Agency Information Collection Activities: Proposed Collection; Comment Request

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.

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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;

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(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 Sec. 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 Sec. 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

Sec. 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 multi-

product submission should cross-reference 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

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Total

Form No. of Total Annual Hours per Estimated

Respondents Responses Response Hours

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FDA 2253 612 12,379 2 24,758

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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 Sec. 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

Sec. 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