68466 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 

of medical devices; (2) promote 

technological innovation; and (3) 

facilitate international trade. GHTF 

provides further information concerning 

the structure, goals, and procedures at 

the GHTF Web site and can be accessed 

at http://ghtf.org. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s Good Guidance 

Practice (GGP) regulation (21 CFR 

10.115). The guidance represents the 

agency’s current thinking on the GHTF 

recommendations as related to 

premarket submission to FDA. 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 statute and regulations. 

III. Electronic Access 

To receive a copy of ‘‘A Pilot Program 

to Evaluate a Proposed Globally 

Harmonized Alternative for Premarket 

Procedures; Guidance for Industry and 

FDA Staff,’’ by fax call CDRH Facts-OnDemand system at 800–899–0381 or 

301–827–0111 from a touch-tone 

telephone. Press 1 to enter the system. 

At the second voice prompt press 1 to 

order a document. Enter the document 

number (1347) followed by the pound 

sign #. Follow the remaining voice 

prompts to complete your request. 

To receive ‘‘A Pilot Program to 

Evaluate a Proposed Globally 

Harmonised Alternative for Premarket 

Procedures; Guidance for Industry and 

FDA Staff,’’ you may either send a fax 

request to 301–443–8818 to receive a 

hard copy of the document, or send an 

e-mail request to gwa@cdrh.fda.gov to 

receive a hard copy or an electronic 

copy. Please use the document number 

1347 to identify the guidance you are 

requesting. 

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes: Device safety 

alerts, Federal Register reprints, 

information on premarket submissions 

(including lists of approved applications 

and manufacturers’ addresses), small 

manufacturer’s, information on video 

conferencing, and electronic 

submissions, Mammography Matters, 

and other device-related information. 

The CDRH web site home page may be 

accessed at http://www.fda.gov/cdrh. A 

search capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. 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. Comments 

received may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: November 2, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22387 Filed 11–9–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

Program Exclusions: October 2005 

AGENCY: Office of Inspector General, 

HHS. 

ACTION: Notice of program exclusions. 

During the month of October 2005, 

the HHS Office of Inspector General 

imposed exclusions in the cases set 

forth below. When an exclusion is 

imposed, no program payment is made 

to anyone for any items or services 

(other than an emergency item or 

service not provided in a hospital 

emergency room) furnished, ordered or 

prescribed by an excluded party under 

the Medicare, Medicaid, and all Federal 

Health Care programs. In addition, no 

program payment is made to any 

business or facility, e.g., a hospital, that 

submits bills for payment for items or 

services provided by an excluded party. 

Program beneficiaries remain free to 

decide for themselves whether they will 

continue to use the services of an 

excluded party even though no program 

payments will be made for items and 

services provided by that excluded 

party. The exclusions have national 

effect and also apply to all Executive 

Branch procurement and nonprocurement programs and activities. 

Subject name/address Effective 

date 

PROGRAM-RELATED CONVICTIONS 

ADAIR, KARISTA ..................... 11/20/2005 

LEWISBURG, TN 

AUSTIN, HOWARD .................. 11/20/2005 

OAKDALE, LA 

BAILEY, LAWRENCE ............... 11/20/2005 

SHREVEPORT, LA 

BESAW NALEN, KIMBERLY ... 11/20/2005 

MANCHESTER, NH 

BLACK, ANTONIA .................... 11/20/2005 

FLINT, TX 

CONVENIENT DENTAL CARE 

CENTER, PC ........................ 11/20/2005 

OKEMOS, MI 

DE LA CRUZ, ALFONSO ......... 11/20/2005 

LOS ANGELES, CA 

ERLICH, RUSSELL .................. 11/20/2005 

BROOKLYN, NY 

FLORES, SILVIA ...................... 11/20/2005 

ONTARIO, CA 

GARCIA, ROSEMARIE ............ 11/20/2005 

SAN DIEGO, CA 

HAMILTON BENNETT, 

MAISHA ................................ 11/20/2005 

CHICAGO, IL 

HAWKINS, KIMBERLY ............. 11/20/2005 

SHAKOPEE, MN 

HERNANDEZ, KAREN ............. 11/20/2005 

OKLAHOMA CITY, OK 

KATZ, RONALD ....................... 11/20/2005 

OTISVILLE, NY 

KEMMETT, BARBARA ............. 11/20/2005 

BRIDGEWATER, MA 

KUBRICKY, MARK ................... 11/20/2005 

OGDEN, UT 

LAKHTER, ALEXANDER ......... 11/20/2005 

E STROUDSBURG, PA 

LEBEL, ALEXANDER ............... 11/20/2005 

BROOKLYN, NY 

LEEDS, LORI ........................... 11/20/2005 

SHAKOPEE, MN 

LITTLE, MARK ......................... 11/20/2005 

ANTHONY, TX 

MALVAREZ, NORBERTO ........ 11/20/2005 

MIAMI, FL 

MARTINEZ, CESAR ................. 11/20/2005 

MIAMI, FL 

MORAN, PAT ........................... 11/20/2005 

WICHITA FALLS, TX 

SHUMATE, TAMMY ................. 11/20/2005 

LOUISVILLE, KY 

UTUK, BECALO ....................... 11/20/2005 

BRYAN, TX 

VU, PHOUA .............................. 11/20/2005 

SAN DIEGO, CA 

WALLACE, SHIRLEY ............... 11/20/2005 

JONESBORO, AR 

WILLIAMS-WRIGHT, MYRA .... 11/20/2005 

MIAMI, FL 

FELONY CONVICTION FOR HEALTH CARE 

FRAUD 

CHAVEZ, WILLIAM .................. 11/20/2005 

MIAMI, FL 

GONZALEZ, DUVIEL ............... 11/20/2005 

MIAMI, FL 

GORRIN, EDDY ....................... 11/20/2005 

MIAMI, FL 

KRZYS, PENNY ....................... 11/20/2005 

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

Subject name/address Effective 

date 

ASHTABULA, OH 

FELONY CONTROL SUBSTANCE 

CONVICTION 

BROWN, MARY ....................... 11/20/2005 

MARICOPA, AZ 

CASTAGNETTI, LEINA ............ 11/20/2005 

HILO, HI 

GUY, CRYSTAL ....................... 11/20/2005 

COLUMBIA, MS 

ILIADES, EMMANUEL ............. 11/20/2005 

CENTERVILLE, MA 

MASCOLO, JOSEPHINE ......... 11/20/2005 

ELMWOOD PARK, NJ 

MEHTA, DONNA ...................... 11/20/2005 

CHATTANOOGA, TN 

THATCHER, GILIE ................... 11/20/2005 

CHARLOTTESVILLE, VA 

WELCH, PAUL ......................... 11/20/2005 

EDGEFIELD, SC 

PATIENT ABUSE/NEGLECT CONVICTIONS 

ACKLEY, CHRISTINE .............. 11/20/2005 

CANON CITY, CO 

BEDDIE, ELIZABETH ............... 11/20/2005 

BURLINGTON, VT 

COLBY, DEBORAH .................. 11/20/2005 

EAST PROVIDENCE, RI 

COOK, SHANNON ................... 11/20/2005 

FRESNO, CA 

CRUZ, EVELYN ....................... 11/20/2005 

BROOKLYN, NY 

HALLMARK NURSING CENTER, INC ............................... 11/20/2005 

SCHENECTADY, NY 

MANLAPAZ, CARLOS ............. 11/20/2005 

CERRITOS, CA 

PRIMO, ROFINO ...................... 11/20/2005 

LONDON, OH 

SANDY, ANJI ........................... 11/20/2005 

MCLOUD, OK 

YOUNG, LAKEYSHA ............... 11/20/2005 

MONTGOMERY, AL 

CONVICTION FOR HEALTH CARE FRAUD 

BROWNING, MISTY ................ 11/20/2005 

WALLKER, LA 

JUNKINS, MICHELLE .............. 11/20/2005 

HAMPTON, ME 

SPOTWOOD, JEFFREY .......... 11/20/2005 

VERNON, TX 

LICENSE REVOCATION/SUSPENSION/ 

SURRENDERED 

ABBINANTE, ROBIN ................ 11/20/2005 

MADISON, AL 

ALOISI, MARTHA ..................... 11/20/2005 

WORCESTER, MA 

ANDREWS, TRACIE ................ 11/20/2005 

ORMOND BEACH, FL 

BAIRD, TIMOTHY .................... 11/20/2005 

PARKERS LAKE, KY 

BILODEAU, JOHN .................... 11/20/2005 

HOOKSETT, NH 

BRINSER, STACEY ................. 11/20/2005 

PINETOP, AZ 

CARTER, BRENDA .................. 11/20/2005 

HOOVER, AL 

CAUDILL, TAMMY ................... 11/20/2005 

Subject name/address Effective 

date 

FLATWOODS, KY 

CAVANAUGH, TRACIE ............ 11/20/2005 

RENSSELAER, NY 

CHAN, DENNIS ........................ 11/20/2005 

SACRAMENTO, CA 

CLAYTON, MICHELLE ............. 11/20/2005 

VERNON, VT 

COLBY, JULIE .......................... 11/20/2005 

BYFIELD, MA 

CORBETT, KELLY ................... 11/20/2005 

LAGUNA BEACH, CA 

CUNNINGHAM, RICHARD ...... 11/20/2005 

DAPHNE, AL 

DAVIS, LACIANA ..................... 11/20/2005 

METAIRIE, LA 

DENHALTER, MARY ............... 11/20/2005 

CLEARFIELD, UT 

DENTON, TAMMY ................... 11/20/2005 

MORTON, MS 

DINKINS, LINDA ...................... 11/20/2005 

JACKSONVILLE, FL 

DOVE, LAURA ......................... 11/20/2005 

SHREVEPORT, LA 

DUBRULE, ROSAIRE .............. 11/20/2005 

TIPTONVILLE, TN 

ECKLUND, DAN ....................... 11/20/2005 

SILVERHILL, AL 

FARCHIONE, LOUIS ................ 11/20/2005 

PITTSFORD, NY 

FENSKE, JOANA ..................... 11/20/2005 

TUCSON, AZ 

FLOYD, AMANDA .................... 11/20/2005 

MARIETTA, MS 

FRANKS, SUSANN .................. 11/20/2005 

TOWN CREEK, AL 

GIRARDI, DEBORAH ............... 11/20/2005 

NAPLES, FL 

GIROUARD, MARGARET ........ 11/20/2005 

BEDFORD, MA 

GOEPP, JULIUS ...................... 11/20/2005 

ROCHESTER, NY 

GOODLUCK-JONES, KANDY 11/20/2005 

PHOENIX, AZ 

GULLEDGE, WILLIAM ............. 11/20/2005 

MOUNDVILLE, AL 

HANSON, ROBIN ..................... 11/20/2005 

LOGANSPORT, LA 

HARRIS, KANDY ...................... 11/20/2005 

MAYFIELD, KY 

HAVARD, REBA ....................... 11/20/2005 

MOBILE, AL 

HOLLAND, ANNISSA ............... 11/20/2005 

MILLRY, AL 

JOHNSON, ROSIE ................... 11/20/2005 

HATTIESBURG, MS 

JONES, CINDY ........................ 11/20/2005 

LONE WOLF, OK 

KASH, CONNIE ........................ 11/20/2005 

CAMPTON, KY 

KINCHEN, STACEY ................. 11/20/2005 

NEW BERLIN, WI 

KROL, GERALD ....................... 11/20/2005 

EVERGREEN PARK, IL 

LANDRUM, DEBORAH ............ 11/20/2005 

FT MYERS, FL 

LONGWOOD MASSAGE AND 

TANNING STUDIO ............... 11/20/2005 

LONGWOOD, FL 

LOPEZ, LISA ............................ 11/20/2005 

WILDWOOD, FL 

MABE, MARY ........................... 11/20/2005 

LAKE FOREST, CA 

MACKEY, CHARLOTTE ........... 11/20/2005 

Subject name/address Effective 

date 

WEST HOLLYWOOD, CA 

MAESTRE, NANCY .................. 11/20/2005 

KEYSTONE HEIGHTS, FL 

MARRON, TIMOTHY ............... 11/20/2005 

APACHE JUNCTION, AZ 

MARTIN, ELIZABETH .............. 11/20/2005 

DOTHAN, AL 

MARTINEZ, SYNTHIA .............. 11/20/2005 

TYLER, TX 

MCBRIDE, MARGO ................. 11/20/2005 

ANNAPOLIS, MD 

MCCALL, STEVEN ................... 11/20/2005 

GOODYEAR, AZ 

MCCOY, TIERRA ..................... 11/20/2005 

RICHMOND, VA 

MCGEOGHEAN, ANTOINETTE 11/20/2005 

GILFORD, NH 

MCHUGH, LAURA ................... 11/20/2005 

CHELMSFORD, MA 

MCMAHON, KATHY ................. 11/20/2005 

MOSA POINT, MS 

MIRANNE, CHRISTOPHER ..... 11/20/2005 

OAKLAND, CA 

MORRIS, LAWRENCE ............. 11/20/2005 

FT LAUDERDALE, FL 

O’DAY, JAMES ......................... 11/20/2005 

CANTON, MI 

PALUMBO, TAMARA ............... 11/20/2005 

GOLDEN, CO 

PATTERSON, ENOLA ............. 11/20/2005 

SPRINGFIELD, IL 

PAYTON, JEAN ........................ 11/20/2005 

GRENADA, MS 

PEEPLES, DEBRA ................... 11/20/2005 

DINSMORE, FL 

PETERS, ALONZO .................. 11/20/2005 

HOUSTON, TX 

RAINEY, APRIL ........................ 11/20/2005 

DAYTON, NV 

RICHARD, MARY ..................... 11/20/2005 

SPRINGFIELD, IL 

SANDS, VANESSA .................. 11/20/2005 

PHOENIX, AZ 

SCALLY, MICHAEL .................. 11/20/2005 

HOUSTON, TX 

SCHIRMER, BARBARA ........... 11/20/2005 

DUDLEY, NC 

SCHWARTZ, MONTY .............. 11/20/2005 

OAKLAND, FL 

SHAFFER, CYNTHIA ............... 11/20/2005 

CLEARWATER, FL 

SINDERS, DONITTA ................ 11/20/2005 

DUGGER, IN 

STREETER, WILBERT ............ 11/20/2005 

TOPEKA, IN 

URSIDA, JOSEPH .................... 11/20/2005 

ALIQUIPPA, PA 

VOIT, SHARON ........................ 11/20/2005 

DWIGHT, IL 

WARD, TINIKA ......................... 11/20/2005 

HATTIESBURG, MS 

WEISS, LEENA ........................ 11/20/2005 

MERRITT ISLAND, FL 

WILLIAMS, LEANNE ................ 11/20/2005 

TUPELO, MS 

WILLIAMS, SUSAN .................. 11/20/2005 

WAKE FOREST, NC 

WILMSHURST, SANDRA ........ 11/20/2005 

VAN NUYS, CA 

WOODALL, JOHN .................... 11/20/2005 

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

Subject name/address Effective 

date 

PARIS, KY 

OWNED/CONTROLLED BY CONVICTED 

ENTITIES 

INTEGRITY OXYGEN & MEDICAL EQUIPMENT, INC ....... 11/20/2005 

SHREVEPORT, LA 

JACKSONVILLE HEALTH 

CARE SYSTEMS INC .......... 11/20/2005 

JACKSONVILLE, FL 

OK MEDICAL EQUIPMENT & 

SUPPLY COMPANY LLC ..... 11/20/2005 

SOUTHFIELD, MI 

OLD TOWNE CHIROPRACTIC 11/20/2005 

CHISAGO CITY, MN 

DEFAULT ON HEAL LOAN 

ESTE-MCDONALD, JAIME ...... 11/20/2005 

ANDOVER, MA 

RATLIFF, CYNTHIA ................. 11/20/2005 

APTOS, CA 

SNOW, EDDIE ......................... 11/20/2005 

OAKLAND, CA 

WELLMAN, FRED .................... 11/20/2005 

FLORENCE, MA 

WOODS, REBEKAH ................ 11/20/2005 

LOUISVILLE, KY 

OWNERS OF EXCLUDED ENTITIES 

ZAGERMAN, RHEA ................. 11/20/2005 

FARMINGTON HILLS, MI 

Dated: November 1, 2005. 

Katherine B. Petrowski, 

Director, Exclusions Staff, Office of Inspector 

General. 

[FR Doc. 05–22438 Filed 11–9–05; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Program Project 

Review Meeting. 

Date: December 5, 2005. 

Time: 8 a.m. to 2 p.m. 

Agenda: To Review and evaluate grant 

applications. 

Place: Hyatt Arlington, 1325 Wilson 

Boulevard, Arlington, VA 22209. 

Contact Person: John F. Connaughton, 

PhD., Scientific Review Administrator, 

Review Branch, DEA, NIDDK, National 

Institutes of Health, Room 757, 6707 

Democracy Boulevard, Bethesda, MD 20892–

5452. (301) 594–7797, 

connaughtonj@extra.niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: November 2, 2005. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–22479Filed 11–9–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group, Acquired Immunodeficiency 

Syndrome Research Review Committee. 

AIDS Research Review Committee. 

Date: November 28–29, 2005. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Latham Hotel, 3000 M Street, NW., 

Washington, DC 20007. 

Contact Person: Leyla S. Diaz, PhD, 

Scientific Review Administrator, Scientific 

Review Program, Division of Extramural 

Activities, National Institutes of Health/ 

NIAID, 6700B Rockledge Drive, MSC 7616, 

Bethesda, MD 20892, (301) 451–3679, 

diazl@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: November 2, 2005. 

Anne Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–22480 Filed 11–9–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Amended Notice of 

Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Environmental Health Sciences Special 

Emphasis Panel, November 15, 2005, 1 

p.m. to November 15, 2005, 3:30 p.m. 

Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell 

Auditorium, 111 T.W. Alexander Drive, 

Research Triangle Park, NC, 27709 

which was published in the Federal 

Register on October 24, 2005, FR 70 204 

61464. 

The meeting will be held December 6, 

2005 instead of November 15, 2005. The 

meeting is closed to the public. 

Dated: November 2, 2005. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–22481 Filed 11–9–05; 8:45am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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