Document ID: FDA-2017-N-2769-0001
Agency: fda
Document Type: Notice
Title: Development of New Tuberculosis Treatment Regimens—Scientific and
Clinical Trial Design Considerations; Public Workshop; Request for
Comments
Posted Date: 2017-06-21T04:00Z

[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Notices]
[Pages 28321-28322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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 TuberculosisWorkshop2017@fda.hhs.gov. 
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 
TuberculosisWorkshop2017@fda.hhs.gov 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