Professional Documents
Culture Documents
antibodies and other existing IgG III. Comments DEPARTMENT OF HEALTH AND
antibodies. The guidance also identifies HUMAN SERVICES
The draft guidance is being
labeling changes to be submitted as a distributed for comment purposes only
supplement for changes being effected Office of Inspector General
and is not intended for implementation
under § 601.12(f)(2)(i)(E). The guidance at this time. Interested persons may Program Exclusions: September 2005
neither includes recommendations submit to the Division of Dockets
related to implementing Management (see ADDRESSES) written or AGENCY: Office of Inspector General,
Immunoglobulin M antibody collection electronic comments regarding the draft HHS.
programs, nor does it include guidance. Submit written or electronic ACTION: Notice of program exclusions.
recommendations for donors who do comments to ensure adequate
not meet all donor suitability consideration in preparation of the final During the month of September 2005,
requirements under 21 CFR 640.63. guidance. Submit a single copy of the HHS Office of Inspector General
electronic comments or two paper imposed exclusions in the cases set
The draft guidance is being issued
copies of any mailed comments, except forth below. When an exclusion is
consistent with FDA’s good guidance imposed, no program payment is made
practices regulation (21 CFR 10.115). that individuals may submit one paper
copy. Comments are to be identified to anyone for any items or services
The draft guidance, when finalized, will (other than an emergency item or
represent FDA’s current thinking on this with the docket number found in the
brackets in the heading of this service not provided in a hospital
topic. It does not create or confer any emergency room) furnished, ordered or
document. A copy of the draft guidance
rights for or on any person and does not prescribed by an excluded party under
and received comments are available for
operate to bind FDA or the public. An the Medicare, Medicaid, and all Federal
public examination in the Division of
alternative approach may be used if Dockets Management between 9 a.m. Health Care programs. In addition, no
such approach satisfies the requirement and 4 p.m., Monday through Friday. program payment is made to any
of the applicable statutes and business or facility, e.g., a hospital, that
regulations. IV. Electronic Access submits bills for payment for items or
Persons with access to the Internet services provided by an excluded party.
II. Paperwork Reduction Act of 1995 Program beneficiaries remain free to
may obtain the draft guidance at either
This guidance contains information http://www.fda.gov/cber/guidelines.htm decide for themselves whether they will
collection provisions that are subject to or http://www.fda.gov/ohrms/dockets/ continue to use the services of an
review by the Office of Management and default.htm. excluded party even though no program
Budget (OMB) under the Paperwork payments will be made for items and
Dated: October 12, 2005. services provided by that excluded
Reduction Act of 1995 (44 U.S.C. 3501– Jeffrey Shuren, party. The exclusions have national
3520). The collection(s) of information Assistant Commissioner for Policy. effect and also apply to all Executive
in this guidance was approved under [FR Doc. 05–20958 Filed 10–19–05; 8:45 am] Branch procurement and non-
OMB control number 0910–0338. BILLING CODE 4160–01–S procurement programs and activities.
Program-Related Convictions:
Agopian, Ovsanna ................................................................................................. Granada Hills, CA ..................................... 10/20/2005
Altidor, Rejeanne ................................................................................................... Elmont, NY ................................................ 10/20/2005
Andino, Rosario ..................................................................................................... Miami, FL .................................................. 10/20/2005
Arnold, David ......................................................................................................... Athens, PA ................................................ 10/20/2005
Arthur Avenue Pharmacy ...................................................................................... Bronx, NY ................................................. 10/20/2005
Bagley, Barbara .................................................................................................... Los Angeles, CA ....................................... 10/20/2005
Barragan, Elian ..................................................................................................... Bronx, NY ................................................. 10/20/2005
Barrett, Nadine ...................................................................................................... Bronx, NY ................................................. 10/20/2005
Blumberg, Gary ..................................................................................................... Deerfield, FL ............................................. 10/20/2005
Brailsford, Philip .................................................................................................... Escondido, CA .......................................... 10/20/2005
Brown, Roger ........................................................................................................ Trenton, NJ ............................................... 10/20/2005
Burleson, Delpha ................................................................................................... Purcell, OK ................................................ 10/20/2005
Butts, Frank ........................................................................................................... Texarkana, TX .......................................... 10/20/2005
Cansler, Ronnie .................................................................................................... Los Angeles, CA ....................................... 10/20/2005
Cardio Diagnostic Technology & Consultants, Inc ............................................... Westerville, OH ......................................... 10/20/2005
Celestin, Andre ...................................................................................................... Elmont, NY ................................................ 10/20/2005
Central Community Service, Inc ........................................................................... Los Angeles, CA ....................................... 10/20/2005
Chaffin, Alisa ......................................................................................................... Lansing, MI ............................................... 10/20/2005
Choi, Ricardo ........................................................................................................ Miami, FL .................................................. 10/20/2005
Cifelli, Charles ....................................................................................................... The Villages, FL ........................................ 10/20/2005
Cifelli, Darren ........................................................................................................ West Yarmouth, MA ................................. 10/20/2005
Cifelli, Karen .......................................................................................................... West Yarmouth, MA ................................. 10/20/2005
Clark, Harry ........................................................................................................... Pensacola, FL ........................................... 10/20/2005
Clark, Shirley ......................................................................................................... Vallejo, CA ................................................ 10/20/2005
Collins, Monique .................................................................................................... New Orleans, LA ...................................... 10/20/2005
Davidson, Lee ....................................................................................................... Los Angeles, CA ....................................... 10/20/2005
Davis, James ......................................................................................................... Irving, TX .................................................. 10/20/2005
Du, Danny ............................................................................................................. Wasco, CA ................................................ 10/20/2005
Estevez, Maria ...................................................................................................... Coleman, FL ............................................. 10/20/2005
Fabian, Misty ......................................................................................................... Timpson, TX ............................................. 10/20/2005
Flanigan, George .................................................................................................. Los Angeles, CA ....................................... 10/20/2005
Flores, William ....................................................................................................... Los Angeles, CA ....................................... 10/20/2005
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61140 Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
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61142 Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
Dated: October 6, 2005. dopamine released into the extracellular Novobiocin Analogues as Anticancer
Katherine B. Petrowski, space, thereby regulating Agents
neurotransmission. The dopamine
Director, Exclusions Staff, Office of Inspector
Leonard M. Neckers (NCI) et al.
General. transporter plays a significant role in
[FR Doc. 05–20963 Filed 10–19–05; 8:45 am]neurotoxicity and human diseases, such U.S. Provisional Application No. 60/
BILLING CODE 4152–01–P as Parkinson’s disease, drug abuse 624,566 filed 03 Nov 2004 (HHS
(especially cocaine addiction), Attention Reference No. E–065–2005/0–US–01).
Deficit Disorder/Attention Deficit Licensing Contact: George Pipia; 301/
DEPARTMENT OF HEALTH AND 435–5560; pipiag@mail.nih.gov.
Hyperactivity Disorder (ADD/ADHD),
HUMAN SERVICES and a number of other CNS disorders. Functional Hsp90 requires C-terminal
Therefore, the dopamine transporter is a homodimerization of two molecules of
National Institutes of Health Hsp90. Novobiocin competes with ATP
strong target for research and the
discovery of potential therapeutics for for binding to the C-terminus and
Government-Owned Inventions; studies demonstrated that this binding
Availability for Licensing the treatment of these indications.
results in degradation of Hsp90 protein
AGENCY: National Institutes of Health, Benztropine and its analogs bind with through ubiquitination and ultimately
Public Health Service, HHS. high affinity to the DAT and inhibit transportation to proteosome for
ACTION: Notice. dopamine reuptake, but generally do not proteolysis. Twenty three analogs of
produce behavioral effects comparable novobiocin were prepared and screened
SUMMARY: The inventions listed below to those produced by cocaine. Recent for their activity against Hsp90 and the
are owned by an agency of the U.S. benztropine analogs have been shown to most active derivatives were identified.
Government and are available for (1) reduce cocaine-induced stimulant Novobiocin was previously identified as
licensing in the U.S. in accordance with effects, (2) retain long-lasting actions, an inhibitor of type II topoisomerases
35 U.S.C. 207 to achieve expeditious and (3) lack significant abuse liability. and has been used clinically for more
commercialization of results of federally These data suggest that this class of than a decade for the treatment of
funded research and development. compounds may be useful medications cancer. However recent studies have
Foreign patent applications are filed on for human diseases where dopamine- shown that novobiocin selectively
selected inventions to extend market related behavior is compromised, inhibits the maturation of Hsp90
coverage for companies and may also be dependent proteins. In addition to its
especially in situations in which an
available for licensing. effect on Hsp90, novobiocin has been
agonist treatment is indicated.
ADDRESSES: Licensing information and shown to reverse drug resistance and
copies of the U.S. patent applications Although the benztropines bind with increase the intracellular concentration
listed below may be obtained by writing high affinity to the DAT without of topoisomerase II drugs such as
to the indicated licensing contact at the substitution in the 2-position of the Etoposide and tubulin binding drugs,
Office of Technology Transfer, National tropane ring, only a substituent in the S- such as Taxol, making cells more
Institutes of Health, 6011 Executive configuration is tolerated at DAT, in susceptible to chemotherapeutics and
Boulevard, Suite 325, Rockville, direct contrast to cocaine and its analogs induction of apoptosis.
Maryland 20852–3804; telephone: 301/ that must have the 2-position This research is described, in part, in:
496–7057; fax: 301/402–0220. A signed substituent in the R-configuration. In Yu XM, Shen G, Neckers L, Blake H,
Confidential Disclosure Agreement will this invention, substitution at the S-2- Holzbeierlein J, Cronk B and Blagg BSJ.
be required to receive copies of the position of 4′,4″-difluoro-or 4′,4″- ‘‘Hsp90 Inhibitors Identified from a
patent applications. dichlorobenztropines with various Library of Novobiocin Analogues,’’ J.
functional groups such as alkyl, aryl, Am. Chem. Soc., in press.
N- and 2-Substituted Benztropine
akyl, alcohol, ether, etc., as well as In addition to licensing, the
Compounds and Use Thereof for
substitution at the tropane nitrogen technology is available for further
Treating Mental Disorders
were achieved and have demonstrated development through collaborative
Amy H. Newman et al. (NIDA) high affinity and selectivity for the DAT research opportunities with the
U.S. Provisional Application filed 24 over the other monoamine transporters inventors.
Aug 2005 (HHS Reference No. E–234– as well as muscarinic receptors, without Anticancer Effects of Novel Vitamin D
2005/0–US–01). a significant cocaine-like behavioral Receptor Antagonists
Licensing Contact: Marlene Shinn-Astor; profile.
301/435–4426; shinnm@mail.nih.gov. Julianna Barsony (NIDDK)
In addition to licensing, the
Dopamine is a neurotransmitter that U.S. Provisional Application No. 60/
technology is available for further
exerts important effects on locomotor 300,409 filed 22 Jun 2001 (HHS
development through collaborative
activity, motivation and reward, and Reference No. E–213–2001/1–US–01).
research opportunities with the
cognition. The dopamine transporter PCT Patent Application No. PCT/US02/
(DAT) is expressed on the plasma inventors. 19774 filed 20 Jun 2002 (HHS
membrane of dopamine synthesizing Reference No. E–213–2001/2–PCT–
neurons. It is responsible for clearing 01).
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