[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63129-63130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1540]


Migraine: Developing Drugs for Acute Treatment; Draft Guidance 
for Industry; 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availability of a draft guidance for industry entitled ``Migraine: 
Developing Drugs for Acute Treatment.'' The purpose of this guidance is 
to assist sponsors in the clinical development of drugs for the acute 
treatment of migraine. This guidance focuses on specific drug 
development and trial design issues that are unique to the study of 
drugs for the acute treatment of migraine. This guidance is intended to 
serve as a focus for continued discussions among the Division of 
Neurology Products, pharmaceutical sponsors, the academic community, 
and the public.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 22, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993. 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electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Eric Bastings, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4338, Silver Spring, MD 20993-0002, 301-
796-1039.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Migraine: Developing Drugs for Acute Treatment.'' The 
purpose of this guidance is to assist sponsors in the clinical 
development of drugs for the acute treatment of migraine. This guidance 
focuses on specific drug development and trial design issues that are 
unique to the study of drugs for the acute treatment of migraine. This 
guidance is intended to serve as a focus for continued discussions 
among the Division of Neurology Products, pharmaceutical sponsors, the 
academic community, and the public.
    Migraine is a chronic neurovascular disorder characterized by 
recurrent attacks of often severe headache, typically presenting with 
nausea, vomiting, and sensitivity to light and/or sound. Pharmacologic 
approaches to the treatment of migraine include drugs to treat acute 
migraine attacks as they arise (acute treatment of migraine) and drugs 
to reduce the frequency of migraine attacks (preventive treatment). 
This guidance addresses the development program of drugs for the acute 
treatment of migraine, including trial population, trial design, dose 
selection, efficacy endpoints, and statistical considerations. The 
guidance also discusses safety considerations, pediatric studies, and 
labeling considerations.
    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 
drugs for the acute treatment of migraine. 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 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 201, 312, and 314 
have been approved under OMB control numbers 0910-0572, 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

[[Page 63130]]

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: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25048 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P