Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas, 54471-54472 [2024-14477]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 126 / Monday, July 1, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
This guidance recommends an
approach to identifying EDDOs,
provides examples of EDDOs for
specific types of devices, and describes
the information and data related to
EDDOs that is provided in an
application or submission. Examples of
products that are within the scope of
this guidance include syringes, injectors
(e.g., autoinjector, on body injector),
infusion products (e.g., infusion
pumps), nasal sprays, inhalers,
nebulizers, and vaginal systems.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Essential Drug Delivery Outputs for
Devices Intended to Deliver Drugs and
Biological Products.’’ 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
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312 for
investigational new drug applications
have been approved under OMB control
number 0910–0014 and the collections
of information in 21 CFR part 812 for
investigational device exemptions have
been approved under OMB control
number 0910–0078. The collections of
information in 21 CFR part 314 for new
drug applications and abbreviated new
drug applications, including the
collections of information contained in
the guidance for industry entitled
‘‘Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA
Products’’ have been approved under
OMB control number 0910–0001. The
collections of information in 21 CFR
parts 601 and 610 for biologics license
applications have been approved under
OMB control number 0910–0338. The
collections of information in section
351(k) of the Public Health Service Act
(42 U.S.C. 262(k)) have been approved
under OMB control number 0910–0718.
The collections of information in 21
CFR part 814 for premarket approval
applications have been approved under
OMB control number 0910–0231. The
collections of information in section
510(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(k)), subpart
VerDate Sep<11>2014
20:36 Jun 28, 2024
Jkt 262001
E for 510(k) notifications, have been
approved under OMB control number
0910–0120. The collections of
information in 21 CFR 860, subpart D
for De Novo classifications have been
approved under OMB control number
0910–0844. The collections of
information in 21 CFR part 211 for
current good manufacturing practice for
finished pharmaceuticals have been
approved under OMB control number
0910–0139. The collections of
information in 21 CFR part 820 for the
quality system regulation have been
approved under OMB control number
0910–0073. The collections of
information in 21 CFR part 807, subpart
E for premarket notification have been
approved under OMB control number
0910–0120. The collections of
information for meetings related to
generic drug development have been
approved under OMB control number
0910–0727. The collections of
information in the guidance for industry
and FDA staff entitled ‘‘Requests for
Feedback on Medical Device
Submissions: The Q-Submission
Program and Meetings with the Food
and Drug Administration Staff’’ have
been approved under OMB control
number 0910–0756.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/combination-products/
guidance-regulatory-information/
combination-products-guidancedocuments, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: June 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–14409 Filed 6–28–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Lists of Designated Primary Medical
Care, Mental Health, and Dental Health
Professional Shortage Areas
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
This notice informs the public
of the availability of the complete lists
of all geographic areas, population
groups, and facilities designated as
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
54471
primary medical care, dental health, and
mental health professional shortage
areas (HPSAs) in a designated status as
of April 15, 2024. The lists are available
on the shortage area topic page on
HRSA’s data.hrsa.gov website. All
currently designated HPSAs remain
designated until final lists are published
later this fall. HPSA designations that
are currently proposed for withdrawal
will remain in this status until the
publication of the HPSA Federal
Register notice on or before November
1, 2024. HPSAs proposed for withdraw
will be re-evaluated before final
publication if additional information is
made available to HPSA by states. If
these HPSAs do not meet the
requirements for designation at the time
of the publication of the HPSA Federal
Register on or before November 1, 2024,
they will be withdrawn.
ADDRESSES: Complete lists of currently
designated HPSAs as of April 15, 2024,
and include those proposed for
withdraw, are available on the website
at https://data.hrsa.gov/tools/healthworkforce/shortage-areas/frn.
Frequently updated information on
HPSAs is available at https://
data.hrsa.gov/topics/health-workforce/
health-workforce-shortage-areas.
Information on shortage designations is
available at https://bhw.hrsa.gov/
workforce-shortage-areas/shortagedesignation.
For
further information on the HPSA
designations listed on the website or to
request additional designation,
withdrawal, or reapplication for
designation, please contact Matthew
Patterson, Acting Branch Chief,
Shortage Designation Branch, Division
of Policy and Shortage Designation,
Bureau of Health Workforce (BHW),
HRSA, 5600 Fishers Lane, Rockville,
Maryland 20857, sdb@hrsa.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
Section 332 of the Public Health
Service (PHS) Act, 42 U.S.C. 254e,
provides that the Secretary shall
designate HPSAs based on criteria
established by regulation. HPSAs are
defined in section 332 to include (1)
urban and rural geographic areas with
shortages of health professionals, (2)
population groups with such shortages,
and (3) facilities with such shortages.
Section 332 further requires that the
Secretary annually publish lists of the
designated geographic areas, population
groups, and facilities. The lists of
HPSAs are to be reviewed at least
annually and revised as necessary.
E:\FR\FM\01JYN1.SGM
01JYN1
54472
Federal Register / Vol. 89, No. 126 / Monday, July 1, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
Final regulations (42 CFR part 5) were
published on November 17, 1980 (45 FR
75996) that include the criteria for
designating HPSAs. Criteria were
defined for seven health professional
types: primary medical care, dental,
psychiatric, vision care, podiatric,
pharmacy, and veterinary care. The
criteria for correctional facility HPSAs
were published on October 29, 1987 (52
FR 41594) and revised March 2, 1989
(54 FR 8735). The criteria for psychiatric
HPSAs were expanded to mental health
HPSAs on January 22, 1992 (57 FR
2473). Currently funded PHS Act
programs use the primary medical care,
mental health, or dental HPSA or
relevant sub-score designations such as
Maternity Care Target Areas.
HPSA designation offers access to
potential federal assistance. Public or
private nonprofit entities are eligible to
apply for assignment of National Health
Service Corps personnel to provide
primary medical care, mental health, or
dental health services in or to these
HPSAs. National Health Service Corps
health professionals enter into service
agreements to serve in federally
designated HPSAs. Entities with clinical
training sites located in HPSAs are
eligible to receive priority for certain
residency training program grants
administered by HRSA’s Bureau of
Health Workforce (BHW). Other federal
programs also utilize HPSA
designations. For example, under
authorities administered by the Centers
for Medicare & Medicaid Services,
certain qualified providers in
geographic area HPSAs are eligible for
increased levels of Medicare
reimbursement.
Content and Format of Lists
The three lists of designated HPSAs
are available on the HRSA Data
Warehouse shortage area topic web
page, including those proposed for
withdraw, and include a snapshot of all
geographic areas, population groups,
and facilities that were designated
HPSAs as of April 15, 2024. This notice
incorporates the most recent annual
reviews of designated HPSAs and
supersedes the HPSA lists published in
the Federal Register on January 2, 2024
(FR/Vol. 89, No. 1, Tuesday, January 2,
2024/Document Number 2023–28844).
The proposed for withdraw HPSAs will
remain in that status until the lists are
finalized this fall. States have the
opportunity to provide additional
information as part of the review of
proposed for withdraw HPSAs prior to
the lists being finalized this fall.
In addition, all Indian Tribes that
meet the definition of such Tribes in the
Indian Health Care Improvement Act of
VerDate Sep<11>2014
20:36 Jun 28, 2024
Jkt 262001
1976, 25 U.S.C. 1603, are automatically
designated as population groups with
primary medical care and dental health
professional shortages. Further, the
Health Care Safety Net Amendments of
2002 provides eligibility for automatic
facility HPSA designations for all
federally qualified health centers
(FQHCs) and rural health clinics that
offer services regardless of ability to
pay. Specifically, these entities include
FQHCs funded under section 330 of the
PHS Act, FQHC Look-Alikes, and Tribal
and urban Indian clinics operating
under the Indian Self-Determination
and Education Act of 1975 (25 U.S.C.
450) or the Indian Health Care
Improvement Act. Many, but not all, of
these entities are included on this
listing. Absence from this list does not
exclude them from HPSA designation;
facilities eligible for automatic
designation are included in the database
when they are identified.
Each list of designated HPSAs is
arranged by state. Within each state, the
list is presented by county. If only a
portion (or portions) of a county is (are)
designated, a county is part of a larger
designated service area, or a population
group residing in a county or a facility
located in the county has been
designated, the name of the service area,
population group, or facility involved is
listed under the county name. A county
that has a whole county geographic or
population group HPSA is indicated by
the phrase ‘‘County’’ following the
county name.
Development of the Designation and
Withdrawal Lists
Requests for designation or
withdrawal of a particular geographic
area, population group, or facility as a
HPSA are received continuously by
BHW. Under a Cooperative Agreement
between HRSA and the 54 state and
territorial Primary Care Offices (PCOs),
PCOs conduct needs assessments and
submit applications to HRSA to
designate areas as HPSAs. BHW refers
requests that come from other sources to
PCOs for review. In addition, interested
parties, including Governors, state
Primary Care Associations, and state
professional associations, are notified of
requests so that they may submit their
comments and recommendations.
BHW reviews each recommendation
for possible addition, continuation,
revision, or withdrawal. Following
review, BHW notifies the appropriate
agency, individuals, and interested
organizations of each designation of a
HPSA, rejection of recommendation for
HPSA designation, revision of a HPSA
designation, and/or advance notice of
pending withdrawals from the HPSA
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
list. Designations (or revisions of
designations) are effective as of the date
on the notification from BHW and are
updated daily on the HRSA Data
Warehouse website. The effective date
of a withdrawal will be the next
publication of a notice regarding the list
of designated HPSAs in the Federal
Register.
Carole Johnson,
Administrator.
[FR Doc. 2024–14477 Filed 6–28–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information (RFI): Inviting
Comments and Suggestions on an
ODS Strategic Plan 2025–2029: A
Blueprint for a Coordinated Dietary
Supplement Research Agenda at NIH
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Request for information.
The National Institutes of
Health (NIH), Office of Dietary
Supplements (ODS) is continuing to use
a structured planning process to
develop its five-year strategic plans.
After a new director joined ODS in July
2023 a new strategic plan for 2025–2029
was developed titled ‘‘A Blueprint for a
Coordinated Dietary Supplement
Research Agenda at NIH.’’ ODS is
committed to engaging its partners and
other interested parties including
representatives of the scientific
community, industry, other federal
agencies, policymakers, and the public
in the strategic planning process by
soliciting their comments on the draft
ODS Strategic Plan for Fiscal Years (CY)
2025–2029.
DATES: The RFI is open for public
comment for a period of 60 days. To
ensure consideration, comments must
be submitted by August 30, 2024.
ADDRESSES: All comments must be
submitted electronically to ODSplan@
od.nih.gov. You will receive an
electronic confirmation acknowledging
receipt of your response.
FOR FURTHER INFORMATION CONTACT:
Barbara Cohen, Ph.D., at ODSplan@
od.nih.gov or (301) 435–2920.
SUPPLEMENTARY INFORMATION: This
notice is in accordance with the 21st
Century Cures Act, wherein NIH
institutes are required to regularly
update their strategic plans. The
purpose of the CY 2025–2029 ODS
Strategic Plan (https://ods.od.nih.gov/
SUMMARY:
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[Federal Register Volume 89, Number 126 (Monday, July 1, 2024)]
[Notices]
[Pages 54471-54472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14477]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Lists of Designated Primary Medical Care, Mental Health, and
Dental Health Professional Shortage Areas
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice informs the public of the availability of the
complete lists of all geographic areas, population groups, and
facilities designated as primary medical care, dental health, and
mental health professional shortage areas (HPSAs) in a designated
status as of April 15, 2024. The lists are available on the shortage
area topic page on HRSA's data.hrsa.gov website. All currently
designated HPSAs remain designated until final lists are published
later this fall. HPSA designations that are currently proposed for
withdrawal will remain in this status until the publication of the HPSA
Federal Register notice on or before November 1, 2024. HPSAs proposed
for withdraw will be re-evaluated before final publication if
additional information is made available to HPSA by states. If these
HPSAs do not meet the requirements for designation at the time of the
publication of the HPSA Federal Register on or before November 1, 2024,
they will be withdrawn.
ADDRESSES: Complete lists of currently designated HPSAs as of April 15,
2024, and include those proposed for withdraw, are available on the
website at https://data.hrsa.gov/tools/health-workforce/shortage-areas/frn. Frequently updated information on HPSAs is available at https://data.hrsa.gov/topics/health-workforce/health-workforce-shortage-areas.
Information on shortage designations is available at https://bhw.hrsa.gov/workforce-shortage-areas/shortage-designation.
FOR FURTHER INFORMATION CONTACT: For further information on the HPSA
designations listed on the website or to request additional
designation, withdrawal, or reapplication for designation, please
contact Matthew Patterson, Acting Branch Chief, Shortage Designation
Branch, Division of Policy and Shortage Designation, Bureau of Health
Workforce (BHW), HRSA, 5600 Fishers Lane, Rockville, Maryland 20857,
[email protected].
SUPPLEMENTARY INFORMATION:
Background
Section 332 of the Public Health Service (PHS) Act, 42 U.S.C. 254e,
provides that the Secretary shall designate HPSAs based on criteria
established by regulation. HPSAs are defined in section 332 to include
(1) urban and rural geographic areas with shortages of health
professionals, (2) population groups with such shortages, and (3)
facilities with such shortages. Section 332 further requires that the
Secretary annually publish lists of the designated geographic areas,
population groups, and facilities. The lists of HPSAs are to be
reviewed at least annually and revised as necessary.
[[Page 54472]]
Final regulations (42 CFR part 5) were published on November 17,
1980 (45 FR 75996) that include the criteria for designating HPSAs.
Criteria were defined for seven health professional types: primary
medical care, dental, psychiatric, vision care, podiatric, pharmacy,
and veterinary care. The criteria for correctional facility HPSAs were
published on October 29, 1987 (52 FR 41594) and revised March 2, 1989
(54 FR 8735). The criteria for psychiatric HPSAs were expanded to
mental health HPSAs on January 22, 1992 (57 FR 2473). Currently funded
PHS Act programs use the primary medical care, mental health, or dental
HPSA or relevant sub-score designations such as Maternity Care Target
Areas.
HPSA designation offers access to potential federal assistance.
Public or private nonprofit entities are eligible to apply for
assignment of National Health Service Corps personnel to provide
primary medical care, mental health, or dental health services in or to
these HPSAs. National Health Service Corps health professionals enter
into service agreements to serve in federally designated HPSAs.
Entities with clinical training sites located in HPSAs are eligible to
receive priority for certain residency training program grants
administered by HRSA's Bureau of Health Workforce (BHW). Other federal
programs also utilize HPSA designations. For example, under authorities
administered by the Centers for Medicare & Medicaid Services, certain
qualified providers in geographic area HPSAs are eligible for increased
levels of Medicare reimbursement.
Content and Format of Lists
The three lists of designated HPSAs are available on the HRSA Data
Warehouse shortage area topic web page, including those proposed for
withdraw, and include a snapshot of all geographic areas, population
groups, and facilities that were designated HPSAs as of April 15, 2024.
This notice incorporates the most recent annual reviews of designated
HPSAs and supersedes the HPSA lists published in the Federal Register
on January 2, 2024 (FR/Vol. 89, No. 1, Tuesday, January 2, 2024/
Document Number 2023-28844). The proposed for withdraw HPSAs will
remain in that status until the lists are finalized this fall. States
have the opportunity to provide additional information as part of the
review of proposed for withdraw HPSAs prior to the lists being
finalized this fall.
In addition, all Indian Tribes that meet the definition of such
Tribes in the Indian Health Care Improvement Act of 1976, 25 U.S.C.
1603, are automatically designated as population groups with primary
medical care and dental health professional shortages. Further, the
Health Care Safety Net Amendments of 2002 provides eligibility for
automatic facility HPSA designations for all federally qualified health
centers (FQHCs) and rural health clinics that offer services regardless
of ability to pay. Specifically, these entities include FQHCs funded
under section 330 of the PHS Act, FQHC Look-Alikes, and Tribal and
urban Indian clinics operating under the Indian Self-Determination and
Education Act of 1975 (25 U.S.C. 450) or the Indian Health Care
Improvement Act. Many, but not all, of these entities are included on
this listing. Absence from this list does not exclude them from HPSA
designation; facilities eligible for automatic designation are included
in the database when they are identified.
Each list of designated HPSAs is arranged by state. Within each
state, the list is presented by county. If only a portion (or portions)
of a county is (are) designated, a county is part of a larger
designated service area, or a population group residing in a county or
a facility located in the county has been designated, the name of the
service area, population group, or facility involved is listed under
the county name. A county that has a whole county geographic or
population group HPSA is indicated by the phrase ``County'' following
the county name.
Development of the Designation and Withdrawal Lists
Requests for designation or withdrawal of a particular geographic
area, population group, or facility as a HPSA are received continuously
by BHW. Under a Cooperative Agreement between HRSA and the 54 state and
territorial Primary Care Offices (PCOs), PCOs conduct needs assessments
and submit applications to HRSA to designate areas as HPSAs. BHW refers
requests that come from other sources to PCOs for review. In addition,
interested parties, including Governors, state Primary Care
Associations, and state professional associations, are notified of
requests so that they may submit their comments and recommendations.
BHW reviews each recommendation for possible addition,
continuation, revision, or withdrawal. Following review, BHW notifies
the appropriate agency, individuals, and interested organizations of
each designation of a HPSA, rejection of recommendation for HPSA
designation, revision of a HPSA designation, and/or advance notice of
pending withdrawals from the HPSA list. Designations (or revisions of
designations) are effective as of the date on the notification from BHW
and are updated daily on the HRSA Data Warehouse website. The effective
date of a withdrawal will be the next publication of a notice regarding
the list of designated HPSAs in the Federal Register.
Carole Johnson,
Administrator.
[FR Doc. 2024-14477 Filed 6-28-24; 8:45 am]
BILLING CODE 4165-15-P
