[Federal Register Volume 73, Number 190 (Tuesday, September 30, 2008)]
[Notices]
[Pages 56828-56829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22976]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0260]


Agency Information Collection Request; 60-Day Public Comment 
Request

AGENCY: Office of the Secretary.

    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, e-mail 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. Written comments and 
recommendations for the proposed information collections must be 
directed to the OS Paperwork Clearance Officer at the above e-mail 
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.
    The respondents for this collection are institutions engaged in 
such research. Institutional adherence to the Common Rules also is 
required by other federal departments and agencies that have codified 
or follow the Common Rule which is identical to 45 CFR part 46, subpart 
A.
    The information being requested related to the Common Rule should 
be readily available to the institution or organization that registers 
the IRB.
    The burden estimates for the Common Rule include those recently 
approved for use of the Federalwide Assurance (FWA) form under Control 
Number 0990-0278 and for the IRB Registration Form that was recently 
approved under Control Number 0990-0279, and for the institutional 
review board (IRB) verification (former Optional Form 310).
    The burden estimate for the sections of the Common Rule that 
require reporting or recordkeeping are shown in the burden table below. 
The number of respondents is the number of IRBs registered utilizing 
OMB 0990-0279.

[[Page 56829]]



                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     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
----------------------------------------------------------------------------------------------------------------


Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. E8-22976 Filed 9-29-08; 8:45 am]
BILLING CODE 4150-36-P