82 FR 44189 - 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 182 (September 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 182 (September 21, 2017)
| Page Range | 44189-44191 | |
| FR Document | 2017-20108 |
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)] [Notices] [Pages 44189-44191] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20108] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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
![Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44189
SUPPLEMENTARY INFORMATION: go/connectpro_overview. FDA has systems. Attendance is free. Non-USDA
verified the Web site addresses in this employees must enter through the Wing
I. Background
document, as of the date this document 3 entrance on Independence Avenue.
The purpose of this public workshop publishes in the Federal Register, but Attendees must be pre-registered for the
is to provide an opportunity for relevant Web sites are subject to change over meeting (and check-in outside the day
stakeholders, including clinicians, time. of the meeting) and show a valid photo
academia, industry, and FDA, to discuss Transcripts: Please be advised that as ID to enter the building. Only registered
alternative trial designs for product soon as a transcript of the public attendees will be permitted to enter the
development in pediatric heart failure. workshop is available, it will be building. For parking and security
II. Topics for Discussion at the Public accessible at https:// information, please refer to https://
Workshop www.regulations.gov. It may be viewed smithsonianassociates.org/ticketing/
at the Dockets Management Staff Office help/locations/jefferson.htm.
Specifically, the workshop will (HFA–305), Food and Drug You may submit comments as
include application of pediatric Administration, 5630 Fishers Lane, Rm. follows. Please note that late, untimely
extrapolation in drug development for 1061, Rockville, MD 20852. filed comments will not be considered.
pediatric heart failure and a discussion Electronic comments must be submitted
Dated: September 15, 2017.
of alternative approaches to establishing on or before November 24, 2017. The
effectiveness in pediatric heart failure, Anna K. Abram,
Deputy Commissioner for Policy, Planning, https://www.regulations.gov electronic
including the use of Bayesian filing system will accept comments
approaches. Cases will be presented to Legislation, and Analysis.
[FR Doc. 2017–20106 Filed 9–20–17; 8:45 a.m.]
until midnight Eastern Time at the end
exemplify various approaches. of November 24, 2017. Comments
The agenda is located at http:// BILLING CODE 4164–01–P
received by mail/hand delivery/courier
www.cersi.umd.edu/events/
(for written/paper submissions) will be
index.php?mode=4&id=12500.
DEPARTMENT OF HEALTH AND considered timely if they are
III. Participating in the Public HUMAN SERVICES postmarked or the delivery service
Workshop acceptance receipt is on or before that
Registration: To register for the public Food and Drug Administration date.
workshop, visit the following Web site: [Docket No. FDA–2017–N–5056] Electronic Submissions
http://www.cersi.umd.edu/events/
index.php?mode=4&id=12500. 2017 Scientific Meeting of the National Submit electronic comments in the
Registrants will receive confirmation Antimicrobial Resistance Monitoring following way:
when they have been accepted. There System; Public Meeting; Request for • Federal eRulemaking Portal:
will be no onsite registration. Comments https://www.regulations.gov. Follow the
There is a registration fee to attend instructions for submitting comments.
this public workshop in person. Seats AGENCY: Food and Drug Administration, Comments submitted electronically,
are limited and registration will be on HHS. including attachments, to https://
a first-come, first-served basis. The cost ACTION: Notice of public meeting; www.regulations.gov will be posted to
to attend in person is as follows: request for comments. the docket unchanged. Because your
comment will be made public, you are
Category Cost SUMMARY: The Food and Drug solely responsible for ensuring that your
Administration (FDA, the Agency, or comment does not include any
Industry Representative ................ $50 we), together with the NARMS partner confidential information that you or a
Nonprofit Organization and Aca- agencies, is announcing a public third party may not wish to be posted,
demic Other Than University of meeting entitled ‘‘2017 Scientific such as medical information, your or
Maryland ................................... 50 Meeting of the National Antimicrobial anyone else’s Social Security number, or
University of Maryland, College Resistance Monitoring System.’’ The
Park and Baltimore ................... 0 confidential business information, such
purpose of the public meeting is to as a manufacturing process. Please note
Federal Government ..................... 0
discuss the current status of the that if you include your name, contact
If you need special accommodations National Antimicrobial Resistance information, or other information that
due to a disability, please contact Monitoring System (NARMS) and identifies you in the body of your
Jacquline Yancy (see FOR FURTHER directions for the future. comments, that information will be
INFORMATION CONTACT) at least 7 days in DATES: The public meeting will be held posted on https://www.regulations.gov.
advance. on October 24 and 25, 2017, from 8:30 • If you want to submit a comment
Streaming Webcast of the Public a.m. to 5 p.m. Eastern Time. Submit with confidential information that you
Workshop: This public workshop will either electronic or written comments do not wish to be made available to the
also be webcast. There is no registration on this public meeting by November 24, public, submit the comment as a
fee for attending the workshop via the 2017. See the SUPPLEMENTARY written/paper submission and in the
webcast, but registration is still INFORMATION section for registration date manner detailed (see ‘‘Written/Paper
required. Information regarding access and information. Submissions’’ and ‘‘Instructions’’).
asabaliauskas on DSKBBXCHB2PROD with NOTICES
to the webcast link is available at http:// ADDRESSES: The public meeting will be
Written/Paper Submissions
www.cersi.umd.edu/events/ held at the Jefferson Auditorium in the
index.php?mode=4&id=12500. South Building, U.S. Department of Submit written/paper submissions as
If you have never attended a Connect Agriculture (USDA), 14th and follows:
Pro event before, test your connection at Independence Avenue SW., • Mail/Hand Delivery/Courier (for
https://collaboration.fda.gov/common/ Washington, DC 20250. The South written/paper submissions): Dockets
help/en/support/meeting_test.htm. To Building is a Federal facility, and Management Staff (HFA–305), Food and
get a quick overview of the Connect Pro attendees should plan adequate time to Drug Administration, 5630 Fishers
program, visit https://www.adobe.com/ pass through the security screening Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 17:52 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1](https://thefederalregister.org/doc/82_FR_44371/page/1.svg)
![Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44191
Staff (see ADDRESSES). A link to the SUMMARY: HRSA announces the award Justification: The Maternal and Child
transcript will also be available on the of an extension in the amount of Health Bureau (MCHB) is proposing that
internet at https://www.fda.gov/ $2,000,000 for the Severe Combined JMF continue activities under the
AnimalVeterinary/SafetyHealth/ Immunodeficiency (SCID) Newborn current cooperative agreement to ensure
AntimicrobialResistance/ Screening program at the Jeffrey Modell the implementation of newborn
NationalAntimicrobial Foundation (JMF). The extension will screening for SCID in all 50 states,
ResistanceMonitoringSystem/ allow JMF, the cooperative agreement particularly in the states that have yet to
ucm059172.htm. recipient, during the budget period of implement SCID screening (i.e.,
Dated: September 15, 2017. May 1, 2017 to April 30, 2018, to Alabama, Arizona, Indiana, Kansas,
provide technical assistance and
Anna K. Abram, Louisiana, Nevada and North Carolina).
support to states for the implementation
Deputy Commissioner for Policy, Planning, Using its resources and centers, JMF
of population based newborn screening
Legislation, and Analysis.
for SCID. will provide technical assistance in
[FR Doc. 2017–20108 Filed 9–20–17; 8:45 am] areas of funding, state government
FOR FURTHER INFORMATION CONTACT: Jill
BILLING CODE 4164–01–P education, and linkage to expert care
F. Shuger, ScM, Division of Services for
Children with Special Health Needs, and patient access to a national network
MCHB, HRSA, 5600 Fishers Lane, of specialized treatment centers.
DEPARTMENT OF HEALTH AND Further, JMF will continue to support
Rockville, Maryland 20857, Phone:
HUMAN SERVICES states with implementation of SCID
(301) 443–3247, Email: JShuger@
hrsa.gov. screening and follow up as well as the
Health Resources and Services
immediate treatment of infants
Administration SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: identified with SCID. JMF will use the
Notice of Single-Award Deviation From Jeffrey Modell Foundation. data collected from the states to educate
Competition Requirements for the Amount of Non-Competitive Awards: clinical immunologists, neonatologists
Severe Combined Immunodeficiency $2,000,000. and other providers on effective
(SCID) Newborn Screening Program at Budget Period of Supplemental screening for SCID. Additionally, JMF
the Jeffrey Modell Foundation Funding: May 1, 2017 to April 30, 2018. will continue to support education and
CFDA Number: 93.110. awareness of newborn screening for
AGENCY: Health Resources and Services Authority: Public Health Service Act, SCID to families and health care
Administration (HRSA), Department of § 1109, as amended by the Newborn providers and provide education to
Health and Human Services. Screening Saves Lives Reauthorization primary care providers and medically
Act of 2014 (Public Law 110–204) (42 underserved populations.
ACTION: Notice of award.
U.S.C. 300b–8).
Fiscal year
Fiscal year 2017
2017
Grantee/organization name Grant No. State estimated
authorized supplemental
funding level funding
Jeffrey Modell Foundation ............................................................................... UG5MC28325 UT $2,000,000 $2,000,000
Dated: September 7, 2017. property such as patentable material, Musculoskeletal Diseases RISK R61/R33 Peer
George Sigounas, and personal information concerning Review.
Administrator. individuals associated with the grant Date: October 11, 2017.
[FR Doc. 2017–20116 Filed 9–20–17; 8:45 am] applications, the disclosure of which Time: 8:00 a.m. to 5:00 p.m.
would constitute a clearly unwarranted Agenda: To review and evaluate grant
BILLING CODE 4165–15–P
invasion of personal privacy. applications.
Place: Bethesda North Marriott Hotel &
Name of Committee: National Institute of Conference Center, 5701 Marinelli Rd,
DEPARTMENT OF HEALTH AND Arthritis and Musculoskeletal and Skin
Bethesda, MD 20852.
HUMAN SERVICES Diseases Special Emphasis Panel; T32
Institutional Training Grant Review. Contact Person: Xincheng Zheng, MD,
National Institutes of Health Date: October 6, 2017. Ph.D., Scientific Review Officer, Scientific
Time: 8:00 a.m. to 5:00 p.m. Review Branch, National Institute of
National Institute of Arthritis and Agenda: To review and evaluate grant Arthritis, Musculoskeletal and Skin Diseases,
Musculoskeletal and Skin Diseases; applications. NIH, 6701 Democracy Boulevard, Suite 820,
Notice of Closed Meetings Place: National Institute of Dental and Bethesda, MD 20892, 301–451–4838,
Craniofacial Research, Democracy One, 6701 xincheng.zheng@nih.gov.
Pursuant to section 10(d) of the Democracy Blvd., Suite 602, Bethesda, MD (Catalogue of Federal Domestic Assistance
Federal Advisory Committee Act, as 20892.
Program Nos. 93.846, Arthritis,
Contact Person: Kan Ma, Ph.D., Scientific
asabaliauskas on DSKBBXCHB2PROD with NOTICES
amended, notice is hereby given of the Musculoskeletal and Skin Diseases Research,
Review Officer, Scientific Review Branch,
following meetings. National Institutes of Health, HHS)
National Institute of Arthritis,
The meetings will be closed to the Musculoskeletal and Skin Diseases, NIH, Dated: September 15, 2017.
public in accordance with the 6701 Democracy Boulevard, Suite 814,
provisions set forth in sections Sylvia L. Neal,
Bethesda, MD 20892, 301–451–4838, mak2@
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., mail.nih.gov. Program Analyst, Office of Federal Advisory
as amended. The grant applications and Committee Policy.
Name of Committee: National Institute of
the discussions could disclose Arthritis and Musculoskeletal and Skin [FR Doc. 2017–20095 Filed 9–20–17; 8:45 am]
confidential trade secrets or commercial Diseases Special Emphasis Panel; Division of BILLING CODE 4140–01–P
VerDate Sep<11>2014 19:03 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1](https://thefederalregister.org/doc/82_FR_44371/page/3.svg)
Document Created: 2018-10-24 14:34:13
Document Modified: 2018-10-24 14:34:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 82 FR 44189 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR