
[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1873-1874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00259]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1630]


Draft Guidance for Industry on Qualification of Exacerbations of 
Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute 
Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic 
Obstructive Pulmonary Disease; 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availability of a draft guidance for industry entitled ``Qualification 
of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of 
Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in 
Patients with Chronic Obstructive Pulmonary Disease.'' This draft 
guidance provides a statement of qualification for the Exacerbations of 
Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome 
instrument and summarizes the concept of interest and context of use 
(COU) for which the tool is qualified through the Center for Drug 
Evaluation and Research's (CDER's) drug development tool (DDT) 
qualification program. Qualification of the EXACT represents a 
conclusion that, within the stated COU, the instrument can be relied on 
to have a specific interpretation and application in drug development 
and regulatory review. This draft guidance is an attachment to the 
guidance for industry entitled ``Qualification Process for Drug 
Development Tools.''

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency

[[Page 1874]]

considers your comment on this draft guidance before it begins work on 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comments on the draft guidance by April 10, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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: Elektra J. Papadopoulos, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6429, Silver Spring, MD 20993-0002, 301-
796-0900.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Qualification of Exacerbations of Chronic Pulmonary Disease 
Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of 
Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary 
Disease.''
    In March 2006, FDA issued the ``Critical Path Opportunities Report 
and List'', in which FDA described six key areas along the critical 
path to improved therapies and listed specific opportunities for 
advancement within these topic areas. The report noted that a new 
product development toolkit containing new scientific and technical 
methods was needed to improve the efficiency of drug development.
    Innovative and improved DDTs can help streamline the drug 
development process, improve the chances for clinical trial success, 
and yield more information about a treatment and/or disease. DDTs 
include, but are not limited to, biomarkers and clinical outcome 
assessments (COAs). CDER has developed a formal process, the DDT 
qualification process, to work with developers of these tools to guide 
them as they refine the tools and rigorously evaluate them for use in 
the regulatory context. Once qualified, DDTs will be publicly available 
for use in any drug development program for the qualified COU. COA DDTs 
are developed and reviewed using this process when they are intended 
ultimately for use as primary or secondary endpoints in clinical trials 
designed to provide substantial evidence of treatment benefit. Upon 
qualification by CDER, a qualification statement is provided describing 
the concept of interest and COU for which the tool is qualified. This 
draft guidance describes the qualification statement for the EXACT, a 
COA DDT.
    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 
qualification of the EXACT COA DDT. 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. 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.

III. 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 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00259 Filed 1-9-14; 8:45 am]
BILLING CODE 4160-01-P


