13438 Federal Register / Vol. 60, No. 48 / Monday, March 13, 1995 / Notices

Non-Nuclear Ship Repair

GSA does not procure non-nuclear

ship repairs.

Dated: March 2, 1995.

Ida M. Ustad,

Associate Administrator for Acquisition

Policy.

[FR Doc. 95–6113 Filed 3–10–95; 8:45 am]

BILLING CODE 6820–61–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0059]

Drug Export; Abbott HTLV–I/HTLV–II

EIA

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Abbott Laboratories, Inc., has filed

an application requesting approval for

the export of the human biological

product HTLV–I/HTLV–II EIA to

Australia, Austria, Belgium, Denmark,

Federal Republic of Germany, Finland,

France, Iceland, Ireland, Italy,

Luxembourg, The Netherlands, New

Zealand, Norway, Portugal, Sweden,

Switzerland, and The United Kingdom.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human biological products under the

Drug Export Amendments Act of 1986

should also be directed to the contact

person.

FOR FURTHER INFORMATION CONTACT:

Frederick W. Blumenschein, Center for

Biologics Evaluation and Research

(HFM–660), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

1070.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of human biological products

that are not currently approved in the

United States. Section 802(b)(3)(B) of

the act sets forth the requirements that

must be met in an application for

approval. Section 802(b)(3)(C) of the act

requires that the agency review the

application within 30 days of its filing

to determine whether the requirements

of section 802(b)(3)(B) have been

satisfied. Section 802(b)(3)(A) of the act

requires that the agency publish a notice

in the Federal Register within 10 days

of the filing of an application for export

to facilitate public participation in its

review of the application. To meet this

requirement, the agency is providing

notice that Abbott Laboratories, Inc.,

One Abbott Park Rd., Abbott Park, IL

60064, has filed an application

requesting approval for the export of the

human biological product Abbott

HTLV–I/HTLV–II EIA to Australia,

Austria, Belgium, Denmark, Federal

Republic of Germany, Finland, France,

Iceland, Ireland, Italy, Luxembourg, The

Netherlands, New Zealand, Norway,

Portugal, Sweden, Switzerland, and The

United Kingdom. The test is intended as

a screen for donated blood to prevent

transmission of HTLV–I and HTLV–II to

recipients of cellular blood products

and as an aid in the clinical diagnosis

of HTLV–I and HTLV–II related

diseases. The application was received

and filed in the Center for Biologics

Evaluation and Research on January 9,

1995, which shall be considered the

filing date for purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by March 23,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Biologics

Evaluation and Research (21 CFR 5.44).

Dated: February 28, 1995.

James C. Simmons,

Acting Director, Office of Compliance, Center

for Biologics Evaluation and Research.

[FR Doc. 95–6127 Filed 3–10–95; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Blood Products Advisory Committee

Date, time, and place. March 15,

1995, 1:30 p.m., Food and Drug

Administration, Nicholson Lane

Research Center, conference room 244B,

5516–B Nicholson Lane, Kensington,

MD.

Type of meeting and contact person.

This meeting will be held by a

telephone conference call. A speaker

telephone will be provided in the

conference room to allow public

participation in the meeting. Open

committee discussion, March 15, 1995,

1:30 p.m. to 2:35 p.m.; closed committee

deliberations, 2:35 p.m. to 3:35 p.m.;

open public hearing, 3:35 p.m. to 4:35

p.m., unless public participation does

not last that long; Linda A. Smallwood,

Center for Biologics Evaluation and

Research (HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–594–6700, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area), Blood

Products Advisory Committee, code

12388.
Federal Register / Vol. 60, No. 48 / Monday, March 13, 1995 / Notices 13439

General function of the committee.

The committee reviews and evaluates

data on the safety, effectiveness, and

appropriate use of blood products

intended for use in the diagnosis,

prevention, or treatment of human

diseases.

Agenda—Open public hearing.

Interested persons requesting to present

data, information, or views, orally or in

writing, on issues pending before the

committee, should communicate with

the contact person.

Open committee discussion. The

committee will discuss the intramural

scientific program of the Laboratory of

Hepatitis, Division of Transfusion

Transmitted Diseases.

Closed committee deliberations. The

committee will discuss the intramural

scientific program. This portion of the

meeting will be closed to prevent

disclosure of personal information

concerning individuals associated with

the research program, disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy (5 U.S.C. 552b(c)(6)).

FDA regrets that it was unable to

publish this notice 15 days prior to the

meeting held on March 15, 1995, due in

part to scheduling conflicts. FDA is

giving less than 15 days public notice of

this Blood Products Advisory

Committee meeting because the agency

believes that it is in the public interest

to provide committee input into the

FDA process for reviewing intramural

research, even if there is not sufficient

time for the customary 15-day public

notice. FDA does not believe it

appropriate to wait until the next

available regularly scheduled meeting of

the committee on June 22 and 23, 1995.

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.
13440 Federal Register / Vol. 60, No. 48 / Monday, March 13, 1995 / Notices

Dated: March 8, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–6126 Filed 3–8–95; 4:20 pm]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Vaccines and Related Biological

Products Advisory Committee

Date, time, and place. March 17,

1995, 3 p.m., Food and Drug

Administration, Bldg. 29, conference

room 121, 8800 Rockville Pike,

Bethesda, MD.

Type of meeting and contact person.

This meeting will be held by a

telephone conference call. A speaker

telephone will be provided in the

conference room to allow public

participation in the meeting. Open

committee discussion, 3 p.m. to 4:30

p.m.; open public hearing, 4:30 p.m. to

5:30 p.m., unless public participation

does not last that long; Nancy T. Cherry

or Stephanie A. Milwit, Center for

Biologics Evaluation and Research

(HFM–21), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–0314, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Vaccines and Related Biological

Products Advisory Committee, code

12388.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

vaccines intended for use in the

diagnosis, prevention, or treatment of

human diseases.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person.

Open committee discussion. The

committee will discuss the influenza

virus vaccine formulation for 1995–

1996.

FDA regrets that it was unable to

publish this notice 15 days prior to the

March 17, 1995, Vaccines and Related

Biological Products Advisory

Committee meeting because of the need

to update the committee on late

developing influenza activity and to

formulate a vaccine for the 1995–1996

year based on that data while providing

manufacturers sufficient lead time to

develop and produce the vaccine. This

meeting is a followup to the January

1995 advisory committee meeting. The

agency decided that it was in the public

interest to hold this meeting in midMarch even if there was not sufficient

time for the customary 15-day public

notice.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.