[Federal Register Volume 69, Number 122 (Friday, June 25, 2004)]
[Notices]
[Pages 35628-35629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: OS-0990-NEW]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 proposed collections 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.
    #1 Type of Information Collection Request: Existing collection in 
use without OMB Control Number;
    Title of Information Collection: Federal wide Assurance (FWA)
    Form/OMB No.: OS-0990-;
    Use: The FWA is designed to provide a simplified procedure for 
institutions engaged in HHS-conducted or supported research to satisfy 
the assurance requirements of Section 491(a) of the Public Health 
Service Act and of HHS regulations for the protection of human subjects 
at 45 CFR 46.103. The respondents are institutions engaged in human 
subjects research conducted or supported by HHS.
    Frequency: On occasion, Reporting;
    Affected Public: Individuals or households, business or other for-
profit, Not-for-profit institutions, Federal, State, local, or tribal 
governments;
    Annual Number of Respondents 15,000;
    Total Annual Responses: 30,000;
    Average Burden Per Response: 2 hours;
    Total Annual Hours: 22,500;
    #2 Type of Information Collection Request: Existing collection in 
use without an OMB control number;
    Title of Information Collection: Institutional Review Board/
Independent Ethics Committee Registration Form
    Form/OMB No.: OS-0990-NEW;
    Use: The Institutional Review Board (IRB)/Independent Ethics 
committee (IEC) Registration Forms designed to provide a simplified 
procedure for institutions engaged in HHS-conducted or supported 
research to satisfy the assurance requirements of Section 491(a) of the 
Public Health Service Act and of HHS regulations for the protection of 
human subjects at 45 CFR 46.103. The respondents are IRBs or IECs 
designed by an Institution under an assurance of compliance approved 
for federal wide use by the Office for Human Research Protections 
(OHRP), under HHS protection of human subjects regulations at 45 CFR 
46.103(a), and that review human subjects research conducted or 
supported by HHS.
    Frequency: On occasion, Reporting;
    Affected Public: Individuals or households, business or other for-
profit, Not-for-profit institutions, Federal, State, local, or tribal 
governments;

[[Page 35629]]

    Annual Number of Respondents: 5,000;
    Total Annual Responses: 5,000;
    Average Burden Per Response: 2 hours;
    Total Annual Hours: 3,500;
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access the HHS 
Web site address at http://www.hhs.gov/oirm/infocollect/pending/ or 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) 690-6162. Written comments and 
recommendations for the proposed information collections must be mailed 
within 30 days of this notice directly to the OMB Desk Officer at the 
address below:
    OMB Desk Officer: John Kraemer. OMB Human Resources and Housing 
Branch, Attention: (OMB 0990-NEW), New Executive Office 
Building, Room 10235, Washington DC 20503.

    Dated: June 17, 2004.
Robert Polson,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. 04-14476 Filed 6-24-04; 8:45 am]
BILLING CODE 4168-17-P