55408 Federal Register / Vol. 62, No. 206 / Friday, October 24, 1997 / Notices

training, personal protective equipment

and other activities used to limit

workers’ exposure.

3. Identification of industries or

occupations where intermittent or low

concentrations of inorganic lead may

occur.

4. Descriptions of work practices and

engineering controls used to reduce

workplace exposure.

5. Case reports or other health data

that demonstrate adverse health effects

in workers exposed to inorganic lead at

or below the OSHA PEL and any

information pertinent to evaluating the

feasibility of establishing a more

protective exposure limit. Case reports

and health data should be submitted

without personal identifiers.

6. Information regarding methods for

BLL determination that could be used

routinely in the workplace (e.g.,

determination of BLLs using portable

equipment). NIOSH is evaluating

whether the routine biological

monitoring of inorganic lead exposed

workers (through BLLs) may be a more

appropriate measure than airborne

concentrations for estimating the

potential for developing adverse health

effects.

This information will be used by

NIOSH to determine the need for

developing new recommendations for

lowering the occupational exposure to

inorganic lead and improving strategies

for monitoring inorganic lead exposure.

All information received in response

to this notice will be available for public

examination and copying at the NIOSH

Docket Office, 4676 Columbia Parkway,

Cincinnati, Ohio 45226.

References

43 FR 52952, November 14, 1978. Chapter

XVII—Occupational Safety and Health

Administration, Department of Labor; Part

1910—Occupational safety and health

standards: occupational exposure to lead.

58 FR 26590, May 4, 1993. Occupational

Safety and Health Administration: lead

exposure in construction; interim final rule.

(To be codified at 29 CFR 1926.)

NIOSH [1978]. Criteria for a recommended

standard * * * occupational exposure to

inorganic lead, revised criteria. Rockville,

MD: U.S. Department of Health, Education,

and Welfare, Public Health Service, Center

for Disease Control, National Institute for

Occupational Safety and Health, DHEW

(NIOSH) Publication No. 78–158.

Dated: October 20, 1997.

Linda Rosenstock,

Director, National Institute for Occupational

Safety and Health (NIOSH), Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97–28219 Filed 10–23–97; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0424]

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 a

proposed revision of the form for the

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 and

to allow 60 days for public comment in

response to the notice. This notice

solicits comments on a revised,

harmonized transmittal form,

‘‘Transmittal of Advertisements and

Promotional Labeling for Drugs and

Biologics for Human Use’’ (Form FDA

2253). This revised and harmonized

form will be used for the submission of

advertisements and promotional

labeling for prescription drugs,

antibiotics, and biological products that

are regulated by the Center for Drug

Evaluation and Research (CDER) and the

Center for Biologics Evaluation and

Research (CBER).

DATES: Submit written comments on the

collection of information by December

23, 1997.

ADDRESSES:

CDER Information: Submit written

requests for single copies of the

revised, harmonized transmittal

form, Form FDA 2253, to the Drug

Information Branch (HFD–210),

Division of Communications

Management, Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

594–1012. Send one self-addressed

adhesive label to assist that office in

processing your requests. The form

may also be obtained by calling the

CDER Fax–on–Demand System at

1–800–342–2722 or 1–301–827–

0577.

CBER Information: Submit written

requests for single copies of the

revised, harmonized transmittal

form, Form FDA 2253, to the Office

of Communications, Training, and

Manufacturers Assistance (HFM–

40), Center for Biologics Evaluation

and Research, Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448.

Send one self-addressed adhesive

label to assist that office in

processing your requests. The form

may also be obtained by calling the

CBER Voice Information System at

1–800–835–4709.

Submit written comments on the

revised, harmonized transmittal form,

Form FDA 2253, and its proposed use

in collection of information, to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted except

that individuals may submit one copy.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the revised,

harmonized transmittal form, Form FDA

2253, and received comments are

available for public examination in the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

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;
Federal Register / Vol. 62, No. 206 / Friday, October 24, 1997 / Notices 55409

(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.

Transmittal of Advertisements and

Promotional Labeling for Drugs and

Biologics for Human Use (Form FDA

2253)

Under § 314.81(b)(3)(i) (21 CFR

314.81(b)(3)(i)), sponsors of approved

applications for marketed prescription

drugs and antibiotic drugs for human

use are required to submit specimens of

promotional labeling and

advertisements at the time of initial

dissemination of the labeling and at the

time of initial publication of the

advertisement. Each submission is

required to be accompanied by a

completed transmittal Form FDA 2253

(Transmittal of Advertisements and

Promotional Labeling for Drugs for

Human Use). Statutory authority for the

collection of this information is

provided by sections 505(a), (b), (j), and

(k), 507(g), and 701(a) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(a), (b), (j), and (k), 357(g), and

371(a)).

Similarly, under § 601.12(f)(4) (21

CFR 601.12(f)(4)) (62 FR 39890, July 24,

1997; effective October 7, 1997),

manufacturers of licensed biological

products are required to submit

specimens of advertising and

promotional labeling to FDA in

accordance with § 314.81(b)(3)(i).

Statutory authority for the collection of

this information is provided by section

351 of the Public Health Service Act (42

U.S.C. 262), which gives FDA the

responsibility to prescribe standards

designed to ensure the safety, purity,

potency, and effectiveness of biological

products. In furtherance of this

responsibility, FDA regulates

advertising and labeling for biological

products. Currently, specimens of

advertising and promotional labeling are

submitted to FDA with Form FDA 2567,

a two-part transmittal form that is also

used to transmit other forms of labeling

(e.g., circulars, package labels, and

container labels) for FDA review when

a firm is requesting premarket approval

of a product or proposing changes to

product carton or container labeling.

FDA is revising Form FDA 2253 to

enable it to be used to transmit

specimens of promotional labeling and

advertisements for biological products

as well as for prescription drugs and

antibiotics. The proposed revised form

has the following major changes:

1. The revised, harmonized form will

be used by sponsors of approved

applications for marketed prescription

drugs and antibiotic drugs regulated by

CDER who must submit specimens of

advertisements and promotional

labeling to the agency, and may be used

by manufacturers of licensed biological

products regulated by CBER who submit

draft and/or final copies of promotional

labeling and advertisements to the

agency. Revising and harmonizing Form

FDA 2253 will eliminate the need for

sponsors to use two different forms to

transmit similar materials for

submission to the agency; however,

manufacturers of biological products

may continue to use Form FDA 2567 to

transmit advertisements and

promotional labeling if they wish. The

other uses of Form FDA 2567 will

remain unchanged.

2. The revised, harmonized form

updates the information about the types

of promotional materials and the codes

that are used to clarify the type of

advertisement or labeling submitted;

clarifies the intended audience for the

advertisements or promotional labeling

(e.g., consumers, professionals, news

services); and helps ensure that the

submission is complete.

3. Currently, when more than one

prescription drug product is promoted

in the promotional labeling or in an

advertisement, sponsors submit

specimens of the promotional labeling

or advertisement to the approved

application for each product promoted

in the promotional labeling or

advertisement. The revised form

provides for sponsors to submit

specimens of multi-product promotional

labeling and advertisements to only two

files; to the approved product

application most frequently promoted,

and to a company name file. This multiproduct submission should crossreference the other approved

applications. The agency anticipates

that the proposed revised form and

revised submission procedures will save

sponsors time and money by

eliminating the need for making

multiple submissions and for

maintaining dual inventories of both

forms and multiple processing

capabilities.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

Form No. of

Respondents

Total Annual

Responses

Hours per

Response

Total Estimated

Hours

FDA 2253 612 12,379 2 24,758

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

In FY 95, CDER received 10,879

submissions of advertising and

promotional labeling under Form FDA

2253 from an estimated 512

manufacturers. In the same period of

time, CBER received 1,034 submissions

from 57 manufacturers that could have

made use of revised Form FDA 2253.

Prior to October 7, 1997, the submission

of advertising and promotional labeling

to CBER using Form FDA 2567 was a

voluntary procedure. Under

§ 601.12(f)(4) (62 FR 39890),

manufacturers of licensed biological

products are required to submit

specimens of advertising and

promotional labeling to FDA in

accordance with § 314.81(b)(3)(i). FDA

estimates that under the new regulation,

CBER will receive over 1,500

submissions from approximately 100

manufacturers that may use the revised

Form FDA 2253. Thus, FDA estimates

that there may be 12,379 submissions of

advertising and promotional labeling to

FDA under revised Form FDA 2253.

Based on contacts with industry

representatives, FDA estimates that 2

hours would be required for an industry

regulatory affairs specialist to fill out the

proposed form, collate the

documentation, and send the

submission to CDER or CBER.

Manufacturers of biological products

may use the revised Form FDA 2253 or

may continue to use Form FDA 2567 for

the submission of advertisements and

promotional labeling to CBER.

Dated: October 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–28225 Filed 10–23–97; 8:45 am]

BILLING CODE 4160–01–F