Developing Rabies Monoclonal Antibody Products as a Component of Rabies Post-Exposure Prophylaxis; Public Workshop; Request for Comments, 26494-26495 [2017-11820]
Download as PDF
26494
Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11818 Filed 6–6–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2094]
Developing Rabies Monoclonal
Antibody Products as a Component of
Rabies Post-Exposure Prophylaxis;
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 announcing a public workshop
regarding development of rabies
monoclonal antibody products to be
used in conjunction with licensed rabies
vaccine as part of a rabies post-exposure
prophylaxis (PEP) regimen. 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 on various aspects of
development efforts pertaining to
animal models, laboratory assays, and
clinical trials.
DATES: The public workshop will be
held on July 17, 2017, from 8:30 a.m. to
5 p.m. Submit either electronic or
written comments on this public
workshop on or before July 31, 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/
ucm540832.htm prior to the meeting.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 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
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:37 Jun 06, 2017
Jkt 241001
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 July 31, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of July
31, 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): 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.’’
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–2094 for ‘‘Developing Rabies
Monoclonal Antibody Products as a
Component of Rabies Post-Exposure
Prophylaxis.’’ 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 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
https://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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
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.
E:\FR\FM\07JNN1.SGM
07JNN1
Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
workshop regarding development of
rabies monoclonal antibody products to
be used in conjunction with a licensed
rabies vaccine as part of rabies PEP.
Rabies immunoglobulin, in combination
with rabies vaccine, is currently
recommended for rabies PEP following
suspected or proven rabies exposure.
Rabies monoclonal antibody products
may offer a potential alternative to
rabies immunoglobulin as a component
of rabies PEP.
II. Topics for Discussion at the Public
Workshop
FDA is conducting this workshop to
discuss the scientific work needed to
advance the development of rabies
monoclonal antibodies targeting rabies
viruses for use in a PEP regimen.
Discussions are planned around the
following topics:
• Rabies epidemiology and vectors
• Current rabies PEP standard of care
• Scientific challenges of assessing the
likely effects of rabies monoclonal
antibodies
• Potential utility of animal models and
laboratory assays in rabies
monoclonal antibody development
• Clinical trial design challenges related
to the scientific evaluation of rabies
monoclonal antibody efficacy as a
component of rabies PEP
• Ethical considerations regarding
potential clinical trial designs
The Agency encourages health care
providers, other U.S. Government
Agencies, academic experts, industry,
and other stakeholders to attend this
public workshop.
sradovich on DSK3GMQ082PROD 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
12, 2017, midnight Eastern Time. To
register, please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone to
RabiesWorkshop2017@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
VerDate Sep<11>2014
16:37 Jun 06, 2017
Jkt 241001
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
12, 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. 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, midnight Eastern Time. If
selected for presentation, any
presentation materials must be emailed
to RabiesWorkshop2017@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 Web
site: https://collaboration.fda.gov/
r6811zievzz/.
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 Division of Dockets Management
(see ADDRESSES). A link to the transcript
will also be available on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm540832.htm approximately 45 days
after the workshop.
Dated: May 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11820 Filed 6–6–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
26495
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2730]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Oncologic Drugs Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The public meeting will be held
on July 11, 2017, from 12:30 p.m. to 5
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–2730.
The docket will close on July 10, 2017.
Submit either electronic or written
comments on this public meeting by
July 10, 2017. Late, untimely filed
comments will not be considered.
Electronic comments must be submitted
on or before July 10, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of July
10, 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.
Comments received on or before June
26, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
You may submit comments as
follows:
SUMMARY:
E:\FR\FM\07JNN1.SGM
07JNN1
Agencies
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26494-26495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11820]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2094]
Developing Rabies Monoclonal Antibody Products as a Component of
Rabies Post-Exposure Prophylaxis; 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
announcing a public workshop regarding development of rabies monoclonal
antibody products to be used in conjunction with licensed rabies
vaccine as part of a rabies post-exposure prophylaxis (PEP) regimen.
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 on various
aspects of development efforts pertaining to animal models, laboratory
assays, and clinical trials.
DATES: The public workshop will be held on July 17, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public workshop on or before July 31, 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/ucm540832.htm prior to the meeting.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 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 July 31, 2017. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of July 31, 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): 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-2017-N-2094 for ``Developing Rabies Monoclonal Antibody Products as
a Component of Rabies Post-Exposure Prophylaxis.'' 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 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 https://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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori 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.
[[Page 26495]]
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public workshop regarding development of rabies
monoclonal antibody products to be used in conjunction with a licensed
rabies vaccine as part of rabies PEP. Rabies immunoglobulin, in
combination with rabies vaccine, is currently recommended for rabies
PEP following suspected or proven rabies exposure. Rabies monoclonal
antibody products may offer a potential alternative to rabies
immunoglobulin as a component of rabies PEP.
II. Topics for Discussion at the Public Workshop
FDA is conducting this workshop to discuss the scientific work
needed to advance the development of rabies monoclonal antibodies
targeting rabies viruses for use in a PEP regimen. Discussions are
planned around the following topics:
Rabies epidemiology and vectors
Current rabies PEP standard of care
Scientific challenges of assessing the likely effects of
rabies monoclonal antibodies
Potential utility of animal models and laboratory assays in
rabies monoclonal antibody development
Clinical trial design challenges related to the scientific
evaluation of rabies monoclonal antibody efficacy as a component of
rabies PEP
Ethical considerations regarding potential clinical trial
designs
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 12, 2017, midnight
Eastern Time. To register, please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone to RabiesWorkshop2017@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 12, 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. 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,
midnight Eastern Time. If selected for presentation, any presentation
materials must be emailed to RabiesWorkshop2017@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 Web site: https://collaboration.fda.gov/r6811zievzz/.
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 Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm540832.htm approximately 45 days after the workshop.
Dated: May 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11820 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P