[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Rules and Regulations]
[Pages 30534-30535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14085]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2012-N-0447]


Antimicrobial Animal Drug Sales and Distribution Reporting; Small 
Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a final guidance for industry #252 
entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting 
Small Entity Compliance Guide.'' The small entity compliance guide 
(SECG) is intended to help small entities comply with the final rule we 
issued in the Federal Register of May 11, 2016, entitled 
``Antimicrobial Animal Drug Sales and Distribution Reporting.''

DATES: The announcement of the guidance is published in the Federal 
Register on June 29, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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-2012-N-0447 for ``Antimicrobial Animal Drug Sales and Distribution 
Reporting; Small Entity Compliance Guide.'' Received comments 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.'' We will review 
this copy, including the claimed confidential information, in our 
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

[[Page 30535]]

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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the SECG to the Policy 
and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send two 
self-addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the SECG.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5671, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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), as amended by section 105 of the Animal Drug Use Fee 
Amendments of 2008 (ADUFA 105) (Pub. L. 110-316), to submit to us an 
annual report on the amount of each such ingredient in the drug that is 
sold or distributed for use in food-producing animals. We are also 
required by ADUFA 105 to publish annual summary reports of the data we 
receive from animal drug sponsors. In accordance with the law, sponsors 
of the affected antimicrobial new animal drug products began submitting 
their sales and distribution data to us on an annual basis, and we have 
published summaries of such data for each calendar year beginning with 
2009.
    In the Federal Register of May 11, 2016 (81 FR 29129), we published 
a final rule entitled ``Antimicrobial Animal Drug Sales and 
Distribution Reporting'' that amended our existing records and reports 
regulation in part 514 (21 CFR part 514) to incorporate the sales and 
distribution data reporting requirements specific to antimicrobial new 
animal drugs that were added to the FD&C Act by ADUFA 105. The rule 
also added an additional reporting provision intended to improve our 
understanding of antimicrobial animal drug sales intended for use in 
specific food-producing animal species. In accordance with the new 
rule, the sponsor of each approved or conditionally approved new animal 
drug product that contains an antimicrobial active ingredient must 
submit an annual report to us on the amount of each such ingredient in 
the drug product that is sold or distributed for use in food-producing 
animals, including information on any distributor-labeled product. The 
final rule, which is codified at Sec. Sec.  514.80 and 514.87, became 
effective July 11, 2016.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined 
that the final rule will not have a significant economic impact on a 
substantial number of small entities (81 FR 29129 at 29138). 
Nonetheless, we determined not to certify that finding due to the 
remote possibility that, in the future, a very small company could 
enter the market and sponsor an application for an antimicrobial new 
animal drug product that would be sold or distributed for use in food-
producing animals. Thus, in compliance with section 212 of the Small 
Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as 
amended by Pub. L. 110-28), we are making available this SECG to 
explain the actions that a potential future market entrant small entity 
must take to comply with the rule.
    We are issuing this SECG consistent with our good guidance 
practices regulation (21 CFR 10.115(c)(2)). The SECG represents the 
current thinking of FDA on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec.  514.87 have been approved under OMB 
control number 0910-0659. The collections of information in Sec.  
514.80 have been approved under OMB control number 0910-0284.

III. Electronic Access

    Persons with access to the internet may obtain the SECG at either 
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14085 Filed 6-28-18; 8:45 am]
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