[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31945-31946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0133]


Chronic Obstructive Pulmonary Disease: Developing Drugs for 
Treatment; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Chronic 
Obstructive Pulmonary Disease: Developing Drugs for Treatment.'' This 
guidance is intended to assist sponsors in designing a clinical 
development program for new drug products for the treatment of chronic 
obstructive pulmonary disease (COPD). This guidance revises the draft 
guidance of the same name, issued November 9, 2007, by adding 
information regarding the St. George's Respiratory Questionnaire 
(SGRQ).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 19, 2016.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.

[[Page 31946]]

     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-2007-D-0133 for ``Chronic Obstructive Pulmonary Disease: Developing 
Drugs for Treatment; 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: Badrul A. Chowdhury, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3326, 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 Obstructive Pulmonary Disease: Developing Drugs for 
Treatment.'' This guidance is intended to assist sponsors in designing 
a clinical development program for new drug products for the treatment 
of COPD. The emphasis of this guidance is on the assessment of efficacy 
of a new molecular entity (NME) in phase 3 clinical studies of COPD. 
Development of NMEs for COPD poses challenges and opportunities. Not 
all drugs developed for COPD will fit into the types described, and the 
efficacy endpoints discussed in this guidance may not fit the need for 
all drugs. FDA encourages sponsors to develop clinical programs that 
fit their particular needs and to discuss their planned approach with 
the Center for Drug Evaluation and Research's Division of Pulmonary, 
Allergy, and Rheumatology Products. For novel approaches, where 
warranted, outside expertise can be sought, including consultation with 
the Pulmonary-Allergy Drugs Advisory Committee.
    This guidance revises the draft guidance of the same name, issued 
November 9, 2007 (72 FR 63618), by adding information on the use of 
SGRQ in COPD studies. FDA acknowledges the importance of assessing 
patient perspectives in clinical trials and therefore is interested in 
eliciting comment on the SGRQ, included in Appendix A.
    Also, this guidance outlines FDA's thinking based on information 
that was available in 2007 on the development of various types of drugs 
for COPD. FDA acknowledges that the landscape of clinical trials has 
evolved since 2007 and therefore is encouraging public comment on the 
body of the guidance in addition to public comment on the SGRQ 
information added in Appendix A.
    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 
development of drug products for the treatment of 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: May 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11855 Filed 5-19-16; 8:45 am]
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