Document ID: FDA-2011-N-0509-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine
Posted Date: 2011-07-13T04:00Z

[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Pages 41264-41265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17532]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 either electronic or written comments on the collection 
of information by September 12, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments or 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

[[Page 41265]]

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

    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, who 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:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
10.75...........................               1               3               3              10              30
----------------------------------------------------------------------------------------------------------------
\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: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17532 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P