[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18662-18663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07587]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4470]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Antimicrobial Animal
Drug Sales and Distribution
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 June 2, 2025.
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 0910-0659. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Antimicrobial Animal Drug Sales and Distribution--21 CFR 514.87
OMB Control Number 0910-0659--Extension
This information collection helps support implementation of Agency
statutory and regulatory requirements regarding new animal drugs
containing an antimicrobial active ingredient. Sponsors of approved or
conditionally approved applications for new animal drugs containing an
antimicrobial active ingredient are required by section 512 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) to
submit to FDA an annual report on the amount of each such ingredient in
the drug that is sold or distributed for use in food-producing animals.
Sponsors are also required to maintain distribution records for their
animal drug products, including separate information for each month of
the calendar year, under section 512(l)(3) of the FD&C Act. These
provisions were enacted to assist FDA in our continuing analysis of the
interactions (including drug resistance), efficacy, and safety of
antimicrobials approved for use in both humans and food-producing
animals for the purpose of mitigating the public health risk associated
with antimicrobial resistance.
Section 514.87 of our regulations (21 CFR 514.87) codifies the
reporting requirements established in the FD&C Act. Sponsors submit
antimicrobial animal drug sales and distribution reports to us on Form
FDA 3744. Each report must specify: (1) the amount of each
antimicrobial active ingredient by container size, strength, and dosage
form; (2) quantities distributed domestically and quantities exported;
and (3) a listing of the target animals, indications, and production
classes that are specified on the approved label of the product. The
report must cover the period of the preceding calendar year and include
separate information for each month of the calendar year. Each report
must also provide a species-specific estimate of the percentage of each
product that was sold or distributed domestically in the reporting year
for use in cattle, swine, chickens, or turkeys for such species that
appear on the approved label.
Description of Respondents: Animal drug manufacturers (sponsors).
Respondents include individuals and the private sector (for-profit
businesses).
In the Federal Register of October 24, 2024 (89 FR 84887), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
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 Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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514.87(a)-(e)--Annual Reports 1 1 1 62 62
for Sponsors With Active
Applications--Paper Submission.
514.87(a)-(e)--Annual Reports 15 10.1 152 52 7,904
for Sponsors With Active
Applications--Electronic
Submission.....................
514.87(a)-(e)--Annual Reports 2 3.5 7 2 14
for Sponsors With Inactive
Applications--Paper Submission.
[[Page 18663]]
514.87(a)-(e)--Annual Reports 10 17.9 179 2 358
for Sponsors With Inactive
Applications--Electronic
Submission.....................
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Total....................... .............. .............. .............. .............. 8,338
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimate of the average burden per response on our
recent experience with the existing antimicrobial animal drug
distribution reports program. We base our estimate of the number of
affected respondents reported in tables 1 and 2 and the average number
of responses per respondent in table 1 on a review of our records of
sponsors with active and inactive applications. We estimate sponsors
with active applications, who submit an annual antimicrobial annual
drug sales and distribution report on paper, will spend 62 hours to
assemble the necessary information, prepare, and submit to FDA. We
estimate sponsors with active applications, who submit an annual
antimicrobial animal drug sales and distribution report electronically,
will spend 52 hours to assemble the necessary information, prepare, and
submit to FDA. We estimate that sponsors with inactive applications
will spend 2 hours preparing their annual antimicrobial animal drug
sales and distribution reports, whether electronically or on paper.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Recordkeeping required by section 512(l)(3) of the FD&C Act........ 23 1 23 2 46
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Animal drug manufacturers are already required to maintain
distribution records for their animal drug products to comply with
FDA's current good manufacturing regulations for periodic drug reports
under Sec. 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), approved under
OMB control number 0910-0284. Section 512(l)(3) of the FD&C Act differs
from Sec. 514.80(b)(4)(i) in that it requires that records include
separate information for each month of the calendar year. In addition,
under 21 CFR 211.196 (approved under OMB control number 0910-0139),
manufacturers currently are required to maintain distribution records
that include dosage form, and date drug is distributed. Based on these
requirements, FDA believes that manufacturers already keep detailed
records of the dates when antimicrobial drugs are distributed for
marketing and recall purposes from which monthly reports can be
prepared as part of usual and customary business practices. However,
FDA estimates an additional recordkeeping burden of 46 hours for
further compliance with section 512(l)(3), as detailed in table 2.
After a review of the information collection since our last request
for OMB approval, we have adjusted our estimates based on our
experience with the antimicrobial animal drug distribution reports
program. Our estimated burden for the information collection reflects a
decrease of 54 burden hours and a corresponding decrease of 27 total
annual responses. We attribute this to respondents who submitted by
paper in previous years and are now reporting electronically.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07587 Filed 4-30-25; 8:45 am]
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