Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Guidance for Industry; Availability, 4821-4823 [2019-02692]
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4821
Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices
previously approved data collection
instruments and for two additional data
collection instruments.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
Description: The STREAMS
evaluation includes two components, an
impact study and a process study. The
evaluation will examine HMRE
programs for youth in high school, adult
couples, and adult individuals.
1. Impact Study. The goal of the
impact study is to provide rigorous
estimates of the effectiveness of program
services and interventions to improve
program implementation. The impact
study uses an experimental design.
Eligible program applicants are
randomly assigned to either a program
group that is offered program services or
a control group that is not. STREAMS
collects baseline information from
eligible program applicants prior to
random assignment and administers a
follow-up survey to participants 12
months after random assignment.
2. Process study. The goal of the
process study is to support the
interpretation of impact findings and
document program operations to
support future replication. STREAMS
conducts semi-structured interviews
with program staff and selected
community stakeholders, conducts
focus groups with program participants,
administers a survey to program staff,
and collects data on adherence to
program curricula through an add on to
an existing program MIS (nFORM, OMB
no. 0970–0460).
This data collection request is for an
extension of previously approved data
collection instruments for the impact
study and for two additional data
collection instruments associated with
the impact study. The two additional
instruments will allow for longer-term
follow-up in two of the five evaluation
sites. (1) The second follow-up survey
for youth will be administered
approximately 24 to 36 months after
random assignment to study
participants in the STREAMS site
serving youth. (2) The second follow-up
survey for adults will be administered
approximately 30 months after random
assignment to study participants in one
of the STREAMS evaluation sites
serving adults.
Respondents: Study participants.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Annual
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
Previously Approved Burden that Remains
Introductory script, grantee staff ..........................................
Introductory script, program applicants ...............................
Add-on to nFORM to conduct random assignment .............
Follow-up survey for youth ..................................................
Baseline survey for adults ...................................................
Follow-up survey for adults ..................................................
8
600
8
690
600
2,300
8
200
8
230
200
767
25
1
25
1
1
1
0.08
0.08
0.08
0.5
0.5
0.75
16
16
16
115
100
575
500
267
1
1
0.5
0.75
250
200
Current Request for Approval
Second follow-up survey for youth ......................................
Second follow-up survey for adults .....................................
Estimated Total Annual Burden
Hours: 1,288.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: 42 U.S.C. 603; Sec. 811 (b)
Healthy Marriage Promotion and Promoting
Responsible Fatherhood Grants of the Claims
Resolution Act of 2010, Pub. L. 111–291, 124
Stat. 3064.
Mary B. Jones,
ACF/OPRE Certifying Officer.
tkelley on DSKBCP9HB2PROD with NOTICES
[FR Doc. 2019–02693 Filed 2–15–19; 8:45 am]
BILLING CODE 4184–73–P
1,500
800
Food and Drug Administration
[Docket No. FDA–2017–D–6154]
Evaluation of Devices Used With
Regenerative Medicine Advanced
Therapies; Guidance for Industry;
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 ‘‘Evaluation of
SUMMARY:
VerDate Sep<11>2014
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Frm 00059
Fmt 4703
Sfmt 4703
Devices Used with Regenerative
Medicine Advanced Therapies;
Guidance for Industry.’’ The guidance
document provides manufacturers,
applicants, and sponsors engaged in the
development of regenerative medicine
therapies, with our current thinking
regarding evaluation of devices used in
the recovery, isolation or delivery of
regenerative advanced therapies, which
FDA generally refers to as ‘‘regenerative
medicine advanced therapies’’ or
‘‘RMATs.’’ Specifically, the guidance
addresses how FDA intends to simplify
and streamline its application of
regulatory requirements for combination
device and cell or tissue products; what,
if any, intended uses or specific
attributes would result in a device used
E:\FR\FM\19FEN1.SGM
19FEN1
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Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices
with a regenerative therapy product to
be classified as a class III device; the
factors to consider in determining
whether a device may be labeled for use
with a specific RMAT or class of
RMATs; when a device may be limited
to a specific intended use with only one
particular type of cell; and application
of the least burdensome approach to
demonstrate how a device may be used
with more than one cell type. The
issuance of this guidance fulfills the
statutory requirement set forth in a
certain section of the 21st Century Cures
Act (Cures Act). The guidance
announced in this notice finalizes the
draft guidance of the same title dated
November 2017.
DATES: The announcement of the
guidance is published in the Federal
Register on February 19, 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’’).
tkelley on DSKBCP9HB2PROD with NOTICES
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
VerDate Sep<11>2014
17:46 Feb 15, 2019
Jkt 247001
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–6154 for ‘‘Evaluation of Devices
Used with Regenerative Medicine
Advanced Therapies; Guidance for
Industry.’’ 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/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)).
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Evaluation of
Devices Used with Regenerative
Medicine Advanced Therapies;
Guidance for Industry.’’ The guidance
provides manufacturers, applicants and
sponsors engaged in the development of
regenerative medicine therapies, with
our current thinking regarding
evaluation of devices used in the
recovery, isolation or delivery of
regenerative advanced therapies, which
FDA generally refers to as ‘‘RMATs.’’
Specifically, the guidance addresses
how FDA intends to simplify and
streamline its application of regulatory
requirements for combination device
and cell or tissue products; what, if any,
intended uses or specific attributes
would result in a device used with a
regenerative therapy product to be
classified as a class III device; the
factors to consider in determining
whether a device may be labeled for use
with a specific RMAT or class of
RMATs; when a device may be limited
to a specific intended use with only one
particular type of cell; and application
of the least burdensome approach to
demonstrate how a device may be used
with more than one cell type.
The issuance of the final guidance
fulfills the statutory requirement set
forth in section 3034(b) of the Cures Act
(Pub. L. 114–255) and sets forth
information about a wide range of
concepts related to the regulation of
devices used in the recovery, isolation,
and delivery of RMATs. As our
experience with these products grows,
we may consider issuing guidance on
more specific topics related to these
E:\FR\FM\19FEN1.SGM
19FEN1
Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices
devices to provide additional
recommendations to stakeholders.
In the Federal Register of November
17, 2017 (82 FR 54349), FDA announced
the availability of the draft guidance of
the same title dated November 2017.
FDA considered comments received on
the draft guidance. FDA revised the
guidance as appropriate in response to
the comments and made editorial
changes to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated
November 2017.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of a document entitled
‘‘Expedited Programs for Regenerative
Medicine Therapies for Serious
Conditions; Guidance for Industry.’’
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 ‘‘Evaluation of
Devices Used with Regenerative
Medicine Advanced Therapies.’’ 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.
tkelley on DSKBCP9HB2PROD with NOTICES
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. 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 807 have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 814 have been approved under
OMB control numbers 0910–0231 and
0910–0332; the collections of
information in 21 CFR part 1271 have
been approved under OMB control
number 0910–0543; and the collections
of information in the guidance
document ‘‘De Novo Classification
Process (Evaluation of Automatic Class
III Designation)’’ have been approved
under OMB control number 0910–0844.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
VerDate Sep<11>2014
17:46 Feb 15, 2019
Jkt 247001
default.htm or https://
www.regulations.gov.
Dated: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02692 Filed 2–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4711]
Nonbinding Feedback After Certain
Food and Drug Administration
Inspections of Device Establishments;
Draft 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 the draft
guidance entitled ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments.’’ The FDA
Reauthorization Act of 2017 (FDARA)
mandated that FDA issue draft guidance
specifying how FDA provides
nonbinding feedback to the owner,
operator, or agent in charge of a device
establishment after an inspection of
such establishment within 45 days of
FDA’s receipt of a request for such
feedback if the request meets certain
statutory criteria. This draft guidance
describes FDA’s proposed approach for
providing nonbinding feedback,
including the procedures for requesting
nonbinding feedback and FDA’s review
of requests for nonbinding feedback.
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 April 22, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments on the collection of
information by April 22, 2019.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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,
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
4823
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–
2018–D–4711 for ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments.’’ 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
E:\FR\FM\19FEN1.SGM
19FEN1
Agencies
[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4821-4823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02692]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6154]
Evaluation of Devices Used With Regenerative Medicine Advanced
Therapies; Guidance for Industry; 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 ``Evaluation of Devices
Used with Regenerative Medicine Advanced Therapies; Guidance for
Industry.'' The guidance document provides manufacturers, applicants,
and sponsors engaged in the development of regenerative medicine
therapies, with our current thinking regarding evaluation of devices
used in the recovery, isolation or delivery of regenerative advanced
therapies, which FDA generally refers to as ``regenerative medicine
advanced therapies'' or ``RMATs.'' Specifically, the guidance addresses
how FDA intends to simplify and streamline its application of
regulatory requirements for combination device and cell or tissue
products; what, if any, intended uses or specific attributes would
result in a device used
[[Page 4822]]
with a regenerative therapy product to be classified as a class III
device; the factors to consider in determining whether a device may be
labeled for use with a specific RMAT or class of RMATs; when a device
may be limited to a specific intended use with only one particular type
of cell; and application of the least burdensome approach to
demonstrate how a device may be used with more than one cell type. The
issuance of this guidance fulfills the statutory requirement set forth
in a certain section of the 21st Century Cures Act (Cures Act). The
guidance announced in this notice finalizes the draft guidance of the
same title dated November 2017.
DATES: The announcement of the guidance is published in the Federal
Register on February 19, 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-6154 for ``Evaluation of Devices Used with Regenerative
Medicine Advanced Therapies; Guidance for Industry.'' 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
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Evaluation of Devices Used with Regenerative Medicine Advanced
Therapies; Guidance for Industry.'' The guidance provides
manufacturers, applicants and sponsors engaged in the development of
regenerative medicine therapies, with our current thinking regarding
evaluation of devices used in the recovery, isolation or delivery of
regenerative advanced therapies, which FDA generally refers to as
``RMATs.'' Specifically, the guidance addresses how FDA intends to
simplify and streamline its application of regulatory requirements for
combination device and cell or tissue products; what, if any, intended
uses or specific attributes would result in a device used with a
regenerative therapy product to be classified as a class III device;
the factors to consider in determining whether a device may be labeled
for use with a specific RMAT or class of RMATs; when a device may be
limited to a specific intended use with only one particular type of
cell; and application of the least burdensome approach to demonstrate
how a device may be used with more than one cell type.
The issuance of the final guidance fulfills the statutory
requirement set forth in section 3034(b) of the Cures Act (Pub. L. 114-
255) and sets forth information about a wide range of concepts related
to the regulation of devices used in the recovery, isolation, and
delivery of RMATs. As our experience with these products grows, we may
consider issuing guidance on more specific topics related to these
[[Page 4823]]
devices to provide additional recommendations to stakeholders.
In the Federal Register of November 17, 2017 (82 FR 54349), FDA
announced the availability of the draft guidance of the same title
dated November 2017. FDA considered comments received on the draft
guidance. FDA revised the guidance as appropriate in response to the
comments and made editorial changes to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated November
2017.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a document entitled ``Expedited Programs for
Regenerative Medicine Therapies for Serious Conditions; Guidance for
Industry.''
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 ``Evaluation of Devices Used with
Regenerative Medicine Advanced Therapies.'' 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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. 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 807 have been approved under
OMB control number 0910-0120; the collections of information in 21 CFR
part 812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 814 have been approved under
OMB control numbers 0910-0231 and 0910-0332; the collections of
information in 21 CFR part 1271 have been approved under OMB control
number 0910-0543; and the collections of information in the guidance
document ``De Novo Classification Process (Evaluation of Automatic
Class III Designation)'' have been approved under OMB control number
0910-0844.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02692 Filed 2-15-19; 8:45 am]
BILLING CODE 4164-01-P