Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 66009 

Dated: September 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20903 Filed 9–25–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–2925] 

Defining Durations of Use for 

Approved Medically Important 

Antimicrobial Drugs Fed to FoodProducing Animals; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry (GFI) #273 

entitled ‘‘Defining Durations of Use for 

Approved Medically Important 

Antimicrobial Drugs Fed to FoodProducing Animals.’’ This draft 

guidance document, when finalized, 

will provide recommendations on how 

sponsors may voluntarily establish 

defined durations of use for certain 

antimicrobial new animal drugs used in 

or on the medicated feed of foodproducing animals that are currently 

approved with one or more indications 

that lack a defined duration of use. 

Establishing defined durations of use 

within the approved new animal drug 

applications (NADAs) and abbreviated 

new animal drug applications 

(ANADAs) is intended to mitigate 

development of antimicrobial resistance 

for these antimicrobial drugs, which are 

important to human medicine. It also, 

when finalized, will propose timelines 

for stakeholders wishing to voluntarily 

align their affected applications with 

this guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 26, 2023, 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draft guidance before it begins work on 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– 

2023–D–2925 for ‘‘Defining Durations of 

Use for Approved Medically Important 

Antimicrobial Drugs Fed to FoodProducing Animals.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

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 selfaddressed 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: John 

Mussman, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0589, 

John.Mussman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft GFI #273 entitled ‘‘Defining 

Durations of Use for Approved 

Medically Important Antimicrobial 

Drugs Fed to Food-Producing Animals.’’ 

This draft guidance, when finalized, 

will provide information to sponsors of 

certain antimicrobial animal drug 

products who are interested in 

establishing appropriately defined 

durations of therapeutic administration 

to food-producing animals where none 

currently exist. The draft guidance, 

when finalized, will also propose 

timelines for stakeholders wishing to 

comply voluntarily with this guidance. 


lotter on DSK11XQN23PROD with NOTICES1
66010 Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 

1See GFI #213, ‘‘New Animal Drugs and New 

Animal Drug Combination Products Administered 

in or on Medicated Feed or Drinking Water of FoodProducing Animals: Recommendations for Drug 

Sponsors for Voluntarily Aligning Product Use 

Conditions with GFI #209,’’ December 2013. 

(https://www.fda.gov/media/83488/download) 

2See GFI #263, ‘‘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,’’ June 

2021. (https://www.fda.gov/media/130610/ 

download) 

3See FDA’s 5-year action plan entitled 

‘‘Supporting Antimicrobial Stewardship in 

Veterinary Settings: Goals for Fiscal Years 2019– 

2023.’’ (https://www.fda.gov/media/115776/ 

download) 4See Action item 1.1.2 of the 5-year plan. 

In response to recommendations 

made by FDA in GFI #213,1 as part of 

a strategy to address antimicrobial 

resistance associated with the use of 

antimicrobial drugs in animal 

agriculture, sponsors of all NADAs and 

ANADAs for antimicrobial drugs 

important to human medicine 

(medically important antimicrobial 

drugs) approved for use in or on the 

feed or in the drinking water of foodproducing animals worked with FDA 

over a 3-year period from 2013 to 2016 

to voluntarily withdraw approval of 

indications that were not considered 

necessary for ensuring animal health 

(production indications). In response to 

FDA recommendations made in GFI 

#263,2 sponsors also voluntarily worked 

with FDA to change the marketing 

status of all remaining approved uses of 

such new animal drugs from over-thecounter (OTC) to either by veterinary 

prescription (Rx) or by veterinary feed 

directive, as applicable. 

In September 2016, FDA announced 

that it intended to enter the next phase 

of its efforts to mitigate antimicrobial 

resistance by focusing on medically 

important antimicrobials used in animal 

feed or water that have at least one 

therapeutic indication without a defined 

duration of use. In a notice published in 

the Federal Register of September 14, 

2016 (81 FR 63187), the Agency 

requested comments from the public 

about how to establish appropriately 

targeted durations of use for therapeutic 

products within the scope of GFI #213 

with no currently defined duration of 

use. Public feedback received in 

response to that request for information 

was taken into consideration during 

subsequent development of a concept 

paper released in 2021. 

On September 14, 2018, FDA released 

a 5-year action plan for supporting 

antimicrobial stewardship in veterinary 

settings.3 This plan includes an action 

item intended ‘‘to ensure that all 

medically important antimicrobial drugs 

used in the feed or drinking water of 

food-producing animals have an 

appropriately targeted duration of 

use.’’ 4

In a notice published in the Federal 

Register of January 11, 2021 (86 FR 

1979), FDA requested comments from 

the public on a concept paper that 

outlined a potential framework for how 

sponsors of NADAs and ANADAs for 

products containing medically 

important antimicrobial drugs approved 

for use in or on the feed of foodproducing animals could voluntarily 

work with FDA to change the approved 

conditions of use of these drugs to 

establish appropriately defined 

durations of use for those indications 

that currently have an undefined 

duration of use. The concept paper 

generated invaluable public comment; 

FDA considered all information and 

feedback received on the concept paper 

as it developed this draft 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 ‘‘Defining Durations 

of Use for Approved Medically 

Important Antimicrobial Drugs Fed to 

Food-Producing 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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). 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. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20920 Filed 9–25–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0313–60D] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 27, 

2023. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041 and PRA@HHS.GOV. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0313 and 

project title for reference, to Sherrette A. 

Funn, email: Sherrette.Funn@hhs.gov, 

PRA@HHS.GOV or call (202) 264–0041 

the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: National Blood 

Collection & Utilization Survey 

(NBCUS). 

Type of Collection: Revision. 

OMB No.: 0990–0313 Office of the 

Assistant Secretary for Health/HHS. 

Abstract: The Office of the Assistant 

Secretary for Health (OASH) is 

requesting approval for a three-year 

revised information collection request 

(ICR) titled ‘‘National Blood Collection 

& Utilization Survey (NBCUS).’’ The 

NBCUS is a biennial survey that 


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