[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88634-88635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28287]


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

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.

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

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:
     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-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 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

[[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 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 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, [email protected].

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:
     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.''
     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.
     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 
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: 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