Notice of Request for Information; A Notice by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 59386-59388 [2018-25435]
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Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Notices
ACF to fulfill the ongoing legislative
mandate for program evaluation
specified in the Foster Care
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Respondents: Semi-structured
interviews will be held with program
leaders, partners and stakeholders, and
front-line staff as well as young adults
being served by the programs.
ANNUAL BURDEN ESTIMATES
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of respondents
Instrument
Outreach email for discussion with program administrators
and staff ............................................................................
Outreach email for Focus Group Recruiters .......................
Discussion Guide for program leaders ................................
Discussion Guide for program partners and stakeholders ..
Discussion Guide for program front-line staff ......................
Focus Group Guide for program participants ......................
Compilation and Submission of Administrative Data Files ..
Estimated Total Annual Burden
Hours: 1,056.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
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Therefore, a comment is best assured of
having its full effect if OMB receives it
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SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
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ACF/OPRE Certifying Officer.
[FR Doc. 2018–25548 Filed 11–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2018–N–1262]
Approval of Product Under Voucher:
Rare Pediatric Disease Priority Review
Voucher
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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Annual
number of
respondents
16
12
48
60
104
160
48
8
6
24
30
52
80
24
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Food and Drug Administration Safety
and Innovation Act (FDASIA),
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the
issuance of vouchers as well as the
approval of products redeeming a
voucher. FDA has determined that
AJOVY (fremanezumab-vfrm), approved
September 14, 2018, meets the
redemption criteria.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9858,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA,
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that AJOVY
(fremanezumab-vfrm), approved
September 14, 2018, meets the
redemption criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about AJOVY
(fremanezumab-vfrm) go to the ‘‘Drugs@
FDA’’ website at https://
SUMMARY:
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Number of
responses per
respondent
Average
burden hours
per response
1
1
4
2
1
1
2
Annual burden
hours
8
8
1
1
1
2
12
64
48
96
60
52
160
576
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: November 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–25480 Filed 11–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Request for Information; A
Notice by the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Presidential Advisory
Council on Combating AntibioticResistant Bacteria (Advisory Council)
requests information from the general
public and stakeholders related to
efforts and strategies to combat
Antibiotic Resistance (AR). Given the
evolution of AR and the long-term
nature of the problem, the Secretary of
Health and Human Services (HHS)
tasked the Advisory Council with
identifying significant areas that have
emerged since the release of the
National Action Plan (NAP) for
Combatting Antibiotic-Resistant
Bacteria (CARB) in 2015. To aid in the
process of developing its response to the
Secretary’s task, the Advisory Council
has posted this Request for Information
(RFI) to hear from a wide range of
stakeholders and sectors relevant to the
overall CARB effort. This RFI offers the
opportunity for the public, including
interested individuals, organizations,
associations, industries, and others, to
provide their input on new priority
SUMMARY:
E:\FR\FM\23NON1.SGM
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Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Notices
areas within each of the five goals of the
NAP that should be considered by the
United States Government (USG) for
2020–2025.
Responses to the RFI must be received
by 11:59 p.m. on January 7, 2019 to be
considered. The questions in the RFI are
available through an online form on the
Advisory Council’s web page at
www.hhs.gov/ash/carb. Individuals
unable to submit their answers using the
online platform should send an email to
CARB@hhs.gov, indicating ‘‘RFI
Response’’ in the subject line, along
with the corresponding goal number(s)
for which they are responding.
DATES AND TIMES: Comments must be
received by 11:59 p.m. on January 7,
2019 to be considered.
ADDRESSES: Individuals are encouraged
to submit their responses through one of
the following methods. Utilization of
the online form available on
www.hhs.gov/ash/carb is the preferred
method of submission. Should you
choose to send in your responses via
email, please be sure to include ‘‘RFI
Response’’ along with the corresponding
goal number(s) in the subject line.
Responses should not include
information of a confidential nature,
such as sensitive personal information
or proprietary information. Responses to
this notice are not offers and cannot be
accepted by the federal government to
form a binding contract or issue a grant.
Please be aware that your comments
will not be posted publicly, however
they may be made available to the
public, in part or in full, subject to
applicable laws and regulations.
• Online Form: www.hhs.gov/ash/
carb. Online submissions will receive
an automatic confirmation
acknowledging receipt of your response,
but you will not receive individualized
feedback on any suggestions.
• Email: CARB@hhs.gov. Please
indicate ‘‘RFI Response’’ and the
corresponding goal number(s) in the
subject line of your email.
• All submissions will receive an
electronic confirmation acknowledging
receipt of your response, but you will
not receive individualized feedback on
any suggestions.
FOR FURTHER INFORMATION CONTACT: Dr.
Jomana Musmar, Acting Designated
Federal Officer, Presidential Advisory
Council on Combating AntibioticResistant Bacteria, Office of the
Assistant Secretary for Health, U.S.
Department of Health and Human
Services, Room 715H, Hubert H.
Humphrey Building, 200 Independence
Avenue SW, Washington, DC 20201.
Phone: (202) 690–5566; email: CARB@
hhs.gov.
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Jkt 247001
Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of Health and Human
Services (HHS) to establish the Advisory
Council, in consultation with the
Secretaries of Defense and Agriculture.
Activities of the Advisory Council are
governed by the provisions of Public
Law 92–463, as amended (5 U.S.C.
App.), which sets forth standards for the
formation and use of federal advisory
committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for CARB and the Action Plan (NAP).
The Advisory Council shall function
solely for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating AR and conducting antibiotic
stewardship; strengthen surveillance of
antibiotic-resistant bacterial infections;
prevent the transmission of antibioticresistant bacterial infections; advance
the development of rapid point-of-care
and agricultural diagnostics; further
research on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat AR.
Background: Antibiotic Resistance
(AR) poses a significant threat to our
Nation’s public health, economy, and
national security. The Centers for
Disease Control and Prevention (CDC)
estimates that every year more than two
million people in the United States
(U.S.) contract infections that are
resistant to antibiotics, and at least
23,000 people die as a result. The
United States exceeds $20 billion in
direct health care costs, and loses $35
billion in indirect costs due to loss of
productivity associated with antibioticresistant infections. By 2050, drugresistant bacterial infections worldwide
are estimated to result in greater than 10
million deaths yearly and cost up to
$100 trillion in losses to the world
economy. Drug-resistant infections also
complicate the U.S. medical response to
SUPPLEMENTARY INFORMATION:
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59387
chemical, biological, radiological, or
nuclear emergencies, and the global
spread of AR makes our deployed
service members particularly
vulnerable.
In response to the AR threat, the USG
developed the National Strategy for
Combating Antibiotic-Resistant Bacteria
(CARB) in 2014. The Strategy takes a
One Health approach to combating
antibiotic resistance based on the
persistence of AR within our global
environment and the recognition that
integrated multi-sectoral action is
needed to prevent the emergence and
spread of AR. In 2015, the U.S.
government issued the corresponding
National Action Plan (NAP) for CARB,
providing a five-year roadmap (2015–
2020) to guide the Nation in
implementing the following five goals
outlined in the Strategy:
1. Slow the emergence of resistant
bacteria and prevent the spread of
resistant infections;
2. Strengthen national One Health
surveillance efforts to combat resistance;
3. Advance development and use of
rapid and innovative diagnostic tests for
identification and characterization of
resistant bacteria;
4. Accelerate basic and applied
research and development for new
antibiotics and other therapeutics,
including vaccines; and
5. Improve international collaboration
and capacities for antibiotic resistance
prevention, surveillance, control and
antibiotic research and development.
The U.S. government has made
meaningful progress towards these
goals; however, since the issuance of the
NAP in 2015, the domestic and
international landscape has changed
with continued unparalleled
advancement and innovation in
technology and the life sciences.
Additional action is needed and
opportunities exist to continue this
progress beyond 2020. As such, the U.S.
Government will issue a second
iteration of the NAP that will guide
action on AR for the period of 2020–
2025. The development of this draft will
involve the U.S. Government’s careful
consideration of progress to date on the
current NAP, including barriers to
progress in certain areas and new
developments across sectors, at home
and abroad.
Request for Information: To inform
the Advisory Council’s deliberation on
recommended priorities to consider in
the USG’s process of developing the
next NAP (2020–2025), please review
the five goals in the current NAP, and
provide the following information:
• In the context of the existing five
goals, on what new priorities should the
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59388
Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Notices
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federal government focus in the next
NAP for CARB—that are not already
included in the current plan—and why
are they the most important? Your
response can cover a range of priority
areas for human, animal, and
environmental health, including
surveillance, research and development,
stewardship practices, infection
prevention and control practices, and/or
other areas for consideration.
In preparing your response, please be
sure to:
Æ Consider how your response fits
into the existing One Health paradigm,
and how your proposed priority should
be further pursued by the U.S.
Government;
Æ Provide an answer that is feasible
and actionable by the U.S. Government;
Æ Limit your responses to no more
than two priorities for each of the five
goals (a maximum of 10 can be
submitted);
Æ Summarize your response for each
priority area in 250 words or less,
including its scientific justification;
Æ Indicate whether your response is
relevant domestically, internationally,
or both;
Æ Indicate the domain(s) to which
your response applies—human, animal,
and/or environmental health;
Æ Include citations to support your
response (references must be in the form
of an active link or citation; we will not
accept attachments. Peer-reviewed
citations and journal links are highly
encouraged.
Response to this RFI is voluntary.
Responders are free to address any or all
of the goals listed in the NAP. Please
note that the USG will not pay for
response preparation or for the use of
any information contained in the
response. The answers provided in this
RFI must not include any confidential
or proprietary data. Responses to this
notice are not offers and cannot be
accepted by the USG to form a binding
contract or issue a grant. Please be
aware that your comments will not be
posted publicly, however, they may be
made available to the public, in part or
in full, subject to applicable laws and
regulations.
More information can be found at
www.hhs.gov/ash/carb.
Dated: November 13, 2018.
Jomana F. Musmar,
Acting Designated Federal Officer,
Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria Committee
Manager.
[FR Doc. 2018–25435 Filed 11–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(Advisory Council). The meeting will be
open to the public; a public comment
session will be held during the meeting.
Pre-registration is required for members
of the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
should send an email to CARB@hhs.gov.
Registration information is available on
the website https://www.hhs.gov/ash/
carb/ and must be completed by January
23, 2019; all in-person attendees must
pre-register by this date. Additional
information about registering for the
meeting and providing public comment
can be obtained at https://www.hhs.gov/
ash/carb/ on the Meetings page.
DATES: The meeting is scheduled to be
held on January 30, 2019, from 9:00 a.m.
to 5:00 p.m. and January 31, 2019, from
9:00 a.m. to 5:00 p.m. ET (times are
tentative and subject to change). The
confirmed times and agenda items for
the meeting will be posted on the
website for the Advisory Council at
https://www.hhs.gov/ash/carb/ when this
information becomes available. Preregistration for attending the meeting in
person is required to be completed no
later than January 23, 2019; public
attendance at the meeting is limited to
the available space.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW, Washington,
DC 20201.
The meeting can also be accessed
through a live webcast on the day of the
meeting. For more information, visit
https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT: Dr.
Jomana Musmar, Acting Designated
Federal Officer, Presidential Advisory
Council on Combating AntibioticResistant Bacteria, Office of the
Assistant Secretary for Health, U.S.
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Department of Health and Human
Services, Room 715H, Hubert H.
Humphrey Building, 200 Independence
Avenue SW, Washington, DC 20201.
Phone: (202) 690–5566; email: CARB@
hhs.gov.
Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. Activities of the Advisory
Council are governed by the provisions
of Public Law 92–463, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall
function solely for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat antibiotic resistance.
The public meeting will be dedicated
to hosting stakeholders to explore
priority areas that have emerged since
the original National Action Plan on
Combating Antibiotic Resistant Bacteria
was launched in 2015. The meeting
agenda will be posted on the Advisory
Council website at https://www.hhs.gov/
ash/carb/ when it has been finalized.
All agenda items are tentative and
subject to change.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23NON1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Notices]
[Pages 59386-59388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25435]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice of Request for Information; A Notice by the Presidential
Advisory Council on Combating Antibiotic-Resistant Bacteria
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Presidential Advisory Council on Combating Antibiotic-
Resistant Bacteria (Advisory Council) requests information from the
general public and stakeholders related to efforts and strategies to
combat Antibiotic Resistance (AR). Given the evolution of AR and the
long-term nature of the problem, the Secretary of Health and Human
Services (HHS) tasked the Advisory Council with identifying significant
areas that have emerged since the release of the National Action Plan
(NAP) for Combatting Antibiotic-Resistant Bacteria (CARB) in 2015. To
aid in the process of developing its response to the Secretary's task,
the Advisory Council has posted this Request for Information (RFI) to
hear from a wide range of stakeholders and sectors relevant to the
overall CARB effort. This RFI offers the opportunity for the public,
including interested individuals, organizations, associations,
industries, and others, to provide their input on new priority
[[Page 59387]]
areas within each of the five goals of the NAP that should be
considered by the United States Government (USG) for 2020-2025.
Responses to the RFI must be received by 11:59 p.m. on January 7,
2019 to be considered. The questions in the RFI are available through
an online form on the Advisory Council's web page at www.hhs.gov/ash/carb. Individuals unable to submit their answers using the online
platform should send an email to [email protected], indicating ``RFI
Response'' in the subject line, along with the corresponding goal
number(s) for which they are responding.
DATES AND TIMES: Comments must be received by 11:59 p.m. on January 7,
2019 to be considered.
ADDRESSES: Individuals are encouraged to submit their responses through
one of the following methods. Utilization of the online form available
on www.hhs.gov/ash/carb is the preferred method of submission. Should
you choose to send in your responses via email, please be sure to
include ``RFI Response'' along with the corresponding goal number(s) in
the subject line. Responses should not include information of a
confidential nature, such as sensitive personal information or
proprietary information. Responses to this notice are not offers and
cannot be accepted by the federal government to form a binding contract
or issue a grant. Please be aware that your comments will not be posted
publicly, however they may be made available to the public, in part or
in full, subject to applicable laws and regulations.
Online Form: www.hhs.gov/ash/carb. Online submissions will
receive an automatic confirmation acknowledging receipt of your
response, but you will not receive individualized feedback on any
suggestions.
Email: [email protected]. Please indicate ``RFI Response'' and
the corresponding goal number(s) in the subject line of your email.
All submissions will receive an electronic confirmation
acknowledging receipt of your response, but you will not receive
individualized feedback on any suggestions.
FOR FURTHER INFORMATION CONTACT: Dr. Jomana Musmar, Acting Designated
Federal Officer, Presidential Advisory Council on Combating Antibiotic-
Resistant Bacteria, Office of the Assistant Secretary for Health, U.S.
Department of Health and Human Services, Room 715H, Hubert H. Humphrey
Building, 200 Independence Avenue SW, Washington, DC 20201. Phone:
(202) 690-5566; email: [email protected].
SUPPLEMENTARY INFORMATION: Under Executive Order 13676, dated September
18, 2014, authority was given to the Secretary of Health and Human
Services (HHS) to establish the Advisory Council, in consultation with
the Secretaries of Defense and Agriculture. Activities of the Advisory
Council are governed by the provisions of Public Law 92-463, as amended
(5 U.S.C. App.), which sets forth standards for the formation and use
of federal advisory committees.
The Advisory Council will provide advice, information, and
recommendations to the Secretary of HHS regarding programs and policies
intended to support and evaluate the implementation of Executive Order
13676, including the National Strategy for CARB and the Action Plan
(NAP). The Advisory Council shall function solely for advisory
purposes.
In carrying out its mission, the Advisory Council will provide
advice, information, and recommendations to the Secretary regarding
programs and policies intended to preserve the effectiveness of
antibiotics by optimizing their use; advance research to develop
improved methods for combating AR and conducting antibiotic
stewardship; strengthen surveillance of antibiotic-resistant bacterial
infections; prevent the transmission of antibiotic-resistant bacterial
infections; advance the development of rapid point-of-care and
agricultural diagnostics; further research on new treatments for
bacterial infections; develop alternatives to antibiotics for
agricultural purposes; maximize the dissemination of up-to-date
information on the appropriate and proper use of antibiotics to the
general public and human and animal healthcare providers; and improve
international coordination of efforts to combat AR.
Background: Antibiotic Resistance (AR) poses a significant threat
to our Nation's public health, economy, and national security. The
Centers for Disease Control and Prevention (CDC) estimates that every
year more than two million people in the United States (U.S.) contract
infections that are resistant to antibiotics, and at least 23,000
people die as a result. The United States exceeds $20 billion in direct
health care costs, and loses $35 billion in indirect costs due to loss
of productivity associated with antibiotic-resistant infections. By
2050, drug-resistant bacterial infections worldwide are estimated to
result in greater than 10 million deaths yearly and cost up to $100
trillion in losses to the world economy. Drug-resistant infections also
complicate the U.S. medical response to chemical, biological,
radiological, or nuclear emergencies, and the global spread of AR makes
our deployed service members particularly vulnerable.
In response to the AR threat, the USG developed the National
Strategy for Combating Antibiotic-Resistant Bacteria (CARB) in 2014.
The Strategy takes a One Health approach to combating antibiotic
resistance based on the persistence of AR within our global environment
and the recognition that integrated multi-sectoral action is needed to
prevent the emergence and spread of AR. In 2015, the U.S. government
issued the corresponding National Action Plan (NAP) for CARB, providing
a five-year roadmap (2015-2020) to guide the Nation in implementing the
following five goals outlined in the Strategy:
1. Slow the emergence of resistant bacteria and prevent the spread
of resistant infections;
2. Strengthen national One Health surveillance efforts to combat
resistance;
3. Advance development and use of rapid and innovative diagnostic
tests for identification and characterization of resistant bacteria;
4. Accelerate basic and applied research and development for new
antibiotics and other therapeutics, including vaccines; and
5. Improve international collaboration and capacities for
antibiotic resistance prevention, surveillance, control and antibiotic
research and development.
The U.S. government has made meaningful progress towards these
goals; however, since the issuance of the NAP in 2015, the domestic and
international landscape has changed with continued unparalleled
advancement and innovation in technology and the life sciences.
Additional action is needed and opportunities exist to continue this
progress beyond 2020. As such, the U.S. Government will issue a second
iteration of the NAP that will guide action on AR for the period of
2020-2025. The development of this draft will involve the U.S.
Government's careful consideration of progress to date on the current
NAP, including barriers to progress in certain areas and new
developments across sectors, at home and abroad.
Request for Information: To inform the Advisory Council's
deliberation on recommended priorities to consider in the USG's process
of developing the next NAP (2020-2025), please review the five goals in
the current NAP, and provide the following information:
In the context of the existing five goals, on what new
priorities should the
[[Page 59388]]
federal government focus in the next NAP for CARB--that are not already
included in the current plan--and why are they the most important? Your
response can cover a range of priority areas for human, animal, and
environmental health, including surveillance, research and development,
stewardship practices, infection prevention and control practices, and/
or other areas for consideration.
In preparing your response, please be sure to:
[cir] Consider how your response fits into the existing One Health
paradigm, and how your proposed priority should be further pursued by
the U.S. Government;
[cir] Provide an answer that is feasible and actionable by the U.S.
Government;
[cir] Limit your responses to no more than two priorities for each
of the five goals (a maximum of 10 can be submitted);
[cir] Summarize your response for each priority area in 250 words
or less, including its scientific justification;
[cir] Indicate whether your response is relevant domestically,
internationally, or both;
[cir] Indicate the domain(s) to which your response applies--human,
animal, and/or environmental health;
[cir] Include citations to support your response (references must
be in the form of an active link or citation; we will not accept
attachments. Peer-reviewed citations and journal links are highly
encouraged.
Response to this RFI is voluntary. Responders are free to address
any or all of the goals listed in the NAP. Please note that the USG
will not pay for response preparation or for the use of any information
contained in the response. The answers provided in this RFI must not
include any confidential or proprietary data. Responses to this notice
are not offers and cannot be accepted by the USG to form a binding
contract or issue a grant. Please be aware that your comments will not
be posted publicly, however, they may be made available to the public,
in part or in full, subject to applicable laws and regulations.
More information can be found at www.hhs.gov/ash/carb.
Dated: November 13, 2018.
Jomana F. Musmar,
Acting Designated Federal Officer, Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria Committee Manager.
[FR Doc. 2018-25435 Filed 11-21-18; 8:45 am]
BILLING CODE 4150-44-P
