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  5. FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs - 11/16/2020 - 11/16/2020
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Event Title
FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs
November 16, 2020


Date:
November 16, 2020
Time:
9:30 AM - 4:00 PM ET
Organized By:

On November 16, 2020, the U.S. Food and Drug Administration is hosting a virtual Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs. 

The purpose of this meeting is to obtain early public input on a potential revised process and criteria for ranking antimicrobial drugs based on their importance in human medicine. The Agency is seeking public input on a concept paper which includes a potential revised process for ranking antimicrobials according to their relative importance in human medicine, the potential criteria for their ranking, and the resulting ranked list of antimicrobial drugs. 

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 as to their 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 proposed criteria been applied correctly to the antimicrobial classes as reflected in their proposed 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?  

MEETING INFORMATION

The public meeting will be hosted via a live virtual webcast on Monday, November 16, (9:30 a.m. to 4:00 p.m. ET). Advance registration is required to attend.

REGISTRATION

People 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, mailing 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.

Request to Make an Oral Presentation

During registration you may indicate if you wish to present during the public comment session. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. All requests to make oral presentations must be received by October 23, 2020

FDA will then determine the amount of time allotted to each presenter and the approximate start time for each oral presentation.  All presenters will be notified of their allotted time and placement in the agenda by October 27, 2020. If selected for presentation, any presentation materials must be emailed to Kelly.Covington@fda.hhs.gov no later than 4:00 p.m. on Monday, November 9, 2020

No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

Public Comments

The FDA is accepting public comments October 9, 2020 through January 15, 2021.  To electronically submit comments to the docket, visit https://www.regulations.gov and type FDA-2020-N-1736 in the search box. For assistance in submitting electronic comments, please see regulations.gov/help. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process.  Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov

Due to the COVID-19 pandemic, Dockets Management Staff is receiving USPS mail intermittently. Therefore, electronic submissions are preferred. To submit comments to the docket by mail, use the following address: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  Be sure to include docket number FDA-2020-N-1736 on each page of your written comments. Received comments filed in a timely manner will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov

To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.  You should submit two copies total.  One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION."  The Agency will review this copy, including the claimed confidential information, in its consideration of comments.  The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff.  If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential."  Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.  For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015.

For access to the docket to read the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts.

TRANSCRIPT

A transcript of the meeting will be made available within 30 days after the meeting. It will be accessible at https://www.regulations.gov under docket number FDA-2020-N-1736. A link to the transcript will also be available on this webpage.

FOR MORE INFORMATION: 

Contact Kelly.Covington@fda.hhs.gov.

Event Materials and Supporting Documents 

Concept Paper: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs

Guidance for Industry #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern”

 

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