2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments, 44189-44191 [2017-20108]
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Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of this public workshop
is to provide an opportunity for relevant
stakeholders, including clinicians,
academia, industry, and FDA, to discuss
alternative trial designs for product
development in pediatric heart failure.
II. Topics for Discussion at the Public
Workshop
Specifically, the workshop will
include application of pediatric
extrapolation in drug development for
pediatric heart failure and a discussion
of alternative approaches to establishing
effectiveness in pediatric heart failure,
including the use of Bayesian
approaches. Cases will be presented to
exemplify various approaches.
The agenda is located at https://
www.cersi.umd.edu/events/
index.php?mode=4&id=12500.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, visit the following Web site:
https://www.cersi.umd.edu/events/
index.php?mode=4&id=12500.
Registrants will receive confirmation
when they have been accepted. There
will be no onsite registration.
There is a registration fee to attend
this public workshop in person. Seats
are limited and registration will be on
a first-come, first-served basis. The cost
to attend in person is as follows:
Category
asabaliauskas on DSKBBXCHB2PROD with NOTICES
$50
50
0
0
If you need special accommodations
due to a disability, please contact
Jacquline Yancy (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast. There is no registration
fee for attending the workshop via the
webcast, but registration is still
required. Information regarding access
to the webcast link is available at https://
www.cersi.umd.edu/events/
index.php?mode=4&id=12500.
If you have never attended a Connect
Pro event before, 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/
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Food and Drug Administration
systems. Attendance is free. Non-USDA
employees must enter through the Wing
3 entrance on Independence Avenue.
Attendees must be pre-registered for the
meeting (and check-in outside the day
of the meeting) and show a valid photo
ID to enter the building. Only registered
attendees will be permitted to enter the
building. For parking and security
information, please refer to https://
smithsonianassociates.org/ticketing/
help/locations/jefferson.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 November 24, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 24, 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.
[Docket No. FDA–2017–N–5056]
Electronic Submissions
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20106 Filed 9–20–17; 8:45 a.m.]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
2017 Scientific Meeting of the National
Antimicrobial Resistance Monitoring
System; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we), together with the NARMS partner
agencies, is announcing a public
meeting entitled ‘‘2017 Scientific
Meeting of the National Antimicrobial
Resistance Monitoring System.’’ The
purpose of the public meeting is to
discuss the current status of the
National Antimicrobial Resistance
Monitoring System (NARMS) and
directions for the future.
DATES: The public meeting will be held
on October 24 and 25, 2017, from 8:30
a.m. to 5 p.m. Eastern Time. Submit
either electronic or written comments
on this public meeting by November 24,
2017. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at the Jefferson Auditorium in the
South Building, U.S. Department of
Agriculture (USDA), 14th and
Independence Avenue SW.,
Washington, DC 20250. The South
Building is a Federal facility, and
attendees should plan adequate time to
pass through the security screening
SUMMARY:
Cost
Industry Representative ................
Nonprofit Organization and Academic Other Than University of
Maryland ...................................
University of Maryland, College
Park and Baltimore ...................
Federal Government .....................
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 Office
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
44189
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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.
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44190
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
• 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–5056 for ‘‘2017 Scientific
Meeting of the National Antimicrobial
Resistance Monitoring System; Public
Meeting; 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.
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FOR FURTHER INFORMATION CONTACT:
Laura Bradbard, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl.
(HFV–1), Rockville, MD 20855, 240–
402–5672, email: laura.bradbard@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Topics for
Discussion
NARMS periodically conducts public
meetings to inform stakeholders of
NARMS activities and receive
comments on ways to improve. The last
NARMS public meeting (held in 2014)
focused on the achievement of several
2012–2016 NARMS Strategic Plan
objectives and interagency research. The
purpose of this meeting will be to
summarize NARMS progress since that
meeting, to present recommendations
made by the recent FDA Science Board
review of NARMS in 2017, and to
explore new directions for NARMS
within a One Health paradigm. Items
that will be discussed during this
meeting include an update on the
development of new analytical and
reporting tools, the latest advances in
the use of DNA sequencing
technologies, and new surveillance
results. The meeting agenda will be
posted no later than 5 days before the
meeting at https://www.fda.gov/
AnimalVeterinary/SafetyHealth/
AntimicrobialResistance/
NationalAntimicrobial
ResistanceMonitoringSystem/
ucm576281.htm.
In addition to discussion generated
through this public meeting, FDA and
the NARMS partners are interested in
receiving stakeholder input on the
following questions through electronic
or written comments, which can be
submitted to the Dockets Management
Staff (see ADDRESSES).
1. Recently, NARMS modified its
Integrated Reports and online data
display tools (https://www.fda.gov/
AnimalVeterinary/SafetyHealth/
AntimicrobialResistance/
NationalAntimicrobial
ResistanceMonitoringSystem/
ucm416741.htm). Do you find this more
user-friendly and informative? Please
explain.
2. How can NARMS accomplish better
stakeholder engagement, which modes
of engagement are preferred, and how
frequent?
3. Where should the NARMS program
focus over the next 5–10 years? What
are the top three gaps in the NARMS
program and how should they be
addressed?
4. Which of the Science Board
recommendations do you see as highest
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priority, and how should they be
achieved?
At the conclusion of this meeting, a
separate interagency meeting on whole
genome sequencing will be held in the
Jefferson Auditorium on October 26 and
27, 2017. A notice will be published in
the Federal Register by the Food Safety
Inspection Service to announce this
meeting.
II. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting must
register online by October 10, 2017.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
There is no fee to register for the
public meeting, but pre-registration by
October 10, 2017, is mandatory for
participants attending in person. Onsite
registration will not be permitted. Early
registration is recommended as space is
limited. All attendees must pre-register
online by emailing laura.bradbard@
fda.hhs.gov with the subject line
‘‘NARMS Public Meeting 2017’’ with
information including name, title,
organization, address, and telephone
and Fax numbers. If you need special
accommodations due to a disability,
please contact Laura Bradbard (see FOR
FURTHER INFORMATION CONTACT) no later
than October 2, 2017.
Requests for Oral Presentations:
Interested persons may make oral
presentations on the topic of the
discussion of the meeting. Oral
presentations from the public during the
open public comment period will be
scheduled between 4:00 p.m. and 4:50
p.m. on October 25, 2017. Those
desiring to make oral presentations
should notify Laura Bradbard (see FOR
FURTHER INFORMATION CONTACT) by
October 2, 2017, and submit a brief
statement of the general nature of
information they wish to present. In an
effort to accommodate all who desire to
speak, time allotted for each
presentation may be limited. The
contact person will inform each speaker
of their schedule prior to the meeting.
If selected for presentation, speakers
will be contacted by October 13, 2017,
and presentation material should be
submitted by email to Laura Bradbard
(see FOR FURTHER INFORMATION CONTACT)
by October 20, 2017. No commercial or
promotional material will be permitted
to be presented or distributed at the
public meeting.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
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Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
AnimalVeterinary/SafetyHealth/
AntimicrobialResistance/
NationalAntimicrobial
ResistanceMonitoringSystem/
ucm059172.htm.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20108 Filed 9–20–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Single-Award Deviation From
Competition Requirements for the
Severe Combined Immunodeficiency
(SCID) Newborn Screening Program at
the Jeffrey Modell Foundation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
HRSA announces the award
of an extension in the amount of
$2,000,000 for the Severe Combined
Immunodeficiency (SCID) Newborn
Screening program at the Jeffrey Modell
Foundation (JMF). The extension will
allow JMF, the cooperative agreement
recipient, during the budget period of
May 1, 2017 to April 30, 2018, to
provide technical assistance and
support to states for the implementation
of population based newborn screening
for SCID.
FOR FURTHER INFORMATION CONTACT: Jill
F. Shuger, ScM, Division of Services for
Children with Special Health Needs,
MCHB, HRSA, 5600 Fishers Lane,
Rockville, Maryland 20857, Phone:
(301) 443–3247, Email: JShuger@
hrsa.gov.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Jeffrey Modell Foundation.
Amount of Non-Competitive Awards:
$2,000,000.
Budget Period of Supplemental
Funding: May 1, 2017 to April 30, 2018.
CFDA Number: 93.110.
Authority: Public Health Service Act,
§ 1109, as amended by the Newborn
Screening Saves Lives Reauthorization
Act of 2014 (Public Law 110–204) (42
U.S.C. 300b–8).
SUMMARY:
Notice of award.
Justification: The Maternal and Child
Health Bureau (MCHB) is proposing that
JMF continue activities under the
current cooperative agreement to ensure
the implementation of newborn
screening for SCID in all 50 states,
particularly in the states that have yet to
implement SCID screening (i.e.,
Alabama, Arizona, Indiana, Kansas,
Louisiana, Nevada and North Carolina).
Using its resources and centers, JMF
will provide technical assistance in
areas of funding, state government
education, and linkage to expert care
and patient access to a national network
of specialized treatment centers.
Further, JMF will continue to support
states with implementation of SCID
screening and follow up as well as the
immediate treatment of infants
identified with SCID. JMF will use the
data collected from the states to educate
clinical immunologists, neonatologists
and other providers on effective
screening for SCID. Additionally, JMF
will continue to support education and
awareness of newborn screening for
SCID to families and health care
providers and provide education to
primary care providers and medically
underserved populations.
Grantee/organization name
Grant No.
State
Fiscal year
2017
authorized
funding level
Jeffrey Modell Foundation ...............................................................................
UG5MC28325
UT
$2,000,000
Dated: September 7, 2017.
George Sigounas,
Administrator.
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2017–20116 Filed 9–20–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSKBBXCHB2PROD with NOTICES
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
VerDate Sep<11>2014
19:03 Sep 20, 2017
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Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; T32
Institutional Training Grant Review.
Date: October 6, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, Democracy One, 6701
Democracy Blvd., Suite 602, Bethesda, MD
20892.
Contact Person: Kan Ma, Ph.D., Scientific
Review Officer, Scientific Review Branch,
National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Boulevard, Suite 814,
Bethesda, MD 20892, 301–451–4838, mak2@
mail.nih.gov.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; Division of
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44191
Fiscal year
2017
estimated
supplemental
funding
$2,000,000
Musculoskeletal Diseases RISK R61/R33 Peer
Review.
Date: October 11, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Rd,
Bethesda, MD 20852.
Contact Person: Xincheng Zheng, MD,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of
Arthritis, Musculoskeletal and Skin Diseases,
NIH, 6701 Democracy Boulevard, Suite 820,
Bethesda, MD 20892, 301–451–4838,
xincheng.zheng@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: September 15, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–20095 Filed 9–20–17; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44189-44191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20108]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5056]
2017 Scientific Meeting of the National Antimicrobial Resistance
Monitoring System; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we),
together with the NARMS partner agencies, is announcing a public
meeting entitled ``2017 Scientific Meeting of the National
Antimicrobial Resistance Monitoring System.'' The purpose of the public
meeting is to discuss the current status of the National Antimicrobial
Resistance Monitoring System (NARMS) and directions for the future.
DATES: The public meeting will be held on October 24 and 25, 2017, from
8:30 a.m. to 5 p.m. Eastern Time. Submit either electronic or written
comments on this public meeting by November 24, 2017. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be held at the Jefferson Auditorium
in the South Building, U.S. Department of Agriculture (USDA), 14th and
Independence Avenue SW., Washington, DC 20250. The South Building is a
Federal facility, and attendees should plan adequate time to pass
through the security screening systems. Attendance is free. Non-USDA
employees must enter through the Wing 3 entrance on Independence
Avenue. Attendees must be pre-registered for the meeting (and check-in
outside the day of the meeting) and show a valid photo ID to enter the
building. Only registered attendees will be permitted to enter the
building. For parking and security information, please refer to https://smithsonianassociates.org/ticketing/help/locations/jefferson.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 November 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 24, 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.
[[Page 44190]]
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-5056 for ``2017 Scientific Meeting of the National
Antimicrobial Resistance Monitoring System; Public Meeting; 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: Laura Bradbard, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-1),
Rockville, MD 20855, 240-402-5672, email: laura.bradbard@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Topics for Discussion
NARMS periodically conducts public meetings to inform stakeholders
of NARMS activities and receive comments on ways to improve. The last
NARMS public meeting (held in 2014) focused on the achievement of
several 2012-2016 NARMS Strategic Plan objectives and interagency
research. The purpose of this meeting will be to summarize NARMS
progress since that meeting, to present recommendations made by the
recent FDA Science Board review of NARMS in 2017, and to explore new
directions for NARMS within a One Health paradigm. Items that will be
discussed during this meeting include an update on the development of
new analytical and reporting tools, the latest advances in the use of
DNA sequencing technologies, and new surveillance results. The meeting
agenda will be posted no later than 5 days before the meeting at
https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm576281.htm.
In addition to discussion generated through this public meeting,
FDA and the NARMS partners are interested in receiving stakeholder
input on the following questions through electronic or written
comments, which can be submitted to the Dockets Management Staff (see
ADDRESSES).
1. Recently, NARMS modified its Integrated Reports and online data
display tools (https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm416741.htm). Do you
find this more user-friendly and informative? Please explain.
2. How can NARMS accomplish better stakeholder engagement, which
modes of engagement are preferred, and how frequent?
3. Where should the NARMS program focus over the next 5-10 years?
What are the top three gaps in the NARMS program and how should they be
addressed?
4. Which of the Science Board recommendations do you see as highest
priority, and how should they be achieved?
At the conclusion of this meeting, a separate interagency meeting
on whole genome sequencing will be held in the Jefferson Auditorium on
October 26 and 27, 2017. A notice will be published in the Federal
Register by the Food Safety Inspection Service to announce this
meeting.
II. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online by October 10, 2017. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
There is no fee to register for the public meeting, but pre-
registration by October 10, 2017, is mandatory for participants
attending in person. Onsite registration will not be permitted. Early
registration is recommended as space is limited. All attendees must
pre-register online by emailing laura.bradbard@fda.hhs.gov with the
subject line ``NARMS Public Meeting 2017'' with information including
name, title, organization, address, and telephone and Fax numbers. If
you need special accommodations due to a disability, please contact
Laura Bradbard (see FOR FURTHER INFORMATION CONTACT) no later than
October 2, 2017.
Requests for Oral Presentations: Interested persons may make oral
presentations on the topic of the discussion of the meeting. Oral
presentations from the public during the open public comment period
will be scheduled between 4:00 p.m. and 4:50 p.m. on October 25, 2017.
Those desiring to make oral presentations should notify Laura Bradbard
(see FOR FURTHER INFORMATION CONTACT) by October 2, 2017, and submit a
brief statement of the general nature of information they wish to
present. In an effort to accommodate all who desire to speak, time
allotted for each presentation may be limited. The contact person will
inform each speaker of their schedule prior to the meeting. If selected
for presentation, speakers will be contacted by October 13, 2017, and
presentation material should be submitted by email to Laura Bradbard
(see FOR FURTHER INFORMATION CONTACT) by October 20, 2017. No
commercial or promotional material will be permitted to be presented or
distributed at the public meeting.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management
[[Page 44191]]
Staff (see ADDRESSES). A link to the transcript will also be available
on the internet at https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm059172.htm.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20108 Filed 9-20-17; 8:45 am]
BILLING CODE 4164-01-P
