2017-20108. 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we), together with the NARMS partner agencies, is announcing a public meeting entitled “2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System.” The purpose of the public meeting is to discuss the current status of the National Antimicrobial Resistance Monitoring System (NARMS) and directions for the future.

DATES:

The public meeting will be held on October 24 and 25, 2017, from 8:30 a.m. to 5 p.m. Eastern Time. Submit either electronic or written comments on this public meeting by November 24, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information.

ADDRESSES:

The public meeting will be held at the Jefferson Auditorium in the South Building, U.S. Department of Agriculture (USDA), 14th and Independence Avenue SW., Washington, DC 20250. The South Building is a Federal facility, and attendees should plan adequate time to pass through the security screening systems. Attendance is free. Non-USDA employees must enter through the Wing 3 entrance on Independence Avenue. Attendees must be pre-registered for the meeting (and check-in outside the day of the meeting) and show a valid photo ID to enter the building. Only registered attendees will be permitted to enter the building. For parking and security information, please refer to https://smithsonianassociates.org/​ticketing/​help/​locations/​jefferson.htm.

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 24, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. 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.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-5056 for “2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—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, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or 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 and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Laura Bradbard, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-1), Rockville, MD 20855, 240-402-5672, email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background and Topics for Discussion

NARMS periodically conducts public meetings to inform stakeholders of NARMS activities and receive comments on ways to improve. The last NARMS public meeting (held in 2014) focused on the achievement of several 2012-2016 NARMS Strategic Plan objectives and interagency research. The purpose of this meeting will be to summarize NARMS progress since that meeting, to present recommendations made by the recent FDA Science Board review of NARMS in 2017, and to explore new directions for NARMS within a One Health paradigm. Items that will be discussed during this meeting include an update on the development of new analytical and reporting tools, the latest advances in the use of DNA sequencing technologies, and new surveillance results. The meeting agenda will be posted no later than 5 days before the meeting at https://www.fda.gov/​AnimalVeterinary/​SafetyHealth/​AntimicrobialResistance/​NationalAntimicrobialResistanceMonitoringSystem/​ucm576281.htm.

In addition to discussion generated through this public meeting, FDA and the NARMS partners are interested in receiving stakeholder input on the following questions through electronic or written comments, which can be submitted to the Dockets Management Staff (see ADDRESSES).

1. Recently, NARMS modified its Integrated Reports and online data display tools (https://www.fda.gov/​AnimalVeterinary/​SafetyHealth/​AntimicrobialResistance/​NationalAntimicrobialResistanceMonitoringSystem/​ucm416741.htm). Do you find this more user-friendly and informative? Please explain.

2. How can NARMS accomplish better stakeholder engagement, which modes of engagement are preferred, and how frequent?

3. Where should the NARMS program focus over the next 5-10 years? What are the top three gaps in the NARMS program and how should they be addressed?

4. Which of the Science Board recommendations do you see as highest priority, and how should they be achieved?

At the conclusion of this meeting, a separate interagency meeting on whole genome sequencing will be held in the Jefferson Auditorium on October 26 and 27, 2017. A notice will be published in the Federal Register by the Food Safety Inspection Service to announce this meeting.

II. Participating in the Public Meeting

Registration: Persons interested in attending this public meeting must register online by October 10, 2017. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

There is no fee to register for the public meeting, but pre-registration by October 10, 2017, is mandatory for participants attending in person. Onsite registration will not be permitted. Early registration is recommended as space is limited. All attendees must pre-register online by emailing [e-mail] with the subject line “NARMS Public Meeting 2017” with information including name, title, organization, address, and telephone and Fax numbers. If you need special accommodations due to a disability, please contact Laura Bradbard (see FOR FURTHER INFORMATION CONTACT) no later than October 2, 2017.

Requests for Oral Presentations: Interested persons may make oral presentations on the topic of the discussion of the meeting. Oral presentations from the public during the open public comment period will be scheduled between 4:00 p.m. and 4:50 p.m. on October 25, 2017. Those desiring to make oral presentations should notify Laura Bradbard (see FOR FURTHER INFORMATION CONTACT) by October 2, 2017, and submit a brief statement of the general nature of information they wish to present. In an effort to accommodate all who desire to speak, time allotted for each presentation may be limited. The contact person will inform each speaker of their schedule prior to the meeting. If selected for presentation, speakers will be contacted by October 13, 2017, and presentation material should be submitted by email to Laura Bradbard (see FOR FURTHER INFORMATION CONTACT) by October 20, 2017. 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 be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/​AnimalVeterinary/​SafetyHealth/​AntimicrobialResistance/​NationalAntimicrobialResistanceMonitoringSystem/​ucm059172.htm.

Dated: September 15, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.