Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices 41681

TABLE 1

Workshop Address Date and Local Time

Long Beach Convention Center,

300 East Ocean Blvd.,

Long Beach, CA 90802.

Tuesday, September 26, 2000,

9 a.m. to 4:30 p.m.

Pacific time.

Embassy Suites, 150 Anza Blvd.,

Burlingame, CA 94010,

650–340–0327.

Friday, December 8, 2000,

9 a.m. to 4:30 p.m.

Pacific time.

Contact: Marcia Madrigal, Industry

and Small Business Representative,

Food and Drug Administration, Oakland

Federal Bldg., 1301 Clay St., suite

1180N, Oakland, CA 94612, 510–637–

3980; FAX 510–637–3977 or via e-mail:

mmadriga@ora.fda.gov.

Registration: The registration fee is

$295 for ISPE members and $450 for

nonmembers (which will cover

refreshments, lunch, and materials). The

ISPE tax number is FEI 59–2009272.

Contact ISPE for registration forms, and

other registration details at ISPE 3816

W. Linebaugh Ave, suite 412, Tampa,

FL 33624, 813–960–2105; FAX 813–

264–2816, or visit the ISPE website at

http://www.ispe.org. Registrations are

due 1 week prior to the start of each

course. Space is limited, therefore,

interested parties are encouraged to

register early. Limited onsite registration

may be available. Please arrive early to

ensure prompt registration. Persons

needing hotel rooms for the Embassy

Suites location on December 8, 2000,

should mention that they are attending

the FDA/SUPAC workshop. A special

rate is available until November 16,

2000, or until the room block is

exhausted, whichever comes first.

If you need special accommodations

due to a disability, please contact ISPE

at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The

workshops are designed to help achieve

objectives set forth in section 406 of the

FDA Modernization Act of 1997 (21

U.S.C 393) and discussed in the FDA

Plan for Statutory Compliance, which

include working more closely with

stakeholders; maximizing the

availability of, and clarifying

information about the process for review

and submissions; and ensuring access to

needed scientific and technical

expertise.

The workshops also are consistent

with the Small Business Regulatory

Enforcement Fairness Act (Public Law

104–121), as outreach activities by

Government agencies directed to small

businesses.

The topics to be discussed include the

following: (1) The history of SUPAC

development; (2) the impact of scale-up

postapproval change guidances and of

the regulation rewrite of 21 CFR 314.70

(Supplements and other changes to an

approved application); (3) comparison

of SUPAC immediate-release solid

dosage forms, modified-release oral

dosage forms, and semisolid-topical

dosage forms; (4) postapproval changes

sterile aqueous solutions; (5) FDA field

staff’s involvement in SUPAC; (6)

description and use of the equipment

addenda to SUPAC; and (7) facts,

figures, and future directions.

Dated: June 27, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–16979 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources And Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA)

publishes periodic summaries of

proposed projects being developed for

submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Scholarships for

Disadvantaged Students Program—New

The Scholarships for Disadvantaged

Students (SDS) Program has as its

purpose the provision of funds to

eligible schools to provide scholarships

to full-time, financially needy students

from disadvantaged backgrounds

enrolled in health professions and

nursing programs.

To qualify for participation in the SDS

program, a school must be carrying out

a program for recruiting and retaining

students from disadvantaged

backgrounds, including students who

are members of racial and ethnic

minority groups (section 737(d)(1)(B) of

the PHS Act). A school must meet the

eligibility criteria to demonstrate that

the program has achieved success based

on the number and/or percentage of

disadvantaged students who graduate

from the school. In awarding SDS funds

to eligible schools, funding priorities

must be given to schools based on the

proportion of graduating students going

into primary care, the proportion of

underrepresented minority students,

and the proportion of graduates working

in medically underserved communities

(section 737(c) of the PHS Act).

The estimated response burden is as

follows:

41682 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Notices

Form Number of respondents

Responses

per respondent

Hours per responseTotal hour burden

SDS .................................................................................................................. 450 1 25.5 11,475

Total .......................................................................................................... 450 ........................ ........................ 11,475

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–33, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: June 29, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–16973 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. appendix 2), notice

is hereby given of the meeting of the

Board of Scientific Counselors, National

Cancer Institute.

The meeting will be closed to the

public as indicated below in accordance

with the provisions set forth in sections

552b(c)(6) and 552b(c)(9)(B), title 5

U.S.C., as amended. The discussions

could reveal information of a personal

nature where disclosure would

constitute a clearly unwarranted

invasion of personal privacy and the

premature disclosure of discussions

related to personnel and programmatic

issues would be likely to significantly

frustrate the subsequent implementation

of recommendations.

Name of Committee: Board of Scientific

Counselors, National Cancer Institute,

Subcommittee A—Clinical Sciences and

Epidemiology.

Date: July 24, 2000.

Time: 8:30 a.m. to 4:00 p.m.

Agenda: Discussion of personnel and

programmatic issues and Review and

evaluate individual Principal Investigators.

Place: National Cancer Institute, Building

31, C Wing, 6th floor, Conference Room 6,

9000 Rockville Pike, Bethesda, MD 20892.

Contact Person: Abby Sandler, Executive

Secretary, Institute Review Office, Office of

the Director, National Cancer Institute,

National Institutes of Health, 6116 Executive

Boulevard, Room 7019, Bethesda, MD 20892,

(301) 496–7628.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology

Research; 93.397, Cancer Centers Support;

93.398, Cancer Research Manpower, 93.399,

Cancer Control, National Institutes of Health,

HHS)

Dated: June 29, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–17096 Filed 7–5–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

Notice of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. appendix 2), 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 on

Drug Abuse Special Emphasis Panel Program

Projects.

Date: August 4, 2000.

Time: 8:30 a.m. to 3 p.m.

Agenda: To review and evaluate grant

applications.

Place: Key Bridge Marriott, 1401 Lee

Highway, Arlington, VA 22209.

Contact Person: Rita Liu, Health Scientist

Administrator, Office of Extramural Affairs,

National Institute on Drug Abuse, National

Institutes of Health, DHHS, 6001 Executive

Boulevard, Room 3158, MSC 9547, Bethesda,

MD 20892–9547, (301) 443–2620.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.277, Drug Abuse Scientist

Development Award for Clinicians, Scientist

Development Awards, and Research Scientist

Awards; 93.278, Drug Abuse National

Research Service Awards for Research

Training; 93.279, Drug Abuse Research

Programs, National Institutes of Health, HHS)

Dated: June 29, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–17097 Filed 7–5–00; 8:45 am]

BILLING CODE 4140–01–M

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. appendix 2), 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 contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute on

Drug Abuse Special Emphasis Panel Phase II

SBIR: ‘‘Prevention Activities Handbook: A

Practioner’s Guide to Selecting and

Implementing Interactive Drug Use

Prevention Activities for Children and

Adolescents’’.

Date: July 18, 2000.

Time: 10 a.m. to 12 p.m.

Agenda: To review and evaluate contract

proposals.

Place: Neuroscience Center, National

Institutes of Health, 6001 Executive Blvd.,

Bethesda, MD 20892 (Telephone Conference

Call).

Contact Person: Eric Zatman, Contract

Review Specialist, Office of Extramural

Affairs, National Institute on Drug Abuse,

National Institutes of Health, DHHS, 6001

Executive Boulevard, Room 3158, MSC 9547,

Bethesda, MD 20892–9547, (301) 435–1438.

Name of Committee: National Institute on

Drug Abuse Special Emphasis Panel

‘‘Clinical Trial Network Administrative

Coordinating Center’’.

Date: July 25–26, 2000.

Time: 9 a.m. to 5 p.m.