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HHS/NIH RIN: 0925-AA53 Publication ID: Fall 2010 
Title: Amendment of Regulation of the Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought and Responsible Prospective Contractors 
Abstract: The Department of Health and Human Services (HHS) and the Public Health Service (PHS) proposes to amend the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought and Responsible Prospective Contractors. Since the promulgation of the current regulations in 1995, biomedical and behavioral research and the resulting interactions among government research institutions and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, have led to the proposal of amendments that would expand and add transparency to investigator disclosure of significant financial of interests, enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests, as well as the agency's ability to ensure compliance. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 45 CFR 94   
Legal Authority: 42 USC 216    42 USC 289b-1    42 USC 299c-4    Sec. 219, Tit.II, Div D, Pub 111-117, 123 Stat. 3034   
Legal Deadline:  None
Action Date FR Cite
ANPRM  05/08/2009  74 FR 21610   
ANPRM Comment Period End  07/07/2009    
NPRM  05/21/2010  75 FR 28688   
NPRM Comment Period End  08/19/2010  75 FR 42362   
Final Action  04/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  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

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