Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas, 30941-30942 [2018-14115]
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30941
Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Survey of Current Manufacturing
Practices for the Cosmetics Industry—
OMB Control Number 0910—New
FDA has the responsibility to protect
public health and, as part of this broad
mandate, oversees the safety of the
nation’s cosmetic products. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act) prohibits the introduction into
interstate commerce of any cosmetic
that is adulterated or misbranded.
The FD&C Act defines cosmetics as
articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced
into, or otherwise applied to the human
body for cleansing, beautifying,
promoting attractiveness, or altering the
appearance. Among the products
included in this definition are skin
moisturizers, perfumes, lipsticks,
fingernail polishes, eye and facial
makeup, cleansing shampoos,
permanent waves, hair colors,
deodorants, and tattoo inks, as well as
any substance intended for use as a
component of a cosmetic product. Some
cosmetic products are also regulated as
drugs.
As with other commodities FDA
regulates, the safety of cosmetic
products can be ensured in part through
a manufacturer’s approach to the
management of cosmetic quality. To
date, FDA has not identified in the
published literature any systematic,
detailed study of the diversity of the
practices and standards employed
across the cosmetic industry to ensure
product quality and safety. This study is
intended to fill this gap. FDA proposes
to conduct a voluntary survey of
cosmetics establishments to identify the
current quality management and safety
practices in the cosmetic industry.
The survey instrument will collect
data, on a voluntary basis, from
cosmetic product manufacturers on the
following topics:
• Written Procedures and
Documentation—including written
procedures and records for
manufacturing involving personnel, raw
materials, processing, cleaning,
maintenance, finished products, and
training.
• Buildings and Equipment—
including facility space, pest control,
practices ensuring the cleanliness and
sanitation, water usage and treatment,
and the proper functioning and
operation of equipment.
• Materials and Manufacturing—
including practices for inventory
management, labeling and storage of
raw materials, closures, and in process
materials; and in process standard
operating procedures.
• Quality Control/Product Testing—
including the scope of the quality
control unit, laboratory testing, dealing
with rejected or returned products and
complaints, and corrective actions.
In addition, FDA will obtain the
characteristics of surveyed
establishments such as the types of
cosmetics produced, published
standards and guidelines followed, the
number of employees, the volume of
production, and the approximate
revenue. The survey will be
administered by web or by mail
(respondent choice) and it will be
directed to the Plant Manager of the
cosmetics establishment.
This is a new, one-time data
collection. FDA does not plan to collect
this data from the cosmetics industry on
an ongoing basis.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Survey Invitation .........................................................
Survey ........................................................................
898
564
1
1
898
564
0.08 (5 minutes) ......
0.5 (30 minutes) ......
71.84
282.00
Total ....................................................................
........................
........................
........................
.................................
353.84
daltland on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We will select a sample of 898
establishments. After adjusting for
ineligibility (i.e., firms that do not
produce cosmetic products and those no
longer in operation) and a response rate
of 70 percent, we expect 564 completed
surveys.
We expect each individual survey
invitation to take 5 minutes (0.08 hour)
to complete. Multiplying by the 898
establishments that will receive the
survey invitation, we estimate the time
burden of the survey invitation to be
71.84 hours. We expect each individual
survey to take 30 minutes (0.5 hour) to
complete. Multiplying by the estimated
564 establishments that will complete
the survey, we estimate the time burden
of the survey to be 282 hours. We
estimate the total hourly reporting
VerDate Sep<11>2014
17:40 Jun 29, 2018
Jkt 244001
burden for this collection of information
to be 353.84 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Health Resources and Services
Administration
[FR Doc. 2018–14158 Filed 6–29–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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, mental health,
and dental health professional shortage
SUMMARY:
Frm 00033
Fmt 4703
Sfmt 4703
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02JYN1
30942
Federal Register / Vol. 83, No. 127 / Monday, July 2, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
areas (HPSAs) as of May 1, 2018. The
lists are available on HRSA’s HPSAFind
website.
ADDRESSES: Complete lists of HPSAs
designated as of May 1, 2018, are
available on the HPSAFind website at
https://datawarehouse.hrsa.gov/tools/
analyzers/hpsafind.aspx. Frequently
updated information on HPSAs is
available at https://
datawarehouse.hrsa.gov. Information on
shortage designations is available at
https://bhw.hrsa.gov/shortagedesignation.
FOR FURTHER INFORMATION CONTACT: For
further information on the HPSA
designations listed on the HPSAFind
website or to request additional
designation, withdrawal, or
reapplication for designation, please
contact Melissa Ryan, Acting Director,
Division of Policy and Shortage
Designation, Bureau of Health
Workforce, HRSA, 11SWH03, 5600
Fishers Lane, Rockville, Maryland
20857, (301) 594–5168 or MRyan@
hrsa.gov.
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.
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
VerDate Sep<11>2014
17:40 Jun 29, 2018
Jkt 244001
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 Bureau of
Health Workforce (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 HPSAFind website
and include a snapshot of all geographic
areas, population groups, and facilities
that were designated HPSAs as of May
1, 2018. This notice incorporates the
most recent annual reviews of
designated HPSAs and supersedes the
HPSA lists published in the Federal
Register on June 26, 2017 (Federal
Register/Vol. 82, No. 121/Monday, June
26, 2017/Notices 28863).
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(d), 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 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. 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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
listed under the county name. A county
that has a whole county geographic
HPSA is indicated by the phrase ‘‘Entire
county HPSA’’ following the county
name.
Development of the Designation and
Withdrawal Lists
Requests for designation or
withdrawal of a particular geographic
area, population group, or a 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 the majority of the 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 HPSAFind
website. The effective date of a
withdrawal will be the next publication
of a notice regarding the list in the
Federal Register.
Dated: June 26, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018–14115 Filed 6–29–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990—new]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
E:\FR\FM\02JYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Notices]
[Pages 30941-30942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14115]
-----------------------------------------------------------------------
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, mental health, and
dental health professional shortage
[[Page 30942]]
areas (HPSAs) as of May 1, 2018. The lists are available on HRSA's
HPSAFind website.
ADDRESSES: Complete lists of HPSAs designated as of May 1, 2018, are
available on the HPSAFind website at https://datawarehouse.hrsa.gov/tools/analyzers/hpsafind.aspx. Frequently updated information on HPSAs
is available at https://datawarehouse.hrsa.gov. Information on shortage
designations is available at https://bhw.hrsa.gov/shortage-designation.
FOR FURTHER INFORMATION CONTACT: For further information on the HPSA
designations listed on the HPSAFind website or to request additional
designation, withdrawal, or reapplication for designation, please
contact Melissa Ryan, Acting Director, Division of Policy and Shortage
Designation, Bureau of Health Workforce, HRSA, 11SWH03, 5600 Fishers
Lane, Rockville, Maryland 20857, (301) 594-5168 or [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.
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 Bureau of
Health Workforce (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 HPSAFind
website and include a snapshot of all geographic areas, population
groups, and facilities that were designated HPSAs as of May 1, 2018.
This notice incorporates the most recent annual reviews of designated
HPSAs and supersedes the HPSA lists published in the Federal Register
on June 26, 2017 (Federal Register/Vol. 82, No. 121/Monday, June 26,
2017/Notices 28863).
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(d), 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 HPSA is
indicated by the phrase ``Entire county HPSA'' following the county
name.
Development of the Designation and Withdrawal Lists
Requests for designation or withdrawal of a particular geographic
area, population group, or a 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 the majority of the 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 HPSAFind website. The effective date of a
withdrawal will be the next publication of a notice regarding the list
in the Federal Register.
Dated: June 26, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018-14115 Filed 6-29-18; 8:45 am]
BILLING CODE 4165-15-P
