October 15, 2021

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HHS Extends Comment Period for Advanced Notice of Proposed Rule Making Concerning the Common Rule

On July 26, 2011, the U.S. Department of Health and Human Services (HHS) issued an advance notice of proposed rulemaking (ANPRM) entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” (Volume 76, Number 143, page 44512).  The comment period was to close on September 26, 2011, however, in light of numerous requests, HHS has extended it by 30 days.  Thus the comment period now ends October 26, 2011.  Due to the wide-ranging potential impact of the proposed changes on human subjects research conducted domestically, this extension gives sponsors, investigators, institutional review boards, contract research organizations and others likely to be affected by the sweeping proposed changes much needed additional time to fully review and comment on the ANPRM. 

For additional information about the ANPRM, please click here and here.

© 2021 McDermott Will & EmeryNational Law Review, Volume I, Number 254
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About this Author

Bernadette M. Broccolo, McDermott Will Emery Law Firm, Health Care Attorney
Partner

Bernadette M. Broccolo is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  Bernadette has been counseling health industry organizations for over  33 years on leading edge health industry relationship formation and realignments, with a recent focus on development of provider network strategies for responding to health reform; health information technology acquisitions; electronic health information network strategy development and implementation to support innovations in care delivery and payment models, translational research and...

312-984-6911
Jennifer S. Geetter, McDermott Will & Emery LLP, Attorney
Partner

Jennifer S. Geetter is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office.  She focuses her practice on emerging biotechnology and safety issues, advising hospital, industry, insurance and provider clients on matters relating to research, drug and device development, off-label use, personalized medicine, formulary compliance, privacy and security, electronic health records and data strategy initiatives, patient safety, conflicts of interest, scientific review and research misconduct, internal hospital disciplinary proceedings,...

202 756 8205
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