[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4931-4932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01669]


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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 March 
2, 2015.

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 emailed to [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002 [email protected].

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 CVM--21 
CFR 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.
    The Center for Veterinary Medicine's (CVM's) guidance for industry 
#79 entitled ``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

[[Page 4932]]

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 November 6, 2014 (79 FR 65976), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but it did not 
respond to any of the four collection of information topics solicited 
in the notice and therefore is not discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                     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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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01669 Filed 1-28-15; 8:45 am]
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