44 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Notices

This will be a one-time survey. The

burden estimate is based on FDA’s

experience with the 1992–1993 survey

mentioned in the previous paragraph.

Dated: March 20, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7604 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97N–0007]

Land O’Lakes, Inc., et al.; Withdrawal

of Approval of NADA’s

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of two new animal drug

applications (NADA’s) held by Land O’

Lakes, Inc., and three NADA’s held by

ADM Animal Health & Nutrition Div.

The sponsors requested voluntary

withdrawal of approval of the NADA’s.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is amending the regulations by

removing those portions which reflect

approval of these NADA’s.

EFFECTIVE DATE: April 4, 1997.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: Land

O’Lakes, Inc., Agricultural Services,

2827 Eighth Avenue South, Fort Dodge,

IA 50501, has requested withdrawal of

approval of NADA 42–489 tylosin Type

A medicated articles and NADA 98–156

tylosin/sulfamethazine Type A

medicated articles.

ADM Animal Health & Nutrition Div.,

P.O. Box 2508, Fort Wayne, IN 46801–

2508, has requested withdrawal of

approval of NADA 118–874 pyrantel

tartrate Type A medicated articles (the

NADA originally held by Henwood

Feed Additives, Inc.), NADA 127–825

hygromycin B Type A medicated

articles and NADA 127–826 tylosin/

sulfamethazine Type A medicated

articles (the NADA’s originally held by

Music City Supplement Co.).

The sponsors requested withdrawal of

approval of the NADA’s.

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.84), and in accordance with 21 CFR

514.115 Withdrawal of approval of

applications (21 CFR 514.115), notice is

given that approval of NADA’s 42–489,

98–156, 118–874, 127–825, and 127–826

and all supplements and amendments

thereto is hereby withdrawn, effective

April 4, 1997.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is amending 21 CFR 510.600, 558.274,

558.485, 558.625, and 558.630 to reflect

withdrawal of approval of these

NADA’s.

Dated: March 13, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–7540 Filed 3–25–97; 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:

Transmissible Spongiform

Encephalopathies Advisory Committee

Date, time, and place. April 23, 1997,

9 a.m., and April 24, 1997, 8 a.m.,

Holiday Inn—Bethesda, Versailles

Ballrooms III and IV, 8120 Wisconsin

Ave., Bethesda, MD.

Type of meeting and contact person.

Open public hearing, April 23, 1997, 9

a.m. to 10 a.m., unless public

participation does not last that long;

open committee discussion, 10 a.m. to

5 p.m.; closed committee deliberations,

5 p.m. to 6 p.m.; open committee

discussion, April 24, 1997, 8 a.m. to 5

p.m.; William Freas or Jane S. Brown,

Center for Biologics Evaluation and

Research (HFM–21), 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),

Transmissible Spongiform

Encephalopathies Advisory Committee,

code 12388. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee reviews and evaluates

available scientific data concerning the

safety of products which may be at risk

for transmission of spongiform

encephalopathies having an impact on

the public health.

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 18, 1997,

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 provide

recommendations on the safety of both

domestic and imported gelatin and

gelatin byproducts with regard to the

risk imposed by bovine spongiform

encephalopathy.

Closed committee deliberations. On

April 23, 1997, the committee will

review trade secret and/or confidential

commercial information relevant to

current and pending products. 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

will depend upon the specific meeting

involved. The dates and times reserved