38036 Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices 

The guidance describes the sensitivity 

and specificity of various indicators of 

hepatotoxic potential, as well as the 

observations needed to evaluate those 

indicators, including detection, 

confirmation and monitoring of liver 

test abnormalities, close evaluation and 

exclusion of other causes, and careful 

supportive care and follow-up to 

normality or return to baseline status. 

The guidance makes specific 

recommendations about the use of Hy’s 

Law and interpretation of Hy’s Law 

cases that are identified during clinical 

development and suggests research 

opportunities to learn more about what 

makes certain people more susceptible 

to DILI than are most persons exposed 

to the drug. 

The guidance was issued in draft form 

in October 2007 for public comments. 

We received a total of 12 comments 

submitted to Docket No. 2007D–0396. 

FDA organized a public meeting in 

March 2008 for discussion of issues 

raised by the draft guidance and 

reopened the public comment period 

from March 6, 2008, to June 30, 2008, 

with Docket No. FDA–2008–D–0128 

(formerly Docket No. 2007D–0396). One 

comment was submitted to Docket No. 

FDA–2008–D–0128. The comments are 

available at http://www.fda.gov/Drugs/ 

ScienceResearch/ResearchAreas/ 

ucm071471.htm. Presentations, 

discussion, and materials from the 

March 2008 public meeting also are 

available at the above Web site. 

FDA considered written and verbal 

comments submitted to the dockets and 

at the public meeting before finalizing 

the guidance. The guidance reflects 

clarifying and editorial changes made in 

response to comments and at our own 

initiative. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the premarketing 

evaluation of a drug’s potential for 

causing severe DILI. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312, 314, 

and 601 have been approved under 

OMB Control Numbers 0910–0014, 

0910–0001, and 0910–0338, 

respectively. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/cber/guidelines.htm, or 

http://www.regulations.gov. 

Dated: July 22, 2009. 

Jeffrey Shuren, 

Associate Comissioner for Policy and 

Planning. 

[FR Doc. E9–18135 Filed 7–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Fiscal Year (FY) 2009 Funding 

Opportunity 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice of intent to award a 

Single Source Supplement Grant to the 

Community Anti-Drug Coalitions of 

America (CADCA). 

SUMMARY: This notice is to inform the 

public that the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) intends to award 

approximately $30,000 (total costs) for 

one year to the Community Anti-Drug 

Coalitions of America (CADCA). This is 

not a formal request for applications. 

Assistance will be provided only to the 

Community Anti-Drug Coalitions of 

America (CADCA) based on the receipt 

of a satisfactory application that is 

approved by an independent review 

group. 

Funding Opportunity Title: SP–09– 

007. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.243. 

Authority: Sections 509, 516 and 520A of 

the Public Health Service Act, as amended. 

Justification: Only the Community 

Anti-Drug Coalitions of America 

(CADCA) is eligible to apply. The 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) is 

seeking to supplement a single source 

grant to the Community Anti-Drug 

Coalitions of America (CADCA) to 

support a Prevention Town Hall 

Meeting and a Partners Meeting at 

CADCA’s Mid-Year Training Institute. 

The Training Institute will disseminate 

knowledge and transfer state-of-the-art 

information, assisting community 

leaders in developing effective local 

programs, practices, and policies that 

support national substance abuse goals, 

outcomes and efforts, such as National 

Alcohol and Drug Addiction Recovery 

Month, and prevention of underage 

drinking. The Prevention Town Hall 

Meeting will provide an in-depth 

overview of substance abuse prevention 

principles, and make the link to 

community-level change strategies 

promoted by the Drug-Free 

Communities grant program. The 

Partners Meeting is intended to bring all 

Federal and other key constituents 

together to update and discuss new 

initiatives and ongoing projects. Grant 

funds will also support evaluation of the 

Prevention Town Hall Meeting to obtain 

findings and identify directions for 

future trainings. 

The Community Anti-Drug Coalitions 

of America (CADCA) is uniquely 

qualified to carry out the activities of 

this program because the purpose of the 

program is to partner with a national 

organization that has special expertise 

and unique broad, national-level 

experience in working with community 

anti-drug coalitions. CADCA is the only 

national organization that annually 

provides training and technical 

assistance through a mid-year 

leadership conference for thousands of 

members of community coalitions 

dedicated to preventing substance 

abuse. CADCA currently is the sole 

organization that plays a major role in 

helping to strengthen and develop the 

nation’s prevention infrastructure of 

anti-drug coalitions in support of ongoing activities funded by SAMHSA’s 

priority grant programs including: the 

Substance Abuse Prevention and 

Treatment Block Grant, the Strategic 

Prevention Framework State Incentive 

Grant, and the Drug Free Communities 

Support Program. CADCA is the only 

identified organization that currently 

meets this experience level and national 

reach to over 5,000 identified anti-drug 

coalitions across the country. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices 38037 

Contact: Shelly Hara, Substance 

Abuse and Mental Health Services 

Administration, 1 Choke Cherry Road, 

Room 8–1081, Rockville, MD 20857; 

telephone: (240) 276–2321; E-mail: 

shelly.hara@samhsa.hhs.gov. 

Dated: July 24, 2009. 

Toian Vaughn, 

Committee Management Officer, Substance 

Abuse and Mental Health, Services 

Administration. 

[FR Doc. E9–18187 Filed 7–29–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; Immunobiology of 

Xenotransplantation. 

Date: September 18, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, 3264, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Maryam Feili-Hariri, PhD, 

Scientific Review Officer, Immunology 

Review Branch, Scientific Review Program, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–402–5658, 

haririmf@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: July 24, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–18225 Filed 7–29–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 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 on 

Drug Abuse Special Emphasis Panel; NIDA– 

F Special Emphasis Panel. 

Date: August 3, 2009. 

Time: 1 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Nadine Rogers, PhD, 

Scientific Review Administrator, Office of 

Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Boulevard, Bethesda, 

MD 20892–8401, 301–402–2105, 

rogersn2@nida.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Diversity-promoting Institutions’ Drug Abuse 

Research Development Program. 

Date: August 3, 2009. 

Time: 1 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Nadine Rogers, PhD, 

Scientific Review Administrator, Office of 

Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Boulevard, Bethesda, 

MD 20892–8401, 301–402–2105, 

rogersn2@nida.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: July 23, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–18017 Filed 7–29–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of meetings of the National 

Diabetes and Digestive and Kidney 

Diseases Advisory Council. 

The meetings will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

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 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 Diabetes and 

Digestive and Kidney Diseases Advisory 

Council. 

Date: September 9, 2009. 

Open: 8:30 a.m. to 11:45 a.m. 

Agenda: To present the Director’s Report 

and other scientific presentations. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Closed: 4:15 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Contact Person: Brent B. Stanfield, PhD, 

Director, Division of Extramural Activities, 

National Institute of Diabetes and Digestive 

and Kidney Diseases, 6707 Democracy Blvd., 

Room 715, MSC 5452, Bethesda, MD 20892, 

(301) 594–8843, stanfibr@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council Diabetes, Endocrinology, and 

Metabolic Diseases Subcommittee. 


erowe on DSK5CLS3C1PROD with NOTICES