Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
| Published date | 09 November 2021 |
| Citation | 86 FR 62178 |
| Record Number | 2021-24433 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 214 (Tuesday, November 9, 2021)
[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62178-62181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24433]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3353]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of our reporting and recordkeeping requirements for
antimicrobial animal drug sales and distribution.
DATES: Submit either electronic or written comments on the collection
of information by January 10, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 10,
[[Page 62179]]
2022. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of January 10,
2022. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3353 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Antimicrobial Animal Drug
Distribution Reports and Recordkeeping.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
[[Page 62180]]
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.
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 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 3744 4 1.5 6 62 372
Applications--Paper Submission.........................
514.87(a)-(e)--Annual Reports for Sponsors With Active 3744 16 9.1 146 52 7,592
Applications--Electronic Submission....................
514.87(a)-(e)--Annual Reports for Sponsors With Inactive 3744 5 3 15 2 30
Applications--Paper Submission.........................
514.87(a)-(e)--Annual Reports for Sponsors With Inactive 3744 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.
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.
[[Page 62181]]
Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24433 Filed 11-8-21; 8:45 am]
BILLING CODE 4164-01-P
