67874 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Notices

Agency for Health Care Policy and

Research (AHCPR), the Centers for

Disease Control (CDC), the Food and

Drug Administration (FDA), the Health

Care Financing Administration (HCFA),

the National Institutes of Health (NIH),

and the Office of Public Health and

Science (OPHS), serve on the Board.

This public meeting will have two

purposes:

1. Members of the Orphan Products

Board will discuss their agencies recent

orphan product development activities.

2. In keeping with its mandate to

foster actions within the Department of

Health and Human Services to facilitate

the research, development, and

approval of orphan products and to

coordinate Government activities with

the private sector in order to achieve

these goals, the board encourages

presentations by members of the public

on any issues involving the

development and availability of orphan

products. Those persons wishing to

make a presentation at the meeting

should submit a written request for a

time slot to the Executive Director of the

Orphan Products Board. The request for

participation should be submitted

before February 4, 1998, and should

include: (a) Name, address, and

telephone number of the person desiring

to make a presentation; (b) affiliation, if

any; (c) a summary of the presentation;

and (d) the approximate amount of time

required for the presentation (no more

than 10 minutes, unless more time can

be justified).

Individuals and organizations with

common interests or proposals are urged

to coordinate or consolidate their

presentations. Joint presentations may

be required of persons or organizations

with a common interest. The time

available will be allocated among the

individuals who request an opportunity

for a presentation. Formal written

statements or extensions of remarks

(five copies) should be presented to the

Executive Director on the day of the

meeting for inclusion in the record of

the meeting. At the discretion of the

Chairman, and as time permits, any

person in attendance may be heard. This

time will, most likely, be at the end of

the scheduled session. For those unable

to attend the meeting, comments may be

sent to the listed contact person.

Dated: December 18, 1997.

John M. Eisenberg,

Acting Assistant Secretary for Health.

[FR Doc. 97–33869 Filed 12–29–97; 8:30 am]

BILLING CODE 4160–17–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency For Health Care Policy and

Research

Notice of Health Care Policy and

Research; Special Emphasis Panel

Meeting

In accordance with section 10(a) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2) announcement is

made of the following special emphasis

panel scheduled to meet during the

month of January 1998:

Name: Health Care Policy and Research

Special Emphasis Panel.

Date and Time: January 6–7, 1998, 8:00

a.m.

Place: Doubletree Hotel, 1750 Rockville

Pike, Rockville Room, Rockville, MD 20852.

Open January 6, 8:00 a.m. to 8:30 a.m. Closed

for remainder of meeting.

Purpose: This Panel is charged with

conducting the initial review of grant

applications proposing health services

research training programs under the

National Research Service Awards Program.

Agenda: The open session of the meeting

on January 6, from 8:00 a.m. to 8:30 a.m., will

be devoted to a business meeting covering

administrative matters. During the closed

session, the committee will be reviewing and

discussing grant applications dealing with

health services research issues. In accordance

with the Federal Advisory Committee Act,

section 10(d) of 5 U.S.C., Appendix 2 and 5

U.S.C., 552b(c)(6), the Administrator, Agency

for Health Care Policy and Research, has

made a formal determination that this latter

session will be closed because the

discussions are likely to reveal personal

information concerning individuals

associated with the grant applications. This

information is exempt from mandatory

disclosure.

Anyone wishing to obtain a roster of

members or other relevant information

should contact Sheila Simmons, Agency for

Health Care Policy and Research, Suite 400,

2101 East Jefferson Street, Rockville,

Maryland, 20852, Telephone (301) 594–1452

x 1627.

Agenda items for this meeting are subject

to change as priorities dictate.

Dated: December 22, 1997.

John Eisenberg,

Administrator.

[FR Doc. 97–33870 Filed 12–29–97; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0446]

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 notice in the Federal Register

concerning each proposed collection of

information, including each proposed

reinstatement of an existing collection

of information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

adverse drug experience reporting and

recordkeeping requirements.

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. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen L. 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,

including each proposed reinstatement

of an existing collection of information,

before submitting the collection to OMB
Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Notices 67875

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.

Postmarketing Reporting of Adverse

Drug Experiences—21 CFR 310.305 and

314.80—(OMB Control Number 0910–

0230—Reinstatement)

Sections 201, 502, 505, and 701 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 321, 352, 355, and

371) require that marketed drugs be safe

and effective. In order to know whether

drugs that are not safe and effective are

on the market, FDA must be promptly

informed of adverse experiences

occasioned by the use of marketed

drugs. In order to help ensure this, FDA

issued regulations in §§ 310.305 and

314.80 (21 CFR 310.305 and 314.80) to

impose reporting and recordkeeping

requirements on the drug industry that

would enable FDA to take actions

necessary for protection of the public

health from adverse drug experiences.

All applicants who have received

marketing approval of drug products are

required to report to FDA serious,

unexpected adverse drug experiences,

as well as followup reports when

needed (§ 314.80(c)(1)). This includes

reports of all foreign or domestic

adverse experiences as well as those

obtained in scientific literature and from

postmarketing epidemiological/

surveillance studies. Under

§ 314.80(c)(2) applicants must provide

periodic reports of adverse drug

experiences. Under § 314.80(i)

applicants must keep for 10 years

records of all adverse drug experience

reports known to the applicant.

For marketed prescription drug

products without approved new drug

applications or abbreviated new drug

applications, manufacturers, packers,

and distributors are required to report to

FDA serious, unexpected adverse drug

experiences as well as followup reports

when needed (§ 310.305(c)(1) and

(c)(3)). Under § 310.305(f) each

manufacturer, packer, and distributor

shall maintain for 10 years records of all

adverse drug experiences required to be

reported.

The primary purpose of FDA’s

adverse drug experience reporting

system is to provide a signal for

potentially serious safety problems with

marketed drugs. Although premarket

testing discloses a general safety profile

of a new drug’s comparatively common

adverse effects, the larger and more

diverse patient populations exposed to

the marketed drug provides, for the first

time, the opportunity to collect

information on rare, latent, and longterm effects. Signals are obtained from

a variety of sources, including reports

from patients, treating physicians,

foreign regulatory agencies, and clinical

investigators. Information derived from

the adverse drug experience reporting

system contributes directly to increased

public health protection because the

information enables FDA to make

important changes to the product’s

labeling (such as adding a new warning)

and, when necessary, to initiate removal

of a drug from the market.

Respondents to this collection of

information are manufacturers, packers,

distributors and applicants. FDA

estimates the burden of this collection

of information as follows:

TABLE 1.—Estimated Annual Reporting Burden1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

310.305(c)(5) 1 1 1 1 1

314.80(c)(1)(iii) 5 1 5 1 5

314.80(c)(2) 683 1.5 1,025 5 5,125

Total 5,131

1The reporting burden for §§ 310.305(c)(1)(i), 310.305(c)(3), and 314.80(c)(1)(i) was reported in 0910–0291. There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

310.305(f) 25 1 25 1 25

314.80(i) 683 1 683 1 683

Total 6,547

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