[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69691-69693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27770]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-4079]


Draft Guidance for Industry on Product Name Placement, Size, and 
Prominence in Advertising and Promotional Labeling; 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availability of a draft guidance for industry entitled ``Product Name 
Placement, Size, and Prominence in Advertising and Promotional 
Labeling.'' When finalized, the draft guidance will replace the 
guidance of the same title issued January 25, 2012. The draft guidance 
clarifies the requirements for product name placement, size, 
prominence, and frequency in promotional labeling and advertising for 
prescription human drugs, including biological drug products, and 
prescription animal drugs and articulates the circumstances under which 
FDA intends to exercise enforcement discretion.

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 comment 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 21, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 
Cynthia Ng, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3278, 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, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
    Regarding animal prescription drugs: Julie Garnier, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6878.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Product Name Placement, Size, and Prominence in Advertising 
and Promotional Labeling.'' In the Federal Register of January 25, 2012 
(77 FR 3779), FDA announced the availability of a guidance entitled 
``Product Name Placement, Size, and Prominence in Advertising and 
Promotional Labeling.'' The 2012 guidance discusses the requirements 
for product name placement, size, prominence, and frequency in 
promotional labeling and advertising for prescription human and animal 
drugs and biological products. The draft guidance clarifies these 
requirements and articulates the circumstances under which FDA intends 
to exercise enforcement discretion.
    The disclosure of the product name in promotional labeling and 
advertising for all prescription human and animal drug and biological 
products is important for the proper identification of such products to 
ensure their safe and effective use.
    The placement, size, prominence, and frequency of proprietary and 
established names for human and animal prescription drug products are 
specified in labeling and advertising regulations (21 CFR 201.10(g) and 
(h); 202.1(b), (c), and (d)). These regulations are also applicable to 
biological product labeling and advertising materials.
    The recommendations in the draft guidance pertain to product names 
in traditional print media promotion (e.g., journal ads, detail aids, 
brochures), audiovisual promotional labeling (e.g.,

[[Page 69692]]

videos shown in a health care provider's office), broadcast media 
promotion (e.g., television advertisements, radio advertisements), and 
electronic and computer-based promotional labeling and advertisements 
such as Internet promotion, social media, emails, CD-ROMs, and DVDs.
    Following issuance of the guidance in 2012, FDA recognized the need 
for additional clarification and explanation of how FDA would exercise 
its enforcement discretion.
    This draft guidance updates the 2012 guidance as follows:
     Clarifies issues about intervening matter in relation to 
the juxtaposition of the proprietary and established name;
     States that FDA intends to exercise enforcement discretion 
regarding the requirements surrounding the use of the established name 
on pages or spreads and offers an example of what is expected;
     Clarifies the requirements regarding the use of 
proprietary names in the running text;
     States that FDA intends to exercise enforcement discretion 
regarding the established name's presentation in columns;
     Removes the recommendation that the established name be 
included in the audio portion of an audiovisual promotion; and
     Clarifies issues relating to the established name's 
presentation on Web pages or electronic screens.
    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 product name 
placement, size, and prominence in advertising and promotional 
labeling. 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 notice of the proposed 
collection of information set forth in this document.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in Sec.  202.1 have been approved under OMB control number 0910-0686.
    With respect to the following collection of information, 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.
    Title: Product Name Placement, Size, and Prominence in Advertising 
and Promotional Labeling.
    Description of Respondents: Respondents to this collection of 
information are manufacturers and distributors (firms) of prescription 
human drug products, including biological drug products, and 
prescription animal drug products.
    Burden Estimate: The draft guidance pertains to the requirement for 
prescription drug advertising and promotional labeling to include the 
established name in conjunction with the proprietary name.
    The draft guidance, in part, explains FDA's current policy as 
follows:
     Firms should include the established name at least once 
per page or spread where the proprietary name most prominently appears.
     The established name should be placed either directly 
beside or below the proprietary name without any intervening matter.
     The size of the established name should be at least half 
the size of the presentation of the proprietary name wherever the 
established name is required.
     For superimposed text that is equivalent to a headline or 
tagline, the established name should be presented alongside the most 
prominent presentation of the proprietary name in audiovisual 
promotional materials.
     For electronic and computer-based promotion, the 
established name should accompany the proprietary name at least once 
per Web page or screen, and this should generally be where the 
proprietary name most prominently appears on the Web page or screen.
    Thus, the draft guidance recommends that firms disclose certain 
information to others when fulfilling the product name placement 
requirements. This ``third-party disclosure'' constitutes a 
``collection of information'' under the PRA.
    FDA estimates that approximately 400 firms disseminate 
approximately 82,100 advertisements and promotional pieces each year. 
FDA estimates that it will take firms approximately 3 hours to compile 
and draft the information needed to fulfill the product name placement, 
size, and prominence requirement in advertising and promotional 
labeling.

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
  Product name placement, size, and prominence in  advertising and      Number of     disclosures per    Total annual   Average  burden    Total hours
                        promotional labeling                           respondents       respondent      disclosures    per  disclosure
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Submissions Related to Product Name Placement, Size, and Prominence             400              205           82,100                3          246,300
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 69693]]

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27770 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P