Supplemental Award to the National Network for Oral Health Access, 55382-55383 [2017-25191]
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Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
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.
513(g) Request for Information
OMB Control Number 0910–0705—
Extension
Section 513(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(g)) provides a means for
obtaining the Agency’s views about the
classification and regulatory
requirements that may be applicable to
a particular device. Section 513(g)
provides that, within 60 days of the
receipt of a written request of any
person for information respecting the
class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act, the
Secretary of Health and Human Services
shall provide such person a written
statement of the classification (if any) of
such device and the requirements of the
FD&C Act applicable to the device.
The guidance document entitled
‘‘FDA and Industry Procedures for
Section 513(g) Requests for Information
Under the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry
and Food and Drug Administration
Staff’’ establishes procedures for
submitting, reviewing, and responding
to requests for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act that are
submitted in accordance with section
513(g) of the FD&C Act. FDA does not
review data related to substantial
equivalence or safety and effectiveness
in a 513(g) request for information.
FDA’s responses to 513(g) requests for
information are not device classification
decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or
approval for marketing require
submissions under different sections of
the FD&C Act.
Additionally, the FD&C Act, as
amended by the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), requires FDA to
collect user fees for 513(g) requests for
information. The guidance document
entitled ‘‘Guidance for Industry and
Food and Drug Administration Staff;
User Fees for 513(g) Requests for
Information’’ assists FDA staff and
regulated industry by describing the
user fees associated with 513(g)
requests. The Medical Device User Fee
Cover Sheet (Form FDA 3601), which
accompanies the supplemental material
described in this information collection
is approved under OMB control number
0910–0511 and expires August 31, 2019.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
CDRH 513(g) requests ........................................................
CBER 513(g) requests .........................................................
114
4
1
1
114
4
12
12
1,368
48
Total ..............................................................................
........................
........................
........................
........................
1,416
1 There
are no capital costs of operating and maintenance costs associated with this collection off information.
Respondents of this collection of
information are mostly device
manufacturers; however, anyone may
submit a 513(g) request for information.
The total number of annual responses is
based on the average number of 513(g)
requests received each year by the
Agency.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–25159 Filed 11–20–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Supplemental Award to the National
Network for Oral Health Access
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
HRSA announces the award
of a supplement in the amount of
$250,000 for a HRSA-funded
cooperative agreement awarded to the
National Network for Oral Health
Access (NNOHA). The supplement,
awarded on September 25, 2017, will
fund demonstration projects to increase
the integration of oral health and
primary care practice through the
SUMMARY:
PO 00000
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adoption of HRSA’s core clinical oral
health competencies for non-dental
health care providers in Health Center
(HC) settings, focusing on services for
pregnant women and children.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
National Network for Oral Health
Access.
Amount of Non-Competitive Awards:
$250,000.
Budget Periods of Supplemental
Funding: July 1, 2017, through June 30,
2018.
CFDA Number: 93.110.
Authority: Special Projects of
Regional and National Significance
program (Social Security Act, Title V,
§ 501(a)(2) (42 U.S.C. 701(a)(2)).
Justification: The National Network
for Oral Health Access (NNOHA)
supports goals to improve access to oral
E:\FR\FM\21NON1.SGM
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Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices
health care, increase awareness of the
connection between oral health and
overall health, prevent disease and
promote oral health, and improve health
literacy to health providers and patients
alike. HRSA developed a core set of oral
health clinical competencies for nondental providers as part of its
Integration of Oral Health and Primary
Care Practice (IOHPCP) initiative in
response to recommendations from two
Institute of Medicine (IOM) reports:
Advancing Oral Health in America and
Improving Access to Oral Health Care
for Vulnerable and Underserved
Populations. NNOHA participated in
the IOHPCP initiative and in fiscal year
(FY) 2012 received supplemental
funding (U30CS09745–05–02) to
implement a pilot project in safety net
settings to inform the impact and
effectiveness of oral health core clinical
competencies and inter-professional
collaboration in primary care settings.
The goal of the project was to increase
integration of oral health and primary
health care. NNOHA published the pilot
project results in a user guide entitled,
User’s Guide for Implementation of
inter-professional oral health core
clinical competencies and continues to
provide technical assistance to health
centers and training on oral health
integration and primary care practice.
The Joint Explanatory Statement to
the Consolidated Appropriations Act of
FY 2017 encouraged HRSA to allocate
$250,000 for demonstration projects to
support the implementation of
integrating oral health and primary care
projects. The projects are to model the
core clinical oral health competencies
for non-dental providers that HRSA
published and initially tested in its 2014
report, Integration of Oral Health and
Primary Care Practice. In order to
achieve this goal, HRSA will provide
supplemental funding to the NNOHA to
advance and expand the
implementation of oral health core
clinical competencies in health centers,
focusing on services for pregnant
women and children. Additionally,
these demonstration projects will
directly align with four HRSA
recommendations for effectively
incorporating the competencies into
clinical practice as described in the
2014 Integrating Oral Health and
Primary Care Practice report. This
activity is consistent with the current
work plan of NNOHA and includes
providing training and technical
assistance on IOHPCP. NNOHA’s
primary roles are to coordinate all
activities at the planning,
implementation, evaluation, and
dissemination stages, as well as provide
technical assistance and training to
participating HCs. NNOHA shall select
no fewer than six HCs, which it
supports as part of the current HRSAfunded National Training and Technical
Assistance Cooperative Agreement
Program (U30CS29051). NNOHA will
assure that each HC will propose,
implement, and track data for an
innovative inter-professional oral health
project that measurably increases the
adoption of the core clinical oral health
competencies among non-dental
providers in the delivery of care to
pregnant women and children.
FOR FURTHER INFORMATION CONTACT:
Chinyere Amaefule, Office of Quality
Improvement, Division of Strategic
Partnerships, Bureau of Primary Health
Care, Health Resources and Services
Administration, 5600 Fishers Lane,
Rockville, Maryland 20857, Phone:
(301) 594–4417, Email: Camaefule@
hrsa.gov.
Grantee/organization name
Grant No.
National Network of Oral Health Access ......................................................................
U30CS29051
Dated: November 14, 2017.
George Sigounas,
Administrator.
[FR Doc. 2017–25191 Filed 11–20–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Federal Matching Shares for Medicaid,
the Children’s Health Insurance
Program, and Aid to Needy Aged,
Blind, or Disabled Persons for October
1, 2018 Through September 30, 2019
Office of the Secretary, DHHS.
Notice.
AGENCY:
ACTION:
The percentages listed in Table
1 will be effective for each of the four
quarter-year periods beginning October
1, 2018 and ending September 30, 2019.
FOR FURTHER INFORMATION CONTACT:
Caryn Marks or Rose Chu, Office of
Health Policy, Office of the Assistant
Secretary for Planning and Evaluation,
Room 447D—Hubert H. Humphrey
Building, 200 Independence Avenue
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
18:56 Nov 20, 2017
Jkt 244001
SW., Washington, DC 20201, (202) 690–
6870.
SUPPLEMENTARY INFORMATION: The
Federal Medical Assistance Percentages
(FMAP), Enhanced Federal Medical
Assistance Percentages (eFMAP), and
disaster-recovery FMAP adjustments for
Fiscal Year 2019 have been calculated
pursuant to the Social Security Act (the
Act). These percentages will be effective
from October 1, 2018 through
September 30, 2019. This notice
announces the calculated FMAP rates,
in accordance with sections 1101(a)(8)
and 1905(b) of the Act, that the U.S.
Department of Health and Human
Services (HHS) will use in determining
the amount of federal matching for state
medical assistance (Medicaid),
Temporary Assistance for Needy
Families (TANF) Contingency Funds,
Child Support Enforcement collections,
Child Care Mandatory and Matching
Funds of the Child Care and
Development Fund, Title IV–E Foster
Care Maintenance payments, Adoption
Assistance payments and Kinship
Guardianship Assistance payments, and
the eFMAP rates for the Children’s
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55383
State
CO
FY 2017
authorized
funding level
FY 2017–2018
estimated
supplemental
amount
$500,000
$250,000
Health Insurance Program (CHIP)
expenditures. Table 1 gives figures for
each of the 50 states, the District of
Columbia, Puerto Rico, the Virgin
Islands, Guam, American Samoa, and
the Commonwealth of the Northern
Mariana Islands. This notice reminds
states of available disaster-recovery
FMAP adjustments for qualifying states,
and adjustments available for states
meeting requirements for negative
growth in total state personal income.
At this time, no states qualify for such
adjustments.
This notice also contains the
increased eFMAPs for CHIP as
authorized under the Patient Protection
and Affordable Care Act (PPACA) for
fiscal years 2016 through 2019 (October
1, 2015 through September 30, 2019).
Programs under title XIX of the Act
exist in each jurisdiction. Programs
under titles I, X, and XIV operate only
in Guam and the Virgin Islands. The
percentages in this notice apply to state
expenditures for most medical
assistance and child health assistance,
and assistance payments for certain
social services. The Act provides
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]]>Agencies
[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Notices]
[Pages 55382-55383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25191]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Supplemental Award to the National Network for Oral Health Access
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a supplement in the amount of
$250,000 for a HRSA-funded cooperative agreement awarded to the
National Network for Oral Health Access (NNOHA). The supplement,
awarded on September 25, 2017, will fund demonstration projects to
increase the integration of oral health and primary care practice
through the adoption of HRSA's core clinical oral health competencies
for non-dental health care providers in Health Center (HC) settings,
focusing on services for pregnant women and children.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: National Network for Oral Health
Access.
Amount of Non-Competitive Awards: $250,000.
Budget Periods of Supplemental Funding: July 1, 2017, through June
30, 2018.
CFDA Number: 93.110.
Authority: Special Projects of Regional and National Significance
program (Social Security Act, Title V, Sec. 501(a)(2) (42 U.S.C.
701(a)(2)).
Justification: The National Network for Oral Health Access (NNOHA)
supports goals to improve access to oral
[[Page 55383]]
health care, increase awareness of the connection between oral health
and overall health, prevent disease and promote oral health, and
improve health literacy to health providers and patients alike. HRSA
developed a core set of oral health clinical competencies for non-
dental providers as part of its Integration of Oral Health and Primary
Care Practice (IOHPCP) initiative in response to recommendations from
two Institute of Medicine (IOM) reports: Advancing Oral Health in
America and Improving Access to Oral Health Care for Vulnerable and
Underserved Populations. NNOHA participated in the IOHPCP initiative
and in fiscal year (FY) 2012 received supplemental funding (U30CS09745-
05-02) to implement a pilot project in safety net settings to inform
the impact and effectiveness of oral health core clinical competencies
and inter-professional collaboration in primary care settings. The goal
of the project was to increase integration of oral health and primary
health care. NNOHA published the pilot project results in a user guide
entitled, User's Guide for Implementation of inter-professional oral
health core clinical competencies and continues to provide technical
assistance to health centers and training on oral health integration
and primary care practice.
The Joint Explanatory Statement to the Consolidated Appropriations
Act of FY 2017 encouraged HRSA to allocate $250,000 for demonstration
projects to support the implementation of integrating oral health and
primary care projects. The projects are to model the core clinical oral
health competencies for non-dental providers that HRSA published and
initially tested in its 2014 report, Integration of Oral Health and
Primary Care Practice. In order to achieve this goal, HRSA will provide
supplemental funding to the NNOHA to advance and expand the
implementation of oral health core clinical competencies in health
centers, focusing on services for pregnant women and children.
Additionally, these demonstration projects will directly align with
four HRSA recommendations for effectively incorporating the
competencies into clinical practice as described in the 2014
Integrating Oral Health and Primary Care Practice report. This activity
is consistent with the current work plan of NNOHA and includes
providing training and technical assistance on IOHPCP. NNOHA's primary
roles are to coordinate all activities at the planning, implementation,
evaluation, and dissemination stages, as well as provide technical
assistance and training to participating HCs. NNOHA shall select no
fewer than six HCs, which it supports as part of the current HRSA-
funded National Training and Technical Assistance Cooperative Agreement
Program (U30CS29051). NNOHA will assure that each HC will propose,
implement, and track data for an innovative inter-professional oral
health project that measurably increases the adoption of the core
clinical oral health competencies among non-dental providers in the
delivery of care to pregnant women and children.
FOR FURTHER INFORMATION CONTACT: Chinyere Amaefule, Office of Quality
Improvement, Division of Strategic Partnerships, Bureau of Primary
Health Care, Health Resources and Services Administration, 5600 Fishers
Lane, Rockville, Maryland 20857, Phone: (301) 594-4417, Email:
Camaefule@hrsa.gov.
----------------------------------------------------------------------------------------------------------------
FY 2017-2018
FY 2017 estimated
Grantee/organization name Grant No. State authorized supplemental
funding level amount
----------------------------------------------------------------------------------------------------------------
National Network of Oral Health Access.. U30CS2CO51 $500,000 $250,000
----------------------------------------------------------------------------------------------------------------
Dated: November 14, 2017.
George Sigounas,
Administrator.
[FR Doc. 2017-25191 Filed 11-20-17; 8:45 am]
BILLING CODE 4165-15-P
