
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12506-12508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05224]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0712]


Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary 
Disease, a Patient-Reported Outcome, for the Measurement of Severity of 
Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: 
Qualification for Exploratory Use; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Evaluating 
Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a 
Patient-Reported Outcome, for the Measurement of Severity of 
Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: 
Qualification for Exploratory Use.'' This draft guidance provides a 
statement of qualification for exploratory use for the evaluating 
respiratory symptoms in chronic obstructive pulmonary disease (E-RS: 
COPD), a 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

[[Page 12507]]

and Research's (CDER's) drug development tool (DDT) qualification 
program. Qualification for exploratory use of the E-RS: COPD 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 This draft guidance is an attachment 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 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-0712 for ``Evaluating Respiratory Symptoms in Chronic 
Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the 
Measurement of Severity of Respiratory Symptoms in Stable Chronic 
Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft 
Guidance for Industry; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 20993-0002. 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.

FOR FURTHER INFORMATION CONTACT: Elektra Papadopoulos, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6377, Silver Spring, MD 20993-0002, 301-
796-0900.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Evaluating Respiratory Symptoms in Chronic Obstructive 
Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of 
Severity of Respiratory Symptoms in Stable Chronic Obstructive 
Pulmonary Disease: Qualification for Exploratory Use.''
    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

[[Page 12508]]

describing the concept of interest and COU for which the tool is 
qualified. This draft guidance describes the qualification statement 
for the E-RS: COPD, 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 current thinking of FDA on the 
qualification for exploratory use of the E-RS: COPD. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Electronic Access

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

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05224 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P


