Notice Number: NOT-OD-10-099
Update: The following update relating to this announcement has been issued:
- July 21, 2010 - See Notice NOT-OD-10-113 Notice of Extension of Comment Period 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.
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.
- Electronically through Regulations.gov.
- By regular mail to:
Attention: Jerry Moore
NIH Regulations Officer
NIH Office of Management Assessment
6011 Executive Boulevard
Suite 601, MSC 7669
Rockville, MD 20852-7669.
- By fax to: 301-402-0169
- Hand Delivery/Courier (for paper, disk, or CD-ROM submissions).
Attention: Jerry Moore
6011 Executive Boulevard
Suite 601, Rockville, MD 20852-7669.
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:
- Investigators disclosure of information regarding significant financial interests to Institutions;
- Institutions management of identified financial conflicts of interest (FCOI) and reporting of FCOI to NIH and other PHS agencies;
- Public disclosure of information regarding Investigator FCOI.
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
and Human Services (HHS)
