[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48989-48990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0849]


Draft Guidance for Industry on Suicidal Ideation and Behavior: 
Prospective Assessment of Occurrence in Clinical Trials; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Suicidal 
Ideation and Behavior: Prospective Assessment of Occurrence in Clinical 
Trials.'' The purpose of this guidance is to assist sponsors in 
prospectively assessing the occurrence of treatment-emergent suicidal 
ideation and behavior in clinical trials of drug and biological 
products, including drugs for psychiatric and nonpsychiatric 
indications. This guidance revises and replaces a previous draft 
guidance

[[Page 48990]]

entitled ``Suicidality: Prospective Assessment of Occurrence in 
Clinical Trials'' issued in September 2010.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 15, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Thomas Laughren, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4114, Silver Spring, MD 20993-0002, 301-
796-2260.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Suicidal Ideation and Behavior: Prospective Assessment of 
Occurrence in Clinical Trials.'' The purpose of this guidance is to 
assist sponsors in prospectively assessing the occurrence of treatment-
emergent suicidal ideation and behavior in clinical trials of drug and 
biological products. Specifically, this guidance addresses FDA's 
current thinking regarding the importance of suicidal ideation and 
behavior assessment in psychiatric and nonpsychiatric drug trials and 
the general principles for how best to accomplish this assessment 
during drug development.
    Prospective assessment of suicidal ideation and behavior involves 
actively querying patients about the occurrence of suicidal thinking 
and behavior, rather than relying on patients to report such 
occurrences spontaneously, followed by retrospective classification of 
events into appropriate categories. This guidance recommends a specific 
suicidal ideation and behavior assessment instrument that can be used 
to conduct such prospective assessments and offers guidance on the use 
of alternative instruments.
    This guidance is intended to serve as a focus for continued 
discussions among FDA, pharmaceutical sponsors, the academic community, 
and the public. This guidance does not address the complex analytic 
issues involved in the analysis of the suicidal ideation and behavior 
data that will be derived from prospective assessments of suicidal 
ideation and behavior; these issues will be addressed in separate 
guidances.
    This guidance is a revision of the draft guidance for industry 
entitled ``Suicidality: Prospective Assessment of Occurrence in 
Clinical Trials'' issued September 9, 2010 (75 FR 54889). Comments we 
received on the draft guidance have been considered and the guidance 
has been revised. The revision: (1) Replaces the term ``suicidality'' 
with the terms ``suicidal ideation and behavior''; (2) provides an 
expanded set of the Columbia Classification Algorithm for Suicide 
Assessment (C-CASA) categories, along with definitions and 
explanations; (3) revises the advice on which trials and patients would 
need assessments of suicidal ideation and behavior and the timing of 
such assessments; (4) addresses concerns about the time burden of 
assessments; (5) addresses questions about the possible value of the 
assessments providing protection for patients in the trials themselves; 
(6) makes it clear that use of an assessment instrument that directly 
classifies relevant thoughts and behaviors into C-CASA categories 
eliminates the need for any additional coding; (7) provides multiple 
additional references; and (8) revises advice on evaluation of 
alternative instruments.
    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 prospective 
assessment of occurrence of suicidal ideation and behavior in clinical 
trials. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: August 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19993 Filed 8-14-12; 8:45 am]
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