Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 67763 

box: ‘‘By checking this box, the 

prospective primary participant is 

agreeing to the Assurances set out 

above.’’ 

Section 22—Attachments 

• Add optional attachment section for 

the following items: Policy Manual; 

Subrecipient Contract; Model Plan 

Participation Notes for Tribes. 

Respondents: States, the District of 

Columbia, U.S. territories, and tribal 

governments. 

Annual Burden Estimates 

The estimated time per response for 

the FY 2025 Model Plan has been 

increased based on the revisions. The 

estimated time per response for the FY 

2026 Model Plan will reduce back after 

revisions are in place and respondents 

can duplicate response in OLDC. 

Instrument 

Total annual 

number of 

respondents 

Total annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

for each form 

LIHEAP Detailed Model Plan—FY24 .............................................................. 210 1 .5 105 

LIHEAP Detailed Model Plan—FY25 .............................................................. 206 1 1 206 

LIHEAP Detailed Model Plan FY26 ................................................................. 206 1 .5 103 

Estimated Total Burden Hours: ................................................................ ........................ ........................ ........................ 414 

Average Annual Burden Hours: ............................................................... ........................ ........................ ........................ 138 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 8621. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–21663 Filed 9–29–23; 8:45 am] 

BILLING CODE 4184–80–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3976] 

Support for Clinical Trials Advancing 

Rare Disease Therapeutics Pilot 

Program; Program Announcement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research’s (CBER) Office of Therapeutic 

Products (OTP) and Center for Drug 

Evaluation and Research’s (CDER) 

Office of New Drugs are announcing the 

opportunity for a limited number of 

development programs to participate in 

the Support for clinical Trials 

Advancing Rare disease Therapeutics 

(START) Pilot Program, with the goal of 

further accelerating the pace of 

development of certain CBER- and 

CDER-regulated products (novel drug 

and biological products) that are 

intended to treat a rare disease. Because 

each Center has identified specific 

needs concerning regulated products for 

rare diseases, the eligibility criteria for 

the pilot differ between CBER and 

CDER. This pilot would augment the 

currently available formal meetings 

between FDA and sponsors by 

addressing issues related to the 

development of individual products 

through more rapid, ad-hoc 

communication mechanisms. Sponsors, 

if selected for the pilot, would receive 

more frequent advice related to such 

specific issues through additional 

interactions to facilitate novel drug and 

biological product program 

development and generate high quality 

and reliable data intended to support a 

Biologics License Application (BLA) or 

New Drug Application (NDA). This 

notice outlines the eligibility criteria, 

what to submit in a request to 

participate in the pilot, selection 

criteria, process, and FDA-Sponsor 

interactions expected to occur for 

programs participating in the pilot. 

DATES: From January 2, 2024, to March 

1, 2024, FDA will accept requests to 

participate in the START Pilot Program 

and select no more than three 

participants from each Center (CBER 

and CDER). See the ‘‘Participation’’ 

section for eligibility criteria, 

instructions on how to submit a request 

to participate, and information 

regarding the selection process. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Harvan, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7268, 

Silver Spring, MD 20993–0002, 240– 

402–7911; or Quyen Tran, Center for 

Drugs Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6301, 

Silver Spring, MD 20993–0002, 301– 

796–2771. 

For general questions about the 

START Pilot Program for CBER: 

Industry.biologics@fda.hhs.gov. For 

general questions about the START Pilot 

Program for CDER: 

CDER.STARTProgram@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The purpose of the START Pilot 

Program is to further accelerate the pace 

of development of novel drug and 

biological products that are intended to 

address an unmet medical need as a 

treatment for a rare disease. The pilot is 

designed to be milestone-driven (i.e., to 

facilitate the progression of a 

development program to pivotal clinical 

study stage or the pre-BLA or pre-NDA 

meeting stage) where product 

development programs selected would 

benefit from enhanced communications 

with FDA. Participation in the pilot will 

be considered concluded when the 

development program has reached a 

significant regulatory milestone such as 

initiation of the pivotal clinical study 

stage or the pre-BLA or pre-NDA 

meeting stage as agreed upon with the 

sponsor. Pilot participants will be 

selected based on demonstrated 

development program readiness. The 

START Pilot Program is intended to 

provide a mechanism for addressing 

clinical development issues that 

otherwise would delay or prevent a 

promising novel drug or biological 

product from progressing to the pivotal 


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67764 Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 

1A rare disease or condition ‘‘means any disease 

or condition which affects less than 200,000 

persons in the United States . . .’’ (Section 

526(a)(2) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360bb(a)(2))). The START Pilot 

Program in CBER is not intended to encompass all 

rare diseases, but only a subset of rare diseases that 

are likely to lead to significant disability or death 

within the first decade of life. 

clinical trial stage or pre-BLA/pre-NDA 

meeting stage. 

The pilot would augment the 

currently available formal meetings 

between FDA and sponsors (see FDA’s 

draft guidance for industry entitled 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ ((September 2023) (Ref. 1))) 

through more rapid, ad-hoc 

communications with FDA by 

addressing issues with specific 

programmatic needs for individual 

products. For example, these issues can 

be related to clinical study design, 

choice of control group, fine-tuning the 

choice of patient population, selecting 

appropriate endpoints for efficacy trials 

to support marketing approval, selecting 

statistical methodology, leveraging 

nonclinical information, or product 

characterization. For eligible 

development programs sponsors and 

FDA could benefit from such additional 

communication beyond the currently 

available formal meeting mechanisms to 

address specific programmatic needs 

that require in-depth discussions. The 

increased communication between FDA 

review staff and sponsors is intended to 

facilitate program development for 

specific products and to help generate 

high quality and reliable data intended 

to support a BLA or NDA. 

II. Participation 

From January 2, 2024, to March 1, 

2024, FDA will accept requests to 

participate in the START Pilot Program 

and will initially select up to three 

participants in each Center. Taking into 

consideration lessons and sponsors’ 

experiences from the initial iteration of 

this program, a second iteration of the 

pilot may be conducted to include more 

participants in the future. At a later 

date, FDA may also publish another 

notice in the Federal Register to 

announce a second iteration of the 

program. 

Sponsors who are interested in 

participating in the START Pilot 

Program should submit a request to 

participate as an amendment to their 

Investigational New Drug (IND) 

application. 

A. Eligibility Criteria 

To be considered for the START Pilot 

Program, participants must meet the 

following eligibility criteria: 

1. Joint CBER and CDER Eligibility 

Criteria 

• IND has been submitted in or 

converted to Electronic Common 

Technical Document (eCTD) format, 

unless the IND is of a type granted a 

waiver from eCTD format (see FDA’s 

guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Certain Human 

Pharmaceutical Product Applications 

and Related Submissions using the 

eCTD Specifications’’ ((February 2020) 

(Ref. 2))) and remains in active status. 

• Sponsor has demonstrated 

substantial effort to ensure that that 

Chemistry, Manufacturing, and Controls 

(CMC) development aligns with clinical 

development, for example, through 

documented control of manufacturing 

and testing procedures to ensure clinical 

and CMC development timeline are in 

alignment. 

Given the specific identified needs for 

the products regulated by each Center 

for rare diseases, the following 

eligibility criteria differ between CBER 

and CDER: 

2. CBER-Specific Eligibility Criteria 

• Existing OTP-regulated IND for a 

cellular or gene therapy under which 

the product is being developed toward 

a marketing application. 

• Such product is intended to address 

an unmet medical need as a treatment 

for a rare disease 1 or serious condition, 

which is likely to lead to significant 

disability or death within the first 

decade of life. 

3. CDER-Specific Eligibility Criteria 

• Such product is intended to treat 

rare neurodegenerative conditions 

(including those of rare genetic 

metabolic etiology). 

B. What To Submit in a Request To 

Participate in the START Pilot 

To participate in the START Pilot 

Program, sponsors should submit a 

written request as an amendment to the 

IND. The cover letter should (1) state 

‘‘Request to participate in the START 

Pilot Program’’, (2) note whether there is 

a breakthrough therapy (BT) designation 

for the product and for CBER-regulated 

products only—whether there is a BT 

designation and/or regenerative 

medicine advanced therapy (RMAT) 

designation, and (3) provide a point of 

contact. 

The request should include the initial 

specific development issue(s) for a given 

product for enhanced communication 

and a proposed communication plan 

between the sponsor and review staff. In 

addition, the following information 

should be provided: 

1. Program development plan. 

The plan should describe the current 

state of program development, including 

any ongoing activities not already 

detailed in the IND. 

• CMC development plan and current 

status. 

• Nonclinical development plan and 

current status. 

• Clinical development plan and 

current status. 

2. Any specific issue(s) (grouped by 

review disciplines) for which the 

prospective applicants are seeking 

enhanced communications with FDA 

review staff to facilitate program 

development, including, for example, to 

ensure a mutual understanding of 

information needed to facilitate 

initiating the pivotal clinical study or to 

the pre-BLA/pre-NDA meeting stage. 

3. The planned timeline for initiation 

of the clinical study(ies) intended to 

provide the primary evidence of 

effectiveness to support a marketing 

application or for a pre-BLA/pre-NDA 

meeting request. 

4. The proposed communication plan 

for interactions between FDA review 

staff and the sponsor, including the 

proposed timing (i.e., month and year) 

for the initial teleconference and format 

(e.g., email or teleconference) of the 

subsequent communications on a 

scheduled and/or as needed basis. 

C. Selection Criteria and Process 

FDA intends to select participant 

CBER and CDER INDs based on the 

criteria outlined below. FDA will make 

its determination of participants 

following the close of the application 

period. FDA intends to issue a letter to 

notify each sponsor of FDA’s decision 

on sponsor requests to participate 

within 90 days of the application 

deadline. 

For the initial selection of up to three 

INDs from each Center for the START 

Pilot Program from eligible applicants, 

FDA intends to consider factors such as: 

(1) potential clinical benefits of the 

product, (2) whether resolution of the 

specific issues noted by the sponsor in 

their request to participate in the pilot 

could be facilitated through enhanced 

communication to improve efficiency of 

program development, (3) whether there 

is an BT or RMAT designation for the 

product, (4) whether CMC development 

timeline aligns with clinical 

development plans, and (5) while INDs 

for combination products (21 CFR 

3.2(e)(1)) may be eligible, products that 

require significant cross-Center 

interactions (e.g., complex combination 

products) may be less likely to be 


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Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 67765 

selected for the pilot. Overall, pilot 

participants will be selected based on 

application readiness (e.g., sponsors 

who demonstrate having the ability to 

move the program forward towards a 

marketing application). 

D. FDA-Sponsor Interactions During the 

START Pilot Program 

If selected for the START Pilot 

Program, sponsors will receive 

enhanced communications with FDA 

review staff. These enhanced 

communications may vary between 

CBER and CDER but will include at a 

minimum an initial meeting to review 

features of the pilot, discuss a pathway 

intended to support a marketing 

application, and to discuss specific 

issues for which a sponsor requests 

enhanced communication with FDA. 

Additional communications will 

include ongoing interactions via email 

or teleconference that take place on a 

scheduled and/or as needed basis as 

agreed upon by the sponsor and FDA. 

III. Paperwork Reduction Act of 1995 

This notice refers to previously 

approved FDA collections of 

information. 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. 3501–3521). The 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014 and 

the collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338. 

IV. References 

The following references are on 

display at the Dockets Management Staff 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, and are available for viewing by 

interested persons between 9 a.m. and 4 

p.m., Monday through Friday; they are 

also available electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA Draft Guidance for Industry 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ (September 2023): https://

www.fda.gov/media/172311/download. 

2. FDA Guidance for Industry 

‘‘Providing Regulatory Submissions in 

Electronic Format—Certain Human 

Pharmaceutical Product Applications 

and Related Submissions using the 

eCTD Specifications’’ (February 2020): 

https://www.fda.gov/media/135373/ 

download. 

Dated: September 25, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21235 Filed 9–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0219] 

Human Prescription Drug and 

Biological Products—Labeling for 

Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘‘Dose Banding’’; 

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 final 

guidance for industry entitled ‘‘Human 

Prescription Drug and Biological 

Products—Labeling for Dosing Based on 

Weight or Body Surface Area for Readyto-Use Containers—‘Dose Banding.’ ’’ 

The guidance is intended to assist 

applicants in incorporating dose 

banding information, based on dosing 

information of a previously approved 

drug product that is based on weight or 

body surface area (BSA), into the 

proposed labeling of injectable drug 

products that are the subject of certain 

marketing applications submitted to 

FDA. This guidance finalizes the draft 

guidance of the same title issued on July 

21, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 2, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2022–D–0219 for ‘‘Human Prescription 

Drug and Biological Products—Labeling 

for Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘Dose Banding.’ ’’ 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 


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