[Federal Register Volume 63, Number 110 (Tuesday, June 9, 1998)]
[Notices]
[Pages 31503-31505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15192]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0424]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by July 
9, 1998.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: 
Desk Officer for FDA.
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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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 advertisements. 
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 (the 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 the Center for Drug Evaluation and Research (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 the Center for Biologics Evaluation and Research 
(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

[[Page 31504]]

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 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.
    Under Executive Order 12866, FDA published a notice in the Federal 
Register of October 24, 1997 (62 FR 55408 through 55409), that 
announced an opportunity for public comment on a proposed revision of 
Form FDA 2253. Based on the five responses to FDA's proposal to 
streamline the submission of promotional labeling and advertisements 
via Form FDA 2253, none of the respondents objected to the agency 
revising the form, and two respondents had very favorable comments 
regarding the initiative to revise the form and streamline the 
submission process for multiple product submissions.
    One respondent stated that it was unclear whose burden had been 
measured for the estimate and stated that information about methodology 
and assumptions was insufficient for it to comment. The agency noted in 
the October 24, 1997, notice that its estimate was based on contacts 
with industry representatives. The agency's estimate of 2 hours per 
response, including time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing the collection of information, was obtained from an 
informal survey of current respondents who were asked how long it took 
them to prepare and submit data and materials intended to accompany 
Form FDA 2253. The comment did not provide an alternative estimate for 
the proposed burden hours. The agency's estimate, thus, will remain the 
same. No other comment provided an alternative estimate.
    Several respondents commented on the physical layout of the form 
and suggested that some parts of the form be made larger or smaller. 
The agency agrees with some of these suggestions and will modify the 
layout of the form. In the section of the form that describes various 
submitted promotional items, some respondents suggested different 
descriptions for types of promotional materials (such as replace the 
proposed term ``profession journal ad'' with ``profession print 
advertisements''), and suggested combining various similar types of 
materials with the addition and deletion of specific promotional items. 
The agency agrees that the consolidation of material types will make 
the form easier to understand and plans to make these modifications.
    Two respondents questioned whether it was necessary to identify the 
submission preparer, and whether it was necessary for the ``responsible 
official'' to actually sign the form. The agency agrees that it is not 
necessary to know who prepared the submission, because agency inquiries 
will be directed to the ``responsible official'' (contact person) 
either by telephone or by written correspondence. The agency considers 
that it would be helpful to have the ``responsible official'' sign the 
form to assure that the actual submission was seen or reviewed by the 
contact person.
    One respondent commented on whether the revised Form FDA 2253 
should accompany draft promotional materials intended for CBER for 
promoting a biologic. The respondent suggested that the revised form 
created an artificial distinction between drugs and biologics by 
requiring that draft biologic promotional materials submitted for 
voluntary preclearance continue to be accompanied by a form (now Form 
FDA 2253 in place of Form FDA 2567) because CDER does not use a form to 
accompany draft promotional materials. Thus, the respondent considered 
use of the form to be unnecessary for voluntary submissions.
    CBER notes that some sponsors have submitted proposed promotional 
materials to CBER for comment without the Form FDA 2567, and that this 
has been, and continues to be, an acceptable method of submitting draft 
promotional materials. However, from past experience, CBER considers 
that the use of the Form FDA 2567 to accompany draft promotional 
materials makes tracking and followup of the materials more efficient 
and more timely. For example, the form provides a quick and efficient 
way of providing comments to sponsors without the need for a formal 
letter which would require more time. CBER also wants to emphasize that 
the option of using Form FDA 2253 or 2567 to accompany draft 
promotional materials to CBER does in no way mandate or obligate drug 
sponsors to use a form when submitting proposed promotional materials 
to CDER for comment.
    Another respondent asked for clarification regarding the biologic 
license application (BLA) number referenced in number 3. The respondent 
stated that the form provided for the sponsor to identify the BLA 
number for biologics, but that the BLA number for the original 
application becomes obsolete upon approval. Later supplements are 
assigned new BLA numbers, and a sponsor can have multiple submissions 
under review at the same time, each with a different number. Therefore, 
the respondent requested clarification of which number would be 
appropriate to list in number 3. The agency agrees that further 
clarification of number 3 is required. We believe the least confusing 
and most efficient way to reference the BLA number would be for 
sponsors to include the ``most recent reference number'' for an 
application concerning a labeling change.
    Four of the five respondents requested further explanation 
regarding the multiple submissions procedures. The agency will clearly 
explain the procedures regarding multiple submissions on the form, and 
how to submit multiple drug product promotional materials. 
Additionally, one respondent asked whether the ``company named file'' 
will be releasable under the Freedom of Information Act (FOIA). 
Currently, CDER's Division of Drug Marketing, Advertising, and 
Communications (DDMAC) maintains two types of files related to 
promotional materials. One file contains promotional materials 
submitted under the postmarketing requirements of Sec. 314.81. These 
promotional materials have been submitted to the agency because they 
were already publicly disseminated. The agency would consider this 
information releasable under FOIA. The ``company named file'' for 
multiple submissions of Form FDA 2253-related materials would be this 
type of file. The other types of materials maintained by DDMAC are 
related to: (1) Advisory opinions (generally on proposed promotional 
materials) which are not

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releasable, and (2) enforcement actions which are releasable.
    Three respondents were not clear whether approved product labeling 
was still required to accompany promotional materials, and one 
respondent proposed an alternative method of submitting labeling. The 
agency presently requests that sponsors submit two copies of the 
approved product labeling for each referenced drug product. This has 
been clarified on the form. Alternative methods of submitting approved 
product labeling may be considered at a later time.
    Three respondents proposed that the agency provide the revised Form 
FDA 2253 in electronic form, and accept some promotional materials via 
electronic means. The agency currently provides many forms on the 
Internet using the World Wide Web (WWW) at ``<a href="http://www.fda.gov/opacom/
morechoices/fdaforms/fdaforms.html">http://www.fda.gov/opacom/
morechoices/fdaforms/fdaforms.html</a>'' and intends to add the revised 
Form FDA 2253 shortly after it is an approved form. As for the 
submission of promotional materials by electronic means, DDMAC is 
currently reviewing a pilot project where proposed promotional 
materials are submitted for review via CD-ROM and in hard copy. If 
successful, DDMAC plans to continue the pilot project and refine the 
means of submitting promotional materials by electronic means.
    FDA estimates the burden of this collection of information as 
follows:

              Table 1.--Estimated Annual Reporting Burden<SUP>1              
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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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\1\ There are no capital costs or operating and maintenance costs       
  associated with this collection of information.                       

    In fiscal year 1995, 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: June 2, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15192 Filed 6-8-98; 8:45 am]
BILLING CODE 4160-01-F