Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Guidance for Industry; Availability, 53428-53429 [2024-13922]

Download as PDF 53428 Federal Register / Vol. 89, No. 123 / Wednesday, June 26, 2024 / Notices I. Background In the Federal Register of December 18, 2023 (88 FR 87433), FDA published the notice of availability for a draft GFI #283 entitled ‘‘Priority Zoonotic Animal Drug Designation and Review Process’’ giving interested persons until February 16, 2024, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Changes to the final guidance include the following: providing examples of preliminary clinical evidence for the purposes of PZAD designation; confirming that PZAD indications may appear on the same product labeling as non-PZAD indications; and confirming that PZAD designation does not impact potential qualification for other review incentive programs within or outside of the Center for Veterinary Medicine. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated December 2023. This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the Priority Zoonotic Animal Drug Designation and Review Process. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032; the collections of information in 21 CFR 511.1 have been approved under OMB control number 0910–0117. ddrumheller on DSK120RN23PROD with NOTICES1 III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. VerDate Sep<11>2014 18:15 Jun 25, 2024 Jkt 262001 Dated: June 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–13921 Filed 6–25–24; 8:45 am] BILLING CODE 4164–01–P 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; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #276 entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.’’ The guidance provides recommendations for the effectiveness evaluation of drugs indicated for the prevention of heartworm disease caused by Dirofilaria immitis in dogs. These recommendations should be read in conjunction with related Agency Veterinary International Conference on Harmonization (VICH) guidance documents and are intended to provide additional detail to elements of study design and interpretation under the recommendations laid out in the VICH guidances. DATES: The announcement of the guidance is published in the Federal Register on June 26, 2024. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: 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, PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 89, No. 123 / Wednesday, June 26, 2024 / Notices 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: ddrumheller on DSK120RN23PROD with NOTICES1 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: I. Background In the Federal Register of November 30, 2022 (87 FR 73560), FDA announced the availability of draft GFI #276, entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs,’’ giving interested persons until January 30, 2023, to comment on the draft guidance. In response to a request for an extension, the comment period was extended to May 1, 2023 (88 FR 3744). FDA received eight comment submissions on the draft guidance, some with numerous discrete comments within the submission; all comments were considered as the guidance was finalized. We clarified our discussion and recommendations related to geographic locations, laboratory dose VerDate Sep<11>2014 18:15 Jun 25, 2024 Jkt 262001 confirmation studies, and field effectiveness studies. We also clarified that the recommendations in this guidance are based on current technology and veterinary epidemiology, including available diagnostic methodologies. Individuals are encouraged to discuss deviations from these recommendations with FDA, especially as advances in veterinary medicine related to heartworm disease, including disease epidemiology, isolate characterization, or diagnostic testing are identified. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 511 have been approved under OMB control number 0910–0117; the collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/animal-veterinary/ guidance-regulations/guidanceindustry, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: June 18, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–13922 Filed 6–25–24; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 53429 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–1201] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by July 26, 2024. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The title of this information collection is Voluntary Total Product Life Cycle Advisory Program Pilot. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot OMB Control Number 0910–NEW This information collection supports the TPLC TAP. FDA’s Center for Devices and Radiological Health launched the voluntary TAP Pilot in 2023 (87 FR 61605; October 12, 2022). The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the reauthorization of the Medical Device E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Notices]
[Pages 53428-53429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13922]


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

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; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance for industry (GFI) #276 
entitled ``Effectiveness of Anthelmintics: Specific Recommendations for 
Products Proposed for the Prevention of Heartworm Disease in Dogs.'' 
The guidance provides recommendations for the effectiveness evaluation 
of drugs indicated for the prevention of heartworm disease caused by 
Dirofilaria immitis in dogs. These recommendations should be read in 
conjunction with related Agency Veterinary International Conference on 
Harmonization (VICH) guidance documents and are intended to provide 
additional detail to elements of study design and interpretation under 
the recommendations laid out in the VICH guidances.

DATES: The announcement of the guidance is published in the Federal 
Register on June 26, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 53429]]

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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

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:

I. Background

    In the Federal Register of November 30, 2022 (87 FR 73560), FDA 
announced the availability of draft GFI #276, entitled ``Effectiveness 
of Anthelmintics: Specific Recommendations for Products Proposed for 
the Prevention of Heartworm Disease in Dogs,'' giving interested 
persons until January 30, 2023, to comment on the draft guidance. In 
response to a request for an extension, the comment period was extended 
to May 1, 2023 (88 FR 3744). FDA received eight comment submissions on 
the draft guidance, some with numerous discrete comments within the 
submission; all comments were considered as the guidance was finalized. 
We clarified our discussion and recommendations related to geographic 
locations, laboratory dose confirmation studies, and field 
effectiveness studies. We also clarified that the recommendations in 
this guidance are based on current technology and veterinary 
epidemiology, including available diagnostic methodologies. Individuals 
are encouraged to discuss deviations from these recommendations with 
FDA, especially as advances in veterinary medicine related to heartworm 
disease, including disease epidemiology, isolate characterization, or 
diagnostic testing are identified.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Effectiveness of Anthelmintics: Specific 
Recommendations for Products Proposed for the Prevention of Heartworm 
Disease in Dogs.'' It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 511 have been approved under OMB control number 0910-
0117; the collections of information in 21 CFR part 514 have been 
approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13922 Filed 6-25-24; 8:45 am]
BILLING CODE 4164-01-P

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