Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas, 37637-37638 [2015-16168]
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37637
Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
are also subject to state laws and
regulations. Under the BPCI Act, a
biological product that has been
approved as an ‘‘interchangeable’’ may
be substituted for the reference product
without the intervention of the health
care provider who prescribed the
reference product.
into account, among other things, the
expiration dates of patents that relate to
potential reference products and general
market interest in biological products
that could be candidates for 351(k)
applications.
FDA estimates the burden of this
collection of information as follows:
Based on the number of 351(k)
applications FDA received through FY
2014, we estimate that we will receive
approximately five 351(k) applications
annually. The number of respondents
submitting 351(k) applications is based
on the number of sponsors submitting
351(k) applications through FY 2014. In
making these estimates, FDA has taken
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
351(k)(2)(A)(i) and 351(k)(2)(A)(iii) Biosimilar Product Applications ...........................................................................
351(k)(2)(B) and (k)(4) Interchangeable Product Applications or Supplements .......................................................
351(l)(6)(C) Patent Infringement Notifications .....................
Total ..............................................................................
1 There
Average
burden per
response
Total annual
responses
Total hours
5
1
5
860
4,300
2
5
1
1
2
5
860
2
1,720
10
........................
........................
........................
........................
6,030
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Division of Policy and Shortage
Designation, Bureau of Health
Workforce, Health Resources and
Services Administration, Mail Stop
11SWH03, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland
20857, (301) 594–5168.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–16128 Filed 6–30–15; 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, HHS.
ACTION: Notice.
AGENCY:
This notice advises the public
of the published lists of all geographic
areas, population groups, and facilities
designated as primary medical care,
mental health, and dental health
professional shortage areas (HPSAs) as
of May 29, 2015, available on the Health
Resources and Services Administration
(HRSA) Web site at https://
www.hrsa.gov/shortage/. HPSAs are
designated or withdrawn by the
Secretary of Health and Human Services
(HHS) under the authority of section
332 of the Public Health Service (PHS)
Act and 42 CFR part 5.
FOR FURTHER INFORMATION CONTACT:
Requests for further information on the
HPSA designations listed on the HRSA
Web site and requests for additional
designations, withdrawals, or
reapplication for designations should be
submitted to Kae Brickerd, Ph.D.,
Director, Shortage Designation Branch,
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
351(k) Applications (42 U.S.C. 262(k))
VerDate Sep<11>2014
18:30 Jun 30, 2015
Jkt 235001
Background
Section 332 of the PHS Act, 42 U.S.C.
254e, provides that the Secretary of HHS
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 a list of the
designated geographic areas, population
groups, and facilities. The lists of
HPSAs are to be reviewed at least
annually and revised as necessary.
HRSA’s Bureau of Health Workforce
(BHW) has the responsibility for
designating and updating HPSAs.
Public or private nonprofit entities are
eligible to apply for assignment of
National Health Service Corps (NHSC)
personnel to provide primary care,
mental, or dental health services in or
to these HPSAs. NHSC health
professionals with a service obligation
may enter into service agreements to
serve only 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
the BHW. Many other federal programs
also utilize HPSA designations. For
example, under authorities
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
administered by the Centers for
Medicare and Medicaid Services,
certain qualified providers in
geographic area HPSAs are eligible for
increased levels of Medicare
reimbursement.
Development of the Designation and
Withdrawal Lists
Criteria for designating HPSAs were
published as final regulations (42 CFR
part 5) in 1980. Criteria then were
defined for each of seven health
professional types (primary medical
care, dental, psychiatric, vision care,
podiatric, pharmacy, and veterinary
care). The criteria for correctional
facility HPSAs were revised and
published on 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 only the primary medical
care, mental health, or dental HPSA
designations.
Individual requests for designation or
withdrawal of a particular geographic
area, population group, or a facility as
a HPSA are received and reviewed
continuously by BHW. The majority of
the requests come from the Primary Care
Offices (PCO) in the State Health
Departments, who have access to the online application and review system.
Requests that come from other sources
are referred to the PCOs for their review
and concurrence. In addition, interested
parties, including the Governor, the
State Primary Care Association and state
professional associations are notified of
each request submitted for their
comments and recommendations.
E:\FR\FM\01JYN1.SGM
01JYN1
37638
Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
Annually, lists of designated HPSAs
are made available to all PCOs, state
medical and dental societies and others,
with a request to review and update the
data on which the designations are
based. Emphasis is placed on updating
those designations that are more than 3
years old or where significant changes
relevant to the designation criteria have
occurred.
Recommendations for possible
additions, continuations, revisions, or
withdrawals from a HPSA list are
reviewed by BHW, and the review
findings are provided by letter to the
agency or individual requesting action
or providing data, with copies to other
interested organizations and
individuals. These letters constitute the
official notice of designation as a HPSA,
rejection of recommendations 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 letter from BHW.
Proposed withdrawals become effective
only after interested parties in the area
affected have been afforded the
opportunity to submit additional
information to BHW in support of its
continued or revised designation. If no
new data are submitted, or if BHW
review confirms the proposed
withdrawal, the withdrawal becomes
effective upon publication of the lists of
designated HPSAs in the Federal
Register. In addition, lists of HPSAs are
updated daily on the HRSA Web site at
https://www.hrsa.gov/shortage/, so that
interested parties can access the most
accurate and timely information.
Publication and Format of Lists
Due to the large volume of
designations, a printed version of the
list is no longer distributed. This notice
serves to inform the public of the
availability of the complete listings of
designated HPSA on the HRSA Web
site. The three lists (primary medical
care, mental health, and dental) of
designated HPSAs are available at a link
on the HRSA Web site at https://
www.hrsa.gov/shortage/ and include a
snapshot of all geographic areas,
population groups, and facilities that
were designated HPSAs as of May 29,
2015. This notice incorporates the most
recent annual reviews of designated
HPSAs and supersedes the HPSA lists
published in the Federal Register on
June 25, 2014 (Federal Register/Vol. 79,
No. 122/Wednesday, June 25, 2014/
Notices 36075). The lists also include
automatic facility HPSAs, designated as
a result of the Health Care Safety Net
Amendments of 2002 (Pub. L. 107–251),
VerDate Sep<11>2014
18:30 Jun 30, 2015
Jkt 235001
not subject to update requirements.
Each list of designated HPSAs (primary
medical care, mental health, and dental)
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, or if the county is part
of a larger designated service area, or if
a population group residing in the
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. Counties that have a
whole county geographic HPSA are
indicated by the ‘‘Entire county HPSA’’
notation following the county name.
Further details on the snapshot of
HPSAs listed can be found on the HRSA
Web site at https://www.hrsa.gov/
shortage/.
In addition to the specific listings
included in this notice, all Indian Tribes
that meet the definition of such Tribes
in the Indian Health Care Improvement
Act of 1976, 25 U.S.C. 1603(d), are
automatically designated as population
groups with primary medical care and
dental health professional shortages.
The Health Care Safety Net
Amendments of 2002 also made the
following entities eligible for automatic
facility HPSA designations: All federally
qualified health centers (FQHCs) and
rural health clinics that offer services
regardless of ability to pay. These
entities include: FQHCs funded under
section 330 of the PHS Act, FQHC LookAlikes, and Tribal and urban Indian
clinics operating under the Indian SelfDetermination 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. Exclusion from this list
does not exclude them from HPSA
designation; any facilities eligible for
automatic designation will be included
in the database as they are identified.
Future Updates of Lists of Designated
HPSAs
The lists of HPSAs on the HRSA Web
site consist of all those that were
designated as of May 29, 2015. It should
be noted that HPSAs are currently
updated on an ongoing basis based on
the identification of new areas,
population groups, facilities, and sites
that meet the eligibility criteria or that
no longer meet eligibility criteria and/or
are being replaced by another type of
designation. As such, additional HPSAs
may have been designated by letter
since that date. The appropriate
agencies and individuals have been or
will be notified of these actions by
letter. These newly designated HPSAs
will be included in the next publication
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
of the HPSA list and are currently
included in the daily updates posted on
the HRSA Web site at https://
www.hrsa.gov/shortage/find.html.
Any designated HPSA listed on the
HRSA Web site is subject to withdrawal
from designation if new information
received and confirmed by HRSA
indicates that the relevant data for the
area involved have significantly
changed since its designation. The
effective date of such a withdrawal will
be the next publication of a notice
regarding this list in the Federal
Register.
All requests for new designations,
updates, or withdrawals should be
based on the relevant criteria in
regulations published at 42 CFR part 5.
Electronic Access Address
The complete list of HPSAs
designated as of May 29, 2015, are
available on the HRSA Web site at
https://www.hrsa.gov/shortage/.
Frequently updated information on
HPSAs is also available at https://
datawarehouse.hrsa.gov.
Dated: June 25, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015–16168 Filed 6–30–15; 8:45 am]
BILLING CODE 4165–15–P
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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than July 31, 2015.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
SUMMARY:
E:\FR\FM\01JYN1.SGM
01JYN1
Agencies
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37637-37638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16168]
-----------------------------------------------------------------------
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, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice advises the public of the published lists of all
geographic areas, population groups, and facilities designated as
primary medical care, mental health, and dental health professional
shortage areas (HPSAs) as of May 29, 2015, available on the Health
Resources and Services Administration (HRSA) Web site at https://www.hrsa.gov/shortage/. HPSAs are designated or withdrawn by the
Secretary of Health and Human Services (HHS) under the authority of
section 332 of the Public Health Service (PHS) Act and 42 CFR part 5.
FOR FURTHER INFORMATION CONTACT: Requests for further information on
the HPSA designations listed on the HRSA Web site and requests for
additional designations, withdrawals, or reapplication for designations
should be submitted to Kae Brickerd, Ph.D., Director, Shortage
Designation Branch, Division of Policy and Shortage Designation, Bureau
of Health Workforce, Health Resources and Services Administration, Mail
Stop 11SWH03, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland
20857, (301) 594-5168.
SUPPLEMENTARY INFORMATION:
Background
Section 332 of the PHS Act, 42 U.S.C. 254e, provides that the
Secretary of HHS 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 a list of the designated geographic areas, population groups,
and facilities. The lists of HPSAs are to be reviewed at least annually
and revised as necessary. HRSA's Bureau of Health Workforce (BHW) has
the responsibility for designating and updating HPSAs.
Public or private nonprofit entities are eligible to apply for
assignment of National Health Service Corps (NHSC) personnel to provide
primary care, mental, or dental health services in or to these HPSAs.
NHSC health professionals with a service obligation may enter into
service agreements to serve only 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 the BHW. Many other federal programs also utilize HPSA
designations. For example, under authorities administered by the
Centers for Medicare and Medicaid Services, certain qualified providers
in geographic area HPSAs are eligible for increased levels of Medicare
reimbursement.
Development of the Designation and Withdrawal Lists
Criteria for designating HPSAs were published as final regulations
(42 CFR part 5) in 1980. Criteria then were defined for each of seven
health professional types (primary medical care, dental, psychiatric,
vision care, podiatric, pharmacy, and veterinary care). The criteria
for correctional facility HPSAs were revised and published on 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 only the primary medical care, mental health, or
dental HPSA designations.
Individual requests for designation or withdrawal of a particular
geographic area, population group, or a facility as a HPSA are received
and reviewed continuously by BHW. The majority of the requests come
from the Primary Care Offices (PCO) in the State Health Departments,
who have access to the on-line application and review system. Requests
that come from other sources are referred to the PCOs for their review
and concurrence. In addition, interested parties, including the
Governor, the State Primary Care Association and state professional
associations are notified of each request submitted for their comments
and recommendations.
[[Page 37638]]
Annually, lists of designated HPSAs are made available to all PCOs,
state medical and dental societies and others, with a request to review
and update the data on which the designations are based. Emphasis is
placed on updating those designations that are more than 3 years old or
where significant changes relevant to the designation criteria have
occurred.
Recommendations for possible additions, continuations, revisions,
or withdrawals from a HPSA list are reviewed by BHW, and the review
findings are provided by letter to the agency or individual requesting
action or providing data, with copies to other interested organizations
and individuals. These letters constitute the official notice of
designation as a HPSA, rejection of recommendations 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 letter
from BHW. Proposed withdrawals become effective only after interested
parties in the area affected have been afforded the opportunity to
submit additional information to BHW in support of its continued or
revised designation. If no new data are submitted, or if BHW review
confirms the proposed withdrawal, the withdrawal becomes effective upon
publication of the lists of designated HPSAs in the Federal Register.
In addition, lists of HPSAs are updated daily on the HRSA Web site at
https://www.hrsa.gov/shortage/, so that interested parties can access
the most accurate and timely information.
Publication and Format of Lists
Due to the large volume of designations, a printed version of the
list is no longer distributed. This notice serves to inform the public
of the availability of the complete listings of designated HPSA on the
HRSA Web site. The three lists (primary medical care, mental health,
and dental) of designated HPSAs are available at a link on the HRSA Web
site at https://www.hrsa.gov/shortage/ and include a snapshot of all
geographic areas, population groups, and facilities that were
designated HPSAs as of May 29, 2015. This notice incorporates the most
recent annual reviews of designated HPSAs and supersedes the HPSA lists
published in the Federal Register on June 25, 2014 (Federal Register/
Vol. 79, No. 122/Wednesday, June 25, 2014/Notices 36075). The lists
also include automatic facility HPSAs, designated as a result of the
Health Care Safety Net Amendments of 2002 (Pub. L. 107-251), not
subject to update requirements. Each list of designated HPSAs (primary
medical care, mental health, and dental) 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, or if the county is part of
a larger designated service area, or if a population group residing in
the 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. Counties that have a whole county
geographic HPSA are indicated by the ``Entire county HPSA'' notation
following the county name. Further details on the snapshot of HPSAs
listed can be found on the HRSA Web site at https://www.hrsa.gov/shortage/.
In addition to the specific listings included in this notice, all
Indian Tribes that meet the definition of such Tribes in the Indian
Health Care Improvement Act of 1976, 25 U.S.C. 1603(d), are
automatically designated as population groups with primary medical care
and dental health professional shortages. The Health Care Safety Net
Amendments of 2002 also made the following entities eligible for
automatic facility HPSA designations: All federally qualified health
centers (FQHCs) and rural health clinics that offer services regardless
of ability to pay. 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.
Exclusion from this list does not exclude them from HPSA designation;
any facilities eligible for automatic designation will be included in
the database as they are identified.
Future Updates of Lists of Designated HPSAs
The lists of HPSAs on the HRSA Web site consist of all those that
were designated as of May 29, 2015. It should be noted that HPSAs are
currently updated on an ongoing basis based on the identification of
new areas, population groups, facilities, and sites that meet the
eligibility criteria or that no longer meet eligibility criteria and/or
are being replaced by another type of designation. As such, additional
HPSAs may have been designated by letter since that date. The
appropriate agencies and individuals have been or will be notified of
these actions by letter. These newly designated HPSAs will be included
in the next publication of the HPSA list and are currently included in
the daily updates posted on the HRSA Web site at https://www.hrsa.gov/shortage/find.html.
Any designated HPSA listed on the HRSA Web site is subject to
withdrawal from designation if new information received and confirmed
by HRSA indicates that the relevant data for the area involved have
significantly changed since its designation. The effective date of such
a withdrawal will be the next publication of a notice regarding this
list in the Federal Register.
All requests for new designations, updates, or withdrawals should
be based on the relevant criteria in regulations published at 42 CFR
part 5.
Electronic Access Address
The complete list of HPSAs designated as of May 29, 2015, are
available on the HRSA Web site at https://www.hrsa.gov/shortage/.
Frequently updated information on HPSAs is also available at https://datawarehouse.hrsa.gov.
Dated: June 25, 2015.
James Macrae,
Acting Administrator.
[FR Doc. 2015-16168 Filed 6-30-15; 8:45 am]
BILLING CODE 4165-15-P