[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Draft Guidance for Industry on Product Name Placement, Size, and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availability of a draft guidance for industry entitled ``Product Name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 When finalized, the draft guidance will replace the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 The draft guidance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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 21, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.,
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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.
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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