81 FR 4305 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Acetylfentanyl; MT-45; para-Methoxymethylamphetamine (PMMA); α-Pyrrolidinovalerophenone (α-PVP); para-Methyl-4-methylaminorex (4,4′-DMAR); Methoxetamine (MXE); Phenazepam; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 16 (January 26, 2016)

Page Range		4305-4310
FR Document		2016-01474
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 United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2016. This notice is issued under the Controlled Substances Act (the CSA).
Federal Register, Volume 81 Issue 16 (Tuesday, January 26, 2016)
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4305-4310]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0117]


International Drug Scheduling; Convention on Psychotropic 
Substances; Single Convention on Narcotic Drugs; World Health 
Organization; Scheduling Recommendations; Acetylfentanyl; MT-45; para-
Methoxymethylamphetamine (PMMA); [alpha]-Pyrrolidinovalerophenone 
([alpha]-PVP); para-Methyl-4-methylaminorex (4,4'-DMAR); Methoxetamine 
(MXE); Phenazepam; Request for Comments

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 United States' 
position on these proposals for a meeting of the United Nations 
Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2016. 
This notice is issued under the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by February 25, 
2016. Submit requests for a public meeting on or before February 5, 
2016. 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. For additional information, see section IV of this document.

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-0117 for ``International Drug Scheduling; Convention on 
Psychotropic Substances; Single Convention on Narcotic Drugs; World 
Health Organization; Scheduling Recommendations; Acetylfentanyl; MT-45; 
para-Methoxymethylamphetamine (PMMA); [alpha]-Pyrrolidinovalerophenone 
([alpha]-PVP); para-Methyl-4-methylaminorex (4,4'-DMAR); Methoxetamine 
(MXE); Phenazepam; 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.

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 protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic 
Substances (Psychotropic 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 Psychotropic Convention that the CND 
proposes to decide whether to add a drug or other

[[Page 4306]]

substance to one of the schedules of the Psychotropic 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 notification from the Secretary-General of the United Nations 
(the Secretary-General) regarding 5 substances to be considered for 
control under the Psychotropic Convention. This notification reflects 
the recommendation from the 36th WHO Expert Committee for Drug 
Dependence (ECDD), which met in June 2014. In the Federal Register of 
December 30, 2013 (78 FR 79465), 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.
    The United States is also a party to the 1961 Single Convention on 
Narcotic Drugs (1961 Single Convention). The Secretary of State has 
received a notification from the Secretary-General regarding 2 
substances to be considered for control under this convention. The CSA 
does not require HHS to publish a summary of such information in the 
Federal Register. Nevertheless, in an effort to provide interested and 
affected persons an opportunity to submit comments regarding the WHO 
recommendations for narcotic drugs, the notification regarding these 
substances is also included in this Federal Register notice. The 
comments will be shared with other relevant Agencies to assist the 
Secretary of State in formulating the position of the United States on 
the control of these substances. The HHS recommendations are not 
binding on the representative of the United States in discussions and 
negotiations relating to the proposal regarding control of substances 
under the 1961 Single Convention.

II. United Nations Notification

    The formal notification from the United Nations that identifies the 
drug substances and explains the basis for the recommendations is 
reproduced as follows:

Reference:
NAR/CL.5/2015
WHO/ECDD37; 1961C-Art.3; 1971C-Art.2
CU 2014/288/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-General 
of the World Health Organization (WHO), pursuant to article 3, 
paragraphs 1 and 3 of the Single Convention on Narcotic Drugs of 1961 
as amended by the 1972 Protocol (1961 Convention) and article 2, 
paragraphs 1 and 4 of the Convention on Psychotropic Substances of 1971 
(1971 Convention) notified the Secretary-General of the following 
recommendations:
    Acetylfentanyl be placed in Schedule I and in Schedule IV of the 
1961 Convention
    and
    MT-45 be placed in Schedule I of the 1961 Convention
    and
    para-Methoxymethylamphetamine (PMMA) be placed in Schedule I of the 
1971 Convention
    and
    [alpha]-Pyrrolidinovalerophenone ([alpha]-PVP); para-Methyl-4-
methylaminorex (4,4'-DMAR) and methoxetamine (MXE) be placed in 
Schedule II of the 1971 Convention
    and
    Phenazepam be placed in Schedule IV of the 1971 Convention.
    In the letter from the Director-General of the World Health 
Organization to the Secretary-General reference is also made to 
Commission on Narcotic Drugs decision 58/2 of 13 March 2015, by which 
the Commission decided to postpone the consideration of the proposal 
concerning the recommendation to place ketamine in Schedule IV of the 
Convention on Psychotropic Substances of 1971 and to request additional 
information from the World Health Organization and other relevant 
sources.

His Excellency
Mr. John Kerry
Secretary of State of the United States of America

    In accordance with the provisions of article 3, paragraph 2 of the 
1961 Convention and article 2, paragraph 2 of the 1971 Convention, the 
Secretary-General hereby transmits the notification as annex I to the 
present note.
    In accordance with the provisions of article 3, paragraph 2 of the 
1961 Convention and article 2, paragraph 2 of the 1971 Convention, the 
notification from WHO will be brought to the attention of the fifty-
ninth session of the Commission on Narcotic Drugs, 14-22 March 2016.
    In connection with the notification, WHO has also submitted the 
relevant extract from the report of the thirty-seventh session of the 
WHO Expert Committee on Drug Dependence which is hereby transmitted as 
annex II.
    In order 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 scheduling of the afore-mentioned substances 
under the 1961 Convention and the 1971 Convention, at the latest by 1 
February 2016 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: [email protected].

30 December 2015
NAR/CL.5/2015
Annex I

Annex I

Letter addressed to the Secretary-General of the United Nations from 
the Director-General of the World Health Organization

    ``The Thirty-seventh meeting of the WHO Expert Committee on Drug 
Dependence was convened from 16 to 20 November 2015, at WHO 
headquarters in Geneva.
    With reference to Article 2, paragraphs 1, 4 and 6 of the 
Convention on Psychotropic Substances (1971) and Article 3, paragraphs 
1, 3 and 5 of the Single Convention on Narcotic Drugs (1961), as 
amended by the 1972 Protocol, I am pleased to submit recommendations of 
the World Health Organization as follows:

--Acetylfentanyl be placed in Schedule I and in Schedule IV of the 
Single Convention on Narcotic Drugs (1961), and that:
--MT-45 be placed in Schedule I of the Single Convention on Narcotic 
Drugs (1961), and that:

[[Page 4307]]

--para-Methoxymethylamphetamine (PMMA) be placed in Schedule I of the 
Convention on Psychotropic Substances (1971), and that:
--[alpha]-Pyrrolidinovalerophenone ([alpha]-PVP); para-Methyl-4-
methylaminorex (4,4'- DMAR) and methoxetamine (MXE) be placed in 
Schedule II of the Convention on Psychotropic Substances (1971), and 
that:
--Phenazepam be placed in Schedule IV of the Convention on Psychotropic 
Substances (1971).

    The recommendations and the assessments and findings on which they 
are based are set out in detail in the Report of the 37th Expert 
Committee on Drug Dependence, which is the Committee that advises me on 
these issues. An extract of the Committee's Report is attached in Annex 
1 to this letter.
    In decision 58/2 of 13 March 2015, the Commission on Narcotic Drugs 
decided to postpone the consideration of the proposal concerning the 
recommendation to place ketamine in Schedule IV of the Convention on 
Psychotropic Substances of 1971 and to request additional information 
from the World Health Organization and other relevant sources. 
Consequentially, an update review paper on ketamine was commissioned 
and provided to the Expert Committee. Following its deliberations the 
Committee unanimously agreed that it found nothing in the updates, nor 
in what was disclosed during its deliberations, that would give it 
reason to recommend a new pre-review or critical review of ketamine 
with a view to potentially change its standing recommendation of 2014 
that ketamine should not be placed under international control. The 
current standing recommendation is consistent with the earlier 
recommendation made in 2012.
    I am very pleased with the ongoing collaboration between UNODC, 
INCB and WHO, in particular, the support to the work of the WHO Expert 
Committee on Drug Dependence and preparations for the Special Session 
of the United Nations General Assembly on the World Drug Problem in 
2016.''

NAR/CL.5/2015
Annex II

Annex II

Extract from the Report of the 37th Expert Committee on Drug Dependence
    Substance recommended to be scheduled in Schedule I and Schedule IV 
of the Single Convention on Narcotic Drugs (1961), as amended by the 
1972 Protocol:
Acetylfentanyl
    Chemically, acetylfentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-
piperidinyl]acetamide. It is in the phenylpiperidine class of synthetic 
opioids that includes fentanyl, a Schedule I drug under the UN 1961 
Single Convention on Narcotic Drugs. Acetylfentanyl has also been 
referred to as ``desmethyl fentanyl''.
    Acetylfentanyl has not been previously reviewed by the Committee. A 
critical review was proposed based on information brought to WHO's 
attention that acetylfentanyl is clandestinely manufactured, poses a 
risk to public health and society, and has no recognized therapeutic 
use by any Party.
    Acetylfentanyl has effects similar to those of morphine and 
fentanyl that are included in Schedule I of the 1961 Single Convention 
on Narcotic Drugs. It has no recorded therapeutic use and its use has 
resulted in fatalities. Thus, because it meets the required condition 
of similarity, it is recommended that acetylfentanyl be placed in 
Schedule I of the Single Convention on Narcotic Drugs, 1961, as 
consistent with Article 3, paragraph 3 (iii) of that Convention in that 
the substance is liable to similar abuse and productive of similar ill 
effects as drugs in Schedule I. In addition, in accordance with Article 
3, paragraph 5 of that Convention, considering acetylfentanyl is 
particularly liable to abuse and to produce ill-effects, and its 
liability is not offset by substantial therapeutic advantages, it is 
recommended it be included in Schedule IV of the Single Convention on 
Narcotic Drugs, 1961.
    Substance recommended to be scheduled in Schedule I of the Single 
Convention on Narcotic Drugs (1961), as amended by the 1972 Protocol:
MT-45
    Chemically, MT-45 is 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine. 
MT-45 has two enantiomers and is commonly available as the racemic 
mixture.
    MT-45 has not been previously reviewed by the Committee. A critical 
review was proposed based on information brought to WHO's attention 
that MT-45 is clandestinely manufactured, poses a risk to public health 
and society, and has no recognized therapeutic use by any Party.
    MT-45 is a compound with morphine-like effects. The Committee 
considered that the degree of risk to public health and society 
associated with the abuse liability and accompanying evidence warranted 
its placement under international control. Therapeutic use in humans 
has not been recorded. The Committee recommended that MT-45 be placed 
in Schedule I of the 1961 Single Convention, as amended by the 1972 
Protocol.
    Substance recommended to be scheduled in Schedule I of the 
Convention on Psychotropic Substances (1971):

para-Methoxymethylamphetamine (PMMA)

    Chemically, PMMA (para-methoxymethylamphetamine) is 1-(4-
methoxyphenyl)-N-methylpropan-2-amine. PMMA has two enantiomers and is 
commonly available as the racemic mixture.
    PMMA has not been previously reviewed by the Committee. A critical 
review was proposed based on information brought to WHO's attention 
that PMMA is clandestinely manufactured, poses a risk to public health 
and society, and has no recognized therapeutic use by any Party.
    The Committee considered that the effects of PMMA are similar to 
PMA, a drug listed in Schedule I of the Convention on Psychotropic 
Substances of 1971, and the degree of risk to public health and society 
associated with its abuse is especially serious. The Committee also 
noted it has no recorded therapeutic use. The Committee considered that 
the evidence of its abuse warranted its placement under international 
control and recommended that PMMA be placed in Schedule I of the 1971 
Convention.
    Substances recommended to be scheduled in Schedule II of the 
Convention on Psychotropic Substances (1971):
[alpha]-Pyrrolidinovalerophenone ([alpha]-PVP)
    Chemically, [alpha]-PVP ([alpha]-pyrrolidinovalerophenone) is 1-
phenyl-2-(pyrrolidin-1-yl)pentan-1-one. This synthetic cathinone is the 
desmethyl analogue of pyrovalerone that is listed in Schedule IV of the 
1971 United Nations Convention on Psychotropic Substances. [alpha]-PVP 
has two enantiomers and is commonly available as the racemic mixture. 
[alpha]-PVP is closely related to 3',4'-methylenedioxypyrovalerone 
(MDPV) that has recently been placed in Schedule II of the UN 
Convention on Psychotropic Substances (1971).
    [alpha]-PVP has not been previously reviewed by the Committee. A 
direct critical review was proposed based on information brought to 
WHO's attention that [alpha]-PVP is clandestinely manufactured, poses a 
risk to public health and society, and has no recognized therapeutic 
use by any Party.
    The Committee considered that the degree of risk to public health 
and

[[Page 4308]]

society associated with the abuse of [alpha]-PVP is substantial. 
Therapeutic usefulness has not been recorded. Its pharmacological 
effects are similar to methamphetamine and MDPV, psychostimulants 
listed in Schedule II of the 1971 Convention. The Committee considered 
that the evidence of its abuse warranted its placement under 
international control. As per the Guidance on the WHO review of 
psychoactive substances for international control, higher regard was 
accorded to the substantial public health risk than to the lack of 
therapeutic usefulness. The Committee recommended that [alpha]-PVP be 
placed in Schedule II of the 1971 Convention.
para-Methyl-4-methylaminorex (4,4'-DMAR)
    Chemically, 4,4'-DMAR (para-methyl-4-methylaminorex) is 4-methyl-5-
(4-methylphenyl)-4,5-dihydro-1,3- oxazol-2-amine. 4,4'-DMAR has four 
enantiomers and exists as racemic cis- or trans- forms. It is a 
synthetic substituted oxazoline derivative interpretable as an analogue 
of 4-methylaminorex (4-MAR) and aminorex, which are psychostimulants 
listed as Schedule I and Schedule IV substances, respectively, under 
the 1971 United Nations Convention on Psychotropic Substances.
    4,4'-DMAR has not been previously reviewed by WHO. A critical 
review was proposed based on information brought to WHO's attention 
that 4,4'-DMAR is clandestinely manufactured, poses a risk to public 
health and society, and has no recognized therapeutic use by any Party.
    As per the Guidance on the WHO review of psychoactive substances 
for international control, higher regard was accorded to the 
substantial public health risk than to the lack of therapeutic 
usefulness. The Committee considered that the degree of risk to public 
health and society associated with the abuse of 4,4'-DMAR is 
substantial. The Committee recommended that 4,4'-DMAR be placed in 
Schedule II of the 1971 Convention.
Methoxetamine (MXE)
    Chemically, methoxetamine (MXE) is 2-(ethylamino)-2-(3-
methoxyphenyl)cyclohexanone. It is a synthetic drug and belongs to the 
arylcyclohexylamine class like phencyclidine. Methoxetamine has two 
enantiomers and is commonly available as the racemic mixture.
    During its 36th meeting, the WHO Expert Committee on Drug 
Dependence discussed the critical review report on methoxetamine and 
concluded that owing to the insufficiency of data regarding dependence, 
abuse and risks to public health, methoxetamine should not be placed 
under international control at that time, but be kept under 
surveillance. In 2014 the European Union decided to bring methoxetamine 
under control after a risk assessment by the EMCDDA. Furthermore new 
information on its abuse potential and more reports of fatal and non-
fatal intoxications warranted a critical review for the 37th ECDD.
    Methoxetamine has been shown to have effects similar to 
phencyclidine, a compound listed in Schedule II of the Convention on 
Psychotropic Substances of 1971. The Committee considered that the 
degree of risk to public health and society associated with the abuse 
liability of methoxetamine is substantial. The Committee also noted it 
has no recorded therapeutic use. The Committee considered that the 
evidence of its abuse warranted its placement under international 
control. The Committee recommended that methoxetamine be placed in 
Schedule II of the 1971 Convention.
    Substance recommended to be scheduled in Schedule IV of the 
Convention on Psychotropic Substances (1971):
Phenazepam
    Chemically, phenazepam is 7-bromo-5-(2-chlorophenyl)-1,3-dihydro-
2H-1,4-benzodiazepin-2-one.
    Phenazepam has not been previously reviewed by the Committee. The 
Committee undertook a pre-review of the substance and considered that 
the information provided in the pre-review report was sufficient and 
indicated that dependence and harm caused by phenazepam was of such 
magnitude that proceeding directly into critical review within the 
meeting was warranted. All procedural requirements for a critical 
review, including two peer reviews, were fulfilled. Phenazepam has been 
shown to have effects similar to diazepam that is in Schedule IV of the 
Convention on Psychotropic Substances of 1971. The Committee considered 
that the degree of risk to public health and society associated with 
the abuse of phenazepam has a smaller but still significant risk to 
public health compared to substances in Schedules I-III and has a 
therapeutic usefulness from little to great. The Committee considered 
that the evidence of its abuse warranted its placement under 
international control. The Committee further recommended that 
phenazepam be placed in Schedule IV of the 1971 Convention.
    Substance recommended for critical review:
Etizolam (INN)
    Chemically, etizolam is 4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine.
    The Expert Committee on Drug Dependence (ECDD) reviewed etizolam 
for the first time at its 26th meeting in 1989. At that time, the 
Committee rated the abuse liability of etizolam as moderate and the 
therapeutic usefulness as moderate to high. In view of the lack of 
clear-cut abuse, and of public health and social problems associated 
with its use, the Committee was unable to come to a decision concerning 
the scheduling of etizolam and recommended that a decision be deferred 
to the 27th meeting of the Committee.
    At its 27th meeting in 1990, the Committee again rated the abuse 
liability of etizolam as low to moderate and the therapeutic usefulness 
as moderate to high. The Committee noted few public health and social 
problems associated with its use at that time and considered that the 
degree of seriousness of these problems was not great enough to warrant 
international control. Consequently, the Committee did not recommend 
scheduling of etizolam in 1990.
    At the 37 ECDD, on the basis of the evidence available regarding 
dependence, abuse and risks to public health, the Committee recommended 
that a critical review of etizolam is warranted for a future meeting.
    Substance recommended for surveillance:
4-Fluoroamphetamine (4-FA)
    Chemically, 4-FA (4-fluoroamphetamine) is 1-(4-fluorophenyl)propan-
2-amine. 4-FA has two enantiomers and is commonly available as the 
racemic mixture.
    4-FA has not been previously reviewed by the Committee. A critical 
review was proposed based on information brought to WHO's attention 
that 4-FA is clandestinely manufactured, poses a risk to public health 
and society, and has no recognized therapeutic use by any Party.
    Owing to the current insufficiency of data regarding dependence, 
abuse and risks to public health (including risks to the individual), 
the Committee recommended that 4-FA not be placed under international 
control at this time, but be kept under surveillance.
    Update on cannabis:
    The Commission on Narcotic Drugs, in Resolution 52/5, expressed 
that it ``. . . looks forward to an updated

[[Page 4309]]

report on cannabis by the Expert Committee, subject to the availability 
of extra budgetary resources'', and the Report of the International 
Narcotics Control Board for 2014 reiterated, ``. . . its invitation to 
WHO to evaluate the potential medical utility of cannabis and the 
extent to which cannabis poses a risk to human health.'' WHO therefore 
commissioned an update report paper on cannabis and cannabis resin.
    An update on the scientific literature of cannabis was presented 
and reviewed during the session including the pharmacology, toxicology 
and the claimed therapeutic applications. The Committee then 
deliberated about the content of the material presented. The Committee 
requested the Secretariat to begin collecting data towards a pre-review 
of cannabis, cannabis resin, extracts and tinctures of cannabis at a 
future meeting. Furthermore it specifically requested the Secretariat 
to place emphasis on any therapeutic advantages that they may have 
relative to other existing therapeutics.
    Update on ketamine:
    Updates on ketamine were presented in which the levels and 
consequences of its abuse, and new potential medical applications were 
identified. Levels of ketamine abuse appeared to be declining in many 
countries world-wide. Potential new therapeutic uses were identified 
including depression and refractory status epilepticus. Evaluation of 
ketamine for treating depression is in Phase III studies. Ketamine is 
widely used as an anaesthetic agent for human and veterinary use 
globally. Ketamine is the anaesthetic agent of choice in low income 
countries and emergency situations where there are limitations in 
trained medical personnel, anesthesia machines, and consistent sources 
of electricity.
    Following its deliberations, the Committee unanimously agreed that 
it found nothing in the updates, nor that which was disclosed during 
its deliberations, that would give it reason to recommend a new pre-
review or critical review of ketamine with a view to potentially change 
its standing recommendation of 2014 that ketamine should not be placed 
under international control.

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 the following: 
(1) Accept the WHO recommendations; (2) accept the recommendations to 
control, but control the drug substance in a schedule other than that 
recommended; or (3) reject the recommendations entirely.
    Acetylfentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) is 
a potent opioid analgesic in the phenylpiperidine class of synthetic 
opioids. 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 U.S. Attorney General (the 
Attorney General), though, may extend this temporary scheduling for up 
to 1 year. The WHO ECDD met in November 2015 and recommended that 
acetylfentanyl be placed in Schedule I and in Schedule IV of the 1961 
Single Convention. On July 17, 2015, acetylfentanyl was temporarily 
placed in Schedule I of the CSA under the temporary scheduling 
provision of section 201(h) of the CSA. These provisions provide the 
Attorney General with the authority to temporarily place a substance 
into Schedule I of the CSA for 2 years, without regard to the 
requirements of 21 U.S.C. 811(b), if he finds that such action is 
necessary to avoid an imminent hazard to the public safety. In 
addition, if proceedings to control a substance are initiated under 21 
U.S.C. 811(a)(1), the Attorney General may extend the temporary 
scheduling for up to 1 year (21 U.S.C. 811(h)(2)). Therefore, 
considering the previously mentioned time limitations of temporary 
scheduling under section 201(h) of the CSA, it will be necessary to 
adopt non-temporary controls to fulfill U.S. obligations if 
acetylfentanyl is controlled under Schedule I and Schedule IV of the 
1961 Single Convention.
    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. The WHO ECDD met in November 2015 and recommended that MT-45 
be placed in Schedule I of the 1961 Single Convention. MT-45 is not 
currently controlled in the United States under the CSA. As such, 
additional controls will be necessary to fulfill U.S. obligations if 
MT-45 is controlled under Schedule I of the 1961 Single Convention.
    Phenazepam belongs 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. The WHO ECDD at its 37th meeting recommended that 
Phenazepam be placed in Schedule IV of the Psychotropic Convention. 
While Phenazepam is currently prescribed in some countries, it is not 
approved for medical use or controlled in the United States under the 
CSA. Additional controls will be necessary to fulfill U.S. obligations 
if Phenazepam is controlled under Schedule IV of the Psychotropic 
Convention.
    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. The WHO ECDD at its 37th meeting recommended 
PMMA be placed in Schedule I of the Psychotropic Convention. PMMA is 
not currently controlled in the United States under the CSA. Additional 
controls will be necessary if PMMA is placed in Schedule I of the 
Psychotropic Convention.
    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. The WHO ECDD at its 37th meeting recommended 
4,4'-DMAR be placed in Schedule II of the Psychotropic Convention. 
4,4'-DMAR is not currently controlled in the United States under the 
CSA. Additional controls will be necessary to fulfill U.S. obligations 
if 4,4'-DMAR is controlled under Schedule II of the Psychotropic 
Convention.
    [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. 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. The WHO 
ECDD at its 37th meeting recommended that [alpha]-PVP be placed in 
Schedule II of the Psychotropic Convention. Therefore, considering the 
previously mentioned time limitations of temporary scheduling under 
section 201(h) of the CSA, additional controls will be necessary to 
fulfill U.S. obligations if [alpha]-PVP is controlled under Schedule II 
of the Psychotropic Convention.
    Methoxetamine (MXE) is a synthetic drug substance and belongs in 
the arylcyclohexamine class. The WHO

[[Page 4310]]

ECDD at its 37th meeting recommended that MXE be placed in Schedule II 
of the Psychotropic Convention. MXE is not currently controlled under 
the CSA in the United States. Additional controls will be necessary to 
fulfill U.S. obligations if MXE is controlled under Schedule II of the 
Psychotropic Convention.
    FDA, on behalf of the Secretary of HHS, invites interested persons 
to submit comments on the notifications from the United Nations 
concerning these drug substances. FDA, in cooperation with the National 
Institute on Drug Abuse, will consider the comments on behalf of HHS in 
evaluating the WHO scheduling recommendations. Then, under section 
201(d)(2)(B) of the CSA, HHS will recommend to the Secretary of State 
what position the United States should take when voting on the 
recommendations for control of substances under the Psychotropic 
Convention at the CND meeting in March 2015.
    Comments regarding the WHO recommendations for control of 
acetylfentanyl and MT-45 under the 1961 Single Convention will also be 
forwarded to the relevant Agencies for consideration in developing the 
U.S. position regarding narcotic substances at the CND meeting.

IV. Opportunity for Public Meeting

    FDA does not presently plan to hold a public meeting. If any person 
believes that, in addition to 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 5, 2016.

    Dated: January 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01474 Filed 1-25-16; 8:45 am]
BILLING CODE 4164-01-P
Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 4307

—para-Methoxymethylamphetamine Acetylfentanyl recorded. The Committee recommended
(PMMA) be placed in Schedule I of Chemically, acetylfentanyl is N- that MT–45 be placed in Schedule I of
the Convention on Psychotropic phenyl-N-[1-(2-phenylethyl)-4- the 1961 Single Convention, as
Substances (1971), and that: piperidinyl]acetamide. It is in the amended by the 1972 Protocol.
—a-Pyrrolidinovalerophenone (a-PVP); Substance recommended to be
phenylpiperidine class of synthetic
para-Methyl-4-methylaminorex (4,4′- scheduled in Schedule I of the
opioids that includes fentanyl, a
DMAR) and methoxetamine (MXE) be Convention on Psychotropic Substances
Schedule I drug under the UN 1961
placed in Schedule II of the (1971):
Single Convention on Narcotic Drugs.
Convention on Psychotropic Acetylfentanyl has also been referred to para-Methoxymethylamphetamine
Substances (1971), and that: as ‘‘desmethyl fentanyl’’. (PMMA)
—Phenazepam be placed in Schedule IV Acetylfentanyl has not been Chemically, PMMA (para-
of the Convention on Psychotropic previously reviewed by the Committee. methoxymethylamphetamine) is 1-(4-
Substances (1971). A critical review was proposed based on methoxyphenyl)-N-methylpropan-2-
The recommendations and the information brought to WHO’s attention amine. PMMA has two enantiomers and
assessments and findings on which they that acetylfentanyl is clandestinely is commonly available as the racemic
are based are set out in detail in the manufactured, poses a risk to public mixture.
Report of the 37th Expert Committee on health and society, and has no PMMA has not been previously
Drug Dependence, which is the recognized therapeutic use by any Party. reviewed by the Committee. A critical
Committee that advises me on these Acetylfentanyl has effects similar to review was proposed based on
issues. An extract of the Committee’s those of morphine and fentanyl that are information brought to WHO’s attention
Report is attached in Annex 1 to this included in Schedule I of the 1961 that PMMA is clandestinely
letter. Single Convention on Narcotic Drugs. It manufactured, poses a risk to public
In decision 58/2 of 13 March 2015, has no recorded therapeutic use and its health and society, and has no
the Commission on Narcotic Drugs use has resulted in fatalities. Thus, recognized therapeutic use by any Party.
decided to postpone the consideration because it meets the required condition The Committee considered that the
of the proposal concerning the of similarity, it is recommended that effects of PMMA are similar to PMA, a
recommendation to place ketamine in acetylfentanyl be placed in Schedule I drug listed in Schedule I of the
Schedule IV of the Convention on of the Single Convention on Narcotic Convention on Psychotropic Substances
Psychotropic Substances of 1971 and to Drugs, 1961, as consistent with Article of 1971, and the degree of risk to public
request additional information from the 3, paragraph 3 (iii) of that Convention in health and society associated with its
that the substance is liable to similar abuse is especially serious. The
World Health Organization and other
abuse and productive of similar ill Committee also noted it has no recorded
relevant sources. Consequentially, an
effects as drugs in Schedule I. In therapeutic use. The Committee
update review paper on ketamine was
addition, in accordance with Article 3, considered that the evidence of its abuse
commissioned and provided to the
paragraph 5 of that Convention, warranted its placement under
Expert Committee. Following its
considering acetylfentanyl is international control and recommended
deliberations the Committee
that PMMA be placed in Schedule I of
unanimously agreed that it found particularly liable to abuse and to
the 1971 Convention.
nothing in the updates, nor in what was produce ill-effects, and its liability is
Substances recommended to be
disclosed during its deliberations, that not offset by substantial therapeutic scheduled in Schedule II of the
would give it reason to recommend a advantages, it is recommended it be Convention on Psychotropic Substances
new pre-review or critical review of included in Schedule IV of the Single (1971):
ketamine with a view to potentially Convention on Narcotic Drugs, 1961.
change its standing recommendation of Substance recommended to be a-Pyrrolidinovalerophenone (a-PVP)
2014 that ketamine should not be placed scheduled in Schedule I of the Single Chemically, a-PVP (a-
under international control. The current Convention on Narcotic Drugs (1961), as pyrrolidinovalerophenone) is 1-phenyl-
standing recommendation is consistent amended by the 1972 Protocol: 2-(pyrrolidin-1-yl)pentan-1-one. This
with the earlier recommendation made MT–45 synthetic cathinone is the desmethyl
in 2012. analogue of pyrovalerone that is listed
I am very pleased with the ongoing Chemically, MT–45 is 1-cyclohexyl-4- in Schedule IV of the 1971 United
collaboration between UNODC, INCB (1,2-diphenylethyl)piperazine. MT–45 Nations Convention on Psychotropic
and WHO, in particular, the support to has two enantiomers and is commonly Substances. a-PVP has two enantiomers
the work of the WHO Expert Committee available as the racemic mixture. and is commonly available as the
on Drug Dependence and preparations MT–45 has not been previously racemic mixture. a-PVP is closely
for the Special Session of the United reviewed by the Committee. A critical related to 3’,4’-
Nations General Assembly on the World review was proposed based on methylenedioxypyrovalerone (MDPV)
Drug Problem in 2016.’’ information brought to WHO’s attention that has recently been placed in
that MT–45 is clandestinely Schedule II of the UN Convention on
NAR/CL.5/2015
manufactured, poses a risk to public Psychotropic Substances (1971).
Annex II
health and society, and has no a-PVP has not been previously
Annex II recognized therapeutic use by any Party. reviewed by the Committee. A direct
mstockstill on DSK4VPTVN1PROD with NOTICES

MT–45 is a compound with critical review was proposed based on
Extract from the Report of the 37th morphine-like effects. The Committee
Expert Committee on Drug Dependence information brought to WHO’s attention
considered that the degree of risk to that a-PVP is clandestinely
Substance recommended to be public health and society associated manufactured, poses a risk to public
scheduled in Schedule I and Schedule with the abuse liability and health and society, and has no
IV of the Single Convention on Narcotic accompanying evidence warranted its recognized therapeutic use by any Party.
Drugs (1961), as amended by the 1972 placement under international control. The Committee considered that the
Protocol: Therapeutic use in humans has not been degree of risk to public health and

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report on cannabis by the Expert Accept the WHO recommendations; (2) commonly used to treat insomnia,
Committee, subject to the availability of accept the recommendations to control, anxiety, and seizure disorders. The
extra budgetary resources’’, and the but control the drug substance in a WHO ECDD at its 37th meeting
Report of the International Narcotics schedule other than that recommended; recommended that Phenazepam be
Control Board for 2014 reiterated, ‘‘. . . or (3) reject the recommendations placed in Schedule IV of the
its invitation to WHO to evaluate the entirely. Psychotropic Convention. While
potential medical utility of cannabis and Acetylfentanyl (N-(1- Phenazepam is currently prescribed in
the extent to which cannabis poses a phenethylpiperidin-4-yl)-N- some countries, it is not approved for
risk to human health.’’ WHO therefore phenylacetamide) is a potent opioid medical use or controlled in the United
commissioned an update report paper analgesic in the phenylpiperidine class States under the CSA. Additional
on cannabis and cannabis resin. of synthetic opioids. On July 17, 2015, controls will be necessary to fulfill U.S.
An update on the scientific literature acetylfentanyl was temporarily placed obligations if Phenazepam is controlled
of cannabis was presented and reviewed into Schedule I of the CSA for 2 years under Schedule IV of the Psychotropic
during the session including the upon finding that it posed an imminent Convention.
pharmacology, toxicology and the hazard to the public safety. The U.S. Para-Methoxymethylamphetamine
claimed therapeutic applications. The Attorney General (the Attorney (PMMA) is a substituted amphetamine
Committee then deliberated about the General), though, may extend this of the phenethylamine class, as well as
content of the material presented. The temporary scheduling for up to 1 year. a structural analog of para-
Committee requested the Secretariat to The WHO ECDD met in November 2015 methoxyamphetamine (PMA) which
begin collecting data towards a pre- and recommended that acetylfentanyl produces effects similar but not
review of cannabis, cannabis resin, be placed in Schedule I and in Schedule identical to that of MDMA. The WHO
extracts and tinctures of cannabis at a IV of the 1961 Single Convention. On ECDD at its 37th meeting recommended
future meeting. Furthermore it July 17, 2015, acetylfentanyl was PMMA be placed in Schedule I of the
specifically requested the Secretariat to temporarily placed in Schedule I of the Psychotropic Convention. PMMA is not
place emphasis on any therapeutic CSA under the temporary scheduling currently controlled in the United States
advantages that they may have relative provision of section 201(h) of the CSA. under the CSA. Additional controls will
to other existing therapeutics. These provisions provide the Attorney be necessary if PMMA is placed in
Update on ketamine: General with the authority to Schedule I of the Psychotropic
Updates on ketamine were presented temporarily place a substance into Convention.
in which the levels and consequences of Schedule I of the CSA for 2 years, Para-Methyl-4-methylaminorex (4,4′-
its abuse, and new potential medical without regard to the requirements of 21 DMAR) is a derivative of the stimulant
applications were identified. Levels of U.S.C. 811(b), if he finds that such drug 4-methylaminorex and has been
ketamine abuse appeared to be action is necessary to avoid an involved in several deaths in the United
declining in many countries world- imminent hazard to the public safety. In States. The WHO ECDD at its 37th
wide. Potential new therapeutic uses addition, if proceedings to control a meeting recommended 4,4′-DMAR be
were identified including depression substance are initiated under 21 U.S.C. placed in Schedule II of the
and refractory status epilepticus. 811(a)(1), the Attorney General may Psychotropic Convention. 4,4′-DMAR is
Evaluation of ketamine for treating extend the temporary scheduling for up not currently controlled in the United
depression is in Phase III studies. to 1 year (21 U.S.C. 811(h)(2)). States under the CSA. Additional
Ketamine is widely used as an Therefore, considering the previously controls will be necessary to fulfill U.S.
anaesthetic agent for human and mentioned time limitations of obligations if 4,4′-DMAR is controlled
veterinary use globally. Ketamine is the temporary scheduling under section under Schedule II of the Psychotropic
anaesthetic agent of choice in low 201(h) of the CSA, it will be necessary Convention.
income countries and emergency to adopt non-temporary controls to a-Pyrrolidinovalerophenone (a-PVP
situations where there are limitations in fulfill U.S. obligations if acetylfentanyl or alpha-PVP) is a synthetic cathinone
trained medical personnel, anesthesia is controlled under Schedule I and structurally and pharmacologically
machines, and consistent sources of Schedule IV of the 1961 Single similar to amphetamine; 3,4-
electricity. Convention. methylenedioxymethamphetamine
Following its deliberations, the 1-cyclohexyl-4-(1,2-diphenylethyl)- (MDMA); cathinone; and other related
Committee unanimously agreed that it piperazine (MT-45) is a synthetic opioid substances. On March 7, 2014, a-PVP
found nothing in the updates, nor that with potent analgesic activity was temporarily placed into Schedule I
which was disclosed during its comparable to morphine despite being of the CSA for 2 years upon finding that
deliberations, that would give it reason structurally unrelated to most other it posed an imminent hazard to the
to recommend a new pre-review or opioids. MT-45 use has been associated public safety. The Attorney General,
critical review of ketamine with a view with deaths in the United States and in though, may extend this temporary
to potentially change its standing other countries. The WHO ECDD met in scheduling for up to 1 year. The WHO
recommendation of 2014 that ketamine November 2015 and recommended that ECDD at its 37th meeting recommended
should not be placed under MT-45 be placed in Schedule I of the that a-PVP be placed in Schedule II of
international control. 1961 Single Convention. MT-45 is not the Psychotropic Convention. Therefore,
currently controlled in the United States considering the previously mentioned
III. Discussion under the CSA. As such, additional time limitations of temporary
mstockstill on DSK4VPTVN1PROD with NOTICES

Although WHO has made specific controls will be necessary to fulfill U.S. scheduling under section 201(h) of the
scheduling recommendations for each of obligations if MT-45 is controlled under CSA, additional controls will be
the drug substances, the CND is not Schedule I of the 1961 Single necessary to fulfill U.S. obligations if a-
obliged to follow the WHO Convention. PVP is controlled under Schedule II of
recommendations. Options available to Phenazepam belongs to a class of the Psychotropic Convention.
the CND for substances considered for substances known as benzodiazepines. Methoxetamine (MXE) is a synthetic
control under the Psychotropic Benzodiazepines produce central drug substance and belongs in the
Convention include the following: (1) nervous system depression and are arylcyclohexamine class. The WHO

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4310 Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices

ECDD at its 37th meeting recommended ACTION: Notice. NDA 204822, held by Alcon
that MXE be placed in Schedule II of the Laboratories, Inc., and initially
Psychotropic Convention. MXE is not SUMMARY: The Food and Drug approved on May 15, 2014. IZBA is
currently controlled under the CSA in Administration (FDA or Agency) has indicated for the reduction of elevated
the United States. Additional controls determined that IZBA (travoprost intraocular pressure in patients with
will be necessary to fulfill U.S. ophthalmic solution), 0.003 percent, open-angle glaucoma or ocular
obligations if MXE is controlled under was not withdrawn from sale for reasons hypertension.
Schedule II of the Psychotropic of safety or effectiveness. This In a letter dated September 4, 2015,
Convention. determination will allow FDA to Alcon Laboratories, Inc. notified FDA
FDA, on behalf of the Secretary of approve abbreviated new drug that IZBA (travoprost ophthalmic
HHS, invites interested persons to applications (ANDAs) for travoprost solution), 0.003 percent, was
submit comments on the notifications ophthalmic solution/drops, 0.003 discontinued. IZBA (travoprost
from the United Nations concerning percent, if all other legal and regulatory ophthalmic solution), 0.003 percent, is
these drug substances. FDA, in requirements are met. currently listed in the ‘‘Discontinued
cooperation with the National Institute FOR FURTHER INFORMATION CONTACT: Kate Drug Product List’’ section of the Orange
on Drug Abuse, will consider the Greenwood, Center for Drug Evaluation Book.
comments on behalf of HHS in and Research, Food and Drug Jonathan Goodman of Florek & Endres
evaluating the WHO scheduling Administration, 10903 New Hampshire PLLC submitted a citizen petition dated
recommendations. Then, under section Ave., Bldg. 51, Rm. 6286, Silver Spring, August 20, 2015 (Docket No. FDA–
201(d)(2)(B) of the CSA, HHS will MD 20993–0002, 240–402–1748. 2015–P–3053), under 21 CFR 10.30,
recommend to the Secretary of State SUPPLEMENTARY INFORMATION: In 1984, requesting that the Agency determine
what position the United States should Congress enacted the Drug Price whether IZBA (travoprost ophthalmic
take when voting on the Competition and Patent Term solution), 0.003 percent, was withdrawn
recommendations for control of Restoration Act of 1984 (Pub. L. 98–417) from sale for reasons of safety or
substances under the Psychotropic (the 1984 amendments), which effectiveness.
Convention at the CND meeting in authorized the approval of duplicate After considering the citizen petition
March 2015. versions of drug products under an and reviewing Agency records and
Comments regarding the WHO ANDA procedure. ANDA applicants based on the information we have at this
recommendations for control of must, with certain exceptions, show that time, FDA has determined under
acetylfentanyl and MT-45 under the the drug for which they are seeking § 314.161 that IZBA (travoprost
1961 Single Convention will also be approval contains the same active ophthalmic solution), 0.003 percent,
forwarded to the relevant Agencies for ingredient in the same strength and was not withdrawn for reasons of safety
consideration in developing the U.S. dosage form as the ‘‘listed drug,’’ which or effectiveness. The petitioner has
position regarding narcotic substances is a version of the drug that was identified no data or other information
at the CND meeting. previously approved. ANDA applicants suggesting that IZBA (travoprost
do not have to repeat the clinical testing ophthalmic solution), 0.003 percent,
IV. Opportunity for Public Meeting was withdrawn for reasons of safety or
otherwise necessary to gain approval of
FDA does not presently plan to hold a new drug application (NDA). effectiveness. We have carefully
a public meeting. If any person believes The 1984 amendments include what reviewed our files for records
that, in addition to written comments, a is now section 505(j)(7) of the Federal concerning the withdrawal of IZBA
public meeting would contribute to the Food, Drug, and Cosmetic Act (21 U.S.C. (travoprost ophthalmic solution), 0.003
development of the U.S. position on the 355(j)(7)), which requires FDA to percent, from sale. We have also
substances to be considered for control publish a list of all approved drugs. independently evaluated relevant
under the Psychotropic Convention, a FDA publishes this list as part of the literature and data for possible
request for a public meeting and the ‘‘Approved Drug Products With postmarketing adverse events. We have
reasons for such a request should be Therapeutic Equivalence Evaluations,’’ found no information that would
sent to James R. Hunter (see FOR which is known generally as the indicate that this product was
FURTHER INFORMATION CONTACT) on or ‘‘Orange Book.’’ Under FDA regulations, withdrawn from sale for reasons of
before February 5, 2016. drugs are removed from the list if the safety or effectiveness.
Dated: January 20, 2016. Agency withdraws or suspends Accordingly, the Agency will
Leslie Kux, approval of the drug’s NDA or ANDA continue to list IZBA (travoprost
for reasons of safety or effectiveness or ophthalmic solution), 0.003 percent, in
Associate Commissioner for Policy.
if FDA determines that the listed drug the ‘‘Discontinued Drug Product List’’
[FR Doc. 2016–01474 Filed 1–25–16; 8:45 am]
was withdrawn from sale for reasons of section of the Orange Book. The
BILLING CODE 4164–01–P
safety or effectiveness (21 CFR 314.162). ‘‘Discontinued Drug Product List’’
A person may petition the Agency to delineates, among other items, drug
determine, or the Agency may products that have been discontinued
DEPARTMENT OF HEALTH AND
determine on its own initiative, whether from marketing for reasons other than
HUMAN SERVICES
a listed drug was withdrawn from sale safety or effectiveness. ANDAs that refer
Food and Drug Administration for reasons of safety or effectiveness. to IZBA (travoprost ophthalmic
This determination may be made at any solution), 0.003 percent, may be
[Docket No. FDA–2015–P–3053]
mstockstill on DSK4VPTVN1PROD with NOTICES

time after the drug has been withdrawn approved by the Agency as long as they
from sale, but must be made prior to meet all other legal and regulatory
Determination That IZBA (Travoprost
approving an ANDA that refers to the requirements for the approval of
Ophthalmic Solution), 0.003 Percent,
listed drug (§ 314.161 (21 CFR 314.161)). ANDAs. If FDA determines that labeling
Was Not Withdrawn From Sale for
FDA may not approve an ANDA that for this drug product should be revised
Reasons of Safety or Effectiveness
does not refer to a listed drug. to meet current standards, the Agency
AGENCY: Food and Drug Administration, IZBA (travoprost ophthalmic will advise ANDA applicants to submit
HHS. solution), 0.003 percent, is the subject of such labeling.

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Document Created: 2018-02-02 12:38:17
Document Modified: 2018-02-02 12:38:17
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments by February 25, 2016. Submit requests for a public meeting on or before February 5, 2016. 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. For additional information, see section IV of this document.
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 protected]
FR Citation		81 FR 4305
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 16 (January 26, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
