Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry (Revised); Availability, 33366-33367 [2024-09137]

Download as PDF 33366 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices [FR Doc. 2024–09165 Filed 4–26–24; 8:45 am] Written/Paper Submissions BILLING CODE 4120–01–C 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– 2010–N–0155 for ‘‘Veterinary Feed Directive Regulation Questions and Answers.’’ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0155] Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry (Revised); 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 guidance for industry (GFI) #120 entitled ‘‘Veterinary Feed Directive Regulation Questions and Answers.’’ This revised guidance document will aid industry in complying with the requirements of the veterinary feed directive (VFD) regulation. DATES: The announcement of the guidance is published in the Federal Register on April 29, 2024. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 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’’). VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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: Dragan Momcilovic, Center for Veterinary Medicine (HFV–241), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402– 5944, Dragan.Momcilovic@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 30, 2015 (80 FR 58602), FDA announced the availability of GFI #120 entitled ‘‘Veterinary Feed Directive Regulation Questions and Answers’’ to assist industry in complying with the VFD regulation in 21 CFR part 558. This guidance also serves as a Small Entities Compliance Guide (SECG) to aid industry in complying with the requirements of the VFD final rule that published in the Federal Register on June 3, 2015 (80 FR 31708). FDA prepared this SECG in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104–121). In the Federal Register of March 28, 2019 (84 FR 11804), FDA announced the availability of a draft revised GFI #120 to provide additional information in response to questions that have been submitted by interested parties since 2015. FDA reviewed comments submitted in response to that notice by stakeholders, including animal producer organizations, the animal feed industry, veterinarians, and producers of electronic VFD software. The Agency is now announcing the availability of revised GFI #120 which refines and clarifies language in the draft guidance based on stakeholder feedback. Specifically, stakeholders asked FDA to clarify and change language related to the amount of VFD drug in feed, the issuance and effective dates of VFDs, definitions of and requirements for individuals who E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices distribute VFD feeds, and the expiration of medicated feeds. In response to stakeholder comments, FDA clarified language in the respective sections and provided examples to better distinguish roles and responsibilities of involved parties. 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 ‘‘Veterinary Feed Directive Regulation Questions and Answers.’’ 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 558.6 have been approved under OMB control number 0910–0363. 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: April 24, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–09137 Filed 4–26–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions Food and Drug Administration khammond on DSKJM1Z7X2PROD with NOTICES [Docket No. FDA–2024–N–1718] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Biologics License Application 761326 for NNC0148–0287 Injection (Insulin Icodec) AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on May 24, 2024, from 9 a.m. to 4 p.m. Eastern Time. ADDRESSES: All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings, may be accessed at: https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2024–N–1718. The docket will close on May 23, 2024. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 23, 2024. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. Comments received on or before May 16, 2024, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 33367 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– 2024–N–1718 for ‘‘Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ 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, 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.’’ FDA 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 be made publicly available, you can provide this E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Pages 33366-33367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09137]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]


Veterinary Feed Directive Regulation Questions and Answers; Small 
Entity Compliance Guide; Guidance for Industry (Revised); 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 guidance for industry (GFI) #120 entitled 
``Veterinary Feed Directive Regulation Questions and Answers.'' This 
revised guidance document will aid industry in complying with the 
requirements of the veterinary feed directive (VFD) regulation.

DATES: The announcement of the guidance is published in the Federal 
Register on April 29, 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-2010-N-0155 for ``Veterinary Feed Directive Regulation Questions 
and Answers.'' 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 the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-241), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5944, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 30, 2015 (80 FR 58602), FDA 
announced the availability of GFI #120 entitled ``Veterinary Feed 
Directive Regulation Questions and Answers'' to assist industry in 
complying with the VFD regulation in 21 CFR part 558. This guidance 
also serves as a Small Entities Compliance Guide (SECG) to aid industry 
in complying with the requirements of the VFD final rule that published 
in the Federal Register on June 3, 2015 (80 FR 31708). FDA prepared 
this SECG in accordance with section 212 of the Small Business 
Regulatory Enforcement Fairness Act (Pub. L. 104-121). In the Federal 
Register of March 28, 2019 (84 FR 11804), FDA announced the 
availability of a draft revised GFI #120 to provide additional 
information in response to questions that have been submitted by 
interested parties since 2015. FDA reviewed comments submitted in 
response to that notice by stakeholders, including animal producer 
organizations, the animal feed industry, veterinarians, and producers 
of electronic VFD software.
    The Agency is now announcing the availability of revised GFI #120 
which refines and clarifies language in the draft guidance based on 
stakeholder feedback. Specifically, stakeholders asked FDA to clarify 
and change language related to the amount of VFD drug in feed, the 
issuance and effective dates of VFDs, definitions of and requirements 
for individuals who

[[Page 33367]]

distribute VFD feeds, and the expiration of medicated feeds. In 
response to stakeholder comments, FDA clarified language in the 
respective sections and provided examples to better distinguish roles 
and responsibilities of involved parties.
    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 ``Veterinary Feed Directive Regulation 
Questions and Answers.'' 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 558.6 have been approved under OMB control number 0910-0363.

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: April 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09137 Filed 4-26-24; 8:45 am]
BILLING CODE 4164-01-P

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