67876 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Notices

These estimates are based on FDA’s

knowledge of adverse drug experience

reporting, including knowledge about

the time needed to prepare the reports

and the number of reports submitted to

the agency.

Dated: December 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33797 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–0529]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish a notice in the Federal Register

concerning each proposed collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a three-part telephone survey of tobacco

retailers, to assess the effectiveness of an

advertising campaign aimed at

increasing retailers’ awareness of, and

motivating retailers to comply with,

new regulations that prohibit retailers

from selling cigarettes and smokeless

tobacco to persons younger than 18

years of age, and require retailers to

verify, by means of photographic

identification containing the bearer’s

date of birth, the age of every purchaser

who is younger than 27 years old.

DATES: Submit written comments on the

collection of information by March 2,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Requests and two

copies of any comment are to be

submitted except that individuals may

submit one copy comments should be

identified with the docket number

found in brackets in the heading of this

document. Received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

National Tobacco Retailer Tracking

Survey

On February 28, 1997, new Federal

regulations in 21 CFR part 897 went into

effect that prohibit retailers from selling

cigarettes and smokeless tobacco to

persons younger than 18 years of age,

and require retailers to verify, by means

of photographic identification, the age

of purchaser younger than 27 years old.

To enforce these requirements, FDA is

commissioning State officials to conduct

compliance checks during which an

adolescent, accompanied by a

commissioned official, will attempt to

purchase cigarettes and smokeless

tobacco at retail establishments.

FDA is planning to conduct a national

advertising campaign aimed at raising

retailers’ awareness of the new

regulations and motivating retailers to

comply. The campaign will target

persons who sell cigarettes or smokeless

tobacco to consumers for their personal

use, including clerks and cashiers in

grocery and convenience stores,

pharmacies and drug stores, gas

stations, liquor stores, taverns and bars,

and tobacco stores. As a part of the

campaign, FDA is proposing to conduct

a three-part telephone survey of tobacco

retailers to measure their awareness of,

and compliance with, the new

regulations before and after exposure to

the advertising campaign.

The initial overall media campaign

would focus on the 10 States with

which FDA has already contracted to

conduct compliance checks, and would

be expanded as additional States

contract with FDA. The media campaign

would be conducted over a 12-month

period in each State that receives it.

States that have contracted with FDA

and are exposed to the media campaign

(test States) will be compared with

States that have not contracted with

FDA (control States). Although some of

the control States may contract with

FDA during the course of the data

collection, at the start of the data

collection there would be 10 test States

and 10 control States.

A total of 6,000 tobacco retailers

would be randomly selected to

participate in a telephone interview

over three phases of data collection.

Data would be collected in three phases

over a 12-month period. The first phase

would occur immediately before the 10

test States that have contracted with

FDA are exposed to the media

campaign. The second phase would

occur approximately 6 months later and

would allow for an assessment of

retailer awareness of and compliance

with the new regulations after recent

exposure to the advertising campaign in

the original 10 test States. A third phase

of data collection would be conducted

approximately 6 months after the

second phase. This phase would

address retailer awareness of and

compliance with the new regulations

after extended exposure to the media

campaign in the original 10 test States,

and would address retailer awareness of

and compliance with the new

regulations after recent exposure to the

advertising campaign in those former

control States that contracted with FDA

after the first phase of data collection.

All interviewing would be conducted by

a single-market research firm that would
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