[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Notices]
[Pages 13658-13659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0264]


Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic 
Encephalomyelitis: Developing Drug Products for Treatment; 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availability of a draft guidance for industry entitled ``Chronic 
Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products 
for Treatment.'' The purpose of this draft guidance is to assist 
sponsors in the development of drug products for the treatment of 
chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 12, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Janet Maynard, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3185, Silver Spring, MD 20993-0002, 301-
796-2300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: 
Developing Drug Products for Treatment.'' The purpose of this draft 
guidance is to assist sponsors in the development of drug products for 
the treatment of CFS/ME.
    Currently, there are no approved therapies indicated to treat CFS/
ME. The lack of approved therapies indicated for the treatment of CFS/
ME represents a public health concern. To foster drug development in 
CFS/ME, this draft guidance outlines the following key issues in drug 
development in CFS/ME:
     The case definitions or criteria for CFS/ME that could be 
used to define a patient population in the context of drug development

[[Page 13659]]

     Recommendations for establishing efficacy in CFS/ME based 
on patient-reported symptoms and measurements of exercise capacity
     Recommended trial design and duration
     Recommendations for establishing safety in CFS/ME
    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 
drug products for the treatment of CFS/ME. 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 part 314 have been 
approved under OMB control number 0910-0001.

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: March 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05189 Filed 3-10-14; 8:45 am]
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