[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44189-44191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20108]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5056]


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.

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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.

[[Page 44190]]

     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: [email protected].

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 [email protected] 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

[[Page 44191]]

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.
[FR Doc. 2017-20108 Filed 9-20-17; 8:45 am]
 BILLING CODE 4164-01-P