[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49395-49398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21208]


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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 November 30, 2018.

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 November 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 30, 2018.

[[Page 49396]]

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 ``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.
     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.gpo.gov/fdsys/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.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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

[[Page 49397]]

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.
    Description of Respondents: Animal drug manufacturers (sponsors).
    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                          FDA Form        Number of     responses per   Total  annual    burden per      Total hours
                                                                            respondents     respondent       responses       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.

    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
            Activity                 Number of      records per    Total  annual    burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Recordkeeping required by                     27               1              27               2              54
 section 512(l)(3) of the FD&C
 Act............................
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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

[[Page 49398]]

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: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21208 Filed 9-28-18; 8:45 am]
BILLING CODE 4164-01-P