[Federal Register Volume 84, Number 186 (Wednesday, September 25, 2019)]
[Notices]
[Pages 50456-50457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20688]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3614]


Recommendations for Sponsors of Medically Important Antimicrobial 
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary 
Oversight All Products That Continue To Be Available Over-the-Counter; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of a draft guidance for industry (GFI) #263 
entitled ``Recommendations for Sponsors of Medically Important 
Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring 
Under Veterinary Oversight All Products That Continue to be Available 
Over-the-Counter.'' This draft guidance document, when finalized, will 
provide information to sponsors of medically important antimicrobial 
new animal drug products who are interested in changing the approved 
marketing status of these products from over-the-counter (OTC) to by 
veterinary prescription (Rx) consistent with FDA's recommendation that 
the use of such drugs in animals be limited to uses that include 
veterinary oversight to mitigate development of antimicrobial 
resistance. It also will recommend timeframes for stakeholders wishing 
to comply voluntarily with this guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by December 24, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-3614 for ``Recommendations for Sponsors of Medically 
Important Antimicrobial Drugs Approved for Use in Animals to 
Voluntarily Bring Under Veterinary Oversight All Products That Continue 
to be Available Over-the-Counter.'' 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.'' 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

[[Page 50457]]

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 guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Cindy Burnsteel, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0817, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft GFI #263 entitled 
``Recommendations for Sponsors of Medically Important Antimicrobial 
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary 
Oversight All Products That Continue to be Available Over-the-
Counter.'' This draft guidance, when finalized, will provide 
information to sponsors of certain new animal drug products who are 
interested in changing the approved marketing status of these products 
from OTC to Rx consistent with FDA's recommendation that the use of 
such drugs in animals be limited to uses that include veterinary 
oversight in order to mitigate development of antimicrobial resistance 
and thereby preserve the effectiveness of these drugs for use as 
therapies to treat infections in humans and animals. The draft 
guidance, when finalized, also will recommend timeframes for 
stakeholders wishing to comply voluntarily with this guidance.
    In 2016, in response to recommendations made by FDA as part of a 
strategy to address antimicrobial resistance associated with the use of 
antimicrobial drugs in animal agriculture, sponsors of all medically 
important antimicrobial drugs approved for use in or on the feed or 
drinking water of food-producing animals worked with FDA to voluntarily 
withdraw approval of indications that were not considered necessary for 
assuring animal health (production indications), and voluntarily change 
all remaining approved uses of such new animal drugs from OTC to either 
Veterinary Feed Directive or Rx marketing status, as applicable.\1\
---------------------------------------------------------------------------

    \1\ See GFI #213, ``New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or 
Drinking Water of Food-Producing Animals: Recommendations for Drug 
Sponsors for Voluntarily Aligning Product Use Conditions with GFI 
#209'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-213-new-animal-drugs-and-new-animal-drug-combination-products-administered-or-medicated-feed)
---------------------------------------------------------------------------

    Although all medically important antimicrobials used in feed or 
water for food-producing animals are currently under veterinary 
oversight, some other dosage form products (e.g., injectable, tablet, 
intramammary infusion) intended for use in food-producing and non-food-
producing animals remain available OTC. This draft guidance, when 
finalized, will provide sponsors with specific recommendations on how 
to facilitate voluntary changes to the approved conditions of use of 
these drugs to prescription marketing status. The voluntary process 
outlined in this draft guidance will help to ensure new animal drugs 
containing antimicrobials of human medical importance are administered 
only under veterinary oversight and only for therapeutic uses.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
veterinary oversight of medically important antimicrobial drugs 
administered to animals. 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 draft guidance is not subject to 
Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft 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 section 512(n)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) have been approved under 
OMB control number 0910-0669. The collections of information in 21 CFR 
part 514 have been approved under OMB control number 0910-0032.

IV. Electronic Access

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

    Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20688 Filed 9-23-19; 11:15 am]
BILLING CODE 4164-01-P