[Federal Register Volume 77, Number 20 (Tuesday, January 31, 2012)]
[Pages 4819-4820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2038]



[Document Identifier OS-0990-0260]

Agency Information Collection Request; 60-Day Public Comment 

AGENCY: Office of the Secretary, HHS.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Office of the Secretary (OS), 
Department of Health and Human Services (HHS), is publishing the 
following summary of a proposed information collection request for 
public comment. Interested persons are invited to send comments 
regarding this burden estimate or any other aspect of this collection 
of information, including any of the following subjects: (1) The 
necessity and utility of the proposed information collection for the 
proper performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, email your 
request, including your address, phone number, OMB number, and OS 
document identifier, to Sherette.funncoleman@hhs.gov, or call the 
Reports Clearance Office on (202) 690-5683. Written comments and 
recommendations for the proposed information collections must be 
directed to the OS Paperwork Clearance Officer at the above email 
address within 60 days.
    Proposed Project: Protection of Human Subjects: Assurance of 
Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed 
Consent/Consent Documentation--OMB No. 0990-0260--Office for Human 
Research Protections.
    Abstract: Section 491(a) of Public Law 99-158 states that the 
Secretary of HHS shall by regulation require that each entity applying 
for HHS support (e.g., a grant, contract, or cooperative agreement) to 
conduct research involving human subjects submit to HHS assurances 
satisfactory to the Secretary that it has established an institutional 
review board (IRB) to review the research in order to ensure protection 
of the rights and welfare of the human research subjects. IRBs are 
boards, committees, or groups formally designated by an entity to 
review, approve, and have continuing oversight of research involving 
human subjects.
    Pursuant to the requirement of the Public Law 99-158, HHS 
promulgated regulations at 45 CFR part 46, subpart A, the basic HHS 
Policy for the Protection of Human Subjects. The June 18, 1991 adoption 
of the common Federal Policy (56 FR 28003) by 15 departments and 
agencies implements a recommendation of the President's Commission for 
the Study of Ethical Problems in Medicine and Biomedical and Behavioral 
Research which was established on November 9, 1974, by Public Law 95-
622. The Common Rule is based on HHS regulations at 45 CFR part 46, 
subpart A, the basic HHS Policy for the Protection of Human Subjects.

                                   Total Estimated Annualized Burden--Dollars
                                                                   Total burden     Hourly wage    Total burden
                                                                       hours           rate           dollars
Total...........................................................       1,138,000          $23.20     $26,400,000

[[Page 4820]]

Keith A. Tucker,
Paperwork Reduction Act Clearance Officer, Office of the Secretary.
[FR Doc. 2012-2038 Filed 1-30-12; 8:45 am]