Notice2023-28287
Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Guidance for Industry; Availability
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Published
December 22, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry (GFI) #61 entitled "Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species." This guidance is intended to assist those interested in pursuing FDA approval of new animal drugs intended for minor uses in major species or for use in minor species (MUMS drugs). It outlines the basic statutory and regulatory requirements and special considerations for these approvals and describes the incentives available to encourage the development of MUMS drugs.
Full Text
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<title>Federal Register, Volume 88 Issue 245 (Friday, December 22, 2023)</title>
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[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88634-88635]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28287]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1997-D-0444]
Special Considerations, Incentives, and Programs To Support the
Approval of New Animal Drugs for Minor Uses and for Minor Species;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a final guidance for industry (GFI) #61
entitled ``Special Considerations, Incentives, and Programs to Support
the Approval of New Animal Drugs for Minor Uses and for Minor
Species.'' This guidance is intended to assist those interested in
pursuing FDA approval of new animal drugs intended for minor uses in
major species or for use in minor species (MUMS drugs). It outlines the
basic statutory and regulatory requirements and special considerations
for these approvals and describes the incentives available to encourage
the development of MUMS drugs.
DATES: The announcement of the guidance is published in the Federal
Register on December 22, 2023.
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-1997-D-0444 for ``Special Considerations, Incentives, and Programs
to Support the Approval of New Animal Drugs for Minor Uses and for
Minor Species.'' 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
[[Page 88635]]
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
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: Dorothy Bailey, Center for Veterinary
Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0565, <a href="/cdn-cgi/l/email-protection#23474c514c574b5a0d41424a4f465a634547420d4b4b500d444c55"><span class="__cf_email__" data-cfemail="1e7a716c716a7667307c7f77727b675e787a7f3076766d30797168">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 15, 2020 (85 FR 42876), FDA
published the notice of availability for draft GFI #61 entitled
``Special Considerations, Incentives, and Programs to Support the
Approval of New Animal Drugs for Minor Uses and for Minor Species''
giving interested persons until November 12, 2020, to comment on the
draft guidance. In response to a request for an extension, the comment
period was extended to January 11, 2021 (85 FR 71659). FDA received 14
comments on the draft guidance and those comments were considered as
the guidance was finalized. Changes to the final guidance include the
following:
<bullet> In our draft guidance we referred to Minor Use
Determinations. Our experience has shown that our stakeholders
frequently confuse ``MUMS Determination'' with ``MUMS Designation.''
Therefore, the final guidance substitutes the word ``Assessment'' for
the word ``Determination.''
<bullet> Section XII.C.3.a.i. ``Anthelmintics and Ectoparasiticides
for Terrestrial Minor Species'' has been added to the final guidance in
response to comments received requesting additional detail on this
subject. This section also references the relevant ``International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH)'' guidance.
<bullet> CVM received many comments pertaining to aquaculture
species grouping. Due to the complexity of this topic, CVM has removed
examples of aquaculture species groupings in the final guidance. We
continue to consider this topic and intend to work with individual drug
sponsors wishing to use species groupings for new animal drug approvals
to identify an appropriate species grouping strategy and subsequent
data needs for specific projects.
In addition, editorial changes were made to improve clarity. The
guidance announced in this notice finalizes the draft guidance dated
July 2020.
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 ``Special Considerations, Incentives,
and Programs to Support the Approval of New Animal Drugs for Minor Uses
and for Minor Species.'' 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 part 511 have been approved under OMB control number 0910-
0117; the collections of information in 21 CFR part 514 have been
approved under OMB control numbers 0910-0032 and 0910-0284; and the
collections of information in 21 CFR part 516 have been approved under
OMB control numbers 0910-0605.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</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: December 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28287 Filed 12-21-23; 8:45 am]
BILLING CODE 4164-01-P
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