[Federal Register Volume 65, Number 246 (Thursday, December 21, 2000)]
[Notices]
[Pages 80437-80439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1637]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Transmittal of Advertising and Promotional Labeling 
for Drugs and Biologics for Human Use

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 the proposed 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
regarding the promotion of prescription human drugs and biologics--
specifically advertising and promotional labeling.

[[Page 80438]]


DATES: Submit written or electronic comments on the collection of 
information by February 20, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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: 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, including 
each proposed extension of an existing 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 set forth in this document.
    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; (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 Advertising and Promotional Labeling for Drugs and 
Biologics for Human Use (OMB Control Number 0910-0376) (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 and Biologics for Human Use). Statutory 
authority for the collection of this information is provided by 
sections 505(a), (b), (j), and (k) and 701(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(a), (b), (j), and (k) and 
371(a)). Similarly, under 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's Center for Biologics 
Evaluation and Research (CBER) with either Form FDA 2253 or Form FDA 
2567, which is a two-part transmittal form that is also used to 
transmit other forms of labeling (e.g., circulars, package labels, and 
container labels) for CBER review when a sponsor is requesting 
premarket approval of a product or proposing changes to a product 
carton or container labeling.
    The many types of promotional materials are described on Form FDA 
2253 for easy reference. For example, possible submitted promotional 
materials could be a consumer advertisement, a professional sales aid, 
or a consumer broadcast advertisement. A single submission would 
include two copies each of the promotional materials, Form FDA 2253, 
and the approved product labeling. Submissions of multiple applications 
are handled in a similar manner as described in the form.
    In 1998, FDA revised 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 revised form had the following major changes:
    1. The revised, harmonized form is now 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 it may be used by manufacturers of licensed biological 
products regulated by the Center for Biologics and Research (CBER) who 
submit draft and/or final copies of promotional labeling and 
advertisements to the agency. The revised and harmonized Form FDA 2253 
eliminated the need for sponsors to use two different forms to transmit 
similar materials for submission to the two centers. Although 
manufacturers of biological products had the option to continue to use 
Form FDA 2567 to transmit advertisements and promotional labeling if 
they wished, the other uses of Form FDA 2567 remained unchanged.
    2. The revised, harmonized form updated the information about the 
types of promotional materials and the codes that are used to clarify 
the type of advertisement or promotional labeling (e.g., consumers, 
professionals, news services); and it helped ensure that the submission 
is complete.
    3. The revised form provides for sponsors to submit specimens of 
multiproduct promotional labeling and advertisements to only two files; 
to the approved product application of the sponsor's choice (generally 
the most frequently promoted product), and to a company name file. This 
revision in the form has saved sponsors time and money by eliminating 
the need for making multiple submissions of the same promotional 
materials. In addition, because the form was revised, sponsors no 
longer need to maintain dual inventories of both forms, and they now 
have multiple processing capabilities.
    From October 1, 1999, through September 30, 2000, 386 sponsors 
submitted 12,235 postmarketing reports via Form FDA 2253 to CDER; this 
included 2,343 multiple submissions. In the same time period, 134 
sponsors submitted 4,243 postmarketing reports via Forms FDA 2253 and 
2567 to CBER.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 80439]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents    Response \2\    Responses \3\     Response
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CBER (none)                       134 \4\              32           4,243               2           8,486
CDER Sec.  314.81(b)(3)(i)        386 \5\              32          12,395               2          24,790
Total                                                                                             33,276
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Average number (rounded to the nearest whole number) of submissions submitted annually per sponsor. We note
  that some sponsors submit only once per year, whereas one sponsor had 893 submissions in 1999.
\3\ Total number of Form FDA 2253 submissions to CDER and Form FDA 2253 plus Form FDA 2567 to CBER in fiscal
  year (FY) 1999.
\4\ Number of sponsors that submitted establishment license applications and product license applications to
  CBER in FY 1999.
\5\ Number of sponsors that submitted new drug applications (including applications for new antibiotics),
  abbreviated new drug applications, and abbreviated antibiotic applications in FY 1999.

    In FY 1999, CDER received a total of 12,395 submissions and CBER 
received 4,353 submissions that would require the use of this form. FDA 
estimates that 2 hours would be required for an industry regulatory 
affairs specialist to fill out the form, collate the documentation, and 
send the submissions to CDER or CBER.

Electronic Submission of Promotional Materials Regarding 
Prescription Drugs and Biologics for Human Use

    CDER and CBER are currently piloting with approximately 20 
sponsors, different methods to submit postmarketing submissions of 
advertising and promotional labeling. FDA anticipates publishing in the 
Federal Register a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Prescription Drug 
Advertising and Promotional Labeling.'' By using this suggested format 
for electronically submitting promotional materials, we anticipate that 
by January 2002, sponsors will submit about 20 percent of all materials 
electronically via Form FDA 2253. Further, we anticipate posting a 
fillable electronic Form FDA 2253 on FDA's Internet site. Applicants 
may then have the option to fill out the form on their computer, and 
with additional software, they can maintain records regarding submitted 
promotional materials.

    Dated: December 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32617 Filed 12-20-00 8:45 am]
BILLING CODE 4160-01-F