Professional Documents
Culture Documents
Therapeutic usefulness convertible into thebaine, and because ADDRESSES) written or electric
Dronabinol preparations have been used in thebaine is in turn convertible into comments regarding this document.
a limited number of countries in the morphine. Thebaine and morphine are both Submit a single copy of electronic
treatment of nausea and vomiting associated in Schedule I of the 1961 Convention. Owing
comments or two paper copies of any
with cancer chemotherapy in patients who to uncertainties regarding the scheduling of
have failed to respond adequately to oripavine based on the additional possibility mailed comments, except that
conventional antiemetic treatments and in of applying the 1988 Convention (2), the individuals may submit one paper copy.
the treatment of anorexia associated with Committee did not finalize this review at its Comments are to be identified with the
weight loss in patients with acquired thirty-third meeting, but asked WHO for docket number found in brackets in the
immunodeficiency syndrome (AIDS). It has clarification of issues related to the heading of this document. Received
also been indicated in the treatment of conversion of precursors into scheduled comments may be seen in the Division
chronic pain (e.g. in multiple sclerosis, substances. Subsequent clarification of these of Dockets Management between 9 a.m.
neuropathic disorders and arthritis), issues allowed the Committee to come to a
and 4 p.m., Monday through Friday.
neurological disorders and appetite loss in conclusion at its thirty-fourth meeting.
cachexia, and is being evaluated for use in Recommendation The abbreviated period for the
various other clinical situations. The Committee decided that oripavine is a submission of comments is necessary to
Recommendation substance that is easily convertible into allow sufficient time for the Secretary of
The Committee reconsidered the thebaine and other substances controlled in HHS to carry out the required action
recommendation of the thirty-third Expert Schedule I of the 1961 Convention. Hence, and respond to the United Nations.
Committee after considering the updated the Committee recommended that oripavine
Dated: December 6, 2006.
critical review report. The Committee be scheduled, like the substances mentioned,
concluded that dronabinol constitutes a in Schedule I of the 1961 Convention. Jeffrey Shuren,
substantial risk to public health. However References Assistant Commissioner for Policy.
this risk is different from those related to 1. WHO Expert Committee on Drug [FR Doc. E6–21318 Filed 12–14–06; 8:45 am]
cannabis—controlled under the 1961 Dependence. Thirty-third report. Geneva, BILLING CODE 4160–01–S
Convention. The substance has a moderate World Health Organization, 2003 (WHO
therapeutic usefulness and as a result of Technical Report Series, No. 915).
continuing clinical research its medical use 2. United Nations Convention against Illicit
DEPARTMENT OF HEALTH AND
is likely to increase. Therefore, the Traffic in Narcotic Drugs and Psychotropic
Committee recommended that dronabinol Substances, 1988. New York, United Nations, HUMAN SERVICES
(INN) and its stereoisomers should be 1991.
rescheduled from Schedule II to Schedule III Office of Inspector General
of the 1971 Convention. III. Discussion
To avoid legal and forensic chemical
Notice of Program Exclusions
Although WHO has made specific
problems that may arise in some countries scheduling recommendations for each of AGENCY: Office of Inspector General,
when placing stereoisomers of the same the drug substances, CND is not obliged HHS.
substance under different control systems,
to follow the WHO recommendations. ACTION: Notice of program exclusions.
the Committee indicated that the
recommendation pertains to all Options available to CND for substances
considered for control under the 1971 Important Announcement: This is the
stereoisomeric forms of delta-9-
tetrahydrocannabinol as specified above. Convention include the following: (1) final publication of the Office of
References Acceptance of the WHO Inspector General’s (OIG) monthly
1. WHO Expert Committee on Drug recommendations; (2) acceptance of the exclusion actions in the Federal
Dependence. Twenty-sixth report. Geneva, recommendations to control, but control Register. Downloadable files of
World Health Organization, 1989 (WHO the drug substance in a schedule other exclusion actions taken each month are
Technical Report Series, No. 787). than that recommended; or (3) reject the available on the OIG’s Web site. In
2. WHO Expert Committee on Drug addition, the Web site has a
recommendations entirely.
Dependence. Twenty-seventh report. Geneva, downloadable data file and an online
World Health Organization, 1991 (WHO
Synthetic delta-9-
tetrahydrocannabinol (delta–9–THC), or searchable database containing all
Technical Report Series, No. 808).
3. Report of the thirty-fourth session (29 dronabinol, is the active component of exclusion actions currently in effect.
April–9 May 1991). Economic and Social the drug product Marinol, which is This data is called the List of Excluded
Council, Commission on Narcotic Drugs, marketed in the United States as an Individuals/Entities (LEIE) and is
Official Records, 1991, Supplement No. 4. antiemetic in the setting of cancer located at http://oig.hhs.gov. Click on
New York, United Nations, 1991 (E/1991/24, chemotherapy and for treatment of AIDS EXCLUSIONS DATABASE to access the
E/Cn.7/1991/26). wasting syndrome. Marinol is currently LEIE and other important information
4. WHO Expert Committee on Drug controlled in Schedule III of the CSA, about the OIG’s exclusion program.
Dependence. Thirty-second report. Geneva, Program Exclusions: November 2006.
World Health Organization, 2001 (WHO
and the drug substance dronabinol
(which is the synthetic equivalent of the During the month of November 2006,
Technical Report Series, No. 903). the HHS Office of Inspector General
5. WHO Expert Committee on Drug natural active component of marijuana,
Dependence. Thirty-third report. Geneva, delta–9–THC) is controlled in Schedule imposed exclusions in the cases set
World Health Organization, 2003 (WHO I of the CSA. The drug substance forth below. When an exclusions is
Technical Report Series, No. 915). dronabinol, including its stereoisomers, imposed, no program payment is made
Recommendation on oripavine is controlled internationally in Schedule to anyone for any items or services
Substance identification II of the Psychotropic Convention. (other than an emergency item or
Oripavine, 3-O-demethylthebaine, or 6,7,8, Oripavine is controlled domestically service not provided in a hospital
14-tetradehydro-4,5-alpha-epoxy-6-methoxy- in Schedule II of the CSA because it is emergency room) furnished, ordered or
17-methylmorphinan-3-ol is a phenanthrene prescribed by an excluded party under
a derivative of thebaine, opium, and
mstockstill on PROD1PC61 with NOTICES
alkaloid contained in species of the Papaver the Medicare, Medicaid, and all Federal
plant. It is a major metabolite of thebaine. other opiates. Oripavine is not under
Previous review international control. Health Care programs. In addition, no
Oripavine was pre-reviewed at the thirty- program payment is made to any
IV. Comments business or facility, e.g., a hospital, that
third meeting of the Expert Committee in
2002 (1). The reason for pre-review in 2002 Interested persons may submit to the submits bills for payment for items or
was that oripavine is a substance that is Division of Dockets Management (see services provided by an excluded party.
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Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices 75563
Program beneficiaries remain free to payments will be made for items and Branch procurement and non-
decide for themselves whether they will services provided by that excluded procurement programs and activities.
continue to use the services of an party. The exclusions have national
excluded party even though no program effect and also apply to all Executive
PROGRAM-RELATED CONVICTION
CONVICTION-OBSTRUCTION OF AN INVESTIGATION
LICENSE REVOCATION/SUSPENSION/SURRENDER
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75564 Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices
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Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices 75565
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75566 Federal Register / Vol. 71, No. 241 / Friday, December 15, 2006 / Notices
Dated: December 6, 2006. Date: January 22, 2007. Dated: December 11, 2006.
Maureen R. Byer, Open: 8:30 a.m. to 12 p.m. Anna Snouffer,
Director, Exclusions Staff, Office of Inspector Agenda: Directors’ Report, Budget Update, Acting Director, Office of Federal Advisory
General. The NIEHS ONES Program: Encouraging New Committee Policy.
[FR Doc. E6–21363 Filed 12–14–06; 8:45 am] Investigators, Center for Scientific Review: [FR Doc. 06–9730 Filed 12–14–06; 8:45 am]
BILLING CODE 4152–01–P
New Approaches in Peer Review for New BILLING CODE 4140–01–M
Investigators
Place: National Institutes of Health,
DEPARTMENT OF HEALTH AND Building 31, C Wing, 31 Center Drive, 6th DEPARTMENT OF HEALTH AND
HUMAN SERVICES Floor, Conference Room 6, Bethesda, MD HUMAN SERVICES
20892.
National Institutes of Health Closed: 1 p.m. to 4:30 p.m. National Institutes of Health
Agenda: To review and evaluate grant
National Institute of Dental & applications and/or proposals. National Institute of Dental and
Craniofacial Research; Notice of Place: National Institutes of Health, Craniofacial Research; Notice of
Meeting Building 31, C Wing, 31 Center Drive, 6th Closed Meetings
Floor, Conference Room 6, Bethesda, MD
Pursuant to section 10(d) of the 20892. Pursuant to section 10(d) of the
Federal Advisory Committee Act, as Contact Person: Norman S. Braveman, Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice PhD, Assistant to the Director, NIH–NIDCR, amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the Building 31, Rm. 5B55, Bethesda, MD 20892, is hereby given of the following
National Advisory Dental and 301 594–2089, meetings.
Craniofacal Research Council. NORMAN.BRAVEMAN@NIH.GOV. The meetings will be closed to the
The meeting will be open to the Any interested person may file written public in accordance with the
public as indicated below, with comments with the committee by forwarding provisions set forth in sections
attendance limited to space available. the statement to the Contact Person listed on 552b(c)(4) and 552(c)(6), Title 5 U.S.C.,
Individuals who plan to attend and this notice. The statement should include the as amended. The grant applications and
need special assistance, such as sign name, address, telephone number and when the discussions could disclose
language interpretation or other applicable, the business or professional confidential trade secrets or commercial
reasonable accommodations, should affiliation of the interested person. property such as patentable material,
notify the Contact Person listed below In the interest of security, NIH has and personal information concerning
in advance of the meeting. instituted stringent procedures for entrance individuals associated with the grant
The meeting will be closed to the onto the NIH campus. All visitor vehicles, applications, the disclosure of which
public in accordance with the including taxicabs, hotel, and airport shuttles would constitute a clearly unwarranted
provisions set forth in sections will be inspected before being allowed on invasion of personal privacy.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., campus. Visitors will be asked to show one
Name of Committee: National Institute of
as amended. The grant applications form of identification (for example, a Dental and Craniofacial Research Special
and/or contract proposals and the government-issued photo ID, driver’s license, Emphasis Panel, 07–22, Review PAR–05–101
discussions could disclose confidential or passport) and to state the purpose of their Institutional Dental Research Training
trade secrets or commercial property visit. Program.
such as patentable material, and Information is also available on the Date: January 9, 2007.
personal information concerning Institute’s/Center’s home page: http:// Time: 8 a.m. to 5 p.m.
individuals associated with the grant www.nidcr.nih.gov/about, where an agenda Agenda: To review and evaluate grant
mstockstill on PROD1PC61 with NOTICES
applications and/or contracts proposals, and any additional information for the applications.
the disclosure of which would meeting will be posted when available. Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
constitute a clearly unwarranted (Catalogue of Federal Domestic Assistance Contact Person: Lynn M. King, PhD,
invasion of personal privacy. Program Nos. 93.121, Oral Diseases and Scientific Review Administrator, Scientific
Name of Committee: National Advisory Disorders Research, National Institutes of Review Branch, 45 Center Dr., Rm 4AN–32F,
Dental and Craniofacial Research Council. Health, HHS) National Institute of Dental and Craniofacial
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