Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The National Health Service Corps Loan Repayment Programs, 4317-4318 [2024-01224]
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Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
I. Cellular, Tissue, and Gene Therapies
Advisory Committee
The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies, and
xenotransplantation products, which are
intended for transplantation,
implantation, infusion, and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair, or replacement of
tissues for various conditions. The
Committee also considers the quality
and relevance of FDA’s research
program, which provides scientific
support for the regulation of these
products, and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter via email stating that interest to
the FDA contact (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). Within the subsequent 30 days,
FDA will send a notification to each
organization that has expressed an
interest, attaching a complete list of all
such organizations; and a list of all
nominees along with their current
re´sume´s. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
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III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nomination
must include a current, complete
re´sume´ or curriculum vitae for each
nominee, including current business
address and telephone number, email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES) within 30 days of
publication of this document (see
DATES). Nominations must also specify
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the advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14,
relating to advisory committees.
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01154 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
4317
FDA is
announcing the approval of a product
redeeming a rare pediatric disease
priority review voucher. Under section
529 of the FD&C Act (21 U.S.C. 360ff),
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that VEOZAH
(fezolinetant) meets the redemption
criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about VEOZAH (fezolinetant), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01163 Filed 1–22–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) authorizes FDA to
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA is required to
publish notice of the issuance of priority
review vouchers as well as the approval
of products redeeming a priority review
voucher. FDA has determined that
VEOZAH (fezolinetant), approved May
12, 2023, meets the criteria for
redeeming a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; The National Health Service
Corps Loan Repayment Programs
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 25, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
SUMMARY:
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Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The National Health Service Corps Loan
Repayment Programs OMB No. 0915–
0127—Revision.
Abstract: The National Health Service
Corps (NHSC) Loan Repayment Program
(LRP) was established to assure an
adequate supply of trained primary care
health professionals to provide services
in Health Professional Shortage Areas
(HPSAs) of the United States with the
greatest need. The NHSC Substance Use
Disorder Workforce LRP and the NHSC
Rural Community LRP were established
to recruit and retain a health
professional workforce with specific
training and credentials to provide
evidence-based substance use disorder
treatment in HPSAs. Under these
programs, HHS agrees to repay the
qualifying educational loans of selected
primary care health professionals. In
return, the health professionals agree to
serve for a specified period of time in
an NHSC-approved site located in a
federally-designated HPSA approved by
the Secretary of HHS for LRP
participants.
The forms used by each LRP include
the following: (1) the NHSC LRP
Application, (2) the Authorization for
Disclosure of Loan Information Form,
(3) the Privacy Act Release
Authorization Form, and, if applicable,
(4) the Verification of Disadvantaged
Background Form, (5) the Private
Practice Option Form, and (6) the NHSC
Spanish Language Assessment
Proficiency Test Form. The first four of
the NHSC LRP Forms collect
information that is needed for selecting
participants and repaying qualifying
educational loans. The Private Practice
Option and Spanish Language
Assessment forms are needed to collect
information from applicants who wish
to be considered for those options.
Need and Proposed Use of the
Information: The need and proposed
use of this information collection is to
assess an LRP applicant’s eligibility and
qualifications for the LRP, and to
determine LRP applicants’ Spanish
language proficiency if relevant to their
application, and to obtain information
for NHSC site applicants. The NHSC
LRP application asks for personal,
professional, and financial/loan
information.
Likely Respondents: Likely
respondents include licensed primary
care medical, dental, and behavioral
health providers who are employed or
seeking employment and are interested
in serving underserved populations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Total burden
hours
NHSC LRP Application ........................................................
Authorization for Disclosure of Loan Information Form .......
Privacy Act Release Authorization Form .............................
Verification of Disadvantaged Background Form ................
Private Practice Option Form ..............................................
NHSC Comprehensive Behavioral Health Services Checklist .....................................................................................
NHSC Spanish Language Assessment Proficiency Test
Form .................................................................................
NHSC Site Application (including recertification) ................
9,020
7,150
303
660
330
1
1
1
1
1
9,020
7,150
303
660
330
1.00
0.10
0.10
0.50
0.10
9,020
715
30
330
33
4,400
1
4,400
0.13
572
3,006
4,070
1
1
3,006
4,070
0.50
0.50
1,503
2,035
Total ..............................................................................
28,939
........................
28,939
........................
14,238
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–01224 Filed 1–22–24; 8:45 am]
BILLING CODE 4165–15–P
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Average
burden per
response
(in hours)
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]]>Agencies
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4317-4318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01224]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; The National Health
Service Corps Loan Repayment Programs
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than March 25,
2024.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
[[Page 4318]]
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: The National Health Service
Corps Loan Repayment Programs OMB No. 0915-0127--Revision.
Abstract: The National Health Service Corps (NHSC) Loan Repayment
Program (LRP) was established to assure an adequate supply of trained
primary care health professionals to provide services in Health
Professional Shortage Areas (HPSAs) of the United States with the
greatest need. The NHSC Substance Use Disorder Workforce LRP and the
NHSC Rural Community LRP were established to recruit and retain a
health professional workforce with specific training and credentials to
provide evidence-based substance use disorder treatment in HPSAs. Under
these programs, HHS agrees to repay the qualifying educational loans of
selected primary care health professionals. In return, the health
professionals agree to serve for a specified period of time in an NHSC-
approved site located in a federally-designated HPSA approved by the
Secretary of HHS for LRP participants.
The forms used by each LRP include the following: (1) the NHSC LRP
Application, (2) the Authorization for Disclosure of Loan Information
Form, (3) the Privacy Act Release Authorization Form, and, if
applicable, (4) the Verification of Disadvantaged Background Form, (5)
the Private Practice Option Form, and (6) the NHSC Spanish Language
Assessment Proficiency Test Form. The first four of the NHSC LRP Forms
collect information that is needed for selecting participants and
repaying qualifying educational loans. The Private Practice Option and
Spanish Language Assessment forms are needed to collect information
from applicants who wish to be considered for those options.
Need and Proposed Use of the Information: The need and proposed use
of this information collection is to assess an LRP applicant's
eligibility and qualifications for the LRP, and to determine LRP
applicants' Spanish language proficiency if relevant to their
application, and to obtain information for NHSC site applicants. The
NHSC LRP application asks for personal, professional, and financial/
loan information.
Likely Respondents: Likely respondents include licensed primary
care medical, dental, and behavioral health providers who are employed
or seeking employment and are interested in serving underserved
populations.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
NHSC LRP Application............ 9,020 1 9,020 1.00 9,020
Authorization for Disclosure of 7,150 1 7,150 0.10 715
Loan Information Form..........
Privacy Act Release 303 1 303 0.10 30
Authorization Form.............
Verification of Disadvantaged 660 1 660 0.50 330
Background Form................
Private Practice Option Form.... 330 1 330 0.10 33
NHSC Comprehensive Behavioral 4,400 1 4,400 0.13 572
Health Services Checklist......
NHSC Spanish Language Assessment 3,006 1 3,006 0.50 1,503
Proficiency Test Form..........
NHSC Site Application (including 4,070 1 4,070 0.50 2,035
recertification)...............
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Total....................... 28,939 .............. 28,939 .............. 14,238
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-01224 Filed 1-22-24; 8:45 am]
BILLING CODE 4165-15-P
