[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Draft Guidance for Industry on Suicidal Ideation and Behavior: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availability of a draft guidance for industry entitled ``Suicidal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 This guidance revises and replaces a previous draft
guidance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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 15, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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