[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14811-14813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0022]


Draft Guidance for Industry on Direct-to-Consumer Television 
Advertisements--the Food and Drug Administration Amendments Act of 2007 
Direct-to-Consumer Television Ad Pre-Dissemination Review Program; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Direct-to-
Consumer Television Advertisements--FDAAA DTC Television Ad Pre-
Dissemination Review Program.'' This draft guidance is intended to 
assist sponsors of human prescription drug products, including 
biological drug products, who are subject to the pre-dissemination 
review of television advertisements (TV ads) provision of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre-
dissemination review'' is used throughout the guidance to refer to 
review under the FD&C Act, which is entitled ``Prereview of Television 
Advertisements.'') The draft guidance describes which TV ads FDA 
intends to make subject to this provision, explains how FDA will notify 
sponsors that an ad is subject to review under this provision, and 
describes the general and center-specific procedures sponsors should 
follow to submit their TV ads to FDA for pre-dissemination review in 
compliance with the FD&C Act. These proposed TV ads will be subject to 
a 45-calendar day review clock by FDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 14, 2012. Submit written comments on the proposed 
collection of information by May 14, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs: 
Marci Kiester, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3368, Silver 
Spring, MD 20993-0002, 301-796-1200.
    Regarding prescription human biological products: Stephen Ripley, 
Center for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike,

[[Page 14812]]

suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Direct-to-Consumer Television Advertisements--FDAAA DTC 
Television Ad Pre-Dissemination Review Program.'' The Food and Drug 
Administration Amendments Act of 2007 (FDAAA) added new section 503B to 
the FD&C Act, which gives FDA the authority to ``* * * require the 
submission of any television advertisement for a drug * * * not later 
than 45 days before dissemination of the television advertisement.'' In 
conducting a review of a TV ad under this section, FDA may make 
recommendations with respect to information included in the label of 
the drug on:
    <bullet> Changes that are necessary to protect the consumer good 
and well-being, or that are consistent with prescribing information for 
the product under review; and
    <bullet> Statements for inclusion in the advertisement to address 
the specific efficacy of the drug as it relates to specific population 
groups, including elderly populations, children, and racial and ethnic 
minorities, if appropriate and if such information exists. (21 U.S.C. 
353b(b)(1) and (b)(2)).
    FDA is issuing this guidance to communicate the categories of TV 
ads it generally intends to require sponsors to submit under this 
provision, to explain how it will notify sponsors that FDA is requiring 
review under section 503B of the FD&C Act for ads for a particular drug 
or group of drugs, and to provide sponsors with recommendations for the 
information they need to properly submit these ads to the Agency for 
pre-dissemination review.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on which TV ads 
it intends to require be submitted under section 503B of the FD&C Act 
and on the submission process for these ads. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 that 
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 for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on these topics: (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.
    FDA estimates the burden of this collection of information as 
follows:
    Based on the number of TV ads produced annually by sponsors of 
human prescription drug and biological products, we estimate that we 
will receive approximately 80 ads per year for pre-dissemination review 
from approximately 30 sponsors for the Center for Drug Evaluation and 
Research (CDER) and 2 ads from 2 sponsors for CBER. FDA professionals 
familiar with TV ads and the recommendations in the draft guidance 
estimate that it should take a sponsor approximately 25 hours to 
prepare and send the pre-dissemination review package and 
documentation. This burden estimate includes all of the information 
specified for CDER and CBER in the draft guidance section entitled 
``Contents of a Complete Pre-Dissemination Review Package'' and in the 
Appendix entitled ``Center-Specific Submission Procedures.''
    FDA cannot provide final comments on the acceptability of a TV ad 
without reviewing a final recorded version in its entirety. However, 
some sponsors may wish to receive comments from the Agency before 
producing a final recorded version. Once the final recorded version is 
produced, it should be submitted to the Agency for pre-dissemination 
review. In this document, we have included in the table 1 burden 
estimate for section 503B of the FD&C Act the time necessary to prepare 
the final ad for submission.
    If FDA receives an incomplete submission package from a sponsor, we 
will inform that sponsor and request a submission package that contains 
the missing materials. We estimate that we will request a package 
containing missing materials a total of 6 times from 6 different 
sponsors annually, and that it will take each sponsor 5 hours to 
prepare the resubmission with the missing materials. This resubmission 
with missing materials is included in table 1 of this document.
    There is a 45-day review clock for TV ads submitted under section 
503B. Under this review clock, FDA must notify the sponsor if the 
Agency is not able to provide comments within a 45-day timeframe. When 
a sponsor is notified by FDA that the Agency is not able to provide 
comments, the sponsor should inform FDA whether it will disseminate the 
TV ad without waiting for FDA comments, or wait for the Agency's 
comments before disseminating the ad. We anticipate that we will be 
able to review and comment on all TV ads submitted to the Agency within 
the 45-day review clock timeframe, but for the purposes of this 
collection of information, we are estimating that the Agency will be 
unable to provide comments within the 45-day timeframe to one sponsor 
for one TV ad per year. We estimate that the time needed for a sponsor 
to prepare a letter informing FDA of its decision to disseminate or not 
to disseminate the TV ad will be 1 hour.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. In the draft guidance, the 
Agency has noted that sponsors subject to the section 503B pre-
dissemination review provision may revise their TV ads after receiving 
comments from the Agency but before disseminating the ads, and may wish 
to request additional comments under the voluntary submission process 
delineated in Sec.  202.1(j)(4) (21 CFR 202.1(j)(4)). The collections 
of information in Sec.  202.1(j)(4) have been approved under OMB 
control number 0910-0686. For pre-dissemination review packages for 
biological drug products under the purview of CBER, the Agency is 
requesting a copy of the most current version of Form FDA 2253 to

[[Page 14813]]

accompany the TV ad submission package. This collection of information 
for Form FDA 2253 has been approved under OMB control number 0910-0001.
    Therefore, we estimate the annual reporting burden as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
       Type of submission           respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
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Advertisements prepared in                    32            2.56              82              25           2,050
 accordance with section 503B of
 the FD&C Act...................
Resubmissions of incomplete                    6               1               6               5              30
 submission packages............
45-Day review clock decision                   1               1               1               1               1
 letter.........................
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    Total.......................  ..............  ..............  ..............  ..............           2,581
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6040 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P