Noncompetitive Program Extension Supplemental Awards, 21753-21754 [2011-9269]

Download as PDF Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/ RegulatoryInformation/Guidances/ ucm122047.htm or http:// www.regulations.gov. I. Background Dated: April 11, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–9261 Filed 4–15–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0240] Site Tours Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is announcing a notice for participation in its Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or tobacco products. These visits are intended to provide CTP staff with the opportunity to gain a better understanding of the tobacco industry and its operations. The purpose of this notice is to alert parties interested in participating in the Site Tours Program to submit requests to CTP. SUMMARY: Interested parties should submit either an electronic or written request for participation by June 17, 2011. The request should include a description of your facility, including as applicable, a list of all tobacco products processed and/or manufactured there. Please specify the physical address(es) of the site(s) for which you are submitting a erowe on DSK5CLS3C1PROD with NOTICES DATES: VerDate Mar<15>2010 15:25 Apr 15, 2011 Jkt 223001 request along with a proposed 1-day tour agenda. ADDRESSES: If your facility is interested in offering a site visit, you should submit a request to participate in the program either electronically to http:// www.regulations.gov or in writing to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lucinda Miner, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 877–287–1373, e-mail: lucinda.miner@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31; 123 Stat. 1776) was signed into law, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing. This includes, among other things, the authority to issue regulations related to health warnings, tobacco product standards, good manufacturing practices, as well as tobacco product constituents, ingredients, and additives. CTP is instituting the Site Tours Program to provide its scientific and regulatory staff the opportunity to gain a better understanding of the tobacco industry and its operations, including tobacco product manufacturing and aspects of tobacco growing, processing, and storage that may affect the physical and chemical properties of tobacco. Although FDA generally does not regulate tobacco farms and tobacco warehouses, the Agency believes that gaining a better understanding of the operations performed at these facilities may be helpful. The goals of the Site Tours Program are to: (1) Provide CTP firsthand exposure to industry’s manufacturing processes; (2) learn about control measures used by tobacco product manufacturers to ensure product consistency; (3) understand the processing of different forms of tobacco and the manufacturing processes used for various types of tobacco products and their influences on product constituents; and (4) understand how growing conditions, curing, storage, and manufacturing processes might influence the levels of tobacco or tobacco smoke constituents. II. Description of Site Tours Program In the Site Tours Program, small groups of CTP staff plan to observe the PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 21753 operations of tobacco growers, tobacco warehouses, and manufacturing facilities of cigarette, roll-your-own, and smokeless tobacco companies. Please note that the Site Tours Program is not intended to include official FDA inspections of facilities to determine compliance with the FD&C Act; rather, the program is meant to educate CTP staff and improve their understanding of the tobacco industry and its operations. III. Site Selection CTP plans to select one or more of each of the following types of facilities: A large cigarette manufacturing facility, a small cigarette manufacturing facility, a smokeless tobacco manufacturing facility, a burley tobacco farm, a fluecured tobacco farm, a tobacco rolling paper facility, and a tobacco warehouse. All travel expenses associated with the site tours will be the responsibility of CTP. Final site selections will be based on the availability of CTP funds and resources for the relevant fiscal year, as well as the following factors: (1) Compliance status of the requesting facility and affiliated firm, if applicable; (2) whether the requesting facility is in arrears for user fees; (3) whether the requesting facility or affiliated firm, if applicable, has a significant request or marketing application or submission pending with FDA; and (4) whether the requesting facility will be engaged in active manufacturing or processing during the proposed time of the visit. IV. Requests for Participation Requests are to be identified with the docket number found in brackets in the heading of this document. Requests received by the Agency are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 11, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–9260 Filed 4–15–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Noncompetitive Program Extension Supplemental Awards Health Resources and Services Administration, HHS. AGENCY: ACTION: E:\FR\FM\18APN1.SGM Notice. 18APN1 21754 Federal Register / Vol. 76, No. 74 / Monday, April 18, 2011 / Notices The Health Resources and Services Administration (HRSA) will be issuing non-competitive supplemental funding to the Maternal Child and Health Bureau’s (MCHB) Comprehensive Hemophilia Diagnostic and Treatment Centers. MCHB’s Division of Children with Special Health Needs and the Genetic Services Branch are currently undergoing a strategic planning process. This will provide feasible time for the MCHB to SUMMARY: align fiscal resources and programmatic goals as determined by this strategic planning process with the least disruption to the States, communities, and constituencies that currently receive assistance and services from these grantees. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Comprehensive Hemophilia Diagnostic and Treatment Centers—12 Regional Centers (see table below). Amount of the Award: 12 awards ranging from $184,846 to $595,453. CFDA Number: 93.110. Project Period: The period of supplemental support is from June 1, 2011, to May 31, 2012. Authority: This activity is under the authority of Section 501(a) (2) of the Social Security Act, the Maternal and Child Health Federal Set-Aside Program: Special Projects of Regional and National Significance (SPRANS) (42 U.S.C. 701). REGIONAL COMPREHENSIVE HEMOPHILIA DIAGNOSTIC AND TREATMENT CENTERS FY 2010 Funding Level Grantee Grant No. Region University of Massachusetts ............................................... H30 MC00037– 12–00. H30 MC00019– 20–00. H30 MC09625– 02–00. H30 MC05053– 07–01. H30 MC00011– 20–00. H30 MC00015– 20–00. H30 MC00032– 21–02. H30MC00029–20– 06. H30 MC00040– 10–00. H30 MC00008– 20–00. H30 MC00036– 12–00. H30 MC00025– 20–00. Region 1 .............................................................. $312,472 Region 2 .............................................................. 595,453 Region 3 .............................................................. 530,808 Region 4–N ......................................................... 329,980 Region 4–S ......................................................... 228,857 Region 5–E ......................................................... 365,256 Region 5–W ........................................................ 446,520 Region 6 .............................................................. 455,871 Region 7 .............................................................. 371,228 Region 8 .............................................................. 321,921 Region 9 .............................................................. 714,832 Region 10 ............................................................ 184,846 Mt. Sinai School of Medicine .............................................. Children’s Hospital of Philadelphia ..................................... University of North Carolina ................................................ Hemophilia of Georgia ........................................................ Hemophilia Foundation of Michigan .................................... Great Lakes Hemophilia Foundation .................................. University of Texas HSC at Houston .................................. Children’s Mercy Hospital ................................................... University of Colorado ......................................................... Children’s Hospital of Orange County ................................ erowe on DSK5CLS3C1PROD with NOTICES Oregon Health and Science University ............................... Justification for the Exception to Competition Since the inception of HRSA’s genetic services program, the landscape of our health care system has changed dramatically. In addition, our knowledge base for genetic medicine in general and blood disorders in particular has expanded. Unfortunately, the changes in our knowledge base and standards of care are not currently reflected in what we measure through this program nor how they are integrated into day to day activities that influence the health of individuals with hemophilia, thrombophilia and von Willebrand Disease and other congenital bleeding disorders. To better reflect the current landscape, the MCHB is undertaking a strategic planning process this year. At the end of the process, we hope to have better defined measures that will reflect our new plan and the goals for the next 10 years. This will provide us with the basis to expand the applicant pool as VerDate Mar<15>2010 15:25 Apr 15, 2011 Jkt 223001 well as improve the evidence base for the utility of the National Hemophilia Program. MCHB proposes this course of action for three reasons: (1) To appropriately respond to the directions that will be outlined after the strategic planning process, (2) to provide for sufficient fiscal resource to continue programmatic activities at current levels, and (3) to maintain MCH programmatic support with the least disruption to the State, community, and MCH constituencies who are currently receiving assistance and services from these grantees and the grantees themselves. Without this approach, the programmatic changes indicated through the strategic planning process will not be outlined nor implemented for another 3 years when the next competitive process will begin. Delaying the competition into mid fiscal year 2011 ensures continuity of funding for all eligible entities, with no eligible entity being harmed by the extension. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Sara Copeland, M.D., Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A–19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone (301) 443–8860, scopeland@hrsa.gov. FOR FURTHER INFORMATION CONTACT: Dated: April 12, 2011. Mary K. Wakefield, Administrator. [FR Doc. 2011–9269 Filed 4–15–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\18APN1.SGM 18APN1

Agencies

[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21753-21754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Noncompetitive Program Extension Supplemental Awards

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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[[Page 21754]]

SUMMARY: The Health Resources and Services Administration (HRSA) will 
be issuing non-competitive supplemental funding to the Maternal Child 
and Health Bureau's (MCHB) Comprehensive Hemophilia Diagnostic and 
Treatment Centers. MCHB's Division of Children with Special Health 
Needs and the Genetic Services Branch are currently undergoing a 
strategic planning process. This will provide feasible time for the 
MCHB to align fiscal resources and programmatic goals as determined by 
this strategic planning process with the least disruption to the 
States, communities, and constituencies that currently receive 
assistance and services from these grantees.

SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: 
Comprehensive Hemophilia Diagnostic and Treatment Centers--12 Regional 
Centers (see table below).
    Amount of the Award: 12 awards ranging from $184,846 to $595,453.
    CFDA Number: 93.110.
    Project Period: The period of supplemental support is from June 1, 
2011, to May 31, 2012.

    Authority: This activity is under the authority of Section 
501(a) (2) of the Social Security Act, the Maternal and Child Health 
Federal Set-Aside Program: Special Projects of Regional and National 
Significance (SPRANS) (42 U.S.C. 701).

                       Regional Comprehensive Hemophilia Diagnostic and Treatment Centers
----------------------------------------------------------------------------------------------------------------
                                                                                                       FY 2010
                Grantee                             Grant No.                       Region             Funding
                                                                                                        Level
----------------------------------------------------------------------------------------------------------------
University of Massachusetts...........  H30 MC00037-12-00...............  Region 1.................     $312,472
Mt. Sinai School of Medicine..........  H30 MC00019-20-00...............  Region 2.................      595,453
Children's Hospital of Philadelphia...  H30 MC09625-02-00...............  Region 3.................      530,808
University of North Carolina..........  H30 MC05053-07-01...............  Region 4-N...............      329,980
Hemophilia of Georgia.................  H30 MC00011-20-00...............  Region 4-S...............      228,857
Hemophilia Foundation of Michigan.....  H30 MC00015-20-00...............  Region 5-E...............      365,256
Great Lakes Hemophilia Foundation.....  H30 MC00032-21-02...............  Region 5-W...............      446,520
University of Texas HSC at Houston....  H30MC00029-20-06................  Region 6.................      455,871
Children's Mercy Hospital.............  H30 MC00040-10-00...............  Region 7.................      371,228
University of Colorado................  H30 MC00008-20-00...............  Region 8.................      321,921
Children's Hospital of Orange County..  H30 MC00036-12-00...............  Region 9.................      714,832
Oregon Health and Science University..  H30 MC00025-20-00...............  Region 10................      184,846
----------------------------------------------------------------------------------------------------------------

Justification for the Exception to Competition

    Since the inception of HRSA's genetic services program, the 
landscape of our health care system has changed dramatically. In 
addition, our knowledge base for genetic medicine in general and blood 
disorders in particular has expanded. Unfortunately, the changes in our 
knowledge base and standards of care are not currently reflected in 
what we measure through this program nor how they are integrated into 
day to day activities that influence the health of individuals with 
hemophilia, thrombophilia and von Willebrand Disease and other 
congenital bleeding disorders.
    To better reflect the current landscape, the MCHB is undertaking a 
strategic planning process this year. At the end of the process, we 
hope to have better defined measures that will reflect our new plan and 
the goals for the next 10 years. This will provide us with the basis to 
expand the applicant pool as well as improve the evidence base for the 
utility of the National Hemophilia Program.
    MCHB proposes this course of action for three reasons: (1) To 
appropriately respond to the directions that will be outlined after the 
strategic planning process, (2) to provide for sufficient fiscal 
resource to continue programmatic activities at current levels, and (3) 
to maintain MCH programmatic support with the least disruption to the 
State, community, and MCH constituencies who are currently receiving 
assistance and services from these grantees and the grantees 
themselves. Without this approach, the programmatic changes indicated 
through the strategic planning process will not be outlined nor 
implemented for another 3 years when the next competitive process will 
begin. Delaying the competition into mid fiscal year 2011 ensures 
continuity of funding for all eligible entities, with no eligible 
entity being harmed by the extension.

FOR FURTHER INFORMATION CONTACT: Sara Copeland, M.D., Maternal and 
Child Health Bureau, Health Resources and Services Administration, Room 
18A-19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 
20857, Telephone (301) 443-8860, scopeland@hrsa.gov.

    Dated: April 12, 2011.
Mary K. Wakefield,
Administrator.
 [FR Doc. 2011-9269 Filed 4-15-11; 8:45 am]
BILLING CODE 4165-15-P