Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; Public Workshop, 11923-11924 [2017-03751]
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VerDate Sep<11>2014
20:23 Feb 24, 2017
Jkt 241001
Dated: February 22, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–03809 Filed 2–24–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0696]
Current State and Further
Development of Animal Models of
Serious Infections Caused by
Acinetobacter baumannii and
Pseudomonas aeruginosa; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public workshop regarding the current
state and further development of animal
models for serious infections caused by
Acinetobacter baumannii and
Pseudomonas aeruginosa. FDA is
conducting this workshop in order to
facilitate the development of narrowspectrum antibacterial drugs, such as
those that are active against only a
single species of bacteria that may not
occur frequently.
This public workshop is intended to
provide information for and gain
perspective from health care providers,
other U.S. Government Agencies,
academic experts, contract research
organizations, and industry on various
aspects of development efforts
pertaining to animal models of serious
infections. The input from this public
workshop will also help FDA in
developing topics for future discussion.
DATES: The public workshop will be
held on March 1, 2017, from 8:30 a.m.
to 5 p.m. Submit either electronic or
written comments on this public
workshop by March 15, 2017. See the
SUPPLEMENTARY INFORMATION section for
registration information. The workshop
draft Agenda will be made available at:
https://www.fda.gov/Drugs/NewsEvents/
ucm534031.htm prior to the meeting.
ADDRESSES: The public workshop will
be held at the DoubleTree by Hilton
Hotel Washington DC-Silver Spring,
8727 Colesville Rd., Silver Spring, MD
20910. The hotel’s phone number is
301–589–5200.
You may submit comments as
follows:
SUMMARY:
PO 00000
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Fmt 4703
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11923
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–0696 for ‘‘Current State and
Further Development of Animal Models
of Serious Infections Caused by
Acinetobacter baumannii and
Pseudomonas aeruginosa.’’ Received
comments 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
E:\FR\FM\27FEN1.SGM
27FEN1
mstockstill on DSK3G9T082PROD with NOTICES
11924
Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding animal model development
for infectious diseases. FDA is
conducting this workshop in order to
facilitate the development of narrowspectrum antibacterial drugs, such as
those that are active against only a
single species of bacteria that may not
occur frequently. When the species
occurs infrequently, performing clinical
trials can be extremely challenging.
Therefore, animal models of infection
may be useful to explore the activity of
a candidate antibacterial drug and may
help to predict whether the drug will be
efficacious in humans. A discussion of
the additional scientific work needed to
evaluate current animal models of
infection and evaluate potential animal
VerDate Sep<11>2014
20:23 Feb 24, 2017
Jkt 241001
models that may predict response in
humans could advance the development
of antibacterial drugs targeting a single
species.
FDA is particularly interested in
infections due to Acinetobacter
baumannii and Pseudomonas
aeruginosa as pathogens because there
are limited therapeutic options to treat
patients with serious infections caused
by these bacteria, including those
resistant to currently available
antibacterial drugs. In addition, it is
difficult to enroll an adequate number of
patients to conduct clinical trials since
the frequency with which these
organisms cause clinical disease is
sufficiently low. Discussions will focus
on the current state of animal models of
serious infections, lessons learned from
the development efforts for past and
current animal models of infection, and
scientific challenges and future
direction and next steps in animal
model development.
This public workshop is intended to
provide information for and gain
perspective from health care providers,
other U.S. Government Agencies,
academic experts, contract research
organizations, and industry on various
aspects of development efforts
pertaining to animal models of serious
infections. The input from this public
workshop will also help FDA in
developing topics for future discussion.
The Agency encourages health care
providers, other U.S. Government
Agencies, academic experts, contract
research organizations, industry, and
other interested persons to attend this
public workshop.
Registration: Interested parties are
encouraged to register early. To register
electronically, email registration
information (including name, title, firm
name, address, telephone, and fax
number) to AnimalModelsInfection
Workshop2017@fda.hhs.gov. Persons
without access to the Internet can call
301–796–1300 to register. Registration is
free and will be on a first-come, firstserved basis. However, FDA may limit
the number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the meeting
will be based on space availability.
If you need special accommodations
due to a disability, please contact Jessica
Barnes or Lori Benner (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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. All requests to make
oral presentations must be received by
February 27, 2017. 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 on or
before February 28, 2017. If selected for
presentation, any presentation materials
must be emailed to AnimalModels
InfectionWorkshop2017@fda.hhs.gov no
later than February 28, 2017. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. Transcripts will
also be available on the Internet at:
https://www.fda.gov/Drugs/NewsEvents/
ucm534031.htm approximately 45 days
after the workshop.
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03751 Filed 2–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\27FEN1.SGM
27FEN1
Agencies
[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11923-11924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03751]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0696]
Current State and Further Development of Animal Models of Serious
Infections Caused by Acinetobacter baumannii and Pseudomonas
aeruginosa; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding the current state and further development of animal
models for serious infections caused by Acinetobacter baumannii and
Pseudomonas aeruginosa. FDA is conducting this workshop in order to
facilitate the development of narrow-spectrum antibacterial drugs, such
as those that are active against only a single species of bacteria that
may not occur frequently.
This public workshop is intended to provide information for and
gain perspective from health care providers, other U.S. Government
Agencies, academic experts, contract research organizations, and
industry on various aspects of development efforts pertaining to animal
models of serious infections. The input from this public workshop will
also help FDA in developing topics for future discussion.
DATES: The public workshop will be held on March 1, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public workshop by March 15, 2017. See the SUPPLEMENTARY INFORMATION
section for registration information. The workshop draft Agenda will be
made available at: https://www.fda.gov/Drugs/NewsEvents/ucm534031.htm
prior to the meeting.
ADDRESSES: The public workshop will be held at the DoubleTree by Hilton
Hotel Washington DC-Silver Spring, 8727 Colesville Rd., Silver Spring,
MD 20910. The hotel's phone number is 301-589-5200.
You may submit comments as follows:
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-0696 for ``Current State and Further Development of Animal
Models of Serious Infections Caused by Acinetobacter baumannii and
Pseudomonas aeruginosa.'' Received comments 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
[[Page 11924]]
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.fda.gov/regulatoryinformation/dockets/default.htm.
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.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding animal model development for infectious diseases. FDA is
conducting this workshop in order to facilitate the development of
narrow-spectrum antibacterial drugs, such as those that are active
against only a single species of bacteria that may not occur
frequently. When the species occurs infrequently, performing clinical
trials can be extremely challenging. Therefore, animal models of
infection may be useful to explore the activity of a candidate
antibacterial drug and may help to predict whether the drug will be
efficacious in humans. A discussion of the additional scientific work
needed to evaluate current animal models of infection and evaluate
potential animal models that may predict response in humans could
advance the development of antibacterial drugs targeting a single
species.
FDA is particularly interested in infections due to Acinetobacter
baumannii and Pseudomonas aeruginosa as pathogens because there are
limited therapeutic options to treat patients with serious infections
caused by these bacteria, including those resistant to currently
available antibacterial drugs. In addition, it is difficult to enroll
an adequate number of patients to conduct clinical trials since the
frequency with which these organisms cause clinical disease is
sufficiently low. Discussions will focus on the current state of animal
models of serious infections, lessons learned from the development
efforts for past and current animal models of infection, and scientific
challenges and future direction and next steps in animal model
development.
This public workshop is intended to provide information for and
gain perspective from health care providers, other U.S. Government
Agencies, academic experts, contract research organizations, and
industry on various aspects of development efforts pertaining to animal
models of serious infections. The input from this public workshop will
also help FDA in developing topics for future discussion. The Agency
encourages health care providers, other U.S. Government Agencies,
academic experts, contract research organizations, industry, and other
interested persons to attend this public workshop.
Registration: Interested parties are encouraged to register early.
To register electronically, email registration information (including
name, title, firm name, address, telephone, and fax number) to
AnimalModelsInfectionWorkshop2017@fda.hhs.gov. Persons without access
to the Internet can call 301-796-1300 to register. Registration is free
and will be on a first-come, first-served basis. However, FDA may limit
the number of participants from each organization based on space
limitations. Registrants will receive confirmation once they have been
accepted. Onsite registration on the day of the meeting will be based
on space availability.
If you need special accommodations due to a disability, please
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance.
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. All requests
to make oral presentations must be received by February 27, 2017. 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 on or before February 28, 2017. If selected for
presentation, any presentation materials must be emailed to
AnimalModelsInfectionWorkshop2017@fda.hhs.gov no later than February
28, 2017. No commercial or promotional material will be permitted to be
presented or distributed at the public workshop.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
https://www.fda.gov. Transcripts will also be available on the Internet
at: https://www.fda.gov/Drugs/NewsEvents/ucm534031.htm approximately 45
days after the workshop.
Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03751 Filed 2-24-17; 8:45 am]
BILLING CODE 4164-01-P