Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials; Availability, 54889-54890 [2010-22404]

Download as PDF Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 13, 2010. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2010–22394 Filed 9–8–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR–265] Development of Set 24 Toxicological Profiles Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS). ACTION: Notice. AGENCY: Profiles will be available to the public on or about October 17, 2010. SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR) of the Department of Health and Human Services is developing Set 24 Toxicological Profiles. Set 24 Toxicological Profiles consists of one new draft and one updated draft. Electronic access to these documents will be available at the ATSDR Web site: https://www.atsdr.cdc.gov/toxpro2.html. DATES: Set 24 Toxicological Profiles The following toxicological profiles are now being developed: Toxicological profile Toxaphene ............................ Trichlorobenzene* 1,2,3–Trichlorobenzene 1,2,4–Trichlorobenzene 1,3,5–Trichlorobenzene Trichlorobenzene .... FOR FURTHER INFORMATION CONTACT: Commander Jessilynn B. Taylor, Division of Toxicology and Environmental Medicine, Agency for CAS number Toxic Substances and Disease Registry, 8001–35–2 1600 Clifton Road, NE., Mail Stop F–62, Atlanta, GA 30333; telephone (770) 87–61–6 488–3313; e-mail: JBTaylor@cdc.gov. 120–82–1 108–70–3 12002–48–1 * Denotes new profile. The Superfund Amendments and Reauthorization Act of 1986 (42 U.S.C. 9601 et seq.) amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) (42 U.S.C. 9601 et seq.) by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency (EPA) mstockstill on DSKH9S0YB1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:24 Sep 08, 2010 with regard to hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List. Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the Priority List of Hazardous Substances (https:// www.atsdr.cdc.gov/cercla/07list.html). This list names 275 hazardous substances that pose the most significant potential threat to human health as determined by ATSDR and EPA. The availability of the revised list of the 275 priority substances was announced in the Federal Register on March 6, 2008 (73 FR 12178). For prior versions of the list of substances, see Federal Register notices dated April 17, 1987 (52 FR 12866); October 20, 1988 (53 FR 41280); October 26, 1989 (54 FR 43619); October 17, 1990 (55 FR 42067); October 17, 1991 (56 FR 52166); October 28, 1992 (57 FR 48801); February 28, 1994 (59 FR 9486); April 29, 1996 (61 FR 18744; November 17, 1997 (62 FR 61332); October 21, 1999 (64 FR 56792); October 25, 2001 (66 FR 54014); November 7, 2003 (68 FR 63098); and December 7, 2005 (70FR 70284). Notice of the availability of drafts of one updated and one new toxicological profile for public review and comment will be published in the Federal Register on or about October 17, 2010, with notice of a 90-day public comment period for each profile, starting from the actual release date. Following the close of the comment period, chemicalspecific comments will be addressed, and where appropriate, revisions will be incorporated into each profile. Jkt 220001 Dated: September 3, 2010. Ken Rose, Associate Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. 2010–22439 Filed 9–8–10; 8:45 am] BILLING CODE 4163–70–P PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 54889 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0451] Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Suicidality: Prospective Assessment of Occurrence in Clinical Trials.’’ The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. Specifically, this guidance addresses FDA’s current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development. 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 November 8, 2010. SUMMARY: 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 https:// 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. ADDRESSES: E:\FR\FM\09SEN1.SGM 09SEN1 54890 Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices mstockstill on DSKH9S0YB1PROD with NOTICES SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Suicidality: Prospective Assessment of Occurrence in Clinical Trials.’’ The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. Specifically, this guidance addresses FDA’s current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development. The principles discussed in this guidance for the prospective assessment of suicidality involve 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 suicidality assessment instrument that can be used to conduct such prospective assessments and offers guidance on the use of alternative instruments. This guidance does not address the complex analytic issues involved in the analysis of the suicidality data that will be derived from prospective assessments of suicidality; these issues will be addressed in separate guidances. Comments are welcome regarding the recommended approach of carrying out prospective suicidality assessments in all clinical trials for all drugs that are pharmacologically similar to isotretinoin and other tretinoins, beta blockers (especially those entering the brain), reserpine, drugs for smoking cessation, and drugs for weight loss for which possible signals of risk for suicidality have already been identified. 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 the prospective assessment of suicidality occurrence 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 VerDate Mar<15>2010 17:24 Sep 08, 2010 Jkt 220001 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 Dated: September 2, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–22404 Filed 9–8–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Neonatal Research Network. Date: October 5–6, 2010. Time: 9 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Legacy Hotel and Meeting Center, 1775 Rockville Pike, Rockville, MD 20852. Contact Person: Rita Anand, PhD, Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, 301–496–148, anandr@mail.nih.gov. Frm 00045 Fmt 4703 Dated: September 2, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–22499 Filed 9–8–10; 8:45 am] Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. PO 00000 (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Sfmt 4703 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentablematerial, and personal information concerning individuals associated with the grant applications,the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Aging and Distal Radius Fracture. Date: October 7, 2010. Time: 6 p.m. to 7 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20892. Contact Person: Alicja L. Markowska, PhD, DSC, Scientific Review Branch, National Institute on Aging, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–496– 9666, markowsa@nia.nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel; Aminergic Function in Brain Aging and Alzheimer’s Disease. Date: October 19, 2010. Time: 12 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, National Institute on Aging, Gateway Building 2C/212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–496–9666, PARSADANIANA@NIA.NIH.GOV. E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 75, Number 174 (Thursday, September 9, 2010)]
[Notices]
[Pages 54889-54890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22404]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0451]


Draft Guidance for Industry on Suicidality: Prospective 
Assessment of Occurrence in Clinical Trials; Availability

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 ``Suicidality: 
Prospective Assessment of Occurrence in Clinical Trials.'' The purpose 
of this guidance is to assist sponsors in prospectively assessing the 
occurrence of treatment-emergent suicidality in clinical trials of drug 
and biological products. Specifically, this guidance addresses FDA's 
current thinking regarding the importance of suicidality assessment in 
psychiatric and nonpsychiatric drug trials and the general principles 
for how best to accomplish this assessment during drug development.

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 November 8, 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to https://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.

[[Page 54890]]


SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Suicidality: Prospective Assessment of Occurrence in 
Clinical Trials.'' The purpose of this guidance is to assist sponsors 
in prospectively assessing the occurrence of treatment-emergent 
suicidality in clinical trials of drug and biological products. 
Specifically, this guidance addresses FDA's current thinking regarding 
the importance of suicidality assessment in psychiatric and 
nonpsychiatric drug trials and the general principles for how best to 
accomplish this assessment during drug development.
    The principles discussed in this guidance for the prospective 
assessment of suicidality involve 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 suicidality assessment instrument 
that can be used to conduct such prospective assessments and offers 
guidance on the use of alternative instruments. This guidance does not 
address the complex analytic issues involved in the analysis of the 
suicidality data that will be derived from prospective assessments of 
suicidality; these issues will be addressed in separate guidances.
    Comments are welcome regarding the recommended approach of carrying 
out prospective suicidality assessments in all clinical trials for all 
drugs that are pharmacologically similar to isotretinoin and other 
tretinoins, beta blockers (especially those entering the brain), 
reserpine, drugs for smoking cessation, and drugs for weight loss for 
which possible signals of risk for suicidality have already been 
identified.
    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 the 
prospective assessment of suicidality occurrence 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22404 Filed 9-8-10; 8:45 am]
BILLING CODE 4160-01-P
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