Development of New Tuberculosis Treatment Regimens-Scientific and Clinical Trial Design Considerations; Public Workshop; Request for Comments, 28321-28322 [2017-12906]
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
You may submit comments,
identified by CDC–2017–0028 and
Docket Number NIOSH–290, by either
of the following two methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
ADDRESSES:
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2017–12942 Filed 6–20–17; 8:45 am]
BILLING CODE 4163–19–P
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.
Notice of public workshop;
request for comments.
ACTION:
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.
SUMMARY:
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.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
19:12 Jun 20, 2017
Jkt 241001
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
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
28321
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/201523389.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
E:\FR\FM\21JNN1.SGM
21JNN1
28322
Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
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 preclinical 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.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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
VerDate Sep<11>2014
19:12 Jun 20, 2017
Jkt 241001
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3203]
Wyeth Pharmaceuticals Inc. et al.;
Withdrawal of Approval of 121 New
Drug Applications and 161 Abbreviated
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 121 new drug applications
(NDAs) and 161 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
The withdrawal is effective on
July 21, 2017.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in
table 1 in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
DATES:
E:\FR\FM\21JNN1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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