[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20151-20153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4886]


Utilizing Animal Studies To Evaluate Organ Preservation Devices; 
Guidance for Industry and Food and Drug Administration Staff; 
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 final guidance entitled ``Utilizing Animal 
Studies to Evaluate Organ Preservation Devices.'' The intent of this 
guidance is to provide recommendations regarding best practices for 
utilizing animal

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studies for the evaluation of organ preservation devices.

DATES: The announcement of the guidance is published in the Federal 
Register on May 8, 2019.

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-2017-D-4886 for ``Utilizing Animal Studies to Evaluate Organ 
Preservation Devices.'' 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)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Utilizing Animal Studies to Evaluate Organ Preservation Devices'' to 
the Office of Policy, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Carolyn Neuland, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G226, Silver Spring, MD 20993-0002, 301-
796-6523.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the leapfrog guidance 
``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' 
The intent of this guidance is to provide recommendations regarding 
best practices for utilizing animal studies for the evaluation of organ 
preservation devices, while considering both regulatory least 
burdensome principles and ethical principles in animal testing. This 
guidance provides clarity on premarket recommendations to develop 
animal transplant models for organ preservation technologies, which 
will streamline initiation of clinical studies. Optimizing animal and 
clinical study designs for premarket submissions will allow us to bring 
novel, safe, and effective organ preservation devices to the market 
faster to increase the availability of organs for transplant for 
patients awaiting transplants. FDA recognizes that best practices for 
conducting animal studies to evaluate organ preservation devices are 
evolving with the rapid advancements in such technologies. This 
guidance is not intended to be comprehensive or prescriptive.
    This guidance is a leapfrog guidance; leapfrog guidances are 
intended to serve as a mechanism by which the Agency can share initial 
thoughts regarding the content of premarket submissions for emerging 
technologies and new clinical applications that are likely to be of 
public health importance very early in product development. This 
leapfrog guidance represents the Agency's initial thinking, and our 
recommendations may change as more information becomes available. The 
Agency strongly encourages manufacturers to submit a Pre-Submission to 
obtain more detailed feedback regarding their organ preservation 
device. For more information on Pre-Submissions, please see ``Requests 
for Feedback on Medical Device Submissions: The Pre-Submission Program 
and Meetings with Food and Drug Administration Staff'' at (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176).
    Early stakeholder feedback was sought to inform the development of 
this guidance through the Center for Devices and Radiological Health's 
(CDRH's) notice on the fiscal year 2016 proposed guidance development 
issued

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December 29, 2015 (80 FR 81335). Specific questions were posed to 
solicit input into the content of the draft guidance and comments were 
collected through Docket No. FDA-2012-N-1021. FDA also considered 
comments received on the draft guidance that appeared in the Federal 
Register of September 15, 2017 (82 FR 43390). FDA revised the guidance 
as appropriate in response to the comments.

II. Significance of Guidance

    This 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 ``Utilizing Animal Studies to Evaluate Organ 
Preservation Devices.'' 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. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all CDRH guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. 
This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of 
``Utilizing Animal Studies to Evaluate Organ Preservation Devices'' may 
send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 1500083 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 
the following FDA regulations and guidance and the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) have been approved by OMB as listed in the 
following table:

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21 CFR Part; guidance; or FD&C act                          OMB Control
              section                       Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
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    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09402 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P