81_FR_32043 81 FR 31945 - Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

81 FR 31945 - Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 98 (May 20, 2016)

Page Range31945-31946
FR Document2016-11855

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.''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 This guidance revises the draft guidance of the same name, issued November 9, 2007, by adding information regarding the St. George's Respiratory Questionnaire (SGRQ).

Federal Register, Volume 81 Issue 98 (Friday, May 20, 2016) 
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31945-31946]
From the Federal Register Online  [www.thefederalregister.org]
[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Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Chronic 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 This guidance revises the draft 
guidance of the same name, issued November 9, 2007, by adding 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 19, 2016.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]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31945 Ave., Bldg. 66, Rm. 1650, Silver Spring, Act. The 30-day period for requesting The regulations provide that FDA MD 20993–0002, 301–796–6524. reconsideration of an FDA action under publish a quarterly list of available SUPPLEMENTARY INFORMATION: § 10.33(b) (21 CFR 10.33(b)) for notices safety and effectiveness summaries of announcing approval of a PMA begins PMA approvals and denials that were I. Background on the day the notice is placed on the announced during that quarter. The In accordance with sections 515(d)(4) Internet. Section 10.33(b) provides that following is a list of approved PMAs for and (e)(2) of the Federal Food, Drug, and FDA may, for good cause, extend this which summaries of safety and Cosmetic Act (the FD&C Act) (21 U.S.C. 30-day period. Reconsideration of a effectiveness were placed on the 360e(d)(4) and (e)(2)), notification of an denial or withdrawal of approval of a Internet from January 1, 2016, through order approving, denying, or PMA may be sought only by the March 31, 2016. There were no denial withdrawing approval of a PMA will applicant; in these cases, the 30-day actions during this period. The list continue to include a notice of period will begin when the applicant is provides the manufacturer’s name, the opportunity to request review of the notified by FDA in writing of its product’s generic name or the trade order under section 515(g) of the FD&C decision. name, and the approval date. TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2016, THROUGH MARCH 31, 2016 PMA No., Applicant Trade name Approval date Docket No. H130006, FDA–2015–M–4950 Torax Medical, Inc .................. FENIX Continence Restoration System ................................... 12/18/2015 H140005, FDA–2015–M–4948 ARUP Laboratories ................. PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syn- 12/18/2015 drome/Myeloproliferative Disease (MDS/MPD). H140006, FDA–2015–M–4949 ARUP Laboratories ................. KIT D816V Mutation Detection by PCR for Gleevec Eligibility 12/18/2015 in Aggressive Systemic Mastocytosis (ASM). P130007/S004, FDA–2016–M– Animas Corp ........................... Animas Vibe System ................................................................ 12/24/2015 0120. P900033/S042, FDA–2016–M– Integra LifeSciences Corp ...... Integra Omnigraft Dermal Regeneration Matrix and Integra 1/7/2016 0121. Dermal Regeneration Template. P080028, FDA–2016–M–0122 Storz Medical Ag .................... Storz Medical Duolith SD1 Shock Wave Therapy ................... 1/8/2016 P150011, FDA–2016–M–0123 LivaNova Canada Corp .......... Perceval Sutureless Heart Valve ............................................. 1/8/2016 P150027, FDA–2016–M–0803 Dako North America, Inc ........ PD–L1 IHC 28–8 pharmDx ...................................................... 1/23/2016 P150004, FDA–2016–M–0804 Spinal Modulation, Inc ............ Axium Neurostimulator System ................................................ 2/11/2016 P150022, FDA–2016–M–0805 Rex Medical, L.P .................... Closer Vascular Sealing System ............................................. 2/12/2016 P120018, FDA–2016–M–0806 Sharps Terminator, LLC ......... Sharps Terminator ................................................................... 2/17/2016 P150005, FDA–2016–M–0807 Boston Scientific Corp ............ Blazer Open-Irrigated Ablation Catheter System .................... 2/24/2016 P130009/S037, FDA–2016–M– Edwards Lifesciences, LLC .... SAPIEN XT Transcatheter Heart Valve and Accessories ....... 2/29/2016 0926. P020004/S123, FDA–2016–M– W.L. Gore & Associates, Inc .. GORE EXCLUDER Iliac Branch Endoprosthesis .................... 2/29/2016 0928. II. Electronic Access ACTION: Notice of availability. ADDRESSES: You may submit comments Persons with access to the Internet as follows: may obtain the documents at http:// SUMMARY: The Food and Drug Electronic Submissions www.fda.gov/MedicalDevices/ Administration (FDA or Agency) is ProductsandMedicalProcedures/ announcing the availability of a draft Submit electronic comments in the DeviceApprovalsandClearances/ guidance for industry entitled ‘‘Chronic following way: PMAApprovals/default.htm. Obstructive Pulmonary Disease: • Federal eRulemaking Portal: http:// Dated: May 16, 2016. Developing Drugs for Treatment.’’ This www.regulations.gov. Follow the Leslie Kux, guidance is intended to assist sponsors instructions for submitting comments. Associate Commissioner for Policy. in designing a clinical development Comments submitted electronically, program for new drug products for the including attachments, to http:// [FR Doc. 2016–11856 Filed 5–19–16; 8:45 am] treatment of chronic obstructive www.regulations.gov will be posted to BILLING CODE 4164–01–P pulmonary disease (COPD). This the docket unchanged. Because your guidance revises the draft guidance of comment will be made public, you are DEPARTMENT OF HEALTH AND the same name, issued November 9, solely responsible for ensuring that your HUMAN SERVICES 2007, by adding information regarding comment does not include any the St. George’s Respiratory confidential information that you or a Food and Drug Administration Questionnaire (SGRQ). third party may not wish to be posted, such as medical information, your or [Docket No. FDA–2007–D–0133] DATES: Although you can comment on anyone else’s Social Security number, or mstockstill on DSK3G9T082PROD with NOTICES any guidance at any time (see 21 CFR confidential business information, such Chronic Obstructive Pulmonary 10.115(g)(5)), to ensure that the Agency as a manufacturing process. Please note Disease: Developing Drugs for considers your comment on this draft that if you include your name, contact Treatment; Draft Guidance for guidance before it begins work on the information, or other information that Industry; Availability final version of the guidance, submit identifies you in the body of your AGENCY: Food and Drug Administration, either electronic or written comments comments, that information will be HHS. on the draft guidance by July 19, 2016. posted on http://www.regulations.gov. VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1

31946 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices • If you want to submit a comment comments to public dockets, see 80 FR November 9, 2007 (72 FR 63618), by with confidential information that you 56469, September 18, 2015, or access adding information on the use of SGRQ do not wish to be made available to the the information at: http://www.fda.gov/ in COPD studies. FDA acknowledges the public, submit the comment as a regulatoryinformation/dockets/ importance of assessing patient written/paper submission and in the default.htm. perspectives in clinical trials and manner detailed (see ‘‘Written/Paper Docket: For access to the docket to therefore is interested in eliciting Submissions’’ and ‘‘Instructions’’). read background documents or the comment on the SGRQ, included in electronic and written/paper comments Appendix A. Written/Paper Submissions received, go to http:// Also, this guidance outlines FDA’s Submit written/paper submissions as www.regulations.gov and insert the thinking based on information that was follows: docket number, found in brackets in the available in 2007 on the development of • Mail/Hand delivery/Courier (for heading of this document, into the various types of drugs for COPD. FDA written/paper submissions): Division of ‘‘Search’’ box and follow the prompts acknowledges that the landscape of Dockets Management (HFA–305), Food and/or go to the Division of Dockets clinical trials has evolved since 2007 and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. and therefore is encouraging public Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. comment on the body of the guidance in • For written/paper comments Submit written requests for single addition to public comment on the submitted to the Division of Dockets copies of the draft guidance to the SGRQ information added in Appendix Management, FDA will post your Division of Drug Information, Center for A. comment, as well as any attachments, Drug Evaluation and Research, Food This draft guidance is being issued except for information submitted, and Drug Administration, 10001 New consistent with FDA’s good guidance marked and identified, as confidential, Hampshire Ave., Hillandale Building, practices regulation (21 CFR 10.115). if submitted as detailed in 4th Floor, Silver Spring, MD 20993– The draft guidance, when finalized, will ‘‘Instructions.’’ 0002. Send one self-addressed adhesive represent the current thinking of FDA Instructions: All submissions received label to assist that office in processing on the development of drug products for must include the Docket No. FDA– your requests. See the SUPPLEMENTARY the treatment of COPD. It does not 2007–D–0133 for ‘‘Chronic Obstructive INFORMATION section for electronic establish any rights for any person and Pulmonary Disease: Developing Drugs access to the draft guidance document. is not binding on FDA or the public. for Treatment; Draft Guidance for FOR FURTHER INFORMATION CONTACT: You can use an alternative approach if Industry; Availability.’’ Received Badrul A. Chowdhury, Center for Drug it satisfies the requirements of the comments will be placed in the docket Evaluation and Research, Food and applicable statutes and regulations. and, except for those submitted as Drug Administration, 10903 New ‘‘Confidential Submissions,’’ publicly II. Electronic Access Hampshire Ave., Bldg. 22, Rm. 3326, viewable at http://www.regulations.gov Silver Spring, MD 20993–0002, 301– Persons with access to the Internet or at the Division of Dockets 796–2300. may obtain the draft guidance at either Management between 9 a.m. and 4 p.m., http://www.fda.gov/Drugs/Guidance SUPPLEMENTARY INFORMATION: Monday through Friday. ComplianceRegulatoryInformation/ • Confidential Submissions—To I. Background Guidances/default.htm or http:// submit a comment with confidential FDA is announcing the availability of www.regulations.gov. information that you do not wish to be a draft guidance for industry entitled Dated: May 13, 2016. made publicly available, submit your ‘‘Chronic Obstructive Pulmonary comments only as a written/paper Leslie Kux, Disease: Developing Drugs for Associate Commissioner for Policy. submission. You should submit two Treatment.’’ This guidance is intended copies total. One copy will include the [FR Doc. 2016–11855 Filed 5–19–16; 8:45 am] to assist sponsors in designing a clinical information you claim to be confidential development program for new drug BILLING CODE 4164–01–P with a heading or cover note that states products for the treatment of COPD. The ‘‘THIS DOCUMENT CONTAINS emphasis of this guidance is on the CONFIDENTIAL INFORMATION.’’ The DEPARTMENT OF HEALTH AND assessment of efficacy of a new Agency will review this copy, including HUMAN SERVICES molecular entity (NME) in phase 3 the claimed confidential information, in clinical studies of COPD. Development Food and Drug Administration its consideration of comments. The of NMEs for COPD poses challenges and second copy, which will have the opportunities. Not all drugs developed [Docket No. FDA–2016–N–0001] claimed confidential information for COPD will fit into the types redacted/blacked out, will be available Blood Products Advisory Committee; described, and the efficacy endpoints for public viewing and posted on http:// Notice of Meeting discussed in this guidance may not fit www.regulations.gov. Submit both the need for all drugs. FDA encourages AGENCY: Food and Drug Administration, copies to the Division of Dockets sponsors to develop clinical programs HHS. Management. If you do not wish your that fit their particular needs and to ACTION: Notice. name and contact information to be discuss their planned approach with the made publicly available, you can Center for Drug Evaluation and SUMMARY: The Food and Drug provide this information on the cover Research’s Division of Pulmonary, Administration (FDA) announces a sheet and not in the body of your forthcoming public advisory committee mstockstill on DSK3G9T082PROD with NOTICES Allergy, and Rheumatology Products. comments and you must identify this For novel approaches, where warranted, meeting of the Blood Products Advisory information as ‘‘confidential.’’ Any outside expertise can be sought, Committee. The general function of the information marked as ‘‘confidential’’ including consultation with the committee is to provide advice and will not be disclosed except in Pulmonary-Allergy Drugs Advisory recommendations to the Agency on accordance with 21 CFR 10.20 and other Committee. FDA’s regulatory issues. At least one applicable disclosure law. For more This guidance revises the draft portion of the meeting will be closed to information about FDA’s posting of guidance of the same name, issued the public. VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1


Document Created: 2016-05-20 01:59:56
Document Modified: 2016-05-20 01:59:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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.
ContactBadrul 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.
FR Citation81 FR 31945 
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