2016-12043. Notice of Request for Information 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. In the process of developing their report, Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria, the Advisory Council followed the framework of the National Action Plan for Combating Antibiotic Resistant Bacteria (Action Plan) to hear about a wide range of ongoing and planned activities by the federal government, including some stakeholders/sectors relevant to this overall effort. This Request for Information (RFI) offers the opportunity for interested individuals, organizations, associations, industries, and others, to provide their feedback. Responses to the questions must be received by 11:59 p.m. on June 22, 2016 to be considered. The questions are also available through an online form on the Advisory Council Web page at www.hhs.gov/​ash/​carb. Individuals who wish to send in their responses via email should send an email to [e-mail], indicating the question number(s) for which they are responding.

DATES:

Comments must be received by 11:59 p.m. on June 22, 2016 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 the question number(s) in the subject line. Do not include in your response 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 affirmatively 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 will not receive individualized feedback on any suggestions.
• Email: [e-mail]. Please indicate the question number(s) in the subject line of your email. Email submissions will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback on any suggestions.

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 Combating Antibiotic-Resistant Bacteria and the Action Plan. 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. In response to their mission, the Advisory Council recently released their first report, Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria, at their second public meeting held on March 30-31, 2016, in Washington, DC.

Background: In the process of developing their report, the Advisory Council followed the framework of the Action Plan to hear about a wide range of ongoing and planned activities by the federal government, including some stakeholders/sectors relevant to this overall effort. Acknowledging that there are others who the Advisory Council would like to hear from, they are seeking that information through this RFI. The purpose of the questions posed in this RFI is to gain additional information from the public on the subject matter in several areas addressed in the Action Plan. The responses gathered from the RFI will be reviewed by the members of the Advisory Council and will be taken into consideration as they move forward with their activities. The responses provided are for the Advisory Council's informational purposes only. Response to this RFI is voluntary. Responders are free to address any or all of the questions below.

Request for Information: To solicit additional information from the public, including individuals, organizations, associations, and industries involved in combating antibiotic-resistance, the Advisory Council seeks responses on the following requests for information:

1. Describe how organizations are influencing curricula regarding primary prevention (antibiotic stewardship, infection prevention, and control). Please include information about certification examinations, requirements, and continuing education, if relevant.

2. Describe how healthcare organizations can best: (a) Educate and provide feedback to providers in clinics/facilities about infectious diseases diagnostic testing, optimal antibiotic prescribing, and infection prevention; where relevant, please include information about what incentives and disincentives these organizations have in place with the goal of improving antibiotic prescribing (e.g., using clinical decision support) and prevent spread of resistant infections; and, (b) encourage and/or incentivize providers to report antibiotic use and resistance data for all patient populations.

3. Please provide examples of successful behavior change models that can be applied to preventive strategies, such as infection control and antibiotic stewardship.

4. Please provide information on the best ways to collect data on antibiotic use [and resistance] in animal agriculture through public-private collaborations. Your response can include information on the types of data to be collected, including the method of collection, and the metrics for reporting the data. If helpful, please cite sample models as examples to depict your answer.

5. Please provide information on the different resources that exist to promote the understanding of how antibiotics are being used in humans and animals in different parts of the world. Your response can include information on the types of support to connect with such resources, as appropriate (examples include public-private partnerships, strategic resourcing, or other means).

More information can be found at www.hhs.gov/​ash/​carb.

Dated: May 18, 2016.

Bruce Gellin,

Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Deputy Assistant Secretary for Health.