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HHS/NIH RIN: 0925-AA53 Publication ID: Fall 2008 
Title: ●Amendment of Regulation of the Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought and Responsible Prospective Contractors; Request for Comments  
Abstract: On behalf of the Department of Health and Human Services (HHS) and the Public Health Service (PHS), a component of DHHS, the National Institutes of Health (NIH), proposes to issue an Advanced Notice of Proposed Rulemaking (ANPRM) to seek comments from the public on whether DHHS should amend the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought (42 CFR part 50 subpart F) and Responsible Prospective Contractors (45 CFR part 94). The existing regulations provide standards to ensure that there is no reasonable expectation that the design, conduct, and reporting of PHS-funded research will biased by a conflicting financial interest of an investigator. Since the regulations' publication in 1995, biomedical research has progressively become more complex, the Federal-government, PHS-funded institutions and researchers, and the private sector have increasingly interacted in an effort to meet common public health goals, and recent public scrutiny has raised the question of whether a more rigorous approach to investigator disclosure, management of conflicts, and Federal oversight is required. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 45 CFR 94   
Legal Authority: 42 USC 216    42 USC 289b-1    42 USC 299c-4   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  11/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Jerry Moore
NIH Regulations Officer
Department of Health and Human Services
6011 Executive Boulevard, Room 601, MSC 7669,
Rockville, MD 20852
Phone:301 496-4607
Fax:301 402-0169
Email: jm40z@nih.gov