[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51594-51595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21002]
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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Animal Drugs; Draft Guidance for Industry; Availability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 or Agency) is announcing
the availability of a draft guidance for industry (GFI) #261 entitled
``Eligibility Criteria for Expanded Conditional Approval of New Animal
Drugs.'' This draft guidance is intended for persons interested in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 minor species to
include certain major uses. The Center for Veterinary Medicine (CVM)
refers to the process for conditionally approving new animal drugs that
are not minor use and minor species (MUMS) drugs 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 This draft guidance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DATES: Submit either electronic or written comments on the draft
guidance by January 28, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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.
[[Page 51595]]
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 https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
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
``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.gpo.gov/fdsys/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.
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, 7519 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 draft 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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft GFI #261 entitled
``Eligibility Criteria for Expanded Conditional Approval of New Animal
Drugs.'' In 2013, in conjunction with the reauthorization of FDA's
animal drug user fee program, FDA agreed to consider whether it would
be appropriate to expand the concept of conditional approval in section
571 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360ccc) to include new animal drug use in major species for diseases or
conditions that would not be eligible for conditional approval under
the MUMS provisions of the FD&C Act. Through a public process and
working in concert with stakeholders, CVM explored the feasibility of
expanding the eligibility for conditional approval. CVM concluded that
conditional approval may be appropriate for new animal drugs intended
for a serious or life-threatening disease or condition, or for drugs
intended to address an unmet animal or human health need under
circumstances where a demonstration of effectiveness would require a
particularly difficult effectiveness study or studies. The Animal Drug
User Fee Amendments of 2018 amended section 571 of the FD&C Act to
include provisions for expanded conditional approval and directed FDA
to establish guidance or regulations to clarify the eligibility
criteria for expanded conditional approval.
In accordance with the recent amendments to the FD&C Act, this
draft guidance proposes definitions for the following terms that appear
in section 571 of the FD&C Act:
``serious or life-threatening disease or condition''
``unmet animal or human health need,'' and
``complex or particularly difficult study or studies.''
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent 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.
This guidance is not subject to Executive Order 12866.
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations for new animal drug applications
submitted under sections 512(b) (21 U.S.C. 360b(b)) and 571 of the FD&C
Act. These collections of information are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR
514.1, 514.4, 514.5, 514.6, 514.8, and 514.11 have been approved under
OMB control number 0910-0032.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21002 Filed 9-26-19; 11:15 am]
BILLING CODE 4164-01-P