[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]


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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.

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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

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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:
    [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]
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