44188 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 

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: 

LaToya Bonner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, email: 

DODAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

to learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committee will discuss 

the safety and efficacy of new drug 

application (NDA) 208254, for 

netarsudil ophthalmic solution 0.02%, 

submitted by Aerie Pharmaceuticals 

Inc., for the proposed indication to 

reduce elevated intraocular pressure 

(IOP) in patients with open-angle 

glaucoma (OAG) or ocular hypertension 

(OHT). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/default.

htm. Scroll down to the appropriate 

advisory committee meeting link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see the ADDRESSES section) on 

or before September 28, 2017, will be 

provided to the committee. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 

September 20, 2017. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by September 21, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require special accommodations 

due to a disability, please contact 

LaToya Bonner at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20105 Filed 9–20–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Drug Development in Pediatric Heart 

Failure: Extrapolation, Clinical Trial 

Design, and Endpoints; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public workshop entitled 

‘‘FDA-University of Maryland CERSI 

Drug Development in Pediatric Heart 

Failure: Extrapolation, Clinical Trial 

Design, and Endpoints.’’ The purpose of 

the public workshop is to address 

challenges related to the evaluation of 

products in pediatric heart failure 

including population to study, 

endpoints, and extrapolation of adult 

efficacy data. The workshop will also 

provide a forum for discussion on the 

use of registry data, as well as 

alternative trial designs and statistical 

methods. 

DATES: The public workshop will be 

held on Friday, October 27, 2017, from 

8 a.m. to 5 p.m. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Rm. 1503A, Silver Spring, MD 20993– 

0002. Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1, where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Jacquline Yancy, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6319, 

Silver Spring, MD 20993–0002, 301– 

796–7068, Jacquline.Yancy@

fda.hhs.gov. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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