Notice2022-09632
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 5, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA 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.
Full Text
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<title>Federal Register, Volume 87 Issue 87 (Thursday, May 5, 2022)</title>
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[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26764-26766]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09632]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3353]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Antimicrobial Animal
Drug Distribution Reports and Recordkeeping
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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 6, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#306062716344515656705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="de8e8c9f8daabfb8b89eb8babff0b6b6adf0b9b1a8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
[[Page 26765]]
has submitted the following proposed collection of information to OMB
for review and clearance.
Antimicrobial Animal Drug Distribution Reports and Recordkeeping--21
CFR 514.87
OMB Control Number 0910-0659--Extension
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.
In the Federal Register of November 9, 2021 (86 FR 62178), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate 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 FDA form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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514.87(a)-(e)--Annual Reports for Sponsors With Active 3,744 4 1.5 6 62 372
Applications--Paper Submission.........................
514.87(a)-(e)--Annual Reports for Sponsors With Active 3,744 16 9.1 146 52 7,592
Applications--Electronic Submission....................
514.87(a)-(e)--Annual Reports for Sponsors With Inactive 3,744 5 3 15 2 30
Applications--Paper Submission.........................
514.87(a)-(e)--Annual Reports for Sponsors With Inactive 3,744 16 12.6 201 2 402
Applications--Electronic Submission....................
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Total............................................... .............. .............. .............. .............. .............. 8,396
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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 that 20
sponsors will have active applications, and we assume that 75 percent
of the respondents will report electronically, while the other 25
percent will report on paper. We estimate that 4 sponsors with active
applications will spend 62 hours annually to assemble the necessary
information, prepare, and submit an annual antimicrobial animal drug
sales and distribution report on paper and 16 sponsors with active
applications will spend 52 hours annually to assemble the necessary
information, prepare, and electronically submit an annual antimicrobial
animal drug sales and distribution report. We estimate that 21 sponsors
will have inactive applications, and we assume that 93 percent of these
respondents will report electronically, while the other 7 percent will
report on paper. We estimate that sponsors with inactive applications
will spend 2 hours to prepare 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
respondents respondent records recordkeeping
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Recordkeeping required by section 512(l)(3) of the FD&C Act........ 21 1 21 2 42
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 26766]]
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 42 hours for
further compliance with section 512(l)(3) of the FD&C Act, as detailed
in table 2.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. We attribute this to
respondents who reported by paper in previous years and are now
reporting electronically. We also note a decrease in recordkeeping
respondents. We attribute this to the mergers of sponsors over the
years.
Dated: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09632 Filed 5-4-22; 8:45 am]
BILLING CODE 4164-01-P
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