[Federal Register Volume 66, Number 89 (Tuesday, May 8, 2001)]
[Notices]
[Pages 23264-23266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1637]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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.

DATES: Submit written comments on the collection of information by June 
7, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, 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 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Transmittal of Advertising and Promotional Labeling for Drugs and 
Biologics for Human Use

    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

[[Page 23265]]

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 by 
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 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.
    In the Federal Register of December 21, 2000 (65 FR 80437), the 
agency requested comments on the proposed collections of information. 
The comments received were all unrelated to the collection of 
information published in the above Federal Register notice and may be 
viewed on the FDA Dockets Management Branch Web site: http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm, and by 
referring to the above docket number.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                           Annual frequency      Total annual
                   21 CFR section                     No. of respondents    per response\2\      responses\3\     Hours per response      Total hours
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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

[[Page 23266]]

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: May 2, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-11452 Filed 5-7-01; 8:45 am]
BILLING CODE 4160-01-S