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HHS/OPHS RIN: 0940-AA06 Publication ID: Spring 2009 
Title: Human Subjects Protection Regulations: Institutional Review Boards Registration Requirements 
Abstract: This notice of proposed rulemaking proposes to add subpart F to Department of Health and Human Services (HHS) regulations for protection of human subjects, 45 CFR part 46, to require registration of institutional review boards (IRBs) with HHS. The registration information would include contact information, approximate numbers of active protocols involving research conducted or supported by HHS, accreditation status, IRB membership, and staffing for the IRB. The proposed registration requirements will make it easier for the Office for Human Research Protections (OHRP) to convey information to IRBs, and will support the current IRB registration operated by OHRP. Under the current OHRP IRB registration system, the submission of certain registration information is required by human subjects protection regulations, and certain other information may be submitted voluntarily. This proposed information collection was submitted to the Office of Management and Budget under the Paperwork Reduction Act. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with IRB registration requirements of the Food and Drug Administration (FDA), and creating a single HHS IRB Registration system. FDA simultaneously published a proposed rule regarding FDA IRB registration requirements. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 46   
Legal Authority: 5 USC 301    42 USC 289   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/04/2004  69 FR 40584   
NPRM Comment Period End  10/04/2004    
Final Action  01/15/2009  74 FR 2399   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Irene Stith-Coleman Ph.D
Department of Health and Human Services
Office of Public Health and Science
Suite 200, The Tower Building, 1101 Wootten Parkway,
Rockville, MD 20852
Phone:240 453-6900
Fax:301 402-2071
Email: irene.stith-coleman@hhs.gov