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

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

Notice Number: NOT-OD-10-113

Key Dates
Release Date: July 21, 2010
Deadline for Submission of Comments: August 19, 2010

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

Purpose:

The U.S. Department of Health and Human Services (HHS), including the HHS Public Health Service (PHS) recently published a Notice extending the comment period for the proposed rule that would amend the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors, to clarify certain elements of the proposed rule for which HHS is seeking additional comment. The comment period has been extended for 30 days and thus will end on August 19, 2010.

The Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on May 21, 2010 (67 FR 28688). The 30-day extension period will allow HHS to seek public comment on whether the proposed changes to the regulations’ reference to enforcement authorities available to the PHS, including those discussed in the current NPRM, should be further revised and clarified in the regulations. In addition, HHS also seeks comment as to whether it should clarify how the regulations apply in circumstances in which an Investigator or a PHS-funded research project transfers from one Institution to another, or in which a new Institution, and Investigators at the new Institution, become involved in an ongoing PHS-funded research project. The NIH is a part of the PHS and is accepting comments on behalf of the PHS.

To assure consideration, comments must be received by August 19, 2010.

Individuals and organizations interested in submitting comments, identified by (RIN 0925-AA53) and Docket Number [NIH-2010-000]1 may do so by any of the following methods. Electronic submission is preferred.

Electronic Submissions:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions:

Fax: 301-402-0169
Mail: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669
Hand Delivery/Courier (for paper, disk, or CD-ROM submissions).

                        Attention: Jerry Moore
                        6011 Executive Boulevard
                        Suite 601, Rockville, MD 20852-7669

With the publication of the Amended Notice ( http://edocket.access.gpo.gov/2010/pdf/2010-17739.pdf ) and 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