Assessment of Abuse Potential of Drugs; Guidance for Industry; Availability, 5581-5583 [2017-01024]
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Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
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FOR FURTHER INFORMATION CONTACT:
Stefanie S. Kraus, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215,
Silver Spring, MD 20993–0002, 301–
796–9585.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL, is
the subject of NDAs 016023 and 017118,
held by Endo Pharmaceuticals, and
initially approved on February 14, 1968,
and July 20, 1976, respectively.
SYMMETREL is indicated for the
prophylaxis and treatment of signs and
symptoms of infection caused by
various strains of influenza A virus.
SYMMETREL is also indicated for the
treatment of parkinsonism and druginduced extrapyramidal reactions.
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In a letter dated March 19, 2009, Endo
Pharmaceuticals notified FDA that
SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL, was
being discontinued and requested
withdrawal of NDA016023 for that
product. FDA moved the drug product
to the ‘‘Discontinued Drug Product List’’
section of the Orange Book and
announced in the Federal Register of
July 21, 2010 (75 FR 42455), that FDA
was withdrawing approval of NDA
016023, effective August 20, 2010.
Hyman, Phelps & McNamara
submitted a citizen petition dated
August 3, 2016 (Docket No. FDA–2016–
P–2469), under 21 CFR 10.30,
requesting that the Agency determine
whether SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that SYMMETREL
(amantadine hydrochloride), Syrup, 50
mg/5 mL, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that this drug
product was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.1
Accordingly, the Agency will
continue to list SYMMETREL
(amantadine hydrochloride), Syrup, 50
mg/5 mL, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
1 Due to high levels of resistance to currently
circulating Influenza A viruses, the Centers for
Disease Control and Prevention currently
recommends against using amantadine to treat
Influenza A. Given the potential for viral
reassortment, however, amantadine may be
effective against future Influenza A viruses.
Consistent with this, the current label for
SYMMETREL (amantadine hydrochloride), Syrup,
50 mg/5 mL, was revised to caution prescribers to
consider susceptibility and clinical benefit when
deciding whether to use amantadine to treat
Influenza A.
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Fmt 4703
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5581
to SYMMETREL. Additional ANDAs
that refer to SYMMETREL (amantadine
hydrochloride), Syrup, 50 mg/5 mL,
may be approved by the Agency as long
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–01064 Filed 1–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0026]
Assessment of Abuse Potential of
Drugs; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Assessment of Abuse Potential of
Drugs.’’ This guidance is intended to
assist sponsors of investigational new
drugs and applicants for approval of a
new drug in evaluating whether their
new drug product has abuse potential.
Specifically, this guidance provides
recommendations for assessing the
abuse potential of central nervous
system (CNS)-active new drugs. Drug
products with abuse potential generally
contain drug substances that are active
within the CNS and produce
psychoactive effects such as euphoria
and hallucinations. Thus, if a drug
substance is CNS-active, the new drug
product containing that drug substance
will likely need to undergo a thorough
assessment of its abuse potential and
may be subject to control under the
Controlled Substances Act (CSA). This
guidance finalizes the draft guidance of
the same name issued on January 27,
2010.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
E:\FR\FM\18JAN1.SGM
18JAN1
5582
Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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–
2010–D–0026 for ‘‘Assessment of Abuse
Potential of Drugs; Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://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
VerDate Sep<11>2014
17:41 Jan 17, 2017
Jkt 241001
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
https://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: https://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 https://
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.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Dominic Chiapperino, Controlled
Substance Staff, Center for Drug
Evaluation and Research, Bldg. 51, Rm.
5148, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–1183.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Assessment of Abuse Potential of
Drugs.’’ Under the Federal Food, Drug,
and Cosmetic Act, an abuse potential
assessment is part of the general
evaluation of the safety and efficacy of
a new drug to be used under medical
PO 00000
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Fmt 4703
Sfmt 4703
supervision. Additionally, if a new drug
has abuse potential, the Secretary of
Health and Human Services (HHS) is
required under the CSA (21 U.S.C. 801
et seq.) to make a recommendation for
scheduling to the Drug Enforcement
Administration (DEA). The regulatory
responsibilities for this process are
described in Title 21, United States
Code (U.S.C.) 811. FDA, in consultation
with the National Institute on Drug
Abuse (NIDA) conducts the medical and
scientific analysis on behalf of HHS.
Specifically, the Controlled Substance
Staff of FDA performs this scientific
evaluation of the abuse potential of a
drug for FDA, in consultation with
NIDA, as described in a Memorandum
of Understanding (MOU) of March 8,
1985 (50 FR 9518) (available at; https://
www.fda.gov/AboutFDA/Partnerships
Collaborations/Memorandaof
UnderstandingMOUs/DomesticMOUs/
ucm116365.htm). When an applicant
submits a New Drug Application (NDA)
for a drug with abuse potential to FDA
for review, the applicant is required to
propose a CSA schedule for the new
drug (21 CFR 314.50(d)(5)(vii)). The
applicant’s proposal is considered by
the Agency during its evaluation of the
drug’s abuse potential. FDA prepares a
scientific analysis with a
recommendation for scheduling the
drug under the CSA, as warranted,
based on consideration of all relevant
and available data. This
recommendation is forwarded by the
HHS Assistant Secretary for Health to
DEA for their consideration in the
decision on final scheduling of the drug.
Under new legislation enacted in
2015, the Improving Regulatory
Transparency for New Medical
Therapies Act (Pub. L. 114–89), upon
receipt of both: (1) Notification from
FDA that a marketing application has
been approved by FDA and (2) the
scheduling recommendation of HHS
with respect to the subject drug in the
marketing application, DEA shall within
90 days schedule the drug by
rulemaking, thus establishing the
effective date of approval for the drug
product. See 21 U.S.C. 355(x); see also
Public Law 114–89 (November 25,
2015). Control under Schedules II, III,
IV, or V results in schedule-specific
regulatory requirements relating to the
drug’s labeling, prescribing, dispensing,
advertising, manufacturing, distribution,
importation/exportation, promotion,
marketing, and legitimate use in
medical treatment. See generally 21
U.S.C. 821–831 and 21 CFR 1300–1321.
Scheduling of a substance in the CSA is
for the purpose of reducing abuse and
diversion.
E:\FR\FM\18JAN1.SGM
18JAN1
Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
This guidance provides important
recommendations to sponsors,
applicants, and potential applicants in
the approaches to collecting data that
should comprise the abuse potential
assessment submitted in the marketing
application to FDA if one is required
pursuant to § 314.50(d)(5)(vii).
In the Federal Register of January 27,
2010 (75 FR 4400), FDA issued the draft
guidance for industry ‘‘Assessment of
Abuse Potential of Drugs.’’ Based on the
2010 draft guidance, and consideration
of comments received from the public,
this guidance provides the Agency’s
current thinking with respect to the
scientific methods recommended to
assess abuse potential. The guidance
also adds more detailed discussion
about key questions and decision points
to consider during drug development
that will likely determine the
appropriate studies for sponsors and
applicants to conduct to address the
abuse potential of their new drug,
inform appropriate labeling of the
product upon its approval, and allow a
thorough scientific and medical
evaluation to support scheduling
decisions in accordance with the CSA.
In addition, this guidance takes into
consideration other guidance issued and
legislation enacted since 2010.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on assessment of abuse
potential of drugs. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in part 314, including
§ 314.50(d)(5)(vii), has been approved
under OMB control number 0910–0001.
The collection of information in 21 CFR
part 312 for investigational drugs has
been approved under OMB control
number 0910–0014. The collection of
information in the guidance ‘‘Formal
Meetings Between the FDA and
Sponsors or Applicants of PDUFA
Products’’ has been approved under
OMB control number 0910–0429. The
collection of information in 21 CFR
201.56 and 201.57, prescription drug
labeling, has been approved under OMB
control number 0910–0572. The
collection of information in 21 CFR part
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17:41 Jan 17, 2017
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58, Good Laboratory Practice for
Nonclinical Studies, has been approved
under OMB control number 0910–0119.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–01024 Filed 1–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0113]
The Prohibition of Distributing Free
Samples of Tobacco Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘The
Prohibition of Distributing Free Samples
of Tobacco Products; Draft Guidance for
Industry.’’ The draft guidance, when
finalized, would provide information
intended to assist manufacturers,
distributors, and retailers in complying
with the regulations prohibiting the
distribution of free samples of tobacco
products.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 17,
2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
PO 00000
Frm 00062
Fmt 4703
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5583
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 https://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–
2017–D–0113 for ‘‘The Prohibition of
Distributing Free Samples of Tobacco
Products.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
https://www.regulations.gov. Submit
both copies to the Division of Dockets
E:\FR\FM\18JAN1.SGM
18JAN1
Agencies
[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5581-5583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01024]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0026]
Assessment of Abuse Potential of Drugs; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Assessment of
Abuse Potential of Drugs.'' This guidance is intended to assist
sponsors of investigational new drugs and applicants for approval of a
new drug in evaluating whether their new drug product has abuse
potential. Specifically, this guidance provides recommendations for
assessing the abuse potential of central nervous system (CNS)-active
new drugs. Drug products with abuse potential generally contain drug
substances that are active within the CNS and produce psychoactive
effects such as euphoria and hallucinations. Thus, if a drug substance
is CNS-active, the new drug product containing that drug substance will
likely need to undergo a thorough assessment of its abuse potential and
may be subject to control under the Controlled Substances Act (CSA).
This guidance finalizes the draft guidance of the same name issued on
January 27, 2010.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
[[Page 5582]]
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-2010-D-0026 for ``Assessment of Abuse Potential of Drugs; Guidance
for Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://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 https://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: https://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 https://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.
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Dominic Chiapperino, Controlled
Substance Staff, Center for Drug Evaluation and Research, Bldg. 51, Rm.
5148, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, 301-796-1183.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Assessment of Abuse Potential of Drugs.'' Under the Federal
Food, Drug, and Cosmetic Act, an abuse potential assessment is part of
the general evaluation of the safety and efficacy of a new drug to be
used under medical supervision. Additionally, if a new drug has abuse
potential, the Secretary of Health and Human Services (HHS) is required
under the CSA (21 U.S.C. 801 et seq.) to make a recommendation for
scheduling to the Drug Enforcement Administration (DEA). The regulatory
responsibilities for this process are described in Title 21, United
States Code (U.S.C.) 811. FDA, in consultation with the National
Institute on Drug Abuse (NIDA) conducts the medical and scientific
analysis on behalf of HHS. Specifically, the Controlled Substance Staff
of FDA performs this scientific evaluation of the abuse potential of a
drug for FDA, in consultation with NIDA, as described in a Memorandum
of Understanding (MOU) of March 8, 1985 (50 FR 9518) (available at;
https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116365.htm). When an
applicant submits a New Drug Application (NDA) for a drug with abuse
potential to FDA for review, the applicant is required to propose a CSA
schedule for the new drug (21 CFR 314.50(d)(5)(vii)). The applicant's
proposal is considered by the Agency during its evaluation of the
drug's abuse potential. FDA prepares a scientific analysis with a
recommendation for scheduling the drug under the CSA, as warranted,
based on consideration of all relevant and available data. This
recommendation is forwarded by the HHS Assistant Secretary for Health
to DEA for their consideration in the decision on final scheduling of
the drug.
Under new legislation enacted in 2015, the Improving Regulatory
Transparency for New Medical Therapies Act (Pub. L. 114-89), upon
receipt of both: (1) Notification from FDA that a marketing application
has been approved by FDA and (2) the scheduling recommendation of HHS
with respect to the subject drug in the marketing application, DEA
shall within 90 days schedule the drug by rulemaking, thus establishing
the effective date of approval for the drug product. See 21 U.S.C.
355(x); see also Public Law 114-89 (November 25, 2015). Control under
Schedules II, III, IV, or V results in schedule-specific regulatory
requirements relating to the drug's labeling, prescribing, dispensing,
advertising, manufacturing, distribution, importation/exportation,
promotion, marketing, and legitimate use in medical treatment. See
generally 21 U.S.C. 821-831 and 21 CFR 1300-1321. Scheduling of a
substance in the CSA is for the purpose of reducing abuse and
diversion.
[[Page 5583]]
This guidance provides important recommendations to sponsors,
applicants, and potential applicants in the approaches to collecting
data that should comprise the abuse potential assessment submitted in
the marketing application to FDA if one is required pursuant to Sec.
314.50(d)(5)(vii).
In the Federal Register of January 27, 2010 (75 FR 4400), FDA
issued the draft guidance for industry ``Assessment of Abuse Potential
of Drugs.'' Based on the 2010 draft guidance, and consideration of
comments received from the public, this guidance provides the Agency's
current thinking with respect to the scientific methods recommended to
assess abuse potential. The guidance also adds more detailed discussion
about key questions and decision points to consider during drug
development that will likely determine the appropriate studies for
sponsors and applicants to conduct to address the abuse potential of
their new drug, inform appropriate labeling of the product upon its
approval, and allow a thorough scientific and medical evaluation to
support scheduling decisions in accordance with the CSA. In addition,
this guidance takes into consideration other guidance issued and
legislation enacted since 2010.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on assessment of abuse potential of drugs. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in part 314, including Sec.
314.50(d)(5)(vii), has been approved under OMB control number 0910-
0001. The collection of information in 21 CFR part 312 for
investigational drugs has been approved under OMB control number 0910-
0014. The collection of information in the guidance ``Formal Meetings
Between the FDA and Sponsors or Applicants of PDUFA Products'' has been
approved under OMB control number 0910-0429. The collection of
information in 21 CFR 201.56 and 201.57, prescription drug labeling,
has been approved under OMB control number 0910-0572. The collection of
information in 21 CFR part 58, Good Laboratory Practice for Nonclinical
Studies, has been approved under OMB control number 0910-0119.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01024 Filed 1-17-17; 8:45 am]
BILLING CODE 4164-01-P