Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability; Extension of Comment Period, 3743-3744 [2023-01031]

Download as PDF Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Notices applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)— RFA–CE–23–002: Grants to Support New Investigators in Conducting Research Related to Understanding Polydrug Use Risk and Protective Factors. Date: April 11, 2023. Time: 8:30 a.m.–5:30 p.m., EDT. Place: Videoconference. Agenda: To review and evaluate grant applications. For Further Information Contact: Aisha L. Wilkes, M.P.H., Scientific Review Officer, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway NE, Mailstop S106–9, Atlanta, Georgia 30341, Telephone: (404) 639–6473; Email: AWilkes@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. 3743 applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)– RFA–CE–23–004: Research Grants for Preventing Violence and Violence Related Injury. Date: March 28–29, 2023. Time: 8:30 a.m.–5:30 p.m., EDT. Place: Videoconference. Agenda: To review and evaluate grant applications. For Further Information Contact: Aisha L. Wilkes, M.P.H., Scientific Review Officer, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway NE, Mailstop S106–9, Atlanta, Georgia 30341, Telephone: (404)639–6473; Email: AWilkes@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)— CE23–008, Research Grants to Develop and Validate a Prognostic Tool of Mental Health Sequelae After Traumatic Brain Injury for Adolescent Patients (U01). Date: March 14, 2023. Time: 8:30 a.m.–5:30 p.m., EDT. Place: Web Conference. Agenda: To review and evaluate grant applications. For Further Information Contact: Carlisha Gentles, PharmD, BCPS, CDCES, Scientific Review Officer, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway NE, Mailstop F–63, Atlanta, Georgia 30341, Telephone: (770) 488–1504; Email: CGentles@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2023–01010 Filed 1–19–23; 8:45 am] [FR Doc. 2023–01011 Filed 1–19–23; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration Notice of Closed Meeting Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability; Extension of Comment Period [FR Doc. 2023–01012 Filed 1–19–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention lotter on DSK11XQN23PROD with NOTICES1 Notice of Closed Meeting Pursuant to section 1009(d) of 5 U.S.C. 10, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended, and the Determination of the Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, CDC, pursuant to Public Law 117–286. The grant VerDate Sep<11>2014 17:29 Jan 19, 2023 Jkt 259001 Pursuant to section 1009(d) of 5 U.S.C. 10, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended, and the Determination of the Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, CDC, pursuant to Public Law 117–286. The grant applications and the discussions could disclose confidential trade secrets or PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 [Docket No. FDA–2022–D–2899] AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a SUMMARY: E:\FR\FM\20JAN1.SGM 20JAN1 3744 Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Notices draft guidance for industry that appeared in the Federal Register of November 30, 2022. In that notice, FDA requested comments on draft guidance for industry (GFI) #276 entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.’’ The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice published November 30, 2022 (87 FR 73560). Submit either electronic or written comments by May 1, 2023, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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’’). lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:29 Jan 19, 2023 Jkt 259001 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– 2022–D–2899 for ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.’’ Received comments 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for Veterinary Medicine (HFV–110), Food and Drug PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0809, Steven.Fleischer@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of November 30, 2022, FDA published a notice announcing the availability of a draft guidance for industry entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs,’’ and requesting comments on the proposed GFI. Interested persons were originally given until January 30, 2023, to comment on the document. The Agency has received a request for an extension of the comment period. The request stated that an additional 90 days would allow interested parties to thoroughly consider the request for input. FDA has considered the request and is extending the comment period for the request for comments for 90 days, until May 1, 2023. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments. Dated: January 17, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–01031 Filed 1–19–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–1384] Mark Godding: Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Mark Godding for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Godding was convicted of one felony count under Federal law for Introducing or Delivering for Introduction a Misbranded Drug in Interstate Commerce. The factual basis supporting Mr. Godding’s conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Godding was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of SUMMARY: E:\FR\FM\20JAN1.SGM 20JAN1

Agencies

[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Pages 3743-3744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01031]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2899]


Effectiveness of Anthelmintics: Specific Recommendations for 
Products Proposed for the Prevention of Heartworm Disease in Dogs; 
Draft Guidance for Industry; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice announcing the availability 
of a

[[Page 3744]]

draft guidance for industry that appeared in the Federal Register of 
November 30, 2022. In that notice, FDA requested comments on draft 
guidance for industry (GFI) #276 entitled ``Effectiveness of 
Anthelmintics: Specific Recommendations for Products Proposed for the 
Prevention of Heartworm Disease in Dogs.'' The Agency is taking this 
action in response to a request for an extension to allow interested 
persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice published 
November 30, 2022 (87 FR 73560). Submit either electronic or written 
comments by May 1, 2023, to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2022-D-2899 for ``Effectiveness of Anthelmintics: Specific 
Recommendations for Products Proposed for the Prevention of Heartworm 
Disease in Dogs.'' Received comments 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

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 November 30, 
2022, FDA published a notice announcing the availability of a draft 
guidance for industry entitled ``Effectiveness of Anthelmintics: 
Specific Recommendations for Products Proposed for the Prevention of 
Heartworm Disease in Dogs,'' and requesting comments on the proposed 
GFI.
    Interested persons were originally given until January 30, 2023, to 
comment on the document. The Agency has received a request for an 
extension of the comment period. The request stated that an additional 
90 days would allow interested parties to thoroughly consider the 
request for input. FDA has considered the request and is extending the 
comment period for the request for comments for 90 days, until May 1, 
2023. The Agency believes that a 90-day extension allows adequate time 
for interested persons to submit comments.

    Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01031 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P

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