Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas, 35808-35809 [2021-14408]
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khammond on DSKJM1Z7X2PROD with NOTICES
35808
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device ZEPHYR
ENDOBRONCHIAL VALVE IMPLANT.
ZEPHYR ENDOBRONCHIAL VALVE
IMPLANT is indicated for the
bronchoscopic treatment of adult
patients with hyperinflation associated
with severe emphysema in regions of
the lung that have little to no collateral
ventilation. Subsequent to this approval,
the USPTO received patent term
restoration applications for ZEPHYR
ENDOBRONCHIAL VALVE IMPLANT
(U.S. Patent Nos. 6,527,761 and
7,798,147) from Pulmonx Corp., and the
USPTO requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
October 29, 2019, FDA advised the
USPTO that this medical device had
undergone a regulatory review period
and that the approval of ZEPHYR
ENDOBRONCHIAL VALVE IMPLANT
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ZEPHYR ENDOBRONCHIAL VALVE
IMPLANT is 5,744 days. Of this time,
5,565 days occurred during the testing
VerDate Sep<11>2014
17:44 Jul 06, 2021
Jkt 253001
phase of the regulatory review period,
while 179 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)) involving this device became
effective: October 9, 2002. The applicant
claims that the investigational device
exemption (IDE) required under section
520(g) of the FD&C Act for human tests
to begin became effective on March 11,
2005. However, FDA records indicate
that the IDE was determined
substantially complete for clinical
studies to have begun on October 9,
2002, which represents the IDE effective
date.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): January 2, 2018.
The applicant claims December 29,
2017, as the date the premarket approval
application (PMA) for ZEPHYR
ENDOBRONCHIAL VALVE IMPLANT
(PMA 180002) was initially submitted.
However, FDA records indicate that
PMA 180002 was submitted on January
2, 2018.
3. The date the application was
approved: June 29, 2018. FDA has
verified the applicant’s claim that PMA
180002 was approved on June 29, 2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 5 years or 1,510
days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
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Fmt 4703
Sfmt 4703
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14482 Filed 7–6–21; 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 (HHS).
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
primary medical care, dental health, and
mental health professional shortage
areas (HPSAs) as of April 30, 2021. The
lists are available on the shortage area
topic page on HRSA’s data.hrsa.gov
website.
SUMMARY:
Complete lists of HPSAs
designated as of April 30, 2021, are
available on the website at https://
data.hrsa.gov/topics/health-workforce/
shortage-areas. Frequently updated
information on HPSAs is available at
https://data.hrsa.gov/tools/shortagearea. 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 Janelle D.
McCutchen, DHEd, MPH, CHES, Chief,
Shortage Designation Branch, Division
of Policy and Shortage Designation,
Bureau of Health Workforce (BHW),
HRSA, 5600 Fishers Lane, Room
11W14, Rockville, Maryland 20857,
sdb@hrsa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
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.
Final regulations (42 CFR part 5) were
published in 1980 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 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.
HPSA designation offers access to
potential federal assistance. Public or
private nonprofit entities are eligible to
apply for assignment of National Health
Service Corps (NHSC) personnel to
provide primary medical care, mental
health, or dental health services in or to
these HPSAs. NHSC 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 BHW. 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.
khammond on DSKJM1Z7X2PROD with NOTICES
Content and Format of Lists
The three lists of designated HPSAs
are available on the HRSA Data
Warehouse shortage area topic web page
and include a snapshot of all geographic
areas, population groups, and facilities
that were designated HPSAs as of April
30, 2021. This notice incorporates the
most recent annual reviews of
designated HPSAs and supersedes the
HPSA lists published in the Federal
VerDate Sep<11>2014
17:44 Jul 06, 2021
Jkt 253001
Register on June 15, 2020 (Federal
Register/Vol. 85, No. 115/Monday, June
15, 2020/Notices 36219).
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
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Fmt 4703
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35809
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 Find Shortage Area 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.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021–14408 Filed 7–6–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Maternal,
Infant, and Early Childhood Home
Visiting Program Quarterly
Performance Report, OMB No. 0906–
0016, Revision
Health Resources and Service’s
Administration (HRSA), Department of
Health and Human Services.
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 September 7,
2021.
SUMMARY:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, 14N136B, 5600 Fishers Lane,
Rockville, MD 20857.
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 paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
ADDRESSES:
E:\FR\FM\07JYN1.SGM
07JYN1
]]>Agencies
[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35808-35809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14408]
-----------------------------------------------------------------------
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 (HHS).
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) as of April 30, 2021.
The lists are available on the shortage area topic page on HRSA's
data.hrsa.gov website.
ADDRESSES: Complete lists of HPSAs designated as of April 30, 2021, are
available on the website at https://data.hrsa.gov/topics/health-workforce/shortage-areas. Frequently updated information on HPSAs is
available at https://data.hrsa.gov/tools/shortage-area. 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 Janelle D. McCutchen, DHEd, MPH, CHES, Chief, Shortage
Designation Branch, Division of Policy and Shortage Designation, Bureau
of Health Workforce (BHW), HRSA, 5600 Fishers Lane, Room 11W14,
Rockville, Maryland 20857, [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 35809]]
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.
Final regulations (42 CFR part 5) were published in 1980 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 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.
HPSA designation offers access to potential federal assistance.
Public or private nonprofit entities are eligible to apply for
assignment of National Health Service Corps (NHSC) personnel to provide
primary medical care, mental health, or dental health services in or to
these HPSAs. NHSC 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 BHW. 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.
Content and Format of Lists
The three lists of designated HPSAs are available on the HRSA Data
Warehouse shortage area topic web page and include a snapshot of all
geographic areas, population groups, and facilities that were
designated HPSAs as of April 30, 2021. This notice incorporates the
most recent annual reviews of designated HPSAs and supersedes the HPSA
lists published in the Federal Register on June 15, 2020 (Federal
Register/Vol. 85, No. 115/Monday, June 15, 2020/Notices 36219).
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 Find Shortage Area
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.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-14408 Filed 7-6-21; 8:45 am]
BILLING CODE 4165-15-P
