82384 Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 

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Antimicrobial Drugs Fed to FoodProducing Animals; Draft Guidance for 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; Extension of the Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that published in 

the Federal Register of September 26, 

2023. In that notice, FDA requested 

comments on the draft guidance for 

industry (GFI) #273 entitled ‘‘Defining 

Durations of Use for Approved 

Medically Important Antimicrobial 

Drugs Fed to Food-Producing Animals.’’ 

The Agency is taking this action in 

response to requests for an extension to 

allow interested persons additional time 

to develop and submit comments. 

DATES: FDA is extending the comment 

period on the notice of availability 

published September 26, 2023 (88 FR 

66009). Submit either electronic or 

written comments on the draft guidance 

by January 5, 2024, to ensure that the 

Agency considers your comments 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this draft guidance before it begins work 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. 

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: In the 

Federal Register of September 26, 2023, 

FDA published a notice announcing the 

availability of a draft guidance for 

industry (GFI) #273 entitled ‘‘Defining 

Durations of Use for Approved 

Medically Important Antimicrobial 

Drugs Fed to Food-Producing Animals.’’ 

Interested persons were originally given 

until December 26, 2023, to comment on 

the draft guidance. 

The Agency received requests for 

extension of the comment period for the 

draft guidance. After considering the 

requests, and the fact that the original 

comment period is scheduled to close 

on December 26, 2023, FDA has decided 

to extend the comment period for the 

draft guidance until January 5, 2024. 

The Agency believes that this extension 

allows adequate time for interested 

persons to submit comments to ensure 

that FDA can consider the comments 

before it begins work on the final 

version of the guidance. 

Dated: November 20, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25962 Filed 11–22–23; 8:45 am] 

BILLING CODE 4164–01–P 


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