[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43390-43391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19613]


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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; 
Draft Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Utilizing Animal 
Studies to Evaluate Organ Preservation Devices.'' The intent of this 
draft guidance is to provide recommendations regarding best practices 
for utilizing animal studies for the evaluation of organ preservation 
devices. This draft guidance is not final nor is it in effect at this 
time.

DATES: Submit either electronic or written comments on the draft 
guidance by November 14, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.
     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 draft guidance document 
entitled ``Utilizing Animal Studies to Evaluate Organ Preservation 
Devices'' to the Office of the Center Director, Guidance and Policy 
Development, 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: Elizabeth Kunkoski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1504, Silver Spring, MD 20993-0002, 301-
796-6439.

SUPPLEMENTARY INFORMATION: 

[[Page 43391]]

I. Background

    FDA is announcing the availability of a draft leapfrog guidance for 
industry and FDA staff entitled ``Utilizing Animal Studies to Evaluate 
Organ Preservation Devices.'' The intent of this draft guidance is to 
provide recommendations regarding best practices for utilizing animal 
studies for the evaluation of organ preservation devices, with careful 
considerations of regulatory least burdensome principles, as well as, 
ethical principles in animal testing. This draft 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 organ 
preservation devices to the market faster to increase the availability 
of organs for transplant for patients awaiting transplants. Early 
stakeholder feedback was sought to inform the development of this draft 
guidance through CDRH's notice on the fiscal year 2016 proposed 
guidance development issued December 29, 2015 (80 FR 81335), available 
at https://www.federalregister.gov/documents/2015/12/29/2015-32726/medical-device-user-fee-and-modernization-act-notice-to-public-of-web-site-location-of-fiscal-year#h-14. Specific questions were posed to 
solicit input into the context of the guidance and comments were 
collected through Docket No. FDA-2012-N-1021.
    This draft 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 draft guidance represents the Agency's initial thinking, and 
our recommendations may change as more information becomes available. 
The Agency strongly encourages manufacturers to engage with CDRH 
through the Pre-Submission process 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/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf).

II. Significance of Guidance

    This 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 ``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 draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. 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 draft guidance document refers to previously approved 
collections of information found in FDA regulations and guidances. 
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 part 58 
regarding good laboratory practices have been approved under OMB 
control number 0910-0119. The collections of information in 21 CFR part 
801 regarding labeling have been approved under OMB control number 
0910-0485. The collections of information in 21 CFR part 807, subpart E 
regarding premarket notification have been approved under OMB control 
number 0910-0120. The collections of information in 21 CFR part 812 
regarding investigational device exemptions have been approved under 
OMB control number 0910-0078. The collections of information in 21 CFR 
part 814, subparts A through E regarding premarket approval have been 
approved under OMB control number 0910-0231. The collections of 
information in 21 CFR part 814, subpart H have been approved under OMB 
control number 0910-0332. The collections of information in 21 CFR part 
820 regarding the Quality System regulation have been approved under 
OMB control number 0910-0073. The collections of information in the 
guidance document entitled ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' have been approved under OMB control number 
0910-0756.

    Dated: September 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19613 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P