Utilizing Animal Studies To Evaluate Organ Preservation Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 20151-20153 [2019-09402]
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20151
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
(Response) We acknowledge that
accelerated approval products often
constitute the only treatment option or
one of a limited number of treatment
options available to patients. We revised
the questionnaire to include information
for participants in this study about the
treatment landscape for the disease.
(Comment 13) One comment
recommends enrolling a diversity of
participants across demographic
categories and geographic locations.
They suggest screening for pretest
participants, individuals who have
recently participated in prescription
drug research, and individuals with
prior use of oncology products or
accelerated approval products.
(Response) Participants will be
internet panel members. We will use
soft quotas to ensure recruitment of a
low health literacy population as well as
a demographically diverse set of
participants. Pretest participants will
not be allowed to participate in the
main study. We added questionnaire
items asking participants whether they
have been diagnosed with cancer, and if
so whether they have ever taken
prescription drugs, and specifically
accelerated approval products, for
cancer.
(Comment 14) One comment noted
that participants may pay more
attention to information presented in a
study, including claims designed to be
intentionally misleading, and asked
what efforts we will take to avoid
response bias.
(Response) The study design does not
include intentionally misleading claims.
Based on previous research with DTC
prescription drug websites, we expect
the median time spent on the study
stimuli to be under a minute to 2
minutes (Ref. 3). In general, we attempt
to minimize response bias by following
best practices, such as keeping the
survey length short and cognitivetesting and pretesting the questions to
make sure they are clearly written.
(Comment 15) One comment
requested that the screener and consent
form be made available.
(Response) The screener and consent
form are available as part of the
information collection submission to the
OMB.
(Comment 16) One comment noted
that the wording of Q4 and Q9 could
lead participants toward a specific
response.
(Response) These questions are
designed to measure whether
participants processed the information
in the disclosure. Thus, Q4 asks about
the unknown outcome information from
the disclosure, and Q9 asks about the
continuing research information from
the disclosure. Because these are not
meant to be questions about
perceptions, we have changed the
wording of Q4 to clarify that we are
asking about what the website said,
rather than what they might think. We
will evaluate these items in cognitive
interview and pretesting.
(Comment 17) One comment
recommended adding intermediate
response values for Q10–Q17 and Q24–
Q26.
(Response) We have added
intermediate response values for these
items, with the exception of Q26, the
Perspective Taking Scale, to be
consistent with its previous use.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
Activity
Total annual
responses
Average burden per
response
Pretest screener ..........................................................
Study screener ............................................................
Pretest .........................................................................
Main Study ...................................................................
916
1,507
385
633
1
1
1
1
1
1
1
1
Total ......................................................................
........................
........................
........................
1 There
khammond on DSKBBV9HB2PROD with NOTICES
No. of
responses per
respondent
0.08
0.08
0.33
0.33
Total Hours
(5 minutes) .....
(5 minutes) .....
(20 minutes) ...
(20 minutes) ..
73.28
120.56
127.05
208.89
................................
529.78
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on
display with the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; these are not
available electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Beaver J.A., L.J. Howie, L. Pelosof, et al.,
‘‘A 25-Year Experience of U.S. Food and
Drug Administration Accelerated
Approval of Malignant Hematology and
Oncology Drugs and Biologics: A
Review.’’ JAMA Oncology, 4(6):849–856,
2018. doi:10.1001/jamaoncol.2017.5618.
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
2. Sullivan H.W., A.C. O’Donoghue, K.T.
David, et al., ‘‘Disclosing Accelerated
Approval on Direct-to-Consumer
Prescription Drug websites.’’
Pharmacoepidemiology and Drug Safety,
27:1277–1280, 2018. https://doi.org/
10.1002/pds.4664.
3. Sullivan H.W., A.C. O’Donoghue, D.J.
Rupert, et al., ‘‘Placement and Format of
Risk Information on Direct-to-Consumer
Prescription Drug Websites.’’ Journal of
Health Communication, 22:171–181,
2017.
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09418 Filed 5–7–19; 8:45 am]
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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.
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
SUMMARY:
E:\FR\FM\08MYN1.SGM
08MYN1
20152
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
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:
khammond on DSKBBV9HB2PROD with NOTICES
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.
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
• 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/201523389.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.
PO 00000
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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 PreSubmission 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
E:\FR\FM\08MYN1.SGM
08MYN1
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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
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:
Topic
807, subpart E ..............................................................................................................
814, subparts A through E ...........................................................................................
814, subpart H ..............................................................................................................
812 ................................................................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ ...
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
Premarket notification ...............................
Premarket approval ..................................
Humanitarian Device Exemption ..............
Investigational Device Exemption .............
De Novo classification process ................
Q-submissions ..........................................
[FR Doc. 2019–09402 Filed 5–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
FOR FURTHER INFORMATION CONTACT:
Robert Walsh, Designated Federal
Officer, at the Healthcare Systems
Bureau, Division of Transplantation,
HRSA, 5600 Fishers Lane, 8W60,
Rockville, Maryland 20857; 301–443–
6839; or RWalsh@hrsa.gov.
New meeting date: Tuesday, July 2,
2019, rather than May 7, 2019, as
previously announced.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
Meeting of the Advisory Council on
Blood Stem Cell Transplantation
[FR Doc. 2019–09434 Filed 5–7–19; 8:45 am]
BILLING CODE 4165–15–P
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
ACTION:
Notice; correction.
The Advisory Council on
Blood Stem Cell Transplantation
(ACBSCT) meeting has been
rescheduled due to unforeseen
circumstances and will now be held on
Tuesday, July 2, 2019, from 10:00 a.m.–
4:00 p.m. Eastern Time. The meeting
will be held by webinar and conference
call. The webinar link, conference callin number, agenda, and instructions for
registration will be posted 15 business
days before the meeting on the ACBSCT
website at https://
bloodcell.transplant.hrsa.gov/about/
advisory_council/meetings/.
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
Organ Preservation Devices’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1500083 to identify
the guidance you are requesting.
21 CFR Part; guidance; or FD&C act section
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Visioning Session
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee program.
Name: National Committee on Vital
and Health Statistics (NCVHS),
Subcommittee on Standards.
Date and Times: Wednesday, July 10,
2019: 9:00 a.m.–5:00 p.m. (EDT),
Thursday, July 11, 2019: 8:30 a.m.–5:00
p.m. (EDT).
PO 00000
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20153
OMB Control
No.
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
0910–0756
Place: U.S. Department of Health and
Human Services, Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Rm. 505–A, Washington, DC 20201.
Status: Open. There will be a public
comment period during the final 15
minutes of the first day of the meeting.
Purpose: Health Insurance Portability
and Accountability Act (HIPAA)
legislation from 1996, as amended,1
established a regulatory framework to
support the exchange of electronic
information between covered entities,
and directed the Secretary of Health and
Human Services (HHS) to publish
regulations adopting standards, code
sets, and unique identifiers. The
administrative simplification provisions
of HIPAA pertain to retail pharmacy and
medical transactions, such as eligibility,
claims, payment, enrollment, and
authorizations.
NCVHS advises the HHS Secretary on
health data, statistics, privacy, national
health information policy, and is
mandated to report to Congress on the
implementation status of HIPAA. Since
mid-2017, the Subcommittee on
Standards has been focused on
developing a ‘‘predictability roadmap’’
through collaboration with industry to
identify and evaluate barriers to the
efficient and timely update and
1 Along with Section 1104 (c) of the Patient
Protection and Affordable Care Act (ACA) of 2010.
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 20152]]
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
[[Page 20153]]
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:
------------------------------------------------------------------------
21 CFR Part; guidance; or FD&C act OMB Control
section Topic No.
------------------------------------------------------------------------
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''.
------------------------------------------------------------------------
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
