[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This guidance finalizes the draft guidance of the same name issued on 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: 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 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; 
http://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 http://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