Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices 54889 

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: Agency for Toxic Substances 

and Disease Registry (ATSDR), 

Department of Health and Human 

Services (DHHS). 

ACTION: Notice. 

DATES: 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: 

http://www.atsdr.cdc.gov/toxpro2.html. 

Set 24 Toxicological Profiles 

The following toxicological profiles 

are now being developed: 

Toxicological profile CAS number 

Toxaphene ............................ 8001–35–2 

Trichlorobenzene* 

1,2,3–Trichlorobenzene 87–61–6 

1,2,4–Trichlorobenzene 120–82–1 

1,3,5–Trichlorobenzene 108–70–3 

Trichlorobenzene .... 12002–48–1 

* Denotes new profile. 

SUPPLEMENTARY INFORMATION: 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) 

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 (http:// 

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. 

FOR FURTHER INFORMATION CONTACT: 

Commander Jessilynn B. Taylor, 

Division of Toxicology and 

Environmental Medicine, Agency for 

Toxic Substances and Disease Registry, 

1600 Clifton Road, NE., Mail Stop F–62, 

Atlanta, GA 30333; telephone (770) 

488–3313; e-mail: JBTaylor@cdc.gov. 

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 

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 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. 

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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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