Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44187 

TABLE 1—Continued 

Application No. Drug Applicant 

ANDA 091201 ...................... Meropenem for Injection USP, 500 mg/vial and 1 g/vial Sandoz Inc., 100 College Rd. West, Princeton, NJ 

08540. 

ANDA 200156 ...................... Armodafinil Tablets, 100 mg and 200 mg ...................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective October 

23, 2017. Introduction or delivery for 

introduction into interstate commerce of 

products without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in table 1 

that are in inventory on the date that 

this notice becomes effective (see the 

DATES section) may continue to be 

dispensed until the inventories have 

been depleted or the drug products have 

reached their expiration dates or 

otherwise become violative, whichever 

occurs first. 

Dated: September 15, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20107 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–5255] 

Dermatologic and Ophthalmic Drugs 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Dermatologic and Ophthalmic Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. FDA 

is establishing a docket for public 

comment on this document. 

DATES: The public meeting will be held 

on October 13, 2017, from 8:30 a.m. to 

4 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–5255. 

The docket will close on October 12, 

2017. Submit either electronic or 

written comments on this public 

meeting by October 12, 2017. Late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 12, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 12, 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. 

Comments received on or before 

September 28, 2017, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by the Agency. 

You may submit comments as 

follows: 

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–5255 for ‘‘Dermatologic and 

Ophthalmic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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. 


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