Notice: Draft Guidance for Industry on Assessment of Abuse Potential of 
Drugs; Availability

Federal Register: January 27, 2010 (Volume 75, Number 17)             
                  Page 4400-4401

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Assessment of 
Abuse Potential of Drugs.'' This draft guidance is intended to assist 
sponsors who are developing drug and other medical products with the 
potential for abuse that may need to be scheduled under the Controlled 
Substances Act. Drugs with abuse potential generally include drugs that 
affect the central nervous system, drugs that are chemically or 
pharmacologically similar to other drugs with known abuse potential, 
and drugs that produce psychoactive effects such as sedation, euphoria, 
or mood change.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by March 29, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Corinne P. Moody, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 5144, Silver Spring, MD 20993-0002, 301-
796-5402.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 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 drug to be used 
under medical supervision. If a drug has abuse potential, the Secretary 
of Health and Human Services (HHS) is required under the Controlled 
Substances Act of 1970 (CSA) 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, with delegation of authority to FDA from HHS. 
The Controlled Substance Staff (CSS) of FDA performs the scientific 
evaluation of the abuse potential of a drug for HHS, in consultation 
with the National Institute on Drug Abuse (NIDA), as described in a 
Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518).
    When a sponsor submits a marketing application for a drug with 
abuse potential to FDA for review, the sponsor is required to propose a 
CSA schedule and provide a basis for this proposal (21 CFR 
314.50(d)(5)(vii)). The sponsor's proposal is considered by the agency 
during its evaluation of the drug's abuse potential. At the time a 
marketing application is submitted to FDA for review, the sponsor signs 
a statement agreeing not to market the product until the DEA makes a 
final scheduling decision.
    FDA prepares a scientific analysis with a recommendation for 
scheduling, based on the submission of the sponsor that includes a 
scientific and medical evaluation of all relevant and available data, 
an assessment of the public health risk, and a proposal for scheduling. 
This recommendation is forwarded to DEA for consideration in the 
decision on final scheduling of the drug. Scheduling results in 
specific regulatory requirements relating to the drug's labeling, 
prescribing, advertising, manufacturing, promotion, marketing, and use 
in the practice of medicine. Not following these requirements can 
result in criminal penalties.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on assessing 
abuse potential of drugs. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any

[[Page 4401]]

mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

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

    Dated: January 21, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1516 Filed 1-26-10; 8:45 am]
BILLING CODE 4160-01-S