Dear Colleagues,

Because ORI is in the process of revising the rule guiding its work, we want to share with you how this rulemaking process works. ORI is undertaking notice-and-comment rulemaking (also known as informal rulemaking) to update 42 CFR Part 93. Such informal rulemaking is set out in the Administrative Procedure Act (APA) and for those of you so inclined, you can read about it here:

https://www.archives.gov/federal-register/laws/administrative-procedure/553.html.   

In brief, this typically involves: (1) publishing a Notice of Proposed Rulemaking (NPRM) in the Federal Register; (2) inviting public comment; (3) considering the public comment; and (4) publishing a final rule in the Federal Register. 

Our approach gives the general public and our colleagues alike, an opportunity to participate in the rulemaking process. This allows any interested person (including you!) to submit comments as mentioned in Step 2, and as described in our October 19th blog post. 

https://ori.hhs.gov/blog/submitting-comment-regulationsgov 

We appreciate and respect each and every one of your comments. Your point of view and concerns related to any topic within the scope of the NPRM will be fully considered during this rulemaking process. Your comments will be respectfully reviewed by members of the ORI team and regularly posted online as they come in, at the web address below:

https://www.regulations.gov/document/HHS-OASH-2023-0014-0001/comment

If you are interested in learning more about the informal rulemaking process, check out this useful resource:

https://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

We want your input on the contents of the NPRM, both what is appreciated and what we should consider changing. No comment is too small and the perspectives of all commenters are important. 

All the best,

Karen Wehner

Director, Division of Education and Integrity

Office of Research Integrity

Office of the Assistant Secretary for Health

U.S. Department of Health and Human Services