Federal Register / Vol. 61, No. 123 / Tuesday, June 25, 1996 / Notices 32829

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: June 19, 1996.

Larry Guerrero,

Director, Office of Information Management

Services.

[FR Doc. 96–16070 Filed 6–24–96; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings 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.

MEETINGS: The following advisory

committee meetings are announced:

Vaccines and Related Biological

Products Advisory Committee

Date, time, and place. July 10 and 11,

l996, 8 a.m., Holiday Inn—Bethesda,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Type of meeting and contact person.

Closed committee deliberations, July 10,

l996, 8 a.m. to 10 a.m., open committee

discussion, 10 a.m. to 3:45 p.m.; open

public hearing, 3:45 p.m. to 4:30 p.m.,

unless public participation does not last

that long; closed committee

deliberations, July 11, 1996, 8 a.m. to

8:45 a.m.; open committee discussion,

8:45 a.m. to 12 m.; open public hearing,

12 m. to 12:30 p.m., unless public

participation does not last that long;

open committee discussion, 12:30 p.m.

to 2 p.m.; closed committee

deliberations, 2 p.m. to 3:30 p.m.; Nancy

T. Cherry or Sandy M. Salins, 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. Please call the hotline for

information concerning any possible

changes.

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 before July 3, 1996, 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

required to make their comments.

Open committee discussion. On July

10, 1996, the committee will review

safety and efficacy data pertaining to a

diphtheria/tetanus/acellular pertussis

vaccine manufactured by SmithKline

Beecham. On July 11, 1996, the

committee will review safety and

comparative immunogenicity data

pertaining to a liquid version of an

Haemophilus b conjugate vaccine

manufactured by Merck & Co. The

committee will also hear a briefing on

proposed changes in the polio vaccine

recommendations, and a briefing on a

research program in the Division of

Viral Products.

Closed committee deliberations. On

July 10 and 11, l996, the committee will

review trade secret and/or confidential

commercial information relevant to

pending product licensing applications

or amendments. These portions of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)). On July 11, l996, the

committee will also review data of a

personal nature where disclosure would

constitute a clearly unwarranted

invasion of personal privacy. This

portion of the meeting will be closed to

permit discussion of this information (5

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

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee

Date, time, and place. July 15, 1996,

7:30 a.m., Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD. A limited number of

overnight accommodations have been

reserved at the Courtyard by Marriott,

2500 Research Blvd., Rockville, MD.

Attendees requiring overnight

accommodations may contact the hotel

at 301–670–6700, and reference the FDA

Panel meeting block. Reservations will

be confirmed at the group rate based on

availability. Attendees with a disability

requiring special accommodations

should contact Shirley Meeks,

Conference Management, 301–594–

1283, ext. 113. The availability of

appropriate accommodations cannot be

assured unless prior notification is

received.

Type of meeting and contact person.

Closed committee deliberations, 7:30

a.m. to 8:30 a.m.; open public hearing,

8:30 a.m. to 9:30 a.m., unless public

participation does not last that long;

open committee discussion, 9:30 a.m. to

3:30 p.m.; Ramiah Subramanian, Center

for Devices and Radiological Health

(HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–443–8320, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Circulatory System Devices Panel, code

12625. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

Agenda—Open public hearing.

Interested persons may present data,
32830 Federal Register / Vol. 61, No. 123 / Tuesday, June 25, 1996 / Notices

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before July 1, 1996, 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

required to make their comments.

Open committee discussion. The

committee will discuss and vote on a

premarket approval application (PMA)

for a pacemaker lead. The committee

will also discuss issues related to the

draft guidance for Automatic

Implantable Pacer Cardioverter

Defibrillator (AIPCD) submissions,

primarily focusing on new suggested

labeling changes. Single copies of the

draft guidance document are available

from the Division of Small

Manufacturers Assistance, Center for

Devices and Radiological Health (HFZ–

220), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 1–800–638–2041 or 301–443–

6597.

Closed committee deliberations. FDA

staff will present to the committee trade

secret and/or confidential commercial

information relevant to investigational

device exemption applications and

PMA’s for cardiovascular system

devices. This portion of the meeting will

be closed to permit discussion of this

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

Gastroenterology and Urology Devices

Panel of the Medical Devices Advisory

Committee

Date, time, and place. July 25, 1996,

8:30 a.m., Gaithersburg Hilton,

Ballroom, 620 Perry Pkwy.,

Gaithersburg, MD. A limited number of

overnight accommodations have been

reserved at the hotel. Attendees

requiring overnight accommodations

may contact the hotel at 301–977–8900

and reference the FDA Panel meeting

block. Reservations will be confirmed at

the group rate based on availability.

Attendees with a disability requiring

special accommodations should contact

Shirley Meeks, Conference

Management, 301–594–1283, ext. 113.

The availability of appropriate

accommodations cannot be assured

unless prior notification is received.

Type of meeting and contact person.

Open public hearing, 8:30 a.m. to 9:30

a.m., unless public participation does

not last that long; open committee

discussion, 9:30 a.m. to 4 p.m.; closed

committee deliberations, 4 p.m. to 5

p.m.; Mary J. Cornelius, Center for

Devices and Radiological Health (HFZ–

470), Food and Drug Administration,

9200 Corporate Blvd. Rockville, MD

20850, 301–594–2194, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Gastroenterology

and Urology Devices Panel, code 12523.

Please call the hotline for information

concerning any possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

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 before July 16, 1996, 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

required to make their comments.

Open committee discussion. The

committee will discuss general issues

related to a premarket approval

application for a device intended to

manage female urinary incontinence.

Closed committee deliberations. FDA

staff will present to the committee trade

secret and/or confidential commercial

information regarding medical devices.

This portion of the meeting will be

closed to permit discussion of this

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

Ophthalmic Devices Panel of the

Medical Devices Advisory Committee

Date, time, and place. July 26, 1996,

8:30 a.m., Gaithersburg Hilton,

Ballroom, 620 Perry Pkwy.,

Gaithersburg, MD. A limited number of

overnight accommodations have been

reserved at the hotel. Attendees

requiring overnight accommodations

may contact the hotel at 301–977–8900

and reference the FDA Panel meeting

block. Reservations will be confirmed at

the group rate based on availability.

Attendees with a disability requiring

special accommodations should contact

Joanne Choy, Conference Management,

301–594–1283, ext. 105. The availability

of appropriate accommodations cannot

be assured unless prior notification is

received.

Type of meeting and contact person.

Closed presentation of data, 8:30 a.m. to

9 a.m.; open committee discussion (first

session), 9 a.m. to 10:30 a.m.; open

public hearing, 10:30 a.m. to 11:30 a.m.,

unless public participation does not last

that long; open committee discussion

(second session), 11:30 a.m. to 5 p.m.;

Sara M. Thornton, Center for Devices

and Radiological Health (HFZ–460),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2053, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Ophthalmic

Devices Panel, code 12396. Please call

the hotline for information concerning

any possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

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 before July 12, 1996, 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

required to make their comments.

Open committee discussion. First

Session—The Vitreoretinal and

Extraocular Devices Branch will present

a summary report of public comments

received on the proposed rule that

published in the Federal Register of

April 1, 1996 (61 FR 14277), for

reclassification of contact lens care

products. The committee will review

and recommend the classification status

for currently unclassified devices which

may include corneal storage media and

external eyelid weights. Second

Session—FDA staff will present to the

committee the regulatory status of lasers

for the correction of refractive error

currently in use in the United States and

FDA’s policies and regulations

regarding those lasers.

Closed presentation of data. FDA staff

will present to the committee trade

secret and/or confidential commercial

information relevant to investigational

device exemption applications and

premarket approval applications. This

portion of the meeting will be closed to

permit discussion of this information (5

U.S.C. 552b(c)(4)).

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
Federal Register / Vol. 61, No. 123 / Tuesday, June 25, 1996 / Notices 32831

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, 5600 Fishers Lane, rm.

12A–16, 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,

12420 Parklawn Dr., rm. 1–23,

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 (a)(2) of the Federal

Advisory Committee Act (5 U.S.C. app.

2), and FDA’s regulations (21 CFR part

14) on advisory committees.

Dated: June 19, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–16174 Filed 6–24–96; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Project Grants for Renovation or

Construction of Non-Acute Health Care

Facilities

AGENCY: Health Resources and Services

Administration.

ACTION: Correction.

SUMMARY: The Notice of Availability of

Funds, Project Grants for Renovation or

Construction of Non-Acute Health Care

Facilities, which was published on June

13, 1996, at 61 FR 30077, is corrected

to include the following areas in Puerto

Rico that were not on the original list:

Appendix I—Metropolitan Areas

Puerto Rico (part):

Loiza Municipio

Luquillo Municipio

Manati Municipio

Mayaguez Municipio

Moca Municipio

Naranjito Municipio

Ponce Municipio

Quebradillas Municipio

Rio Grande Municipio

San German Municipio

San Juan Municipio

San Lorenzo Municipio

Toa Alta Municipio

Toa Baja Municipio

Trujillo Alto Municipio

Vega Alta Municipio

Vega Baja Municipio

Dated: June 20, 1996.

Ciro V. Sumaya,

Administrator.

[FR Doc. 96–16183 Filed 6–24–96; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as