statements 
must be provided to all other parties under Sec.  93.513.
    (c) The parties may conduct direct witness examination and cross-
examination in person, by telephone, or by audio-visual communication 
as permitted by the ALJ. However, a respondent must always appear in-
person to present testimony and for cross-examination.
    (d) The ALJ may exercise reasonable control over the mode and order 
of questioning witnesses and presenting evidence to--
    (1) Make the witness questioning and presentation relevant to 
deciding the truth of the matter; and
    (2) Avoid undue repetition or needless consumption of time.
    (e) The ALJ must permit the parties to conduct cross-examination of 
witnesses.
    (f) Upon request of a party, the ALJ may exclude a witness from the 
hearing before the witness' own testimony. However, the ALJ may not 
exclude--
    (1) A party or party representative;
    (2) Persons whose presence is shown by a party to be essential to 
the presentation of its case; or
    (3) Expert witnesses.


Sec.  93.519  Admissibility of evidence.

    (a) The ALJ decides the admissibility of evidence offered at the 
hearing.
    (b) Except as provided in this part, the ALJ is not bound by the 
Federal Rules of Evidence (FRE). However, the ALJ may apply the FRE 
where appropriate (e.g., to exclude unreliable evidence).
    (c) The ALJ must admit evidence unless it is clearly irrelevant, 
immaterial, or unduly repetitious. However, the ALJ may exclude 
relevant and material evidence if its probative value is substantially 
outweighed by the danger of unfair prejudice, confusion of the issues, 
or by considerations of undue delay or needless presentation of 
cumulative evidence under FRE 401-403.
    (d) The ALJ must exclude relevant and material evidence if it is 
privileged, including but not limited to evidence protected by the 
attorney-client privilege, the attorney-work product doctrine, or 
Federal law or regulation.
    (e) The ALJ may take judicial notice of matters upon the ALJ's own 
initiative or upon motion by a party as permitted under FRE 201 
(Judicial Notice of Adjudicative Facts).
    (1) The ALJ may take judicial notice of any other matter of 
technical, scientific, or commercial fact of established character.
    (2) The ALJ must give the parties adequate notice of matters 
subject to judicial notice and adequate opportunity to show that the 
ALJ erroneously noticed the matters.
    (f) Evidence of crimes, wrongs, or acts other than those at issue 
in the hearing is admissible only as permitted under FRE 404(b) 
(Character Evidence not Admissible to Prove Conduct; Exceptions, Other 
Crimes).
    (g) Methods of proving character are admissible only as permitted 
under FRE 405 (Methods of Proving Character).
    (h) Evidence related to the character and conduct of witnesses is 
admissible only as permitted under FRE Rule 608 (Evidence of Character 
and Conduct of Witness).
    (i) Evidence about offers of compromise or settlement made in this 
action is inadmissible as provided in FRE 408 (Compromise and Offers to 
Compromise).
    (j) The ALJ must admit relevant and material hearsay evidence, 
unless an objecting party shows that the offered hearsay evidence is 
not reliable.
    (k) The parties may introduce witnesses and evidence on rebuttal.
    (l) All documents and other evidence offered or admitted into the 
record must be open to examination by both parties, unless otherwise 
ordered by the ALJ for good cause shown.
    (m) Whenever the ALJ excludes evidence, the party offering the 
evidence may make an offer of proof, and the ALJ must include the offer 
in the transcript or recording of the hearing in full. The offer of 
proof should consist of a brief oral statement describing the evidence 
excluded. If the offered evidence consists of an exhibit, the ALJ must 
mark it for identification and place it in the hearing record. However, 
the ALJ may rely upon the offered evidence in reaching the decision on 
the case only if the ALJ admits it.


Sec.  93.520  The record.

    (a) HHS will record and transcribe the hearing, and if requested, 
provide a transcript to the parties at HHS' expense.
    (b) The exhibits, transcripts of testimony, any other evidence 
admitted at the hearing, and all papers and requests filed in the 
proceeding constitute the record for the decision by the ALJ.

[[Page 28400]]

    (c) For good cause shown, the ALJ may order appropriate redactions 
made to the record at any time.
    (d) The DAB may return original research records and other similar 
items to the parties or awardee institution upon request after final 
HHS action, unless under judicial review.


Sec.  93.521  Correction of the transcript.

    (a) At any time, but not later than the time set for the parties to 
file their post-hearing briefs, any party may file a motion proposing 
material corrections to the transcript or recording.
    (b) At any time before the filing of the ALJ's decision and after 
consideration of any corrections proposed by the parties, the ALJ may 
issue an order making any requested corrections in the transcript or 
recording.


Sec.  93.522  Filing post-hearing briefs.

    (a) After the hearing and under a schedule set by the ALJ , the 
parties may file post-hearing briefs, and the ALJ may allow the parties 
to file reply briefs.
    (b) The parties may include proposed findings of fact and 
conclusions of law in their post-hearing briefs.


Sec.  93.523  The Administrative Law Judge's ruling.

    (a) The ALJ shall issue a ruling in writing setting forth proposed 
findings of fact and any conclusions of law within 60 days after the 
last submission by the parties in the case. If unable to meet the 60-
day deadline, the ALJ must set a new deadline and promptly notify the 
parties, the Assistant Secretary for Health and the debarring official, 
if debarment or suspension is under review. The ALJ shall serve a copy 
of the ruling upon the parties and the Assistant Secretary for Health.
    (b) The ruling of the ALJ constitutes a recommended decision to the 
Assistant Secretary for Health. The Assistant Secretary for Health may 
review the ALJ's recommended decision and modify or reject it in whole 
or in part after determining it, or the part modified or rejected, to 
be arbitrary and capricious or clearly erroneous. The Assistant 
Secretary for Health shall notify the parties of an intention to review 
the ALJ's recommended decision within 30 days after service of the 
recommended decision. If that notification is not provided within the 
30-day period, the ALJ's recommended decision shall become final. An 
ALJ decision that becomes final in that manner or a decision by the 
Assistant Secretary for Health modifying or rejecting the ALJ's 
recommended decision in whole or in part is the final HHS action, 
unless debarment or suspension is an administrative action recommended 
in the decision.
    (c) If a decision under Sec.  93.523(b) results in a recommendation 
for debarment or suspension, the Assistant Secretary for Health shall 
serve a copy of the decision upon the debarring official and the 
decision shall constitute findings of fact to the debarring official in 
accordance with 45 CFR 76.845(c). The decision of the debarring 
official on debarment or suspension is the final HHS decision on those 
administrative actions.
[FR Doc. 05-9643 Filed 5-16-05; 8:45 am]

BILLING CODE 4150-31-P

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