Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44189 

SUPPLEMENTARY INFORMATION: 

I. Background 

The purpose of this public workshop 

is to provide an opportunity for relevant 

stakeholders, including clinicians, 

academia, industry, and FDA, to discuss 

alternative trial designs for product 

development in pediatric heart failure. 

II. Topics for Discussion at the Public 

Workshop 

Specifically, the workshop will 

include application of pediatric 

extrapolation in drug development for 

pediatric heart failure and a discussion 

of alternative approaches to establishing 

effectiveness in pediatric heart failure, 

including the use of Bayesian 

approaches. Cases will be presented to 

exemplify various approaches. 

The agenda is located at http://

www.cersi.umd.edu/events/ 

index.php?mode=4&id=12500. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, visit the following Web site: 

http://www.cersi.umd.edu/events/ 

index.php?mode=4&id=12500. 

Registrants will receive confirmation 

when they have been accepted. There 

will be no onsite registration. 

There is a registration fee to attend 

this public workshop in person. Seats 

are limited and registration will be on 

a first-come, first-served basis. The cost 

to attend in person is as follows: 

Category Cost 

Industry Representative ................ $50 

Nonprofit Organization and Academic Other Than University of 

Maryland ................................... 50 

University of Maryland, College 

Park and Baltimore ................... 0 

Federal Government ..................... 0 

If you need special accommodations 

due to a disability, please contact 

Jacquline Yancy (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast. There is no registration 

fee for attending the workshop via the 

webcast, but registration is still 

required. Information regarding access 

to the webcast link is available at http:// 

www.cersi.umd.edu/events/ 

index.php?mode=4&id=12500. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

Web sites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff Office 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20106 Filed 9–20–17; 8:45 a.m.] 

BILLING CODE 4164–01–P 

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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
44190 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 

• 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: laura.bradbard@

fda.hhs.gov. 

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/ 

NationalAntimicrobial

ResistanceMonitoringSystem/ 

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/ 

NationalAntimicrobial

ResistanceMonitoringSystem/ 

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 laura.bradbard@

fda.hhs.gov 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44191 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/

AnimalVeterinary/SafetyHealth/ 

AntimicrobialResistance/ 

NationalAntimicrobial

ResistanceMonitoringSystem/ 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Single-Award Deviation From 

Competition Requirements for the 

Severe Combined Immunodeficiency 

(SCID) Newborn Screening Program at 

the Jeffrey Modell Foundation 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of award. 

SUMMARY: HRSA announces the award 

of an extension in the amount of 

$2,000,000 for the Severe Combined 

Immunodeficiency (SCID) Newborn 

Screening program at the Jeffrey Modell 

Foundation (JMF). The extension will 

allow JMF, the cooperative agreement 

recipient, during the budget period of 

May 1, 2017 to April 30, 2018, to 

provide technical assistance and 

support to states for the implementation 

of population based newborn screening 

for SCID. 

FOR FURTHER INFORMATION CONTACT: Jill 

F. Shuger, ScM, Division of Services for 

Children with Special Health Needs, 

MCHB, HRSA, 5600 Fishers Lane, 

Rockville, Maryland 20857, Phone: 

(301) 443–3247, Email: JShuger@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: 

Jeffrey Modell Foundation. 

Amount of Non-Competitive Awards: 

$2,000,000. 

Budget Period of Supplemental 

Funding: May 1, 2017 to April 30, 2018. 

CFDA Number: 93.110. 

Authority: Public Health Service Act, 

§ 1109, as amended by the Newborn 

Screening Saves Lives Reauthorization 

Act of 2014 (Public Law 110–204) (42 

U.S.C. 300b–8). 

Justification: The Maternal and Child 

Health Bureau (MCHB) is proposing that 

JMF continue activities under the 

current cooperative agreement to ensure 

the implementation of newborn 

screening for SCID in all 50 states, 

particularly in the states that have yet to 

implement SCID screening (i.e., 

Alabama, Arizona, Indiana, Kansas, 

Louisiana, Nevada and North Carolina). 

Using its resources and centers, JMF 

will provide technical assistance in 

areas of funding, state government 

education, and linkage to expert care 

and patient access to a national network 

of specialized treatment centers. 

Further, JMF will continue to support 

states with implementation of SCID 

screening and follow up as well as the 

immediate treatment of infants 

identified with SCID. JMF will use the 

data collected from the states to educate 

clinical immunologists, neonatologists 

and other providers on effective 

screening for SCID. Additionally, JMF 

will continue to support education and 

awareness of newborn screening for 

SCID to families and health care 

providers and provide education to 

primary care providers and medically 

underserved populations. 

Grantee/organization name Grant No. State 

Fiscal year 

2017 

authorized 

funding level 

Fiscal year 

2017 

estimated 

supplemental 

funding 

Jeffrey Modell Foundation ............................................................................... UG5MC28325 UT $2,000,000 $2,000,000 

Dated: September 7, 2017. 

George Sigounas, 

Administrator. 

[FR Doc. 2017–20116 Filed 9–20–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; T32 

Institutional Training Grant Review. 

Date: October 6, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Dental and 

Craniofacial Research, Democracy One, 6701 

Democracy Blvd., Suite 602, Bethesda, MD 

20892. 

Contact Person: Kan Ma, Ph.D., Scientific 

Review Officer, Scientific Review Branch, 

National Institute of Arthritis, 

Musculoskeletal and Skin Diseases, NIH, 

6701 Democracy Boulevard, Suite 814, 

Bethesda, MD 20892, 301–451–4838, mak2@

mail.nih.gov. 

Name of Committee: National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; Division of 

Musculoskeletal Diseases RISK R61/R33 Peer 

Review. 

Date: October 11, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Rd, 

Bethesda, MD 20852. 

Contact Person: Xincheng Zheng, MD, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute of 

Arthritis, Musculoskeletal and Skin Diseases, 

NIH, 6701 Democracy Boulevard, Suite 820, 

Bethesda, MD 20892, 301–451–4838, 

xincheng.zheng@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 

Dated: September 15, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–20095 Filed 9–20–17; 8:45 am] 

BILLING CODE 4140–01–P 


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