Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 97011 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: Since 2005, Congress has 

authorized dedicated funding for 

discretionary awards from ACF’s Office 

of Family Assistance to support HMRF 

programs. Per the 2020 HMRF Notice of 

Funding Opportunities issued by ACF, 

HMRF grant recipients that are carrying 

out local evaluations are required to 

submit a final evaluation report to ACF 

at the end of their grant. The final 

reports must document the research 

questions, measures, study design, 

planned and actual implementation of 

the program, analytic methods for their 

evaluation, and evaluation findings. 

OPRE is conducting the HMRF Local 

Evaluation Technical Assistance (LETA) 

projects, jointly referred to as the 

HMRF–LETA projects, to support 

federally funded programs in evaluating 

their healthy relationship and family 

stability services to adult couples, adult 

individuals, fathers, and youth. As part 

of the HMRF–LETA project, grant 

recipients receive technical assistance to 

support planning and executing a local 

evaluation and analyzing and reporting 

local evaluation findings. 

The purpose of the current 

information collection request is to 

provide standardized report templates 

and table shells to grant recipients to 

document their evaluation’s analysis 

and findings. A structured final report 

template will facilitate grant recipients’ 

efficient and consistent reporting of 

evaluation findings in their final 

reports. The completed draft reports 

will be reviewed by the HMRF–LETA 

teams to determine whether the analysis 

and reports meet standards set by ACF, 

and to develop recommendations for 

grant recipients to improve the analysis 

and reports before final submission to 

ACF. Grant recipients will finalize and 

submit their final reports to ACF, as 

required. This request includes the time 

to develop and submit the reports. 

Respondents: The respondents are 

HMRF grant recipients conducting a 

local evaluation. There are currently 79 

grant recipients conducting local 

evaluations: 50 evaluations using 

descriptive designs (‘‘descriptive 

evaluations’’) and 29 evaluations using 

impact designs (‘‘impact evaluations’’). 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Descriptive Evaluation Final Report Template .................................... 50 1 40 2,000 

Impact Evaluation Final Report Template ........................................... 29 1 30 870 

Impact Evaluation Final Report Table Shells ...................................... 29 1 10 290 

Estimated Total Annual Burden 

Hours: 3,160. 

Authority: 42 U.S.C. 603(a)(2). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–28555 Filed 12–5–24; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–2033] 

Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics; 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 entitled 

‘‘Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics.’’ Accelerated 

approval is one of FDA’s expedited 

programs intended to facilitate and 

expedite development and review of 

certain drugs and biological products for 

serious or life-threatening conditions. 

This guidance provides information on 

FDA’s policies and procedures for the 

accelerated approval program, including 

discussions of which products may be 

candidates for accelerated approval, the 

standards for granting accelerated 

approval, and the procedures for 

withdrawing accelerated approval. 

When finalized, this draft guidance will 

replace the accelerated approval-related 

content in the final guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ issued on May 30, 2014 (the 

2014 final guidance). Additional 

programs to expedite product 

development are covered in the 2014 

final guidance as well as other 

guidances. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 4, 2025. 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 


lotter on DSK11XQN23PROD with NOTICES1
97012 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 

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– 

2024–D–2033 for ‘‘Expedited Program 

for Serious Conditions—Accelerated 

Approval of Drugs and Biologics.’’ 

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 draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed 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: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926 or 301– 

796–2500, dat.doan@fda.hhs.gov; James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911; or Paul 

Kluetz, Oncology Center of Excellence, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 22, Rm. 

2223, Silver Spring, MD 20993, 301– 

796–9567, Paul.Kluetz@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics.’’ Accelerated 

approval allows drugs for serious 

conditions that fill an unmet medical 

need to be approved based on a 

surrogate endpoint or an intermediate 

clinical endpoint that is reasonably 

likely to predict an effect on irreversible 

morbidity or mortality or other clinical 

benefit. Accelerated approval is one of 

FDA’s expedited programs intended to 

facilitate and expedite development and 

review of new drugs to address an 

unmet medical need in the treatment of 

a serious or life-threatening condition. 

In 1992, FDA issued accelerated 

approval regulations. In 1997, Congress 

codified the accelerated approval 

program in the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115), adding section 

506 to the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

356). In 2012, Congress amended 

section 506 of the FD&C Act via the 

Food and Drug Administration Safety 

and Innovation Act (Pub. L. 112–144) to 

provide that FDA should consider the 

‘‘severity, rarity, or prevalence of the 

condition and the availability or lack of 

alternative treatments.’’ In 2014, FDA 

issued a final guidance for industry 

entitled ‘‘Expedited Programs for 

Serious Conditions—Drugs and 

Biologics,’’ which provides information 

on FDA’s policies and procedures for 

four expedited programs (fast track 

designation, breakthrough therapy 

designation, accelerated approval, and 

priority review designation), as well as 

threshold criteria applicable to 

concluding that a drug is a candidate for 

these expedited programs. 

Section 506(c) of the FD&C Act was 

most recently amended by the 

Consolidated Appropriations Act, 2023 

(Pub. L. 117–328), which granted FDA 

additional authorities and imposed on 

FDA additional obligations regarding 

the accelerated approval pathway. 

Among other revisions, section 3210 of 

the Consolidated Appropriations Act, 

2023 requires FDA to set forth 

conditions, not later than the date of 

accelerated approval, for confirmatory 

trials, which ‘‘may include enrollment 

targets, the study protocol, and 

milestones, including the target date of 

study completion.’’ Congress also 

revised the provisions in section 506(c) 

of the FD&C Act related to the expedited 

withdrawal of approval of a product 

approved under accelerated approval, 

including by adding new procedures for 

expedited withdrawal. Section V of this 

draft guidance describes these recently 

added procedures for the expedited 

withdrawal of approval of a product 

approved under accelerated approval. 

This draft guidance addresses the 

accelerated approval process, including 

granting accelerated approval (e.g., 

discussion of endpoints, evidentiary 

criteria, confirmatory trials and other 

conditions of accelerated approval), and 

withdrawal of accelerated approval. 

Changes from the 2014 final guidance 

include early consultation on novel 

endpoints, timely conduct of 

confirmatory trials, other aspects of 

confirmatory trials, and the expedited 

withdrawal of accelerated approval. 

Other changes include a revised title 

and editorial changes for clarity, as well 

as updated references and contact 

information for FDA. When finalized, 

this guidance will replace the 

accelerated approval-related content 

contained in the 2014 final guidance 

issued on May 30, 2014 (79 FR 31117). 

Additionally, via the Consolidated 

Appropriations Act, 2023, Congress 

gave FDA the authority to require, as 

appropriate, that a confirmatory trial be 

underway prior to accelerated approval 

or within a specified time period after 

the date of accelerated approval. The 


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Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 97013 

Agency intends to address this authority 

in a separate guidance. 

This 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 ‘‘Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics.’’ 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 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3521), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

This draft guidance contains proposed 

collections of information including 

information submitted to FDA in 

support of maintaining an accelerated 

approval. ‘‘Collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to publish a 60-day notice in 

the Federal Register soliciting public 

comment on each proposed collection of 

information before submitting the 

collection to OMB for approval. To 

comply with this requirement, FDA will 

publish a 60-day notice on the proposed 

collections of information in this draft 

guidance in a separate issue of the 

Federal Register. This notice will 

encompass the collection of information 

discussed in the guidance relating to 

expedited procedures for the 

withdrawal of accelerated approval of 

drugs and biologics. Those procedures 

include the sponsor’s submission of 

their objections to withdrawal as well as 

their supporting data and evidence. This 

collection of information is not included 

in any currently approved information 

collection. 

This draft guidance also refers to 

previously approved FDA collections of 

information. The collections of 

information in 21 CFR parts 10, 12–16, 

and 19 pertaining to administrative 

practice and procedures have been 

approved under OMB control number 

0910–0191. The collections of 

information in 21 CFR part 312 relating 

to clinical trials associated with 

accelerated approval pathways have 

been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 314 relating 

to the submission of new drug 

applications, including accelerated 

approval of new drugs for serious or 

life-threatening conditions, have been 

approved under OMB control number 

0910–0001. The collections of 

information in 21 CFR part 601 relating 

to the submission of biologics license 

applications have been approved under 

OMB control number 0910–0338. The 

collections of information pertaining to 

expedited programs for serious 

conditions for drugs and biologics and 

breakthrough therapy-designation for 

drugs and biologics have been approved 

under OMB control number 0910–0765. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: November 27, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28392 Filed 12–5–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Public Comment Request: Request for 

Information Regarding HRSA Sickle 

Cell Disease Programs 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of request for public 

comment. 

SUMMARY: HRSA’s Maternal and Child 

Health Bureau Sickle Cell Disease (SCD) 

Programs are requesting input from the 

public to inform future SCD program 

development. 

DATES: Submit comments no later than 

January 6, 2025. 

ADDRESSES: Submit electronic 

comments to scdprograms@hrsa.gov. 

Please submit your response only one 

time. 

FOR FURTHER INFORMATION CONTACT: 

Oriana Sanchez, Public Health Analyst, 

Maternal and Child Health Bureau, 

HRSA, 5600 Fishers Lane, Rockville, 

Maryland 20857; scdprograms@hrsa.gov 

or call (347) 415–1458. 

SUPPLEMENTARY INFORMATION: SCD is a 

group of inherited red blood cell 

disorders affecting an estimated 100,000 

individuals in the United States. The 

Centers for Disease Control and 

Prevention report that SCD is a lifelong 

condition disproportionately affecting 

Black (1 of every 365 births) and 

Hispanic Americans (1 of every 16,300 

births) with cases also occurring in 

individuals of Mediterranean, Middle 

Eastern, and Asian descent. SCD causes 

the body to produce red blood cells that 

are crescent shaped which impedes 

blood flow and cause anemia, severe 

pain, organ damage and other 

complications. Without access to 

comprehensive and routine services, life 

expectancy is greatly reduced for 

individuals with SCD. HRSA currently 

funds a portfolio of three coordinated 

programs with several recipients to 

improve outcomes of individuals with 

SCD and their families: the SCD 

Newborn Screening Follow-up Program 

(authorized by 42 U.S.C. 701(a)(2) (sec. 

501(a)(2) of the Social Security Act)) 

funds 25 community-based 

organizations, the SCD Treatment 

Demonstration Program (authorized by 

42 U.S.C. 300b–5(b) (sec. 1106(b) of the 

Public Health Service Act)) funds five 

regional organizations, and one 

Hemoglobinopathies National 

Coordinating Center (authorized by 42 

U.S.C. 300b–5(b) (sec. 1106(b) of the 

Public Health Service Act). 

Together the programs strengthen the 

SCD system of care and support by (1) 

educating patients, families, and 

clinicians to improve knowledge and 

capacities; (2) linking individuals and 

families to evidence-based care; and (3) 

fostering partnerships between 

clinicians, community organizations, 

and other stakeholders to improve the 

ability to deliver coordinated, 

comprehensive care across the lifespan. 

HRSA’s SCD portfolio seeks to support 

and strengthen regional networks of 

SCD care, education, and social services 

across the United States. More 

information about the HRSA SCD 

programs is available online at: https:// 

mchb.hrsa.gov/programs-impact/ 

programs/sickle-cell. 

Responses 

HRSA is seeking responses that 

address the following questions. A 

response to each question is not 

required. When drafting responses, 

highlight strategies that HRSA should 

consider or prioritize to meet the needs 

of individuals with SCD and their 

families within the United States. 


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