[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Notices]
[Pages 38695-38696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1197]


The Food and Drug Administration's Proposed Method for Adjusting 
Data on Antimicrobials Sold or Distributed for Use in Food-Producing 
Animals Using a Biomass Denominator; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability for public comment of a proposed method for applying a 
food animal biomass denominator to annual data on antimicrobials sold 
and distributed for use in food animals in the United States. This 
method will allow us to obtain a corrected estimate of antimicrobial 
drug sales relative to the animal population potentially being treated 
with those drugs, thereby lending further context to the antimicrobial 
sales data we are collecting and analyzing.

DATES: Submit either electronic or written comments on the proposed 
method by November 13, 2017.

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 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 13, 2017. 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-2017-N-1197 for ``FDA's Proposed Method for Adjusting Data on 
Antimicrobials Sold or Distributed for Use in Food-Producing Animals 
Using a Biomass Denominator.'' 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.
    Submit written requests for single copies of the proposed method to 
the Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. Persons with access to the Internet may 
obtain the proposed method at either https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeAct

[[Page 38696]]

ADUFA/ucm042896.htm or in this docket at https://www.regulations.gov.

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: Animal drug sponsors are required to report 
annually to FDA the amount of antimicrobials sold or distributed for 
use in food-producing animals and provide species-specific estimates of 
the percentage of their drug product sales for use in any of the four 
major food-producing species (cattle, swine, chickens, and turkeys) 
identified on the approved product label (21 CFR 514.87(c)). FDA is 
announcing the availability of a proposed method for using a biomass 
denominator to adjust these sales data. The proposed method will 
provide estimates of annual antimicrobial drug sales adjusted for the 
size of the animal population (the animal biomass of each such species) 
potentially being treated with those drugs. The adjusted estimates will 
provide insight into broad shifts in the amount of antimicrobials sold 
for use in food-producing animals and give the Agency a more nuanced 
view of why sales increase or decrease over time in a manner that is 
specific to U.S. animal production. Such analysis will also 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.
    Application of a biomass denominator to normalize antimicrobial 
sales data has been used internationally. In developing this proposal 
for applying a biomass denominator to antimicrobial sales data in the 
United States, FDA has considered methods being utilized and discussed 
in other countries. FDA's intent in publishing the proposed method is 
to initiate discussion with stakeholders on the biomass correction 
method FDA is considering, and to seek comment on the methodology and 
the utility of this type of data analysis.

    Dated: August 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17206 Filed 8-14-17; 8:45 am]
 BILLING CODE 4164-01-P