[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Pages 18820-18821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7464]



[Document Identifier OS-0990-0260; 30-Day Notice]

Agency Information Collection Request; 30-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, is publishing the following 
summary of a proposed collection 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 
    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 [email protected], or call the 
Reports Clearance Office on (202) 690-5683. Send written comments and 
recommendations for the proposed information collections within 30 days 
of this notice directly to the OS OMB Desk Officer; faxed to OMB at 
    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.

[[Page 18821]]

                                   Total Estimated Annualized Burden--Dollars
                                                     Number of       Number of      burden per     Total  burden
                      Title                         respondents   responses  per   response (in        hours
                                                                    respondent        hours)
.103(b)(4), .109(d) IRB Actions, .116 and .117             6,000           39.33               1         235,980
 Informed Consent...............................
.115(a) IRB Recordkeeping.......................           6,000              15              10         900,000
.103(b)(5) Incident Reporting, .113 Suspension             6,000             0.5           45/60           2,250
 or Termination Reporting.......................
    Total.......................................  ..............  ..............  ..............       1,138,230

Keith A. Tucker,
 Paperwork Reduction Act Clearance Officer, Office of the Secretary.
[FR Doc. 2012-7464 Filed 3-27-12; 8:45 am]