[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33303-33305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2462]


Eligibility for the Index of Legally Marketed Unapproved New 
Animal Drugs for Minor Species; Request for Comments

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
soliciting comments on our current policy on eligibility for indexing. 
Indexing is the process of adding an unapproved drug for a minor 
species to our index of legally marketed unapproved new animal drugs 
for minor species (the Index). Except for in some early non-food life 
stages, members of a food-producing minor species are not eligible for 
indexing, even if a subset of animals within a food-producing minor 
species is not intended to be consumed by humans or food-producing 
animals. Specifically, we are requesting comment on this policy.

DATES: Submit either electronic or written comments on the notice by 
September 22, 2021.

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 September 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 22, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
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 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-2017-D-2462 for ``Eligibility for the Index of Legally Marketed 
Unapproved New Animal Drugs for Minor Species.'' 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 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

[[Page 33304]]

``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.

FOR FURTHER INFORMATION CONTACT: Dorothy Bailey, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 240-402-0565, dorothy.bailey@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Minor Use and Minor Species Animal Health Act of 2004 (MUMS 
Act) (Pub. L. 108-282) amended the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) to provide incentives to develop new animal drugs for minor 
species and minor uses. By enacting the MUMS Act, Congress sought to 
encourage the development of animal drugs that are unavailable to minor 
species (species other than cattle, horses, swine, chickens, turkeys, 
dogs, and cats) or to major species afflicted with uncommon diseases or 
conditions (minor use), while still ensuring appropriate safeguards for 
animal and human health. Congress recognized that the markets for drugs 
intended to treat these species, diseases, or conditions are too small 
to motivate animal drug companies to develop data to support drug 
approvals. Further, Congress recognized that some minor species 
populations have management systems too diverse to make it practical to 
conduct traditional studies to demonstrate safety and effectiveness of 
animal drugs for such uses.
    One of the incentives established by the MUMS Act is the Index of 
Legally Marketed Unapproved New Animal Drugs for Minor Species (section 
572 of the FD&C Act (21 U.S.C. 360ccc-1)). The final rule establishing 
administrative procedures and criteria for adding a new animal drug to 
the Index was published in the Federal Register on December 6, 2007 (72 
FR 69108). The regulations are codified in Title 21, Code of Federal 
Regulations (CFR) part 516, subpart C.
    We refer to the process of adding a new animal drug to the Index as 
``indexing.'' Instead of using the new animal drug approval process, 
indexing is a faster and less expensive pathway to legal marketing of 
unapproved new animal drugs for use in some minor species. Adding a new 
animal drug to the Index uses a combination of FDA and qualified expert 
panel review. It is a three-step process with each step involving a 
submission from a requestor (the person making a request for 
determination of eligibility) and a review and decision by FDA. The 
three steps are as follows:
    1. Requesting determination of eligibility for indexing (see 21 CFR 
516.129);
    2. Proposing a qualified expert panel to evaluate safety to the 
animal being treated (target animal safety) and effectiveness (see 21 
CFR 516.141); and
    3. Requesting addition to the Index (see 21 CFR 516.145).
    As part of this process, FDA reviews information to support 
environmental safety, human user safety, manufacturing processes, and 
human food safety considerations. A qualified expert panel, once 
accepted by FDA, reviews information to support effectiveness and 
target animal safety of the new animal drug. The expert panel reviews 
all available information regarding target animal safety and 
effectiveness information, which can include study data, literature, 
and anecdotal information, to determine if the benefit of using the new 
animal drug outweighs the risk to the target animal. The expert panel 
must be unanimous that the benefit outweighs the risk for a drug to be 
added to the Index. FDA reviews the findings of the expert panel and 
the labeling for the new animal drug as part of the final submission. 
If we agree with the expert panel's conclusions, the drug is added to 
the Index found on our website at https://www.fda.gov/animal-veterinary/minor-useminor-species/index-legally-marketed-unapproved-new-animal-drugs-minor-species. Once a drug is listed in the Index, the 
holder (the requestor of an index listing after a request is granted) 
is required to report to us any adverse events associated with use of 
the new animal drug. Extra-label use of an indexed drug is prohibited. 
This means a veterinarian or animal owner using an indexed drug can 
only do so legally by following label instructions.
    Section 572(a)(1) of the FD&C Act states that the Index is limited 
to new animal drugs intended for use in a minor species for which there 
is a reasonable certainty that the animal or edible products from the 
animal will not be consumed by humans or food-producing animals; and 
new animal drugs intended for use only in a hatchery, tank, pond, or 
other similar contained man-made structure in an early, non-food life 
stage of a food-producing minor species, where safety for humans is 
demonstrated in accordance with the standard of section 512(d) of the 
FD&C Act (including, for an antimicrobial new animal drug, with respect 
to antimicrobial resistance).
    For the purposes of indexing, FDA's Guidance for Industry #210 
entitled ``The Index of Legally Marketed Unapproved New Animal Drugs 
for Minor Species'' \1\ states that we consider a minor species to be a 
food-producing minor species when some members of the species are bred, 
cultured, farmed, ranched, hunted, caught, trapped, or otherwise 
harvested for the purpose of having the animals or edible products of 
the animals commercially distributed for consumption by humans or food-
producing animals in the United States. When defining food-producing 
minor species for the indexing process, we adhered to current policy 
for new animal drug approvals regarding food-producing animals. For 
many years, we have considered an animal to be food-producing if any 
member of that species is raised to be food for humans. For example, 
some rabbits are raised to be used as food for humans; under current 
policy, including indexing policy, all rabbits, regardless of where 
they are housed, are considered to be food-producing. This means that a 
drug for use in laboratory rabbits is ineligible for indexing even 
though a rabbit raised for use in research is not intended to be 
consumed by humans or other food-producing animals.
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    \1\ Available at: https://www.fda.gov/media/107583/download.
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II. Stakeholder Feedback

    We have received feedback from multiple animal stakeholder groups 
regarding the current indexing policy for eligibility. These 
stakeholders have asked us to allow indexing of drugs for use in 
certain populations of animals that would be considered food-producing 
under current indexing policy. Instead of considering any member of a 
food-producing minor species ineligible for indexing, they have 
requested that we establish criteria that, if met, could determine that 
a subset of animals within a food-producing minor species is eligible 
for

[[Page 33305]]

indexing because they are not consumed by humans or by food-producing 
animals. Using the previous example of rabbits, this would mean a drug 
intended for use in laboratory rabbits could be eligible for indexing 
because this distinct population of rabbits is not intended to enter 
the human food chain. The stakeholders assert that because there is a 
reasonable certainty that laboratory rabbits will not be eaten, they 
should be considered to be non-food-producing for the purposes of 
indexing.
    We want to optimize the incentives provided in the MUMS Act and 
support its intended purpose to increase legal drug availability for 
minor species. Changing current indexing policy for eligibility could 
help promote legal drug availability for underserved populations of 
animals; however, we do not intend to implement such a change if it 
might adversely affect human or animal health. The purpose of this 
notice is to give stakeholders the opportunity to provide feedback 
about this potential change to the current indexing policy for 
eligibility.

III. Request for Comments

    We request comments, including response to the specific questions 
that follow, to assist in evaluating whether changing our current 
indexing policy for eligibility can increase the availability of safe 
and effective new animal drugs for use in some minor species while 
continuing to protect human and animal health.
    Specifically, we request comment on the following:
    1. What are the reasons we should or should not expand eligibility 
for indexing to certain discrete subsets of food-producing minor 
species?
    2. If you support the expansion of indexing, please describe the 
information we should evaluate when determining which discrete subsets 
of food-producing minor species should be eligible.
    3. Are there any discrete subsets of food-producing minor species 
that you believe should be eligible for indexing because they are not 
intended for consumption by humans or food-producing animals?

    Dated: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13417 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P


