NIH Requests Comments on the Proposed Rule applicable to Regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors

Notice Number: NOT-OD-10-099

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: May 21, 2010
Deadline for Submission of Comments: July 20, 2010

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose:

The U.S. Department of Health and Human Services (HHS) has issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register  (http://edocket.access.gpo.gov/2010/pdf/2010-11885.pdf) to seek public comment  on the proposed changes to the Public Health Service (PHS) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).  The National Institutes of Health (NIH) is a part of the PHS and is accepting comments on behalf of the PHS.
To assure consideration, comments must be received by July 20, 2010.

Individuals and organizations interested in submitting comments, identified by (RIN 0925-AA53) and Docket Number [NIH-2010-0001], may do so by any of the following methods. Electronic submission is preferred.

Background

In 1995, HHS published the regulations at 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94, designed to promote objectivity in PHS-funded research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements, or contracts is not biased by any conflicting financial interest of an Investigator.
Since the existing rules were implemented, the growing complexity of biomedical and behavioral research; the increased interaction among Government, research institutions, and the private sector in attaining common public health goals while meeting public expectations for research integrity; as well as increased public scrutiny, all have raised questions as to whether a more rigorous approach to investigator disclosure, management of financial conflicts, and Federal oversight is required.  Because of the paramount importance that biomedical research be conducted with the highest standards of integrity and be free of bias, an Advanced Notice of Proposed Rulemaking (ANPRM) was issued last year soliciting comments on potential changes to the existing rules.  Following analysis of the comments received in response to the ANPRM, as well as further internal review and deliberation, we have proposed changes to the regulations in the NPRM.
The NRPM proposes comprehensive changes to the entire set of regulations, including a focus on three areas, in particular:

With the publication of the Notice of Proposed Rulemaking (http://edocket.access.gpo.gov/2010/pdf/2010-11885.pdf), we invite comments on all aspects of the proposed regulations during the public comment period.

Inquiries

Email: FCOI-NPRM@MAIL.NIH.GOV


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