Notice2021-13417
Eligibility for the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Request for Comments
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Published
June 24, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33303-33305]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<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-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 <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 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
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``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.
FOR FURTHER INFORMATION CONTACT: Dorothy Bailey, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-0565, <a href="/cdn-cgi/l/email-protection#2d49425f42594554034f4c444148546d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="eb8f8499849f8392c5898a82878e92ab8d8f8ac5838398c58c849d">[email protected]</span></a>.
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 <a href="https://www.fda.gov/animal-veterinary/minor-useminor-species/index-legally-marketed-unapproved-new-animal-drugs-minor-species">https://www.fda.gov/animal-veterinary/minor-useminor-species/index-legally-marketed-unapproved-new-animal-drugs-minor-species</a>. 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: <a href="https://www.fda.gov/media/107583/download">https://www.fda.gov/media/107583/download</a>.
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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
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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
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