Federal Register / Vol. 72, No. 42 / Monday, March 5, 2007 / Notices 9767 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Manufacturing Subcommittee of the 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology (Formerly Advisory 

Committee for Pharmaceutical 

Science); Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Manufacturing 

Subcommittee of the Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology (formerly 

Advisory Committee for Pharmaceutical 

Science). 

General Function of the 

Subcommittee: To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 30, 2007, from 8:30 a.m. 

to 5 p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research Advisory 

Committee Conference Room, rm. 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Victoria FerrettiAceto, Center for Drug Evaluation and 

Research (HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093) Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

Victoria.FerrettiAceto@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572) 

in the Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The subcommittee will do 

the following: (1) As an awareness topic, 

discuss issues pertaining to the stability 

of tablets split for patient use; (2) 

receive a general update and discuss 

current strategies on quality by design 

and the Office of Generic Drugs’

question-based review; and (3) receive 

an update on and discuss the status of 

the Office of New Drug Quality 

Assessment Chemistry, Manufacturing, 

and Controls Pilot Program. 

FDA intends to make background 

material available to the public no later 

than 1 business day before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person on or before April 16, 2007. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before April 6, 2007. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 9, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Victoria 

Ferretti-Aceto at least 7 days in advance 

of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 26, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–3717 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Project: School Climate Survey for the 

National Cross-Site Evaluation of Safe 

School/Healthy Student (SS/HS) 

Initiative Grants–NEW. 

The SS/HS Initiative is a collaborative 

grant program supported by three 

Federal departments—the U.S. 

Departments of Health and Human 

Services, Education, and Justice. The 

program is authorized under the 

Elementary and Secondary Education 

Act of 1965, as amended, and the Higher 

Education Act of 1965, Title IV, Part A, 

Subpart 2 (National Programs), Section 

4121 (Federal Activities). It is also 

authorized under Section 581 of the 

Public Health Service Act. 

This initiative, instituted by Congress 

following the murderous assaults at 

Columbine High School in Colorado, is 

designed to provide Local Educational 

Agencies (LEAs), including school 

districts and multi-district regional 

consortia, with 3 years of funding to 

simultaneously improve school safety, 

student access to mental health services, 

the reduction of violence and substance 

abuse, school relationships with the 

larger community, and early childhood 

preparation for learning. Collectively, 

Congress expects these changes to be 

reflected in improved school climate. 

Local Education Agencies (LEAs) 

serve as the primary applicants for SS/ 

HS grants, but the LEAs are required to 

establish formal partnerships with the 

local mental health system, the local 

law enforcement agency, and the local 

juvenile justice agency. Other partners 

often include public and private social 

services agencies, businesses, civic 

organizations, the faith community, and 

private citizens. As a result of these 

partnerships, comprehensive plans are 

developed, implemented, evaluated, 

and sustained with the goals of 

promoting the healthy development of 

children and youth, fostering their 

resilience in the face of adversity, and 

preventing violence. 


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