80_FR_60343 80 FR 60151 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ketamine and Nine Other Substances; Request for Comments

80 FR 60151 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ketamine and Nine Other Substances; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 192 (October 5, 2015)

Page Range60151-60153
FR Document2015-25201

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 10 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 (the CSA).

Federal Register, Volume 80 Issue 192 (Monday, October 5, 2015)
[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Notices]
[Pages 60151-60153]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0045]


International Drug Scheduling; Convention on Psychotropic 
Substances; Single Convention on Narcotic Drugs; Ketamine and Nine 
Other Substances; Request for Comments

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 10 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 (the CSA).

DATES: Submit either electronic or written comments by October 15, 
2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-0045 for International Drug Scheduling; Convention on 
Psychotropic Substances; Single Convention on Narcotic Drugs; Ketamine; 
Phenazepam; Etizolam; 1-cyclohexyl-4-(1,2-diphenylethyl)-piperazine 
(MT-45); N-(1-Phenethylpiperidin-4-yl)-N-phenylacetamide 
(Acetylfentanyl); [alpha]-Pyrrolidinovalerophenone ([alpha]-PVP); 4-
Fluoroamphetamine (4-FA); para-Methyl-4-methylaminorex (4,4'-DMAR); 
para-Methoxymethylamphetamine (PMMA); 2-(ethylamino)-2-(3-
methoxyphenyl)-cyclohexanone (Methoxetamine or MXE); Request for 
Comments. Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

[[Page 60152]]


FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug 
Evaluation and Research, Controlled Substance Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver 
Spring, MD 20993-0002, 301-796-3156, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic 
Substances (Psychotropic Convention). Article 2 of the Psychotropic 
Convention 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 (the U.N. Secretary-General) 
and provide the U.N. Secretary-General with information in support of 
its opinion.
    Section 201 of the CSA (21 U.S.C. 811) (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 
Psychotropic Convention that it has information that may justify adding 
a drug or other substances to one of the schedules of the Psychotropic 
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 
(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.

II. WHO Notification

    The Secretary of HHS received the following notice from WHO 
(emphasis removed):

    Ref.: C.L.28.2015

    The World Health Organization (WHO) presents its compliments to 
Member States and Associate Members and has the pleasure of 
informing that the Thirty-sixth Expert Committee on Drug Dependence 
(ECDD) will meet in Geneva from 16 to 20 November 2015 to review a 
number of substances with potential for dependence, abuse and harm 
to health, and will make recommendations to the U.N. Secretary-
General, on the need for and level of international control of these 
substances.
    At its 126th session in January 2010, the Executive Board 
approved the publication ``Guidance on the WHO review of 
psychoactive substances for international control'' (EB126/2010/
REC1, Annex 6) which requires the Secretariat to request relevant 
information from Ministers of Health in Member States to prepare a 
report for submission to the ECDD. For this purpose, a questionnaire 
was designed to gather information on the legitimate use, harmful 
use, status of national control and potential impact of 
international control for each substance under evaluation. Member 
States are invited to collaborate, as in the past, in this process 
by providing pertinent information as requested in the questionnaire 
and concerning substances under review.
    It would be appreciated if a person from the Ministry of Health 
could be designated as the focal point responsible for coordinating 
and answering the questionnaire. It is requested that the focal 
point's contact details (including email address) be emailed to: 
[email protected]. The designated focal point, and only this 
person, should access and complete the questionnaires via these 
links:

1. Ketamine INN--https://extranet.who.int/dataform/961512/lang-en
2. Phenazepam--https://extranet.who.int/dataform/482684/lang-en
3. Etizolam--https://extranet.who.int/dataform/278963/lang-en
4. MT-45--https://extranet.who.int/dataform/465468/lang-en
5. Acetylfentanyl--https://extranet.who.int/dataform/495475/lang-en
6. [alpha]-Pyrrolidinovalerophenone ([alpha]-PVP)--https://extranet.who.int/dataform/758275/lang-en
7. 4-Fluoroamphetamine (4-FA)--https://extranet.who.int/dataform/538126/lang-en
8. para-Methyl-4-methylaminorex (4,4'-DMAR)--https://extranet.who.int/dataform/422472/lang-en
9. para-Methoxymethylamphetamine (PMMA)--https://extranet.who.int/dataform/665818/lang-en
10. Methoxetamine (MXE)--https://extranet.who.int/dataform/266376/lang-en

    Upon accessing the links the focal point will be prompted for a 
token (password) which is the country name in English, non-case 
sensitive and without spaces.
    For ease of reference a PDF version of the questionnaire in 
English, French and Spanish may be downloaded from the link http://www.who.int/medicines/access/controlled-substances/ecdd/en/. Further 
clarification regarding the questionnaire may be obtained from the 
Secretariat by emailing: [email protected].
    Replies to the questionnaire must reach the Secretariat by 15 
October 2015 in order to facilitate analyses and preparation of the 
report before the planned meeting. Where there is a competent 
National Authority under the International Drug Control Treaties, it 
is kindly requested that the questionnaire be completed in 
collaboration with such body.
    The summary information from the questionnaire will be published 
online as part of the report on the Web site for the 37th ECDD 
linked to the Department of Essential Medicines and Health Products 
(EMP).
    The World Health Organization takes this opportunity to renew to 
Member States and Associate Members the assurance of its highest 
consideration.

GENEVA, 11 September 2015

    FDA has verified the Web site addresses contained in the WHO 
notice, as of the date this document publishes in the Federal Register, 
but Web sites are subject to change over time.

III. Substances Under WHO Review

    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 product for medical and veterinary use. Ketamine is 
controlled in Schedule III of the CSA in the United States. It is not 
controlled internationally under either the Psychotropic Convention or 
the Single Convention on Narcotic Drugs. The WHO Expert Committee on 
Drug Dependence reviewed ketamine at its 34th, 35th, and 36th meetings. 
On March 13, 2015, the Commission on Narcotic Drugs decided by 
consensus to postpone the consideration of a proposal concerning the 
recommendation to place ketamine in Schedule IV of the Psychotropic 
Convention and to request additional information from the WHO.
    Phenazepam and Etizolam belong to a class of substances known as 
benzodiazepines. Benzodiazepines produce central nervous system 
depression and are commonly used to treat insomnia, anxiety, and 
seizure disorders. Phenazepam and Etizolam are currently prescribed in 
some countries, but neither drug substance is approved for medical use 
or controlled in the United States under the CSA.
    1-cyclohexyl-4-(1,2-diphenylethyl)-piperazine (MT-45) is a 
synthetic opioid with potent analgesic activity comparable to morphine 
despite being structurally unrelated to most other opioids. MT-45 use 
has been associated with deaths in the United States and in other 
countries. MT-45 is not currently controlled in the United States under 
the CSA.
    Acetylfentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) is 
a potent opioid analgesic in the phenylpiperidine class of synthetic 
opioids. With the exception of its analgesic effects, this fentanyl-
like substance is similar to other opioid analgesics that produce a 
variety of pharmacological effects, including alteration in mood, 
euphoria, drowsiness, respiratory depression, constriction of pupils 
(miosis), and impaired gastrointestinal motility. Acetylfentanyl has 
been associated with

[[Page 60153]]

several confirmed deaths in the United States. On July 17, 2015, 
Acetylfentanyl was temporarily placed into Schedule I of the CSA for 2 
years upon finding that it posed an imminent hazard to the public 
safety. The Attorney General, though, may extend this temporary 
scheduling for up to 1 year.
    [alpha]-Pyrrolidinovalerophenone ([alpha]-PVP or alpha-PVP) is a 
synthetic cathinone structurally and pharmacologically similar to 
amphetamine, 3,4-methylenedioxymethamphetamine (MDMA); cathinone; and 
other related substances. Effects reported by abusers of synthetic 
cathinone substances include euphoria; sense of well-being; and 
increased sociability, energy, empathy, alertness, and concentration 
and focus. Abusers also report experiencing unwanted effects such as 
tremor, vomiting, agitation, sweating, fever, and chest pain. Other 
adverse or toxic effects that have been reported with the abuse of 
synthetic cathinones include tachycardia, hypertension, hyperthermia, 
mydriasis, rhabdomyolysis, hyponatremia, seizures, altered mental 
status (e.g., paranoia, hallucinations, or delusions), and even death. 
On March 7, 2014, alpha-PVP was temporarily placed into Schedule I of 
the CSA for 2 years upon finding that it posed an imminent hazard to 
the public safety. The Attorney General, though, may extend this 
temporary scheduling for up to 1 year.
    4-Fluoroamphetamine (4-FA) is a psychoactive substance of the 
phenethylamine and substituted amphetamine chemical classes and 
produces stimulant effects. 4-FA is not currently controlled in the 
United States under the CSA.
    Para-Methyl-4-methylaminorex (4,4'-DMAR) is a derivative of the 
stimulant drug 4-methylaminorex and has been involved in several deaths 
in the United States. 4,4'-DMAR is not currently controlled in the 
United States under the CSA.
    Para-Methoxymethylamphetamine (PMMA) is a substituted amphetamine 
of the phenethylamine class, as well as a structural analog of para-
methoxyamphetamine (PMA) which produces effects similar but not 
identical to that of MDMA. PMMA is not currently controlled in the 
United States under the CSA.
    2-(ethylamino)-2-(3-methoxyphenyl)-cyclohexanone (Methoxetamine or 
MXE) is an arylcyclohexamine and is not currently controlled under the 
CSA in the United States. At its 36th meeting, the WHO Expert Committee 
on Drug Dependence noted the insufficiency of data regarding 
dependence, abuse, and risks to the public health, thereby recommending 
that Methoxetamine not be placed under international control but be 
kept under international surveillance.

IV. 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 the Department of Health and Human 
Services (HHS), invites interested persons to submit comments regarding 
the 10 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.
    Although FDA is, through this notice, requesting comments from 
interested persons which will be considered by HHS when it prepares an 
evaluation of these drugs, 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 2016. 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.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25201 Filed 10-2-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                                                Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices                                         60151

                                                  on NCQA’s evaluation of SNPs using                      considered in preparing a response from               Convention on Narcotic Drugs;
                                                  MOC scoring guidelines. Based on their                  the United States to the World Health                 Ketamine; Phenazepam; Etizolam; 1-
                                                  scores, SNPs receive an approval for a                  Organization (WHO) regarding the abuse                cyclohexyl-4-(1,2-diphenylethyl)-
                                                  period of 1-, 2-, or 3-years. We are                    liability and diversion of these drugs.               piperazine (MT-45); N-(1-
                                                  developing an MOC off-cycle revision                    WHO will use this information to                      Phenethylpiperidin-4-yl)-N-
                                                  process so that SNPs can revise the                     consider whether to recommend that                    phenylacetamide (Acetylfentanyl); a-
                                                  MOC to modify its processes and                         certain international restrictions be                 Pyrrolidinovalerophenone (a-PVP); 4-
                                                  strategies for providing care during their              placed on these drugs. This notice                    Fluoroamphetamine (4-FA); para-
                                                  MOC approval period. We will require                    requesting comments is required by the                Methyl-4-methylaminorex (4,4’-DMAR);
                                                  that SNPs submit summaries of their                     Controlled Substances Act (the CSA).                  para-Methoxymethylamphetamine
                                                  MOC revisions to CMS for NCQA                           DATES: Submit either electronic or                    (PMMA); 2-(ethylamino)-2-(3-
                                                  evaluation when a SNP makes                             written comments by October 15, 2015.                 methoxyphenyl)-cyclohexanone
                                                  significant changes to its MOC as                                                                             (Methoxetamine or MXE); Request for
                                                                                                          ADDRESSES: You may submit comments
                                                  described in the annual Announcement                                                                          Comments. Received comments will be
                                                                                                          as follows:
                                                  of Medicare Capitation Rates and                                                                              placed in the docket and, except for
                                                  Medicare Advantage and Part D                           Electronic Submissions                                those submitted as ‘‘Confidential
                                                  Payment Policies and Final Call letter                                                                        Submissions,’’ publicly viewable at
                                                                                                            Submit electronic comments in the
                                                  for CY 2015 and CY2016. The NCQA                                                                              http://www.regulations.gov or at the
                                                                                                          following way:
                                                  will review the summary of changes to                                                                         Division of Dockets Management
                                                                                                            • Federal eRulemaking Portal: http://
                                                  verify that the revisions are consistent                                                                      between 9 a.m. and 4 p.m., Monday
                                                                                                          www.regulations.gov. Follow the
                                                  with the acceptable, high quality                                                                             through Friday.
                                                                                                          instructions for submitting comments.                    • Confidential Submissions—To
                                                  standards as included in the original
                                                                                                          Comments submitted electronically,                    submit a comment with confidential
                                                  approved MOC. The package has been
                                                                                                          including attachments, to http://                     information that you do not wish to be
                                                  revised subsequent to the publication of
                                                                                                          www.regulations.gov will be posted to                 made publicly available, submit your
                                                  the 60-day Federal Register notice (June
                                                                                                          the docket unchanged. Because your                    comments only as a written/paper
                                                  17, 2015; 80 FR 34647). Form Number:
                                                  CMS–10565 (OMB control number                           comment will be made public, you are                  submission. You should submit two
                                                  0938-New); Frequency: Occasionally;                     solely responsible for ensuring that your             copies total. One copy will include the
                                                  Affected Public: Private sector (Business               comment does not include any                          information you claim to be confidential
                                                  or other for-profits and Not-for-profit                 confidential information that you or a                with a heading or cover note that states
                                                  institutions); Number of Respondents:                   third party may not wish to be posted,                ‘‘THIS DOCUMENT CONTAINS
                                                  313; Total Annual Responses: 421; Total                 such as medical information, your or                  CONFIDENTIAL INFORMATION’’. The
                                                  Annual Hours: 2,400. (For policy                        anyone else’s Social Security number, or              Agency will review this copy, including
                                                  questions regarding this collection                     confidential business information, such               the claimed confidential information, in
                                                  contact Susan Radke at 410–786–4450).                   as a manufacturing process. Please note               its consideration of comments. The
                                                                                                          that if you include your name, contact                second copy, which will have the
                                                     Dated: September 30, 2015.                           information, or other information that                claimed confidential information
                                                  William N. Parham, III,                                 identifies you in the body of your                    redacted/blacked out, will be available
                                                  Director, Paperwork Reduction Staff, Office             comments, that information will be                    for public viewing and posted on http://
                                                  of Strategic Operations and Regulatory                  posted on http://www.regulations.gov.
                                                  Affairs.
                                                                                                                                                                www.regulations.gov. Submit both
                                                                                                            • If you want to submit a comment                   copies to the Division of Dockets
                                                  [FR Doc. 2015–25212 Filed 10–2–15; 8:45 am]             with confidential information that you                Management. If you do not wish your
                                                  BILLING CODE 4120–01–P                                  do not wish to be made available to the               name and contact information to be
                                                                                                          public, submit the comment as a                       made publicly available, you can
                                                                                                          written/paper submission and in the                   provide this information on the cover
                                                  DEPARTMENT OF HEALTH AND                                manner detailed (see ‘‘Written/Paper                  sheet and not in the body of your
                                                  HUMAN SERVICES                                          Submissions’’ and ‘‘Instructions’’).                  comments and you must identify this
                                                  Food and Drug Administration                            Written/Paper Submissions                             information as ‘‘confidential.’’ Any
                                                                                                                                                                information marked as ‘‘confidential’’
                                                  [Docket No. FDA–2015–N–0045]                               Submit written/paper submissions as                will not be disclosed except in
                                                                                                          follows:                                              accordance with 21 CFR 10.20 and other
                                                  International Drug Scheduling;                             • Mail/Hand delivery/Courier (for                  applicable disclosure law. For more
                                                  Convention on Psychotropic                              written/paper submissions): Division of               information about FDA’s posting of
                                                  Substances; Single Convention on                        Dockets Management (HFA–305), Food                    comments to public dockets, see 80 FR
                                                  Narcotic Drugs; Ketamine and Nine                       and Drug Administration, 5630 Fishers                 56469, September 18, 2015, or access
                                                  Other Substances; Request for                           Lane, rm. 1061, Rockville, MD 20852.                  the information at: http://www.fda.gov/
                                                  Comments                                                   • For written/paper comments                       regulatoryinformation/dockets/
                                                  AGENCY:    Food and Drug Administration,                submitted to the Division of Dockets                  default.htm.
                                                  HHS.                                                    Management, FDA will post your                           Docket: For access to the docket to
                                                  ACTION:   Notice.                                       comment, as well as any attachments,                  read background documents or the
                                                                                                          except for information submitted,                     electronic and written/paper comments
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  SUMMARY:   The Food and Drug                            marked and identified, as confidential,               received, go to http://
                                                  Administration (FDA) is requesting                      if submitted as detailed in                           www.regulations.gov and insert the
                                                  interested persons to submit comments                   ‘‘Instructions.’’                                     docket number, found in brackets in the
                                                  concerning abuse potential, actual                         Instructions: All submissions received             heading of this document, into the
                                                  abuse, medical usefulness, trafficking,                 must include the Docket No. FDA–                      ‘‘Search’’ box and follow the prompts
                                                  and impact of scheduling changes on                     2015–N–0045 for International Drug                    and/or go to the Division of Dockets
                                                  availability for medical use of 10 drug                 Scheduling; Convention on                             Management, 5630 Fishers Lane, rm.
                                                  substances. These comments will be                      Psychotropic Substances; Single                       1061, Rockville, MD 20852.


                                             VerDate Sep<11>2014   18:34 Oct 02, 2015   Jkt 238001   PO 00000   Frm 00038   Fmt 4703   Sfmt 4703   E:\FR\FM\05OCN1.SGM   05OCN1


                                                  60152                         Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices

                                                  FOR FURTHER INFORMATION CONTACT:                        requires the Secretariat to request relevant          Associate Members the assurance of its
                                                  James R. Hunter, Center for Drug                        information from Ministers of Health in               highest consideration.
                                                  Evaluation and Research, Controlled                     Member States to prepare a report for                 GENEVA, 11 September 2015
                                                                                                          submission to the ECDD. For this purpose, a
                                                  Substance Staff, Food and Drug                                                                                  FDA has verified the Web site
                                                                                                          questionnaire was designed to gather
                                                  Administration, 10903 New Hampshire                     information on the legitimate use, harmful            addresses contained in the WHO notice,
                                                  Ave., Bldg. 51, Rm. 5150, Silver Spring,                use, status of national control and potential         as of the date this document publishes
                                                  MD 20993–0002, 301–796–3156, email:                     impact of international control for each              in the Federal Register, but Web sites
                                                  james.hunter@fda.hhs.gov.                               substance under evaluation. Member States             are subject to change over time.
                                                  SUPPLEMENTARY INFORMATION:                              are invited to collaborate, as in the past, in
                                                                                                          this process by providing pertinent                   III. Substances Under WHO Review
                                                  I. Background                                           information as requested in the questionnaire
                                                                                                          and concerning substances under review.                  Ketamine is classified as a rapid-
                                                     The United States is a party to the                                                                        acting general anesthetic agent used for
                                                                                                             It would be appreciated if a person from
                                                  1971 Convention on Psychotropic                         the Ministry of Health could be designated as         short diagnostic and surgical procedures
                                                  Substances (Psychotropic Convention).                   the focal point responsible for coordinating          that do not require skeletal muscle
                                                  Article 2 of the Psychotropic                           and answering the questionnaire. It is                relaxation. It is marketed in the United
                                                  Convention provides that if a party to                  requested that the focal point’s contact              States as an injectable product for
                                                  the convention or WHO has information                   details (including email address) be emailed          medical and veterinary use. Ketamine is
                                                  about a substance, which in its opinion                 to: ecddsecretariat@who.int. The designated
                                                                                                                                                                controlled in Schedule III of the CSA in
                                                  may require international control or                    focal point, and only this person, should
                                                                                                          access and complete the questionnaires via            the United States. It is not controlled
                                                  change in such control, it shall so notify                                                                    internationally under either the
                                                                                                          these links:
                                                  the Secretary-General of the United                                                                           Psychotropic Convention or the Single
                                                  Nations (the U.N. Secretary-General)                    1. Ketamine INN—https://extranet.who.int/
                                                                                                                dataform/961512/lang-en                         Convention on Narcotic Drugs. The
                                                  and provide the U.N. Secretary-General                  2. Phenazepam—https://extranet.who.int/               WHO Expert Committee on Drug
                                                  with information in support of its                            dataform/482684/lang-en                         Dependence reviewed ketamine at its
                                                  opinion.                                                3. Etizolam—https://extranet.who.int/                 34th, 35th, and 36th meetings. On
                                                     Section 201 of the CSA (21 U.S.C.                          dataform/278963/lang-en                         March 13, 2015, the Commission on
                                                  811) (Title II of the Comprehensive Drug                4. MT–45—https://extranet.who.int/                    Narcotic Drugs decided by consensus to
                                                  Abuse Prevention and Control Act of                           dataform/465468/lang-en
                                                                                                                                                                postpone the consideration of a
                                                  1970) provides that when WHO notifies                   5. Acetylfentanyl—https://extranet.who.int/
                                                                                                                dataform/495475/lang-en                         proposal concerning the
                                                  the United States under Article 2 of the                                                                      recommendation to place ketamine in
                                                  Psychotropic Convention that it has                     6. a-Pyrrolidinovalerophenone (a-PVP)—
                                                                                                                https://extranet.who.int/dataform/              Schedule IV of the Psychotropic
                                                  information that may justify adding a                         758275/lang-en                                  Convention and to request additional
                                                  drug or other substances to one of the                  7. 4-Fluoroamphetamine (4–FA)—https://                information from the WHO.
                                                  schedules of the Psychotropic                                 extranet.who.int/dataform/538126/lang-             Phenazepam and Etizolam belong to a
                                                  Convention, transferring a drug or                            en                                              class of substances known as
                                                  substance from one schedule to another,                 8. para-Methyl-4-methylaminorex (4,4’-
                                                                                                                                                                benzodiazepines. Benzodiazepines
                                                  or deleting it from the schedules, the                        DMAR)—https://extranet.who.int/
                                                                                                                dataform/422472/lang-en                         produce central nervous system
                                                  Secretary of State must transmit the                                                                          depression and are commonly used to
                                                  notice to the Secretary of Health and                   9. para-Methoxymethylamphetamine
                                                                                                                (PMMA)—https://extranet.who.int/                treat insomnia, anxiety, and seizure
                                                  Human Services (Secretary of HHS). The                        dataform/665818/lang-en                         disorders. Phenazepam and Etizolam are
                                                  Secretary of HHS must then publish the                  10. Methoxetamine (MXE)—https://                      currently prescribed in some countries,
                                                  notice in the Federal Register and                            extranet.who.int/dataform/266376/lang-          but neither drug substance is approved
                                                  provide opportunity for interested                            en                                              for medical use or controlled in the
                                                  persons to submit comments that will be                    Upon accessing the links the focal point           United States under the CSA.
                                                  considered by HHS in its preparation of                 will be prompted for a token (password)                  1-cyclohexyl-4-(1,2-diphenylethyl)-
                                                  the scientific and medical evaluations of               which is the country name in English, non-
                                                                                                                                                                piperazine (MT–45) is a synthetic
                                                  the drug or substance.                                  case sensitive and without spaces.
                                                                                                             For ease of reference a PDF version of the         opioid with potent analgesic activity
                                                  II. WHO Notification                                    questionnaire in English, French and Spanish          comparable to morphine despite being
                                                     The Secretary of HHS received the                    may be downloaded from the link http://               structurally unrelated to most other
                                                  following notice from WHO (emphasis                     www.who.int/medicines/access/controlled-              opioids. MT–45 use has been associated
                                                                                                          substances/ecdd/en/. Further clarification            with deaths in the United States and in
                                                  removed):                                               regarding the questionnaire may be obtained           other countries. MT–45 is not currently
                                                     Ref.: C.L.28.2015                                    from the Secretariat by emailing:                     controlled in the United States under
                                                     The World Health Organization (WHO)                  ecddsecretariat@who.int.
                                                                                                                                                                the CSA.
                                                  presents its compliments to Member States                  Replies to the questionnaire must reach the
                                                                                                          Secretariat by 15 October 2015 in order to               Acetylfentanyl (N-(1-
                                                  and Associate Members and has the pleasure
                                                  of informing that the Thirty-sixth Expert               facilitate analyses and preparation of the            phenethylpiperidin-4-yl)-N-
                                                  Committee on Drug Dependence (ECDD) will                report before the planned meeting. Where              phenylacetamide) is a potent opioid
                                                  meet in Geneva from 16 to 20 November 2015              there is a competent National Authority               analgesic in the phenylpiperidine class
                                                  to review a number of substances with                   under the International Drug Control                  of synthetic opioids. With the exception
                                                  potential for dependence, abuse and harm to             Treaties, it is kindly requested that the             of its analgesic effects, this fentanyl-like
                                                                                                          questionnaire be completed in collaboration
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                                                  health, and will make recommendations to                                                                      substance is similar to other opioid
                                                  the U.N. Secretary-General, on the need for             with such body.                                       analgesics that produce a variety of
                                                  and level of international control of these                The summary information from the
                                                                                                                                                                pharmacological effects, including
                                                  substances.                                             questionnaire will be published online as
                                                     At its 126th session in January 2010, the            part of the report on the Web site for the 37th       alteration in mood, euphoria,
                                                  Executive Board approved the publication                ECDD linked to the Department of Essential            drowsiness, respiratory depression,
                                                  ‘‘Guidance on the WHO review of                         Medicines and Health Products (EMP).                  constriction of pupils (miosis), and
                                                  psychoactive substances for international                  The World Health Organization takes this           impaired gastrointestinal motility.
                                                  control’’ (EB126/2010/REC1, Annex 6) which              opportunity to renew to Member States and             Acetylfentanyl has been associated with


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                                                                                Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices                                          60153

                                                  several confirmed deaths in the United                  dependence, abuse, and risks to the                   DEPARTMENT OF HEALTH AND
                                                  States. On July 17, 2015, Acetylfentanyl                public health, thereby recommending                   HUMAN SERVICES
                                                  was temporarily placed into Schedule I                  that Methoxetamine not be placed under
                                                  of the CSA for 2 years upon finding that                international control but be kept under               Food and Drug Administration
                                                  it posed an imminent hazard to the                      international surveillance.                           [Docket No. FDA–2012–N–0559]
                                                  public safety. The Attorney General,
                                                  though, may extend this temporary                       IV. Opportunity To Submit Domestic                    Agency Information Collection
                                                  scheduling for up to 1 year.                            Information                                           Activities; Proposed Collection;
                                                     a-Pyrrolidinovalerophenone (a-PVP                                                                          Comment Request; Public Health
                                                  or alpha-PVP) is a synthetic cathinone                    As required by section 201(d)(2)(A) of
                                                                                                                                                                Service Guideline on Infectious
                                                  structurally and pharmacologically                      the CSA (21 U.S.C. 811(d)(2)(A)), FDA,
                                                                                                                                                                Disease Issues in Xenotransplantation
                                                  similar to amphetamine, 3,4-                            on behalf of the Department of Health
                                                  methylenedioxymethamphetamine                           and Human Services (HHS), invites                     AGENCY:    Food and Drug Administration,
                                                  (MDMA); cathinone; and other related                    interested persons to submit comments                 HHS.
                                                  substances. Effects reported by abusers                 regarding the 10 named drugs. Any                     ACTION:   Notice.
                                                  of synthetic cathinone substances                       comments received will be considered
                                                  include euphoria; sense of well-being;                                                                        SUMMARY:   The Food and Drug
                                                                                                          by HHS when it prepares a scientific
                                                  and increased sociability, energy,                                                                            Administration (FDA) is announcing an
                                                                                                          and medical evaluation of these drugs.
                                                  empathy, alertness, and concentration                                                                         opportunity for public comment on the
                                                                                                          HHS will forward a scientific and
                                                  and focus. Abusers also report                                                                                proposed collection of certain
                                                                                                          medical evaluation of these drugs to                  information by the Agency. Under the
                                                  experiencing unwanted effects such as                   WHO, through the Secretary of State, for
                                                  tremor, vomiting, agitation, sweating,                                                                        Paperwork Reduction Act of 1995 (the
                                                                                                          WHO’s consideration in deciding                       PRA), Federal Agencies are required to
                                                  fever, and chest pain. Other adverse or                 whether to recommend international
                                                  toxic effects that have been reported                                                                         publish notice in the Federal Register
                                                                                                          control/decontrol of any of these drugs.              concerning each proposed collection of
                                                  with the abuse of synthetic cathinones                  Such control could limit, among other
                                                  include tachycardia, hypertension,                                                                            information, including each proposed
                                                                                                          things, the manufacture and distribution              extension of an existing collection of
                                                  hyperthermia, mydriasis,
                                                                                                          (import/export) of these drugs and could              information, and to allow 60 days for
                                                  rhabdomyolysis, hyponatremia,
                                                  seizures, altered mental status (e.g.,                  impose certain recordkeeping                          public comment in response to this
                                                  paranoia, hallucinations, or delusions),                requirements on them.                                 notice. This notice solicits comments on
                                                  and even death. On March 7, 2014,                         Although FDA is, through this notice,               the collection of information contained
                                                  alpha-PVP was temporarily placed into                   requesting comments from interested                   in the Public Health Service (PHS)
                                                  Schedule I of the CSA for 2 years upon                  persons which will be considered by                   guideline entitled ‘‘PHS Guideline on
                                                  finding that it posed an imminent                       HHS when it prepares an evaluation of                 Infectious Disease Issues in
                                                  hazard to the public safety. The                        these drugs, HHS will not now make                    Xenotransplantation’’ dated January 19,
                                                  Attorney General, though, may extend                                                                          2001.
                                                                                                          any recommendations to WHO
                                                  this temporary scheduling for up to 1                   regarding whether any of these drugs                  DATES: Submit either electronic or
                                                  year.                                                   should be subjected to international                  written comments on the collection of
                                                     4-Fluoroamphetamine (4–FA) is a                                                                            information by December 4, 2015.
                                                                                                          controls. Instead, HHS will defer such
                                                  psychoactive substance of the                                                                                 ADDRESSES: You may submit comments
                                                                                                          consideration until WHO has made
                                                  phenethylamine and substituted                                                                                as follows:
                                                                                                          official recommendations to the
                                                  amphetamine chemical classes and
                                                  produces stimulant effects. 4–FA is not                 Commission on Narcotic Drugs, which                   Electronic Submissions
                                                  currently controlled in the United States               are expected to be made in early 2016.                  Submit electronic comments in the
                                                  under the CSA.                                          Any HHS position regarding                            following way:
                                                     Para-Methyl-4-methylaminorex (4,4’-                  international control of these drugs will               • Federal eRulemaking Portal: http://
                                                  DMAR) is a derivative of the stimulant                  be preceded by another Federal Register               www.regulations.gov. Follow the
                                                  drug 4-methylaminorex and has been                      notice soliciting public comments, as                 instructions for submitting comments.
                                                  involved in several deaths in the United                required by section 201(d)(2)(B) of the               Comments submitted electronically,
                                                  States. 4,4’-DMAR is not currently                      CSA.                                                  including attachments, to http://
                                                  controlled in the United States under                                                                         www.regulations.gov will be posted to
                                                                                                          V. Electronic Access                                  the docket unchanged. Because your
                                                  the CSA.
                                                     Para-Methoxymethylamphetamine                          Persons with access to the Internet                 comment will be made public, you are
                                                  (PMMA) is a substituted amphetamine                     may obtain the document at either                     solely responsible for ensuring that your
                                                  of the phenethylamine class, as well as                 http://www.fda.gov/Drugs/Guidance                     comment does not include any
                                                  a structural analog of para-                            ComplianceRegulatoryInformation/                      confidential information that you or a
                                                  methoxyamphetamine (PMA) which                                                                                third party may not wish to be posted,
                                                                                                          Guidances/default.htm or http://
                                                  produces effects similar but not                                                                              such as medical information, your or
                                                                                                          www.regulations.gov.
                                                  identical to that of MDMA. PMMA is                                                                            anyone else’s Social Security number, or
                                                  not currently controlled in the United                    Dated: September 29, 2015.                          confidential business information, such
                                                  States under the CSA.                                   Leslie Kux,                                           as a manufacturing process. Please note
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                                                     2-(ethylamino)-2-(3-methoxyphenyl)-                  Associate Commissioner for Policy.                    that if you include your name, contact
                                                  cyclohexanone (Methoxetamine or                         [FR Doc. 2015–25201 Filed 10–2–15; 8:45 am]
                                                                                                                                                                information, or other information that
                                                  MXE) is an arylcyclohexamine and is                                                                           identifies you in the body of your
                                                                                                          BILLING CODE 4164–01–P
                                                  not currently controlled under the CSA                                                                        comments, that information will be
                                                  in the United States. At its 36th                                                                             posted on http://www.regulations.gov.
                                                  meeting, the WHO Expert Committee on                                                                            • If you want to submit a comment
                                                  Drug Dependence noted the                                                                                     with confidential information that you
                                                  insufficiency of data regarding                                                                               do not wish to be made available to the


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Document Created: 2015-12-15 08:53:01
Document Modified: 2015-12-15 08:53:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments by October 15, 2015.
ContactJames R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver Spring, MD 20993-0002, 301-796-3156, email: [email protected]
FR Citation80 FR 60151 

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