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HHS/OPHS RIN: 0940-AA04 Publication ID: Fall 2005 
Title: Public Health Service Policies on Research Misconduct 
Abstract: This notice of proposed rulemaking proposes substantial revisions to the existing regulations at 42 CFR part 50, subpart A, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science," 54 FR 32449, August 8, 1989. The National Institutes of Health Revitalization Act of 1993 (NIH Act), Public Law 103-43, contains provisions that affect the current rule. For example, section 161 of the NIH Act established the Office of Research Integrity (ORI) as an independent entity reporting to the Secretary, and recent organizational changes have also affected the ORI's operations. In addition, the Office of Science and Technology Policy (OSTP) published a Governmentwide policy that applies to federally-funded research and proposals submitted to the Federal agencies for research funding, 65 FR 76260, December 6, 2000. The proposed revised regulation will implement this OSTP policy, which contains a definition of research misconduct and basic guidelines for the response of Federal agencies and research institutions to allegations of research misconduct. The current regulation, which implemented section 493(e) of the Public Health Service Act, would be deleted, and a new part 93, subparts A, B, C, D, and E would be added. 
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: 42 CFR 93   
Legal Authority: 42 USC 216    42 USC 241    42 USC 289b   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/16/2004  69 FR 20778   
NPRM Comment Period End  06/15/2004    
Final Action  05/17/2005  70 FR 28370   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Related to 0940-AA01 
Agency Contact:
Chris Pascal
Director, Office of Research Integrity
Department of Health and Human Services
Office of Public Health and Science
Suite 750, 1101 Wootten Parkway,
Rockville, MD 20852
Phone:240 453-8200
Fax:301 443-5351