Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability, 58421-58424 [2017-26725]
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
Perception: Evidence from a MetaAnalysis.’’ Journal of Communication,
58(2), 280–300, 2008.
19. DeLorme, D.E., J. Huh, and L.N. Reid.
‘‘Perceived Effects of Direct-ToConsumer (DTC) Prescription Drug
Advertising on Self and Others.’’ Journal
of Advertising, 35(3), 47–65, 2006.
20. Fisher, R.A. The Design of Experiments.
Edinburgh, United Kingdom: Oliver and
Boyd, 1937.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26704 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–2659]
Determination That NOROXIN
(Norfloxacin) Tablets, 400 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that NOROXIN (norfloxacin)
tablets, 400 milligrams (mg), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for norfloxacin
tablets, 400 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
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SUMMARY:
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gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NOROXIN (norfloxacin) tablets, 400
mg, is the subject of NDA 019384, held
by Merck & Company, Inc. (Merck), and
initially approved on October 31, 1986.
NOROXIN is indicated for the treatment
of adults with the following infections
caused by susceptible strains of certain
designated microorganisms:
Uncomplicated urinary tract infections
(including cystitis), uncomplicated
urethral and cervical gonorrhea, and
prostatitis.
In a letter dated October 13, 2015,
Merck notified FDA that NOROXIN
(norfloxacin) tablets, 400 mg, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In the Federal Register of October
4, 2016 (81 FR 68427), FDA announced
that it was withdrawing approval of
NDA 019384, effective November 3,
2016.
Jubilant Generics Ltd. submitted a
citizen petition dated April 27, 2017
(Docket No. FDA–2017–P–2659), under
21 CFR 10.30, requesting that the
Agency determine whether NOROXIN
(norfloxacin) tablets, 400 mg, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that NOROXIN (norfloxacin)
tablets, 400 mg, was not withdrawn for
reasons of safety or effectiveness. The
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58421
petitioner has identified no data or other
information suggesting that NOROXIN
(norfloxacin) tablets, 400 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of NOROXIN
(norfloxacin) tablets, 400 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NOROXIN (norfloxacin)
tablets, 400 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to NOROXIN
(norfloxacin) tablets, 400 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised,
the Agency will advise ANDA
applicants to submit such labeling.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26693 Filed 12–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–4079]
Product Name Placement, Size, and
Prominence in Promotional Labeling
and Advertisements; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Product
Name Placement, Size, and Prominence
in Promotional Labeling and
Advertisements.’’ The guidance clarifies
the requirements for product name
placement, size, prominence, and
frequency in promotional labeling and
advertisements for human prescription
drugs, including prescription biological
products, and for animal prescription
SUMMARY:
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
drugs. This guidance finalizes the
revised draft guidance issued on
November 20, 2013 (‘‘Product Name
Placement, Size, and Prominence in
Advertising and Promotional
Labeling’’).
FDA is also announcing that a
proposed collection of information has
been submitted to the Office of
Management and Budget (OMB) for
review and clearance under the
Paperwork Reduction Act of 1995 (the
PRA).
The announcement of the
guidance is published in the Federal
Register on December 12, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
title ‘‘Product Name Placement, Size,
and Prominence in Promotional
Labeling and Advertisements.’’ Also,
include the FDA docket number found
in brackets in the heading of this
document.
You may submit either electronic or
written comments on Agency guidances
at any time as follows:
DATES:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
1999–D–4079 for ‘‘Product Name
Placement, Size, and Prominence in
Promotional Labeling and
Advertisements; Guidance for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
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received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002; or
the Policy and Regulations Staff
(HFV–6), 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 guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding human prescription drugs:
Sheila Ryan, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3320, Silver Spring,
MD 20993–0002, 301–796–1200.
Regarding human prescription
biological products: Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
Regarding animal prescription drugs:
Thomas Moskal, Center for Veterinary
Medicine (HFV–216), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6251.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Product Name Placement, Size, and
Prominence in Promotional Labeling
and Advertisements.’’ This guidance
clarifies the requirements for product
name placement, size, prominence, and
frequency in promotional labeling and
advertisements for human prescription
drugs, including prescription biological
products, and for animal prescription
drugs. The disclosure of the product
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
name in promotional labeling and
advertisements for all human
prescription drugs, including
prescription biological products, and
animal prescription drugs is important
for the proper identification of such
products to ensure their safe and
effective use.
The placement, size, prominence, and
frequency of the proprietary and
established names for human
prescription drugs, including
prescription biological products, and for
prescription animal drugs are specified
in labeling and advertising regulations
(21 CFR 201.10(g) and (h) and 202.1(b),
(c), and (d)).
The recommendations in this
guidance pertain to product names in
traditional print promotional labeling
and advertisements (e.g., journal ads,
detail aids, brochures), audiovisual
promotional labeling (e.g., videos shown
in a health care provider’s office),
broadcast advertisements (e.g.,
television advertisements, radio
advertisements), and electronic and
computer-based promotions (e.g.,
internet, social media, emails, CD–
ROMs, DVDs).
In the Federal Register of November
20, 2013 (78 FR 69691), FDA announced
the availability of the revised draft
guidance entitled ‘‘Product Name
Placement, Size, and Prominence in
Advertising and Promotional Labeling.’’
FDA received one comment on the
revised draft guidance, which requested
additional clarification on the
individual recommendations in the
guidance, and FDA considered this
comment as the guidance was finalized.
In addition to a title change and
editorial changes made primarily for
clarification, the guidance has been
revised to clarify certain concepts
discussed in the revised draft guidance
and to provide examples illustrating
prominence issues.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Product Name
Placement, Size, and Prominence in
Promotional Labeling and
Advertisements.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
In compliance with 44 U.S.C. 3507,
FDA has submitted the following
proposed collection of information to
OMB for review and clearance. The
information collection requests in
support of the guidance are discussed
below. Specifically, the guidance
discusses the requirement in FDA’s
regulations for prescription drug
promotional labeling and
advertisements to include the
established name in conjunction with
the proprietary name, and explains FDA
recommendations that:
• 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.
58423
• 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
(promotional labeling and broadcast
advertisements).
• For electronic and computer-based
promotion, the established name should
accompany the proprietary name at least
once per Web page, and this should
generally be where the proprietary name
most prominently appears on the Web
page.
Thus, the guidance recommends that
firms disclose certain information to
others to fulfill the product name
placement requirements found in FDA’s
regulations. This ‘‘third-party
disclosure’’ constitutes a ‘‘collection of
information’’ under the PRA.
Disclosures in advertising pursuant to
21 CFR 202.1 are covered by an existing
information collection (OMB control
number 0910–0686), so this information
collection request covers only
disclosures in labeling in accordance
with 21 CFR 201.10(g) and (h).
In the Federal Register of November
20, 2013, FDA published a 60-day
notice requesting public comment on
the proposed collection of information
and the estimated annual burden for
third party disclosure. FDA received no
comments in response to the four
information collection topics solicited
in the notice. FDA has received more
up-to-date submission data since the 60day notice published, therefore, we have
adjusted our estimates of respondents
and disclosures accordingly. The
estimated amount of time per disclosure
has not changed. We therefore estimate
the burden associated with the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Guidance recommendations
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
(in hours)
Total hours
Disclosures Related to Product Name Placement, Size,
and Prominence ...............................................................
407
256.4
104,358
3
313,074
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
As reflected in table 1, we provide an
estimate of the annual third-party
disclosure burden associated with this
collection of information. The
placement, size, prominence, and
frequency of the proprietary and
established names for human
prescription drugs, including
prescription biological products, and
animal prescription drugs are specified
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Jkt 244001
in labeling and advertising regulations
(21 CFR 201.10(g) and (h); 202.1(b), (c)
and (d); and 610.62). Using calendar
year 2015 data, FDA estimates that, for
prescription human and animal drugs
and biological products, approximately
407 firms disseminate approximately
104,358 advertisements and
promotional pieces each year. We
further estimate that the burden hours
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associated with the regulatory
requirements would be approximately 3
hours per disclosure.
FDA is issuing this final guidance
subject to OMB approval of the
information collection. Before
implementing the information
collection provisions of the guidance,
FDA will publish a notice in the Federal
Register announcing OMB’s decision to
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Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
approve, modify, or disapprove the
collections of information, including
OMB control number(s) for newly
approved collections.
This guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information
associated with 21 CFR 202.1 have been
approved under OMB control number
0910–0686.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.
fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm, or
https://www.regulations.gov.
Orphan Products Development; Food
and Drug Administration Orphan Drug
Designation Request Form and The
Common European Medicines Agency/
Food and Drug Administration Form
for Orphan Medicinal Product
Designation (Formerly Orphan Drugs;
Common European Medicines Agency/
FDA Application Form for Orphan
Medicinal Product Designation (Form
FDA 3671))—21 CFR Part 316
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB Control Number 0910–0167—
Extension
Food and Drug Administration
[Docket No. FDA–2011–N–0015]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Orphan Products
Development; Food and Drug
Administration Orphan Drug
Designation Request Form and The
Common European Medicines Agency/
Food and Drug Administration Form
for Orphan Medicinal Product
Designation
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 11,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
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SUMMARY:
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Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2017–26725 Filed 12–11–17; 8:45 am]
ACTION:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0167. Also
include the FDA docket number found
in brackets in the heading of this
document.
Sections 525 through 528 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360aa–360dd)
give FDA statutory authority to do the
following: (1) Provide recommendations
on investigations required for approval
of marketing applications for orphan
drugs, (2) designate eligible drugs as
orphan drugs, (3) set forth conditions
under which a sponsor of an approved
orphan drug obtains exclusive approval,
and (4) encourage sponsors to make
orphan drugs available for treatment on
an ‘‘open protocol’’ basis before the drug
has been approved for general
marketing. The implementing
regulations for these statutory
requirements have been codified under
part 316 (21 CFR part 316) and specify
procedures that sponsors of orphan
drugs use in availing themselves of the
incentives provided for orphan drugs in
the FD&C Act and sets forth procedures
FDA will use in administering the FD&C
Act with regard to orphan drugs.
Section 316.10 specifies the content
and format of a request for written
recommendations concerning the
nonclinical laboratory studies and
clinical investigations necessary for
approval of marketing applications.
Section 316.12 provides that, before
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providing such recommendations, FDA
may require results of studies to be
submitted for review. Section 316.14
contains provisions permitting FDA to
refuse to provide written
recommendations under certain
circumstances. Within 90 days of any
refusal, a sponsor may submit
additional information specified by
FDA. Based on past experience, FDA
estimates that there will be one
respondent to §§ 316.10, 316.12, and
316.14 requiring 50 hours of human
resources annually.
Section 316.20 specifies the content
and format of an orphan drug
application which includes
requirements that an applicant
document that the disease is rare (affects
fewer than 200,000 persons in the
United States annually) or that the
sponsor of the drug has no reasonable
expectation of recovering costs of
research and development of the drug.
Section 316.21 specifies content of a
request for orphan drug designation
required for verification of orphan-drug
status. Section 316.26 allows an
applicant to amend the applications
under certain circumstances. Based on
past experience, FDA estimates 496
respondents to §§ 316.20, 316.21, and
316.26, requiring 83,700 hours of
human resources annually.
The Common EMEA/FDA
Application for Orphan Medicinal
Product Designation form for orphan
designation of drugs intended for rare
diseases or conditions (Form FDA 3671)
is intended to benefit sponsors who
desire to seek orphan designation of
drugs intended for rare diseases or
conditions from both the European
Commission and FDA by reducing the
burden of preparing separate
applications to meet the regulatory
requirements in each jurisdiction. It
highlights the regulatory cooperation
between the United States and the
European Union mandated by the
Transatlantic Economic Council. The
FDA Orphan Drug Designation Request
Form (Form FDA 4035) is intended to
benefit sponsors who desire to seek
orphan designation of drugs intended
for rare diseases or conditions from only
FDA. The form is a simplified method
for sponsors to provide only information
required by 21 CFR 316.20 for FDA to
make a decision. Based on past
experience, FDA estimates there will be
496 respondents using the form
requiring 19,840 hours of human
resources annually.
Section 316.22 specifies requirement
of a permanent resident agent for foreign
sponsors. Based on past experience,
FDA estimates 70 respondents requiring
140 hours of human resources annually.
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]]>Agencies
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58421-58424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26725]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-4079]
Product Name Placement, Size, and Prominence in Promotional
Labeling and Advertisements; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Product Name
Placement, Size, and Prominence in Promotional Labeling and
Advertisements.'' The guidance clarifies the requirements for product
name placement, size, prominence, and frequency in promotional labeling
and advertisements for human prescription drugs, including prescription
biological products, and for animal prescription
[[Page 58422]]
drugs. This guidance finalizes the revised draft guidance issued on
November 20, 2013 (``Product Name Placement, Size, and Prominence in
Advertising and Promotional Labeling'').
FDA is also announcing that a proposed collection of information
has been submitted to the Office of Management and Budget (OMB) for
review and clearance under the Paperwork Reduction Act of 1995 (the
PRA).
DATES: The announcement of the guidance is published in the Federal
Register on December 12, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--New and
title ``Product Name Placement, Size, and Prominence in Promotional
Labeling and Advertisements.'' Also, include the FDA docket number
found in brackets in the heading of this document.
You may submit either electronic or written comments on Agency
guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-1999-D-4079 for ``Product Name Placement, Size, and Prominence in
Promotional Labeling and Advertisements; Guidance for Industry;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Policy and Regulations Staff (HFV-6), 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs:
Sheila Ryan, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3320, Silver
Spring, MD 20993-0002, 301-796-1200. Regarding human prescription
biological products: Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Regarding animal prescription drugs: Thomas Moskal, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-6251.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Product Name Placement, Size, and Prominence in Promotional
Labeling and Advertisements.'' This guidance clarifies the requirements
for product name placement, size, prominence, and frequency in
promotional labeling and advertisements for human prescription drugs,
including prescription biological products, and for animal prescription
drugs. The disclosure of the product
[[Page 58423]]
name in promotional labeling and advertisements for all human
prescription drugs, including prescription biological products, and
animal prescription drugs is important for the proper identification of
such products to ensure their safe and effective use.
The placement, size, prominence, and frequency of the proprietary
and established names for human prescription drugs, including
prescription biological products, and for prescription animal drugs are
specified in labeling and advertising regulations (21 CFR 201.10(g) and
(h) and 202.1(b), (c), and (d)).
The recommendations in this guidance pertain to product names in
traditional print promotional labeling and advertisements (e.g.,
journal ads, detail aids, brochures), audiovisual promotional labeling
(e.g., videos shown in a health care provider's office), broadcast
advertisements (e.g., television advertisements, radio advertisements),
and electronic and computer-based promotions (e.g., internet, social
media, emails, CD-ROMs, DVDs).
In the Federal Register of November 20, 2013 (78 FR 69691), FDA
announced the availability of the revised draft guidance entitled
``Product Name Placement, Size, and Prominence in Advertising and
Promotional Labeling.'' FDA received one comment on the revised draft
guidance, which requested additional clarification on the individual
recommendations in the guidance, and FDA considered this comment as the
guidance was finalized. In addition to a title change and editorial
changes made primarily for clarification, the guidance has been revised
to clarify certain concepts discussed in the revised draft guidance and
to provide examples illustrating prominence issues.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Product Name Placement, Size, and
Prominence in Promotional Labeling and Advertisements.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance. The
information collection requests in support of the guidance are
discussed below. Specifically, the guidance discusses the requirement
in FDA's regulations for prescription drug promotional labeling and
advertisements to include the established name in conjunction with the
proprietary name, and explains FDA recommendations that:
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 (promotional labeling and broadcast
advertisements).
For electronic and computer-based promotion, the
established name should accompany the proprietary name at least once
per Web page, and this should generally be where the proprietary name
most prominently appears on the Web page.
Thus, the guidance recommends that firms disclose certain
information to others to fulfill the product name placement
requirements found in FDA's regulations. This ``third-party
disclosure'' constitutes a ``collection of information'' under the PRA.
Disclosures in advertising pursuant to 21 CFR 202.1 are covered by an
existing information collection (OMB control number 0910-0686), so this
information collection request covers only disclosures in labeling in
accordance with 21 CFR 201.10(g) and (h).
In the Federal Register of November 20, 2013, FDA published a 60-
day notice requesting public comment on the proposed collection of
information and the estimated annual burden for third party disclosure.
FDA received no comments in response to the four information collection
topics solicited in the notice. FDA has received more up-to-date
submission data since the 60-day notice published, therefore, we have
adjusted our estimates of respondents and disclosures accordingly. The
estimated amount of time per disclosure has not changed. We therefore
estimate the burden associated with the information collection as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Guidance recommendations Number of disclosures Total annual per disclosure Total hours
respondents per respondent disclosures (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosures Related to Product Name Placement, Size, and Prominence 407 256.4 104,358 3 313,074
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
As reflected in table 1, we provide an estimate of the annual
third-party disclosure burden associated with this collection of
information. The placement, size, prominence, and frequency of the
proprietary and established names for human prescription drugs,
including prescription biological products, and animal prescription
drugs are specified in labeling and advertising regulations (21 CFR
201.10(g) and (h); 202.1(b), (c) and (d); and 610.62). Using calendar
year 2015 data, FDA estimates that, for prescription human and animal
drugs and biological products, approximately 407 firms disseminate
approximately 104,358 advertisements and promotional pieces each year.
We further estimate that the burden hours associated with the
regulatory requirements would be approximately 3 hours per disclosure.
FDA is issuing this final guidance subject to OMB approval of the
information collection. Before implementing the information collection
provisions of the guidance, FDA will publish a notice in the Federal
Register announcing OMB's decision to
[[Page 58424]]
approve, modify, or disapprove the collections of information,
including OMB control number(s) for newly approved collections.
This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information
associated with 21 CFR 202.1 have been approved under OMB control
number 0910-0686.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26725 Filed 12-11-17; 8:45 am]
BILLING CODE 4164-01-P
