54890 Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / 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a draft guidance for industry entitled 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This draft guidance is being issued 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The draft guidance, when finalized, will 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 

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/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

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 

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. 

(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) 

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] 

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. 

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