82 FR 58421 - Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 237 (December 12, 2017)

Page Range		58421-58424
FR Document		2017-26725

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 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 This guidance finalizes the revised draft guidance issued on November 20, 2013 (``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling'').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).

Federal Register, Volume 82 Issue 237 (Tuesday, December 12, 2017)

[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58421-58424]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26725]


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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 This guidance finalizes the revised draft guidance issued on 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.thefederalregister.org/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

Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 58421

Perception: Evidence from a Meta- gain approval of a new drug application petitioner has identified no data or other
Analysis.’’ Journal of Communication, (NDA). information suggesting that NOROXIN
58(2), 280–300, 2008. The 1984 amendments include what (norfloxacin) tablets, 400 mg, was
19. DeLorme, D.E., J. Huh, and L.N. Reid. is now section 505(j)(7) of the Federal withdrawn for reasons of safety or
‘‘Perceived Effects of Direct-To- Food, Drug, and Cosmetic Act (21 U.S.C.
Consumer (DTC) Prescription Drug
effectiveness. We have carefully
Advertising on Self and Others.’’ Journal
355(j)(7)), which requires FDA to reviewed our files for records
of Advertising, 35(3), 47–65, 2006. publish a list of all approved drugs. concerning the withdrawal of NOROXIN
20. Fisher, R.A. The Design of Experiments. FDA publishes this list as part of the (norfloxacin) tablets, 400 mg, from sale.
Edinburgh, United Kingdom: Oliver and ‘‘Approved Drug Products With We have also independently evaluated
Boyd, 1937. Therapeutic Equivalence Evaluations,’’ relevant literature and data for possible
Dated: December 6, 2017. which is known generally as the postmarketing adverse events. We have
‘‘Orange Book.’’ Under FDA regulations, reviewed the available evidence and
Leslie Kux,
drugs are removed from the list if the determined that this drug product was
Associate Commissioner for Policy. Agency withdraws or suspends not withdrawn from sale for reasons of
[FR Doc. 2017–26704 Filed 12–11–17; 8:45 am] approval of the drug’s NDA or ANDA safety or effectiveness.
BILLING CODE 4164–01–P for reasons of safety or effectiveness or Accordingly, the Agency will
if FDA determines that the listed drug continue to list NOROXIN (norfloxacin)
was withdrawn from sale for reasons of tablets, 400 mg, in the ‘‘Discontinued
DEPARTMENT OF HEALTH AND safety or effectiveness (21 CFR 314.162).
HUMAN SERVICES Drug Product List’’ section of the Orange
A person may petition the Agency to Book. The ‘‘Discontinued Drug Product
determine, or the Agency may List’’ delineates, among other items,
Food and Drug Administration determine on its own initiative, whether drug products that have been
a listed drug was withdrawn from sale discontinued from marketing for reasons
[Docket No. FDA–2017–P–2659] for reasons of safety or effectiveness. other than safety or effectiveness.
This determination may be made at any ANDAs that refer to NOROXIN
Determination That NOROXIN time after the drug has been withdrawn
(Norfloxacin) Tablets, 400 Milligrams, (norfloxacin) tablets, 400 mg, may be
from sale, but must be made prior to approved by the Agency as long as they
Was Not Withdrawn From Sale for approving an ANDA that refers to the
Reasons of Safety or Effectiveness meet all other legal and regulatory
listed drug (§ 314.161 (21 CFR 314.161)). requirements for the approval of
AGENCY: Food and Drug Administration, FDA may not approve an ANDA that ANDAs. If FDA determines that labeling
HHS. does not refer to a listed drug. for this drug product should be revised,
NOROXIN (norfloxacin) tablets, 400
ACTION: Notice. the Agency will advise ANDA
mg, is the subject of NDA 019384, held
applicants to submit such labeling.
SUMMARY: The Food and Drug by Merck & Company, Inc. (Merck), and
initially approved on October 31, 1986. Dated: December 6, 2017.
Administration (FDA or Agency) has
determined that NOROXIN (norfloxacin) NOROXIN is indicated for the treatment Leslie Kux,
tablets, 400 milligrams (mg), was not of adults with the following infections Associate Commissioner for Policy.
withdrawn from sale for reasons of caused by susceptible strains of certain [FR Doc. 2017–26693 Filed 12–11–17; 8:45 am]
safety or effectiveness. This designated microorganisms: BILLING CODE 4164–01–P
determination will allow FDA to Uncomplicated urinary tract infections
approve abbreviated new drug (including cystitis), uncomplicated
applications (ANDAs) for norfloxacin urethral and cervical gonorrhea, and DEPARTMENT OF HEALTH AND
tablets, 400 mg, if all other legal and prostatitis. HUMAN SERVICES
regulatory requirements are met. In a letter dated October 13, 2015,
Merck notified FDA that NOROXIN Food and Drug Administration
FOR FURTHER INFORMATION CONTACT: (norfloxacin) tablets, 400 mg, was being
Darren Eicken, Center for Drug [Docket No. FDA–1999–D–4079]
discontinued, and FDA moved the drug
Evaluation and Research, Food and product to the ‘‘Discontinued Drug
Drug Administration, 10903 New Product Name Placement, Size, and
Product List’’ section of the Orange Prominence in Promotional Labeling
Hampshire Ave., Bldg. 51, Rm. 6206, Book. In the Federal Register of October
Silver Spring, MD 20993–0002, 240– and Advertisements; Guidance for
4, 2016 (81 FR 68427), FDA announced Industry; Availability
402–0978. that it was withdrawing approval of
SUPPLEMENTARY INFORMATION: In 1984, NDA 019384, effective November 3, AGENCY: Food and Drug Administration,
Congress enacted the Drug Price 2016. HHS.
Competition and Patent Term Jubilant Generics Ltd. submitted a ACTION: Notice of availability.
Restoration Act of 1984 (Pub. L. 98–417) citizen petition dated April 27, 2017
(the 1984 amendments), which (Docket No. FDA–2017–P–2659), under SUMMARY: The Food and Drug
authorized the approval of duplicate 21 CFR 10.30, requesting that the Administration (FDA or Agency) is
versions of drug products under an Agency determine whether NOROXIN announcing the availability of a
ANDA procedure. ANDA applicants (norfloxacin) tablets, 400 mg, was guidance for industry entitled ‘‘Product
must, with certain exceptions, show that withdrawn from sale for reasons of Name Placement, Size, and Prominence
the drug for which they are seeking safety or effectiveness. in Promotional Labeling and
ethrower on DSK3G9T082PROD with NOTICES

approval contains the same active After considering the citizen petition Advertisements.’’ The guidance clarifies
ingredient in the same strength and and reviewing Agency records and the requirements for product name
dosage form as the ‘‘listed drug,’’ which based on the information we have at this placement, size, prominence, and
is a version of the drug that was time, FDA has determined under frequency in promotional labeling and
previously approved. ANDA applicants § 314.161 that NOROXIN (norfloxacin) advertisements for human prescription
do not have to repeat the extensive tablets, 400 mg, was not withdrawn for drugs, including prescription biological
clinical testing otherwise necessary to reasons of safety or effectiveness. The products, and for animal prescription

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58424 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices

approve, modify, or disapprove the Information and Regulatory Affairs, providing such recommendations, FDA
collections of information, including OMB, Attn: FDA Desk Officer, Fax: 202– may require results of studies to be
OMB control number(s) for newly 395–7285, or emailed to oira_ submitted for review. Section 316.14
approved collections. submission@omb.eop.gov. All contains provisions permitting FDA to
This guidance also refers to comments should be identified with the refuse to provide written
previously approved collections of OMB control number 0910–0167. Also recommendations under certain
information found in FDA regulations. include the FDA docket number found circumstances. Within 90 days of any
The collections of information in brackets in the heading of this refusal, a sponsor may submit
associated with 21 CFR 202.1 have been document. additional information specified by
approved under OMB control number FDA. Based on past experience, FDA
FOR FURTHER INFORMATION CONTACT:
0910–0686. estimates that there will be one
Amber Sanford, Office of Operations,
respondent to §§ 316.10, 316.12, and
III. Electronic Access Food and Drug Administration, Three
316.14 requiring 50 hours of human
Persons with access to the internet White Flint North, 10A–12M, 11601
resources annually.
may obtain the guidance at https:// Landsdown St., North Bethesda, MD Section 316.20 specifies the content
www.fda.gov/Drugs/Guidance 20852, 301–796–8867, PRAStaff@ and format of an orphan drug
ComplianceRegulatoryInformation/ fda.hhs.gov. application which includes
Guidances/default.htm, https://www. SUPPLEMENTARY INFORMATION: In requirements that an applicant
fda.gov/BiologicsBloodVaccines/ compliance with 44 U.S.C. 3507, FDA document that the disease is rare (affects
GuidanceComplianceRegulatory has submitted the following proposed fewer than 200,000 persons in the
Information/default.htm, https:// collection of information to OMB for United States annually) or that the
www.fda.gov/AnimalVeterinary/ review and clearance. sponsor of the drug has no reasonable
GuidanceComplianceEnforcement/ expectation of recovering costs of
Orphan Products Development; Food research and development of the drug.
GuidanceforIndustry/default.htm, or
and Drug Administration Orphan Drug Section 316.21 specifies content of a
https://www.regulations.gov.
Designation Request Form and The request for orphan drug designation
Dated: December 7, 2017. Common European Medicines Agency/ required for verification of orphan-drug
Leslie Kux, Food and Drug Administration Form status. Section 316.26 allows an
Associate Commissioner for Policy. for Orphan Medicinal Product applicant to amend the applications
[FR Doc. 2017–26725 Filed 12–11–17; 8:45 am] Designation (Formerly Orphan Drugs; under certain circumstances. Based on
BILLING CODE 4164–01–P Common European Medicines Agency/ past experience, FDA estimates 496
FDA Application Form for Orphan respondents to §§ 316.20, 316.21, and
Medicinal Product Designation (Form 316.26, requiring 83,700 hours of
DEPARTMENT OF HEALTH AND FDA 3671))—21 CFR Part 316 human resources annually.
HUMAN SERVICES OMB Control Number 0910–0167— The Common EMEA/FDA
Extension Application for Orphan Medicinal
Food and Drug Administration Product Designation form for orphan
[Docket No. FDA–2011–N–0015]
Sections 525 through 528 of the designation of drugs intended for rare
Federal Food, Drug, and Cosmetic Act diseases or conditions (Form FDA 3671)
Agency Information Collection (the FD&C Act) (21 U.S.C. 360aa–360dd) is intended to benefit sponsors who
Activities; Submission for Office of give FDA statutory authority to do the desire to seek orphan designation of
Management and Budget Review; following: (1) Provide recommendations drugs intended for rare diseases or
Comment Request; Orphan Products on investigations required for approval conditions from both the European
Development; Food and Drug of marketing applications for orphan Commission and FDA by reducing the
Administration Orphan Drug drugs, (2) designate eligible drugs as burden of preparing separate
Designation Request Form and The orphan drugs, (3) set forth conditions applications to meet the regulatory
Common European Medicines Agency/ under which a sponsor of an approved requirements in each jurisdiction. It
Food and Drug Administration Form orphan drug obtains exclusive approval, highlights the regulatory cooperation
for Orphan Medicinal Product and (4) encourage sponsors to make between the United States and the
Designation orphan drugs available for treatment on European Union mandated by the
an ‘‘open protocol’’ basis before the drug Transatlantic Economic Council. The
AGENCY: Food and Drug Administration, has been approved for general FDA Orphan Drug Designation Request
HHS. marketing. The implementing Form (Form FDA 4035) is intended to
ACTION: Notice. regulations for these statutory benefit sponsors who desire to seek
requirements have been codified under orphan designation of drugs intended
SUMMARY: The Food and Drug part 316 (21 CFR part 316) and specify for rare diseases or conditions from only
Administration (FDA) is announcing procedures that sponsors of orphan FDA. The form is a simplified method
that a proposed collection of drugs use in availing themselves of the for sponsors to provide only information
information has been submitted to the incentives provided for orphan drugs in required by 21 CFR 316.20 for FDA to
Office of Management and Budget the FD&C Act and sets forth procedures make a decision. Based on past
(OMB) for review and clearance under FDA will use in administering the FD&C experience, FDA estimates there will be
the Paperwork Reduction Act of 1995. Act with regard to orphan drugs. 496 respondents using the form
ethrower on DSK3G9T082PROD with NOTICES

DATES: Fax written comments on the Section 316.10 specifies the content requiring 19,840 hours of human
collection of information by January 11, and format of a request for written resources annually.
2018. recommendations concerning the Section 316.22 specifies requirement
ADDRESSES: To ensure that comments on nonclinical laboratory studies and of a permanent resident agent for foreign
the information collection are received, clinical investigations necessary for sponsors. Based on past experience,
OMB recommends that written approval of marketing applications. FDA estimates 70 respondents requiring
comments be faxed to the Office of Section 316.12 provides that, before 140 hours of human resources annually.

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Document Created: 2018-10-25 10:48:39
Document Modified: 2018-10-25 10:48:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on December 12, 2017.
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.
FR Citation		82 FR 58421

82 FR 58421 - Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 237 (December 12, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration