82_FR_28439 82 FR 28321 - Development of New Tuberculosis Treatment Regimens-Scientific and Clinical Trial Design Considerations; Public Workshop; Request for Comments

82 FR 28321 - Development of New Tuberculosis Treatment Regimens-Scientific and Clinical Trial Design Considerations; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 118 (June 21, 2017)

Page Range28321-28322
FR Document2017-12906

The Food and Drug Administration (FDA, the Agency, or we) is/ are announcing a public workshop regarding scientific and clinical trial design considerations for the development of new tuberculosis (TB) treatment regimens. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders regarding scientific and clinical trial design considerations related to the development of new TB regimens.

Federal Register, Volume 82 Issue 118 (Wednesday, June 21, 2017) 
[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Notices]
[Pages 28321-28322]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2769]


Development of New Tuberculosis Treatment Regimens--Scientific 
and Clinical Trial Design Considerations; Public Workshop; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is/
are announcing a public workshop regarding scientific and clinical 
trial design considerations for the development of new tuberculosis 
(TB) treatment regimens. This public workshop is intended to provide 
information for and gain perspective from health care providers, other 
U.S. Government Agencies, academic experts, industry, and other 
stakeholders regarding scientific and clinical trial design 
considerations related to the development of new TB regimens.

DATES: The public workshop will be held on July 19, 2017, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public workshop by August 1, 2017. See the SUPPLEMENTARY INFORMATION 
section for registration date and information. The workshop draft 
agenda will be made available at https://www.fda.gov/Drugs/NewsEvents/ucm548365.htm prior to the meeting.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before August 1, 2017. The https://www.regulations.gov 
electronic filing system will accept comments until midnight eastern 
time on August 1, 2017. Comments received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-2769 for ``Development of New Tuberculosis Treatment 
Regimens--Scientific and Clinical Trial Design Considerations; Public 
Workshop; Request for Comments.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes, 
Center for

[[Page 28322]]

Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop regarding scientific and 
clinical trial design considerations for the development of new TB drug 
regimens. As such, discussions will focus on drug development programs 
and studies intended to evaluate shorter and better tolerated TB drug 
regimens and new regimens that have efficacy for treatment of sensitive 
and drug-resistant TB.

II. Topics for Discussion at the Public Workshop

    The FDA is conducting this workshop to focus on scientific 
considerations needed to advance the development of new TB treatment 
regimens. FDA is particularly interested in discussing pre-clinical and 
clinical considerations relevant to the development of new TB treatment 
regimens. Discussions are planned around the following topics:
     Current landscape and challenges in TB drug development.
     In vitro and in vivo nonclinical models that may help 
select or deselect new investigational TB drug regimens to enter into 
clinical development.
     Biomarkers that may help predict responses to therapy at a 
time earlier than standard liquid or solid culture results would allow.
     Surrogate endpoints that may be used to predict clinical 
benefit.
     An update on TB diagnostics.
     Options for assessing the contribution of individual drugs 
in a new TB treatment regimen.
     Clinical trial design challenges in pediatric and special 
populations.
    The Agency encourages health care providers, other U.S. Government 
Agencies, academic experts, industry, and other stakeholders to attend 
this public workshop.

III. Participating in the Public Workshop

    Registration: Registration is free and based on space availability, 
with priority given to early registrants. Persons interested in 
attending this public workshop must register by July 14, 2017, midnight 
eastern standard time. To register, please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone to [email protected]. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted. If time and space permit, onsite registration on the day of 
the public workshop will be provided beginning at 7:30 a.m. We will let 
registrants know if registration closes before the day of the public 
workshop.
    If you need special accommodations due to a disability, please 
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION 
CONTACT) no later than July 14, 2017.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session and 
which topic(s) you wish to address. We will do our best to accommodate 
requests to make public comments. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations, and request time for a joint presentation, or submit 
requests for designated representatives to participate in the focused 
sessions. Following the close of registration, we will determine the 
amount of time allotted to each presenter and the approximate time each 
oral presentation is to begin, and will select and notify participants 
by July 11, 2017. All requests to make oral presentations must be 
received by July 10, 2017. If selected for presentation, any 
presentation materials must be emailed to 
[email protected] no later than July 13, 2017. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast at the following site at https://collaboration.fda.gov/tbdd071917.
    If you have never attended a Connect Pro event before, please test 
your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro 
program, visit https://www.adobe.com/go/connectpro_overview. FDA has 
verified the Web site addresses in this document, as of the date this 
document publishes in the Federal Register, but Web sites are subject 
to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
Internet at http://www.fda.gov/Drugs/NewsEvents/ucm548365.htm 
approximately 45 days after the workshop.

    Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12906 Filed 6-20-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices 28321 ADDRESSES: You may submit comments, Entrance for the public workshop information submitted, marked and identified by CDC–2017–0028 and participants (non-FDA employees) is identified, as confidential, if submitted Docket Number NIOSH–290, by either through Building 1 where routine as detailed in ‘‘Instructions.’’ of the following two methods: security check procedures will be Instructions: All submissions received • Federal eRulemaking Portal: http:// performed. For parking and security must include the Docket No. FDA– www.regulations.gov. Follow the information, please refer to https:// 2017–N–2769 for ‘‘Development of New instructions for submitting comments. www.fda.gov/AboutFDA/ Tuberculosis Treatment Regimens— • Mail: National Institute for WorkingatFDA/BuildingsandFacilities/ Scientific and Clinical Trial Design Occupational Safety and Health, NIOSH WhiteOakCampusInformation/ Considerations; Public Workshop; Docket Office, 1090 Tusculum Avenue, ucm241740.htm. Request for Comments.’’ Received MS C–34, Cincinnati, Ohio 45226–1998. You may submit comments as comments, those filed in a timely follows. Please note that late, untimely manner (see ADDRESSES), will be placed John Howard, filed comments will not be considered. in the docket and, except for those Director, National Institute for Occupational Electronic comments must be submitted submitted as ‘‘Confidential Safety and Health, Centers for Disease Control and Prevention. on or before August 1, 2017. The https:// Submissions,’’ publicly viewable at www.regulations.gov electronic filing https://www.regulations.gov or at the [FR Doc. 2017–12942 Filed 6–20–17; 8:45 am] system will accept comments until Dockets Management Staff between 9 BILLING CODE 4163–19–P midnight eastern time on August 1, a.m. and 4 p.m., Monday through 2017. Comments received by mail/hand Friday. DEPARTMENT OF HEALTH AND delivery/courier (for written/paper • Confidential Submissions—To HUMAN SERVICES submissions) will be considered timely submit a comment with confidential if they are postmarked or the delivery information that you do not wish to be Food and Drug Administration service acceptance receipt is on or made publicly available, submit your before that date. comments only as a written/paper [Docket No. FDA–2017–N–2769] Electronic Submissions submission. You should submit two Development of New Tuberculosis copies total. One copy will include the Submit electronic comments in the information you claim to be confidential Treatment Regimens—Scientific and following way: Clinical Trial Design Considerations; with a heading or cover note that states • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS Public Workshop; Request for https://www.regulations.gov. Follow the Comments CONFIDENTIAL INFORMATION.’’ The instructions for submitting comments. Agency will review this copy, including AGENCY: Food and Drug Administration, Comments submitted electronically, the claimed confidential information, in HHS. including attachments, to https:// its consideration of comments. The ACTION: Notice of public workshop; www.regulations.gov will be posted to second copy, which will have the request for comments. the docket unchanged. Because your claimed confidential information comment will be made public, you are redacted/blacked out, will be available SUMMARY: The Food and Drug solely responsible for ensuring that your for public viewing and posted on Administration (FDA, the Agency, or comment does not include any https://www.regulations.gov. Submit we) is/are announcing a public confidential information that you or a both copies to the Dockets Management workshop regarding scientific and third party may not wish to be posted, Staff. If you do not wish your name and clinical trial design considerations for such as medical information, your or contact information to be made publicly the development of new tuberculosis anyone else’s Social Security number, or available, you can provide this (TB) treatment regimens. This public confidential business information, such information on the cover sheet and not workshop is intended to provide as a manufacturing process. Please note in the body of your comments and you information for and gain perspective that if you include your name, contact must identify this information as from health care providers, other U.S. information, or other information that ‘‘confidential.’’ Any information marked Government Agencies, academic identifies you in the body of your as ‘‘confidential’’ will not be disclosed experts, industry, and other comments, that information will be except in accordance with 21 CFR 10.20 stakeholders regarding scientific and posted on https://www.regulations.gov. and other applicable disclosure law. For clinical trial design considerations • If you want to submit a comment more information about FDA’s posting related to the development of new TB with confidential information that you of comments to public dockets, see 80 regimens. do not wish to be made available to the FR 56469, September 18, 2015, or access public, submit the comment as a the information at: https://www.gpo.gov/ DATES: The public workshop will be written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- held on July 19, 2017, from 8:30 a.m. to manner detailed (see ‘‘Written/Paper 23389.pdf. 5 p.m. Submit either electronic or Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to written comments on this public workshop by August 1, 2017. See the Written/Paper Submissions read background documents or the SUPPLEMENTARY INFORMATION section for Submit written/paper submissions as electronic and written/paper comments registration date and information. The follows: received, go to https:// workshop draft agenda will be made • Mail/Hand delivery/Courier (for www.regulations.gov and insert the asabaliauskas on DSKBBXCHB2PROD with NOTICES available at https://www.fda.gov/Drugs/ written/paper submissions): Dockets docket number, found in brackets in the NewsEvents/ucm548365.htm prior to Management Staff (HFA–305), Food and heading of this document, into the the meeting. Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management be held at FDA’s White Oak Campus, • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061, 10903 New Hampshire Ave., Building submitted to the Dockets Management Rockville, MD 20852. 31 Conference Center, the Great Room Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT: Lori (Rm. 1503), Silver Spring, MD 20993. well as any attachments, except for Benner and/or Jessica Barnes, Center for VerDate Sep<11>2014 19:12 Jun 20, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1

28322 Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices Drug Evaluation and Research, Food telephone to accessible at https:// and Drug Administration, 10903 New TuberculosisWorkshop2017@ www.regulations.gov. It may be viewed Hampshire Ave., Bldg. 22, Rm. 6221, fda.hhs.gov. Early registration is at the Dockets Management Staff (see Silver Spring, MD 20993–0002, 301– recommended because seating is ADDRESSES). A link to the transcript will 796–1300. limited; therefore, FDA may limit the also be available on the Internet at SUPPLEMENTARY INFORMATION: number of participants from each http://www.fda.gov/Drugs/NewsEvents/ organization. Registrants will receive ucm548365.htm approximately 45 days I. Background confirmation when they have been after the workshop. FDA is announcing a public accepted. If time and space permit, Dated: June 15, 2017. workshop regarding scientific and onsite registration on the day of the Anna K. Abram, clinical trial design considerations for public workshop will be provided Deputy Commissioner for Policy, Planning, the development of new TB drug beginning at 7:30 a.m. We will let Legislation, and Analysis. regimens. As such, discussions will registrants know if registration closes [FR Doc. 2017–12906 Filed 6–20–17; 8:45 am] focus on drug development programs before the day of the public workshop. BILLING CODE 4164–01–P and studies intended to evaluate shorter If you need special accommodations and better tolerated TB drug regimens due to a disability, please contact Jessica and new regimens that have efficacy for Barnes or Lori Benner (see FOR FURTHER DEPARTMENT OF HEALTH AND treatment of sensitive and drug-resistant INFORMATION CONTACT) no later than July HUMAN SERVICES TB. 14, 2017. Requests for Oral Presentations: Food and Drug Administration II. Topics for Discussion at the Public During online registration you may Workshop indicate if you wish to present during a public comment session and which [Docket No. FDA–2017–N–3203] The FDA is conducting this workshop to focus on scientific considerations topic(s) you wish to address. We will do Wyeth Pharmaceuticals Inc. et al.; needed to advance the development of our best to accommodate requests to Withdrawal of Approval of 121 New new TB treatment regimens. FDA is make public comments. Individuals and Drug Applications and 161 Abbreviated particularly interested in discussing pre- organizations with common interests are New Drug Applications clinical and clinical considerations urged to consolidate or coordinate their relevant to the development of new TB presentations, and request time for a AGENCY: Food and Drug Administration, treatment regimens. Discussions are joint presentation, or submit requests for HHS. planned around the following topics: designated representatives to participate ACTION: Notice. • Current landscape and challenges in the focused sessions. Following the in TB drug development. close of registration, we will determine SUMMARY: The Food and Drug • In vitro and in vivo nonclinical the amount of time allotted to each Administration (FDA) is withdrawing models that may help select or deselect presenter and the approximate time approval of 121 new drug applications new investigational TB drug regimens to each oral presentation is to begin, and (NDAs) and 161 abbreviated new drug enter into clinical development. will select and notify participants by applications (ANDAs) from multiple • Biomarkers that may help predict July 11, 2017. All requests to make oral applicants. The holders of the responses to therapy at a time earlier presentations must be received by July applications notified the Agency in than standard liquid or solid culture 10, 2017. If selected for presentation, writing that the drug products were no results would allow. any presentation materials must be longer marketed and requested that the • Surrogate endpoints that may be emailed to TuberculosisWorkshop2017@ approval of the applications be used to predict clinical benefit. fda.hhs.gov no later than July 13, 2017. withdrawn. • An update on TB diagnostics. No commercial or promotional material DATES: The withdrawal is effective on • Options for assessing the will be permitted to be presented or July 21, 2017. contribution of individual drugs in a distributed at the public workshop. new TB treatment regimen. Streaming Webcast of the Public FOR FURTHER INFORMATION CONTACT: • Clinical trial design challenges in Workshop: This public workshop will Florine P. Purdie, Center for Drug pediatric and special populations. also be Webcast at the following site at Evaluation and Research, Food and The Agency encourages health care https://collaboration.fda.gov/ Drug Administration, 10903 New providers, other U.S. Government tbdd071917. Hampshire Ave., Bldg. 51, Rm. 6248, Agencies, academic experts, industry, If you have never attended a Connect Silver Spring, MD 20993–0002, 301– and other stakeholders to attend this Pro event before, please test your 796–3601. public workshop. connection at https:// SUPPLEMENTARY INFORMATION: The collaboration.fda.gov/common/help/en/ holders of the applications listed in III. Participating in the Public support/meeting_test.htm. To get a table 1 in this document have informed Workshop quick overview of the Connect Pro FDA that these drug products are no Registration: Registration is free and program, visit https://www.adobe.com/ longer marketed and have requested that based on space availability, with go/connectpro_overview. FDA has FDA withdraw approval of the priority given to early registrants. verified the Web site addresses in this applications under the process in asabaliauskas on DSKBBXCHB2PROD with NOTICES Persons interested in attending this document, as of the date this document § 314.150(c) (21 CFR 314.150(c)). The public workshop must register by July publishes in the Federal Register, but applicants have also, by their requests, 14, 2017, midnight eastern standard Web sites are subject to change over waived their opportunity for a hearing. time. To register, please provide time. Withdrawal of approval of an complete contact information for each Transcripts: Please be advised that as application or abbreviated application attendee, including name, title, soon as a transcript of the public under § 314.150(c) is without prejudice affiliation, address, email, and workshop is available, it will be to refiling. VerDate Sep<11>2014 19:12 Jun 20, 2017 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1


Document Created: 2018-11-14 10:08:54
Document Modified: 2018-11-14 10:08:54
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 public workshop; request for comments.
DatesThe public workshop will be held on July 19, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by August 1, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. The workshop draft agenda will be made available at https://www.fda.gov/Drugs/NewsEvents/ ucm548365.htm prior to the meeting.
ContactLori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-0002, 301- 796-1300.
FR Citation82 FR 28321 
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