National Advisory Committee on Rural Health and Human Services; Notice of Meeting, 5977-5978 [E7-2125]

Download as PDF Federal Register / Vol. 72, No. 26 / Thursday, February 8, 2007 / Notices jlentini on PROD1PC65 with NOTICES 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to this guidance document. FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug Evaluation and Research (HFD–5), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.’’ The guidance describes the circumstances under which user fees will not be assessed for certain applications for FDC and copackaged versions of previously approved antiretroviral therapies for the treatment of HIV under PEPFAR. The guidance also describes some circumstances under which some of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver. In May 2004, as part of PEPFAR, FDA issued a draft guidance entitled ‘‘Fixed Dose Combination and Co-Packaged Drug Products for the Treatment of HIV’’ (Fixed Dose Guidance) (69 FR 28931, May 19, 2004). The draft Fixed Dose Guidance described some scenarios for approval of FDC or co-packaged products for the treatment of HIV and provided examples of drug combinations considered acceptable for FDC/co-packaging and examples of those not considered acceptable for FDC/co-packaging. The guidance also explained that the Federal Food, Drug, and Cosmetic Act provides for certain circumstances in which FDA can grant sponsors a waiver or reduction in fees. The guidance also stated that the agency was evaluating the circumstances under which it may grant user fee waivers or reductions for sponsors developing FDC and co-packaged versions of previously approved antiretroviral therapies for the treatment of HIV. Since issuance of the draft Fixed Dose Guidance, several potential applicants have asked that we clarify whether sponsors submitting VerDate Aug<31>2005 15:58 Feb 07, 2007 Jkt 211001 drug applications covered by the draft Fixed Dose Guidance and proposed for use in the PEPFAR program will be required to pay user fees under the Prescription Drug User Fee Act (PDUFA) and, if so, whether they would be eligible for a waiver of those fees. In the Federal Register of April 18, 2005 (70 FR 20145), FDA announced the availability of a draft version of this guidance. FDA did not receive any comments in response to that draft guidance, and the agency has made only minor editorial changes to the guidance. This guidance describes some of the scenarios under which a sponsor could qualify for fee exemptions or would only be assessed a half fee, either because the sponsor is using an active ingredient that has already been approved or the application does not require clinical data for approval. A sponsor of an application that would be assessed either a full or a half fee may also qualify for a waiver of the application fee under several provisions of PDUFA. We expect that most of the applications, products, and establishments for FDC and co-packaged HIV therapies proposed for use in the PEPFAR program will either not be assessed fees in the first instance or will qualify for a waiver under the ‘‘other circumstances’’ part of the barrier-toinnovation user fee waiver. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on waivers for FDC and co-packaged HIV PEPFAR products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 5977 III. Electronic Access Persons with access to the Internet may obtain the guidance document at either http://www.fda.gov/cder/ guidance/index.htm or http:// www.fda.gov/ohrms/dockets/ default.htm. Dated: February 1, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2124 Filed 2–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given that the following committee will convene its fifty-fifth meeting. Name: National Advisory Committee on Rural Health and Human Services. Dates and Times: February 28, 2007, 9 a.m.–4:15 p.m., March 1, 2007, 9 a.m.–4:15 p.m., March 2, 2007, 9 a.m.–10:30 a.m. Place: The Sofitel Lafayette Square, 806 15th Street NW., Washington, DC 20005, Phone: 202–730–8800. Status: The meeting will be open to the public. Purpose: The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, development and administration of health and human services in rural areas. Agenda: Wednesday morning, February 28, at 9 a.m., the meeting will be called to order by the Chairperson of the Committee, the Honorable David Beasley. Elizabeth M. Duke, Administrator of the Health Resources and Services Administration, has been invited to give opening remarks. The first presentation is titled Rural America: Then, Now and in the Future. The speakers will be John Cromartie and Carol Jones, Economic Research Service, U.S. Department of Agriculture. Following this session will be three panels on rural health and human services issues. The first will be a rural health panel with Becky Slifkin of the North Carolina Rural Health Research and Policy Analysis Center at the University of North Carolina at Chapel Hill; Gary Hart of the WWAMI Rural Health Research Center at the University of Washington; and Andy Coburn of the Maine Rural Health Research Center at the University of Southern Maine. The second will be a rural health panel with the following speakers: Julie Schoenman of the National Opinion Research Center at the University of Chicago; Michelle Casey of the E:\FR\FM\08FEN1.SGM 08FEN1 5978 Federal Register / Vol. 72, No. 26 / Thursday, February 8, 2007 / Notices Upper Midwest Rural Health Research Center at the University of Minnesota; and Keith Mueller of the Rural Policy Research Institute. The final panel of the day will be a rural human services panel with Robert Gibbs of the Economic Research Service at the U.S. Department of Agriculture; Dennis Dudley with the U. S. Administration on Aging; and Brian Dabson of the Poverty Center at the Rural Policy Research Institute. The Wednesday meeting will close at 4:15 p.m. Thursday morning, March 1, at 9 a.m., the Committee will open with a discussion on Wednesday’s sessions. Immediately following, the Committee Chair will lead a discussion of the topics for the 2008 Report to the Secretary and assign Subcommittees. The first presentation of the day will be on Rural Policy Moving Forward by Mike O’ Grady, Senior Fellow with the National Opinion Research Center. This will be followed by a presentation on the Commonwealth Fund Activity by Mary Wakefield, Director of the Center for Rural Health at the University of North Dakota. After lunch the Committee will have discussion on the day’s presentations. The formal Committee meeting for Thursday will close at 2:30 p.m. The Subcommittees will meet from 2:30 p.m. to 4 p.m. The final session will be convened Friday morning, March 2, at 9 a.m. The Committee will receive reports from the Subcommittee discussions on Thursday, draft the letter to the Secretary, and discuss the June meeting. The meeting will be adjourned at 10:30 a.m. For Further Information Contact: Anyone requiring information regarding the Committee should contact Tom Morris, M.P.A., Executive Secretary, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, Parklawn Building, Room 9A–55, 5600 Fishers Lane, Rockville, MD 20857, Telephone (301) 443–0835, Fax (301) 443–2803. Persons interested in attending any portion of the meeting should contact Michele PrayGibson, Office of Rural Health Policy (ORHP), Telephone (301) 443–0835. The Committee meeting agenda will be posted on ORHP’s Web site http:// www.ruralhealth.hrsa.gov. Dated: February 2, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7–2125 Filed 2–7–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General jlentini on PROD1PC65 with NOTICES Program Exclusions: Correction AGENCY: Office of Inspector General, HHS. Notice of program exclusions; correction. ACTION: VerDate Aug<31>2005 16:48 Feb 07, 2007 Jkt 211001 SUMMARY: The HHS Office of Inspector General Published a document in the Federal Register of October 18, 2006, imposed exclusions. The document contained the incorrect monthly exclusions. FOR FURTHER INFORMATION CONTACT: Jacqueline Freeman, (410) 786–5197. Correction In the Federal Register of October 18, 2006, in FR Doc. 71 FR 61485, on page 61492, The list was for the September 2006 exclusions. The correct exclusions for September 2006 should read: Subject name, address Effective date PROGRAM-RELATED CONVICTION ABAD, NILDA ........................... ALPINE, CA ALLISON, KEITH ...................... LOS ANGELES, CA ANDERSON, THEODORE ....... KINGSTON, WA BOUCHARD, JOHN ................. PHILLIPSBURG, KS BOUGHTON, LLOYD ............... LOS ANGELES, CA BRAZIL, MICHAEL ................... ARLINGTON, VA CACAL, ROQUE ...................... LOS ANGELES, CA CACAL, ROSA ......................... LOS ANGELES, CA CARDILLO, JOHN .................... BERKELEY HEIGHTS, NJ DELATOUR, GREGORY .......... MIAMI, FL DELGADO, JOSUE .................. BALDWIN PARK, CA DODDS, KYLE ......................... INDEPENDENCE, OR EASON, KIM ............................. FRESNO, CA EDWARDS, PHYLLIS .............. HAMILTON, OH EVANS, AMY ............................ PATASKALA, OH FINLEY, SANDRA .................... OKLAHOMA CITY, OK FLORES, VERGIL .................... MESQUITE, TX FRANK, PAUL .......................... FORT DIX, NJ GALLEGOS, JODY .................. THORNTON, CO GORDON, RICHARD ............... SURPRISE, AZ GOTTSCHALL, ZAY ................. BUTTE, MT HABEEB, GREGORY ............... CLARK SUMMIT, PA HARRIS, KATRINA .................. NILES, OH HARRIS, TAMMY ..................... AUSTIN, TX HARTSFIELD, ARCHIE ............ EL PASO, TX HERIC, THOMAS ..................... HAWTHORNE, CA HERNANDEZ, JOSE ................ PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 Subject name, address MIAMI, FL HOLSAN, JASON ..................... GRAND JUNCTION, CO HOVATTER, KATHY ................ PARMA, OH ISHAK, MAHER ........................ HARRIMAN, NY JOHNSON, SHELIA ................. SARDINIA, OH JONES, WANDA ...................... YOUNGSTOWN, OH LAZARO, JUAN ........................ WESTBROOK, ME LUETTGEN, TAMMIE .............. ALLENTOWN, PA MALAHIMOV, BORIS ............... BRADFORD, PA MALCOLM-FORBES, SONIA ... COLUMBUS, OH MAYHUGH, JEFFREY ............. THORNVILLE, OH MORTON, GEORGE ................ PHENIX, VA PARKER, ROGER .................... HAMPTON, VA PETERSON, RENE .................. DES MOINES, IA REISBORD, DAVID .................. LOS ANGELES, CA RUMMELT, HERMAN .............. DULUTH, MN SERRANO, SUSAN ................. DUBLIN, CA SHUMAKER, MARY ................. SARDINIA, OH SISNEY, DEBRA ...................... BULL SHOALS, AR SOLIS, MARY ........................... WEST COVINA, CA SPEARS, RAMESHIA .............. GRANDVIEW, MO SPEIGHT, DIANNA .................. LAS VEGAS, NV STATLER, JOHN ...................... DAYTON, OH STIMPSON, RIETA .................. HELENA, MT WALLED, RAFAEL ................... MIAMI, FL WALLERICK, MELANIE ........... YOUNGSTOWN, OH WILLIAMS, DRANETTA ........... GATESVILLE, TX WILLIAMS, HENRY .................. HUNTSVILLE, TX WOODBURY PHARMACY, INC ........................................ HARRIMAN, NY Effective date 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 7/5/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 FELONY CONVICTION FOR HEALTH CARE FRAUD 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 BAILEY, LLEWELLYN .............. ROSEDALE, NY BALL, HEIDI ............................. SPRINGFIELD, OR BATTERTON, CAROL ............. CHEYENNE, OK BENTLEY, WILLIAM ................ MONROE, WA BLEVINS, CHARLES ............... MONTGOMERY, AL BOUGHTON, DARLA ............... E:\FR\FM\08FEN1.SGM 08FEN1 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006 10/19/2006

Agencies

[Federal Register Volume 72, Number 26 (Thursday, February 8, 2007)]
[Notices]
[Pages 5977-5978]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2125]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Advisory Committee on Rural Health and Human Services; 
Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given that the 
following committee will convene its fifty-fifth meeting.

    Name: National Advisory Committee on Rural Health and Human 
Services.
    Dates and Times: February 28, 2007, 9 a.m.-4:15 p.m., March 1, 
2007, 9 a.m.-4:15 p.m., March 2, 2007, 9 a.m.-10:30 a.m.
    Place: The Sofitel Lafayette Square, 806 15th Street NW., 
Washington, DC 20005, Phone: 202-730-8800.
    Status: The meeting will be open to the public.
    Purpose: The National Advisory Committee on Rural Health and 
Human Services provides advice and recommendations to the Secretary 
with respect to the delivery, research, development and 
administration of health and human services in rural areas.
    Agenda: Wednesday morning, February 28, at 9 a.m., the meeting 
will be called to order by the Chairperson of the Committee, the 
Honorable David Beasley. Elizabeth M. Duke, Administrator of the 
Health Resources and Services Administration, has been invited to 
give opening remarks. The first presentation is titled Rural 
America: Then, Now and in the Future. The speakers will be John 
Cromartie and Carol Jones, Economic Research Service, U.S. 
Department of Agriculture. Following this session will be three 
panels on rural health and human services issues. The first will be 
a rural health panel with Becky Slifkin of the North Carolina Rural 
Health Research and Policy Analysis Center at the University of 
North Carolina at Chapel Hill; Gary Hart of the WWAMI Rural Health 
Research Center at the University of Washington; and Andy Coburn of 
the Maine Rural Health Research Center at the University of Southern 
Maine. The second will be a rural health panel with the following 
speakers: Julie Schoenman of the National Opinion Research Center at 
the University of Chicago; Michelle Casey of the

[[Page 5978]]

Upper Midwest Rural Health Research Center at the University of 
Minnesota; and Keith Mueller of the Rural Policy Research Institute. 
The final panel of the day will be a rural human services panel with 
Robert Gibbs of the Economic Research Service at the U.S. Department 
of Agriculture; Dennis Dudley with the U. S. Administration on 
Aging; and Brian Dabson of the Poverty Center at the Rural Policy 
Research Institute. The Wednesday meeting will close at 4:15 p.m.
    Thursday morning, March 1, at 9 a.m., the Committee will open 
with a discussion on Wednesday's sessions. Immediately following, 
the Committee Chair will lead a discussion of the topics for the 
2008 Report to the Secretary and assign Subcommittees. The first 
presentation of the day will be on Rural Policy Moving Forward by 
Mike O' Grady, Senior Fellow with the National Opinion Research 
Center. This will be followed by a presentation on the Commonwealth 
Fund Activity by Mary Wakefield, Director of the Center for Rural 
Health at the University of North Dakota. After lunch the Committee 
will have discussion on the day's presentations. The formal 
Committee meeting for Thursday will close at 2:30 p.m. The 
Subcommittees will meet from 2:30 p.m. to 4 p.m.
    The final session will be convened Friday morning, March 2, at 9 
a.m. The Committee will receive reports from the Subcommittee 
discussions on Thursday, draft the letter to the Secretary, and 
discuss the June meeting. The meeting will be adjourned at 10:30 
a.m.
    For Further Information Contact: Anyone requiring information 
regarding the Committee should contact Tom Morris, M.P.A., Executive 
Secretary, National Advisory Committee on Rural Health and Human 
Services, Health Resources and Services Administration, Parklawn 
Building, Room 9A-55, 5600 Fishers Lane, Rockville, MD 20857, 
Telephone (301) 443-0835, Fax (301) 443-2803.
    Persons interested in attending any portion of the meeting 
should contact Michele Pray-Gibson, Office of Rural Health Policy 
(ORHP), Telephone (301) 443-0835. The Committee meeting agenda will 
be posted on ORHP's Web site http://www.ruralhealth.hrsa.gov.

    Dated: February 2, 2007.
Caroline Lewis,
Acting Associate Administrator for Administration and Financial 
Management.
 [FR Doc. E7-2125 Filed 2-7-07; 8:45 am]
BILLING CODE 4165-15-P