Document ID: FDA-2020-N-1652-0002
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 by the Center
for Veterinary Medicine
Posted Date: 2021-02-22T05:00Z

[Federal Register Volume 86, Number 33 (Monday, February 22, 2021)]
[Notices]
[Pages 10581-10582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03431]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1652]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Dispute Resolution 
Procedures for Science-Based Decisions on Products 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, Agency, or we) 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: Submit written comments (including recommendations) on the 
collection of information by March 24, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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, 
PRAStaff@fda.hhs.gov.

[[Page 10582]]

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 
by the Center for Veterinary Medicine--21 CFR 10.75

OMB Control Number 0910-0566--Extension

    The Center for Veterinary Medicine (CVM) Guidance for Industry 
(GFI) #79, ``Dispute Resolution Procedures for Science-Based Decisions 
on Products Regulated by the Center for Veterinary Medicine'' (https://www.fda.gov/media/70279/download), 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 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 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 found in GFI #79.
    In the Federal Register of August 18, 2020 (85 FR 50827), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
      21 CFR part; activity          Number of     responses per   Total  annual    burden per     Total  hours
                                    respondents     respondent       responses       response
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10.75, Request for review of a                 1               4               4              10              40
 scientific dispute.............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We note that the 60-day notice included an inadvertent error in the 
estimated burden, which has been corrected in table 1. Based on a 
review of the information collection since our last request for OMB 
approval, we have made no adjustments to our burden estimate.

    Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03431 Filed 2-19-21; 8:45 am]
BILLING CODE 4164-01-P