Document ID: FDA-2011-N-0509-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Appeals of Science-Based Decisions above Division Level at Center for Veterinary Medicine
Posted Date: 2011-10-11T04:00Z

[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62812-62813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26132]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0509]

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 
November 10, 2011.

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: 202-395-7285, or e-mailed to oira_submission@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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@fda.hhs.gov.

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--21 CFR Part 10.75 (OMB Control Number 
0910-0566)--Extension

    Respondents: Respondents to this collection of information are 
applicants that wish to submit a request for review of a scientific 
dispute.
    The Center for Veterinary Medicine's 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 the Center for Veterinary Medicine (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 procedures for persons who are sponsors, 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 
a sponsor, applicant, or manufacturer has a scientific disagreement 
with a written decision by CVM, they may submit a request for a review 
of that decision by following the established Agency channels of 
supervision for review.
    In the Federal Register of July 13, 2011 (76 FR 41264), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 62813]]

                                                      Table 1--Estimated Annual Reporting Burden\1\
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                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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10.75..............................................................               1                3                3               10               30
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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 number of 
responses per respondent equals the total annual responses. The average 
burden per response (in hours) 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: October 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26132 Filed 10-7-11; 8:45 am]
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