Small Health Care Provider Quality Improvement Program, 51184-51185 [2014-20389]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 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); VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 • 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 http://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 http:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.accessdata.fda.gov/Static/ widgets/tobacco/SMNA_MRTPA_FDA2014-N-1051.html or http:// 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] BILLING CODE 4164–01–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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] BILLING CODE 4164–01–P 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: E:\FR\FM\27AUN1.SGM 27AUN1 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 VerDate Mar<15>2010 17:44 Aug 26, 2014 Jkt 232001 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] BILLING CODE 4165–15–P 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 Frm 00048 Fmt 4703 Sfmt 9990 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.] BILLING CODE 4140–01–P 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: http:// 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] BILLING CODE 4140–01–P E:\FR\FM\27AUN1.SGM 27AUN1

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.

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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