[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Animal Drugs; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry (GFI) #261 entitled 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 This draft guidance is intended for persons interested in 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 This draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by January 28, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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, 
christopher.loss@fda.hhs.gov.

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


