[Federal Register Volume 62, Number 206 (Friday, October 24, 1997)]
[Notices]
[Pages 55408-55409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28225]


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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;

[[Page 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 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