Document ID: FDA-2008-N-0173-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science- Based Decisions Above the Division Level at the Center for Veterinary Medicine
Posted Date: 2008-06-26T04:00Z

[Federal Register: June 26, 2008 (Volume 73, Number 124)]
[Notices]               
[Page 36331-36332]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn08-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0173]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Appeals of Science-
Based Decisions Above the Division Level at the Center for Veterinary 
Medicine

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 
28, 2008.

[[Page 36332]]

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, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0566. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

Appeals of Science-Based Decisions Above the Division Level at the 
Center for Veterinary Medicine (OMB Control Number 0910-0566)--
Extension

    CVM's (Center for Veterinary Medicine) ``Guidance for Industry 
79--Dispute Resolution Procedures for Science-Based Decisions 
on Products Regulated by the Center for Veterinary Medicine'' describes 
the process by which CVM formally resolves disputes relating to 
scientific controversies. A scientific controversy involves issues 
concerning a specific product regulated by CVM related to matters of 
technical expertise and requires specialized education, training or 
experience to be understood and resolved. Further, the guidance details 
information on how the agency intends to interpret and apply provisions 
of the existing regulations regarding internal agency review of 
decisions. In addition, the guidance outlines the established 
recommended procedures for persons who are applicants, including 
sponsor applicants or manufacturers, for animal drugs or other products 
regulated by CVM, that wish to submit a request for review of a 
scientific dispute. When an applicant has a scientific disagreement and 
a written decision by CVM, the applicant may submit a request for 
review of that decision by following the established agency channels of 
supervision for review.
    Respondents to this collection of information are applicants that 
wish to submit a request for review of a scientific dispute.
    In the Federal Register of March 26, 2008 (73 FR 16021), 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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                                                              No. of         Annual frequency       Total annual        Hours per
                    21 CFR section                         respondents         per response          responses           response         Total hours
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10.75                                                                   2                     4                  8                 10                 80
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimated annual reporting burden is based on CVM's experience 
over the past 3 years in handling formal appeals for scientific 
disputes. The number of respondents multiplied by the annual frequency 
of response equals the total annual responses. The number of hours per 
response is based on discussions with industry and may vary depending 
on the complexity of the issue(s) involved and the duration of the 
appeal process.

    Dated: June 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14515 Filed 6-25-08; 8:45 am]

BILLING CODE 4160-01-S