The Department of Health and Human Services (“HHS”) in coordination with the Office of Science and Technology Policy (“OSTP”) will reportedly announce on September 1, 2011, an extension to the comment period for an advanced notice of proposed rulemaking (“ANPRM”) in the Federal Register. The ANPRM was published in the Federal Register on July 26, 2011 (76 FR 44512) and requested comments and ideas for modernizing and enhancing current regulations protecting human research subjects (45 CFR Parts 46, 160 and 164; 21 CFR Parts 50 and 56). Specifically, HHS is seeking ideas on how to better protect human subjects, while reducing the burden, delay and ambiguity for investigators and research subjects. The original deadline for submitting comments was September 26, 2011, but comments will now be received through October 26, 2011. The extension is being given in response to requests for additional time to fully review the ANPRM.
This is the first substantive revision of the Federal Policy for Protection of Human Subjects or the “Common Rule” (45 CFR Part 46, Subpart A) since its adoption two decades ago. The updates will also affect regulations for human subject research that is subject to the jurisdiction of the Food and Drug Administration (“FDA”). Institutions that conduct research involving human subjects should review the ANPRM and consider submitting comments regarding any changes they’d like to see.
Comments should be identified by docket ID number HHS-OPHS-2011-005. They may be submitted online at http://www.regulations.gov or may be mailed to Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Any comments received will be posted online at http://www.regulations.gov.
The ANPRM from July 26 can be found at:
http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm
The announcement of the anticipated extension can be found at:
http://www.ofr.gov/OFRUpload/OFRData/2011-22341_PI.pdf
If you have any questions or would like further information, please contact Melissa L. Markey at248.457.7853
or mmarkey@wp.hallrender.com, Andrea B. Anantharam at 248.457.7822 or aanantharam@wp.hallrender.com or your regular Hall Render attorney.
