Document ID: FDA-2018-N-3353-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Posted Date: 2019-05-08T04:00Z

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20142-20143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09425]

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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) 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: Fax written comments on the collection of information by June 7, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0659. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St, North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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 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 the Agency 
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.
    Collection of information on the amount of animal antimicrobials 
being distributed, including species-specific information, is necessary 
to support our ongoing efforts to encourage the judicious use of 
antimicrobials in food-producing animals to help ensure the continued 
availability of safe and effective antimicrobials for animals and 
humans. We intend to use these data to supplement existing information, 
including data collected under the National Animal Health Monitoring 
System and the National Antimicrobial Resistance Monitoring System 
programs. Data from multiple sources are needed to provide a 
comprehensive and science-based picture of antimicrobial drug use and 
resistance in animal agriculture.
    In the Federal Register of October 1, 2018 (83 FR 49395), 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
                     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) through (e)--Annual Reports for Sponsors With             3744              10             7.5              75              62           4,650
 Active Applications--Paper Submission..................
514.87(a) through (e)--Annual Reports for Sponsors With             3744              10             7.5              75              52           3,900
 Active Applications--Electronic Submission.............
514.87(a) through (e)--Annual Reports for Sponsors With             3744               4            26.5             106               2             212
 Inactive Applications--Paper Submission................
514.87(a) through (e)--Annual Reports for Sponsors With             3744               3              35             105               2             210
 Inactive Applications--Electronic Submission...........
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           8,972
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 20143]]

    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 half of the 
respondents will report electronically, while the other half will 
report on paper. We estimate that 10 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 10 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 seven sponsors will 
have inactive applications, and we assume that half of these 
respondents will report electronically, while the other half 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
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Recordkeeping required by section 512(l)(3) of the FD&C Act........              27                1               27                2               54
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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 the date the 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 54 hours for 
further compliance with section 512(l)(3) of the FD&C Act, as detailed 
in table 2.
    Based on a review of the information collection since our last 
request for OMB approval, which was submitted with a final rule, we 
have made no adjustments to our burden estimates as reported in tables 
1 and 2, other than to remove the one-time burden of 787 hours, which 
represented the time needed to review the provisions of the final rule 
and develop a compliance plan in the first year of compliance.

    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09425 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P