International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine; Khat; Tramadol; Zopiclone; Buprenorphine; Oripavine, 73775-73779 [05-23958]
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Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices
accepted definition of what constitutes
a stillbirth, and there are no universally
recommended, standardized stillbirth
evaluation protocols in use for the
evaluation of fetal deaths. The proposed
survey has been designed to evaluate
and assess the knowledge, attitudes and
practice management patterns of
obstetricians in the metropolitan Atlanta
area regarding stillbirths in general, as
well as in their medical practice. This
information will be used to identify
prevailing deficiencies leading to
incomplete and inaccurate reporting of
data relative to stillbirths, and to
develop targeted awareness and
educational strategies for participating
MACDP facilities. Ongoing, accurate
and reliable population-based registries
of stillbirths are essential for conducting
epidemiologic studies on the causes of
and risk factors for this pregnancy
outcome. This survey will be mailed to
randomly selected obstetricians whose
practices serve residents of the 5
counties comprising metropolitan
Atlanta. This survey will be conducted
once and will take approximately 2–3
months to collect the data. NCBDDD is
requesting OMB clearance for 1 (one)
year. There is no cost to the survey
respondents except for the time
necessary to complete the survey.
ESTIMATED ANNUALIZED BURDEN TABLE
Respondents
(type)
Respondents
(number)
Obstetricians ............................................................................................
Total ..................................................................................................
Dated: December 7, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E5–7260 Filed 12–12–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0479]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; Butorphanol; Delta–9–
tetrahydrocannabinol (Dronabinol);
Gamma-Hydroxybutyric Acid;
Ketamine; Khat; Tramadol; Zopiclone;
Buprenorphine; Oripavine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
interested persons to submit comments
concerning abuse potential, actual
abuse, medical usefulness, trafficking,
and impact of scheduling changes on
availability for medical use of nine drug
substances. These comments will be
considered in preparing a response from
the United States to the World Health
Organization (WHO) regarding the abuse
liability and diversion of these drugs.
WHO will use this information to
consider whether to recommend that
certain international restrictions be
placed on these drugs. This notice
requesting comments is required by the
Controlled Substances Act (CSA).
DATES: Submit written or electronic
comments by January 12, 2006.
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600
600
Number of
responses per
respondent
Average burden
per response
(in hrs.)
1
..........................
30/60
..........................
Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
James R. Hunter, Center for Drug
Evaluation and Research (HFD–9), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–443–
5563, e mail: hunterj@cder.FDA.gov.
SUPPLEMENTARY INFORMATION: The
United States is a party to the 1971
Convention on Psychotropic
Substances. Article 2 of the Convention
on Psychotropic Substances provides
that if a party to the convention or WHO
has information about a substance,
which in its opinion may require
international control or change in such
control, it shall so notify the Secretary
General of the United Nations and
provide the Secretary General of the
United Nations with information in
support of its opinion.
The CSA (21 U.S.C. 811 et seq.) (Title
II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970)
provides that when WHO notifies the
United States under Article 2 of the
Convention on Psychotropic Substances
that it has information that may justify
adding a drug or other substances to one
of the schedules of the convention,
transferring a drug or substance from
one schedule to another, or deleting it
from the schedules, the Secretary of
State must transmit the notice to the
Secretary of the Department of Health
and Human Services (the Secretary of
HHS). The Secretary of HHS must then
publish the notice in the Federal
Register and provide opportunity for
interested persons to submit comments
that will be considered by HHS in its
ADDRESSES:
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Total burden
(in hrs.)
300
300
preparation of the scientific and medical
evaluations of the drug or substance.
I. WHO Notification
The Secretary of HHS received the
following notices from WHO:
Ref: C.L.29.2005
WHO Questionnaire for Collection of
Information for Review of DependenceProducing Psychoactive Substances
The WHO presents its compliments and
has the pleasure of informing Member States
and Associate Members that the Thirty-fourth
Expert Committee on Drug Dependence will
meet from March 28 to 31, 2006 to review the
following substances:
1. Butorphanol (INN)
2. Dronabinol (INN)1
3. Gamma-hydroxybutyric acid
4. Ketamine (INN)
5. Khat (Catha edulis Forsk)
6. Tramadol (INN)
7. Zopiclone (INN)
As a follow-up for the thirty-third meeting
of the Expert Committee on Drug
Dependence, final decisions will be taken for
buprenorphine (INN) and oripavine (INN).
One of the essential elements of the
established review procedure is for the
Secretariat to collect relevant information
from Member States to prepare a Critical
Review Report for submission to the Expert
Committee on Drug Dependence. WHO
invites Member States to collaborate, as in
the past, in this process by providing
pertinent information mentioned in the
attached questionnaire concerning
substances listed above.
Further clarification on any of the above
items can be obtained from Quality
Assurance and Safety: Medicines,
Department of Medicines Policy and
Standards, WHO, Geneva, to which replies
should be sent not later than January 3, 2006.
WHO takes this opportunity to renew to
Member States and Associate Members the
assurance of its highest consideration.
GENEVA, October 27, 2005
*
*
1Including
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*
*
its stereo-isomers.
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If statistical information requested is not
readily available, a brief descriptive answer
would be appreciated.
Please attach copies of relevant study
reports and other background information as
appropriate.
*
*
*
*
*
1. BUTORPHANOL (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
Trade Name
Dosage Form
1.2 If the answer to 1.1 is ‘‘no,’’ is there
other legitimate use of the substance? (Yes/
No)
If ‘‘yes,’’ please describe the purpose of
use.
1.3 If there is legitimate use of the
substance, how is the substance supplied?
(Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused2 in
your country? (Yes/No/No Information)
2.2 If ‘‘yes,’’ any information on the extent
of abuse?
2.3 Any information on the extent of public
health or social problems associated with the
abuse of the substance (statistics on cases of
overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE
SUBSTANCE
3.1 Any information on the nature and
extent of illicit activities involving the
substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If butorphanol is placed under
international control, do you think that its
Trade Name
Dosage Form
1.2 If the answer to 1.1 is ‘‘no,’’ is there
other legitimate use of the substance? (Yes/
No)
If ‘‘yes,’’ please describe the purpose of
use.
1.3 If there is legitimate use of the
substance, how is the substance supplied?
(Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in
your country? (Yes/No/No information)
2.2 If ‘‘yes,’’ any information on the extent
of abuse?
2.3 Any information on the extent of public
health or social problems associated with the
abuse of the substance (statistics on cases of
overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE
SUBSTANCE
3.1 Any information on the nature and
extent of illicit activities involving the
substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
Trade Name
Dosage Form
1.2 If the answer to 1.1 is ‘‘no,’’ is there
other legitimate use of the substance? (Yes/
No)
If ‘‘yes,’’ please describe the purpose of
use.
1.3 If there is legitimate use of the
substance, how is the substance supplied?
(Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in
your country? (Yes/No/No information)
2.2 If ‘‘yes,’’ any information on the extent
of abuse?
2.3 Any information on the extent of public
health or social problems associated with the
abuse of the substance (statistics on cases of
overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE
SUBSTANCE
3.1 Any information on the nature and
extent of illicit activities involving the
substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
1.1 Is the substance currently registered as
a medical product? (Yes/No)
If ‘‘yes,’’ since when (year of marketing)?
19lll
Please indicate trade name(s), dosage
form(s) with strength(s) and indication(s):
Strength(s)
availability for medical use will be affected?
(Yes/No)
4.2 If ‘‘yes,’’ how do you think the transfer
will impact its medical availability?
2. DRONABINOL (INN) AND ITS STEREOISOMERS
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as
a medical product? (Yes/No)
If ‘‘yes,’’ since when (year of marketing)?
19lll
Please indicate trade name(s), dosage
form(s) with strength(s) and indication(s):
Strength(s)
00:22 Dec 13, 2005
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Indication(s)
3. GAMMA-HYDROXYBUTYRIC ACID
(GHB)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as
a medical product? (Yes/No)
If ‘‘yes,’’ since when (year of marketing)?
19lll
Please indicate trade name(s), dosage
form(s) with strength(s) and indication(s):
Strength(s)
Indication(s)
4. IMPACT OF TRANSFER TO SCHEDULE II
or III OF THE CONVENTION ON
PSYCHOTROPIC SUBSTANCES, 1971, ON
MEDICAL AVAILABILITY
4.1 If gamma-hydroxybutyric acid is
transferred from Schedule IV of the
Convention on Psychotropic Substances,
1971, to either Schedule II or III of the
Convention on Psychotropic Substances, do
you think that its availability for medical use
will be affected? (Yes/No)
4.2 If ‘‘yes,’’ how do you think the transfer
will impact its medical availability?
2In this questionnaire, ‘‘abuse or misuse’’ refers
to use of the substance other than for medical or
scientific purposes.
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4. KETAMINE (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as
a medical product? (Yes/No)
If ‘‘yes,’’ since when (year of marketing)?
19lll
Trade Name
Dosage Form
1.2 If the answer to 1.1 is ‘‘no,’’ is there
other legitimate use of the substance? (Yes/
No)
If ‘‘yes,’’ please describe the purpose of
use.
1.3 If there is legitimate use of the
substance, how is the substance supplied?
(Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in
your country? (Yes/No/No information)
2.2 If ‘‘yes,’’ any information on the extent
of abuse?
2.3 Any information on the extent of public
health or social problems associated with the
abuse of the substance (statistics on cases of
overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE
SUBSTANCE
3.1 Any information on the nature and
extent of illicit activities involving the
substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If ketamine is placed under
international control, do you think that its
Trade Name
Dosage Form
1.2 If the answer to 1.1 is ‘‘no,’’ is there
other legitimate use of the substance? (Yes/
No)
If ‘‘yes,’’ please describe the purpose of
use.
1.3 If there is legitimate use of the
substance, how is the substance supplied?
(Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in
your country? (Yes/No/No information)
2.2 If ‘‘yes,’’ any information on the extent
of abuse?
2.3 Any information on the extent of public
health or social problems associated with the
abuse of the substance (statistics on cases of
overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE
SUBSTANCE
3.1 Any information on the nature and
extent of illicit activities involving the
substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If khat is placed under international
control, do you think that its availability for
medical use will be affected? (Yes/No)
Trade Name
Dosage Form
1.2 If the answer to 1.1 is ‘‘no,’’ is there
other legitimate use of the substance? (Yes/
No)
If ‘‘yes,’’ please describe the purpose of
use.
1.3 If there is legitimate use of the
substance, how is the substance supplied?
(Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in
your country? (Yes/No/No information)
2.2 If ‘‘yes,’’ any information on the extent
of abuse?
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2.3 Any information on the extent of public
health or social problems associated with the
abuse of the substance (statistics on cases of
overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE
SUBSTANCE
3.1 Any information on the nature and
extent of illicit activities involving the
substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If tramadol is placed under
international control, do you think that its
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Please indicate trade name(s), dosage
form(s) with strength(s) and indication(s):
Strength(s)
Indication(s)
availability for medical use will be affected?
(Yes/No)
4.2 If ‘‘yes,’’ how do you think the transfer
will impact its medical availability?
5. KHAT (CATHA EDULIS Forsk.)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as
a medical product? (Yes/No)
If ‘‘yes,’’ since when (year of marketing)?
19lll
Please indicate trade name(s), dosage
form(s) with strength(s) and indication(s):
Strength(s)
Indication(s)
4.2 If ‘‘yes,’’ how do you think the transfer
will impact its medical availability?
6. TRAMADOL (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as
a medical product? (Yes/No)
If ‘‘yes,’’ since when (year of marketing)?
19lll
Please indicate trade name(s), dosage
form(s) with strength(s) and indication(s):
Strength(s)
Indication(s)
availability for medical use will be affected?
(Yes/No)
4.2 If ‘‘yes,’’ how do you think the transfer
will impact its medical availability?
7. ZOPICLONE (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as
a medical product? (Yes/No)
If ‘‘yes,’’ since when (year of marketing)?
19lll
Please indicate trade name(s), dosage
form(s) with strength(s) and indication(s):
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Trade Name
Dosage Form
1.2 If the answer to 1.1 is ‘‘no,’’ is there
other legitimate use of the substance? (Yes/
No)
If ‘‘yes,’’ please describe the purpose of
use.
1.3 If there is legitimate use of the
substance, how is the substance supplied?
(Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in
your country? (Yes/No/No information)
2.2 If ‘‘yes,’’ any information on the extent
of abuse?
2.3 Any information on the extent of public
health or social problems associated with the
abuse of the substance (statistics on cases of
overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE
SUBSTANCE
3.1 Any information on the nature and
extent of illicit activities involving the
substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If zopiclone is placed under
international control, do you think that its
availability for medical use will be affected?
(Yes/No)
4.2 If ‘‘yes,’’ how do you think the transfer
will impact its medical availability?
8. BUPRENORPHINE (INN)
1. IMPACT OF TRANSFER TO SCHEDULE I
OF THE SINGLE CONVENTION ON
NARCOTIC DRUGS, 1961, ON MEDICAL
AVAILABILITY
1.1 If buprenorphine is transferred from
Schedule III of the Convention on
Psychotropic Substances, 1971, to Schedule
I of the Single Convention on Narcotic Drugs,
1961, do you think that its availability for
medical use will be affected? (Yes/No)
1.2 If ‘‘yes,’’ how do you think the
transfer will impact its medical
availability?
II. Background
Butorphanol is classified as a
synthetic opiate partial agonist
analgesic. It is marketed in the United
States for the management of pain as an
injectable and as a nasal spray solution.
It is controlled domestically in Schedule
IV of the CSA and is not controlled
internationally under the Psychotropic
Convention or the Single Convention on
Narcotic Drugs.
Synthetic delta–9–
tetrahydrocannabinol (delta–9–THC), or
dronabinol, is the active component of
the drug product Marinol, which is
marketed in the United States as an
antiemetic in the setting of cancer
chemotherapy and for treatment of AIDS
wasting syndrome. Marinol is currently
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controlled in Schedule III of the CSA,
and the drug substance dronabinol
(which is the synthetic equivalent of the
natural active component of marijuana,
delta–9–THC) is controlled in Schedule
I of the CSA. The drug substance
dronabinol, including its isomers, is
controlled internationally in Schedule II
of the Psychotropic Convention.
Gamma-hydroxybutyric acid (GHB) is
classified as a central nervous system
depressant. In 2002, FDA approved a
GHB-containing product, Xyrem, for the
treatment of cataplexy associated with
narcolepsy. Xyrem was approved under
the regulations in 21 CFR part 314,
subpart H (21 CFR 314.520), and the
product labeling contained a
comprehensive risk management
program, which includes restricted
distribution of the drug through a
central pharmacy. Xyrem is controlled
domestically in Schedule III of the CSA,
while bulk GHB and all other material
containing GHB is controlled in
Schedule I. In addition, illicit use of
Xyrem is subject to Schedule I penalties
of the CSA. GHB is controlled
internationally in Schedule IV of the
Psychotropic Convention.
Ketamine is classified as a rapidacting general anesthetic agent used for
short diagnostic and surgical procedures
that do not require skeletal muscle
relaxation. It is marketed in the United
States as an injectable. Ketamine is
controlled domestically in Schedule III
of the CSA. It is not controlled
internationally under the Psychotropic
Convention or the Single Convention on
Narcotic Drugs.
Khat (or qat) refers to the leaves and
young shoots of the plant Cathia edulis
Forsk. The principal psychoactive
substances contained in khat leaves are
cathinone and cathine. Cathinone (aketoamphetamine) is a monoamine
alkaloid that is controlled domestically
and internationally in Schedule I. The
DEA published a final rule on January
14, 1993 (58 FR 4316), that results in the
placement of any material that contains
cathinone into Schedule I, which
includes khat. Cathine, also a
monoamine alkaloid, is controlled
domestically in Schedule IV of the CSA
and internationally in Schedule III drug
under the Convention on Psychotropic
Substances. In 1980, WHO classified
khat as a drug of abuse that can produce
mild to moderate psychic dependence,
however khat is not controlled
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Strength(s)
Indication(s)
internationally under the Psychotropic
Convention or the Single Convention on
Narcotic Drugs.
Tramadol is a centrally acting
synthetic analgesic. At least two
complementary mechanisms of action
appear applicable: binding of parent and
metabolite to mu-opioid receptors and
inhibition of the reuptake of
norepinephrine and serotonin. It is
marketed in the United States for the
treatment of moderate to moderately
severe pain. Cases of abuse and
dependence of tramadol have been
reported. It is not controlled in the
United States under the CSA or
controlled internationally under the
Psychotropic Convention or the Single
Convention on Narcotic Drugs.
Zopiclone is classified as a
nonbenzodiazepine hypnotic. The pure
enantiomer (optical isomer) of
zopiclone, eszopiclone, is marketed in
the United States for the treatment of
insomnia. The precise mechanism of
action of eszopiclone as a hypnotic is
unknown, but its effect is believed to
result from its interaction with gammaaminobutyric acid (GABA)-receptor
complexes at binding domains located
close to or allosterically coupled to
benzodiazepine receptors. Eszopiclone
and zopiclone are controlled
domestically in Schedule IV of the CSA
and are not controlled internationally
under the Psychotropic Convention or
Single Convention on Narcotic Drugs.
Buprenorphine is a semisynthetic
opium derivative with partial mu-opioid
receptor agonist activity. In the United
States, buprenorphine is available as a
parenteral product marketed for the
relief of moderate to severe pain, as a
sublingual single-entity tablet, and as a
sublingual combination tablet with
naloxone. The sublingual tablets are
used for the treatment of opiate
addiction. Buprenorphine is controlled
domestically in Schedule III of the CSA
as a narcotic and is controlled
internationally in Schedule III of the
Psychotropic Convention.
Oripavine is a phenanthrene alkaloid
contained in the species of the Papaver
plant. It is a chemical derivative of
thebaine, a naturally-occurring
substance found in the opium plant.
Oripavine is controlled domestically in
Schedule II of the CSA because it is a
derivative of thebaine, opium, and other
opiates. Oripavine is not under
international control.
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III. Opportunity to Submit Domestic
Information
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
As required by section 201(d)(2)(A) of
the CSA (21 U.S.C. 811(d)(2)(A)), FDA,
on behalf of HHS, invites interested
persons to submit comments regarding
the nine named drugs. Any comments
received will be considered by HHS
when it prepares a scientific and
medical evaluation of these drugs. HHS
will forward a scientific and medical
evaluation of these drugs to WHO,
through the Secretary of State, for
WHO’s consideration in deciding
whether to recommend international
control/decontrol of any of these drugs.
Such control could limit, among other
things, the manufacture and distribution
(import/export) of these drugs and could
impose certain recordkeeping
requirements on them.
HHS will not now make any
recommendations to WHO regarding
whether any of these drugs should be
subjected to international controls.
Instead, HHS will defer such
consideration until WHO has made
official recommendations to the
Commission on Narcotic Drugs, which
are expected to be made in early 2006.
Any HHS position regarding
international control of these drugs will
be preceded by another Federal Register
notice soliciting public comments as
required by section 201(d)(2)(B) of the
CSA.
National Institutes of Health
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the drugs. The
abbreviated comment period is
necessary to allow sufficient time to
prepare and submit the domestic
information package by the deadline
imposed by WHO. Two copies of any
comments are to be submitted, except
that individuals may submit one copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: December 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23958 Filed 12–12–05; 8:45 am]
BILLING CODE 4160–01–S
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Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Tri-Functional Nanospheres
Yun-bo Shi (NICHD) et al.
U.S. Patent Application No. 11/135,380
filed 24 May 2005 (HHS Reference
No. E–145–2005/0–US–01).
Licensing Contact: Cristina
Thalhammer-Reyero; 301/435–4507;
thalhamc@mail.nih.gov.
Available for licensing and
commercial development is an
invention related to ‘‘biofunctional’’ trifunctional nanospheres (TFNs) or multifunctional nanospheres (MFNs)
obtained by binding one or more
biomaterials, such as folate, IgG, biotin
or streptavidin, to fluorescent-magnetic
bifunctional nanospheres (BFNs).
Unlike other BFNs available, which are
virtually all based on having a magnetic
core, the present invention is based on
mesoporous BFNs with hydrophobic
inner cavities. The properties of the
TFNs of the subject invention have
superior qualities for use for the various
applications that require aqueous
solutions.
Nanospheres are becoming the
materials of choice for a rapidly
increasing number of pharmaceutical
and biomedical applications, including
the use of quantum dots (QDs) and
magnetic nanoparticles. Materials with
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
73779
the combined function of fluorescent
labeling and magnetic separation have
many applications in biomedical
science, including those resulting from
the encapsulation of both particles in
polymer microcapsules. However, these
related prior technologies are
predominantly dependent on core-shell
type technologies. Typically, a magnetic
material such as magnetite or a
fluorescent particle such as a QD is used
as a core. Such a core-shell structure is
chemically unstable and
disadvantageous for fluorescence
applications because the shell tends to
absorb either or both of the excitation
and emission lights, thus dimming the
fluorescent signal. The nanoparticles of
this invention are composed of a
mesoporous copolymer, a magnetic
material embedded into the mesoporous
copolymer, a fluorescent nanomaterial
concurrently embedded into the
mesoporous copolymer, and one or
more biomaterials coupled to the
mesoporous copolymer.
TFNs and MFNs have multiple uses.
When the TFNs are labeled by a single
biomaterial, the nanoparticles may
specifically bind to a cell, or a protein
or any other moiety that to which the
biomaterial specifically binds. For
instance, the biomaterial may be a small
molecule ligand that is specifically
bound by a cell surface receptor. MFNs
in which two bioagents are coupled to
single BFNs allow using one bioagent to
target a macromolecule or a cell and
using the second one to alter the
function/properties of the
macromolecule or cell, e.g., using a
protein to target a cell and using a toxin
or cell death protein to kill the targeted
cell, or using a chemical or protein to
target a protein within a complex and
another one to alter the function of a
different component of the complex.
The technology is further described in
‘‘Biofunctionalization of fluorescentmagnetic-biofunctional nanospheres
and their applications,’’ Guo-Ping Wang,
Er-Qun Song, Hai-Yan Xie, Zhi-Ling
Zhang, Zhi-Quan Tian, Chao Zuo, DaiWen Pang, Dao-Cheng Wu and Yun-Bo
Shi; Chemical Communications, 2005,
(34), 4276–4278; DOI: 10.1039/
b508075d.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Efficient Growth of Wild-Type Hepatitis
A Virus in Cell Culture for
Development of Live Vaccines
Gerarado Kaplan and Krishnamurthy
Konduru (FDA).
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 70, Number 238 (Tuesday, December 13, 2005)]
[Notices]
[Pages 73775-73779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23958]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0479]
International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-
tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
Khat; Tramadol; Zopiclone; Buprenorphine; Oripavine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
interested persons to submit comments concerning abuse potential,
actual abuse, medical usefulness, trafficking, and impact of scheduling
changes on availability for medical use of nine drug substances. These
comments will be considered in preparing a response from the United
States to the World Health Organization (WHO) regarding the abuse
liability and diversion of these drugs. WHO will use this information
to consider whether to recommend that certain international
restrictions be placed on these drugs. This notice requesting comments
is required by the Controlled Substances Act (CSA).
DATES: Submit written or electronic comments by January 12, 2006.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research (HFD-9), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5563, e mail:
hunterj@cder.FDA.gov.
SUPPLEMENTARY INFORMATION: The United States is a party to the 1971
Convention on Psychotropic Substances. Article 2 of the Convention on
Psychotropic Substances provides that if a party to the convention or
WHO has information about a substance, which in its opinion may require
international control or change in such control, it shall so notify the
Secretary General of the United Nations and provide the Secretary
General of the United Nations with information in support of its
opinion.
The CSA (21 U.S.C. 811 et seq.) (Title II of the Comprehensive Drug
Abuse Prevention and Control Act of 1970) provides that when WHO
notifies the United States under Article 2 of the Convention on
Psychotropic Substances that it has information that may justify adding
a drug or other substances to one of the schedules of the convention,
transferring a drug or substance from one schedule to another, or
deleting it from the schedules, the Secretary of State must transmit
the notice to the Secretary of the Department of Health and Human
Services (the Secretary of HHS). The Secretary of HHS must then publish
the notice in the Federal Register and provide opportunity for
interested persons to submit comments that will be considered by HHS in
its preparation of the scientific and medical evaluations of the drug
or substance.
I. WHO Notification
The Secretary of HHS received the following notices from WHO:
Ref: C.L.29.2005
WHO Questionnaire for Collection of Information for Review of
Dependence-Producing Psychoactive Substances
The WHO presents its compliments and has the pleasure of
informing Member States and Associate Members that the Thirty-fourth
Expert Committee on Drug Dependence will meet from March 28 to 31,
2006 to review the following substances:
1. Butorphanol (INN)
2. Dronabinol (INN)\1\
---------------------------------------------------------------------------
\1\Including its stereo-isomers.
---------------------------------------------------------------------------
3. Gamma-hydroxybutyric acid
4. Ketamine (INN)
5. Khat (Catha edulis Forsk)
6. Tramadol (INN)
7. Zopiclone (INN)
As a follow-up for the thirty-third meeting of the Expert
Committee on Drug Dependence, final decisions will be taken for
buprenorphine (INN) and oripavine (INN).
One of the essential elements of the established review
procedure is for the Secretariat to collect relevant information
from Member States to prepare a Critical Review Report for
submission to the Expert Committee on Drug Dependence. WHO invites
Member States to collaborate, as in the past, in this process by
providing pertinent information mentioned in the attached
questionnaire concerning substances listed above.
Further clarification on any of the above items can be obtained
from Quality Assurance and Safety: Medicines, Department of
Medicines Policy and Standards, WHO, Geneva, to which replies should
be sent not later than January 3, 2006.
WHO takes this opportunity to renew to Member States and
Associate Members the assurance of its highest consideration.
GENEVA, October 27, 2005
* * * * *
[[Page 73776]]
If statistical information requested is not readily available, a
brief descriptive answer would be appreciated.
Please attach copies of relevant study reports and other
background information as appropriate.
* * * * *
1. BUTORPHANOL (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as a medical product?
(Yes/No)
If ``yes,'' since when (year of marketing)? 19------
Please indicate trade name(s), dosage form(s) with strength(s)
and indication(s):
----------------------------------------------------------------------------------------------------------------
Trade Name Dosage Form Strength(s) Indication(s)
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
1.2 If the answer to 1.1 is ``no,'' is there other legitimate
use of the substance? (Yes/No)
If ``yes,'' please describe the purpose of use.
1.3 If there is legitimate use of the substance, how is the
substance supplied? (Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused\2\ in your country? (Yes/
No/No Information)
---------------------------------------------------------------------------
\2\In this questionnaire, ``abuse or misuse'' refers to use of
the substance other than for medical or scientific purposes.
---------------------------------------------------------------------------
2.2 If ``yes,'' any information on the extent of abuse?
2.3 Any information on the extent of public health or social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE
3.1 Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If butorphanol is placed under international control, do you
think that its availability for medical use will be affected? (Yes/
No)
4.2 If ``yes,'' how do you think the transfer will impact its
medical availability?
2. DRONABINOL (INN) AND ITS STEREO-ISOMERS
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as a medical product?
(Yes/No)
If ``yes,'' since when (year of marketing)? 19------
Please indicate trade name(s), dosage form(s) with strength(s)
and indication(s):
----------------------------------------------------------------------------------------------------------------
Trade Name Dosage Form Strength(s) Indication(s)
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
1.2 If the answer to 1.1 is ``no,'' is there other legitimate
use of the substance? (Yes/No)
If ``yes,'' please describe the purpose of use.
1.3 If there is legitimate use of the substance, how is the
substance supplied? (Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in your country? (Yes/No/
No information)
2.2 If ``yes,'' any information on the extent of abuse?
2.3 Any information on the extent of public health or social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE
3.1 Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
3. GAMMA-HYDROXYBUTYRIC ACID (GHB)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as a medical product?
(Yes/No)
If ``yes,'' since when (year of marketing)? 19------
Please indicate trade name(s), dosage form(s) with strength(s)
and indication(s):
----------------------------------------------------------------------------------------------------------------
Trade Name Dosage Form Strength(s) Indication(s)
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
1.2 If the answer to 1.1 is ``no,'' is there other legitimate
use of the substance? (Yes/No)
If ``yes,'' please describe the purpose of use.
1.3 If there is legitimate use of the substance, how is the
substance supplied? (Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in your country? (Yes/No/
No information)
2.2 If ``yes,'' any information on the extent of abuse?
2.3 Any information on the extent of public health or social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE
3.1 Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF TRANSFER TO SCHEDULE II or III OF THE CONVENTION ON
PSYCHOTROPIC SUBSTANCES, 1971, ON MEDICAL AVAILABILITY
4.1 If gamma-hydroxybutyric acid is transferred from Schedule IV
of the Convention on Psychotropic Substances, 1971, to either
Schedule II or III of the Convention on Psychotropic Substances, do
you think that its availability for medical use will be affected?
(Yes/No)
4.2 If ``yes,'' how do you think the transfer will impact its
medical availability?
[[Page 73777]]
4. KETAMINE (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as a medical product?
(Yes/No)
If ``yes,'' since when (year of marketing)? 19------
Please indicate trade name(s), dosage form(s) with strength(s)
and indication(s):
----------------------------------------------------------------------------------------------------------------
Trade Name Dosage Form Strength(s) Indication(s)
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
1.2 If the answer to 1.1 is ``no,'' is there other legitimate
use of the substance? (Yes/No)
If ``yes,'' please describe the purpose of use.
1.3 If there is legitimate use of the substance, how is the
substance supplied? (Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in your country? (Yes/No/
No information)
2.2 If ``yes,'' any information on the extent of abuse?
2.3 Any information on the extent of public health or social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE
3.1 Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If ketamine is placed under international control, do you
think that its availability for medical use will be affected? (Yes/
No)
4.2 If ``yes,'' how do you think the transfer will impact its
medical availability?
5. KHAT (CATHA EDULIS Forsk.)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as a medical product?
(Yes/No)
If ``yes,'' since when (year of marketing)? 19------
Please indicate trade name(s), dosage form(s) with strength(s)
and indication(s):
----------------------------------------------------------------------------------------------------------------
Trade Name Dosage Form Strength(s) Indication(s)
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
1.2 If the answer to 1.1 is ``no,'' is there other legitimate
use of the substance? (Yes/No)
If ``yes,'' please describe the purpose of use.
1.3 If there is legitimate use of the substance, how is the
substance supplied? (Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in your country? (Yes/No/
No information)
2.2 If ``yes,'' any information on the extent of abuse?
2.3 Any information on the extent of public health or social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE
3.1 Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If khat is placed under international control, do you think
that its availability for medical use will be affected? (Yes/No)
4.2 If ``yes,'' how do you think the transfer will impact its
medical availability?
6. TRAMADOL (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as a medical product?
(Yes/No)
If ``yes,'' since when (year of marketing)? 19------
Please indicate trade name(s), dosage form(s) with strength(s)
and indication(s):
----------------------------------------------------------------------------------------------------------------
Trade Name Dosage Form Strength(s) Indication(s)
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
1.2 If the answer to 1.1 is ``no,'' is there other legitimate
use of the substance? (Yes/No)
If ``yes,'' please describe the purpose of use.
1.3 If there is legitimate use of the substance, how is the
substance supplied? (Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in your country? (Yes/No/
No information)
2.2 If ``yes,'' any information on the extent of abuse?
2.3 Any information on the extent of public health or social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE
3.1 Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If tramadol is placed under international control, do you
think that its availability for medical use will be affected? (Yes/
No)
4.2 If ``yes,'' how do you think the transfer will impact its
medical availability?
7. ZOPICLONE (INN)
1. LEGITIMATE USE OF THE SUBSTANCE
1.1 Is the substance currently registered as a medical product?
(Yes/No)
If ``yes,'' since when (year of marketing)? 19------
Please indicate trade name(s), dosage form(s) with strength(s)
and indication(s):
[[Page 73778]]
----------------------------------------------------------------------------------------------------------------
Trade Name Dosage Form Strength(s) Indication(s)
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
....................... ....................... .......................
----------------------------------------------------------------------------------------------------------------
1.2 If the answer to 1.1 is ``no,'' is there other legitimate
use of the substance? (Yes/No)
If ``yes,'' please describe the purpose of use.
1.3 If there is legitimate use of the substance, how is the
substance supplied? (Imported/Manufactured in the country)
2. ABUSE OF THE SUBSTANCE
2.1 Is the substance abused or misused in your country? (Yes/No/
No information)
2.2 If ``yes,'' any information on the extent of abuse?
2.3 Any information on the extent of public health or social
problems associated with the abuse of the substance (statistics on
cases of overdose deaths, dependence, etc.)?
3. ILLICIT ACTIVITIES INVOLVING THE SUBSTANCE
3.1 Any information on the nature and extent of illicit
activities involving the substance (clandestine manufacture,
smuggling, diversion, seizure, etc.)?
4. IMPACT OF SCHEDULING
4.1 If zopiclone is placed under international control, do you
think that its availability for medical use will be affected? (Yes/
No)
4.2 If ``yes,'' how do you think the transfer will impact its
medical availability?
8. BUPRENORPHINE (INN)
1. IMPACT OF TRANSFER TO SCHEDULE I OF THE SINGLE CONVENTION ON
NARCOTIC DRUGS, 1961, ON MEDICAL AVAILABILITY
1.1 If buprenorphine is transferred from Schedule III of the
Convention on Psychotropic Substances, 1971, to Schedule I of the
Single Convention on Narcotic Drugs, 1961, do you think that its
availability for medical use will be affected? (Yes/No)
1.2 If ``yes,'' how do you think the transfer will impact its
medical availability?
II. Background
Butorphanol is classified as a synthetic opiate partial agonist
analgesic. It is marketed in the United States for the management of
pain as an injectable and as a nasal spray solution. It is controlled
domestically in Schedule IV of the CSA and is not controlled
internationally under the Psychotropic Convention or the Single
Convention on Narcotic Drugs.
Synthetic delta-9-tetrahydrocannabinol (delta-9-THC), or
dronabinol, is the active component of the drug product Marinol, which
is marketed in the United States as an antiemetic in the setting of
cancer chemotherapy and for treatment of AIDS wasting syndrome. Marinol
is currently controlled in Schedule III of the CSA, and the drug
substance dronabinol (which is the synthetic equivalent of the natural
active component of marijuana, delta-9-THC) is controlled in Schedule I
of the CSA. The drug substance dronabinol, including its isomers, is
controlled internationally in Schedule II of the Psychotropic
Convention.
Gamma-hydroxybutyric acid (GHB) is classified as a central nervous
system depressant. In 2002, FDA approved a GHB-containing product,
Xyrem, for the treatment of cataplexy associated with narcolepsy. Xyrem
was approved under the regulations in 21 CFR part 314, subpart H (21
CFR 314.520), and the product labeling contained a comprehensive risk
management program, which includes restricted distribution of the drug
through a central pharmacy. Xyrem is controlled domestically in
Schedule III of the CSA, while bulk GHB and all other material
containing GHB is controlled in Schedule I. In addition, illicit use of
Xyrem is subject to Schedule I penalties of the CSA. GHB is controlled
internationally in Schedule IV of the Psychotropic Convention.
Ketamine is classified as a rapid-acting general anesthetic agent
used for short diagnostic and surgical procedures that do not require
skeletal muscle relaxation. It is marketed in the United States as an
injectable. Ketamine is controlled domestically in Schedule III of the
CSA. It is not controlled internationally under the Psychotropic
Convention or the Single Convention on Narcotic Drugs.
Khat (or qat) refers to the leaves and young shoots of the plant
Cathia edulis Forsk. The principal psychoactive substances contained in
khat leaves are cathinone and cathine. Cathinone ([alpha]-
ketoamphetamine) is a monoamine alkaloid that is controlled
domestically and internationally in Schedule I. The DEA published a
final rule on January 14, 1993 (58 FR 4316), that results in the
placement of any material that contains cathinone into Schedule I,
which includes khat. Cathine, also a monoamine alkaloid, is controlled
domestically in Schedule IV of the CSA and internationally in Schedule
III drug under the Convention on Psychotropic Substances. In 1980, WHO
classified khat as a drug of abuse that can produce mild to moderate
psychic dependence, however khat is not controlled internationally
under the Psychotropic Convention or the Single Convention on Narcotic
Drugs.
Tramadol is a centrally acting synthetic analgesic. At least two
complementary mechanisms of action appear applicable: binding of parent
and metabolite to mu-opioid receptors and inhibition of the reuptake of
norepinephrine and serotonin. It is marketed in the United States for
the treatment of moderate to moderately severe pain. Cases of abuse and
dependence of tramadol have been reported. It is not controlled in the
United States under the CSA or controlled internationally under the
Psychotropic Convention or the Single Convention on Narcotic Drugs.
Zopiclone is classified as a nonbenzodiazepine hypnotic. The pure
enantiomer (optical isomer) of zopiclone, eszopiclone, is marketed in
the United States for the treatment of insomnia. The precise mechanism
of action of eszopiclone as a hypnotic is unknown, but its effect is
believed to result from its interaction with gamma-aminobutyric acid
(GABA)-receptor complexes at binding domains located close to or
allosterically coupled to benzodiazepine receptors. Eszopiclone and
zopiclone are controlled domestically in Schedule IV of the CSA and are
not controlled internationally under the Psychotropic Convention or
Single Convention on Narcotic Drugs.
Buprenorphine is a semisynthetic opium derivative with partial mu-
opioid receptor agonist activity. In the United States, buprenorphine
is available as a parenteral product marketed for the relief of
moderate to severe pain, as a sublingual single-entity tablet, and as a
sublingual combination tablet with naloxone. The sublingual tablets are
used for the treatment of opiate addiction. Buprenorphine is controlled
domestically in Schedule III of the CSA as a narcotic and is controlled
internationally in Schedule III of the Psychotropic Convention.
Oripavine is a phenanthrene alkaloid contained in the species of
the Papaver plant. It is a chemical derivative of thebaine, a
naturally-occurring substance found in the opium plant. Oripavine is
controlled domestically in Schedule II of the CSA because it is a
derivative of thebaine, opium, and other opiates. Oripavine is not
under international control.
[[Page 73779]]
III. Opportunity to Submit Domestic Information
As required by section 201(d)(2)(A) of the CSA (21 U.S.C.
811(d)(2)(A)), FDA, on behalf of HHS, invites interested persons to
submit comments regarding the nine named drugs. Any comments received
will be considered by HHS when it prepares a scientific and medical
evaluation of these drugs. HHS will forward a scientific and medical
evaluation of these drugs to WHO, through the Secretary of State, for
WHO's consideration in deciding whether to recommend international
control/decontrol of any of these drugs. Such control could limit,
among other things, the manufacture and distribution (import/export) of
these drugs and could impose certain recordkeeping requirements on
them.
HHS will not now make any recommendations to WHO regarding whether
any of these drugs should be subjected to international controls.
Instead, HHS will defer such consideration until WHO has made official
recommendations to the Commission on Narcotic Drugs, which are expected
to be made in early 2006. Any HHS position regarding international
control of these drugs will be preceded by another Federal Register
notice soliciting public comments as required by section 201(d)(2)(B)
of the CSA.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the drugs. The
abbreviated comment period is necessary to allow sufficient time to
prepare and submit the domestic information package by the deadline
imposed by WHO. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23958 Filed 12-12-05; 8:45 am]
BILLING CODE 4160-01-S
