Small Health Care Provider Quality Improvement Program, 51184-51185 [2014-20389]
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51184
Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices
scientific information submitted by the
applicant as well as the scientific
evidence and other information that is
made available to the Agency, including
through public comments.
Section 911(g) of the FD&C Act
describes the demonstrations applicants
must make to obtain an order from FDA
under either section 911(g)(1) or (g)(2).
The applicant, Swedish Match North
America Inc., is seeking an order under
section 911(g)(1) for each of the 10
products that are the subject of the
submitted MRTPAs.
An order under section 911(g)(1) of
the FD&C Act is for a modified risk
tobacco product that significantly
reduces harm and the risk of tobaccorelated disease to individual tobacco
users; and benefits the health of the
population as a whole. A person seeking
an order under section 911(g)(1) of the
FD&C Act must show that the tobacco
product, as it is actually used by
consumers, will significantly reduce
harm and the risk of tobacco-related
disease to individual tobacco users and
will benefit the health of the population
as a whole taking into account both
users of tobacco products and persons
who do not currently use tobacco
products. Section 911(g)(4) of the FD&C
Act describes factors that FDA must take
into account in evaluating whether a
tobacco product benefits the health of
individuals and the population as a
whole.
FDA is issuing this notice to inform
the public that MRTPAs submitted by
Swedish Match North America Inc. for
the following products (identified by
FDA Submission Tracking Numbers
(STN) (MR0000020—MR0000029)) have
been filed and are being made available
for public comment for 180 days:
• MR0000020: General Loose,
smokeless tobacco, loose snus, 1.59 oz
(45g), cardboard can (SKU 4852);
• MR0000021: General Dry Mint
Portion Original Mini, smokeless
tobacco, snus portions, 0.21 oz (6g),
20—0.3g portions, plastic can (SKU
4800);
• MR0000022: General Portion
Original Large, smokeless tobacco, snus
portions, 0.9 oz (24g), 24—1g portions,
plastic can (SKU 4880);
• MR0000023: General Classic Blend
Portion White Large, smokeless tobacco,
snus portions, 0.48 oz (13.5g), 15—0.9g
portions, plastic can (SKU 4877);
• MR0000024: General Classic Blend
Portion White Large, smokeless tobacco,
snus portions, 0.38 oz (10.8g), 12—0.9g
portions, plastic can (SKU 4878);
• MR0000025: General Mint Portion
White Large, smokeless tobacco, snus
portions, 0.9 oz (24g), 24—1g portions,
plastic can (SKU 4352);
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• MR0000026: General Nordic Mint
Portion White Large, smokeless tobacco,
snus portions, 0.48 oz (13.5g), 15—0.9g
portions, plastic can (SKU 4876);
• MR0000027: General Nordic Mint
Portion White Large, smokeless tobacco,
snus portions, 0.38 oz (10.8g), 12—0.9g
portions, plastic can (SKU 4875);
• MR0000028: General Portion White
Large, smokeless tobacco, snus portions,
0.9 oz (24g), 24—1g portions, plastic can
(SKU 4881); and
• MR0000029: General Wintergreen
Portion White Large, smokeless tobacco,
snus portions, 0.9 oz (24g), 24—1g
portions, plastic can (SKU 4882).
FDA believes a 180-day comment
period is appropriate because of the
volume and complexity of the material
being posted in the applications. If you
submit comments that apply to some
but not all 10 of the products, FDA asks
that you identify the applicable
product(s) using the STNs listed in this
document in your comments. To
encourage public participation
consistent with section 911(e) of the
FD&C Act, FDA is placing the MRTPAs
(except for matters in the applications
that are trade secrets or otherwise
confidential commercial information)
that are the subject of this notice on
public display at the Division of Dockets
Management (see DATES and ADDRESSES)
and making them available
electronically (see section III).
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.accessdata.fda.gov/Static/
widgets/tobacco/SMNA_MRTPA_FDA2014-N-1051.html or https://
www.regulations.gov.
Dated: August 22, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20394 Filed 8–26–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0007]
Outsourcing Facility Fee Rates for
Fiscal Year 2015; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Outsourcing Facility Fee Rates
for Fiscal Year 2015’’ that appeared in
the Federal Register of August 1, 2014
(79 FR 44805). The document
announced the rates for fiscal year 2015
for the establishment and reinspection
fees related to human drug
compounding outsourcing facilities that
elect to register under the Federal Food,
Drug, and Cosmetic Act. The document
was published with the incorrect docket
number. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Food and
Administration, 10990 New Hampshire
Ave., Bldg. 32, Rm. 3330, Silver Spring,
MD 20993–0002, 301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Friday, August 1,
2014, in FR Doc. 2014–18111, the
following correction is made:
1. On page 44805, in the first column,
in the Docket No. heading, ‘‘[Docket No.
FDA–2013–N–0007]’’ is corrected to
read ‘‘[Docket No. FDA–2014–N–0007]’’.
SUMMARY:
Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20331 Filed 8–26–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Small Health Care Provider Quality
Improvement Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Class Deviation From
Competition Requirements for Small
Health Care Provider Quality
Improvement.
AGENCY:
The Office of Rural Health
Policy (ORHP) will award program
expansion supplemental awards to the
current Small Health Care Provider
SUMMARY:
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Federal Register / Vol. 79, No. 166 / Wednesday, August 27, 2014 / Notices
Quality Improvement (Quality) program
grantees. The program expansion
supplemental funds will allow current
Quality program grantees: To provide
education to those new to health care
coverage about health care benefits to
which they have access; to raise
awareness about the importance of
receiving routine primary care and
regular preventive services; and to
expand outreach and enrollment
activities for the next Affordable Care
Act’s (ACA) Health Insurance
Marketplace open enrollment period
(November 15, 2014–February 15, 2015).
The goals of this supplemental funding
are to (1) increase the number of newly
insured individuals educated about the
benefits and primary care and
preventive services to which they now
have access, (2) increase the number of
uninsured individuals educated about
their coverage options, and (3) increase
the number of uninsured individuals
enrolled into the Health Insurance
Marketplaces or other available sources
of insurance, such as Medicaid and the
Children’s Health Insurance Program.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Current Quality program grantees
(Quantity: 29).
Amount of Non-Competitive Awards:
$25,000/award
Period of Supplemental Funding:
September 15, 2014–July 31, 2015.
CFDA Number: 93.912
mstockstill on DSK4VPTVN1PROD with NOTICES
Authority: Public Health Service Act,
Section 330A (g) (42 U.S.C. 254c(g)), as
amended.
Justification: The fiscal year (FY) 2014
Quality ACA OEE grantees are uniquely
qualified for the outreach, enrollment
and education work required in this
supplement. First, the supplemental
funding aligns with the Quality
program. The objectives of the Quality
program include: Improved health
outcomes; enhanced chronic disease
management; and better engagement of
patients and their caregivers. These
objectives are consistent with the
activities proposed under this
supplemental funding opportunity,
which includes helping individuals
better understand their health coverage,
raising awareness about the importance
of receiving routine primary care, and
increasing the use of regular preventive
services. Second, Quality program
grantees are encouraged to maximize
funding by billing for third party
reimbursement for covered services.
Educating and enrolling eligible
individuals into health insurance
coverage would help Quality program
grantees achieve this goal. Third, these
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grantees know the rural communities
they serve and have the capacity to
provide the services needed for
outreach, enrollment, and education in
time for the next open enrollment
period for ACA which begins on
November 15, 2014.
Ann
Ferrero, MPH Community Based
Division, Office of Rural Health Policy,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 17W21–B, Rockville, Maryland
20857, By phone: 301–443–3999, or
email: aferrero@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Dated: August 21, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014–20389 Filed 8–26–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Amyloid, Tau
and Aging Brain.
Date: September 25–26, 2014.
Time: 2:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, National
Institute on Aging, Gateway Building 2C/212,
7201 Wisconsin Avenue, Bethesda, MD
20892, 301–496–9666, PARSADANIANA@
NIA.NIH.GOV.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
PO 00000
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51185
Dated: August 21, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–20356 Filed 8–26–14; 8:45 a.m.]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Omnibus
SEP–4.
Date: October 14–15, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Clifford W. Schweinfest,
Ph.D., Scientific Review Officer, Special
Review Branch, Division of Extramural
Activities, National Cancer Institute, 9609
Medical Center Drive, Room 7W108,
Bethesda, MD 20892–9750, 240–276–6343.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: August 21, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–20355 Filed 8–26–14; 8:45 am]
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]]>Agencies
[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51184-51185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20389]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Small Health Care Provider Quality Improvement Program
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of Class Deviation From Competition Requirements for
Small Health Care Provider Quality Improvement.
-----------------------------------------------------------------------
SUMMARY: The Office of Rural Health Policy (ORHP) will award program
expansion supplemental awards to the current Small Health Care Provider
[[Page 51185]]
Quality Improvement (Quality) program grantees. The program expansion
supplemental funds will allow current Quality program grantees: To
provide education to those new to health care coverage about health
care benefits to which they have access; to raise awareness about the
importance of receiving routine primary care and regular preventive
services; and to expand outreach and enrollment activities for the next
Affordable Care Act's (ACA) Health Insurance Marketplace open
enrollment period (November 15, 2014-February 15, 2015). The goals of
this supplemental funding are to (1) increase the number of newly
insured individuals educated about the benefits and primary care and
preventive services to which they now have access, (2) increase the
number of uninsured individuals educated about their coverage options,
and (3) increase the number of uninsured individuals enrolled into the
Health Insurance Marketplaces or other available sources of insurance,
such as Medicaid and the Children's Health Insurance Program.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: Current Quality program grantees
(Quantity: 29).
Amount of Non-Competitive Awards: $25,000/award
Period of Supplemental Funding: September 15, 2014-July 31, 2015.
CFDA Number: 93.912
Authority: Public Health Service Act, Section 330A (g) (42
U.S.C. 254c(g)), as amended.
Justification: The fiscal year (FY) 2014 Quality ACA OEE grantees
are uniquely qualified for the outreach, enrollment and education work
required in this supplement. First, the supplemental funding aligns
with the Quality program. The objectives of the Quality program
include: Improved health outcomes; enhanced chronic disease management;
and better engagement of patients and their caregivers. These
objectives are consistent with the activities proposed under this
supplemental funding opportunity, which includes helping individuals
better understand their health coverage, raising awareness about the
importance of receiving routine primary care, and increasing the use of
regular preventive services. Second, Quality program grantees are
encouraged to maximize funding by billing for third party reimbursement
for covered services. Educating and enrolling eligible individuals into
health insurance coverage would help Quality program grantees achieve
this goal. Third, these grantees know the rural communities they serve
and have the capacity to provide the services needed for outreach,
enrollment, and education in time for the next open enrollment period
for ACA which begins on November 15, 2014.
FOR FURTHER INFORMATION CONTACT: Ann Ferrero, MPH Community Based
Division, Office of Rural Health Policy, Health Resources and Services
Administration, 5600 Fishers Lane, Room 17W21-B, Rockville, Maryland
20857, By phone: 301-443-3999, or email: aferrero@hrsa.gov.
Dated: August 21, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014-20389 Filed 8-26-14; 8:45 am]
BILLING CODE 4165-15-P
