42124 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 

to the meeting to be considered by the 

NAC. Written comments or statements 

received after this date may not be 

provided to the NAC until its next 

meeting. 

Verbal Comments or Statements: 

Pursuant to 41 CFR 102–3.140d, the 

NAC is not obligated to allow a member 

of the public to speak or otherwise 

address the NAC during the meeting. 

Members of the public are invited to 

provide verbal comments or statements 

during the NAC meeting only at the 

time and manner described below. All 

requests to speak or otherwise address 

the NAC during the meeting must be 

submitted to the NAC’s DFO at least 15 

days prior to the meeting, via email, the 

preferred mode of submission, at 

adonald@nhttac.org. The request should 

include a brief statement of the subject 

matter to be addressed by the comment 

and should be relevant to the stated 

agenda of the meeting or in regard to the 

NAC’s mission in general. The DFO will 

log each request in the order received. 

A period near the end of the meeting 

will be available for verbal public 

comments. The time allotted will 

depend on the number of public 

comments or statements received and 

the NAC’s agenda items. To provide 

time for as many people to speak as 

possible, speaking time for each 

individual will be limited to 3 minutes. 

Minutes: The minutes of this meeting 

will be available for public review and 

copying within 90 days at: https://

www.acf.hhs.gov/otip/partnerships/thenational-advisory-committee. 

Dated: August 14, 2018. 

Steven Wagner, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2018–17891 Filed 8–17–18; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1558] 

Food and Drug Administration’s 

Evaluation of Approaches To 

Demonstrate Effectiveness of 

Heartworm Preventatives for Dogs; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments; 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

request for comments that appeared in 

the Federal Register of May 24, 2018. In 

the request for comments, FDA 

requested 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. The Agency is taking this action 

in response to requests for an extension 

to allow interested persons additional 

time to submit comments. 

DATES: FDA is extending the comment 

period on the request for comments 

published May 24, 2018 (83 FR 24122). 

Submit either electronic or written 

comments by November 20, 2018. 

ADDRESSES: 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 20, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 20, 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. 

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– 

2018–N–1558 for ‘‘FDA’s Evaluation of 

Approaches to Demonstrate 

Effectiveness of Heartworm 

Preventatives for Dogs.’’ 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 


daltland on DSKBBV9HB2PROD with NOTICES
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