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Code · REGISTER · 2006-07-18 · Food and Drug Administration, HHS · Notices

Notices. Notice

3,477 words·~16 min read·/register/2006/07/18/06-6262

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0169] Guidance on Useful Written Consumer Medication Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a guidance entitled “Useful Written Consumer Medication Information (CMI).” CMI is written information developed for consumers about prescription drugs that is distributed to consumers when they have prescriptions filled. The guidance discusses general issues and makes recommendations on the content of useful written CMI. DATES: Submit written or electronic comments on agency guidance at any time ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 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, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling the Center for Biologics Evaluation and Research at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist the offices in processing your request. 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 the guidance document. FOR FURTHER INFORMATION CONTACT: Paul Seligman, Center for Drug Evaluation and Research (HFD-001), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5620. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance entitled “Useful Written Consumer Medication Information (CMI).” This guidance is intended to assist individuals or organizations (e.g., pharmacies, private vendors, healthcare associations) in developing useful written consumer medication information to comply with Public Law 104-180. CMI is written information about prescription drugs developed by organizations or individuals, other than a drug's manufacturer, that is intended for distribution to consumers at the time of dispensing. Since neither FDA nor the drug's manufacturer reviews or approves CMI, FDA recommends that the developers of written medication information use the factors discussed in this guidance to help ensure that their CMI is useful to consumers. In the **Federal Register** of May 26, 2005 (70 FR 30467) (the May 2005 guidance), FDA announced the availability of a draft version of this guidance. The May 2005 guidance gave interested persons an opportunity to submit comments through July 25, 2005. All comments received during the comment period have been carefully reviewed and incorporated in this revised guidance where appropriate. As a result of the public comment, we hope that the guidance is clearer and more concise than the draft version. 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 useful written CMI. 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 paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* , *http://www.fda.gov/cber/guidelines.htm* , or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: July 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11329 Filed 7-17-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Program Exclusions: June 2006 AGENCY: Office of Inspector General, HHS. ACTION: Notice of program exclusions. During the month of June 2006, 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 non-procurement programs and activities. Subject name Address Effective date PROGRAM-RELATED CONVICTION AHGOON, BARNEY FLORENCE, AZ 7/20/2006 AMEY, CONNIE FOREST GROVE, OR 7/20/2006 ANAYOOR, ABDUL HOWELL, NJ 7/20/2006 ANTOINE, MIRIAM NEW ORLEANS, LA 6/21/2004 ASHIEDU, CHUKWINWEIKE WILMINGTON, DE 7/20/2006 BADRYAN, ARUTYUN AURORA, CO 7/20/2006 BARCELO, LEMAY MIAMI, FL 7/20/2006 BOVA, SOFIA ENCINO, CA 7/20/2006 BROWN, TAMMY SALINA, KS 7/20/2006 COLINA, BARBARA HIALEAH, FL 7/20/2006 COUNTRYMAN, CHRISTAL SALINA, KS 7/20/2006 CUETARA, LUIS MIAMI, FL 7/20/2006 CUETARA, NERY MIAMI, FL 7/20/2006 DAY, MARNIE SPOKANE VALLEY, WA 7/20/2006 DELGADO, HUMBERTO MIAMI, FL 7/20/2006 DEONARINE, DENIS DORAL, FL 7/20/2006 DIAZ, ALBERTO MIAMI, FL 7/20/2006 DOMINGUEZ, GRACIELA PURCELL, OK 7/20/2006 DORSEY, CRICHELLE NATCHITOCHES, LA 7/20/2006 DUNCAN, HOWARD SABETHA, KS 7/20/2006 EDLIN, CHERYL SPOKANE, WA 7/20/2006 EVANS, ANNIS GLIDE, OR 7/20/2006 FAMILY HOME HEALTH SERVICES BURLINGAME, CA 7/8/2003 FERRER, CARLOS MURRIETA, CA 7/20/2006 FLETCHER, YVONNE LULING, TX 7/20/2006 FULLER, JANICE MUSKOGEE, OK 7/20/2006 HEVIA, ANTONIO MIAMI, FL 7/20/2006 HUYNH, THUY SPRING, TX 7/20/2006 KOELLERMEIER, KELLY ALBANY, OR 7/20/2006 KOMAKI, KEITH ANAHEIM, CA 7/20/2006 KUN, ERIC SAN GABRIEL, CA 7/20/2006 LEAVITT, KAREN POCATELLO, ID 7/20/2006 LOW, EUGENE STOCKTON, CA 7/20/2006 LUPO, DAVID COLORADO SPRINGS, CO 7/20/2006 MABERRY, BRENDA LAWRENCE, KS 7/20/2006 MAGDALENO, DANILO MIAMI, FL 7/20/2006 NEWSOME, BERMAZELL COLLEGE PARK, GA 7/20/2006 OLIVE, JUAN HIALEAH, FL 3/10/2006 ORTEGA, DIOMAR MIAMI, FL 2/24/2006 ORTEGA, SERGIO HIALEAH, FL 2/24/2006 POSTIGLIONE PHARMACY PORT CHESTER, NY 7/20/2006 POSTIGLIONE, JOHN RAY BROOK, NY 7/20/2006 RAMNARINE, DILIAH SCHENECTADY, NY 7/20/2006 REID, JAMES JESUP, GA 7/20/2006 ROSENSWEIG, SANFORD BASTROP, TX 7/20/2006 SARGSIAN, AROUTIOUN TAFT, CA 7/20/2006 SIMMONS, KEVIN WALDORF, MD 7/20/2006 SLATTEN, KARL BOISE, ID 7/20/2006 SMITH, LASHAN TULSA, OK 7/20/2006 SPRINGHART, WILLIAM DAYTON, OH 7/20/2006 STAMBULYAN, KARAPET LOMPOC, CA 7/20/2006 VU, NYOUA SAN DIEGO, CA 7/20/2006 WASHINGTON, LESLIE WHITE CASTLE, LA 7/20/2006 WASKOSKY, REBECCA FARIBAULT, MN 7/20/2006 FELONY CONVICTION FOR HEALTH CARE FRAUD COLEMAN, JESSICA PORTLAND, ME 7/20/2006 DAGDAGAN, MYRNA DELANO, CA 7/20/2006 DAVIS, FELICE W PALM BEACH, FL 7/20/2006 DAVIS, MELINDA HATFIELD, AR 7/20/2006 DIXON, RANDALL JOHNSON CITY, TN 7/20/2006 DOUGLAS, LANITA SEARCY, AR 7/20/2006 FEOLE, KRYSTIN PITTSFIELD, NH 7/20/2006 FUDERICH, DAVID PITTSBURGH, PA 7/20/2006 GRODRIAN, BETTY ODESSA, FL 7/20/2006 HANDLEY, CHASTITY LULING, TX 7/20/2006 HARDYMAN, REBECCA BATAVIA, OH 7/20/2006 JEAN, MAGALIE DAVENPORT, FL 7/20/2006 MCAVOY, GUADALUPE INDIO, CA 7/20/2006 MCCLUNG, DARLETTA PONCA CITY, OK 7/20/2006 MCDONALD, SONIA WEST PALM BEACH, FL 7/20/2006 NEE, MELISSA PORTLAND, ME 7/20/2006 PANICHELLA, ANTHONY AUDUBON, NJ 7/20/2006 PHILLIPS, TINA EAGLE BUTTE, SD 7/20/2006 REGHANTI, MARGUERITE TAMPA, FL 7/20/2006 SCOTT, CHINA HUMMELSTOWN, PA 7/20/2006 STEELE, JAN FAYETTEVILLE, AR 7/20/2006 TODD, LAVENNA SHAKER HEIGHTS, OH 7/20/2006 TOULOUSE, JASON MITCHELL, SD 7/20/2006 WANG, YIH-ING MILPITAS, CA 7/20/2006 WAYCOTT, CAROL LINCOLN, RI 7/20/2006 YUMAN, GEMMA SAN BERNARDINO, CA 7/20/2006 FELONY CONTROLLED SUBSTANCE CONVICTION ACREE, REBECCA FT WORTH, TX 7/20/2006 AGGROIA, ABHAY WOODBRIGE, VA 7/20/2006 ARMSTRONG, JANISE JACKSONVILLE, FL 7/20/2006 BAUM, TERI FORT COLLINS, CO 7/20/2006 BETHENCOURT, MAGALY MIAMI, FL 7/20/2006 BRYANT, TAMMY LEWISBURG, TN 7/20/2006 CHAPMAN, ALFRED CLEARWATER, FL 7/1/2006 COTTER, JOHN SHREVEPORT, LA 7/20/2006 CRAGUN, MICHAEL PHOENIX, OR 7/20/2006 CYNN, STEVEN CHARLOTTE, NC 7/20/2006 DEHART, GAIL GOUVERNEUR, NY 7/20/2006 DEVRIES, LISA STAUNTON, IL 7/20/2006 EVENSEN, VIKKI GRAND JUNCTION, CO 7/20/2006 FULTZ, PATRICIA ZANESVILLE, OH 7/20/2006 GANTT, LISA LAKELAND, FL 7/20/2006 GOUGALOFF, ROBERTO HERMOSA BEACH, CA 7/20/2006 HUGHES, LESLIE SACRAMENTO, CA 7/20/2006 MAZZEO, KIMBERLY DELRAY BEACH, FL 7/20/2006 QUINN, EILEEN HOLLYWOOD, FL 7/20/2006 RUBIO, JODIE IRVING, TX 7/20/2006 SCHULHOF, JERRY PITTSBURGH, PA 7/20/2006 TIMMONS, ARIF SEATTLE, WA 7/20/2006 TORRES, ZORIEL ORLANDO, FL 7/20/2006 TRIPLETT, RICHARD SPRING, TX 7/20/2006 WEAGLE, PAMELA DOUGLASVILLE, GA 7/20/2006 PATIENT ABUSE/NEGLECT CONVICTION ADAMS, RYGENA HONOLULU, HI 7/20/2006 BALDERAS, CAROLINA GUYMON, OK 7/20/2006 CHRISTOR, RUTH SHREVEPORT, LA 7/20/2006 CRAIG, ANITA FARRELL, PA 7/20/2006 DEAN, CHARLES SAN BERNARDINO, CA 7/20/2006 DEL OLMO, MAYRA MIAMI, FL 7/20/2006 DODSON, JAMES EUGENE, OR 7/20/2006 DORMAN, DUANE MITCHELL, SD 7/20/2006 HAYWARD, JOSHUA COUNCIL BLUFFS, IA 7/20/2006 HYDE, JOANN MURRAY, UT 7/20/2006 JEMISON, STEPHEN TUSCALOOSA, AL 7/20/2006 JOHNSON, ERIK SONOMA, CA 7/20/2006 LOCKE, LAURA SPRINFIELD, NH 7/20/2006 MCCLARY, RHONDA BALTIMORE, MD 7/20/2006 MCFADDEN, LORRAINE BUFFALO, NY 7/20/2006 MCKEE, DEBBIE DERBY, KS 7/20/2006 MCLEAN, NAKITTA BALTIMORE, MD 7/20/2006 MONTGOMERY, JESSICA CAMBRIDGE, MD 7/20/2006 MOSHER, EMMA PERRY, IA 7/20/2006 PAMBIANCO, JOHN TRUCKSVILLE, PA 7/20/2006 PEDROZA, JOSE PARAMOUNT, CA 7/20/2006 PEMBLE, AARON WOODWARD, IA 7/20/2006 PENNER, COREY NEWTON, KS 7/20/2006 READING, ANTHONY PANAMA CITY, FL 7/20/2006 STEVENS, CHAD BOONE, IA 7/20/2006 WASHINGTON, GENECE SHREVEPORT, LA 7/20/2006 CONVICTION-OBSTRUCTION OF AN INVESTIGATION HERNANDEZ RIVERA, ALFREDO MIAMI, FL 7/20/2006 LICENSE REVOCATION/SUSPENSION/SURRENDER ACE, EDGAR MIAMI, FL 7/20/2006 ALDEN, CAROLINE LAKELAND, FL 7/20/2006 BALL, GREGORY THOUSAND OAKS, CA 7/20/2006 BARKER, GERTRUDE LEXINGTON, KY 7/20/2006 BEARDSLEY, JACK DELRAY BEACH, FL 7/20/2006 BEELER, BETH PITTSBURGH, PA 7/20/2006 BENNETT, JASON ST AUGUSTINE, FL 7/20/2006 BOX, STEVEN MONTICELLO, FL 7/20/2006 BOYD, LARRY APACHE JUNCTION, AZ 7/20/2006 BROOKS, BRENDA SACRAMENTO, CA 7/20/2006 BROWNING, GLORIA BERRY, KY 7/20/2006 BRYERTON, PATRICIA LACONIA, NH 7/20/2006 CALVERT, JAMES CULLMAN, AL 7/20/2006 CAMPAGNA, MARY CORDOVA, TN 7/20/2006 CARTWRIGHT, TERESA LAUREL, MS 7/20/2006 CHASE, JANET SAN ANTONIO, TX 7/20/2006 CHAVIERS, TRACY ANNISTON, AL 7/20/2006 CICCO, MICHELLE IRWIN, PA 7/20/2006 CLARK, TINA CLEARFIELD, UT 7/20/2006 COLEMAN, NORMA NASHVILLE, TN 7/20/2006 COLEMAN, WILLIAM DALY CITY, CA 7/20/2006 COMPTON, GEORGE RUSSELLVILLE, AL 7/20/2006 COOK, NANCY ELDORADO, AR 7/20/2006 DARR, WILLARD ORANGE PARK, FL 7/20/2006 DAVIS, DORINA LAS VEGAS, NV 7/20/2006 DEO, PARBHA HAYWARD, CA 7/20/2006 DIPINTO, DENNIS CUMBERLAND, RI 7/20/2006 DRISCOLL, RAYMOND DRACUT, MA 7/20/2006 ELLIOTT, ELIZABETH KNOXVILLE, TN 7/20/2006 ENGLE, BRENT HARROGATE, TN 7/20/2006 EVANS, ROBERLYN MEMPHIS, TN 7/20/2006 FARWELL, AILEEN BIRMINGHAM, AL 7/20/2006 FERNANDO, IRENE HAYWARD, CA 7/20/2006 FOULKE, DANNETTE PADUCAH, KY 7/20/2006 FRANKLIN, ZAYRA ELK GROVE, CA 7/20/2006 FREEH, NANCY WINCHESTER, NH 7/20/2006 GARCIA, MARQUES BOTHELL, WA 7/20/2006 GILVARRY, DANA DAYTON, TX 7/20/2006 GOICOECHEA, RUTH BURLEY, ID 7/20/2006 GREENLAW, KAREN ORRINGTON, ME 7/20/2006 GRIFFIN, MICHAEL BELLEAIR BLUFFS, FL 7/20/2006 GUTIERREZ, ROGER SAN FRANCISCO, CA 7/20/2006 HAMILTON, WILLIAM SAN DIEGO, CA 7/20/2006 HAMMONDS, PAMELA JACKSONVILLE, FL 7/20/2006 HANAFY, FOUAD LIVINGSTON, CA 7/20/2006 HENDERSON, RHONDA CORBIN, KY 7/20/2006 HOOVER, BRENDA RIO LINDA, CA 7/20/2006 HOSKIE, EVANGELINE TUCSON, AZ 7/20/2006 HUDSON, MICHELLE RICHMOND, CA 7/20/2006 INGRAM, TERESA HAMPTON, TN 7/20/2006 JOHNSON, ROSAMARIA SAN ANTONIO, TX 7/20/2006 JONES, REGINA TUSCALOOSA, AL 7/20/2006 JONES, ROBERT VALLEJO, CA 7/20/2006 KEMBLE, CHARLOTTE TACOMA, WA 7/20/2006 KENNEDY-RICHARD, KAREN WORCESTER, MA 7/20/2006 KLEINIK, KATHLEEN TOMBSTONE, AZ 7/20/2006 KOHLER, SUSAN HEBER CITY, UT 7/20/2006 KUON, RALPH MONTEBELLO, CA 7/20/2006 LARIOS, DANIEL FRESNO, CA 7/20/2006 LAROCK, JUDITH ENGLEWOOD, CO 7/20/2006 LARUE, LESLIE OAK HARBOR, WA 7/20/2006 LOCKHART, DIONA JASPER, AL 7/20/2006 LOPOTOSKY, MARCI GLASGOW, KY 7/20/2006 MAREK, CASSANDRA HEWITT, TX 7/20/2006 MATHEWS, CHRISTINA LAS VEGAS, NV 7/20/2006 MAXWELL, TIFFANY RICHLAND, WA 7/20/2006 MCCORMACK, SUSAN TUSCUMBIA, AL 7/20/2006 MCDIVITT, LOLA HONOLULU, HI 7/20/2006 MCMURPHEY, BRETT GREAT FALLS, MT 7/20/2006 MCPHAIL, DANIEL NORTHFIELD, NH 7/20/2006 MCPIKE, RONALD BONAPARTE, IA 7/20/2006 MEILLER, MORRIS MOUNT AIRY, MD 7/20/2006 MERZ, AMY MURRAY, UT 7/20/2006 MEYER, SHELLEY DAPHNE, AL 7/20/2006 MILDENHALL, BRYAN WEST VALLEY CITY, UT 7/20/2006 MILLER, CYNTHIA LUTZ, FL 7/20/2006 MILLER, ROBIN SALISBURY, NC 7/20/2006 MILLETT, DEBORAH CAPE NEDDICK, ME 7/20/2006 MILLS, KIMBERLEE PROVO, UT 7/20/2006 MIRANDA, JOYCE TEMPE, AZ 7/20/2006 MORALES, GLORIA ATASCADERO, CA 7/20/2006 MORAN, LAURA TOOELE, UT 7/20/2006 NADREAU, MARC WOODLAND, CA 7/20/2006 NICHOLS, KAY HUNTINGTON, TX 7/20/2006 NIPPER, SUE TUCSON, AZ 7/20/2006 NOBLE, CHRISTOPHER KNOXVILLE, TN 7/20/2006 NUGIEL, DALE LOS ANGELES, CA 7/20/2006 OLDHAM, RACHEAL BELLEVUE, TN 7/20/2006 OSBURN, MARGARET SELMA, AL 7/20/2006 OWENS, DERRICK ATHENS, AL 7/20/2006 PALCONETE, EMMA SAN JOSE, CA 7/20/2006 PEREZ, RONALD LAKEWOOD, CA 7/20/2006 PRASCHUNUS, MAUREEN WARREN, RI 7/20/2006 PROBY, CHARLES PHOENIX, AZ 7/20/2006 PUCKETT, KRISTI FREDRICKSBURG, TX 7/20/2006 RAMIREZ, MANUEL FIREBAUGH, CA 7/20/2006 REESE, LONNIE WENATCHEE, WA 7/20/2006 REILLY, TRACY LOUISVILLE, KY 7/20/2006 REYES, CANDELARIA SANTA MARIA, CA 7/20/2006 ROBERTS, TIMOTHY KINGMAN, AZ 7/20/2006 RODMAN, ANNIE BULLHEAD CITY, AZ 7/20/2006 RUSSELL, KATHERINE LOYALTON, CA 7/20/2006 SACHEK, LEANN WASHINGTON, PA 7/20/2006 SADEGHI, FIROOZ GLENDALE, CA 7/20/2006 SANTIAGO, JOHN JACKSON HEIGHTS, NY 7/20/2006 SARACENI, ESTELLA DORCHESTER, MA 7/20/2006 SCHNEIDER, BRUCE MATAWAN, NJ 7/20/2006 SCOTT, LISA MERIDIAN, MS 7/20/2006 SINGLETON, PAMELA MOBILE, AL 7/20/2006 SMITH, DREW TACOMA, WA 7/20/2006 SMITH, JEANETTA PARAMOUNT, CA 7/20/2006 SPRATLEY, DOUGLAS TEMPE, AZ 7/20/2006 SPRINGER, JACKIE OVERLAND PARK, KS 7/20/2006 STANTON, SHEILA MESA, AZ 7/20/2006 SWINGLE, KERMIT BOULDER CITY, NV 7/20/2006 TATE, BONNIE BIRMINGHAM, AL 7/20/2006 TAYLOR, DULCIE BARRE, VT 7/20/2006 THOMPSON, CARLA GOSHEN, VA 7/20/2006 THRASHER, KIM BIRMINGHAM, AL 7/20/2006 TOMLINSON, KARYN YERINGTON, NV 7/20/2006 TRETBAR, LAWRENCE SHAWNEE MISSION, KS 7/20/2006 TRUMP, CHRISTINA MOORESVILLE, NC 7/20/2006 UNDERWOOD, CARLA MOUNT PLEASANT, TN 7/20/2006 WALRAVEN, MISTI ARAB, AL 7/20/2006 WERMAGER, ANDREA PALMER, AK 7/20/2006 WILCOWSKI, LEANN VANCOUVER, WA 7/20/2006 WILLIAMS, JACQUELINE SAINT AUGUSTINE, FL 7/20/2006 WOOD, MARINA CHULA VISTA, CA 7/20/2006 WORTHINGTON, FRANK TUCSON, AZ 7/20/2006 ZELTZER, JUDY HERNANDO, FL 7/20/2006 FRAUD/KICKBACKS/PROHIBITED ACTS/SETTLEMENT AGREEMENT AIKEN, STUART OLNEY, MD 5/5/2006 DEVALDES, GREGORY VIRGINIA BEACH, VA 4/28/2006 KEATLEY, HUGH BECKLEY, WV 5/12/2006 MOSHER, DENNIS CHEYENNE, WY 8/12/2005 WEBBER, TRACY MABSCOTT, WV 4/28/2006 OWNED/CONTROLLED BY EXCLUDED/CONVICTED INDIVIDUAL+ EARTHMED INC SPARTANBURG, SC 7/20/2006 HOANG T. TRAN, DDS, INC HANFORD, CA 7/20/2006 MAGALY BETHENCOURT MEDICAL SERVICES, INC MIAMI, FL 7/20/2006 PACIFIC CARE MEDICAL SUPPLY, INC LONG BEACH, CA 7/20/2006 RONALD P. MCPIKE, D. O., P. C BONAPARTE, IA 7/20/2006 DEFAULT ON HEAL LOAN BUI, KHAI SPRINGFIELD, MA 7/20/2006 KALTER, HOWARD NAPLES, FL 7/20/2006 KANTRO, SCOTT POUND RIDGE, NY 7/20/2006 LANE, ABBIE BROOKLYN, NY 7/20/2006 RICHARD, PATTI HAVERHILL, MA 7/20/2006 ROSEN, MICHAEL TEMPE, AZ 7/20/2006 SCHWARTZ, GREGG AMBLER, PA 7/20/2006 TAN, DANNY SALINAS, CA 7/20/2006 Dated: June 11, 2006. Maureen R. Byer, Director, Exclusions Staff, Office of Inspector General. [FR Doc. E6-11330 Filed 7-17-06; 8:45 am] BILLING CODE 4152-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Listing of Construction Grant Programs AGENCY: National Institutes of Health, Department of Health and Human Services. ACTION: Notice. SUMMARY: Section 52b.1(b) of the regulations governing National Institutes of Health
(NIH)construction grants, codified at 42 CFR part 52b, authorizes the NIH Director to publish periodically a list of the construction grant programs to which the construction grant regulations apply. This Notice announces the most recent list of the programs covered by the regulations. DATES: *Effective Date:* July 18, 2006. FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, 6011 Executive Boulevard, Room 601, MSC 7669, Rockville, MD 20892, telephone 301-496-4607 (not a toll-free number), fax 301-402-0169, e-mail *jm40z@nih.gov.* SUPPLEMENTARY INFORMATION: The NIH published the final rule, “National Institutes of Health Construction Grants,” in the **Federal Register** , November 22, 1999 (64 FR 63721-63727), revising the regulations at 42 CFR part 52b,
(then)titled, National Cancer Institute Construction Grants, for the purpose of making them applicable to all NIH financial assistance programs with construction or modernization grant authority, except for certain alterations and improvements under research project grants and center grants, and to make certain other changes, including retitled them, “National Institutes of Health Construction Grants.” In lieu of specifically listing each NIH construction grant program to which the regulations apply in § 52b.1 of the regulations, the applicability section, we revised § 52b.1 to apply across-the-board to all NIH construction grant programs, except for those few programs specifically excluded by the section. This action has the advantage of assuring that any new NIH construction grant programs enacted by Congress would have implementing regulations without the necessity of having to amend the regulations. The final rule authorized the Director of NIH to publish periodically a list of construction grant programs covered by the regulations. We indicated that the list would be for informational purposes only and would not restrict the applicability of the regulations. We are publishing this updated list of programs to which the construction grants regulations apply to reflect the extension of authority for construction of research facilities, previously held only by the National Center for Research Resources
(NCRR)under section 481A of the Public Health Service
(PHS)Act, to the National Institute of Allergy and Infectious Diseases (NIAID), as amended by provisions of the Project Bioshield Act of 2004 (Pub. L. 108-276). As amended, section 481A now authorizes the Director of NIH, acting through the Director of NCRR or the Director of NIAID, to make grants or award contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities, subject to the provisions of section 481A. Additionally, we are publishing this updated list of program to reflect the authority of the Director of the National Center on Minority Health and Health Disparities (NCMHD) to make grants to expand, remodel, renovate, or alter existing research facilities or construct new research facilities for the purpose of conducting minority health disparities research and other health disparities research, as authorized under section 485F(b)(2) of the PHS Act, as amended by section 102 of Public Law 106-525, the Minority Health and Health Disparities Research and Education Act of 2000. The updated listing of construction grant authorities to which the National Institutes of Health Construction Grant regulations, codified at 42 CFR Part 52b, apply includes the following:
(1)Grants for construction or renovation of facilities in carrying out the National Cancer Program, as authorized by section 413(b)(6)(B) of the PHS Act (42 U.S.C. 285a-2(b)(6)(B));
(2)Federal payment under a grant for construction to pay for all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for center for basic and clinical research into, training in, and demonstration of advanced diagnostic, prevention, control, and treatment methods for cancer, as authorized by section 414(b) of the PHS Act (42 U.S.C. 285a-3(b));
(3)Grants for construction or renovation of facilities, to carry out the National Heart, Lung, and Blood Disease and Blood Resources Program, as authorized by section 421(b)(2)(B) of the PHS Act (42 U.S.C. 285b-3(b)(2)(B)); Grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basis operating support for centers for basic and clinical research into, training in, and demonstration of the management of blood resources and advanced diagnostic, prevention and treatment methods for heart, blood vessel, lung, or blood diseases, as authorized by section 442(c)(3) of the PHS Act (42 U.S.C. 285b-4(c)(3));
(5)Development and modernization of new and existing centers for arthritis and musculoskeletal diseases, as authorized by section 441(a) of the PHS Act (42 U.S.C. 285d-6(a));
(6)Grants for public and private nonprofit vision research facilities, as authorized under section 455 of the PHS Act (42 U.S.C. 285i);
(7)Development and modernization of new and existing centers for studies of disorders of hearing and other communication processes, as authorized by section 464C(a) of the PHS Act (42 U.S.C. 285m-3(a));
(8)Grants for the construction or renovation of facilities for research into the development and use of medications to treat drug abuse and addiction, as authorized by section 464P(b) of the PHS Act (42 U.S.C. 285o-4(b));
(9)Grants to public and nonprofit private entities to expand, remodel, renovate, or alter existing biomedical and behavioral research facilities or construct new research facilities, as authorized by section 481A(a) of the PHS Act (42 U.S.C. 287a-2(a));
(10)Grants to public or nonprofit private entities to construct, renovate, or otherwise improve regional centers for research on primates, as authorized by section 481B(a) of the PHS Act (42 U.S.C. 287a-3(a));
(11)Grants to expand, remodel, renovate, or alter existing research facilities or construct new research facilities for the purpose of conducting minority health disparities research and other health disparities research, as authorized by section 485F(b)(2) of the PHS Act U.S.C. 287c-32(b)(2)); and
(12)Grants for the construction or renovation of facilities for carrying out AIDS research, as authorized by section 2354(a) of the PHS Act (42 U.S.C. 300cc-41(a)). The Catalogue of Federal Domestic Assistance
(CFDA)numbered programs affected by title 42 of the Code of Federal Regulations, part 52b are: 93.131—Shared Research Facilities for Heart, Lung, and Blood Diseases. 93.173—Research Related to Deafness and Communication Disorders. 93.279—Drug Abuse and Addiction Programs. 93.307—Minority Health and Health Disparities Research. 93.389—National Center for Research Services. 93.392—Cancer Construction. 93.846—Arthritis, Musculoskeletal and Skin Diseases Research. 93.855—Allergy, Immunology and Transplantation Research. 93.867—Vision Search. Dated: May 19, 2006. Elias A. Zerhouni, Director, National Institutes of Health. Approved: July 7, 2006. Michael O. Leavitt, Secretary. [FR Doc. 06-6262 Filed 7-17-06; 8:45 am]
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