[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Notices]
[Pages 13258-13259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6910]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0148]
International Drug Scheduling; Convention on Psychotropic
Substances; Dihydroetorphine; Ephedrine; Remifentanil; Isomers of
Psychotropic Substances
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
interested persons to submit data or comments concerning abuse
potential, actual abuse, medical usefulness, and trafficking of three
drug substances. This information will be considered in preparing a
response from the United States to the World Health Organization (WHO)
regarding abuse liability, actual abuse, and trafficking 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 information is required by the Controlled Substances
Act (CSA).
DATES: Submit written comments by April 17, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Nicholas P. Reuter, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1696, E-mail: [email protected].
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 that 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 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 substance to one of the schedules of that 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 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 to assist HHS in preparing scientific and medical
evaluations about the drug or substance. The Secretary of HHS received
the following notices from WHO:
I. WHO Notification
Ref. : C. L.23 .1997
WHO questionnaire for collection of information for review of
dependence-producing psychoactive substances
The Director-General of the World Health Organization presents
his compliments and has the pleasure of informing Member States that
the Thirty-first Expert Committee on Drug Dependence will meet from
23 to 26 June 1998 to review the following substances:
1. Dihydroetorphine
2. Ephedrine
3. Remifentanil
4. With regard to all substances in Schedules I and II of the
Convention on Psychotropic Substances, 1971:
(a) their isomers, except where expressly excluded, whenever the
existence of such isomers is possible;
(b) their esters and ethers, except where included in another
schedule, whenever the existence of such esters and ethers is
possible;
(c) salts of those esters, ethers and isomers, under the
conditions stated above, whenever the formation of such salts is
possible;
(d) a substance resulting from modification of the chemical
structure of a substance already in these schedules and which
produces pharmacological effects similar to those produced by the
original substance.
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 document for
submission to the Expert Committee on Drug Dependence. The Director-
General invites Member States to collaborate, as in the past, in
this process by providing all pertinent information mentioned in the
attached questionnaire\1\ concerning the substances mentioned in
items 1 to 3 above. The questionnaire does not include any questions
about the groups of substances specified under item 4, since the
required information is already being sought by the Secretary-
General of the United Nations in his Circular Letter NAR/CL.4/1997.
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\1\ For Ministries of Health only.
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Further clarification on any of the above items can be obtained
from Psychotropic and Narcotic Drugs (PND), Division of Drug
Management and Policies, WHO, Geneva, to which replies should be
sent not later than 1 March 1998.
GENEVA, 30 December 1997
Questionnaire for data collection for use by the World Health
Organization and the Commission on Narcotic Drugs of the Economic and
Social Council
Substance reported on:
1. Availability of the substance (registered, marketed,
dispensed, etc.).
2. Extent of abuse of the substance.
3. Degree of seriousness of the public health and social
problems\2\ associated with abuse of the substance.
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\2\ Examples of public health and social problems are acute
intoxication, accidents, work absenteeism, mortality, behaviour
problems, criminality, etc.
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4. Number of seizures of the substance in the illicit traffic
during the previous three years and the quantities involved.
5. Identification of the seized substance as of local or foreign
manufacture and indication of any commercial markings.
6. Existence of clandestine laboratories manufacturing the
substance.
II. United Nations Notifications
The U.S. Government has received two notifications from the
Secretary General of the United Nations. The first notification (NAR/
CL./1997, signed May 28, 1997), transmits under to Article 2, paragraph
1 of the Convention on Psychotropic Substances, 1971, a request from
the Government of Spain to amend Schedules I and II of the Convention
to include:
``(a) isomers, except where expressly excluded, of substances
listed in those Schedules, whenever the existence of such isomers is
possible;
``(b) esters and ethers of substances in those Schedules, except
where included in another Schedule, whenever the existence of such
esters or ethers is possible;
``(c) salts of those esters, ethers and isomers, under the
conditions stated above, whenever the formation of such salts is
possible;
``(d) a substance resulting from modification of the chemical
structure of a substance already in Schedule I or Schedule II and which
produces pharmacological effects similar to those produced by the
original substance.''
The May 28, 1997, notification included as annexes, the original
request from the Government of Spain, along with a questionnaire. A
subsequent notification from the United
[[Page 13259]]
Nations Secretary General dated February 23, 1998 (NAR/CL.2/1998),
identified additional issues to be considered within the context of the
Government of Spain's request.
These notifications appear to relate to the amendment of the
Convention and not to the addition of specific substances to the
schedules of the Convention (See 21 U.S.C. 811 (d)). Therefore, they
are not published in this notice. The notifications are on display and
copies may be obtained by contacting Nicholas Reuter (address above).
Comments submitted in response to the United Nations notifications will
be forwarded to the WHO through the United Nations Secretariat.
III. Background
None of the three substances under consideration by WHO are
controlled internationally. Dihydroetorphine is a hydrogenated
derivative of etorphine and a potent -opioid-receptor agonist
used as a short-acting analgesic in China. It is neither marketed nor
controlled in the United States.
Ephedrine is available in the United States as an over-the-counter
bronchodilator. Further, ephedrine has been designated as a listed
chemical and is subject to chemical diversion regulations under 21 CFR
part 1310 which are enforced by the Drug Enforcement Administration.
According to WHO, information is now available to indicate that illicit
trafficking in ephedrine has increased significantly in recent years.
Further, although the substance is illicitly used primarily in the
manufacture of stimulants, WHO has evidence to indicate the increasing
abuse of ephedrine preparations in some countries.
Remifentanil is a selective -opioid-receptor agonist of
the fentanyl group. Remifentanil is approved in the United States as an
anesthetic for use in animals and is controlled domestically as a
narcotic in schedule II of the CSA.
IV. Opportunity to Submit Domestic Information
As required by section 201(d)(2)(A) of the Controlled Substances
Act (21 U.S.C. 811(c)(2)(A)). FDA on behalf of the Department of Health
and Human Services (DHHS) invites interested persons to submit data or
comments regarding the eight named drugs. Data and information received
in response to this notice will be used to prepare scientific and
medical information on these drugs, with a particular focus on each
drug's abuse liability. DHHS will forward that information to WHO,
through the Secretary of State, for WHO's consideration in deciding
whether to recommend international control 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.
DHHS will not now make any recommendations to WHO regarding whether
any of these drugs should be subjected to international controls.
Instead, DHHS will defer such consideration until WHO has made official
recommendations to the Commission on Narcotic Drugs, which are expected
to be made in late 1998 or early 1999. Any DHHS position regarding
international control of these drugs will be preceded by another
Federal Register notice soliciting public comment as required by 21
U.S.C. 811(d)(2)(B).
V. Comments
Interested persons may, on or before April 17, 1998, submit to the
Docket Management Branch (address above) written comments regarding
this action. This abbreviated acceptance period is necessary to allow
sufficient time to prepare and submit the domestic information package
by the deadline imposed by WHO. Although WHO has requested comments and
information by March 1, 1998, WHO will accept and consider material
transmitted after the March date. Respondents should submit material in
the format set forth by the WHO Questionnaire reprinted previously.
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 office above between 9 a.m. and 4
p.m, Monday through Friday.
This notice contains information collection requirements that were
submitted for review and approval to the Director of the Office of
Management and Budget (OMB). The requirements were approved and
assigned OMB control number 0910-0226.
Dated: March 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-6910 Filed 3-17-98; 8:45 am]
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