Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

AGENCY:

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

ACTION:

Notice.

SUMMARY:

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 of 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 Web site http://www.hhs.gov/ash/carb/ and must be completed by June 18, 2016; 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 http://www.hhs.gov/ash/carb/ on the Meetings page.

DATES:

The meeting is scheduled to be held on June 21, 2016, from 10:00 a.m. to 5:00 p.m. ET, and June 22, 2016, from 9:00 a.m. to 4:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the Web site for the Advisory Council at http://www.hhs.gov/ash/carb/ when this information becomes available. Pre-registration for attending the meeting in person is required to be completed no later than June 18, 2016; 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 also can be accessed through a live webcast on the day of the meeting. For more information, visit http://www.hhs.gov/ash/carb/.

FOR FURTHER INFORMATION CONTACT:

Bruce Gellin, 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) 260-6638; email: CARB@hhs.gov.

SUPPLEMENTARY INFORMATION:

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 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.

On June 21, the public meeting will be dedicated to presentations from federal and non-federal stakeholders surrounding topic areas related to incentives for the development of vaccines, diagnostics, and therapeutics. On June 22, the meeting will focus on the topic of the environment and antibiotic-resistance, in addition to a presentation regarding the new guidance from the Food and Drug Administration for Industry #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209.” The meeting agenda will be posted on the Advisory Council Web site at http://www.hhs.gov/ash/carb/ when it has been finalized. All agenda items are tentative and subject to change.

Public attendance at the meeting is limited to the available space. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Designated Federal Officer at the address/telephone number listed above at least one week prior to the meeting. For those unable to attend in person, a live webcast will be available. More information on registration and accessing the webcast can be found at http://www.hhs.gov/ash/carb/.

Members of the public will have the opportunity to provide comments prior to the Advisory Council meeting by emailing CARB@hhs.gov. Public comments should be sent in by midnight June 15, 2016, and should be limited to no more than one page. All public comments received prior to June 15, 2016, will be provided to Advisory Council members; comments are limited to two minutes per speaker.