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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 http://
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))

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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

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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.

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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
http://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 http://
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),

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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 http://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

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of the HPSA list and are currently
included in the daily updates posted on
the HRSA Web site at http://
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
http://www.hrsa.gov/shortage/.
Frequently updated information on
HPSAs is also available at http://
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:

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