Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices 35237

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit. Should human subjects

reviews be required, the proposed word

play should incorporate timelines for

such development and review activities.

Women, Racial, and Ethnic Minorities

Policy

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDCsupported research projects involving

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian or

Alaskan Native, Asian, Black or African

American, Native Hawaiian or Other

Pacific Islander, and Hispanic or Latino.

Applicants shall ensure that women and

racial and ethnic minority populations

are appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is not feasible, this situation must be

explained as part of the application. In

conducting the review of applications

for scientific merit, review groups will

evaluate proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity and/

or sex of subjects. Further guidance to

this policy is contained in the Federal

Register, Vol. 60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Confidentiality

Any personal identifying information

obtained in connection with the

delivery of services provided to any

individual under any program that is

being carried out with a cooperative

agreement made under this Program

Announcement shall not be disclosed

unless required by a law of a State or

political subdivision or unless such an

individual provides written, voluntary

informed consent.

Application Submission and Deadline

The application must be carefully

completed, following the directions

provided in this Program

Announcement. An original and two

copies of the application PHS Form

5161–1 (Revised 5/96) must be

submitted to Sharron P. Orum, Grants

Management Officer, Procurement and

Grants Office, Centers for Disease

Control and Prevention, (CDC), 255 East

Paces Ferry Road, NE., Mailstop E–18,

Atlanta, GA 30305–2209, on or before

August 14, 1998.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.a. and

1.b. above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where To Obtain Additional

Information

A complete program description and

information on application procedures

are contained in the application

package. Business management

technical assistance may be obtained

from Locke Thompson, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–18, Atlanta, GA 30305–

2209, telephone (404) 842–6595; fax

(404) 842–6513; or Internet or CDC

WONDER E-mail at <lxt1@.cdc.gov>.

Programmatic technical assistance may

be obtained from Bernice A. Moore,

Epidemiology and Statistics Branch,

Division of Diabetes Translation,

National Center for Chronic Disease

Prevention and Health Promotion,

Centers for Disease Control and

Prevention (CDC), Mailstop K–10, 4770

Buford Highway NE., Atlanta, GA

30341–3701, telephone (770) 488–5855;

fax (770) 488–5966; or Internet or CDC

WONDER E-mail at <bamo@cdc.gov>.

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest.

Please refer to Announcement

Number 98086 when requesting

information and submitting an

application.

You may obtain this and other CDC

Announcements from one of two

Internet sites on the actual publication

date: CDC’s homepage at http://

www.cdc.gov or at the Government

Printing Office homepage (including

free on-line access to the Federal

Register at http://www.access.gpo.gov.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325; telephone

202–512–1800.

Dated: June 22, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–17202 Filed 6–26–98; 8:45 am]

BILLING CODE 4163–18–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

The National Center for Infectious

Diseases (NCID), Hepatitis Branch of

the Centers for Disease Control and

Prevention (CDC) Announces the

Following Meeting

Name: Consultants Meeting on the

Prevention and Control of Hepatitis C Virus

(HCV) Infection.

Times and Dates: 6 p.m.–9:30 p.m., July

15, 1998. 8 a.m.-5 p.m., July 16, 1998. 8 a.m.–

12 p.m., July 17, 1998.

Place: Atlanta Marriott Marquis Hotel, 265

Peachtree Center Avenue, Atlanta, Georgia

30303.

Status: Open to the public, limited only by

the space available. Registration is required.

Purpose: The purpose of this working

meeting is to review and discuss draft

recommendations that will serve as a

resource to individuals and organizations

involved in evaluating persons for HCV

infection, and are based on currently

available knowledge.

Matters To Be Discussed: Participants will

discuss recommendations for identifying

persons at risk for HCV infection and the

appropriate counseling and testing of these

persons. Participants will also discuss

recommendations to guide appropriate

medical referral of HCV infected persons.

The agenda will include an overview of HCV

public health strategies; and sessions on (a)

screening; (b) counseling and referral; and (c)

implementation.

The participants will include

representatives from public, private,

voluntary and non-governmental

organizations.

Agenda items are subject to change as

priorities dictate.

Written comments are welcome and should

be received by the contact person listed

below prior to the opening of the meeting.
35238 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices

Contact Person for More Information:

Wesley Hodgson, Hepatitis Branch, NCID,

CDC, M/S G–37, 1600 Clifton Road, NE,

Atlanta, Georgia 30333, telephone 404/639–

3048, fax 404/639–1538, e-mail

wxh9@cdc.gov.

Dated: June 23, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–17203 Filed 6–26–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Antiviral Drugs Advisory Committee;

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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Antiviral Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 14 and 15, 1998, from 8:30

a.m. to 5 p.m.

Location: Bethesda Holiday Inn,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Rhonda W. Stover, or

John B. Schupp, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–7001, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12531.

Please call the Information Line for upto-date information on this meeting.

Agenda: On July 14, 1998, the

committee will hear presentations

concerning general regulatory issues

from the Division of Antiviral Drug

Products.

Procedure: On July 14, 1998, from

8:30 a.m. to 1 p.m. the meeting is open

to the public. Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 6, 1998. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. on July 14, 1998. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 6, 1998, 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.

Closed Committee Deliberations: On

July 14, 1998, from 1 p.m to 5 p.m., and

on July 15 from 8:30 a.m. to 5 p.m., the

meeting will be closed to permit

discussion and review of trade secret

and/or confidential commercial

information (5 U.S.C. 552b(c)(4)). The

meeting will discuss information

relevant to pending investigational new

drug applications and drug

development plans.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C., app. 2).

Dated: June 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17212 Filed 6-26-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

Advisory Committee; 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Biological

Response Modifiers Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 30, 1998, 8 a.m. to 6 p.m.

Location: Bethesda Holiday Inn,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Gail M. Dapolito or

Rosanna L. Harvey, Center for Biologics

Evaluation and Research (HFM–211),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12389.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss:

(1) Biologics license application 97–

0509, Amgen Inc.’s Stemgen

(ancestim); (2) the report from the

December 17, 1997, meeting of the

Xenotransplantation Subcommittee; and

(3) the research programs in the

Laboratory of Immunology and the

Laboratory of Molecular Immunology,

Office of Therapeutics Research and

Review, Center for Biologics Evaluation

and Research. An indication is sought,

in combination with Neupogen

(filgrastim), for use in mobilization of

peripheral blood progenitor cells.

Procedure: On July 30, 1998, from 8

a.m. to 5 p.m., the meeting is open to

the public. Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 20, 1998. Oral

presentations from the public will be

scheduled between approximately 8

a.m. and 9 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 20, 1998, 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.

Closed Committee Deliberations. On

July 30, 1998, from 5 p.m. to 6 p.m., the

meeting will be closed to permit

discussion where disclosure would

constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). The committee will discuss

confidential information relevant to the

scientific site visit report of the

Laboratory of Immunology and the

Laboratory of Molecular Immunology,

Office of Therapeutics Research and

Review, Center for Biologics Evaluation

and Research.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 18, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17146 Filed 6-26-98; 8:45 am]

BILLING CODE 4160–01–F