18152 Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Notices

file required annual reports on these

NDA’s.

EFFECTIVE DATE: May 24, 1996.

FOR FURTHER INFORMATION CONTACT: Lola

E. Batson, Center for Drug Evaluation

and Research (HFD–7), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1038.

SUPPLEMENTARY INFORMATION: The

holders of approved applications to

market new drugs or antibiotic drugs for

human use are required to submit

annual reports to FDA concerning each

of their approved applications in

accordance with § 314.81 (21 CFR

314.81).

In the Federal Register of July 13,

1990 (55 FR 28829), FDA offered an

opportunity for a hearing on a proposal

to withdraw approval of five NDA’s

because the firms had failed to submit

the required annual reports for these

NDA’s.

The agency had two responses to the

notice of opportunity for hearing: From

Astra Pharmaceutical Products, Inc.;

and from The Purdue Frederick Co.

Both responses indicated that the

sponsors had previously submitted

letters requesting voluntary withdrawal

of their NDA’s (NDA 13–077 and NDA

11–160, respectively). In the Federal

Register of March 27, 1996 (61 FR 13506

at 13507), FDA published a notice that

withdrew these applications.

The other three firms did not respond

to the notice of opportunity for hearing.

Failure to file a written notice of

participation and request for a hearing

as required by 21 CFR 314.200

constitutes an election by the applicant

not to make use of the opportunity for

a hearing concerning the proposal to

withdraw approval of the applications

and a waiver of any contentions

concerning the legal status of the drug

products. Therefore, the Director, Center

for Drug Evaluation and Research, is

withdrawing approval of the NDA’s

listed in the table in this document.

Application no. Drug Applicant

NDA 9–394 ............................................... Kasdenol Mouthwash or Gargle ........................... The Kasdenol Corp., Huntington, NY 11743.

NDA 10–094 ............................................. Pepsodent Antiseptic Mouthwash ......................... Lever Brothers Co., Inc., 390 Park Ave., New

York, NY 10022.

NDA 13–397 ............................................. Ampar SRC ........................................................... United Pharmaceutical Inc., 1500 North Wilmut,

Tucson, AZ 85712.

The Director, Center for Drug

Evaluation and Research, under section

505(e) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355(e)), and

under authority of 21 CFR 5.82, finds

that the holders of the applications

listed above have repeatedly failed to

submit reports required by § 314.81.

Therefore, pursuant to this finding,

approval of the NDA’s listed above, and

all amendments and supplements

thereto, is hereby withdrawn, effective

May 24, 1996.

Dated: April 9, 1996.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 96–10022 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

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:

Cardiovascular and Renal Drugs

Advisory Committee

Date, time, and place. May 2, 1996,

8:30 a.m., and May 3, 1996, 9 a.m.,

National Institutes of Health, Clinical

Center, Bldg. 10, Jack Masur

Auditorium, 9000 Rockville Pike,

Bethesda, MD. Parking in the Clinical

Center Visitor area is reserved for

clinical center patients and their

visitors. If you must drive, please use an

outlying lot such as Lot 41B. Free

shuttle bus service is provided from Lot

41B to the Clinical Center every 8

minutes during rush hour and every 15

minutes at other times.

Type of meeting and contact person.

Open public hearing, May 2, 1996, 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

5:30 p.m.; open committee discussion,

May 3, 1996, 9 a.m. to 4:30 p.m.; Joan

C. Standaert, Center for Drug Evaluation

and Research (HFD–110), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 419–259–

6211; or Valerie M. Mealy, Advisors and

Consultants Staff (HFD–21), 301–443–

4695, or FDA Advisory Committee

Information Hotline, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), Cardiovascular and Renal Drugs

Advisory Committee, code 12533.

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 human

drugs for use in cardiovascular and

renal disorders.

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 April 19, 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 May

2, 1996, the committee will discuss: (1)

New drug application (NDA) 20–297,

Supplement 1, Coreg (carvedilol),

SmithKline Beecham, to be indicated for

use in congestive heart failure; and (2)

NDA 20–405, Lanoxin (digoxin)
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