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HHS/NIH RIN: 0925-AA53 Publication ID: Fall 2011 
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 is issuing a final rule to amend the final rule to amend the Public Health Service(PHS) 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 regulations in 1995, biomedical and behavioral 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 need for amendments to expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutional oversight and management of investigators' financial conflicts of interst, 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: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 45 CFR 50, subpart F    45 CFR 94     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 USC 216    42 USC 289b-1    42 USC 299c-4    sec 219, title II, Div D, PL 111-117, 123 Stat 3034   
Legal Deadline:  None
Timetable:
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  08/25/2011  76 FR 53256   
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
Email: jm40z@nih.gov