6698 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘S8 Immunotoxicity Studies for Human 

Pharmaceuticals.’’ The draft guidance 

was prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance describes a weightof-evidence approach to determining 

whether additional immunotoxicity 

testing for nonbiological 

pharmaceuticals is appropriate when 

the findings from standard toxicity 

studies indicate signs of 

immunotoxicity. The draft guidance is 

intended to provide recommendations 

on nonclinical testing to identify 

compounds that have the potential to be 

immunosuppressive and guidance on a 

weight-of-evidence decision making 

approach for immunotoxicity testing.

DATES: Submit written or electronic 

comments on the draft guidance by 

April 11, 2005. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research (CDER), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857; or the Office of 

Communication, Training and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling the CBER Voice Information 

System at 1–800–835–4709 or 301–827–

1800. Send one self-addressed adhesive 

label to assist the office in processing 

your requests. Submit written comments 

on the draft guidance to the Division of 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 the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Kenneth L. 

Hastings, Center for Drug 

Evaluation and Research (HFD–

024), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

5922.

Regarding the ICH:

Michelle Limoli, Office of 

International Programs (HFG–1), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4480.

SUPPLEMENTARY INFORMATION:

I. Background

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission, 

the European Federation of 

Pharmaceutical Industries Associations, 

the Japanese Ministry of Health, Labour, 

and Welfare, the Japanese 

Pharmaceutical Manufacturers 

Association, CDER and CBER (FDA), 

and the Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations.

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization (WHO), Health Canada, 

and the European Free Trade Area.

In November 2004, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘S8 Immunotoxicity Studies for 

Human Pharmaceuticals’’ should be 

made available for public comment. The 

draft guidance is the product of the 

Safety Expert Working Group of the 

ICH. Comments about this draft 

guidance will be considered by FDA 

and the Safety Expert Working Group.

The draft guidance describes a 

weight-of-evidence approach to 

determining whether additional 

immunotoxicity testing for 

nonbiological pharmaceuticals is 

appropriate when the findings from 

standard toxicity studies indicate signs 

of immunotoxicity. The draft guidance 

provides the following: (1) 

Recommendations on nonclinical 

testing approaches to identify 

compounds which have the potential to 

be immunosuppressive and (2) guidance 

on a weight-of-evidence decision 

making approach for immunotoxicity 

testing. The primary data are from 

routine nonclinical toxicology studies 

conducted during drug development. 

Additional causes for concern that can 

affect the decision for additional 

immunotoxicity testing include the 

pharmacology of the drug, intended 

patient population, known drug class 

effects, and retention of the drug in cells 

of the immune system.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This draft guidance, when finalized, 

will represent the agency’s current 

thinking on this topic. 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 on the draft guidance. Two 

copies of mailed comments are to be 

submitted, 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.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/ohrms/dockets/

default.htm, http://www.fda.gov/cder/

guidance/index.htm, or http://

www.fda.gov/cber/publications.htm.

Dated: February 1, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–2418 Filed 2–7–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

Program Exclusions: January 2005

AGENCY: Office of Inspector General, 

HHS.

ACTION: Notice of program exclusions.

During the month of January 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 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6699

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

ABENDROTH, MICHAEL ............................................................................. FLORENCE, CO ....................................... 2/20/2005 

AKHIGBE, SAMUEL ..................................................................................... JONESVILLE, VA ..................................... 2/20/2005 

ALLCUTT, JOSEPH ..................................................................................... ALEXANDRIA, LA ..................................... 2/20/2005 

ALVARINO, MAGDA .................................................................................... MIAMI, FL ................................................. 2/20/2005 

ARMSTRONG, JONI .................................................................................... FORT SMITH, AR ..................................... 2/20/2005 

BALL, DARCY .............................................................................................. AUBURN, WA ........................................... 2/20/2005 

BAQUERIZO, MARIA ................................................................................... MIAMI, FL ................................................. 2/20/2005 

BROOKS, GLORIA ...................................................................................... RENTON, WA ........................................... 2/20/2005 

BROWN, HEATHER .................................................................................... OKLAHOMA CITY, OK ............................. 2/20/2005 

CHAMBERS, DEANA ................................................................................... DAVISON, MI ............................................ 2/20/2005 

DADYAN, GEGAM ....................................................................................... LONG BEACH, CA ................................... 2/20/2005 

DE LA VEGA, HAYDEE ............................................................................... MIAMI, FL ................................................. 2/20/2005 

DENNIE, TONY ............................................................................................ MCDONOUGH, GA .................................. 2/20/2005 

DUNN, FREDERIC ....................................................................................... GULFPORT, MS ....................................... 2/20/2005 

ETHERTON, JERAMEY ............................................................................... LEXINGTON, KY ...................................... 2/20/2005 

FALCON, CORINA ....................................................................................... DOWNEY, CA ........................................... 2/20/2005 

FIELDS, JEFFREY ....................................................................................... SAN ANTONIO, TX .................................. 2/20/2005 

FLORES, JUAN ............................................................................................ LOS ANGELES, CA ................................. 2/20/2005 

GOODMAN, GARY ...................................................................................... SHERIDAN, OR ........................................ 2/20/2005 

HARRIS, LINDA ........................................................................................... ATLANTA, GA .......................................... 2/20/2005 

HICKS, CAROLYN ....................................................................................... BENTONIA, MS ........................................ 2/20/2005 

JAMES, ALMA .............................................................................................. VALRICO, FL ............................................ 2/20/2005 

JIMENEZ, ANAY .......................................................................................... HIALEAH, FL ............................................ 2/20/2005 

JOHNSON, ROSEMARY ............................................................................. FRESNO, CA ............................................ 2/20/2005 

LEAHEY, ROBERT ...................................................................................... BEAVER, WV ........................................... 2/20/2005 

LITTLETON, DARLENE ............................................................................... CHAMPAIGN, IL ....................................... 2/20/2005 

LOPEZ, LIZZETTE ....................................................................................... MIAMI, FL ................................................. 2/20/2005 

MCKINNEY, MICHELLE .............................................................................. FAIRFIELD, OH ........................................ 2/20/2005 

MURPHY, MONICA ..................................................................................... BAKERSFIELD, CA .................................. 2/20/2005 

PARRISH, VIVIAN ........................................................................................ PORT ORANGE, FL ................................. 2/20/2005 

PEKERMAN, KONSTANTYN ....................................................................... FORT DIX, NJ .......................................... 2/20/2005 

PENA, OVIDA .............................................................................................. MIAMI, FL ................................................. 2/20/2005 

PORBEN, MIRIAM ....................................................................................... HIALEAH, FL ............................................ 2/20/2005 

PRIME CARE SERVICES, INC ................................................................... BRADFORD, PA ....................................... 2/20/2005 

QUEVEDO, IDANYS .................................................................................... HIALEAH, FL ............................................ 2/20/2005 

RODRIGUEZ, ALEXIS ................................................................................. MIAMI, FL ................................................. 2/20/2005 

RODRIGUEZ, ALFONSO ............................................................................. MIAMI, FL ................................................. 2/20/2005 

SARMIENTO, DAISY ................................................................................... MIAMI, FL ................................................. 2/20/2005 

SCHMITT, DERIL ......................................................................................... LONG BEACH, CA ................................... 2/20/2005 

ST JOHN, SAMUEL ..................................................................................... PHENIX, VA .............................................. 2/20/2005 

TEJEDA, MARIA .......................................................................................... MIAMI, FL ................................................. 2/20/2005 

TYLER, JOLIE .............................................................................................. LORIS, SC ................................................ 2/20/2005 

VELAZCO, REBECA .................................................................................... MIAMI, FL ................................................. 2/20/2005 

VIDA, ALAIN ................................................................................................. 1410 WATERLOO, BELGIUM, ................. 2/20/2005 

VILLAR, SILVIA ............................................................................................ MIAMI, FL ................................................. 2/20/2005 

YANES, REGLA ........................................................................................... MIAMI, FL ................................................. 2/20/2005 

FELONY CONVICTION FOR HEALTH CARE FRAUD

BLEGGI, NICOLA ......................................................................................... LIVONIA, MI .............................................. 2/20/2005 

CARDENAS, KIMBERLY ............................................................................. LA PORTE, TX ......................................... 2/20/2005 

COTA, PETER ............................................................................................. MADISON, OH .......................................... 2/20/2005 

DIAMOND-RILEY, ANGELA ........................................................................ CHICAGO, IL ............................................ 2/20/2005 

ENGLER, KIMBERLY .................................................................................. ROBERTSVILLE, MO ............................... 2/20/2005 

FERNANDEZ, JOSE .................................................................................... OAKLAND PARK, FL ............................... 2/20/2005 

HOPKINS, WYCONDA ................................................................................ FRESNO, CA ............................................ 2/20/2005 

KLEIN, REBECCA ........................................................................................ PERRYSBURG, OH ................................. 2/20/2005 

LADD, ELLA ................................................................................................. OVERLAND PARK, KS ............................ 2/20/2005 

MANZE, PATRICK ....................................................................................... CHATHAM, NJ .......................................... 2/20/2005 

MARTIN-FREDERICK, CHARMAINE .......................................................... PALMDALE, CA ........................................ 2/20/2005 

MILLER, TONI .............................................................................................. ST JOSEPH, MO ...................................... 2/20/2005 

OBEROI, TEJBIR ......................................................................................... WHITEDEER, PA ..................................... 2/20/2005 

OYSTER, CHERYL ...................................................................................... KIRTLAND, OH ......................................... 2/20/2005 

SMITH, LISA ................................................................................................ WESTMINSTER, SC ................................ 2/20/2005 

6700 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

Subject name Address Effective date 

WINER, CLARENCE .................................................................................... KANSAS CITY, MO .................................. 2/20/2005 

FELONY CONTROL SUBSTANCE CONVICTION

BAKER, MICHAEL ....................................................................................... OCALA, FL ............................................... 2/20/2005 

BERTUCCI, PAMELA .................................................................................. METAIRIE, LA .......................................... 2/20/2005 

CARROLL, BRIDGET .................................................................................. CHESTERFIELD, MO ............................... 2/20/2005 

HOPWOOD, BECKY .................................................................................... DAYTON, WA ........................................... 2/20/2005 

JACKSON, TERI .......................................................................................... AVINGER, TX ........................................... 2/20/2005 

JACOBS, TAMIE .......................................................................................... WEST PALM BEACH, FL ......................... 2/20/2005 

MODI, KAILAS ............................................................................................. OAKWOOD, VA ........................................ 2/20/2005 

PEPPER, CHRISTI ...................................................................................... CADIZ, KY ................................................ 2/20/2005 

PORTALATIN, MICHELE ............................................................................. FLORISSANT, MO ................................... 2/20/2005 

PATIENT ABUSE/NEGLECT CONVICTIONS

BALL, SANDRA ............................................................................................ BROOKHAVEN, MS ................................. 2/20/2005 

BELLANTON, JUDITH ................................................................................. WOODSTOCK, GA ................................... 2/20/2005 

BYNEM, SHAKESHA ................................................................................... GILBERT, SC ........................................... 2/20/2005 

CRAWFORD, PHILIP ................................................................................... VILLAGE OF PALMETTO BAY, FL ......... 2/20/2005 

EVANS, BRIAN ............................................................................................ FONTANA, CA .......................................... 2/20/2005 

EVANS, THOMAS ........................................................................................ RIENZI, MS ............................................... 2/20/2005 

GONZALEZ, ERNESTO ............................................................................... TORRINGTON, WY .................................. 2/20/2005 

GREENE, MARY .......................................................................................... SACRAMENTO, CA ................................. 2/20/2005 

HUNTER, FRANK ........................................................................................ BRIDGETON, NJ ...................................... 2/20/2005 

MANDOLESI, MICHAEL .............................................................................. LONDON, OH ........................................... 2/20/2005 

MCCRAY, RHONDA .................................................................................... SHREVEPORT, LA ................................... 2/20/2005 

NEACE, DARLENE ...................................................................................... CYNTHIANA, KY ...................................... 2/20/2005 

OWENS, BUDDY ......................................................................................... SOMERSET, KY ....................................... 2/20/2005 

PADGETT, TAMEKIA ................................................................................... BATESBURG, SC ..................................... 2/20/2005 

PAVIA, DAILLYN .......................................................................................... GRANITE CITY, IL ................................... 2/20/2005 

SANDIFER, TERESA ................................................................................... GREENWOOD, MS .................................. 2/20/2005 

SLAVNEY, KENNETH .................................................................................. FRESNO, CA ............................................ 2/20/2005 

THOMAS, TAMIKA ....................................................................................... EAST CLEVELAND, OH .......................... 2/20/2005 

WATTS, WARDELL ..................................................................................... CINCINNATI, OH ...................................... 2/20/2005 

LICENSE REVOCATION/SUSPENSION/SURRENDERED

ADAMS, JO .................................................................................................. VIRGIE, KY ............................................... 2/20/2005 

ALBRITTON, CYNTHIA ............................................................................... BOYNTON BEACH, FL ............................ 2/20/2005 

AMES, DIANNE ............................................................................................ BRYAN, TX ............................................... 2/20/2005 

ARNOLD, LISA ............................................................................................. WEST PALM BEACH, FL ......................... 2/20/2005 

ATENCIO, SALLY ........................................................................................ HENDERSON, NV .................................... 2/20/2005 

ATWOOD-ALDEN, DONNA ......................................................................... NEWBURYPORT, MA .............................. 2/20/2005 

AUTHELET, JERILYN .................................................................................. WARREN, RI ............................................ 2/20/2005 

BAILEY, CHERYL ........................................................................................ SPARKS, NV ............................................ 2/20/2005 

BAUKNIGHT, POLLA ................................................................................... BELLEVUE, WA ....................................... 2/20/2005 

BINGHAM, NATHANIEL .............................................................................. CHICAGO, IL ............................................ 2/20/2005 

BLANTON, EBONY ...................................................................................... PALMDALE, CA ........................................ 2/20/2005 

BOUTROS, SAMIR ...................................................................................... BRIARWOOD, NY .................................... 2/20/2005 

BOWLING, SARAH ...................................................................................... JACKSON, KY .......................................... 2/20/2005 

CALLERAME, WILLIAM ............................................................................... LARGO, FL ............................................... 2/20/2005 

CAMPBELL, CHRISTINE ............................................................................. EVERETT, WA ......................................... 2/20/2005 

CHANEY, CINDY ......................................................................................... HAMILTON, OH ........................................ 2/20/2005 

CHEATHAM, DOUGLAS .............................................................................. PHOENIX, AZ ........................................... 2/20/2005 

COMBS, JOYCE .......................................................................................... HAZARD, KY ............................................ 2/20/2005 

CORDELL, KIMBERLY ................................................................................ ARITON, AL .............................................. 2/20/2005 

COX, CASEY ............................................................................................... BARDSTOWN, KY .................................... 2/20/2005 

COX, HILDA ................................................................................................. DORA, AL ................................................. 2/20/2005 

CRIST-LEGG, BARBARA ............................................................................ WESTERVILLE, OH ................................. 2/20/2005 

CRUZ, VANIDY ............................................................................................ NEW BEDFORD, MA ............................... 2/20/2005 

DELACRUZ BROWN, JENNIFER ............................................................... CENTRAL FALLS, RI ............................... 2/20/2005 

DIAZ, MAGDALENA ..................................................................................... HOUSTON, TX ......................................... 2/20/2005 

DORAN, MICHAEL ...................................................................................... MOUNT VERNON, WA ............................ 2/20/2005 

EDDINGS, JOLENE ..................................................................................... SILVER SPRINGS, NV ............................. 2/20/2005 

FERNANDES, SHARON .............................................................................. ARCADIA, FL ............................................ 2/20/2005 

FLANDERS, CHERYL .................................................................................. WILLOUGHBY HILLS, OH ....................... 2/20/2005 

FORD, KAYLA .............................................................................................. KILLEN, AL ............................................... 2/20/2005 

FREE, MICHAEL .......................................................................................... LANSING, IL ............................................. 2/20/2005 

FULLMAN, LINDA ........................................................................................ MIDFIELD, AL ........................................... 2/20/2005 

FUQUA, LYNN ............................................................................................. TONEY, AL ............................................... 2/20/2005 

GABALDON, JENNIFER .............................................................................. FLAGSTAFF, AZ ...................................... 2/20/2005 

GALINDO, VIOLET ...................................................................................... PEORIA, AZ .............................................. 2/20/2005 

GILLEY, VICKIE ........................................................................................... VERBENA, AL .......................................... 2/20/2005 

Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 6701

Subject name Address Effective date 

GINN, DAVID ............................................................................................... COCKEYSVILLE, MD ............................... 2/20/2005 

GLOYD, JASON ........................................................................................... HEBRON, OH ........................................... 2/20/2005 

GLUSCHKE, REGINA .................................................................................. POMPANO BEACH, FL ............................ 2/20/2005 

GOMEZ, ALVERA ........................................................................................ LAKE HAVASU, AZ .................................. 2/20/2005 

GREEN, KARMEN ....................................................................................... HOLYOKE, MA ......................................... 2/20/2005 

GREEN, PRISCILLA .................................................................................... QUINCY, FL .............................................. 2/20/2005 

GREER, KAREN .......................................................................................... GREENEVILLE, TN .................................. 2/20/2005 

GUARA, ANTHONY ..................................................................................... DENVER, CO ........................................... 2/20/2005 

HARDIN, SUSAN ......................................................................................... LAWRENCEBURG, KY ............................ 2/20/2005 

HARDY, JERI ............................................................................................... PORTER, TX ............................................ 2/20/2005 

HARRIS, LINC .............................................................................................. BASTROP, TX .......................................... 2/20/2005 

HAYES, WILEY ............................................................................................ LOCKPORT, IL ......................................... 2/20/2005 

HEATH, RICHARD ....................................................................................... ALAMEDA, CA .......................................... 2/20/2005 

HERNANDEZ, REBECCA ............................................................................ CRESTWOOD, KY ................................... 2/20/2005 

HIGHTOWER, ANNIE .................................................................................. TUSKEGEE, AL ........................................ 2/20/2005 

HINDS, WILLIAM ......................................................................................... SODDY DAISY, TN .................................. 2/20/2005 

HINOJOSA, MARIA ...................................................................................... TEMECULA, CA ....................................... 2/20/2005 

HOWARD, ANNA ......................................................................................... PORT ARTHUR, TX ................................. 2/20/2005 

JENRETTE, VICKY ...................................................................................... SUMMERVILLE, SC ................................. 2/20/2005 

JENSEN, TAMMER ...................................................................................... RIVERSIDE, CA ....................................... 2/20/2005 

JONES, KRISTINE ....................................................................................... HUNTSVILLE, AL ..................................... 2/20/2005 

KANATZAR, MONTI ..................................................................................... NICHOLASVILLE, KY ............................... 2/20/2005 

KERR, SHEILA ............................................................................................. OLIVE BRANCH, MS ............................... 2/20/2005 

KLEIN, GALE ............................................................................................... OLALLA, WA ............................................ 2/20/2005 

KLIMAS, RICHARD ...................................................................................... HUNTSVILLE, AL ..................................... 2/20/2005 

LANE, GREGORY ........................................................................................ BAKERSFIELD, CA .................................. 2/20/2005 

LAZARRE, SANDRA .................................................................................... FT LAUDERDALE, FL .............................. 2/20/2005 

LEONARD, JUDITH ..................................................................................... LONG BRANCH, NJ ................................. 2/20/2005 

LIPSCHUTZ, HOWARD ............................................................................... WYNNEWOOD, PA .................................. 2/20/2005 

LOMAX, AVERY ........................................................................................... ONTARIO, CA .......................................... 2/20/2005 

LUCIANO, CHERYLANNE ........................................................................... ATLANTIC BEACH, FL ............................. 2/20/2005 

LUNA, TRACY .............................................................................................. SPOKANE, WA ......................................... 2/20/2005 

MCCORMICK, NATALIE .............................................................................. INDIANAPOLIS, IN ................................... 2/20/2005 

MEYER, JAMES ........................................................................................... LITTLE ROCK, AR ................................... 2/20/2005 

MOLINAR, ARTHUR .................................................................................... GLENDALE, AZ ........................................ 2/20/2005 

MONTECINO, DOUGLAS ............................................................................ MARRERO, LA ......................................... 2/20/2005 

MOORE, JANICE ......................................................................................... JACKSONVILLE, FL ................................. 2/20/2005 

NAVARRETTE, MARY ................................................................................. EL PASO, TX ............................................ 2/20/2005 

NICOSIA, PATRICIA .................................................................................... BERWYN, IL ............................................. 2/20/2005 

PALMER, LATRICIA .................................................................................... SPRING CITY, TN .................................... 2/20/2005 

PATZ, ERIC .................................................................................................. ORLANDO, FL .......................................... 2/20/2005 

PERRI, JODIE .............................................................................................. BENSALEM, PA ....................................... 2/20/2005 

PITTS, ROCHELLE ...................................................................................... PENSACOLA, FL ...................................... 2/20/2005 

POMONIS, LILLIAN ..................................................................................... MESA, AZ ................................................. 2/20/2005 

POTTER, NICOLE ....................................................................................... W WARWICK, RI ...................................... 2/20/2005 

PRESTON, ROBERT ................................................................................... YOUNGTOWN, AZ ................................... 2/20/2005 

PRINTZ, BRUCE .......................................................................................... WESTFIELD, NJ ....................................... 2/20/2005 

RICE, TONI .................................................................................................. CRESTVIEW, FL ...................................... 2/20/2005 

RILES, RACHEL .......................................................................................... MOCKSVILLE, NC .................................... 2/20/2005 

ROAN, RHONDA ......................................................................................... MONROE, LA ........................................... 2/20/2005 

ROEDERSHEIMER, MARCY ....................................................................... ROCKPORT, TX ....................................... 2/20/2005 

RUIZ, MIREYA ............................................................................................. TUCSON, AZ ............................................ 2/20/2005 

RYAN, MICHAEL ......................................................................................... EL MIRAGE, AZ ....................................... 2/20/2005 

SAUCEDA, MICHELLE ................................................................................ ARLINGTON, TX ...................................... 2/20/2005 

SCOTT, JIMMY ............................................................................................ CUMBERLAND, KY .................................. 2/20/2005 

SEDGWICK, DONNA ................................................................................... SPOKANE, WA ......................................... 2/20/2005 

SHEPHERD, LORETTA ............................................................................... ABERDEEN, OH ....................................... 2/20/2005 

SMITH, ANGELINE ...................................................................................... ORLANDO, FL .......................................... 2/20/2005 

SMITH, JANET ............................................................................................. POLO, IL ................................................... 2/20/2005 

SMITH, LETICIA ........................................................................................... SURPRISE, AZ ......................................... 2/20/2005 

SMITH, MEON ............................................................................................. LANCASTER, CA ..................................... 2/20/2005 

SMOOT, MARY ............................................................................................ PHILADELPHIA, PA ................................. 2/20/2005 

STUBBLEFIELD, MARQUETTA .................................................................. NICHOLASVILLE, KY ............................... 2/20/2005 

SWARTZ, PAUL ........................................................................................... LAFAYETTE, IN ........................................ 2/20/2005 

TANNER, PATTI .......................................................................................... BARLOW, KY ........................................... 2/20/2005 

TREADWELL, DIANE .................................................................................. WARE, MA ................................................ 2/20/2005 

TRUJILLO, RAFAEL .................................................................................... SUNLAND, CA .......................................... 2/20/2005 

VELEZ, LABONNIA ...................................................................................... CLOVIS, CA .............................................. 2/20/2005 

VERA, MIRIAM ............................................................................................. PORT ST LUCIE, FL ................................ 2/20/2005 

WALSH, PATRICIA ...................................................................................... WALTHAM, MA ........................................ 2/20/2005 

WALTERS, PATRICIA ................................................................................. SUWANEE, GA ........................................ 2/20/2005 

WATSON, MARTHA .................................................................................... MAYSLICK, KY ......................................... 2/20/2005 

WEISSMAN, ARTHUR ................................................................................. BUFFALO, NY .......................................... 2/20/2005 

WELBORN, VELVET ................................................................................... FULTON, MS ............................................ 2/20/2005 

6702 Federal Register / Vol. 70, No. 25 / Tuesday, February 8, 2005 / Notices 

Subject name Address Effective date 

WETTEROW, MELANIE .............................................................................. PHOENIX, AZ ........................................... 2/20/2005 

WHITE, SEAN .............................................................................................. GLENDALE, AZ ........................................ 2/20/2005 

WHITTENTON, ANGELA ............................................................................. COATS, NC .............................................. 2/20/2005 

WILD, LISA ................................................................................................... COLUMBIA, CT ........................................ 2/20/2005 

WILLIAMS, PATRICIA .................................................................................. ANNANDALE, VA ..................................... 2/20/2005 

WILLIAMS, WARREN .................................................................................. OAKLAND, CA .......................................... 2/20/2005 

WOOLLEY, TODD ....................................................................................... OLYMPIA, WA .......................................... 2/20/2005 

ZIBA, GRACE ............................................................................................... LOMA LINDA, CA ..................................... 2/20/2005 

FRAUD/KICKBACKS/PROHIBITED ACTS/SETTLEMENT AGREEMENTS

GLANZER, ELROY ...................................................................................... IDAHO FALLS, ID ..................................... 2/18/2004 

OWNED/CONTROLLED BY CONVICTED ENTITIES

MONTECINO’S DRUGS, INC ...................................................................... MARRERO, LA ......................................... 2/20/2005

VALLEY COUNTRY CARE .......................................................................... EDEN VALLEY, MN ................................. 2/20/2005 

DEFAULT ON HEAL LOAN

BUKOWSKI, TODD ...................................................................................... WASHINGTON, DC .................................. 11/19/2004 

MANRIQUEZ, ANTONIO ............................................................................. COACHELLA, CA ..................................... 2/20/2005 

RICHARDS, JOHN ....................................................................................... WASHINGTON, DC .................................. 2/20/2005 

Dated: February 1, 2005. 

Katherine B. Petrowski, 

Director, Exclusions Staff, Office of Inspector 

General.

[FR Doc. 05–2369 Filed 2–7–05; 8:45 am] 

BILLING CODE 4150–04–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing

AGENCY: National Institutes of Health, 

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing.

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Methods for Treating Active Uveitis 

Robert Nussenblatt (NEI) and Thomas 

Waldmann (NCI), Zhuqing Li (NEI), 

Ronald Buggage (NEI). U.S. Provisional Patent Application No. 

60/616,760 filed 06 Oct 2004 (DHHS 

Reference No. E–328–2004/0–US–01). 

Licensing Contact: Susan Carson; 301/

435–5020; carsonsu@mail.nih.gov.

Intraocular inflammatory disease 

(uveitis) is characterized by pain and a 

decrease in vision that can lead to 

blindness if not treated appropriately. 

The incidence and prevalence of the 

disease are approximately 52/100,000 

and 112/100,000, and this translates 

into an incidence of 151,000 per year 

and a prevalence of 322,000. The 

numbers are expected to increase as the 

population ages. Treatment of severe 

uveitis often focuses on the control of 

the inflammatory symptoms using high 

dose corticosteroids, cytotoxic drugs or 

other immunosuppressive agents and 

there is a need for therapies that reduce 

the major side effects associated with 

the prolonged use of systemic steroids 

(e.g. hyperglycemia, osteoporosis and 

loss of immunocompetence). 

Daclizumab is a humanized anti-Tac 

(HAT) antibody that specifically binds 

to the alpha subunit (CD25 or Tac 

subunit) of the human high affinity 

interleukin-2 (IL–2) receptor expressed 

on the surface of activated lymphocytes. 

Dr. Nussenblatt and colleagues at the 

NEI have previously shown that 

daclizumab can be used to successfully 

treat quiescent uveitis. Long term 

daclizumab therapy at a dose of 1mg/kg 

can be used instead of standard 

immunosuppressive agents to treat 

severe uveitis for more than 4 years with 

no adverse effects attributable to the 

medication, and subcutaneously 

administered daclizumab also appeared 

to be clinically effective. However, 

subjects with active uveitis were less 

likely under this regimen to have their 

disease controlled (J. Autoimmunity 

(2003) 21, 283–293). 

The present invention targets patients 

with refractory, active uveitis and 

consists of a high dose intravenous 

induction therapy using daclizumab at 

two different doses and times followed 

by a longer term maintenance therapy. 

Positive therapeutic effects have been 

seen with this protocol in a small group 

of patients within 4–6 weeks after the 

initiation of therapy. As previous work 

indicated that IL–2R receptors have a 

slow turnover rate on CD4 positive 

subpopulation of lymphocytes, a 

possible mechanism of action of this 

new protocol is saturation of CD25 

(TAC) receptors on cells in sequestered 

sites. 

Available for licensing are methods 

directed to this treatment of active 

uveitis using a high dose pulsatile 

induction protocol of an interleukin-2 

(Il–2) receptor antagonist. Methods are 

also provided for the treatment of 

corneal transplant rejection, limbal stem 

cell rejection following transplantation, 

optic neuritis and dry eye. 

Novel Thermostable Y-Family DNA 

Polymerases 

Roger Woodgate (NICHD), John P. 

McDonald (NICHD), and Wei Yang 

(NIDDK). 

U.S. Provisional Patent Application No. 

60/573,684 filed 20 May 2004 (DHHS 

Ref No. E–166–2004/0–US–01); U.S. 

Provisional Patent Application No. 

60/623, 490 filed 29 Oct 2004 (DHHS 

Ref No. E–166–2004/1–US–01).