Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Establishment of a Public Docket; Request for Comments; Notice of Meeting, 85978-85980 [2016-28605]
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85978
Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
published September 14, 2016 (81 FR
63187). Submit either electronic or
written comments by March 13, 2017.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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–
2016–D–2635 for ‘‘Establishing
Appropriate Durations of Therapeutic
Administration.’’ 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
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Jkt 241001
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Cindy Burnsteel, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0817,
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 14, 2016
(81 FR 63187), FDA solicited comments
regarding the establishment of
appropriate durations of use of
antimicrobial drugs of importance to
human medicine when administered in
the feed or water of food-producing
animals for therapeutic purposes with a
90-day comment period.
The Agency has received requests for
an extension of the comment period.
These requests conveyed concern that
the current 90-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the request for comments.
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FDA has considered the requests and
is extending the comment period for 90
additional days, until March 13, 2017.
The Agency believes that a 90-day
extension allows adequate time for
interested persons to submit comments
without significantly delaying FDA’s
consideration of these important issues.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28660 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0067]
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee;
Establishment of a Public Docket;
Request for Comments; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
establishment of a public docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pharmaceutical Science
and Clinical Pharmacology 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.
DATES: The meeting will be held on
March 15, 2017, from 7:30 a.m. to 3:45
p.m.
ADDRESSES: Omni Shoreham Hotel, the
Ballroom, 2500 Calvert St. NW.,
Washington, DC 20008. The hotel
telephone number is 202–234–0700.
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.
You may submit comments as
follows:
SUMMARY:
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,
E:\FR\FM\29NON1.SGM
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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–
2010–N–0067 for ‘‘Pharmaceutical
Science and Clinical Pharmacology
Advisory Committee; Notice of
Meeting.’’ 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
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
VerDate Sep<11>2014
17:48 Nov 28, 2016
Jkt 241001
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 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, ACPSCP@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The use of model-informed
drug development (MIDD) for new and
generic drugs has significantly increased
over the past several years. The
committee will discuss strategies,
approaches, and challenges in MIDD
with specific focus on two areas. During
the morning session, the committee will
discuss approaches and evidentiary
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85979
information needed for applying
physiologically-based pharmacokinetic
modeling and simulation throughout a
drug’s lifecycle. During the afternoon
session, the committee will discuss
mechanistic model-informed safety
evaluation with a focus on drug
potential for causing arrhythmias. The
Comprehensive in Vitro Proarrhythmia
Assay will be discussed as an exemplar.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section) on
or before March 1, 2017, will be
provided to the committee. Oral
presentations from the public will be
scheduled between approximately 9:50
a.m. to 10:20 a.m. and 2:15 p.m. to 2:45
p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 21, 2017. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 22, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Jennifer
E:\FR\FM\29NON1.SGM
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85980
Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
Shepherd at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28605 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Chronic Fatigue
Syndrome Advisory Committee
Office of the Assistant
Secretary for Health, Department of
Health and Human Services, Office of
the Secretary.
ACTION: Notice.
AGENCY:
As required by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that a
meeting of the Chronic Fatigue
Syndrome Advisory Committee
(CFSAC) will take place. This meeting
will be open to the public.
DATES: Thursday, January 12, 2017, from
12:00 p.m. to 5:00 p.m. ET, and Friday,
January 13, 2017, from 9:00 a.m. to 5:00
p.m. ET.
ADDRESSES: Individuals may attend this
meeting in person and/or by utilizing
virtual technology. Information for inperson attendance will be posted on the
CFSAC Web site, https://www.hhs.gov/
ash/advisory-committees/cfsac/
meetings/. Registration is
required for in-person attendance.
Information on the procedure to follow
for registration will be included on the
CFSAC Web site. For individuals
wishing to attend the meeting virtually,
a webinar will be offered. Information
about accessing the webinar will be
included on the CFSAC Web site.
FOR FURTHER INFORMATION CONTACT:
Gustavo Seinos, MPH, Designated
Federal Officer, Chronic Fatigue
Syndrome Advisory Committee,
Department of Health and Human
Services, 200 Independence Avenue
SW., Room 712E, Washington, DC
20201. Please direct all inquiries to
cfsac@hhs.gov.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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The
CFSAC is authorized under 42 U.S.C.
217a, Section 222 of the Public Health
Service Act, as amended. The purpose
of the CFSAC is to provide advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health on
topics related to myalgic
encephalomyelitis/chronic fatigue
syndrome (ME/CFS). The issues can
include factors affecting access and care
for persons with ME/CFS; the science
and definition of ME/CFS; and broader
public health, clinical, research, and
educational issues related to ME/CFS.
The agenda for this meeting, call-in
information, and location will be posted
on the CFSAC Web site https://
www.hhs.gov/ash/advisory-committees/
cfsac/meetings/.
Thirty minutes will be allotted for
public comment via telephone or in
person on each day of the meeting. Each
individual will have three minutes to
present their comments. Priority will be
given to individuals who have not
provided public comment within the
previous year. We are unable to place
international calls for public comments.
Individuals are required to register to
participate in the public comment
sessions. To request a time slot for
public comment, please send an email
to cfsac@hhs.gov by January 5, 2017.
The email should contain the speaker’s
name and the telephone number at
which the speaker can be reached for
the public comment session.
Individuals who would like for their
testimony to be provided to the
Committee members should submit a
copy of the testimony prior to the
meeting. It is preferred, but not
required, that the submitted testimony
be prepared in digital format and typed
using a 12-pitch font. Copies of the
written comment must not exceed 5
single-space pages, and it is preferred,
but not required that the document be
prepared in the MS Word format. Please
note that PDF files, charts, and
photographs cannot be accepted.
Materials submitted should not include
sensitive personal information, such as
Social Security number, birthdate,
driver’s license number, passport
number, financial account number, or
credit or debit card number. If you wish
to remain anonymous, then document
must specify this.
The Committee welcomes input on
any topic related to ME/CFS.
SUPPLEMENTARY INFORMATION:
Gustavo Seinos,
Designated Federal Officer, CDR, USPHS.
[FR Doc. 2016–28723 Filed 11–28–16; 8:45 am]
BILLING CODE 4150–42–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing and
Collaboration
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
Drive, Mail Stop 9702, Rockville, MD
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Genetically
Engineered Mouse-Derived Allograft for
Use in Preclinical Studies of Metastatic
Melanoma Therapies.
Keywords: Melanoma, GDA, Allograft,
Genetically Engineered Mouse,
immunological response.
Description of Technology: The
invention listed below is owned by an
agency of the U.S. Government and is
available for licensing and/or codevelopment in the U.S. in accordance
with 35 U.S.C. 209 and 37 CFR part 404
to achieve expeditious
commercialization of results of
federally-funded research and
development.
Before testing drugs in humans, drug
developers are required to demonstrate
a reasonable expectation of safety and
efficacy by performing so-called preclinical studies. A key element of such
trials is the use of animal models,
SUMMARY:
E:\FR\FM\29NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85978-85980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28605]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0067]
Pharmaceutical Science and Clinical Pharmacology Advisory
Committee; Establishment of a Public Docket; Request for Comments;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; establishment of a public docket;
request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmaceutical Science and
Clinical Pharmacology 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.
DATES: The meeting will be held on March 15, 2017, from 7:30 a.m. to
3:45 p.m.
ADDRESSES: Omni Shoreham Hotel, the Ballroom, 2500 Calvert St. NW.,
Washington, DC 20008. The hotel telephone number is 202-234-0700.
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.
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,
[[Page 85979]]
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-2010-N-0067 for ``Pharmaceutical Science and Clinical Pharmacology
Advisory Committee; Notice of Meeting.'' 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 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 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, ACPS-CP@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The use of model-informed drug development (MIDD) for new
and generic drugs has significantly increased over the past several
years. The committee will discuss strategies, approaches, and
challenges in MIDD with specific focus on two areas. During the morning
session, the committee will discuss approaches and evidentiary
information needed for applying physiologically-based pharmacokinetic
modeling and simulation throughout a drug's lifecycle. During the
afternoon session, the committee will discuss mechanistic model-
informed safety evaluation with a focus on drug potential for causing
arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be
discussed as an exemplar.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before March 1, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 9:50 a.m. to 10:20 a.m. and 2:15 p.m. to 2:45 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
February 21, 2017. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by February 22,
2017.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Jennifer
[[Page 85980]]
Shepherd at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on 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: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28605 Filed 11-28-16; 8:45 am]
BILLING CODE 4164-01-P
