Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability, 69691-69693 [2013-27770]
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Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–4079]
FOR FURTHER INFORMATION CONTACT:
Melissa Reisman, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
Draft Guidance for Industry on Product
Name Placement, Size, and
Prominence in Advertising and
Promotional Labeling; Availability
SUPPLEMENTARY INFORMATION:
HHS.
I. Background
ACTION:
In the Federal Register of July 2, 2013
(78 FR 39736), FDA published a notice
announcing the availability of a draft
guidance document entitled ‘‘Guidance
for Industry: Considerations for the
Design of Early-Phase Clinical Trials of
Cellular and Gene Therapy Products.’’
The notice invited comments on the
draft guidance by November 22, 2013.
We are extending the comment period
for the draft guidance to May 9, 2014.
We are taking this action to allow
interested persons additional time to
submit comments and to allow for
public discussion at the April 10–11,
2014, Cellular, Tissue, and Gene
Therapies Advisory Committee meeting,
where FDA will present the draft
guidance document for review.
The Agency believes that this
extension will not significantly delay
further FDA action on this guidance.
SUMMARY:
AGENCY:
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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 https://
www.regulations.gov.
Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27769 Filed 11–19–13; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
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Food and Drug Administration,
Notice.
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.
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 selfaddressed 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 https://
www.regulations.gov. Submit written
ADDRESSES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
69691
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.,
E:\FR\FM\20NON1.SGM
20NON1
69692
Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices
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 § 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
tkelley on DSK3SPTVN1PROD with NOTICES
Product name placement, size, and prominence in
advertising and promotional labeling
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Submissions Related to Product Name Placement, Size,
and Prominence ...............................................................
400
205
82,100
3
246,300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices
III. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1358]
Draft Guidance for Industry:
Recommendations for Premarket
Notification (510(k)) Submissions for
Nucleic Acid-Based Human Leukocyte
Antigen Test Kits Used for Matching of
Donors and Recipients in Transfusion
and Transplantation; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry:
Recommendations for Premarket
Notification (510(k)) Submissions for
Nucleic Acid-Based Human Leukocyte
Antigen (HLA) Test Kits Used for
Matching of Donors and Recipients in
Transfusion and Transplantation’’ dated
November 2013. The draft guidance
document provides recommendations to
submitters and FDA reviewers in
preparing and reviewing 510(k)
submissions for nucleic acid-based HLA
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:04 Nov 19, 2013
Jkt 232001
test kits used for matching of donors
and recipients in transfusion and
transplantation. The guidance provides
detailed information on the types of
studies FDA recommends for validation
of HLA test kits submitted as 510(k)s.
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 February 18,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance 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
the office in processing your requests.
The draft 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 https://
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: John
Reilly, Center for Biologics Evaluation
and Research (HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Recommendations for
Premarket Notification (510(k))
Submissions for Nucleic Acid-Based
Human Leukocyte Antigen (HLA) Test
Kits Used for Matching of Donors and
Recipients in Transfusion and
Transplantation’’ dated November 2013.
The draft guidance provides
recommendations to submitters and
FDA reviewers in preparing and
reviewing 510(k) submissions for
nucleic acid-based HLA test kits used
for the matching of donors and
recipients in transfusion and
transplantation, whether testing is for a
single locus or for multiple loci
simultaneously. This includes detailed
information on the types of studies FDA
recommends for validation of HLA test
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
69693
kits submitted as 510(k)s. The guidance
document addresses the types of studies
and other information that FDA
recommends be used in designing and
conducting studies for validation of
nucleic acid-based HLA test kits and
preparing a 510(k) submission.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. 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 requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 809 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 812 have been approved under
OMB control numbers 0910–0078 and
0910–0582; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; the collections of
information in 21 CFR part 56 have been
approved under OMB control number
0910–0130; and the collections of
information in 21 CFR part 50 have been
approved under OMB control number
0910–0586.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit either electronic comments
regarding this document to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). 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 https://
www.regulations.gov.
E:\FR\FM\20NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69691-69693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27770]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submissions Related to Product Name Placement, Size, and Prominence 400 205 82,100 3 246,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://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 https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://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
