Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Notices 18153

tablets, Glaxo-Wellcome, for congestive

heart failure, and control of ventricular

rate in atrial fibrillation. On May 3,

1996, the committee will discuss

product license application 95–1167,

reteplase, Boehringer Mannheim, for

management of acute myocardial

infarction (AMI) in adults, lysis of

thrombi obstructing coronary arteries,

improvement of ventricular function

following AMI, reduction of the

incidence of congestive heart failure,

and reduction of mortality associated

with AMI.

FDA regrets that it was unable to

publish this notice 15 days prior to the

May 2, 1996, Cardiovascular and Renal

Drugs Advisory Committee meeting.

Because the agency feels that the issue

needs to be brought to public discussion

urgently, and qualified members of the

Cardiovascular and Renal Drugs

Advisory Committee were available at

this time, the agency decided that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Arthritis Advisory Committee

Date, time, and place. May 7, 1996, 8

a.m., Holiday Inn—Gaithersburg,

Whetstone and Walker Rooms, Two

Montgomery Village Ave., Gaithersburg,

MD.

Type of meeting and contact person.

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

unless public participation does not last

that long; open committee discussion, 9

a.m. to 5 p.m.; Kathleen R. Reedy,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455,

FAX 301–443–0699, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Arthritis

Advisory Committee, code 12532.

Please call the hotline for information

concerning any possible changes.

General function of committee. The

committee reviews and evaluates data

on the safety and effectiveness of

marketed and investigational human

drugs for use in arthritic conditions.

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 May 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 hear presentations and

discuss data submitted regarding the

safety and efficacy of NDA 20–395,

Enable (tenidap sodium), Pfizer, Inc.,

for use in the treatment of rheumatoid

arthritis and osteoarthritis.

FDA regrets that it was unable to

publish this notice 15 days prior to the

May 7, 1996, Arthritis Advisory

Committee meeting. Because the agency

feels that the issue needs to be brought

to public discussion urgently, and

qualified members of the Arthritis

Advisory Committee were available at

this time, the agency decided that it was

in the public interest to hold this

meeting 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.

Dated: April 18, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–10047 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for
18154 Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Notices

review, call the HRSA Reports

Clearance Office on (301)-443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Health Education Assistance Loan

(HEAL) Program: Lender’s Application

for Insurance Claim on a HEAL Loan

and Request for Collection Assistance

Under the HEAL Program (currently

approved under OMB Nos. 0915–0036

and 0915–0100)—Revision and

Extension—This clearance request is for

extension of approval of two forms that

were previously approved by OMB

under separate OMB numbers (shown

above). HEAL lenders use the Lender’s

Application for Insurance Claim to

request payment from the Federal

Government for federally insured loans

lost due to borrowers’ death, disability,

bankruptcy, or default. The Request for

Collection Assistance form is used by

HEAL lenders to request federal

assistance with the collection of

delinquent payments from HEAL

borrowers. Minor changes were made to

the Lender’s Application for Insurance

Claim, to reduce burden and improve

the utility of the information. No

substantive changes were made to the

Request for Collection Assistance form.

The estimates of burden for the two

forms are as follows:

Type of form No. of respondents

Responses

per respondent

Burden per

response

Total burden hours

Lender’s Application for Insurance Claim (Form 510) ..................................................... 35 22.97 .50 402

Request for Collection Assistance (Form 513) ................................................................ 35 957.74 .17 5,598

Total burden is estimated to be 6,000

hours.

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Virginia Huth, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: April 18, 1996.

J. Henry Montes,

Associate Administrator for Policy

Coordination.

[FR Doc. 96–10018 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meetings

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

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: April 23, 1996.

Time: 1 p.m.

Place: River Inn, 924 25th Street NW.,

Washington, DC 20037.

Contact Person: Phyllis L. Zusman,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857.

Telephone: 301, 443–1340.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: April 23, 1996.

Time: 12 p.m.

Place: River Inn, 924 25th Street NW.,

Washington, DC 20037.

Contact Person: Phyllis L. Zusman,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857.

Telephone: 301, 443–1340.

The meetings will be closed in accordance

with the provisions set forth in secs.

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 meetings due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: April 19, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–10182 Filed 4–20–96; 11:49 am]

BILLING CODE 4140–01–M

National Institute of Allergy and

Infectious 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

National Institute of Allergy and

Infectious Diseases Special Emphasis

Panel (SEP) meeting:

Name of SEP: Master Agreement for HIV

Preclinical Vaccine Development proposals,

tasks G and I.

Date: April 25, 1996.

Time: 8:00 a.m.

Place: Washington National Airport Hilton

Hotel, 2399 Jefferson Davis Highway,

Arlington, VA 22202, (703) 418–6800.

Contact Person: Dr. Allen Stoolmiller,

Scientific Review Adm., 6003 Executive

Boulevard, Solar Bldg., Room 4C05,

Bethesda, MD 20892–7610, (301) 496–7966.

Purpose/Agenda: To evaluate contract

proposals.

The meeting will be closed in accordance

with the provisions set forth in secs. 552(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 15

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

Programs Nos. 93.855, Immunology, Allergic

and Immunologic Diseases Research; 93.856,

Microbiology and Infectious Diseases

Research, National Institutes of Health)

Dated: April 19, 1996.

Sustan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–10183 Filed 4–20–96; 11:49 am]

BILLING CODE 4140–01–M

National Institute of General Medical

Sciences; 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:

Committee Name: National Institute of

General Medical Sciences Special Emphasis

Panel–MBRS.

Date: April 30.

Time: 8:00 a.m.–6 p.m.

Place: Gaithersburg Holiday Inn,

Washington Conference Room, 2

Montgomery Village Avenue, Gaithersburg,

Maryland 20879.

Contact Person: Dr. Richard Martinez,

Scientific Review Administrator, NIGMS, 45

Center Drive, Room 1AS–19g, Bethesda, MD

20892–6200.

Purpose: To review grant applications.

The meeting will be closed in accordance

with the provisions set forth in secs.