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This draft guidance is being issued 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The draft guidance, when finalized, will 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This draft guidance contains proposed 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This draft guidance also refers to 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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97014 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 

1. What are the best ways to improve 

the quality of life of individuals living 

with SCD? 

2. What strategies or best practices are 

needed to ensure individuals with SCD 

receive comprehensive evidence-based 

health care? If possible, describe 

different strategies needed for children 

and for adults in both healthcare (e.g., 

clinics, hospitals) and non-healthcare 

settings (e.g., education, housing, 

transportation). 

3. What are the barriers to ensuring 

infants identified with SCD through 

newborn screening are receiving 

appropriate follow-up care? What 

strategies or practices best address these 

barriers? 

4. What are the barriers to successful 

transition from pediatric to adult 

serving systems? What strategies are 

available for individuals with SCD to 

receive evidence-based, comprehensive 

care as they transition into adulthood 

(e.g., in clinics, hospitals)? What 

strategies or programs (e.g., community 

health worker programs) have 

successfully transitioned individuals 

with SCD in non-health settings (e.g., 

education, employment, and living 

situations)? 

5. What are the challenges to 

improving the systems of care that 

support individuals with SCD and their 

families across the lifespan more 

broadly? Please share strategies that can 

bridge the gaps between systems that 

address healthcare (e.g., clinics, 

hospitals) and systems that address 

social determinants of health (e.g., 

education, housing, transportation)? 

Respondents can also provide 

additional comments or 

recommendations that are not 

specifically linked to the questions 

above. All responses may, but are not 

required to, identify the individual’s 

name, address, email, telephone 

number, professional or organizational 

affiliation, background or area of 

expertise (e.g., program participant, 

family member, clinician, public health 

worker, researcher, HRSA SCD grantee), 

and topic/subject matter. Information 

obtained as a result of this request for 

information (RFI) may be used by HRSA 

for program planning. Comments in 

response to this RFI may be made 

publicly available, so respondents 

should bear this in mind when making 

comments. HRSA will not respond to 

any individual comments. 

Special Note to Commenters 

Whenever possible, respondents are 

asked to draw their responses from 

objective, empirical, and actionable 

evidence and to cite this evidence 

within their responses. The information 

obtained through this RFI may help 

inform the next iteration of the HRSA 

SCD portfolio of investments. This RFI 

is issued solely for information and 

planning purposes; it does not 

constitute a Request for Proposal, 

applications, proposal abstracts, or 

quotations. This RFI does not commit 

the U.S. Government to contract for any 

supplies or services or make a grant or 

cooperative agreement award. Further, 

HRSA is not seeking proposals through 

this RFI and will not accept unsolicited 

proposals. HRSA will not respond to 

questions about the policy issues raised 

in this RFI. Responders are advised that 

the U.S. Government will not pay for 

any information or administrative costs 

incurred in response to this RFI; all 

costs associated with responding to this 

RFI will be solely at the interested 

party’s expense. Not responding to this 

RFI does not preclude participation in 

any future procurement or program, if 

conducted. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–28558 Filed 12–5–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Strategic 

Preparedness and Response 

Request for Information on Hospital 

Preparedness Program Funding 

Formula 

AGENCY: Administration for Strategic 

Preparedness and Response (ASPR), 

U.S. Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with section 

319C–2 of the Public Health Service 

(PHS) Act, the Administration for 

Strategic Preparedness and Response 

(ASPR) distributes Hospital 

Preparedness Program (HPP) 

cooperative agreement funding to 

recipients using a statutorily required 

formula. ASPR is seeking comment on 

the risk component of the HPP funding 

formula to inform potential future 

changes to the formula. 

DATES: Comments on this notice must be 

received by December 20, 2024. ASPR 

will not reply individually to 

responders but will consider all 

comments submitted by the deadline. 

ADDRESSES: Please submit all responses 

to the following email address: HPP@

hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Hannah, Director, Office of 

Health Care Readiness (OHCR) via 

Jennifer.Hannah@hhs.gov or call: 202– 

245–0722. 

SUPPLEMENTARY INFORMATION: HPP is a 

cooperative agreement program that, 

through its support for health care 

coalitions, prepares the nation’s health 

care delivery system to save lives during 

emergencies that exceed the day-to-day 

capacity of health care and emergency 

response systems. HPP is the primary 

source of federal funding for health care 

preparedness and response. HPP 

provides funding to 62 recipients, 

including the governments of all 50 

states, eight U.S. territories and freely 

associated states, the District of 

Columbia, Chicago, New York City, and 

Los Angeles County. For the purposes of 

this Request for Information (RFI), ‘‘the 

health care delivery system’’ refers to all 

organizations and persons whose 

mission is to promote, restore, optimize, 

or maintain health. 

Section 319C–2 of the PHS Act 

requires ASPR to distribute HPP 

funding based on the following factors: 

a required base amount determined by 

the HHS Secretary, a required 

adjustment based on population, and an 

amount based on significant unmet need 

and degree of risk. 

The risk component accounts for 

health care risks and hazards capable of 

creating a surge for the U.S. health care 

delivery system. ASPR calculates the 

health care surge-specific risk 

component using publicly available 

national datasets to account for three 

subcomponents: 


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[ __ Base_)+ ( Population ) +[ __ Risk_)