Document ID: FDA-2011-N-0509-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Appeals of Science-Based Decisions Above the
Division Level at the Center for Veterinary Medicine
Posted Date: 2014-11-06T05:00Z

[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 65976-65977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26307]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements for appeals of science-based decisions above the division 
level at the Center for Veterinary Medicine (CVM).

DATES: Submit electronic or written comments on the collection of 
information by January 5, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the

[[Page 65977]]

Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
extension of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Appeals of Science-Based Decisions Above the Division Level at CVM--21 
CFR Part 10.75 (OMB Control Number 0910-0566)--Revision

    Respondents: Respondents to this collection of information are 
applicants that wish to submit a request for review of a scientific 
dispute.
    CVM'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 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.
    FDA estimates the burden of this collection of information as 
follows:
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    \1\ There are no capital costs or operating and maintenance 
costs associated with this collection of information.

                                                     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..............................................................               2                4                8               10               80
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    CVM encourages applicants to begin the resolution of science-based 
disputes with discussions with the review team/group, including the 
Team Leader or Division Director. The Center prefers that differences 
of opinion regarding science or science-based policy be resolved 
between the review team/group and the applicant. If the matter is not 
resolved by this preferred method, then CVM recommends that the 
applicant follow the procedure in Guidance for Industry #79. Of the two 
respondents who were advised on the procedure during the past 3 years, 
one has not followed up to initiate it and the other is working with 
the review team/group to resolve the issue(s). Therefore, this 
estimated annual reporting burden is based on CVM's previous experience 
in handling formal appeals for scientific disputes.

    Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26307 Filed 11-5-14; 8:45 am]
BILLING CODE 4164-01-P