International Drug Scheduling; Convention on Psychotropic Substances; World Health Organization Scheduling Recommendations for Gamma-hydroxybutyric Acid, 9397-9399 [2013-02859]
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Alzheimer’s Disease: Developing Drugs
for the Treatment of Early Stage
Disease.’’ This guidance outlines FDA’s
current thinking as to how a sponsor
could demonstrate efficacy in clinical
trials in patients in the early stages of
Alzheimer’s disease (AD) that occur
before the onset of overt dementia.
Specifically, this guidance addresses
FDA’s current thinking regarding the
selection of patients with early AD, or
who are determined to be at risk of
developing AD, for enrollment into
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measures for trials in these populations
that are designed to demonstrate a
clinical benefit, as well as the manner
in which disease modification might be
demonstrated, are also addressed. The
design of clinical trials that are
specifically focused on the treatment of
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disease dementia (i.e., dementia of the
Alzheimer’s type), or any of the
autosomal dominant forms of AD, are
not explicitly discussed although many
of the principles in this guidance will be
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This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on developing drugs for the treatment of
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person and does not operate to bind
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applicable statutes and regulations.
sroberts on DSK5SPTVN1PROD with NOTICES
Silver Spring, MD 20993–0002, 301–
796–2250.
SUPPLEMENTARY INFORMATION:
Dated: February 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments 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, and
will be posted to the docket at https://
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III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
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BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0448]
International Drug Scheduling;
Convention on Psychotropic
Substances; World Health
Organization Scheduling
Recommendations for Gammahydroxybutyric Acid
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is providing
interested persons with the opportunity
to submit written comments and to
request an informal public meeting
concerning recommendations by the
World Health Organization (WHO) to
impose international manufacturing and
distributing restrictions, under
international treaties, on certain drug
substances. The comments received in
response to this notice and/or public
meeting will be considered in preparing
the U.S. position on these proposals for
a meeting of the United Nations
Commission on Narcotic Drugs (CND) in
Vienna, Austria, in March 2013. This
notice is issued under the Controlled
Substances Act (the CSA).
DATES: Submit either electronic or
written comments by February 25, 2013.
Submit requests for a public meeting on
or before February 19, 2013. (For
additional information, see also section
IV of this document).
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
James R. Hunter, Center for Drug
Evaluation and Research, Controlled
Substance Staff, Food and Drug
Administration, Bldg. 51, rm. 5150,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–3156,
email: james.hunter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
The United States is a party to the
1971 Convention on Psychotropic
Substances (the Convention). Section
201(d)(2)(B) of the CSA (21 U.S.C.
811(d)(2)(B)) provides that when the
United States is notified under Article 2
of the Convention that CND proposes to
decide whether to add a drug or other
substance to one of the schedules of the
Convention, transfer a drug or substance
from one schedule to another, or delete
it from the schedules, the Secretary of
State must transmit notice of such
information to the Secretary of Health
and Human Services (Secretary of HHS).
The Secretary of HHS must then publish
a summary of such information in the
Federal Register and provide
opportunity for interested persons to
submit comments. The Secretary of HHS
must then evaluate the proposal and
furnish a recommendation to the
Secretary of State that shall be binding
on the representative of the United
States in discussions and negotiations
relating to the proposal.
As detailed in the following
paragraphs, the Secretary of State has
received one notification from the
Secretary-General of the United Nations
(the Secretary-General) regarding
substances to be considered for control
under the Convention. This notification
reflects the recommendation from the
35th WHO Expert Committee for Drug
Dependence (ECDD), which met in June
2012. In the Federal Register of
September 05, 2008 (73 FR 51823), FDA
announced the WHO ECDD review and
invited interested persons to submit
information for WHO’s consideration.
The full text of the notification from
the Secretary-General is provided in
section II of this document. Section
201(d)(2)(B) of the CSA requires the
Secretary of HHS, after receiving a
notification proposing scheduling, to
publish a notice in the Federal Register
to provide the opportunity for interested
persons to submit information and
comments on the proposed scheduling
action.
II. United Nations Notification
The formal United Nations
notification that identifies the drug
substance and explains the basis for the
recommendations is reproduced as
follows:
Reference: NAR/CL.6/2012
WHO/ECDD35 1971C–Art.2
CU 2012/196/DTA/SGB
The Secretary-General of the United
Nations presents his compliments to the
Secretary of State of the United States of
America and has the honour to inform
the Government that the Director-
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Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices
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General of the WHO, under article 2,
paragraphs 1, 4, and 6, of the
Convention on Psychotropic Substances
of 1971 (1971 Convention), has notified
the Secretary-General that it is of the
opinion that Gamma-hydroxybutyric
acid (GHB) should be transferred from
Schedule IV to Schedule II of the 1971
Convention.
In accordance with the provisions of
article 2, paragraph 2, of the 1971
Convention, the Secretary-General
hereby transmits the relevant excerpts of
the notification as Annex I to the
present note. Also in accordance with
the same provisions, the notification
from WHO will be brought to the
attention of the CND at its next session
in March 2013.
In connection with the notification,
WHO has also submitted excerpts from
the report of the Thirty-fifth session of
the WHO ECDD (4–8 June 2012) which
reviewed the substance. The excerpts
from that report concerning GHB are
hereby transmitted as Annex II. The
excerpts are currently available in
English only, pending receipt of the
official French translation from the
WHO. The report of the Thirty-fifth
session of the WHO ECDD can be
retrieved from the following Web site:
https://www.who.int/medicines/areas/
quality_safety/35thecddmeet/en/
index.html. (FDA has verified the Web
site address, but FDA is not responsible
for any subsequent changes to the Web
site after this document publishes in the
Federal Register).
Any action or decision taken by the
Commission with respect to this
notification, pursuant to article 2,
paragraphs 5 and 6, of the 1971
Convention, will be communicated to
States Parties in due course. Article 2,
paragraphs 5 and 6, reads as follows:
5. The Commission, taking into account the
communication from the WHO, whose
assessments shall be determinative as to
medical and scientific matters, and bearing in
mind the economic, social, legal,
administrative and other factors it may
consider relevant, may add the substance to
Schedule I, II, III or IV. The Commission may
seek further information from the WHO or
from other appropriate sources.
6. If a notification under paragraph 1
relates to a substance already listed in one of
the Schedules, the WHO shall communicate
to the Commission its new findings, any new
assessment of the substance it may make in
accordance with paragraph 4 and any new
recommendations on control measures it may
find appropriate in the light of that
assessment. The Commission, taking into
account the communication from the WHO
as under paragraph 5 and bearing in mind the
factors referred to in that paragraph, may
decide to transfer the substance from one
Schedule to another or to delete it from the
Schedules.
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To assist the Commission in reaching
a decision, it would be appreciated if
the Government could communicate
any economic, social, legal,
administrative, or other factors that it
considers relevant to the possible
rescheduling under the 1971
Convention, of GHB, at the latest by 28
December 2012 to the Executive
Director of the United Nations Office on
Drugs and Crime, c/o Secretary,
Commission on Narcotic Drugs, P.O.
Box 500, 1400 Vienna, Austria, FAX:
+43–1–26060–5885, email:
sgb@unodc.org.
9 November 2012, NAR/CL.6/201,
Annex I, Page 1.
Annex I
Relevant excerpts of letter addressed to
the Secretary-General of the United
Nations by the Director-General of the
World Health Organization
‘‘With reference to article 2 of the
Convention on Psychotropic Substances
(1971), article 2, paragraphs 1, 4 and 6,
I am pleased to submit the
recommendations of the WHO,
concerning the international control of
y-hydroxybutyric acid (GHB). The
recommendation is that GHB be
rescheduled from Schedule IV to
Schedule II of the 1971 Convention. The
basis for this recommendation is set out
in an extract from the Report of the
ECDD, which advises on these issues,
attached to this letter.’’
Geneva, 22 October 2012, NAR/CL.6/
2012, Annex II, Page 1.
Annex II
Extract From the 35th Report of the
Expert Committee on Drug Dependence
Recommendation on GammaHydroxybutyric Acid (GHB)
This section provides information in
addition to the information presented in
the report of the Thirty-fourth meeting.
The Expert Committee discussed GHB
in the context of Gamma-butyrolactone
and 1,4-butanediol (1,4–BD), precursors
of GHB, see sections 4.4 and 4.5.
Substance Identification and
Pharmacodynamics
Gamma-hydroxybutyric acid (GHB),
also known as 4-hydroxybutanoic acid
and sodium oxybate, is a naturally
occurring substance found in low
concentrations in mammalian tissues. It
is considered to act by binding to GHBspecific receptors and Gammaaminobutyric acid B (GABAB) receptors.
At pharmacological doses, it acts as a
central nervous system depressant.
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Previous Reviews
GHB was pre-reviewed during the
Thirty-first and Thirty-second meetings,
held in 1998 and 2000, respectively. In
2001, GHB was placed in Schedule IV
of the 1971 Convention by a decision of
the CND. It was again pre-reviewed at
the Thirty-fourth ECDD meeting in 2006
(1), at which time the Expert Committee
recommended a new critical review to
consider GHB’s possible rescheduling.
Evidence on Dependence Potential
The Expert Committee examined
additional information from the updated
critical review report and peer-review
reports. The Expert Committee noted
that there is compelling evidence that
dependence on GHB exists in humans
and noted withdrawal syndromes and
withdrawal seizures.
Actual Abuse
The Expert Committee noted that at
present, GHB appears to be mainly used
and abused in the United States of
America, Europe and Australia. Most
GHB used illicitly originates from
clandestine manufacture.
In their discussions, the Expert
Committee and advisers agreed on the
narrow margin of safety of GHB. There
have been numerous reports from
Europe and the United States of
accidental fatal and non-fatal overdoses
where GHB was implicated, both when
used alone and with other substances.
The Expert Committee also noted
there have been reports of GHB being
used to facilitate sexual assault.
Therapeutic Usefulness
GHB is used as a medicine in some
countries on a small scale for various
indications. GHB is not included in the
WHO Model List of Essential Medicines.
Need for the Substance for Other
Purposes (e.g., Industrial)
The Expert Committee acknowledged
the use of GHB in the production of a
wide variety of industrial polymers.
III. Discussion
Although WHO has made specific
scheduling recommendations for each of
the drug substances, the CND is not
obliged to follow the WHO
recommendations. Options available to
the CND for substances considered for
control under the Psychotropic
Convention include: (1) Acceptance of
the WHO recommendations; (2)
acceptance of the recommendations to
control, but control the drug substance
in a schedule other than that
recommended; or (3) reject the
recommendations entirely.
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Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
GHB is classified as a central nervous
system depressant. In 2002, FDA
approved a GHB-containing product,
Xyrem, for the treatment of excessive
daytime sleepiness and cataplexy in
patients with narcolepsy under the
regulations in 21 CFR part 314, subpart
H (21 CFR 314.520). Xyrem was
included on the list of products deemed
to have in effect an approved Risk
Evaluation and Mitigation Strategy
(REMS) under section 505–1 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355–1) at the time of the
passage of the Food and Drug
Administration Amendments Act of
2007 (FDAAA). The REMS for Xyrem
includes a medication guide and
healthcare provider education brochure,
mandatory patient and prescriber
certification through enrollment, and
restricted dispensing 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 are
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. The
WHO ECDD pre-reviewed GHB at its
Thirty-fourth meeting and
recommended it for critical review at a
future meeting. The WHO ECDD met in
Hammamet, Tunisia, from 4–8 June
2012, critically reviewed GHB, and
recommended that it be rescheduled
from Schedule IV to Schedule II of the
Convention on Psychotropic
Substances.
IV. Submission of Comments and
Opportunity for Public Meeting
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments 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, and
will be posted to the docket at https://
www.regulations.gov.
FDA does not presently plan to hold
a public meeting. If any person believes
that, in addition to their written
comments, a public meeting would
contribute to the development of the
U.S. position on the substances to be
considered for control under the
Psychotropic Convention, a request for
a public meeting and the reasons for
such a request should be sent to James
R. Hunter (see FOR FURTHER INFORMATION
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CONTACT)
on or before February 19,
2013.
The short time period for the
submission of comments and requests
for a public meeting is needed to ensure
that HHS may, in a timely fashion, carry
out the required action and be
responsive to the United Nations.
Dated: February 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–02859 Filed 2–7–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
FOR FURTHER INFORMATION CONTACT:
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.
SUMMARY:
Therapeutic Hepatitis C Virus
Antibodies
Description of Technology:
Therapeutic antibodies against Hepatitis
C Virus (HCV) have not been very
effective in the past and there is
evidence that this may result in part
from interfering antibodies generated
during infection that block the action of
neutralizing antibodies. These
neutralizing antibodies prevent HCV
infection of a host cell.
The subject technologies are
monoclonal antibodies against HCV that
can neutralize different genotypes of
HCV. Both antibodies bind to the
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envelope (E2) protein of HCV found on
the surface of the virus. One of the
monoclonal antibodies neutralizes HCV
genotype 1a, the most prevalent HCV
strain in the U.S., infection and in vitro
data show that it is not blocked by
interfering antibodies. The second
antibody binds a conserved region of E2
and can cross neutralize a number of
genotypes including genotypes 1a and
2a. The monoclonal antibodies have the
potential to be developed either alone or
in combination into therapeutic
antibodies that prevent or treat HCV
infection. These antibodies may be
particularly suited for preventing HCV
re-infection in HCV patients who
undergo liver transplants; a population
of patients that is especially vulnerable
to the side effects of current treatments
for HCV infection.
Potential Commercial Applications:
Therapeutic antibodies for the
prevention and/or treatment of HCV
infection.
Competitive Advantages
• Therapeutic antibodies have
generally fewer side effects than current
treatments for HCV infection.
• Potential to be developed into an
alternative treatment for HCV infected
liver transplant patients, who often
cannot tolerate the side effects of
current drug treatments.
Development Stage
• Early-stage
• Pre-clinical
• In vitro data available
Inventors: Stephen M. Feinstone,
Hongying Duan, Pei Zhang, Marian E.
Major, Alla V. Kachko (all of FDA)
Publications
1. Kachko A, et al. New neutralizing
antibody epitopes in hepatitis C virus
envelope glycoproteins are revealed by
dissecting peptide recognition profiles.
Vaccine. 2011 Dec 9;30(1):69–77. [PMID
22041300]
2. Duan H, et al. Amino acid residuespecific neutralization and nonneutralization
of hepatitis C virus by monoclonal antibodies
to the E2 protein. J Virol. 2012
Dec;86(23):12686–94. [PMID 22973024]
Intellectual Property
• HHS Reference No. E–002–2012/
0—U.S. Provisional Patent Application
No. 61/648,386 filed 17 May 2012
• HHS Reference No. E–167–2012/
0—International PCT Application No.
PCT/US12/62197 filed 26 Oct 2012
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov
E:\FR\FM\08FEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9397-9399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02859]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0448]
International Drug Scheduling; Convention on Psychotropic
Substances; World Health Organization Scheduling Recommendations for
Gamma-hydroxybutyric Acid
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments and to request
an informal public meeting concerning recommendations by the World
Health Organization (WHO) to impose international manufacturing and
distributing restrictions, under international treaties, on certain
drug substances. The comments received in response to this notice and/
or public meeting will be considered in preparing the U.S. position on
these proposals for a meeting of the United Nations Commission on
Narcotic Drugs (CND) in Vienna, Austria, in March 2013. This notice is
issued under the Controlled Substances Act (the CSA).
DATES: Submit either electronic or written comments by February 25,
2013. Submit requests for a public meeting on or before February 19,
2013. (For additional information, see also section IV of this
document).
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, Bldg. 51, rm. 5150, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-3156, email: james.hunter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The United States is a party to the 1971 Convention on Psychotropic
Substances (the Convention). Section 201(d)(2)(B) of the CSA (21 U.S.C.
811(d)(2)(B)) provides that when the United States is notified under
Article 2 of the Convention that CND proposes to decide whether to add
a drug or other substance to one of the schedules of the Convention,
transfer a drug or substance from one schedule to another, or delete it
from the schedules, the Secretary of State must transmit notice of such
information to the Secretary of Health and Human Services (Secretary of
HHS). The Secretary of HHS must then publish a summary of such
information in the Federal Register and provide opportunity for
interested persons to submit comments. The Secretary of HHS must then
evaluate the proposal and furnish a recommendation to the Secretary of
State that shall be binding on the representative of the United States
in discussions and negotiations relating to the proposal.
As detailed in the following paragraphs, the Secretary of State has
received one notification from the Secretary-General of the United
Nations (the Secretary-General) regarding substances to be considered
for control under the Convention. This notification reflects the
recommendation from the 35th WHO Expert Committee for Drug Dependence
(ECDD), which met in June 2012. In the Federal Register of September
05, 2008 (73 FR 51823), FDA announced the WHO ECDD review and invited
interested persons to submit information for WHO's consideration.
The full text of the notification from the Secretary-General is
provided in section II of this document. Section 201(d)(2)(B) of the
CSA requires the Secretary of HHS, after receiving a notification
proposing scheduling, to publish a notice in the Federal Register to
provide the opportunity for interested persons to submit information
and comments on the proposed scheduling action.
II. United Nations Notification
The formal United Nations notification that identifies the drug
substance and explains the basis for the recommendations is reproduced
as follows:
Reference: NAR/CL.6/2012
WHO/ECDD35 1971C-Art.2
CU 2012/196/DTA/SGB
The Secretary-General of the United Nations presents his
compliments to the Secretary of State of the United States of America
and has the honour to inform the Government that the Director-
[[Page 9398]]
General of the WHO, under article 2, paragraphs 1, 4, and 6, of the
Convention on Psychotropic Substances of 1971 (1971 Convention), has
notified the Secretary-General that it is of the opinion that Gamma-
hydroxybutyric acid (GHB) should be transferred from Schedule IV to
Schedule II of the 1971 Convention.
In accordance with the provisions of article 2, paragraph 2, of the
1971 Convention, the Secretary-General hereby transmits the relevant
excerpts of the notification as Annex I to the present note. Also in
accordance with the same provisions, the notification from WHO will be
brought to the attention of the CND at its next session in March 2013.
In connection with the notification, WHO has also submitted
excerpts from the report of the Thirty-fifth session of the WHO ECDD
(4-8 June 2012) which reviewed the substance. The excerpts from that
report concerning GHB are hereby transmitted as Annex II. The excerpts
are currently available in English only, pending receipt of the
official French translation from the WHO. The report of the Thirty-
fifth session of the WHO ECDD can be retrieved from the following Web
site: https://www.who.int/medicines/areas/quality_safety/35thecddmeet/en/. (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register).
Any action or decision taken by the Commission with respect to this
notification, pursuant to article 2, paragraphs 5 and 6, of the 1971
Convention, will be communicated to States Parties in due course.
Article 2, paragraphs 5 and 6, reads as follows:
5. The Commission, taking into account the communication from
the WHO, whose assessments shall be determinative as to medical and
scientific matters, and bearing in mind the economic, social, legal,
administrative and other factors it may consider relevant, may add
the substance to Schedule I, II, III or IV. The Commission may seek
further information from the WHO or from other appropriate sources.
6. If a notification under paragraph 1 relates to a substance
already listed in one of the Schedules, the WHO shall communicate to
the Commission its new findings, any new assessment of the substance
it may make in accordance with paragraph 4 and any new
recommendations on control measures it may find appropriate in the
light of that assessment. The Commission, taking into account the
communication from the WHO as under paragraph 5 and bearing in mind
the factors referred to in that paragraph, may decide to transfer
the substance from one Schedule to another or to delete it from the
Schedules.
To assist the Commission in reaching a decision, it would be
appreciated if the Government could communicate any economic, social,
legal, administrative, or other factors that it considers relevant to
the possible rescheduling under the 1971 Convention, of GHB, at the
latest by 28 December 2012 to the Executive Director of the United
Nations Office on Drugs and Crime, c/o Secretary, Commission on
Narcotic Drugs, P.O. Box 500, 1400 Vienna, Austria, FAX: +43-1-26060-
5885, email: sgb@unodc.org.
9 November 2012, NAR/CL.6/201, Annex I, Page 1.
Annex I
Relevant excerpts of letter addressed to the Secretary-General of the
United Nations by the Director-General of the World Health Organization
``With reference to article 2 of the Convention on Psychotropic
Substances (1971), article 2, paragraphs 1, 4 and 6, I am pleased to
submit the recommendations of the WHO, concerning the international
control of y-hydroxybutyric acid (GHB). The recommendation is that GHB
be rescheduled from Schedule IV to Schedule II of the 1971 Convention.
The basis for this recommendation is set out in an extract from the
Report of the ECDD, which advises on these issues, attached to this
letter.''
Geneva, 22 October 2012, NAR/CL.6/2012, Annex II, Page 1.
Annex II
Extract From the 35th Report of the Expert Committee on Drug Dependence
Recommendation on Gamma-Hydroxybutyric Acid (GHB)
This section provides information in addition to the information
presented in the report of the Thirty-fourth meeting. The Expert
Committee discussed GHB in the context of Gamma-butyrolactone and 1,4-
butanediol (1,4-BD), precursors of GHB, see sections 4.4 and 4.5.
Substance Identification and Pharmacodynamics
Gamma-hydroxybutyric acid (GHB), also known as 4-hydroxybutanoic
acid and sodium oxybate, is a naturally occurring substance found in
low concentrations in mammalian tissues. It is considered to act by
binding to GHB-specific receptors and Gamma-aminobutyric acid B (GABAB)
receptors. At pharmacological doses, it acts as a central nervous
system depressant.
Previous Reviews
GHB was pre-reviewed during the Thirty-first and Thirty-second
meetings, held in 1998 and 2000, respectively. In 2001, GHB was placed
in Schedule IV of the 1971 Convention by a decision of the CND. It was
again pre-reviewed at the Thirty-fourth ECDD meeting in 2006 (1), at
which time the Expert Committee recommended a new critical review to
consider GHB's possible rescheduling.
Evidence on Dependence Potential
The Expert Committee examined additional information from the
updated critical review report and peer-review reports. The Expert
Committee noted that there is compelling evidence that dependence on
GHB exists in humans and noted withdrawal syndromes and withdrawal
seizures.
Actual Abuse
The Expert Committee noted that at present, GHB appears to be
mainly used and abused in the United States of America, Europe and
Australia. Most GHB used illicitly originates from clandestine
manufacture.
In their discussions, the Expert Committee and advisers agreed on
the narrow margin of safety of GHB. There have been numerous reports
from Europe and the United States of accidental fatal and non-fatal
overdoses where GHB was implicated, both when used alone and with other
substances.
The Expert Committee also noted there have been reports of GHB
being used to facilitate sexual assault.
Therapeutic Usefulness
GHB is used as a medicine in some countries on a small scale for
various indications. GHB is not included in the WHO Model List of
Essential Medicines.
Need for the Substance for Other Purposes (e.g., Industrial)
The Expert Committee acknowledged the use of GHB in the production
of a wide variety of industrial polymers.
III. Discussion
Although WHO has made specific scheduling recommendations for each
of the drug substances, the CND is not obliged to follow the WHO
recommendations. Options available to the CND for substances considered
for control under the Psychotropic Convention include: (1) Acceptance
of the WHO recommendations; (2) acceptance of the recommendations to
control, but control the drug substance in a schedule other than that
recommended; or (3) reject the recommendations entirely.
[[Page 9399]]
GHB is classified as a central nervous system depressant. In 2002,
FDA approved a GHB-containing product, Xyrem, for the treatment of
excessive daytime sleepiness and cataplexy in patients with narcolepsy
under the regulations in 21 CFR part 314, subpart H (21 CFR 314.520).
Xyrem was included on the list of products deemed to have in effect an
approved Risk Evaluation and Mitigation Strategy (REMS) under section
505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) at
the time of the passage of the Food and Drug Administration Amendments
Act of 2007 (FDAAA). The REMS for Xyrem includes a medication guide and
healthcare provider education brochure, mandatory patient and
prescriber certification through enrollment, and restricted dispensing
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 are 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. The WHO ECDD pre-reviewed GHB at its Thirty-fourth meeting
and recommended it for critical review at a future meeting. The WHO
ECDD met in Hammamet, Tunisia, from 4-8 June 2012, critically reviewed
GHB, and recommended that it be rescheduled from Schedule IV to
Schedule II of the Convention on Psychotropic Substances.
IV. Submission of Comments and Opportunity for Public Meeting
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments 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, and will be posted to the docket at https://www.regulations.gov.
FDA does not presently plan to hold a public meeting. If any person
believes that, in addition to their written comments, a public meeting
would contribute to the development of the U.S. position on the
substances to be considered for control under the Psychotropic
Convention, a request for a public meeting and the reasons for such a
request should be sent to James R. Hunter (see FOR FURTHER INFORMATION
CONTACT) on or before February 19, 2013.
The short time period for the submission of comments and requests
for a public meeting is needed to ensure that HHS may, in a timely
fashion, carry out the required action and be responsive to the United
Nations.
Dated: February 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02859 Filed 2-7-13; 8:45 am]
BILLING CODE 4160-01-P
