Document ID: FDA-2017-N-6145-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Dispute Resolution
Procedures for Science-Based Decisions on Products Regulated by
the Center for Veterinary Medicine
Posted Date: 2018-02-09T05:00Z

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5783-5784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02593]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6145]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Dispute Resolution 
Procedures for Science-Based Decisions on Products Regulated by 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 
12, 2018.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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.

Dispute Resolution Procedures for Science-Based Decisions on Products 
Regulated by the Center for Veterinary Medicine--21 CFR 10.75

OMB Control Number 0910-0566--Extension

    The Center for Veterinary Medicine's (CVM's) Guidance for Industry 
(GIF) #79, ``Dispute Resolution Procedures for Science-Based Decisions 
on Products Regulated by the Center for Veterinary Medicine'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052393.pdf), 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. The guidance details information on how CVM intends to apply 
provisions of existing regulations regarding internal review of Agency 
decisions. In addition, the guidance outlines the established 
procedures for persons who are sponsors, applicants, or manufacturers 
of 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 procedures discussed in the 
guidance.
    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 procedures in GFI #79.
    In the Federal Register of October 27, 2017 (82 FR 49836), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received no comments.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 5784]]

                                                     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, Request for review of a scientific dispute..................               1                4                4               10               40
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the next 3 years, CVM anticipates receiving one or fewer 
requests for review of a scientific dispute per year, on average. We 
base our estimate on CVM's experience over the past 6 years in handling 
formal appeals for scientific disputes. The burden of this collection 
has changed. The number of respondents decreased from two to one 
annually, the number of responses per respondent remained at four 
annually, the hours per response remained at 10 annually, and the total 
number of hours decreased from 80 to 40. This decrease in the total 
hours is the result of a natural fluctuation in the number of 
respondents taking advantage of this dispute resolution process.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02593 Filed 2-8-18; 8:45 am]
 BILLING CODE 4164-01-P