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68466 Federal Register / Vol. 70, No.

217 / Thursday, November 10, 2005 / Notices

of medical devices; (2) promote documents is available at http:// Effective


Subject name/address
technological innovation; and (3) www.fda.gov/cdrh/guidance.html. date
facilitate international trade. GHTF Guidance documents are also available
provides further information concerning on the Division of Dockets Management PROGRAM-RELATED CONVICTIONS
the structure, goals, and procedures at Internet site at http://www.fda.gov/
ADAIR, KARISTA ..................... 11/20/2005
the GHTF Web site and can be accessed ohrms/dockets. LEWISBURG, TN
at http://ghtf.org.
IV. Comments AUSTIN, HOWARD .................. 11/20/2005
II. Significance of Guidance OAKDALE, LA
This guidance is being issued Interested persons may submit to the BAILEY, LAWRENCE ............... 11/20/2005
Division of Dockets Management (see SHREVEPORT, LA
consistent with FDA’s Good Guidance BESAW NALEN, KIMBERLY ... 11/20/2005
Practice (GGP) regulation (21 CFR ADDRESSES) written or electronic
comments regarding this document. MANCHESTER, NH
10.115). The guidance represents the BLACK, ANTONIA .................... 11/20/2005
agency’s current thinking on the GHTF Submit a single copy of electronic
FLINT, TX
recommendations as related to comments or two paper copies of any CONVENIENT DENTAL CARE
premarket submission to FDA. It does mailed comments, except that CENTER, PC ........................ 11/20/2005
not create or confer any rights for or on individuals may submit one copy. OKEMOS, MI
any person and does not operate to bind Comments are to be identified with the DE LA CRUZ, ALFONSO ......... 11/20/2005
FDA or the public. An alternative docket number found in brackets in the LOS ANGELES, CA
approach may be used if such approach heading of this document. Comments ERLICH, RUSSELL .................. 11/20/2005
satisfies the requirements of the received may be seen in the Division of BROOKLYN, NY
applicable statute and regulations. Dockets Management between 9 a.m. FLORES, SILVIA ...................... 11/20/2005
and 4 p.m., Monday through Friday. ONTARIO, CA
III. Electronic Access GARCIA, ROSEMARIE ............ 11/20/2005
Dated: November 2, 2005. SAN DIEGO, CA
To receive a copy of ‘‘A Pilot Program
to Evaluate a Proposed Globally Jeffrey Shuren, HAMILTON BENNETT,
Assistant Commissioner for Policy. MAISHA ................................ 11/20/2005
Harmonized Alternative for Premarket
CHICAGO, IL
Procedures; Guidance for Industry and [FR Doc. 05–22387 Filed 11–9–05; 8:45 am]
HAWKINS, KIMBERLY ............. 11/20/2005
FDA Staff,’’ by fax call CDRH Facts-On- BILLING CODE 4160–01–S SHAKOPEE, MN
Demand system at 800–899–0381 or HERNANDEZ, KAREN ............. 11/20/2005
301–827–0111 from a touch-tone OKLAHOMA CITY, OK
telephone. Press 1 to enter the system. DEPARTMENT OF HEALTH AND KATZ, RONALD ....................... 11/20/2005
At the second voice prompt press 1 to HUMAN SERVICES OTISVILLE, NY
order a document. Enter the document KEMMETT, BARBARA ............. 11/20/2005
number (1347) followed by the pound Office of Inspector General BRIDGEWATER, MA
sign #. Follow the remaining voice KUBRICKY, MARK ................... 11/20/2005
prompts to complete your request. Program Exclusions: October 2005 OGDEN, UT
To receive ‘‘A Pilot Program to LAKHTER, ALEXANDER ......... 11/20/2005
Evaluate a Proposed Globally AGENCY: Office of Inspector General, E STROUDSBURG, PA
Harmonised Alternative for Premarket HHS. LEBEL, ALEXANDER ............... 11/20/2005
BROOKLYN, NY
Procedures; Guidance for Industry and ACTION: Notice of program exclusions. LEEDS, LORI ........................... 11/20/2005
FDA Staff,’’ you may either send a fax SHAKOPEE, MN
request to 301–443–8818 to receive a LITTLE, MARK ......................... 11/20/2005
hard copy of the document, or send an During the month of October 2005,
ANTHONY, TX
e-mail request to gwa@cdrh.fda.gov to the HHS Office of Inspector General MALVAREZ, NORBERTO ........ 11/20/2005
receive a hard copy or an electronic imposed exclusions in the cases set MIAMI, FL
copy. Please use the document number forth below. When an exclusion is MARTINEZ, CESAR ................. 11/20/2005
1347 to identify the guidance you are imposed, no program payment is made MIAMI, FL
requesting. to anyone for any items or services MORAN, PAT ........................... 11/20/2005
Persons interested in obtaining a copy (other than an emergency item or WICHITA FALLS, TX
of the guidance may also do so by using service not provided in a hospital SHUMATE, TAMMY ................. 11/20/2005
the Internet. CDRH maintains an entry emergency room) furnished, ordered or LOUISVILLE, KY
prescribed by an excluded party under UTUK, BECALO ....................... 11/20/2005
on the Internet for easy access to
the Medicare, Medicaid, and all Federal BRYAN, TX
information including text, graphics, VU, PHOUA .............................. 11/20/2005
and files that may be downloaded to a Health Care programs. In addition, no
SAN DIEGO, CA
personal computer with Internet access. program payment is made to any WALLACE, SHIRLEY ............... 11/20/2005
Updated on a regular basis, the CDRH business or facility, e.g., a hospital, that JONESBORO, AR
home page includes: Device safety submits bills for payment for items or WILLIAMS-WRIGHT, MYRA .... 11/20/2005
alerts, Federal Register reprints, services provided by an excluded party. MIAMI, FL
information on premarket submissions Program beneficiaries remain free to
(including lists of approved applications decide for themselves whether they will FELONY CONVICTION FOR HEALTH CARE
and manufacturers’ addresses), small continue to use the services of an FRAUD
manufacturer’s, information on video excluded party even though no program
CHAVEZ, WILLIAM .................. 11/20/2005
conferencing, and electronic payments will be made for items and MIAMI, FL
submissions, Mammography Matters, services provided by that excluded GONZALEZ, DUVIEL ............... 11/20/2005
and other device-related information. party. The exclusions have national MIAMI, FL
The CDRH web site home page may be effect and also apply to all Executive GORRIN, EDDY ....................... 11/20/2005
accessed at http://www.fda.gov/cdrh. A Branch procurement and non- MIAMI, FL
search capability for all CDRH guidance procurement programs and activities. KRZYS, PENNY ....................... 11/20/2005

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Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 68467

Effective Effective Effective


Subject name/address Subject name/address Subject name/address
date date date

ASHTABULA, OH FLATWOODS, KY WEST HOLLYWOOD, CA


CAVANAUGH, TRACIE ............ 11/20/2005 MAESTRE, NANCY .................. 11/20/2005
FELONY CONTROL SUBSTANCE RENSSELAER, NY KEYSTONE HEIGHTS, FL
CONVICTION CHAN, DENNIS ........................ 11/20/2005 MARRON, TIMOTHY ............... 11/20/2005
SACRAMENTO, CA APACHE JUNCTION, AZ
BROWN, MARY ....................... 11/20/2005 CLAYTON, MICHELLE ............. 11/20/2005 MARTIN, ELIZABETH .............. 11/20/2005
MARICOPA, AZ VERNON, VT DOTHAN, AL
CASTAGNETTI, LEINA ............ 11/20/2005 COLBY, JULIE .......................... 11/20/2005 MARTINEZ, SYNTHIA .............. 11/20/2005
HILO, HI BYFIELD, MA TYLER, TX
GUY, CRYSTAL ....................... 11/20/2005 CORBETT, KELLY ................... 11/20/2005
MCBRIDE, MARGO ................. 11/20/2005
COLUMBIA, MS LAGUNA BEACH, CA
CUNNINGHAM, RICHARD ...... 11/20/2005 ANNAPOLIS, MD
ILIADES, EMMANUEL ............. 11/20/2005
DAPHNE, AL MCCALL, STEVEN ................... 11/20/2005
CENTERVILLE, MA
MASCOLO, JOSEPHINE ......... 11/20/2005 DAVIS, LACIANA ..................... 11/20/2005 GOODYEAR, AZ
ELMWOOD PARK, NJ METAIRIE, LA MCCOY, TIERRA ..................... 11/20/2005
MEHTA, DONNA ...................... 11/20/2005 DENHALTER, MARY ............... 11/20/2005 RICHMOND, VA
CHATTANOOGA, TN CLEARFIELD, UT MCGEOGHEAN, ANTOINETTE 11/20/2005
THATCHER, GILIE ................... 11/20/2005 DENTON, TAMMY ................... 11/20/2005 GILFORD, NH
CHARLOTTESVILLE, VA MORTON, MS MCHUGH, LAURA ................... 11/20/2005
WELCH, PAUL ......................... 11/20/2005 DINKINS, LINDA ...................... 11/20/2005 CHELMSFORD, MA
EDGEFIELD, SC JACKSONVILLE, FL MCMAHON, KATHY ................. 11/20/2005
DOVE, LAURA ......................... 11/20/2005 MOSA POINT, MS
PATIENT ABUSE/NEGLECT CONVICTIONS SHREVEPORT, LA MIRANNE, CHRISTOPHER ..... 11/20/2005
DUBRULE, ROSAIRE .............. 11/20/2005 OAKLAND, CA
ACKLEY, CHRISTINE .............. 11/20/2005 TIPTONVILLE, TN MORRIS, LAWRENCE ............. 11/20/2005
CANON CITY, CO ECKLUND, DAN ....................... 11/20/2005 FT LAUDERDALE, FL
BEDDIE, ELIZABETH ............... 11/20/2005 SILVERHILL, AL O’DAY, JAMES ......................... 11/20/2005
BURLINGTON, VT FARCHIONE, LOUIS ................ 11/20/2005 CANTON, MI
COLBY, DEBORAH .................. 11/20/2005 PITTSFORD, NY
PALUMBO, TAMARA ............... 11/20/2005
EAST PROVIDENCE, RI FENSKE, JOANA ..................... 11/20/2005
GOLDEN, CO
COOK, SHANNON ................... 11/20/2005 TUCSON, AZ
FLOYD, AMANDA .................... 11/20/2005 PATTERSON, ENOLA ............. 11/20/2005
FRESNO, CA
MARIETTA, MS SPRINGFIELD, IL
CRUZ, EVELYN ....................... 11/20/2005
FRANKS, SUSANN .................. 11/20/2005 PAYTON, JEAN ........................ 11/20/2005
BROOKLYN, NY
TOWN CREEK, AL GRENADA, MS
HALLMARK NURSING CEN-
TER, INC ............................... 11/20/2005 GIRARDI, DEBORAH ............... 11/20/2005 PEEPLES, DEBRA ................... 11/20/2005
SCHENECTADY, NY NAPLES, FL DINSMORE, FL
MANLAPAZ, CARLOS ............. 11/20/2005 GIROUARD, MARGARET ........ 11/20/2005 PETERS, ALONZO .................. 11/20/2005
CERRITOS, CA BEDFORD, MA HOUSTON, TX
PRIMO, ROFINO ...................... 11/20/2005 GOEPP, JULIUS ...................... 11/20/2005 RAINEY, APRIL ........................ 11/20/2005
LONDON, OH ROCHESTER, NY DAYTON, NV
SANDY, ANJI ........................... 11/20/2005 GOODLUCK-JONES, KANDY 11/20/2005 RICHARD, MARY ..................... 11/20/2005
MCLOUD, OK PHOENIX, AZ SPRINGFIELD, IL
YOUNG, LAKEYSHA ............... 11/20/2005 GULLEDGE, WILLIAM ............. 11/20/2005 SANDS, VANESSA .................. 11/20/2005
MONTGOMERY, AL MOUNDVILLE, AL PHOENIX, AZ
HANSON, ROBIN ..................... 11/20/2005 SCALLY, MICHAEL .................. 11/20/2005
CONVICTION FOR HEALTH CARE FRAUD LOGANSPORT, LA HOUSTON, TX
HARRIS, KANDY ...................... 11/20/2005 SCHIRMER, BARBARA ........... 11/20/2005
BROWNING, MISTY ................ 11/20/2005 MAYFIELD, KY DUDLEY, NC
WALLKER, LA HAVARD, REBA ....................... 11/20/2005 SCHWARTZ, MONTY .............. 11/20/2005
JUNKINS, MICHELLE .............. 11/20/2005 MOBILE, AL OAKLAND, FL
HAMPTON, ME HOLLAND, ANNISSA ............... 11/20/2005 SHAFFER, CYNTHIA ............... 11/20/2005
SPOTWOOD, JEFFREY .......... 11/20/2005 MILLRY, AL CLEARWATER, FL
VERNON, TX JOHNSON, ROSIE ................... 11/20/2005 SINDERS, DONITTA ................ 11/20/2005
HATTIESBURG, MS DUGGER, IN
LICENSE REVOCATION/SUSPENSION/ JONES, CINDY ........................ 11/20/2005
STREETER, WILBERT ............ 11/20/2005
SURRENDERED LONE WOLF, OK
TOPEKA, IN
KASH, CONNIE ........................ 11/20/2005
ABBINANTE, ROBIN ................ 11/20/2005 URSIDA, JOSEPH .................... 11/20/2005
CAMPTON, KY
MADISON, AL KINCHEN, STACEY ................. 11/20/2005 ALIQUIPPA, PA
ALOISI, MARTHA ..................... 11/20/2005 NEW BERLIN, WI VOIT, SHARON ........................ 11/20/2005
WORCESTER, MA KROL, GERALD ....................... 11/20/2005 DWIGHT, IL
ANDREWS, TRACIE ................ 11/20/2005 EVERGREEN PARK, IL WARD, TINIKA ......................... 11/20/2005
ORMOND BEACH, FL LANDRUM, DEBORAH ............ 11/20/2005 HATTIESBURG, MS
BAIRD, TIMOTHY .................... 11/20/2005 FT MYERS, FL WEISS, LEENA ........................ 11/20/2005
PARKERS LAKE, KY LONGWOOD MASSAGE AND MERRITT ISLAND, FL
BILODEAU, JOHN .................... 11/20/2005 TANNING STUDIO ............... 11/20/2005 WILLIAMS, LEANNE ................ 11/20/2005
HOOKSETT, NH LONGWOOD, FL TUPELO, MS
BRINSER, STACEY ................. 11/20/2005 LOPEZ, LISA ............................ 11/20/2005 WILLIAMS, SUSAN .................. 11/20/2005
PINETOP, AZ WILDWOOD, FL WAKE FOREST, NC
CARTER, BRENDA .................. 11/20/2005 MABE, MARY ........................... 11/20/2005 WILMSHURST, SANDRA ........ 11/20/2005
HOOVER, AL LAKE FOREST, CA VAN NUYS, CA
CAUDILL, TAMMY ................... 11/20/2005 MACKEY, CHARLOTTE ........... 11/20/2005 WOODALL, JOHN .................... 11/20/2005

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68468 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices

Effective Name of Committee: National Institute of Review Program, Division of Extramural


Subject name/address Diabetes and Digestive and Kidney Diseases Activities, National Institutes of Health/
date
Special Emphasis Panel; Program Project NIAID, 6700B Rockledge Drive, MSC 7616,
PARIS, KY Review Meeting. Bethesda, MD 20892, (301) 451–3679,
Date: December 5, 2005. diazl@niaid.nih.gov.
OWNED/CONTROLLED BY CONVICTED Time: 8 a.m. to 2 p.m. (Catalogue of Federal Domestic Assistance
ENTITIES Agenda: To Review and evaluate grant Program Nos. 93.855, Allergy, Immunology,
applications. and Transplantation Research; 93.856,
INTEGRITY OXYGEN & MED- Place: Hyatt Arlington, 1325 Wilson Microbiology and Infectious Diseases
ICAL EQUIPMENT, INC ....... 11/20/2005 Boulevard, Arlington, VA 22209. Research, National Institutes of Health, HHS)
SHREVEPORT, LA Contact Person: John F. Connaughton,
JACKSONVILLE HEALTH PhD., Scientific Review Administrator, Dated: November 2, 2005.
CARE SYSTEMS INC .......... 11/20/2005 Review Branch, DEA, NIDDK, National Anne Snouffer,
JACKSONVILLE, FL Institutes of Health, Room 757, 6707 Acting Director, Office of Federal Advisory
OK MEDICAL EQUIPMENT & Democracy Boulevard, Bethesda, MD 20892– Committee Policy.
SUPPLY COMPANY LLC ..... 11/20/2005 5452. (301) 594–7797,
[FR Doc. 05–22480 Filed 11–9–05; 8:45 am]
SOUTHFIELD, MI connaughtonj@extra.niddk.nih.gov.
OLD TOWNE CHIROPRACTIC 11/20/2005 BILLING CODE 4140–01–M
(Catalogue of Federal Domestic Assistance
CHISAGO CITY, MN Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
DEFAULT ON HEAL LOAN 93.848, Digestive Diseases and Nutrition DEPARTMENT OF HEALTH AND
Research; 93.849, Kidney Diseases, Urology HUMAN SERVICES
ESTE-MCDONALD, JAIME ...... 11/20/2005 and Hematology Research, National Institutes
ANDOVER, MA of Health, HHS) National Institutes of Health
RATLIFF, CYNTHIA ................. 11/20/2005
APTOS, CA Dated: November 2, 2005. National Institute of Environmental
SNOW, EDDIE ......................... 11/20/2005 Anna Snouffer, Health Sciences; Amended Notice of
OAKLAND, CA Acting Director, Office of Federal Advisory Meeting
WELLMAN, FRED .................... 11/20/2005 Committee Policy.
FLORENCE, MA Notice is hereby given of a change in
WOODS, REBEKAH ................ 11/20/2005 [FR Doc. 05–22479Filed 11–9–05; 8:45 am]
the meeting of the National Institute of
LOUISVILLE, KY BILLING CODE 4140–01–M
Environmental Health Sciences Special
OWNERS OF EXCLUDED ENTITIES Emphasis Panel, November 15, 2005, 1
DEPARTMENT OF HEALTH AND p.m. to November 15, 2005, 3:30 p.m.
ZAGERMAN, RHEA ................. 11/20/2005 HUMAN SERVICES Nat. Inst. of Environmental Health
FARMINGTON HILLS, MI Sciences, Building 101, Rodbell
National Institutes of Health Auditorium, 111 T.W. Alexander Drive,
Dated: November 1, 2005. Research Triangle Park, NC, 27709
Katherine B. Petrowski,
National Institute of Allergy and which was published in the Federal
Infectious Diseases; Notice of Closed Register on October 24, 2005, FR 70 204
Director, Exclusions Staff, Office of Inspector
General.
Meeting 61464.
The meeting will be held December 6,
[FR Doc. 05–22438 Filed 11–9–05; 8:45 am] Pursuant to section 10(d) of the
2005 instead of November 15, 2005. The
BILLING CODE 4152–01–P Federal Advisory Committee Act, as
meeting is closed to the public.
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following Dated: November 2, 2005.
DEPARTMENT OF HEALTH AND meeting. Anna Snouffer,
HUMAN SERVICES The meeting will be closed to the Acting Director, Office of Federal Advisory
public in accordance with the Committee Policy.
National Institute of Diabetes and provisions set forth in sections [FR Doc. 05–22481 Filed 11–9–05; 8:45am]
Digestive and Kidney Diseases; Notice 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–M
of Closed Meeting as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the property such as patentable material, HUMAN SERVICES
Federal Advisory Committee Act, as and personal information concerning
amended (5 U.S.C. Appendix 2), notice individuals associated with the grant National Institutes of Health
is hereby given of the following applications, the disclosure of which
would constitute a clearly unwarranted National Institute of Allergy and
meeting.
The meeting will be closed to the invasion of personal privacy. Infectious Diseases; Notice of Closed
public in accordance with the Meeting
Name of Committee: Microbiology,
provisions set forth in sections Infectious Diseases and AIDS Initial Review Pursuant to section 10(d) of the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Group, Acquired Immunodeficiency Federal Advisory Committee Act, as
as amended. The grant applications and Syndrome Research Review Committee. amended (5 U.S.C. Appendix 2), notice
the discussions could disclose AIDS Research Review Committee. is hereby given of the following
confidential trade secrets or commercial Date: November 28–29, 2005. meeting.
property such as patentable material, Time: 8:30 a.m. to 5 p.m. The meeting will be closed to the
and personal information concerning Agenda: To review and evaluate grant
applications.
public in accordance with the
individuals associated with the grant Place: Latham Hotel, 3000 M Street, NW., provisions set forth in sections
applications, the disclosure of which Washington, DC 20007. 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
would constitute a clearly unwarranted Contact Person: Leyla S. Diaz, PhD, as amended. the grant applications and
invasion of personal privacy. Scientific Review Administrator, Scientific the discussions could disclose

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