2015-07235. Establishment of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria and Solicitation of Nominations for Appointment to the Council Membership

AGENCY:

Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

Authority: Executive Order 13676, dated September 18, 2014, authorizes establishment of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The Advisory Council will be governed by provisions of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.

SUMMARY:

The U.S. Department of Health and Human Services (HHS) announces establishment of the Advisory Council. The Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria (Strategy) and the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan).

This notice also will serve to announce that HHS is seeking nominations of individuals who are interested in being considered for appointment to the Advisory Council. Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Advisory Council are currently being accepted.

DATES:

Nominations must be received no later than close business April 29, 2015.

ADDRESSES:

All nominations should be sent to: Bruce Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health; Office of the Assistant Secretary for Health; Department of Health and Human Services; 200 Independence Avenue SW., Room 715H; Washington, DC 20201. Nomination materials, including attachments, also may be submitted electronically to [e-mail].

FOR FURTHER INFORMATION CONTACT:

Bruce Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health; Office of the Assistant Secretary for Health; Department of Health and Human Services; Telephone: [phone]; Fax: [phone]; Email address: [e-mail]. The Advisory Council charter may be accessed online at http://www.hhs.gov/​ash/​carb. The charter includes detailed information about the Advisory Council's purpose, function, and structure.

SUPPLEMENTARY INFORMATION:

The rise of antibiotic-resistant bacteria represents a serious threat to public health and the economy. Detecting, preventing, and controlling antibiotic resistance requires a strategic, coordinated, and sustained effort. The federal government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.

Under Executive Order 13676, the Secretary of Health and Human Services (the Secretary) is directed to establish the Advisory Council in consultation with the Secretaries of Defense and Agriculture. The Advisory Council will provide advice and recommendations to the Secretary regarding programs and policies to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria (Strategy) and the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan). On March 24, 2015, the Secretary approved for the Advisory Council to be established. The charter for the Advisory Council was filed with the appropriate Congressional committees and the Library of Congress on the same date. The Advisory Council has been established as a non-discretionary federal advisory committee.

Objectives and Scope of Activities. The Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the Strategy and Action Plan. The Advisory Council will function solely for advisory purposes.

Membership and Designation. The Advisory Council will consist of not more than 30 members, including the voting and non-voting members and Chair and Vice Chair. The members will be appointed or designated by the Secretary, who will designate the Chair and Vice Chair from among the voting members of the Advisory Council.

Voting Members. There will be public voting members selected from individuals who are engaged in research on, or implementation of, interventions regarding efforts 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 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 antibiotic resistance.

The public voting members will represent balanced points of view from human biomedical, public health, and agricultural fields to include surveillance of antibiotic-resistant infections, prevention and/or interruptions of the spread of antibiotic-resistant threats, or development of rapid diagnostics and novel treatments. The public voting members may be physicians, veterinarians, epidemiologists, microbiologists, or other health care professionals (e.g., nurses, pharmacists, others); individuals who have expertise and experience as consumer or patient advocates concerned with antibiotic resistance, or in the fields of agriculture and pharmaceuticals; and they also may be from State or local health agencies or public health organizations. All public voting members will be classified as special Government employees (SGEs).

Ex-officio Members (non-voting). The Advisory Council will include members selected to represent various federal agencies, including HHS, DoD, and USDA, that are involved in the development, testing, licensing, production, procurement, distribution, and/or use of antibiotics and/or antibiotic research. The federal ex-officio members shall possess the knowledge, skills, experience, and expertise necessary to generate informed and intelligent recommendations with respect to the issues mandated by Executive Order 13676. Federal agencies will be invited to participate as non-voting ex-officio members of the Advisory Council, as it is deemed necessary by the Secretary, in consultation with the Secretaries of Defense and Agriculture, to accomplish the mission the Advisory Council.

Liaison Representatives (non-voting). The Advisory Council structure also may include non-voting liaison representatives from organizations and/or interest groups that have involvement in the development, testing, licensing, production, procurement, distribution, and/or use of antibiotics and/or antibiotic research. Organizations will be invited to participate as non-voting liaison representatives as it is deemed necessary by the Secretary or designee to accomplish the established mission of the Advisory Council.

The public voting and non-voting liaison representative members will be appointed to serve for overlapping terms of up to four years. The Chair and Vice Chair will be appointed to serve for three years, unless otherwise specified.

The public voting members are authorized to receive per diem and reimbursement for travel expenses when attending meetings of the Advisory Council, as authorized by Section 5703, Title 5 U.S.C., as amended for persons employed intermittently in Government service. Individuals who are appointed to serve as non-voting liaison representative members also may be allowed to receive per diem and reimbursement for any applicable expenses for travel that is performed to attend meetings of the Advisory Council in accordance with Federal travel regulations.

Estimated Number and Frequency of Meetings. The Advisory Council will meet, at a minimum, two times per fiscal year depending on the availability of funds. Meetings will be open to the public, except as determined otherwise by the Secretary or other official to whom the authority has been delegated in accordance with guidelines under Government in the Sunshine Act, 5 U.S.C. 552b(c).

Nominations: Nominations, including self-nominations, of individuals who have the specified expertise and knowledge will be considered for appointment as public voting and/or non-voting members of the Advisory Council. A nomination should include, at a minimum, the following for each nominee: (1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (i.e., the desired member category and specific attributes which qualify the nominee to be considered for appointment as a public voting and/or non-voting member of the Advisory Council), and a statement from the nominee (including designated representatives of organizations and/or interest groups) that indicates that the individual is willing to serve as a member of the Advisory Council, if selected; (2) the nominator's name, address, and daytime telephone number, and the address, telephone number, and email address of the individual being nominated; and (3) a current copy of the nominee's curriculum vitae or resume, which should be limited to no more than 10 pages.

Every effort will be made to ensure that the Advisory Council is a diverse group of individuals with representation from various geographic locations, racial and ethnic minorities, all genders, and persons living with disabilities.

Individuals being considered for appointment as public voting members will be required to complete and submit a report of their financial holdings. An ethics review must be conducted to ensure that individuals appointed as public voting members of the Advisory Council are not involved in any activity that may pose a potential conflict of interest for the official duties that are to be performed. This is a federal ethics requirement that must be satisfied upon entering the position and annually throughout the established term of appointment on the Advisory Council.

Dated: March 24, 2015.

Sylvia M. Burwell,

Secretary of Health and Human Services.