66008 Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Applications ...................................................................................................... 47 1 24 1,128

State Plans ...................................................................................................... 47 1 40 1,880 

Performance Progress Reports ....................................................................... 47 2 16 1,504 

Estimated Total Annual Burden 

Hours: 4,512. 

Authority: Section 510 of the Social 

Security Act (42 U.S.C. 710), as 

amended by section 50502 of the 

Bipartisan Budget Act of 2018 (Pub. L. 

115–123) and extended by Division CC, 

title III, section 303 of the Consolidated 

Appropriations Act, 2022 (Pub. L. 117– 

103). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–20758 Filed 9–25–23; 8:45 am] 

BILLING CODE 4184–83–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0001] 

Advancing the Development of 

Pediatric Therapeutics on Drug Dosing 

in Pediatric Patients With Renal 

Impairment; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Advancing the 

Development of Pediatric Therapeutics 

(ADEPT 8) on Drug Dosing in Pediatric 

Patients With Renal Impairment.’’ The 

purpose of the public workshop is to 

discuss the current landscape of drug 

dosing in pediatric patients with renal 

impairment, understand the gaps in 

knowledge, and consider innovative 

approaches to improve the current 

paradigm for dosing in pediatric 

patients with renal impairment. 

DATES: The public workshop will be 

held on November 30, 2023, and 

December 1, 2023, from 9 a.m. to 5 p.m. 

eastern time each day. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus 

Great Room and online. Entrance for the 

registered public workshop participants 

(non-FDA employees) is through 

Building 1 where routine security check 

procedures will be performed. For 

parking and security information, please 

refer to https://www.fda.gov/about-fda/ 

visitor-information. 

FOR FURTHER INFORMATION CONTACT: Julie 

Levin, Office of New Drugs Public 

Meeting Support, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6481, Silver Spring, 

MD 20993–0002, 202–567–7565, 

ONDPublicMTGSupport@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The pharmacokinetics of drugs 

excreted by the kidneys may be altered 

by renal (kidney) impairment, requiring 

dosing adjustments. However, the 

majority of drugs that are predominantly 

renally excreted and have dosage 

recommendations for adults with renal 

impairment lack dose adjustment 

recommendations for pediatric patients 

with renal impairment. This is largely 

due to the lack of generation of 

pharmacokinetic data in pediatric 

patients with renal impairment, which 

is attributable to both the ethical and the 

practical limitations of conducting 

dedicated renal impairment studies in 

pediatric patients, as well as the 

exclusion of pediatric patients with 

renal impairment from most clinical 

efficacy and safety studies. For drugs 

that are renally cleared, exposures can 

be impacted by both the maturation of 

kidney function and the renal 

impairment due to kidney disease. 

II. Topics for Discussion at the Public 

Workshop 

The main objective of the ‘‘Advancing 

the Development of Pediatric 

Therapeutics (ADEPT 8) on Drug Dosing 

in Pediatric Patients With Renal 

Impairment’’ workshop is to discuss 

current approaches to classifying renal 

impairment in the pediatric population, 

identify data gaps, and explore 

scientifically supported approaches and 

methods for providing information on 

dosing adjustment. The workshop will 

specifically focus on measurements of 

renal function, extrapolation of adult 

data, and approaches to generating 

clinical trial data to assess the impact of 

renal impairment on the 

pharmacokinetics of drugs in pediatric 

patients. In addition, the workshop will 

allow for an open dialogue around the 

use of these approaches among 

regulators, industry, academia, and 

patient organizations. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://www.eventbrite.com/e/ 

adept-8-pediatric-renal-impairmentworkshop-tickets-687423571407. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by November 15, 2023, 11:59 

p.m. Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

If you need special accommodations 

due to a disability, please contact Julie 

Levin at ONDPublicMTGSupport@

fda.hhs.gov no later than November 15, 

2023. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be via Zoom. A link will be 

provided via email to registered 

participants. If you have never attended 

a Zoom event before, test your internet 

connection by joining a test meeting at 

https://zoom.us/test. FDA has verified 

the website addresses in this document, 

as of the date this document is 

published in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that 

when a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 


lotter on DSK11XQN23PROD with NOTICES1
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. 


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