SUPPLEMENTARY INFORMATION:

I. Background

Antimicrobial drugs have been used since the mid-20th century to control and cure infectious diseases in humans. Since their discovery, these drugs have prevented millions of human deaths worldwide, they have helped to promote animal health, and they have helped to provide an abundant and affordable supply of meat, milk, and eggs. Soon after antimicrobial drugs became widely available, scientists noted that their use could contribute to the emergence and selection of antimicrobial resistance in bacteria, thereby reducing the effectiveness of the antimicrobial drugs. To address the human health risks surrounding the use of antimicrobial new animal drugs, in 2003, FDA issued Guidance for Industry (GFI) #152, entitled “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern.” ^[1] GFI #152 outlines a qualitative risk assessment methodology as a process for evaluating foodborne antimicrobial resistance concerns related to the use of antimicrobial drugs in food-producing animals. One component of the risk assessment is the consequence assessment, which considers the medical importance of an antimicrobial drug or drug class used in human medicine.

GFI #152 also contains an appendix, commonly referred to as “Appendix A,” in which FDA ranks antimicrobial drugs according to their relative importance to human medicine: “critically important,” “highly important,” or “important.” In GFI #152, FDA recommends that sponsors of antimicrobial new animal drugs refer to Appendix A to initially assess the importance of the antimicrobial drug or drug class in question to human medicine and base their consequence assessment conclusion on this human medical importance ranking.

The current list of medically important antimicrobial drugs in Appendix A reflects FDA's thinking at the time of publication, in 2003.

As noted in GFI #152, the development of new antimicrobial drugs for human therapy, the emergence or re-emergence of diseases in humans, and changes in prescribing practices, are some factors that may cause the human medical importance rankings to change over time. It was envisioned at the time of publication of GFI #152 that the Agency would reassess the rankings provided in Appendix A periodically to confirm that the rankings are consistent with contemporary practices and needs.

Given the considerable advances in science that have taken place since 2003, new relevant information has become available. The purpose of the public meeting is to obtain early input on a potential revised process for ranking antimicrobial drugs according to their relative importance in human medicine, as well as potential criteria for their ranking.

II. Topics for Discussion at the Public Meeting

We will publish the public meeting agenda and related information, including a concept paper describing a potential revised ranking process, at https://www.fda.gov/​animal-veterinary/​workshops-conferences-meetings/​fda-public-meeting-potential-approach-ranking-antimicrobial-drugs-according-their-importance-human. We do not intend for this meeting to produce any decisions or new positions on specific regulatory questions. However, we expect this meeting to be an important step in our efforts to gather information and public feedback on a potential revised process for ranking antimicrobial drugs according to their relative importance in human medicine, on the criteria for their ranking, and on a ranked list of antimicrobial drugs.

We are specifically interested in receiving public comments on the following questions:

1. Are the criteria and the tier-based framework described in the potential revised process for ranking antimicrobial drugs according to their relative human medical importance clear, complete, and consistent?

2. What changes do you think are needed to the criteria or tiers, if any?

3. Have the potential criteria been applied correctly to the antimicrobial classes as reflected in the resulting rankings?

4. Are there other issues we should consider regarding these criteria and the tier-based framework?

5. How often and by what process should FDA update the ranking of medically important antimicrobials?

III. Participating in the Public Meeting

Registration: Persons interested in attending this public meeting must register no later than 11:59 p.m. Eastern Time on November 12, 2020, by emailing complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and if you need reasonable accommodations due to a disability ( e.g., Closed Captioning) to Kelly Covington at kelly.covington@fda.hhs.gov. Early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link.

Requests for Oral Presentations: During online registration you may indicate if you wish to make an oral presentation during the public meeting. To facilitate agenda development, ( printed page 64483) registrants requesting to present will be contacted to provide information regarding which topics they intend to address and the title of their presentation. We will do our best to accommodate requests to make an oral presentation. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate. All requests to make oral presentations must be received by October 23, 2020.

We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and we will notify participants by October 27, 2020. Selected presenters planning to use an electronic slide deck must submit an electronic copy of their PowerPoint presentation to Kelly Covington (see FOR FURTHER INFORMATION CONTACT ) with the subject line “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs” on or before November 9, 2020. If presenters choose not to use a slide deck, they are requested to submit a single slide with their name, affiliation, title of their presentation, and contact information. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on the Agency's website at https://www.fda.gov/​animal-veterinary/​workshops-conferences-meetings/​fda-public-meeting-potential-approach-ranking-antimicrobial-drugs-according-their-importance-human.

85 FR 64481