Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability, 73560-73561 [2022-26059]

Download as PDF 73560 Federal Register / Vol. 87, No. 229 / Wednesday, November 30, 2022 / Notices Number of respondents Respondent/data collection activity Hours per response Total annual burden hours State Councils on Developmental Disabilities State plan ............................... 56 1 367 20,522 Total .......................................................................................................... 56 1 367 20,522 Dated: November 23, 2022. Alison Barkoff, Acting Administrator and Assistant Secretary for Aging. [FR Doc. 2022–26077 Filed 11–29–22; 8:45 am] BILLING CODE 4154–01–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of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #276 entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.’’ This draft guidance is intended for sponsors and potential sponsors who may be interested in pursuing approval of investigational new animal drugs for the prevention of heartworm disease in dogs. The draft guidance provides recommendations for the effectiveness evaluation of drugs indicated for the prevention of heartworm disease caused by Dirofilaria immitis in dogs.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 DATES: Submit either electronic or written comments on the draft guidance by January 30, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 Responses per respondent VerDate Sep<11>2014 16:58 Nov 29, 2022 Jkt 259001 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 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 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. 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 E:\FR\FM\30NON1.SGM 30NON1 Federal Register / Vol. 87, No. 229 / Wednesday, November 30, 2022 / Notices the SUPPLEMENTARY INFORMATION section for electronic access to the draft 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, Steven.Fleischer@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of draft GFI #276 entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.’’ The recommended approach to demonstrate substantial evidence of effectiveness of an investigational new animal drug intended for the prevention of heartworm disease in dogs is for the sponsor to conduct two laboratory dose confirmation studies and one multisite field effectiveness study in accordance with the principles of good clinical practice as described in GFI #85 (VICH GL9), ‘‘Good Clinical Practice.’’ This draft guidance provides detail regarding FDA’s recommendations for the effectiveness evaluation of drugs indicated for the prevention of heartworm disease caused by Dirofilaria immitis in dogs. This guidance is informed by comments FDA received in response to the ‘‘Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments,’’ which published in the Federal Register on May 24, 2018 (83 FR 24122). This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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. lotter on DSK11XQN23PROD with NOTICES1 II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. VerDate Sep<11>2014 16:58 Nov 29, 2022 Jkt 259001 The previously approved collections of information are subject to review by OMB under the PRA. 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 draft 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: November 22, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–26059 Filed 11–29–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2855] Mylan Institutional, Inc.; Withdrawal of Approval of a New Drug Application for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution AGENCY: Food and Drug Administration, HHS. ACTION: Notice. Frm 00023 Fmt 4703 NDA 019832’s accelerated approval was ‘‘subject to the requirement that the applicant study the drug further, to verify and describe its clinical benefit, where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate outcome’’ (21 CFR 314.510). To date, however, Mylan has not completed the required confirmatory study. Mylan acknowledged in its December 10, 2021, letter requesting withdrawal of approval that a successful confirmatory study was necessary to fulfill the accelerated approval requirements, but stated that conducting such a study is not feasible. Mylan thus requested that NDA 019832 be withdrawn under 21 CFR 314.150(d), and waived its right to a hearing. Thus, for the reasons discussed above, under 21 CFR 314.150(d), approval of NDA 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, and all amendments and supplements thereto, is withdrawn. Distribution of SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Dated: November 22, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–26057 Filed 11–29–22; 8:45 am] The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held by Mylan Institutional, Inc., a Viatris company (Mylan). Mylan has voluntarily requested withdrawal of this application and has waived its opportunity for a hearing. DATES: Applicable November 30, 2022. FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301–796–3601. SUPPLEMENTARY INFORMATION: On June 5, 1998, the Food and Drug Administration (FDA) approved NDA 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, under the Agency’s accelerated approval regulations (see generally 21 CFR subpart H). It was approved for ‘‘for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.’’ SUMMARY: PO 00000 73561 Sfmt 4703 BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–0099] Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; and Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a draft SUMMARY: E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Pages 73560-73561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26059]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry (GFI) #276 entitled 
``Effectiveness of Anthelmintics: Specific Recommendations for Products 
Proposed for the Prevention of Heartworm Disease in Dogs.'' This draft 
guidance is intended for sponsors and potential sponsors who may be 
interested in pursuing approval of investigational new animal drugs for 
the prevention of heartworm disease in dogs. The draft 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: Submit either electronic or written comments on the draft 
guidance by January 30, 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.
    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

[[Page 73561]]

the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft 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

    FDA is announcing the availability of draft GFI #276 entitled 
``Effectiveness of Anthelmintics: Specific Recommendations for Products 
Proposed for the Prevention of Heartworm Disease in Dogs.'' The 
recommended approach to demonstrate substantial evidence of 
effectiveness of an investigational new animal drug intended for the 
prevention of heartworm disease in dogs is for the sponsor to conduct 
two laboratory dose confirmation studies and one multisite field 
effectiveness study in accordance with the principles of good clinical 
practice as described in GFI #85 (VICH GL9), ``Good Clinical 
Practice.'' This draft guidance provides detail regarding FDA's 
recommendations for the effectiveness evaluation of drugs indicated for 
the prevention of heartworm disease caused by Dirofilaria immitis in 
dogs. This guidance is informed by comments FDA received in response to 
the ``Evaluation of Approaches To Demonstrate Effectiveness of 
Heartworm Preventatives for Dogs; Request for Comments,'' which 
published in the Federal Register on May 24, 2018 (83 FR 24122).
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent 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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 draft 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: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26059 Filed 11-29-22; 8:45 am]
BILLING CODE 4164-01-P

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