[Federal Register: December 21, 2000 (Volume 65, Number 246)]
[Notices]
[Page 80437-80439]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de00-79]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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