83_FR_42285 83 FR 42124 - Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Extension of Comment Period

83 FR 42124 - Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 161 (August 20, 2018)

Page Range42124-42125
FR Document2018-17858

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.

Federal Register, Volume 83 Issue 161 (Monday, August 20, 2018) 
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42124-42125]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17858]


-----------------------------------------------------------------------

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.thefederalregister.org/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

[[Page 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, 
[email protected].

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

42124 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices to the meeting to be considered by the the Federal Register of May 24, 2018. In • Mail/Hand delivery/Courier (for NAC. Written comments or statements the request for comments, FDA written/paper submissions): Dockets received after this date may not be requested comments on the design of Management Staff (HFA–305), Food and provided to the NAC until its next studies intended to generate data to Drug Administration, 5630 Fishers meeting. support substantial evidence of Lane, Rm. 1061, Rockville, MD 20852. Verbal Comments or Statements: effectiveness for investigational new • For written/paper comments Pursuant to 41 CFR 102–3.140d, the animal drugs intended for the submitted to the Dockets Management NAC is not obligated to allow a member prevention of heartworm disease in Staff, FDA will post your comment, as of the public to speak or otherwise dogs. The Agency is taking this action well as any attachments, except for address the NAC during the meeting. in response to requests for an extension information submitted, marked and Members of the public are invited to to allow interested persons additional identified, as confidential, if submitted provide verbal comments or statements time to submit comments. as detailed in ‘‘Instructions.’’ during the NAC meeting only at the Instructions: All submissions received DATES: FDA is extending the comment time and manner described below. All must include the Docket No. FDA– period on the request for comments requests to speak or otherwise address 2018–N–1558 for ‘‘FDA’s Evaluation of published May 24, 2018 (83 FR 24122). the NAC during the meeting must be Approaches to Demonstrate Submit either electronic or written submitted to the NAC’s DFO at least 15 Effectiveness of Heartworm comments by November 20, 2018. days prior to the meeting, via email, the Preventatives for Dogs.’’ Received preferred mode of submission, at ADDRESSES: You may submit comments comments, those filed in a timely adonald@nhttac.org. The request should as follows. Please note that late, manner (see ADDRESSES), will be placed include a brief statement of the subject untimely filed comments will not be in the docket and, except for those matter to be addressed by the comment considered. Electronic comments must submitted as ‘‘Confidential and should be relevant to the stated be submitted on or before November 20, Submissions,’’ publicly viewable at agenda of the meeting or in regard to the 2018. The https://www.regulations.gov https://www.regulations.gov or at the NAC’s mission in general. The DFO will electronic filing system will accept Dockets Management Staff between 9 log each request in the order received. comments until midnight Eastern Time a.m. and 4 p.m., Monday through A period near the end of the meeting at the end of November 20, 2018. Friday. will be available for verbal public Comments received by mail/hand • Confidential Submissions—To comments. The time allotted will delivery/courier (for written/paper submit a comment with confidential depend on the number of public submissions) will be considered timely information that you do not wish to be comments or statements received and if they are postmarked or the delivery made publicly available, submit your the NAC’s agenda items. To provide service acceptance receipt is on or comments only as a written/paper time for as many people to speak as before that date. submission. You should submit two possible, speaking time for each Electronic Submissions copies total. One copy will include the individual will be limited to 3 minutes. information you claim to be confidential Minutes: The minutes of this meeting Submit electronic comments in the with a heading or cover note that states will be available for public review and following way: ‘‘THIS DOCUMENT CONTAINS copying within 90 days at: https:// • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The www.acf.hhs.gov/otip/partnerships/the- https://www.regulations.gov. Follow the Agency will review this copy, including national-advisory-committee. instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, its consideration of comments. The Dated: August 14, 2018. including attachments, to https:// second copy, which will have the Steven Wagner, www.regulations.gov will be posted to claimed confidential information Acting Assistant Secretary for Children and the docket unchanged. Because your redacted/blacked out, will be available Families. comment will be made public, you are for public viewing and posted on [FR Doc. 2018–17891 Filed 8–17–18; 8:45 am] solely responsible for ensuring that your https://www.regulations.gov. Submit BILLING CODE 4184–40–P comment does not include any both copies to the Dockets Management confidential information that you or a Staff. If you do not wish your name and third party may not wish to be posted, contact information to be made publicly DEPARTMENT OF HEALTH AND such as medical information, your or available, you can provide this HUMAN SERVICES anyone else’s Social Security number, or information on the cover sheet and not Food and Drug Administration confidential business information, such in the body of your comments and you as a manufacturing process. Please note must identify this information as [Docket No. FDA–2018–N–1558] that if you include your name, contact ‘‘confidential.’’ Any information marked information, or other information that as ‘‘confidential’’ will not be disclosed Food and Drug Administration’s identifies you in the body of your except in accordance with 21 CFR 10.20 Evaluation of Approaches To comments, that information will be and other applicable disclosure law. For Demonstrate Effectiveness of posted on https://www.regulations.gov. more information about FDA’s posting Heartworm Preventatives for Dogs; • If you want to submit a comment of comments to public dockets, see 80 Extension of Comment Period with confidential information that you FR 56469, September 18, 2015, or access AGENCY: Food and Drug Administration, do not wish to be made available to the the information at: https://www.gpo.gov/ HHS. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- daltland on DSKBBV9HB2PROD with NOTICES ACTION: Notice; request for comments; written/paper submission and in the 23389.pdf. extension of comment period. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Submissions’’ and ‘‘Instructions’’). read background documents or the SUMMARY: The Food and Drug electronic and written/paper comments Administration (FDA or the Agency) is Written/Paper Submissions received, go to https:// extending the comment period for the Submit written/paper submissions as www.regulations.gov and insert the request for comments that appeared in follows: docket number, found in brackets in the VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1

Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42125 heading of this document, into the SUMMARY: The Food and Drug confidential information that you or a ‘‘Search’’ box and follow the prompts Administration (FDA) announces a third party may not wish to be posted, and/or go to the Dockets Management forthcoming public advisory committee such as medical information, your or Staff, 5630 Fishers Lane, Rm. 1061, meeting of the Pediatric Advisory anyone else’s Social Security number, or Rockville, MD 20852. Committee (PAC). The general function confidential business information, such FOR FURTHER INFORMATION CONTACT: of the committee is to provide advice as a manufacturing process. Please note Steven Fleischer, Center for Veterinary and recommendations to FDA on that if you include your name, contact Medicine (HFV–110), Food and Drug regulatory issues. FDA is establishing a information, or other information that Administration, 7500 Standish Pl., docket for public comments on this identifies you in the body of your Rockville, MD 20855, 240–402–0809, document. comments, that information will be steven.fleischer@fda.hhs.gov. posted on https://www.regulations.gov. DATES: The meeting will be held on • If you want to submit a comment SUPPLEMENTARY INFORMATION: In the September 20, 2018, from 8:30 a.m. to with confidential information that you Federal Register of May 24, 2018, FDA 4 p.m. This is a reschedule of a do not wish to be made available to the published a request for comments with postponed meeting announced in the public, submit the comment as a a 90-day comment period to request Federal Register of January 2, 2018 (83 written/paper submission and in the comments on the design of studies FR 125), originally scheduled for March manner detailed (see ‘‘Written/Paper intended to generate data to support 23, 2018. Submissions’’ and ‘‘Instructions’’). substantial evidence of effectiveness for ADDRESSES: FDA White Oak Campus, investigational new animal drugs 10903 New Hampshire Ave., Building Written/Paper Submissions intended for the prevention of 31, Conference Center, the Great Room Submit written/paper submissions as heartworm disease in dogs. Comments (Rm. 1503), Silver Spring, MD 20993– follows: received will inform FDA’s current 002. Answers to commonly asked • Mail/Hand delivery/Courier (for thinking regarding the design of studies questions including information written/paper submissions): Dockets intended to generate data to support regarding special accommodations due Management Staff (HFA–305), Food and substantial evidence of effectiveness for to a disability, visitor parking, and Drug Administration, 5630 Fishers investigational new animal drugs transportation may be accessed at Lane, Rm. 1061, Rockville, MD 20852. intended for the prevention of https://www.fda.gov/Advisory • For written/paper comments heartworm disease in dogs. Committees/AboutAdvisoryCommittees/ submitted to the Dockets Management The Agency has received a request for ucm408555.htm. Staff, FDA will post your comment, as a 90-day extension of the comment FDA is establishing a docket for well as any attachments, except for period for the request for comments. public comment on this meeting. The information submitted, marked and The request conveyed concern that the docket number is FDA–2018–N–3000. identified, as confidential, if submitted current 90-day comment period does The docket will close on September 19, as detailed in ‘‘Instructions.’’ not allow sufficient time to develop a 2018. Submit either electronic or Instructions: All submissions received meaningful or thoughtful response to written comments on this public must include Docket No. FDA–2018–N– the request for comments. meeting by that date. Please note that 3000 for ‘‘Pediatric Advisory FDA has considered the request and late, untimely comments will not be Committee; Establishment of a Public is extending the comment period for the considered. The https:// Docket; Request for Comments.’’ request for comments for 90 days, until www.regulations.gov electronic filing Received comments, those filed in a November 20, 2018. The Agency system will accept comments until timely manner (see ADDRESSES), will be believes that a 90-day extension allows midnight Eastern Time at the end of placed in the docket and, except for adequate time for interested persons to September 19, 2018. Comments received those submitted as ‘‘Confidential submit comments without significantly by mail/hand delivery/courier (for Submissions,’’ publicly viewable at delaying further action on these written/paper submissions) will be https://www.regulations.gov or at the important issues. considered timely if they are Dockets Management Staff between 9 postmarked or the delivery service a.m. and 4 p.m., Monday through Dated: August 14, 2018. acceptance receipt is on or before that Friday. Leslie Kux, • Confidential Submissions—To date. Associate Commissioner for Policy. submit a comment with confidential Comments received on or before [FR Doc. 2018–17858 Filed 8–17–18; 8:45 am] September 6, 2018, will be provided to information that you do not wish to be BILLING CODE 4164–01–P the committee. Comments received after made publicly available, submit your that date will be taken into comments only as a written/paper consideration by FDA. You may submit submission. You should submit two DEPARTMENT OF HEALTH AND comments as follows: copies total. One copy will include the HUMAN SERVICES information you claim to be confidential Electronic Submissions with a heading or cover note that states Food and Drug Administration Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS following way: CONFIDENTIAL INFORMATION.’’ FDA [Docket No. FDA–2018–N–3000] • Federal eRulemaking Portal: will review this copy, including the https://www.regulations.gov. Follow the claimed confidential information, in its Pediatric Advisory Committee; Notice instructions for submitting comments. consideration of comments. The second daltland on DSKBBV9HB2PROD with NOTICES of Meeting; Establishment of a Public Comments submitted electronically, copy, which will have the claimed Docket; Request for Comments including attachments, to https:// confidential information redacted/ AGENCY: Food and Drug Administration, www.regulations.gov will be posted to blacked out, will be available for public HHS. the docket unchanged. Because your viewing and posted on https:// comment will be made public, you are www.regulations.gov. Submit both ACTION: Notice; establishment of a solely responsible for ensuring that your copies to the Dockets Management Staff. public docket; request for comments. comment does not include any If you do not wish your name and VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1


Document Created: 2018-08-18 01:28:52
Document Modified: 2018-08-18 01:28:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments; extension of comment period.
DatesFDA 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.
ContactSteven Fleischer, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0809, [email protected]
FR Citation83 FR 42124 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR