Animal Drug User Fee Act; Public Meeting; Request for Comments, 18989-18991 [2021-07373]

Download as PDF Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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– 2020–N–1736 for ‘‘Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.’’ 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.’’ The VerDate Sep<11>2014 21:37 Apr 09, 2021 Jkt 253001 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: Kelly Covington, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–5661, Kelly.Covington@fda.hhs.gov. In the Federal Register of October 13, 2020, FDA published a notice announcing a public meeting and requesting comments on a concept paper entitled ‘‘Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs,’’ giving interested persons until January 15, 2021, to comment on the public meeting and request for comments. In a notice published in the Federal Register on November 27, 2020 (85 FR 76081), the Agency extended the comment period to March 16, 2021. The Agency has received several comments from stakeholders of technical difficulties submitting comments to the Federal eRulemaking portal. In consideration of these difficulties, FDA is reopening the comment period for 10 days to allow these stakeholders the opportunity to submit comments. All comments SUPPLEMENTARY INFORMATION: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 18989 previously submitted, do not need to be resubmitted. Dated: April 6, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–07452 Filed 4–9–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0656] Animal Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ‘‘Animal Drug User Fee Act.’’ The purpose of the public meeting is to invite public comment on the Animal Drug User Fee Act (ADUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the ADUFA program. The meeting will be open to the public. DATES: The public meeting will be hosted via a live virtual webcast on Thursday, May 20, 2021, from 2 p.m. to 4 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration dates and information. To permit the widest possible opportunity to obtain comments on all aspects of the public meeting, the docket will remain open for comment throughout the reauthorization process of ADUFA, until December 1, 2022. In addition to being publicly viewable at https:// www.regulations.gov, comments received by June 21, 2021, suggesting changes to the program, will also be published on https://www.fda.gov/ industry/animal-drug-user-fee-actadufa/adufa-meetings. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 1, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 1, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery SUMMARY: E:\FR\FM\12APN1.SGM 12APN1 18990 Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices service acceptance receipt is on or before that date. 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 comments will be made public, you are solely responsible for ensuring that your comments do 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– 2011–N–0656 for ‘‘Animal Drug User Fee Act.’’ Received comments, those filed in a timely manner, 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 VerDate Sep<11>2014 21:37 Apr 09, 2021 Jkt 253001 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. A transcript of the public meeting will be made available in the docket, as well as on FDA’s website at: https:// www.fda.gov/industry/animal-druguser-fee-act-adufa/adufa-meetings. FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary Medicine, Food and Drug Administration, 240– 402–6888, lisa.kable@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Introduction The authority for ADUFA expires September 30, 2023. Without new legislation, FDA will no longer have the authority to collect user fees to fund the new animal drug review process for future fiscal years. Prior to beginning negotiations with the regulated industry on ADUFA reauthorization, section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j–13(d)(2)) requires FDA to: (1) Publish a notice in the Federal Register requesting public input on the reauthorization; (2) hold a public meeting at which the public may present its views on the reauthorization PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 including specific suggestions for changes to the goals referred to in section 740A(a) of the FD&C Act; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA’s website. FDA is holding a public meeting to gather information on what FDA should consider including in the reauthorization of ADUFA. FDA is interested in responses from the public on the following two general questions and welcomes other pertinent information that stakeholders would like to share: 1. What is your assessment of the overall performance of the ADUFA program thus far? 2. What aspects of ADUFA should be retained, changed, or discontinued to further strengthen and improve the program? II. Background FDA considers the timely review of new animal drug submissions to be central to the Agency’s mission to protect and promote human and animal health. The ADUFA program began in FY 2004 and is currently in the fourth authorization (ADUFA IV). FDA has published a number of reports that provide useful background on ADUFA I, II, III, and IV. ADUFA-related Federal Register notices, guidances, legislation, performance reports, and financial reports can be found at: https:// www.fda.gov/industry/fda-user-feeprograms/animal-drug-user-fee-actadufa. III. Participating in the Public Meeting Registration: Persons interested in attending this public meeting must register no later than midnight Eastern Time on May 18, 2021, by emailing complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and if you need reasonable accommodations due to a disability (e.g., Closed Captioning) to cvmadufa@ fda.hhs.gov. Early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link. Requests for Oral Presentations: During online registration you may indicate if you wish to make an oral presentation during the public meeting. To facilitate agenda development, registrants requesting to present will be contacted to provide information regarding which topics they intend to address and the title of their presentation. We will do our best to accommodate requests to make an oral E:\FR\FM\12APN1.SGM 12APN1 Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices presentation. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate. All requests to make oral presentations must be received by May 7, 2021. We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and we will notify participants by May 11, 2021. Selected presenters planning to use an electronic slide deck must submit an electronic copy of their presentation to Lisa Kable (see FOR FURTHER INFORMATION CONTACT) with the subject line ‘‘ADUFA Public Meeting Presentation’’ on or before May 17, 2021. If presenters choose not to use a slide deck, they are requested to submit a single slide with their name, affiliation, title of their presentation, and contact information. No commercial or promotional material will be permitted to be presented at the public meeting. Dated: April 5, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–07373 Filed 4–9–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0656] Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate AGENCY: Food and Drug Administration, HHS. Notice: Request for notification of participation. ACTION: The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders—including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts—in developing khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:37 Apr 09, 2021 Jkt 253001 recommendations for the next ADUFA program and hold discussions with these stakeholders at least once every 4 months during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings. DATES: Submit notification of intention to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization by May 20, 2021. These stakeholder meetings are expected to commence in October 2021 and will continue at least once every 4 months during reauthorization negotiations with the regulated industry. See the SUPPLEMENTARY INFORMATION section for further information regarding notification of intention to participate. ADDRESSES: The stakeholder meetings will be held virtually. FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary Medicine, Food and Drug Administration, 240– 402–6888, Lisa.Kable@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Introduction In 2018 Congress passed the Animal Drug User Fee Amendments of 2018 (Pub. L. 115–234; ADUFA IV). The authority for ADUFA IV expires September 30, 2023. Without new legislation to reauthorize the program, FDA will no longer be able to collect user fees for future fiscal years to fund the new animal drug review process. Section 740A(d)(1) of the FD&C Act (21 U.S.C. 379j–13(d)(1)) requires that FDA consult with a range of stakeholders in developing recommendations for consideration for the next ADUFA program, including representatives from patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts. To initiate this process of consultation, elsewhere in this issue of the Federal Register, we are announcing a public meeting to be held on May 20, 2021, where stakeholders and other members of the public will be given an opportunity to present their views on the reauthorization. The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. Section 740A(d)(3) of the FD&C Act further requires that FDA continue meeting with these stakeholders at least once every 4 months during negotiations with the regulated industry to continue discussions of their views on the reauthorization, including suggested changes to the ADUFA program. PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 18991 FDA is issuing this Federal Register notice to request that stakeholders— including veterinary, patient and consumer groups, as well as scientific and academic experts—notify FDA of their intent to participate in the periodic consultation meetings on ADUFA reauthorization. FDA believes that consistent stakeholder representation at these meetings is essential in the reauthorization process. If you wish to participate in this part of the reauthorization process, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions. Stakeholders who identify themselves through this notice will be included in all future stakeholder discussions while FDA negotiates with the regulated industry. If a stakeholder decides to participate in these meetings at a later time, they may still participate in remaining meetings by notifying FDA (see FOR FURTHER INFORMATION CONTACT). These stakeholder discussions will satisfy the requirement in section 740A(d)(3) of the FD&C Act. II. Notification of Intent To Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization, please submit notification by email to: cvmadufa@ fda.hhs.gov by May 18, 2021. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, telephone number, and notice of any special accommodations required due to a disability (e.g., Closed Captioning). Stakeholders will receive confirmation and additional information about the first meeting, and subsequent meetings when scheduled, after FDA receives this notification of intent to participate. Dated: April 5, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–07377 Filed 4–9–21; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\12APN1.SGM 12APN1

Agencies

[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18989-18991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07373]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]


Animal Drug User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following virtual public meeting entitled ``Animal Drug 
User Fee Act.'' The purpose of the public meeting is to invite public 
comment on the Animal Drug User Fee Act (ADUFA) program and suggestions 
regarding the features FDA should consider for the next reauthorization 
of the ADUFA program. The meeting will be open to the public.

DATES: The public meeting will be hosted via a live virtual webcast on 
Thursday, May 20, 2021, from 2 p.m. to 4 p.m. Eastern Time. See the 
SUPPLEMENTARY INFORMATION section for registration dates and 
information. To permit the widest possible opportunity to obtain 
comments on all aspects of the public meeting, the docket will remain 
open for comment throughout the reauthorization process of ADUFA, until 
December 1, 2022. In addition to being publicly viewable at https://www.regulations.gov, comments received by June 21, 2021, suggesting 
changes to the program, will also be published on https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 1, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 1, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery

[[Page 18990]]

service acceptance receipt is on or before that date.

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 comments will be 
made public, you are solely responsible for ensuring that your comments 
do 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-2011-N-0656 for ``Animal Drug User Fee Act.'' Received comments, 
those filed in a timely manner, 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.
    A transcript of the public meeting will be made available in the 
docket, as well as on FDA's website at: https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.

FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary 
Medicine, Food and Drug Administration, 240-402-6888, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Introduction

    The authority for ADUFA expires September 30, 2023. Without new 
legislation, FDA will no longer have the authority to collect user fees 
to fund the new animal drug review process for future fiscal years. 
Prior to beginning negotiations with the regulated industry on ADUFA 
reauthorization, section 740A(d)(2) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 379j-13(d)(2)) requires FDA to: (1) 
Publish a notice in the Federal Register requesting public input on the 
reauthorization; (2) hold a public meeting at which the public may 
present its views on the reauthorization including specific suggestions 
for changes to the goals referred to in section 740A(a) of the FD&C 
Act; (3) provide a period of 30 days after the public meeting to obtain 
written comments from the public suggesting changes; and (4) publish 
the comments on FDA's website. FDA is holding a public meeting to 
gather information on what FDA should consider including in the 
reauthorization of ADUFA. FDA is interested in responses from the 
public on the following two general questions and welcomes other 
pertinent information that stakeholders would like to share:
    1. What is your assessment of the overall performance of the ADUFA 
program thus far?
    2. What aspects of ADUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?

II. Background

    FDA considers the timely review of new animal drug submissions to 
be central to the Agency's mission to protect and promote human and 
animal health. The ADUFA program began in FY 2004 and is currently in 
the fourth authorization (ADUFA IV). FDA has published a number of 
reports that provide useful background on ADUFA I, II, III, and IV. 
ADUFA-related Federal Register notices, guidances, legislation, 
performance reports, and financial reports can be found at: https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register no later than midnight Eastern Time on May 18, 2021, by 
emailing complete contact information for each attendee, including 
name, title, affiliation, address, email, telephone number, and if you 
need reasonable accommodations due to a disability (e.g., Closed 
Captioning) to [email protected]. Early registration is recommended. 
Registrants will receive confirmation when their registration has been 
received and will be provided the webcast link.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to make an oral presentation during the public 
meeting. To facilitate agenda development, registrants requesting to 
present will be contacted to provide information regarding which topics 
they intend to address and the title of their presentation. We will do 
our best to accommodate requests to make an oral

[[Page 18991]]

presentation. Individuals and organizations with common interests are 
urged to consolidate or coordinate their presentations, and request 
time for a joint presentation, or submit requests for designated 
representatives to participate. All requests to make oral presentations 
must be received by May 7, 2021.
    We will determine the amount of time allotted to each presenter and 
the approximate time each oral presentation is to begin, and we will 
notify participants by May 11, 2021. Selected presenters planning to 
use an electronic slide deck must submit an electronic copy of their 
presentation to Lisa Kable (see FOR FURTHER INFORMATION CONTACT) with 
the subject line ``ADUFA Public Meeting Presentation'' on or before May 
17, 2021. If presenters choose not to use a slide deck, they are 
requested to submit a single slide with their name, affiliation, title 
of their presentation, and contact information. No commercial or 
promotional material will be permitted to be presented at the public 
meeting.

    Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07373 Filed 4-9-21; 8:45 am]
BILLING CODE 4164-01-P

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