International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1); Draft Guidance for Industry; Availability, 49851-49852 [2022-17348]

Download as PDF 49851 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices or De Novo request. Manufacturers may include new accessories into a 510(k) or PMA with the parent device (New Accessory Request). New Accessory Requests will have the same deadline as the 510(k) or PMA. Therefore, new accessory types should follow the applicable Medical Device User Fee Amendments of 2017 deadline for the parent submission. The decision for New Accessory Requests will be accessory type. If FDA denies the Accessory Request, FDA must issue a letter with a detailed description and justification for our determination. In the Federal Register of March 16, 2022 (87 FR 14891), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: separate from the decision for the marketing application. For both Existing and New Accessory Requests, manufacturers must request proper classification of their accessory in the submission and include draft special controls, if requesting classification into class II. The processes that we use to classify an accessory will be like those used for De Novo requests. If FDA grants the Accessory Request, FDA must issue an order establishing a new classification regulation for the TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity; guidance for industry (GFI) section Total annual responses Average burden per response Total hours Existing Accessory Request; GFI VI.A ................................ New Accessory Request ...................................................... 10 5 1 1 10 5 40 40 400 200 Total .............................................................................. ........................ ........................ ........................ ........................ 600 1 There are no capital costs or operating and maintenance costs associated with this collection of information. DEPARTMENT OF HEALTH AND HUMAN SERVICES GL16(R1)) entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1).’’ This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes. DATES: Submit either electronic or written comments on the draft guidance by October 11, 2022 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: Food and Drug Administration Electronic Submissions [Docket No. FDA–2022–D–1494] 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 Based on an evaluation of the information collection, we have reduced the estimated number of existing requests from 15 to 10, and we have reduced the estimated number of new requests from 10 to 5. This adjustment results in an overall reduction to the information collection by 10 responses and 400 hours annually. We believe these adjustments more accurately reflect the current number of requests associated with medical device accessory classifications. Dated: August 5, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–17296 Filed 8–11–22; 8:45 am] BILLING CODE 4164–01–P International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1); Draft Guidance for Industry; Availability jspears on DSK121TN23PROD with NOTICES Number of responses per respondent 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) #110 (VICH SUMMARY: VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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–1494 for ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1).’’ 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 E:\FR\FM\12AUN1.SGM 12AUN1 49852 Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices jspears on DSK121TN23PROD with NOTICES 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 the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Aime´e Phillippi-Taylor, Center for Veterinary Medicine (HFV–114), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240–402–0601, aimee.phillippi-taylor@fda.hhs.gov. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:38 Aug 11, 2022 Jkt 256001 I. Background FDA is announcing the availability of a draft GFI #110 (VICH GL16(R1)) entitled ‘‘Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1).’’ It should be read in conjunction with GFI #90 (VICH GL7) entitled ‘‘Effectiveness of Anthelmintics: General Recommendations,’’ which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific porcine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes. FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine; U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association. There are 10 observers to the VICH Steering Committee: One representative from government and one PO 00000 Frm 00054 Fmt 4703 Sfmt 9990 representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals. This 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 Porcines (Revision 1).’’ 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/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Dated: August 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–17348 Filed 8–11–22; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\12AUN1.SGM 12AUN1

Agencies

[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49851-49852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17348]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1494]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; 
Effectiveness of Anthelmintics: Specific Recommendations for Porcines 
(Revision 1); 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) #110 (VICH 
GL16(R1)) entitled ``Effectiveness of Anthelmintics: Specific 
Recommendations for Porcines (Revision 1).'' This draft guidance has 
been developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). This revision clarifies the definition of 
adequate infection in individual animals, updates considerations for 
field studies, and makes additional clarifying changes.

DATES: Submit either electronic or written comments on the draft 
guidance by October 11, 2022 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-1494 for ``Effectiveness of Anthelmintics: Specific 
Recommendations for Porcines (Revision 1).'' 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

[[Page 49852]]

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 the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Aim[eacute]e Phillippi-Taylor, Center 
for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 
Standish Pl, Rockville, MD 20855, 240-402-0601, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft GFI #110 (VICH 
GL16(R1)) entitled ``Effectiveness of Anthelmintics: Specific 
Recommendations for Porcines (Revision 1).'' It should be read in 
conjunction with GFI #90 (VICH GL7) entitled ``Effectiveness of 
Anthelmintics: General Recommendations,'' which should be referred to 
for discussion of broad aspects for providing pivotal data to 
demonstrate product anthelmintic effectiveness. The purpose of this 
guidance is: (1) to be more specific for certain specific porcine 
issues not discussed in GFI #90 (VICH GL7); (2) to highlight 
differences with GFI #90 (VICH GL7) on effectiveness data 
recommendations; and (3) to give explanations for disparities with GFI 
#90 (VICH GL7). This revision clarifies the definition of adequate 
infection in individual animals, updates considerations for field 
studies, and makes additional clarifying changes.
    FDA has participated in efforts to enhance international 
harmonization and is committed to seeking scientifically based 
harmonized technical procedures for pharmaceutical development. One of 
the goals of harmonization is to identify, and then reduce, differences 
in technical requirements for drug development among regulatory 
agencies in different countries. FDA has actively participated in the 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use to develop harmonized technical 
requirements for the approval of human pharmaceutical and biological 
products among the European Union, Japan, and the United States. The 
VICH is a parallel initiative for veterinary medicinal products. The 
VICH is concerned with developing harmonized technical requirements for 
the approval of veterinary medicinal products in the European Union, 
Japan, and the United States, and includes input from both regulatory 
and industry representatives.
    The VICH Steering Committee is composed of member representatives 
from the European Commission and European Medicines Agency; 
AnimalhealthEurope; FDA--Center for Veterinary Medicine; U.S. 
Department of Agriculture--Center for Veterinary Biologics; the U.S. 
Animal Health Institute; the Japanese Ministry of Agriculture, Forestry 
and Fisheries; and the Japanese Veterinary Products Association. There 
are 10 observers to the VICH Steering Committee: One representative 
from government and one representative from industry of Australia, New 
Zealand, Canada, South Africa, and the United Kingdom. The World 
Organisation for Animal Health is an associate member of the VICH. The 
VICH Secretariat, which coordinates the preparation of documentation, 
is provided by HealthforAnimals.
    This 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 Porcines 
(Revision 1).'' 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/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17348 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.