Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42125 

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: 

Steven Fleischer, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0809, 

steven.fleischer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 24, 2018, FDA 

published a request for comments with 

a 90-day comment period to request 

comments on the design of studies 

intended to generate data to support 

substantial evidence of effectiveness for 

investigational new animal drugs 

intended for the prevention of 

heartworm disease in dogs. Comments 

received will inform FDA’s current 

thinking regarding the design of studies 

intended to generate data to support 

substantial evidence of effectiveness for 

investigational new animal drugs 

intended for the prevention of 

heartworm disease in dogs. 

The Agency has received a request for 

a 90-day extension of the comment 

period for the request for comments. 

The request conveyed concern that the 

current 90-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the request for comments. 

FDA has considered the request and 

is extending the comment period for the 

request for comments for 90 days, until 

November 20, 2018. The Agency 

believes that a 90-day extension allows 

adequate time for interested persons to 

submit comments without significantly 

delaying further action on these 

important issues. 

Dated: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17858 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3000] 

Pediatric 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) announces a 

forthcoming public advisory committee 

meeting of the Pediatric Advisory 

Committee (PAC). The general function 

of the committee is to provide advice 

and recommendations to FDA on 

regulatory issues. FDA is establishing a 

docket for public comments on this 

document. 

DATES: The meeting will be held on 

September 20, 2018, from 8:30 a.m. to 

4 p.m. This is a reschedule of a 

postponed meeting announced in the 

Federal Register of January 2, 2018 (83 

FR 125), originally scheduled for March 

23, 2018. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31, Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993– 

002. 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/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–3000. 

The docket will close on September 19, 

2018. Submit either electronic or 

written comments on this public 

meeting by that date. Please note that 

late, untimely comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

September 19, 2018. 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 6, 2018, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by FDA. 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 Docket No. FDA–2018–N– 

3000 for ‘‘Pediatric Advisory 

Committee; 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.’’ FDA 

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 


daltland on DSKBBV9HB2PROD with NOTICES
42126 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 

contact information 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 the 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: 

Marieann Brill, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5154, Silver Spring, 

MD 20993, 240–402–3838, email: 

marieann.brill@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 website 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: On Thursday, September 20, 

2018, the PAC will meet to discuss 

pediatric-focused safety reviews, as 

mandated by the Best Pharmaceuticals 

for Children Act (Pub. L. 107–109) and 

the Pediatric Research Equity Act of 

2003 (Pub. L. 108–155). Comments 

about the upcoming advisory committee 

meeting should be submitted to Docket 

No. FDA–2018–N–3000. 

The PAC will meet to discuss the 

following Center for Drug Evaluation 

and Research products: INTUNIV and 

LEXAPRO. 

The FDA will provide general safety 

updates including updates on the 

following topics without vote by the 

committee: 

• Overview of the FDA Adverse Event 

Reporting System and lack of efficacy; 

• Generic drug approval process; and 

discussion on trade versus generic 

drugs; exceptions; 

• Summary of FDA completed review 

of pediatric safety issues and updated 

labeling changes for EXJADE 

(deferasirox); 

• Update labeling change for inhaled 

corticosteroid long-acting b-2 agonists; 

• Safety labeling for gadolinium. 

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 website 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 website 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. Written 

submissions may be made to the contact 

person on or before September 13, 2018. 

Oral presentations from the public will 

be scheduled between approximately 9 

a.m. and 10 a.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 5, 2018. 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 6, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA 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 accommodations due to a 

disability, please contact Marieann Brill 

(See FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

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: August 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17857 Filed 8–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2946] 

Neurological Devices Panel Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

Advisory Committee meeting of the 

Neurological Devices Panel 

(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. 

DATES: The meeting will be held on 

September 27, 2018, from 8 a.m. to 5 

p.m. 

ADDRESSES: Hilton Washington, DC/ 

North, Salons A, B, C, and D, 620 Perry 

Pkwy., Gaithersburg, MD 20877. The 

hotel’s phone number is 301–977–8900 

and website is: http://www3.hilton.com/ 

en/hotels/maryland/hilton-washingtondc-north-gaithersburg-GAIGHHF/ 

index.html. 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. 

FOR FURTHER INFORMATION CONTACT: 

Aden Asefa, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 


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