19598 Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a cumulative list of

designated orphan drugs and biologics

as of December 31, 1994. FDA has

announced the availability of previous

lists, which are brought up to date

monthly, identifying the drugs and

biologics granted orphan-drug

designation pursuant to the Federal

Food, Drug, and Cosmetic Act (the act).

ADDRESSES: Copies of the list of current

orphan-drug designations and of any

future lists are or will be available from

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and the Office of

Orphan Products Development (HF–35),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–4718.

FOR FURTHER INFORMATION CONTACT:

Peter L. Vaccari, Office of Orphan

Products Development (HF–35), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

4718.

SUPPLEMENTARY INFORMATION: FDA’s

Office of Orphan Products Development

(OPD) reviews and acts on applications

submitted by sponsors seeking orphandrug designation under section 526 of

the act (21 U.S.C. 360bb). In accordance

with this section of the act, which

requires public notification of

designations, FDA maintains a list of

designated orphan drugs and biologics.

This list is made current on a monthly

basis and is available upon request from

OPD (contact identified above). At the

end of each calendar year, the agency

publishes an up-to-date cumulative list

of designated orphan drugs and

biologics, including the names of

designated compounds, the specific

disease or condition for which the

compounds are designated, and the

sponsors’ names and addresses. The

cumulative list of compounds receiving

orphan-drug designation through 1988

was published in the Federal Register of

April 21, 1989 (54 FR 16294). This list

is available on request from FDA’s

Dockets Management Branch (address

above). Those requesting a copy should

specify Docket No. 84N–0102, which is

the docket number for this notice.

The list that is the subject of this

notice consists of designated orphan

drugs and biologics through December

31, 1994, and, therefore, brings the May

9, 1994 (59 FR 23888) publication up to

date.

The orphan-drug designation of a

drug or biologic applies only to the

sponsor who requested the designation.

Each sponsor interested in developing

an orphan drug or biologic must apply

for orphan-drug designation in order to

obtain exclusive marketing rights. Any

request for designation must be received

by FDA before the submission of a

marketing application for the proposed

indication for which designation is

requested. (See 53 FR 47577, November

23, 1988.) Copies of the regulations (see

57 FR 62076, December 29, 1992) for

use in preparing an application for

orphan-drug designation may be

obtained from OPD (address above).

The names used in the cumulative list

for the drug and biological products that

have not been approved or licensed for

marketing may not be the established or

proper names approved by FDA for

those products if they are eventually

approved or licensed for marketing.

Because these products are

investigational, some may not have been

reviewed for purposes of assigning the

most appropriate established proper

name.

Dated: April 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9700 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Notice of Filing of Annual Report of

Federal Advisory Committee

Notice is hereby given that pursuant

to section 13 of Public Law 92–463, the

Annual Report for the following Health

Resources and Service Administration’s

Federal Advisory Committees have been

filed with the Library of Congress:

Departments of Family Medicine Review

Committee

Faculty Development Review Committee

Graduate Training in Family Medicine

Review Committee

Predoctoral Training Review Committee

Residency Training Review Committee

Copies are available to the public for

inspection at the Library of Congress

Newspaper and Current Periodical

Reading Room, Room 1026, Thomas

Jefferson Building, Second Street and

Independence Avenue SE., Washington,

D.C. Copies may be obtained from: Ms.

Sherry Whipple, Executive Secretary,

Room 9A–27, Parklawn Building, 5600

Fishers Lane, Rockville, Maryland

20857, Telephone (301) 443–6874.

Dated: April 14, 1995.

Jackie E. Baum,

Advisory Committee Management Officer,

HRSA.

[FR Doc. 95–9699 Filed 4–18–95; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Institute of Neurological

Disorders and Stroke; Notice of

Meetings

Pursuant to Pub. L. 92–463, notice is

hereby given of meetings of the National

Institute of Neurological Disorders and

Stroke (NINDS).

The National Advisory Neurological

Disorders and Stroke Council and its

subcommittee meetings will be open to

the public as indicated below.

Attendance by the public will be limited

to space available.

The meetings will be closed to the

public as indicated below in accordance

with the provisions set forth in secs.

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

and sec. 10(d) of Pub. L. 92–463, for the

review, discussion and evaluation of

individual grant applications. These

applications and discussions could

reveal confidential trade secrets or

commercial property such as patentable

material, and personal information

concerning individuals associated with

the applications, the disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy.

Summaries of meetings, rosters of

committee members, and other

information pertaining to the meetings

can be obtained from the Executive

Secretary or the Scientific Review

Administrator indicated. Individuals

who plan to attend and need special

assistance, such as sign language

interpretation or other reasonable

accommodations, should contact the

Executive Secretary listed for the

meeting.

Name of Committee: The Planning

Subcommittee of the National Advisory

Neurological Disorders and Stroke Council.

Date: May 31, 1995.

Place: National Institutes of Health,

Building 31, Conference Room 8A28, 9000

Rockville Pike, Bethesda, MD 20892.

Open: 1:30 p.m.–3 p.m.

Agenda: To discuss program planning and

fiscal matters.

Closed: 3 p.m.–recess.

Name of Committee: National Advisory

Neurological Disorders and Stroke Council.

Dates: June 1–2, 1995.

Place: National Institutes of Health,

Building 1, Wilson Hall, 9000 Rockville Pike,

Bethesda, MD 20892.

Open: June 1, 9 a.m.–2 p.m.

Agenda: A report by the Director, NINDS;

a report by the Director, Division of

Extramural Activities, NINDS; and a

presentation by an NINDS grantee.

Closed: June 1, 2 p.m.–recess; June 2, 8:30

a.m.–adjournment.

Executive Secretary: Constance W. Atwell,

Ph.D., Director, Division of Extramural

Activities, NINDS, National Institutes of
Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices 19599

Health, Bethesda, MD 20892, Telephone:

(301) 496–9248.

The following meetings will be totally

closed to review and evaluate grant

applications.

Name of Committee: Neurological

Disorders Program Project Review A

Committee.

Date: June 5–7, 1995.

Time: June 5, 7:30 p.m.–recess; June 6, 8:30

a.m.–recess; June 7, 8:30 a.m.–adjournment.

Place: Hyatt Regency, One Bethesda Metro

Center, Bethesda, MD 20814.

Contact Person: Dr. Katherine Woodbury,

Scientific Review Administrator, National

Institutes of Health, Federal Building, Room

9C14, Bethesda, MD 20892, (301) 496–9223.

Name of Committee: Training Grant and

Career Development Review Committee.

Date: June 15–16, 1995.

Time: June 15, 7:30 p.m.–recess; June 16,

8 a.m.–adjournment.

Place: Hyatt Regency, One Bethesda Metro

Center, Bethesda, MD 20892.

Contact Person: Dr. Alfred Gordon,

Scientific Review Administrator, National

Institutes of Health, Federal Building, Room

9C14, Bethesda, MD 20892, (301) 496–9223.

Name of Committee: Neurological

Disorders Program Project Review B

Committee.

Date: June 26–28, 1995.

Time: June 26, 8 a.m.–recess; June 27, 8

a.m.–recess; June 28, 8 a.m.–adjournment.

Place: Bethesda Ramada Inn, 8400

Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Dr. Paul Sheehy, Scientific

Review Administrator, National Institutes of

Health, Federal Building, Room 9C10,

Bethesda, MD 20892, (301) 496–9223.

(Catalog of Federal Domestic Assistance

Program No. 93.853, Clinical Research

Related to Neurological Disorders; No.

93.854, Biological Basis Research in the

Neurosciences).

Dated: April 11, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–9607 Filed 4–18–95; 8:45 am]

BILLING CODE 4140–01–M

National Institute on Deafness and

Other Communication Disorders;

Notice of a Meeting of the

Epidemiology and Biometry Research

Program Working Group of the

National Deafness and Other

Communication Disorders (NDCD)

Advisory Council

Notice is hereby given of the meeting

of the Epidemiology and Biometry

Research Program Working Group of the

NDCD Advisory Council on April 27,

1995. The meeting will take place from

11 a.m. to 4 p.m. in Conference Room

3C05, Building 31C, National Institutes

of Health , 9000 Rockville Pike,

Bethesda, Maryland 20892.

The meeting, which is open to the

public, will be held to discuss concept

clearance of several scientific projects in

the hearing and other communication

disorders areas. Attendance by the

public is limited to the space available.

Summaries of the meeting and a roster

of members may be obtained from Ms.

Debbie D’Angelo, Program Analyst,

National Institute on Deafness and

Other Communication Disorders,

Executive Plaza South, Room 430, 6120

Executive Blvd., Bethesda, Maryland

20892, 301–402–1843, upon request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. D’Angelo in advance of the

meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.173 Biological Research

Related to Deafness and Communication

Disorders)

Dated: April 12, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–9608 Filed 4–18–95; 8:45 am]

BILLING CODE 4140–01–M

National Cancer Institute; Notice of

Meetings

Pursuant to Pub. L. 92–463, notice is

hereby given of the meetings of the

National Cancer Institute for May and

June 1995.

These meetings will be open to the

public to discuss administrative details

or other issues relating to committee

activities as indicated in the notice and

for the review of concepts being

considered for funding. Attendance by

the public will be limited to space

available.

These meetings will be closed to the

public as indicated below in accordance

with the provisions set forth in secs.

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

and sec. 10(d) of Pub. L. 92–463, for the

review and discussion of previous site

visit reports and evaluation of current

contracts and for the critique and

evaluation of extramural/intramural

programmatic and personnel policies,

including consideration of personnel

qualifications and performance and the

competence of individual investigators.

These contracts and the discussions

could reveal confidential trade secrets

or commercial property such as

patentable material, and personal

information concerning individuals

associated with the programs, projects,

and contracts, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Ms. Carole Frank, the Committee

Management Officer, National Cancer

Institute, Executive Plaza North, Room

630E, 6130 Executive Blvd MSC 7405,

Bethesda, Maryland 20892–7405, (301–

496–5708) will provide a summary of

the meetings and the roster of

committee members, upon request.

Other information pertaining to the

meetings may be obtained from the

contact person indicated below.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

notify the contact person listed for that

particular meeting.

Committee Name: Board of Scientific

Counselors, Division of Cancer Prevention

and Control.

Contact Person: Ms. Linda M. Bremerman,

Executive Secretary, National Cancer

Institute, NIH, Executive Plaza North, Rm

232, 6130 Executive Blvd., Rockville, MD

20892–7094, Telephone: (301) 496–8526.

Date of Meeting: May 4–5, 1995.

Place of Meeting: Building 31, Conference

Room 10, National Institutes of Health, 9000

Rockville Pike, Bethesda, MD 20892.

Open: May 4, 1995 10:45 am to 5 pm May

5, 1995 8:30 am to 11:30 am.

Agenda: Review progress of programs

within the Division and review of concepts

being considered for funding.

Closed: May 5, 1995 11:30 am to

adjournment.

Agenda: Extramural/Intramural

programmatic and personnel policies of a

sensitive nature and consideration of

personnel qualifications and performance

and the competence of individual

investigators.

Committee Name: Cancer Control Science

and Surveillance Subcommittee of the Board

of Scientific Counselors, Division of Cancer

Prevention and Control.

Contact Person: Ms. Linda M. Bremerman,

Executive Secretary, National Cancer

Institute, NIH, Executive Plaza North, Rm

232, 6130 Executive Blvd., Rockville, MD

20892–7994, Telephone: (301) 496–8526.

Date of Meeting: May 4, 1995.

Place of Meeting: Building 31, Conference

Room 8, National Institutes of Health, 9000

Rockville Pike, Bethesda, MD 20892.

Open: 8:30 a.m. to 10:30 a.m.

Agenda: Discuss current and future

programs of the subcommittee and review of

concepts being considered for funding.

Committee Name: Cancer Prevention

Research Subcommittee of the Board of

Scientific Counselors, Division of Cancer

Prevention and Control.

Contact Person: Ms. Linda M. Bremerman,

Executive Secretary, National Cancer

Institute, NIH, Executive Plaza North, Rm

232, 5130 Executive Blvd., Rockville, MD

20892–7094, Telephone: (301) 496–8526.

Date of Meeting: May 4, 1995.

Place of Meeting: Building 31, Conference

Room 10, National Institutes of Health, 9000

Rockville Pike, Bethesda, MD 20892.

Open: 8:30 a.m. to 10:30 a.m.

Agenda: Discuss current and future

programs of the subcommittee and review of

concepts being considered for funding.