Document ID: FDA-2018-N-3353-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Antimicrobial
Animal Drug Distribution Reports and
Recordkeeping
Posted Date: 2022-05-05T04:00Z

[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26764-26766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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, 
[email protected].

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
                     21 CFR section                          FDA form        Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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....................
                                                         -----------------------------------------------------------------------------------------------
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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