[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
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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
[[Page 31505]]
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 ``http://www.fda.gov/opacom/
morechoices/fdaforms/fdaforms.html'' 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 Burden1
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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
