Public Comment Request: Request for Information Regarding HRSA Sickle Cell Disease Programs, 97013-97014 [2024-28558]

Download as PDF Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices lotter on DSK11XQN23PROD with NOTICES1 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 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics.’’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 This draft guidance contains proposed collections of information including information submitted to FDA in support of maintaining an accelerated approval.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 To comply with this requirement, FDA will publish a 60-day notice on the proposed collections of information in this draft guidance in a separate issue of the Federal Register.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 This draft guidance also refers to previously approved FDA collections of information.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 VerDate Sep<11>2014 18:02 Dec 05, 2024 Jkt 265001 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice of request for public comment. AGENCY: HRSA’s Maternal and Child Health Bureau Sickle Cell Disease (SCD) Programs are requesting input from the public to inform future SCD program development. SUMMARY: Submit comments no later than January 6, 2025. ADDRESSES: Submit electronic comments to scdprograms@hrsa.gov. Please submit your response only one time. DATES: FOR FURTHER INFORMATION CONTACT: Oriana Sanchez, Public Health Analyst, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Rockville, PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 97013 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. E:\FR\FM\06DEN1.SGM 06DEN1 97014 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 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 Administration for Strategic Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS). AGENCY: [_ _ Base_)+ ( The risk component accounts for health care risks and hazards capable of creating a surge for the U.S. health care VerDate Sep<11>2014 18:02 Dec 05, 2024 Jkt 265001 Population Frm 00079 Fmt 4703 Sfmt 4703 Notice. 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. SUMMARY: 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. ) + [_ _ Risk_) delivery system. ASPR calculates the health care surge-specific risk component using publicly available PO 00000 ACTION: national datasets to account for three subcomponents: E:\FR\FM\06DEN1.SGM 06DEN1 EN06DE24.005</GPH> lotter on DSK11XQN23PROD with NOTICES1 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

Agencies

[Federal Register Volume 89, Number 235 (Friday, December 6, 2024)]
[Notices]
[Pages 97013-97014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28558]


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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 [email protected]. 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; [email protected] 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.

[[Page 97014]]

    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
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