29234 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices

requests the hearing, making findings

and conclusions, and denying a hearing.

If a hearing is requested and is justified

by the sponsor’s response to this notice,

the issues will be defined, an

administrative law judge will be

assigned, and a written notice of the

time and place at which the hearing will

begin will be issued.

All submissions under this notice

shall be filed in two copies. Except for

information prohibited from public

disclosure under 21 U.S.C. 331(j) or 18

U.S.C. 1905, the submissions may be

seen in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 512(e) (21 U.S.C. 360b(e))) and

under authority delegated to the

Director, Center For Veterinary

Medicine (21 CFR 5.84).

Dated: May 20, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–14103 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Joint Meeting of the Pulmonary-Allergy

Drugs and Endocrinologic and

Metabolic Drugs Advisory Committees;

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 Committees: Joint meeting of

the Pulmonary-Allergy Drugs and the

Endocrinologic and Metabolic Drugs

Advisory Committees.

General Function of the Committees:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on July 30, 1998, 8 a.m. to 5 p.m.,

and on July 31, 1998, 8 a.m. to 3:45 p.m.

Location: Bethesda Marriott Hotel,

Grand Ballroom, 5151 Pooks Hill Rd.,

Bethesda, MD.

Contact Person: Leander B. Madoo or

Kathleen R. Reedy, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), codes 12545 and

12536. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On July 30, 1998, the

committees will: (1) Discuss the impact

of orally inhaled and intranasal

corticosteroids on growth in children,

(2) hear from invited experts regarding

the process of normal growth and

development in children and how

various factors including corticosteroids

may impact on it, and (3) review

examples from industry of completed

‘‘growth studies’’ testing the various

inhaled and intranasal corticosteroid

drug products. On July 31, 1998, the

agency will: (1) Present the proposed

‘‘class labeling’’ for inhaled and

intranasal corticosteroid drug products,

(2) review the data which support it,

and (3) lead a general scientific

discussion among all meeting

participants to reach a consensus

concerning appropriate labeling for

these products and recommendations

for the design and conduct of future

clinical trials which assess growth.

Procedure: 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 23, 1998. Oral

presentations from the public will be

scheduled between approximately 3

p.m. and 4:30 p.m., on July 30, 1998.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 23, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 20, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–14106 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Healthy Start Initiative—Phase II

Limited Competition for the

Mississippi Delta

AGENCY: Health Resources and Services

Administration (HRSA), HHS.

ACTION: Notice of availability of funds

for a limited competition for the ten

counties of Mississippi known as the

Mississippi Delta.

SUMMARY: The HRSA announces the

availability funds in fiscal year 1998 for

a single cooperative agreement for the

replication of the Healthy Start Initiative

(HSI) Phase II within the ten counties of

Mississippi known as the Mississippi

Delta. The Healthy Start Initiative is a

program of projects which, since FY

1991, has developed and implemented

community-based strategies to reduce

infant mortality in areas with a high

incidence of infant mortality. The

purpose of Healthy Start-Phase II is to

operationalize successful infant

mortality reduction strategies developed

during the demonstration phase and to

launch Healthy Start projects in new

rural and urban communities (i.e.,

communities currently without a

Healthy Start Initiative-funded project).

Within the HRSA, the Healthy Start

Initiative is administered by the

Maternal and Child Health Bureau

(MCHB). This cooperative agreement for

Healthy Start-Phase II in the Mississippi

Delta will be made under the program

authority of Section 301 of the Public

Health Service Act. Funds for this

award were appropriated under Public

Law 104–208.

To continue Healthy Start efforts to

meet critical maternal and child health

needs in the Mississippi Delta, public

and nonprofit private organizations

serving the following counties in the

Mississippi Delta—Humphries, Holmes,

Leflore, Bolivar, Quitman, Sunflower,

Tallahatchie, Washington, Cohoma, and

Tunica—are encouraged to apply.

Applicants must provide services to all

ten counties. Only one applicant

organization will be funded.

The project period is three years,

subject to continuing availability of

funds.

ADDRESSES: Interested parties may

contact the HRSA Grants Application

Center for an application package.

Requests should specify the Healthy

Start Initiative—Phase II limited

competition within the Mississippi

Delta (CFDA #93.926b). The Center may
Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices 29235

be contacted by: telephone: 1–888–300-

HRSA, FAX: 301–309–0579, or e-mail:

HRSA.GAC@x.netcom.com. Completed

applications should be returned to:

Grants Management Officer (CFDA

#93.926b), HRSA Grants Application

Center, 40 West Gude Drive, Suite 100,

Rockville, Maryland 20850.

DATES: The application deadline date is

Thursday, July 1, 1998.

Dated: May 21, 1998.

Claude Earl Fox,

Administrator.

[FR Doc. 98–14091 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Eye 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 following

National Eye Institute Special Emphasis

Panel (SEP) meeting:

Name of SEP: Clinical Research.

Date: May 27, 1998.

Time: 2:00 p.m.

Place: Telephone Conference, Executive

Plaza South, Room 350.

Contact Person: Andrew P. Mariani, Ph.D.,

Executive Plaza South, Room 350, 6120

Executive Blvd., Bethesda, MD 20892–7164,

(301) 496–5561.

Purpose/Agenda: Review of Grant

Applications.

Name of SEP: Clinical Research.

Date: May 29, 1998.

Time: 8:30 a.m.

Place: National Eye Institute, Executive

Plaza South, Room 350, 6120 Executive

Blvd., Bethesda, MD 20892–7164.

Contact Person: Andrew P. Mariani, Ph.D.,

Executive Plaza South, Room 350, 6120

Executive Blvd., Bethesda, MD 20892–7164,

(301) 496–5561.

Purpose/Agenda: Review of Grant

Applications.

These meetings will be closed in

accordance with the provisions set forth in

sections 552b(c)(4) and 552b(c)(6), Title 5,

U.S.C. Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than

fifteen days prior to the meeting due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program No. 93.867, Vision Research:

National Institutes of Health)

Dated: May 21, 1998.

LaVerne Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–14137 Filed 5–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Arthritis and

Musculoskeletal and Skin Diseases;

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 of

Arthritis and Musculoskeletal and Skin

Diseases Special Emphasis Panel Program

Project.

Date: June 22, 1998.

Time: 8:00 am to 7:00 pm.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn Bethesda, 8120

Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: AFTAB A. ANSARI, PHD,

NIAMS, 45 CENTER DRIVE, 5AS 25U.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.846, Arthritis,

Musculoskeletal and Skin Diseases Research,

National Institutes of Health, HHS)

Dated: May 20, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–14135 Filed 5–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Alcohol Abuse

and Alcoholism; 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:

Purpose/Agenda: To review and evaluate a

contract proposal.

Name of Committee: National Institute on

Alcohol Abuse and Alcoholism Special

Emphasis Panel.

Date of Meeting: May 21, 1998 (Telephone

Conference).

Time: 10:00 a.m.

Place of Meeting: Willco Building, Suite

400, 6000 Executive Boulevard, Rockville,

MD.

Contact Person: Sean O’Rourke, 6000

Executive Boulevard, Suite 409, Rockville,

MD 20892–7003, 301–443–2861.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

The meeting will be closed in accordance

with the provisions set forth in Sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material, and personal

information concerning individuals

associated with the applications and/or

proposals, the disclosure of which would

constitute a clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance,

Program Nos. 93.271, Alcohol Research

Career Development Awards for Scientists

and Clinicians; 93.272, Alcohol National

Research Service Awards for Research

Training; 93.273, Alcohol Research Programs;

and 93.891, Alcohol Research Center Grants;

National Institutes of Health)

Dated: May 20, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–14136 Filed 5–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Noncompetitive Antagonists

of Dopamine Reuptake Inhibitors To

Treat Drug Addiction

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i), that the National

Institutes of Health (NIH), Department

of Health and Human Services, is

contemplating the grant of an exclusive

license worldwide to practice the

invention embodied in: PCT

Application Serial No. PCT/US97/

19758, entitled, ‘‘Sustained Release

Derivatives of Hydroxylated Analogs of

Substituted 1-(2-

[Bis(aryl)methoxy]ethyl)-piperazines

and -homopiperazines and Their Use as