[Federal Register Volume 72, Number 120 (Friday, June 22, 2007)]
[Notices]
[Pages 34470-34471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000D-0084]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Special Protocol Assessment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
23, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974. All comments should be identified with the OMB 
control number 0910-0470. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857,301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Special Protocol Assessment (OMB Control 
Number 0910-0470)--Extension

    In the Federal Registerof July 31, 2006 (71 FR 43199), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                           Annual Frequency per     Total Annual        Hours per
                   21 CFR Section                     No. of  Respondents        Response            Responses           Response         Total Hours
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Notification for Carcinogenicity Protocols                             21                  2.19                 46                  8                368
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Requests for Special Protocol Assessment                              151                  2.48                374                 15              5,610
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Total                                                ....................  ....................  .................  .................              5,978
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 34471]]

    Dated: June 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12056 Filed 6-21-07; 8:45 am]
BILLING CODE 4160-01-S