Federal Register / Vol. 70, No.

90 / Wednesday, May 11, 2005 / Notices 24819

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers of Recordkeeping Records Recordkeeper Total Hours

11.10 2,500 1 2,500 20 45,000

11.30 2,500 1 2,500 20 45,000

11.50 4,500 1 4,500 20 90,000

11.300 4,500 1 4,500 20 90,000

Total 270,000
1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: May 4, 2005. 240), Center for Drug Evaluation and until June 11, 2005, to allow the public
Jeffrey Shuren, Research, Food and Drug additional time to review and comment
Assistant Commissioner for Policy. Administration, 5600 Fishers Lane, on the contents and to be consistent
[FR Doc. 05–9370 Filed 5–10–05; 8:45 am] Rockville, MD 20857; or the Office of with the time for comment provided by
BILLING CODE 4160–01–S
Communication, Training and other ICH regulatory entities.
Manufacturers Assistance (HFM–40),
II. Comments
Center for Biologics Evaluation and
DEPARTMENT OF HEALTH AND Research (CBER), Food and Drug Interested persons may submit to the
HUMAN SERVICES Administration, 1401 Rockville Pike, Division of Dockets Management (see
Rockville, MD 20852–1448. Send two ADDRESSES) written or electronic
Food and Drug Administration self-addressed adhesive labels to assist comments regarding this document.
the office in processing your requests. Submit a single copy of electronic
[Docket No. 2005D–0021] comments or two paper copies of any
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft mailed comments are to be submitted,
International Conference on
guidance. except that individuals may submit one
Harmonisation; Draft Guidance on Q8
FOR FURTHER INFORMATION CONTACT: copy. Comments are to be identified
Pharmaceutical Development;
Regarding the guidance: Ajaz with the docket number found in
Availability; Reopening of Comment
Hussain, Center for Drug Evaluation brackets in the heading of this
Period
and Research (HFD–3), Food and document. The draft guidance and
AGENCY: Food and Drug Administration, Drug Administration, 5600 Fishers received comments are available for
HHS. Lane, Rockville, MD 20857, 301– public examination in the Division of
ACTION: Notice; reopening of comment 594–2847; or Christopher Joneckis, Dockets Management between 9 a.m.
period. Center for Biologics Evaluation and and 4 p.m. Monday through Friday.
Research (HFM–1), Food and Drug III. Electronic Access
SUMMARY: The Food and Drug Administration, 1401 Rockville
Administration (FDA) is reopening until Pike, Rockville, MD 20852, 301– Persons with access to the Internet
June 11, 2005, the comment period for 435–5681. may obtain the documents at http://
the notice, published in the Federal Regarding the ICH: Michelle Limoli, www.fda.gov/ohrms/dockets/
Register of February 9, 2005 (70 FR Office of International Programs default.htm, http://www.fda.gov/cder/
6888). In the notice, FDA announced the (HFG–1), Food and Drug guidance/index.htm, or http://
availability of a draft guidance entitled Administration, 5600 Fishers Lane, www.fda.gov/cber/publications.htm.
‘‘Q8 Pharmaceutical Development.’’ Rockville, MD 20857, 301–827– Dated: May 4, 2005.
FDA is reopening the comment period 4480. Jeffrey Shuren,
to provide additional time for public Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
comment consistent with the time for
[FR Doc. 05–9369 Filed 5–10–05; 8:45 am]
comment provided by other ICH I. Background
BILLING CODE 4160–01–S
regulatory entities. In the Federal Register of February 9,
DATES: Submit written or electronic 2004 (70 FR 6888), FDA announced the
comments on the draft guidance by June availability of a draft guidance entitled DEPARTMENT OF HEALTH AND
11, 2005. General comments on agency ‘‘Q8 Pharmaceutical Development,’’ HUMAN SERVICES
guidance documents are welcome at any prepared under the auspices of the ICH.
time. The draft guidance provides Office of Inspector General
ADDRESSES: Submit written comments recommendations to sponsors
on the draft guidance to the Division of concerning pharmaceutical studies as Program Exclusions: April 2005
Dockets Management (HFA–305), Food defined in section 3.2.P.2 of module 3 AGENCY: Office of Inspector General,
and Drug Administration, 5630 Fishers of the Common Technical Document HHS.
Lane, rm. 1061, Rockville, MD 20852. (CTD). ACTION: Notice of program exclusions.
Submit electronic comments to http:// Interested persons were given until
www.fda.gov/dockets/ecomments. April 11, 2005, to submit comments on During the month of April 2005, the
Submit written requests for single the draft guidance. HHS Office of Inspector General
copies of the draft guidance to the FDA has decided to reopen the imposed exclusions in the cases set
Division of Drug Information (HFD– comment period on the draft guidance forth below. When an exclusions is

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 24820 Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices

imposed, no program payment is made program payment is made to any payments will be made for items and
to anyone for any items or services business or facility, e.g., a hospital, that services provided by that excluded
(other than an emergency item or submits bills for payment for items or party. The exclusions have national
service not provided in a hospital services provided by an excluded party. effect and also apply to all Executive
emergency room) furnished, ordered or Program beneficiaries remain free to Branch procurement and non-
prescribed by an excluded party under decide for themselves whether they will procurement programs and activities.
the Medicare, Medicaid, and all Federal continue to use the services of an
Health Care programs. In addition, no excluded party even though no program

Subject name Address Effective date

Program-Related Convictions:
Aguiluz, Amable .......................................................................... Whittier, CA ................................................................................ 5/19/2005
Alvis, Sandra ............................................................................... Pennsauken, NJ ......................................................................... 5/19/2005
Antoine L Garabet, MD, Inc ........................................................ Glendora, CA ............................................................................. 5/19/2005
Avello, Alexis ............................................................................... Miami Beach, FL ........................................................................ 5/19/2005
Beal, Darlene .............................................................................. Tulsa, OK ................................................................................... 5/19/2005
Bisig, Peggy ................................................................................ Lexington, KY ............................................................................. 5/19/2005
Blake, Christine ........................................................................... Alpharetta, GA ........................................................................... 5/19/2005
Bolshinsky, Igor ........................................................................... Potomac, MD ............................................................................. 5/19/2005
Bondar, Raisa ............................................................................. Mequon, WI ................................................................................ 5/19/2005
Brooks, Antonio ........................................................................... Washington, NC ......................................................................... 5/19/2005
Brown, Joseph ............................................................................ Florence, SC .............................................................................. 5/19/2005
Chand, Puran .............................................................................. Stanton, CA ................................................................................ 5/19/2005
Coughlin, Daniel .......................................................................... Metairie, LA ................................................................................ 5/19/2005
Cullen, Linda ............................................................................... Kailua Kona, HI .......................................................................... 5/19/2005
Cushing, Monica ......................................................................... Barre, VT .................................................................................... 5/19/2005
Daniels, Salmon .......................................................................... Los Angeles, CA ........................................................................ 5/19/2005
Deguzman, Maria ........................................................................ Cerrutis, CA ............................................................................... 5/19/2005
Doll, Charles ............................................................................... Jacksonville, FL ......................................................................... 2/11/2005
Esposito, Michelina ..................................................................... Portland, ME .............................................................................. 5/19/2005
Fosness, Christopher .................................................................. Mitchell, SD ................................................................................ 5/19/2005
Garabet, Antoine ......................................................................... Glendora, CA ............................................................................. 5/19/2005
Gokhman, Boris .......................................................................... Mequon, WI ................................................................................ 5/19/2005
Goulette, Billy .............................................................................. Long Beach, CA ......................................................................... 5/19/2005
Hall, Harry ................................................................................... Labelle, FL ................................................................................. 5/19/2005
Igbinaduwa, Newton ................................................................... Jamaica, NY ............................................................................... 5/19/2005
Jamias, Alexander ...................................................................... Buena Park, CA ......................................................................... 5/19/2005
Jani, Axat .................................................................................... Saddle River, NJ ........................................................................ 5/19/2005
Jimenez, Jose ............................................................................. Camden, NJ ............................................................................... 5/19/2005
Johnson, Paul ............................................................................. Loma, CO ................................................................................... 5/19/2005
Legro, Danny .............................................................................. Chehalis, WA ............................................................................. 5/19/2005
Lemieux, India ............................................................................. Gretna, LA .................................................................................. 5/19/2005
Lisak, Alla .................................................................................... Bayside, WI ................................................................................ 5/19/2005
Mailyan, Melik ............................................................................. Burbank, CA ............................................................................... 5/19/2005
Melendez, Juanita ....................................................................... Camden, NJ ............................................................................... 5/19/2005
Moore, Garyl ............................................................................... York, PA ..................................................................................... 5/19/2005
Munoz, Cynthia ........................................................................... Phoenix, AZ ............................................................................... 5/19/2005
Myaskovskaya, Valentina ........................................................... Milwaukee, WI ............................................................................ 5/19/2005
Panshi, Surinder ......................................................................... Wasco, CA ................................................................................. 5/19/2005
Passamonte, Christopher ........................................................... Camp Hill, PA ............................................................................ 5/19/2005
Ramos, Robert ............................................................................ Carolina, PR ............................................................................... 5/19/2005
Reyes-Lopez, Harry .................................................................... Hatillo, PR .................................................................................. 5/19/2005
Rizzo, Kenneth ............................................................................ Goshen, NY ............................................................................... 5/19/2005
Salas, Patricia ............................................................................. Las Cruces, NM ......................................................................... 5/19/2005
Salvo, Mark ................................................................................. Glendale, CA .............................................................................. 5/19/2005
Schoenborn, Mark ....................................................................... Ponte Verdra Beach, FL ............................................................ 2/11/2005
Skrinskaya, Natailya ................................................................... Silver Spring, MD ....................................................................... 5/19/2005
TBC Products, Inc ....................................................................... Golden Valley, MN ..................................................................... 11/12/2004
Tirakian, Harutyun ....................................................................... Glendale, CA .............................................................................. 5/19/2005
Turner, Jessie ............................................................................. Chickasha, OK ........................................................................... 5/19/2005
Vann, Sinnaro ............................................................................. Long Beach, CA ......................................................................... 5/19/2005
Walton, Wanda ........................................................................... Vallejo, CA ................................................................................. 5/19/2005
Winding, Devona ......................................................................... New Orleans, LA ........................................................................ 5/19/2005
Yelin, Bella .................................................................................. Mequon, WI ................................................................................ 5/19/2005
Zarlengo, Phillip .......................................................................... Littleton, CO ............................................................................... 5/19/2005
Felony Conviction for Health Care Fraud:
Budenske, Jerry .......................................................................... Oklahoma City, OK .................................................................... 5/19/2005
Faulkner, Glenna ........................................................................ Ewing, KY .................................................................................. 5/19/2005
Fox, Calvin .................................................................................. Tucson, AZ ................................................................................. 5/19/2005
Hinds, Sandra ............................................................................. Wheaton, MD ............................................................................. 5/19/2005
Holliday, Gregory ........................................................................ Bethany, OK ............................................................................... 5/19/2005
Hunt, Kimberly ............................................................................ Oxnard, CA ................................................................................ 5/19/2005
Jango, Angela ............................................................................. Newport News, VA ..................................................................... 5/19/2005
Libson, Todd ............................................................................... Simi Valley, CA .......................................................................... 5/19/2005

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 Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices 24821

Subject name Address Effective date

Moore, Nicole .............................................................................. Broken Arrow, OK ...................................................................... 5/19/2005

Pickering, Joanne ....................................................................... Tucson, AZ ................................................................................. 5/19/2005
Ray, Natacha .............................................................................. Broken Arrow, OK ...................................................................... 5/19/2005
Sanders, Marvin .......................................................................... Charlottsville, VA ........................................................................ 5/19/2005
Santamaria, Rene ....................................................................... Apache Junction, AZ .................................................................. 5/19/2005
Schneider, Harvey ...................................................................... Norton, MA ................................................................................. 5/19/2005
Thompson, Kimberly ................................................................... Danville, KY ............................................................................... 5/19/2005
Felony Control Substance Conviction:
Allen, Jana .................................................................................. Kansas City, MO ........................................................................ 5/19/2005
Aulner, Kathleen ......................................................................... Norfolk, NE ................................................................................. 5/19/2005
Breece, Robin ............................................................................. Groves, TX ................................................................................. 5/19/2005
Chaussee, Mary .......................................................................... Rocklin, CA ................................................................................ 5/19/2005
Christensen, Kim ......................................................................... Mema, AZ .................................................................................. 5/19/2005
Davis, Keri ................................................................................... Flower Mound, TX ..................................................................... 5/19/2005
Fanning, James .......................................................................... Sherman, TX .............................................................................. 5/19/2005
Friedman, Eugene ...................................................................... Port Jefferson, NY ..................................................................... 5/19/2005
Greening, Brian ........................................................................... Edinburg, TX .............................................................................. 5/19/2005
Haskins, Tammy ......................................................................... Midland, TX ................................................................................ 5/19/2005
Hermann, Raymond .................................................................... Vancouver, WA .......................................................................... 5/19/2005
Johnson, Karen ........................................................................... Blue Ridge, GA .......................................................................... 5/19/2005
Libengood, Stacey ...................................................................... Clearwater, FL ........................................................................... 5/19/2005
Moore, Janet ............................................................................... Gainesville, GA .......................................................................... 5/19/2005
Moore, Mary ................................................................................ Painesville, OH .......................................................................... 5/19/2005
Morelli, Timothy ........................................................................... Mercer, PA ................................................................................. 5/19/2005
Palladini, Michael ........................................................................ Beaver, PA ................................................................................. 5/19/2005
Renteria, Jeanette ....................................................................... Burleson, TX .............................................................................. 5/19/2005
Sibley, Leslie ............................................................................... Tulsa, OK ................................................................................... 5/19/2005
Spencer, Verinda ........................................................................ Houston, TX ............................................................................... 5/19/2005
Stanton, James ........................................................................... Houston, TX ............................................................................... 5/19/2005
Ushio, Keri-Ann ........................................................................... Honolulu, HI ............................................................................... 5/19/2005
Varalli, Daniel .............................................................................. Beaver, WV ................................................................................ 5/19/2005
Wein, Fred .................................................................................. Brooklyn, NJ ............................................................................... 5/19/2005
Wisby, Amy ................................................................................. Hamersville, OH ......................................................................... 5/19/2005
Patient Abuse/Neglect Convictions:
Bemah, Elisha ............................................................................. Washington, DC ......................................................................... 5/19/2005
Cage, Christine ........................................................................... Chillicothe, MO ........................................................................... 5/19/2005
Chrisman, Christopher ................................................................ Del City, OK ............................................................................... 5/19/2005
Cotten, Bradley ........................................................................... Canon City, CO .......................................................................... 5/19/2005
Davis, Rose ................................................................................. Santa Fe, NM ............................................................................. 5/19/2005
Garay, Rosalinda ........................................................................ Salt Lake City, UT ...................................................................... 5/19/2005
Harris, Linda ................................................................................ Henryetta, OK ............................................................................ 5/19/2005
Henry, Jonathan .......................................................................... Malone, FL ................................................................................. 5/19/2005
Hewuse, Roselyn ........................................................................ Green Bay, WI ........................................................................... 5/19/2005
Jobes, Philip ................................................................................ Towson, MD ............................................................................... 5/19/2005
Johnson, Arlin ............................................................................. Oklahoma City, OK .................................................................... 5/19/2005
Jones, David ............................................................................... Hodgen, OK ............................................................................... 5/19/2005
Kizziar, Mary ............................................................................... Fairfax, OK ................................................................................. 5/19/2005
Lomas, Terena ............................................................................ Grove, OK .................................................................................. 5/19/2005
Myers, Roger .............................................................................. Trainer, PA ................................................................................. 5/19/2005
Quintero, Mary ............................................................................ Denver, CO ................................................................................ 5/19/2005
Russell, Barbara ......................................................................... Sallisaw, OK ............................................................................... 5/19/2005
Rutherford, Helen ........................................................................ Ruston, LA ................................................................................. 5/19/2005
Simpson, Jimmy .......................................................................... Bartlesville, OK .......................................................................... 5/19/2005
Smith, Ada .................................................................................. Pearl, MS ................................................................................... 5/19/2005
Stultz, Helen ................................................................................ Hugo, OK ................................................................................... 5/19/2005
Thomas, Annamma ..................................................................... Yonkers, NY ............................................................................... 5/19/2005
Topel, Lisa .................................................................................. Chillicothe, MO ........................................................................... 5/19/2005
Torrez, Pearl ............................................................................... Tulsa, OK ................................................................................... 5/19/2005
Turner, Barbara ........................................................................... Louin, MS ................................................................................... 5/19/2005
Valenzula, Carlos ........................................................................ Los Angeles, CA ........................................................................ 5/19/2005
Watters, Winifred ........................................................................ Visalia, CA ................................................................................. 5/19/2005
Wolos, Jeffrey ............................................................................. Swartz Creek, MI ....................................................................... 5/19/2005
Woolen, James ........................................................................... Washington, DC ......................................................................... 5/19/2005
Conviction for Health Care Fraud:
Poehlman, Eric ............................................................................ Quebec, H2L3R8, ...................................................................... 3/17/2005
License Revocation/Suspension/Surrendered:
Agygman, Osei ........................................................................... Pomona, CA ............................................................................... 5/19/2005
Albus, Rhonda ............................................................................ Knox City, TX ............................................................................. 5/19/2005
Alexander, Anu ........................................................................... Tucson, AZ ................................................................................. 5/19/2005
Alexander, Julie .......................................................................... Cherry Hill, NJ ............................................................................ 5/19/2005
Allen, Chandra ............................................................................ Trotwood, OH ............................................................................. 5/19/2005
Ambrose, Dean ........................................................................... Merchantville, NY ....................................................................... 5/19/2005
Archer, Teresa ............................................................................ Johnson City, TN ....................................................................... 5/19/2005
Arvesen Aebischer, Barbara ....................................................... San Diego, CA ........................................................................... 5/19/2005

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 24822 Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices

Subject name Address Effective date

Baker, Patrick .............................................................................. Corona, CA ................................................................................ 5/19/2005

Benninger, Kimberly .................................................................... Los Angeles, CA ........................................................................ 5/19/2005
Benson, Tracy ............................................................................. Murray, UT ................................................................................. 5/19/2005
Boulos–Pludowski, Georgeann ................................................... Phillipsburg, NJ .......................................................................... 5/19/2005
Bowyer, Marvin ........................................................................... St Louis, MO .............................................................................. 5/19/2005
Boyer, Bethany ........................................................................... Valrico, FL .................................................................................. 5/19/2005
Bradshaw, Minnie ....................................................................... Columbia, SC ............................................................................. 5/19/2005
Brennan, Patricia ........................................................................ Punta Gorda, FL ........................................................................ 5/19/2005
Britton, Cory ................................................................................ St George, UT ............................................................................ 5/19/2005
Brown, Alexandria ....................................................................... Williamstown, NJ ........................................................................ 5/19/2005
Brown, Dana ............................................................................... Mount Olive, AL ......................................................................... 5/19/2005
Bruce, Julie ................................................................................. Indianapolis, IN .......................................................................... 5/19/2005
Bryant, Mark ................................................................................ Jasper, AL .................................................................................. 5/19/2005
Bullock, Keith .............................................................................. Detroit, MI .................................................................................. 5/19/2005
Cabatic, Virginia .......................................................................... Randolph, NJ ............................................................................. 5/19/2005
Carlson, Craig ............................................................................. Minneapolis, MN ........................................................................ 5/19/2005
Caron, Marleen ........................................................................... Lincoln, NH ................................................................................ 5/19/2005
Carranto, Manuel ........................................................................ Riverside, CA ............................................................................. 5/19/2005
Carter, Lynda .............................................................................. Loudon, NH ................................................................................ 5/19/2005
Casey, Terry ............................................................................... Covington, KY ............................................................................ 5/19/2005
Chagnon, Stephen ...................................................................... Glens Falls, NY .......................................................................... 5/19/2005
Chard, Suzanne .......................................................................... Parker, CO ................................................................................. 5/19/2005
Charlera, Marie ........................................................................... Boynton Beach, FL .................................................................... 5/19/2005
Charzewski, Stanley ................................................................... Staten Island, NY ....................................................................... 5/19/2005
Childers, Stella ............................................................................ Muskogee, OK ........................................................................... 5/19/2005
Clark, Diane ................................................................................ Longmont, CO ............................................................................ 5/19/2005
Cochran, Stephanie .................................................................... Hackleburg, AL .......................................................................... 5/19/2005
Cohen, Veronica ......................................................................... Lansdowne, PA .......................................................................... 5/19/2005
Collins, Cindy .............................................................................. North Vernon, IN ........................................................................ 5/19/2005
Combs, Vontella .......................................................................... Bulan, KY ................................................................................... 5/19/2005
Cook, Anthony ............................................................................ Beaver, WV ................................................................................ 5/19/2005
Couch, Joann .............................................................................. Bullhead City, AZ ....................................................................... 5/19/2005
Crayton, Donna ........................................................................... Alliance, OH ............................................................................... 5/19/2005
Cruz, Rosalito ............................................................................. Carson, CA ................................................................................ 5/19/2005
Daniels, Arthur ............................................................................ Phoenix, AZ ............................................................................... 5/19/2005
Daniels, James ........................................................................... Panama City, FL ........................................................................ 5/19/2005
Donegan, Kathleen ..................................................................... Yuma, AZ ................................................................................... 5/19/2005
Driscoll, Debra ............................................................................ N Hollywood, CA ........................................................................ 5/19/2005
Duffy, William .............................................................................. Mahtomedi, MN .......................................................................... 5/19/2005
Duncan, Kimberly ........................................................................ Pisgah Forest, NC ..................................................................... 5/19/2005
Ecker, Betty L ............................................................................. Lufkin, TX ................................................................................... 5/19/2005
EdInbyrd, Geraldine .................................................................... San Bernardino, CA ................................................................... 5/19/2005
Edwards, David ........................................................................... Salt Lake City, UT ...................................................................... 5/19/2005
Edwards, Michael ........................................................................ Tarzana, CA ............................................................................... 5/19/2005
Egloff, Mary ................................................................................. Farmingdale, NJ ......................................................................... 5/19/2005
Elder, Kimberly ............................................................................ Marshall, AR .............................................................................. 5/19/2005
Ellison, Amy ................................................................................ Anniston, AL ............................................................................... 5/19/2005
Eskue, Phyllis .............................................................................. Kilgore, TX ................................................................................. 5/19/2005
Esmay, Kristine ........................................................................... Prescott, AZ ............................................................................... 5/19/2005
Evans, Catherine ........................................................................ Hager Hill, KY ............................................................................ 5/19/2005
Ferry, Lois ................................................................................... Cincinnati, OH ............................................................................ 5/19/2005
Fiala, Robin ................................................................................. Manchester, NH ......................................................................... 5/19/2005
Foy, Brian .................................................................................... Melbourne, FL ............................................................................ 5/19/2005
Ghory, Farooq ............................................................................. Winter Park, FL .......................................................................... 5/19/2005
Gill, Joyce ................................................................................... Cincinnati, OH ............................................................................ 5/19/2005
Griesemer, Chantal ..................................................................... Ballston Lake, NY ...................................................................... 5/19/2005
Guardipee, Josette ...................................................................... Pueblo, CO ................................................................................ 5/19/2005
Hart, Eva ..................................................................................... Galena, KS ................................................................................. 5/19/2005
Hart, Kelly ................................................................................... Verona, PA ................................................................................. 5/19/2005
Harvan, Roberto .......................................................................... Glendale, AZ .............................................................................. 5/19/2005
Haskie, Julie ................................................................................ Chinle, AZ .................................................................................. 5/19/2005
Hatfield, Benjamin ....................................................................... Knoxville, TN .............................................................................. 5/19/2005
Hill, Beverly ................................................................................. Phoenix, AZ ............................................................................... 5/19/2005
Hopkins, Mary ............................................................................. Clute, TX .................................................................................... 5/19/2005
Horwitz, Harlene ......................................................................... Oklahoma City, OK .................................................................... 5/19/2005
Hughes, Joyce ............................................................................ Las Vegas, NV ........................................................................... 5/19/2005
Hunter, Angela ............................................................................ Gainesboro, TN .......................................................................... 5/19/2005
Illingworth, Donna ....................................................................... Forked River, NJ ........................................................................ 5/19/2005
Ingles, Sandra ............................................................................. Palm Desert, CA ........................................................................ 5/19/2005
James, Nicholas .......................................................................... Phoenix, AZ ............................................................................... 5/19/2005
Jarke, Cheryl ............................................................................... Rittman, OH ............................................................................... 5/19/2005
Johnson, Anthony ....................................................................... Beverly Hills, CA ........................................................................ 5/19/2005
Johnson, Callie ........................................................................... Tulsa, OK ................................................................................... 5/19/2005
Johnson, Mary ............................................................................ Taft, CA ...................................................................................... 5/19/2005

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 Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices 24823

Subject name Address Effective date

Junge, Rebecca .......................................................................... Saint Louis, MO ......................................................................... 5/19/2005

Kahalioumi, Ronald ..................................................................... Modesto, CA .............................................................................. 5/19/2005
Kaplan, Claudette ....................................................................... Port Orchard, WA ...................................................................... 5/19/2005
Katzorke, Michael ....................................................................... Sioux Falls, SD .......................................................................... 5/19/2005
Kee, Jimmy ................................................................................. Huntingdon, TN .......................................................................... 5/19/2005
Kessler, Susan ............................................................................ Tamarac, FL ............................................................................... 5/19/2005
Kirkpatrick, Molly ......................................................................... Punta Gorda, FL ........................................................................ 5/19/2005
Koscinski, Charles ...................................................................... Downey, CA ............................................................................... 5/19/2005
Kovar, Grace ............................................................................... Brick, NJ ..................................................................................... 5/19/2005
Kroeger, Susan ........................................................................... Evansville, IN ............................................................................. 5/19/2005
Kurtz, Joel ................................................................................... Livingston, NJ ............................................................................ 5/19/2005
Lange, Dennis San ..................................................................... Mateo, CA .................................................................................. 5/19/2005
Langley, Troy .............................................................................. Erin, TN ...................................................................................... 5/19/2005
Lester, Linda ............................................................................... Tucson, AZ ................................................................................. 5/19/2005
Leveque, Phillip ........................................................................... Portland, OR .............................................................................. 5/19/2005
Linn, David .................................................................................. Craig, CO ................................................................................... 5/19/2005
Logue, Bridgette .......................................................................... Shelbyville, TN ........................................................................... 5/19/2005
Long, Andrew .............................................................................. Fayetteville, NC .......................................................................... 5/19/2005
Lovett, Asante ............................................................................. Tulsa, OK ................................................................................... 5/19/2005
Lyde, Marlene ............................................................................. Norwalk, CA ............................................................................... 5/19/2005
Lyon, Robin ................................................................................. Lynnwood, WA ........................................................................... 5/19/2005
Machicek, Sherri ......................................................................... Victoria, TX ................................................................................ 5/19/2005
Malone, Joanne .......................................................................... Dallas, TX .................................................................................. 5/19/2005
Maloney, Jeffrey .......................................................................... Phoenix, AZ ............................................................................... 5/19/2005
Manuel, Christal .......................................................................... Evergreen, LA ............................................................................ 5/19/2005
Marshall, Brenda ......................................................................... Belleview, FL .............................................................................. 5/19/2005
Martinez, Christina ...................................................................... Sahuarita, AZ ............................................................................. 5/19/2005
Mclaurin, Mildred ......................................................................... Carrboro, NC .............................................................................. 5/19/2005
McNamara, Peggy ...................................................................... Puyallup, WA ............................................................................. 5/19/2005
Mohalla, Aiman ........................................................................... Long Beach, CA ......................................................................... 5/19/2005
Moore, Tiffany ............................................................................. Chandler, AZ .............................................................................. 5/19/2005
Morrissey, Maryellen ................................................................... Ormond Beach, FL .................................................................... 5/19/2005
Moss, Albert ................................................................................ Somerset, NJ ............................................................................. 5/19/2005
Mullins, Lonnie ............................................................................ Columbus, OH ........................................................................... 5/19/2005
Murphree, Arlene ........................................................................ Tulsa, OK ................................................................................... 5/19/2005
Nagel, Tiffany .............................................................................. League City, TX ......................................................................... 5/19/2005
Neide, Deborah ........................................................................... Umatilla, FL ................................................................................ 5/19/2005
Nemitz, Lacey ............................................................................. Mount Vernon, WA .................................................................... 5/19/2005
Nenadov, Barney ........................................................................ Canyon Country, CA .................................................................. 5/19/2005
Nesbit, Harriet ............................................................................. Rutland, VT ................................................................................ 5/19/2005
Newington, Marlene .................................................................... Hartford, MI ................................................................................ 5/19/2005
Newmark, Malinda ...................................................................... Monroe TWP, NJ ....................................................................... 5/19/2005
Noel, Beverly ............................................................................... New Hall, CA ............................................................................. 5/19/2005
Nugent, Dana .............................................................................. Pineville, LA ............................................................................... 5/19/2005
Nunnery, Larita ........................................................................... Kent, WA .................................................................................... 5/19/2005
OBright, Teresa ........................................................................... W Chicago, IL ............................................................................ 5/19/2005
Osborne, Robelto ........................................................................ Miami, FL ................................................................................... 5/19/2005
Ottenstein, Alan .......................................................................... Washington Crossing, PA .......................................................... 5/19/2005
Owens, Catherine ....................................................................... Glencoe, AL ............................................................................... 5/19/2005
Pagano, Dwight ........................................................................... New York, NY ............................................................................ 5/19/2005
Parker–Robinson, Letrice ........................................................... Long Beach, CA ......................................................................... 5/19/2005
Paulsen, John ............................................................................. Beaver, UT ................................................................................. 5/19/2005
Paxton, Marla .............................................................................. Delong, IN .................................................................................. 5/19/2005
Pearson, Shirley .......................................................................... Rapid City, SD ........................................................................... 5/19/2005
Penalver, Faith ............................................................................ Roosevelt, NJ ............................................................................. 5/19/2005
Perry, Regan ............................................................................... Huntsville, AL ............................................................................. 5/19/2005
Plaia, Daneta .............................................................................. Hickory Hills, IL .......................................................................... 5/19/2005
Potter, Joan ................................................................................. Ventura, CA ............................................................................... 5/19/2005
Presilla, Alejandro ....................................................................... Weehawken, NJ ......................................................................... 5/19/2005
Ramsey, James .......................................................................... Concord, NH .............................................................................. 5/19/2005
Rice, Ginger ................................................................................ Newport, TN ............................................................................... 5/19/2005
Robinson, Anne .......................................................................... Redondo Beach, CA .................................................................. 5/19/2005
Robles, Karin .............................................................................. Yelm, WA ................................................................................... 5/19/2005
Rodriguez, Callis ......................................................................... Fontana, CA ............................................................................... 5/19/2005
Roring, Kellie ............................................................................... Orem, UT ................................................................................... 5/19/2005
Rudolph, Angaharad ................................................................... Bradenton, FL ............................................................................ 5/19/2005
Sanders, Cheryl .......................................................................... Riverside, AL .............................................................................. 5/19/2005
Schick, Peter ............................................................................... Van Nuys, CA ............................................................................ 5/19/2005
Schirmer, Christopher ................................................................. North Bennington, VT ................................................................ 5/19/2005
Schultz, Becky ............................................................................ Greeley, CO ............................................................................... 5/19/2005
Schunk, Brenda .......................................................................... Tucson, AZ ................................................................................. 5/19/2005
Sieverding, Gregory .................................................................... Peru, NY .................................................................................... 5/19/2005
Silver, Maria ................................................................................ Las Vegas, NV ........................................................................... 5/19/2005
Simon, Lynn ................................................................................ Cape Coral, FL .......................................................................... 5/19/2005

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 24824 Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices

Subject name Address Effective date

Smith, Nicholas ........................................................................... Oviedo, FL ................................................................................. 5/19/2005

Steidl, Elizabeth .......................................................................... Palm Bay, FL ............................................................................. 5/19/2005
Stiver, Dorothea .......................................................................... Clanton, AL ................................................................................ 5/19/2005
Suggs, Sharon ............................................................................ Adamsville, TN ........................................................................... 5/19/2005
Sutphin, Mary .............................................................................. Goodview, VA ............................................................................ 5/19/2005
Swartz, Theresa .......................................................................... Jacksonville, FL ......................................................................... 5/19/2005
Taylor, Ronald ............................................................................. Carson, CA ................................................................................ 5/19/2005
Tebo, Elizabeth ........................................................................... Grover, MO ................................................................................ 5/19/2005
Thomas, Cynthia ......................................................................... Brooksville, FL ........................................................................... 5/19/2005
Turk, Harold ................................................................................ West Hills, CA ............................................................................ 5/19/2005
Valandry, Kelly ............................................................................ Tucson, AZ ................................................................................. 5/19/2005
Vaughn, Barbara ......................................................................... Kingsport, TN ............................................................................. 5/19/2005
Vidal, Emalee .............................................................................. Gig Harbor, WA ......................................................................... 5/19/2005
Vincelette, Brandi ........................................................................ Enosburg Falls, VT .................................................................... 5/19/2005
Von Hoffen, Laura ....................................................................... Chicago, IL ................................................................................. 5/19/2005
Vu, Uong ..................................................................................... San Diego, CA ........................................................................... 5/19/2005
Walker, Robert ............................................................................ Sand Springs, OK ...................................................................... 5/19/2005
Wamsley, Patricia ....................................................................... Mansfield, OH ............................................................................ 5/19/2005
Watkins, William .......................................................................... Vista, CA .................................................................................... 5/19/2005
Wilson, Michael ........................................................................... Chicago, IL ................................................................................. 5/19/2005
Wilson, Orphia ............................................................................ Orlando, FL ................................................................................ 5/19/2005
Wizes, Adrian .............................................................................. Lake George, NY ....................................................................... 5/19/2005
Wood, Danielle ............................................................................ Irving, TX .................................................................................... 5/19/2005
Wood, Margaret .......................................................................... Denver, CO ................................................................................ 5/19/2005
Wukawitz, Thomas ...................................................................... St Paul, MN ................................................................................ 5/19/2005
Zapata, Francisco ....................................................................... Oxnard, CA ................................................................................ 5/19/2005
Zini, Julie ..................................................................................... Annandale, MN .......................................................................... 5/19/2005
Federal/State Exclusion/Suspension:
Gonzales, Thomas ...................................................................... Las Vegas, NV ........................................................................... 5/19/2005
Groombridge, Colleen ................................................................. Gillette, WY ................................................................................ 5/19/2005
Umansky, Olga ........................................................................... Los Angeles, CA ........................................................................ 5/19/2005
Fraud/Kickbacks/Prohibited Acts/Settlement Agreements:
Masri, Asad ................................................................................. Chesterfield, VA ......................................................................... 10/6/1994
Owned/Controlled by Convicted Entities:
Advanced Physicians Management, Inc ..................................... Ocoee, FL .................................................................................. 5/19/2005
Americare Medical Supply, Inc ................................................... Los Angeles, CA ........................................................................ 5/19/2005
Default on Heal Loan:
Kilmer, David ............................................................................... Troutville, VA .............................................................................. 2/22/2005
Mazhar, Mark .............................................................................. Woodland Hills, CA .................................................................... 4/18/2005

Dated: April 28, 2005. 58451 and 58452 and allowed 60-days rapidly conduct high quality clinical
Katherine B. Petrowski, for public comment. No public studies where multiple research
Director, Exclusions Staff, Office of Inspector comments were received. The purpose questions can be addressed.
General. of this notice is to allow an additional Specifically, this study involves (1)
[FR Doc. 05–9374 Filed 5–10–05; 8:45 am] 30 days for public comment. The developing an inventory and database of
BILLING CODE 4152–01–P
National Institutes of Health may not clinical research networks, (2) asking
conduct or sponsor, and the respondent representatives from these networks to
is not required to respond to, an respond to an Inventory Questionnaire
DEPARTMENT OF HEALTH AND information collection that has been (Tier 1) that will allow us to update
HUMAN SERVICES extended, revised, or implemented on or information we collected from public
after October 1, 1995, unless it displays sources and gather additional
National Institutes of Health a currently valid OMB control number. information on network characteristics,
Proposed Collection: and (3) conducting more in-depth
Proposed Collection; Comment Title: Inventory and Evaluation of surveys (Tier 2) with 1⁄3 of the identified
Request; Inventory and Evaluation of Clinical Research Networks. networks (Tier 2). Data will be used to
Clinical Research Networks Type of Information Collection characterize the selected networks in
Request: NEW. terms of network focus, management
Summary: Under the provisions of Need and Use of Information and governance, effectiveness in
Section 3507(a)(1)(D) of the Paperwork Collection: This project is part of the changing clinical practice, informatics
Reduction Act of 1995, the National NIH Roadmap to improve the speed and infrastructure, and training and training
Heart, Lung and Blood Institute effectiveness of translating basic infrastructure. Best practices will be
(NHLBI), the National Institutes of scientific discoveries into clinical identified and presented at a national
Health (NIH) has submitted to the Office products and practices that improve leadership forum.
of Management and Budget (OMB) a health care. The project, which is Frequency of Response: Networks will
request for review and approval of the related to the Reengineering of the be asked to respond to the Inventory
information collection listed below. Clinical Research Enterprise, has been Questionnaire (Tier 1) once. It is
This proposed information collection designed to enhance the efficiency and anticipated that 60% of the networks
was previously published in the Federal productivity of clinical research by queried will actually meet the network
Register on September 30, 2004, page promoting clinical research networks to eligibility criteria. A 1⁄3 sample of the

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