Document ID: FDA-2008-N-0173-0001
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: 2008-03-26T04:00Z

[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Notices]               
[Page 16021-16022]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr08-78]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 written or electronic comments on the collection of 
information by May 27, 2008.

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: 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: 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

[[Page 16022]]

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 the 
Center for Veterinary Medicine--21 CFR Part 10.75 (OMB Control Number 
0910-0566)--Extension

    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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

    Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6065 Filed 3-25-08; 8:45 am]

BILLING CODE 4160-01-S