Notice2021-14938
Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Guidance for Industry; Availability
Primary source
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Published
July 14, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidance for industry (GFI) #261 entitled "Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs." This guidance is intended for sponsors and potential sponsors who may be interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species (MUMS) to include certain major uses in major species. The Center for Veterinary Medicine (CVM or we) refers to the process for conditionally approving new animal drugs that are not intended for MUMS indications as "expanded conditional approval." The purpose of expanded conditional approval is to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.
Full Text
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<title>Federal Register, Volume 86 Issue 132 (Wednesday, July 14, 2021)</title>
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[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Pages 37159-37160]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14938]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-3361]
Eligibility Criteria for Expanded Conditional Approval of New
Animal Drugs; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of final guidance for industry (GFI) #261 entitled
``Eligibility Criteria for Expanded Conditional Approval of New Animal
Drugs.'' This guidance is intended for sponsors and potential sponsors
who may be interested in pursuing conditional approval of new animal
drugs for certain major uses in major species. Eligibility for
conditional approval has been expanded beyond minor uses in major
species and use in minor species (MUMS) to include certain major uses
in major species. The Center for Veterinary Medicine (CVM or we) refers
to the process for conditionally approving new animal drugs that are
not intended for MUMS indications as ``expanded conditional approval.''
The purpose of expanded conditional approval is to incentivize
development of new animal drugs for serious or life-threatening
conditions or unmet animal or human health needs under circumstances
where a demonstration of effectiveness would require a complex or
particularly difficult study or studies. This guidance defines certain
terms, clarifies the eligibility criteria for expanded conditional
approval, and describes the criteria CVM intends to consider when
determining expanded conditional approval eligibility.
DATES: The announcement of the guidance is published in the Federal
Register on July 14, 2021.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2019-D-3361 for ``Eligibility Criteria for Expanded Conditional
Approval of New Animal Drugs.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management
[[Page 37160]]
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Christopher Loss, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0619,
<a href="/cdn-cgi/l/email-protection#33505b415a40475c435b56411d5f5c4040735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="d3b0bba1baa0a7bca3bbb6a1fdbfbca0a093b5b7b2fdbbbba0fdb4bca5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 30, 2019 (84 FR 51594), FDA
published the notice of availability for a draft guidance entitled
``Eligibility Criteria for Expanded Conditional Approval of New Animal
Drugs'' giving interested persons until January 28, 2020, to comment on
the draft guidance. FDA received a few comments on the draft guidance
and those comments were considered as the guidance was finalized.
Editorial changes were made to improve clarity. The guidance announced
in this notice finalizes the draft guidance dated September 2019.
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 eligibility criteria for expanded
conditional approval of new animal drugs. 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 guidance at
either <a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: July 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14938 Filed 7-13-21; 8:45 am]
BILLING CODE 4164-01-P
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