Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Notices 67877

employ computer-aided telephone

interviewing technology to expedite the

fieldwork and improve accuracy. FDA

plans to use the results of the survey to

assess the effectiveness of the

advertising campaign. Under 21 U.S.C.

393 (b)(2)(C), FDA is authorized to

conduct surveys and other research

relating to its responsibilities under the

Federal, Food, Drug, and Cosmetic Act.

Respondents to this collection of

information would be tobacco retailers

and salesclerks.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

897 6,000 1 6,000 .2 1,200

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–33925 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0509]

Hoffmann-La Roche, Inc.; Withdrawal

of Approval of NADA

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of a new animal drug

application (NADA) held by HoffmannLa Roche, Inc. The NADA provides for

use of chlortetracycline Type A

medicated article to make Type B or

Type C medicated feeds. The sponsor

requested the withdrawal of approval

because the animal drug product is no

longer manufactured or marketed.

EFFECTIVE DATE: January 9, 1998.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0212.

SUPPLEMENTARY INFORMATION: HoffmannLa Roche, Inc., 340 Kingsland St.,

Nutley, NJ 07110–1199, is the sponsor

of NADA 100–903 that provides for use

of chlortetracycline Type A medicated

articles to make Tpye B or Type C

medicated feeds. The animal drug

product had been subject to review

under the National Academy of

Sciences/National Research Council,

Drug Efficacy Study Implementation

Program, and it was currently subject to

requirements for finalization under that

program. By letter of August 20, 1997,

the sponsor requested withdrawal of

approval of the NADA because the

animal drug product is no longer

manufactured or marketed.

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

5.48), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADA 100–903 and all

supplements and amendments thereto is

hereby withdrawn, effective January 9,

1998.

This product had not been the subject

of a regulation published under section

512 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360b).

Therefore, an amendment to the animal

drug regulations to reflect the

withdrawal of approval is not required.

Dated: December 19, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33922 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Developing U.S. Public Health Service

Policy on Xenotransplantation; Public

Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Developing U.S.

Public Health Service Policy on

Xenotransplantation. The topic to be

discussed is the current and evolving

U.S. Public Health Service (U.S. PHS)

policy on xenotransplantation.

Xenotransplantation refers to any

procedure that involves the use of live

cells, tissues, and organs from a

nonhuman animal source, transplanted

or implanted into a human or used for

ex vivo perfusion. The meeting is being

sponsored by U.S. PHS agencies

including FDA, National Institutes of

Health, Centers for Disease Control and

Prevention, and the Health Resources

and Services Administration.

Date and Time: The public workshop

will be held on January 21 and 22, 1998,

8 a.m. to 5 p.m.

Location: The public workshop will

be held at the Natcher Auditorium,

National Institutes of Health, 9000

Rockville Pike, Bldg. 45, Bethesda, MD.

Contact: Timothy W. Beth, Center for

Biologics Evaluation and Research

(HFM–17), Food and Drug

Administration, 1401 Rockville Pike,

suite 200N, Rockville, MD 20852, 301–

827–6333, FAX 301–443–3874, or email Beth@a1.cber.fda.gov.

SUPPLEMENTARY INFORMATION: The goals

of the meeting include the following: (1)

Describing the scope of current clinical

trials in xenotransplantation; (2)

exploring the potential public health

benefits and risks of

xenotransplantation; (3) presenting

frameworks for the evaluation of ethical

issues presented by

xenotransplantation; (4) describing

current and evolving PHS policy on

xenotransplantation and the

development of specific public health

mechanisms to implement policy; such

mechanisms may include, but are not

limited to: (a) a revised U.S. PHS

guideline on infectious disease issues in

xenotransplantation; (b) the evolving

regulatory framework for oversight of

xenotransplantation; (c) the pilot

xenotransplantation registry database;

(d) the strategies for archiving biologic

specimens for public health

investigations; (e) the methods for

ensuring public awareness of current

issues and discussion of new

developments in xenotransplantation;

and (5) presenting international

perspectives on xenotransplantation

policy development. The meeting is

open to all interested persons.

Registration: There is no fee to attend

this meeting. To register for the meeting

please contact Cody Bridges, Chris