
[Federal Register Volume 79, Number 151 (Wednesday, August 6, 2014)]
[Notices]
[Pages 45812-45813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0968]


Draft Guidance for Industry on Upper Facial Lines: Developing 
Botulinum Toxin Drug Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Upper Facial 
Lines: Developing Botulinum Toxin Drug Products.'' The purpose of this 
draft guidance is to assist sponsors with their clinical trial designs 
using botulinum toxin drug products intended for the treatment of upper 
facial lines. This draft guidance clarifies FDA's thinking on endpoint 
development and clinical trial design considerations for botulinum 
toxin drug products that present unique safety concerns.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 4, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cristina Attinello, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5181, Silver Spring, MD 20993-0002, 301-
796-3986.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Upper Facial Lines: Developing Botulinum Toxin Drug 
Products.'' The purpose of this draft guidance is to assist sponsors 
with their clinical trial designs using botulinum toxin drug products 
intended for the treatment of upper facial lines. This draft guidance 
clarifies FDA's thinking on endpoint development and clinical trial 
design considerations for botulinum toxin drug products that present 
unique safety concerns related to the potential for local and distant 
spread of toxin effect.
    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 developing 
botulinum toxin drug products for upper facial lines. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995

[[Page 45813]]

(44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 
312 and 314 have been approved under OMB control numbers 0910-0014 and 
0910-0001, respectively.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://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 http://www.regulations.gov.

IV. Electronic Access

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

    Dated: July 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18564 Filed 8-5-14; 8:45 am]
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