[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Page 7203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0091]


Draft Guidance for Industry on Analgesic Indications: Developing 
Drug and Biological 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availability of a draft guidance for industry entitled ``Analgesic 
Indications: Developing Drug and Biological Products.'' This guidance 
provides recommendations to sponsors on the development of prescription 
drugs for the management of acute and chronic pain, as well as the 
management of breakthrough pain. Specifically, this guidance focuses on 
drug development and trial design issues and chemistry, manufacturing, 
and controls concerns that are unique to the study of acute, chronic, 
and breakthrough pain and the labeling considerations for analgesic 
drugs.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 7, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Sharon Hertz, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3156, Silver Spring, MD 20993-0002, 301-
796-2280.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Analgesic Indications: Developing Drug and Biological 
Products.'' Analgesic development involves important concepts that 
should be considered during drug development, such as the duration of 
drug exposure for the treatment of acute and chronic pain and the 
subjective nature of pain intensity measurement. It is important that 
the spectrum of clinical studies planned during analgesic development 
provide an adequate characterization of the clinical, pharmacological, 
and, when feasible, pharmacodynamic behavior of the drug. This draft 
guidance presents the types of indications FDA may be willing to 
approve at present for analgesic drugs. It also presents general trial 
design issues, appropriate endpoints, and important safety 
considerations. For example, the guidance discusses the importance of 
appropriate statistical considerations that take into account the 
amount of nonrandom missing data in analgesic drug trials.
    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 the 
development of drug and biological products for analgesic indications. 
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 were approved under OMB control 
numbers 0910-0001, 0910-0338, and 0910-0014.

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: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02557 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P