Mouse Embryo Assay for Assisted Reproduction Technology Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 312-314 [2020-29081]
Download as PDF
<![CDATA[
312
Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices
coordination and collaboration with two
new required narratives and associated
drop-down menu data.
Comment Summary: Two AT grantees
commented in support.
ACL Response: No changes made.
Leveraged Funding—eliminated
Section B and folded data into Section
A to simplify.
Comment Summary: Two AT grantees
commented in support.
ACL Response: No changes made.
Instruction Manual—deleted
redundant text and updated AT
Taxonomy.
Comment Summary: Two AT grantees
commented in support.
ACL Response: No changes made.
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows:
require no change in data burden
estimates.
(B) The fifty-six grantees ask
consumers to complete surveys that
provide information on their
performance related to the state’s
measurable goals. Historical data from
states indicates that the average state
will ask for this information from 3,242
consumers at 1 minute per consumer to
complete the question survey, for a total
of 54 hours annually.
(C) The fifty-six grantees also ask
consumers to complete customer
satisfaction surveys. Historical data
from states indicated that the average
state asks for this information from
3,242 consumers at 1 minute per
consumer, for a total of 54 hours
annually.
(A) A web-based system that collects
data from states.
(B) A performance measurement
survey that states collect from
individuals
(C) A customer satisfaction survey
that states collect from individuals.
(A) Fifty-six grantees report to ACL
using the web-based data collection
system. A workgroup of grantees
estimated that the average amount of
time required to complete all responses
to the data collection instrument is 80
hours annually. The estimated response
burden includes time to review the
instructions, gather existing data, and
complete and review the data entries.
These estimates are based on the
experience of staff who implement these
programs at the state level. In addition,
we project that clean-up and
clarification of data elements will
Number of
responses
Annual
burden per
grantee
Total annual
burden hours
Work-Based System ........................................................................................
Performance Measurement .............................................................................
Customer Satisfaction ......................................................................................
56
3,242
3,242
1.428
0.01666
0.01666
80
54
54
4,480
3.024
3,024
Subtotal .....................................................................................................
Program Support .............................................................................................
Record Keeping Burden ..................................................................................
........................
56
56
........................
4
0.14286
188
208
8
10,528
11,648
448
Subtotal .....................................................................................................
........................
........................
216
12,096
Total ...................................................................................................
........................
........................
404
22,624
Dated: December 29, 2020.
Lance Robertson,
Administrator and Assistant Secretary for
Aging.
on conducting the mouse embryo assay
to support premarket submissions and
lot release of assisted reproduction
technology devices.
DATES: The announcement of the
guidance is published in the Federal
Register on January 5, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
[FR Doc. 2020–29150 Filed 1–4–21; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2105]
Mouse Embryo Assay for Assisted
Reproduction Technology Devices;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
jbell on DSKJLSW7X2PROD with NOTICES
Hours per
response
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Mouse Embryo
Assay for Assisted Reproduction
Technology Devices.’’ This guidance
document provides recommendations
SUMMARY:
VerDate Sep<11>2014
17:09 Jan 04, 2021
Jkt 253001
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
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
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.’’
E:\FR\FM\05JAN1.SGM
05JAN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–2105 for ‘‘Mouse Embryo Assay
for Assisted Reproduction Technology
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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
VerDate Sep<11>2014
17:09 Jan 04, 2021
Jkt 253001
313
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Mouse Embryo
Assay for Assisted Reproduction
Technology Devices’’ to the Office of
Policy, 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 selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT: PeiHsuan (Chris) Hung, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2647, Silver Spring,
MD 20993–0002, 240–402–5928.
SUPPLEMENTARY INFORMATION:
specificity on the number of embryos
that should be used; discuss how
accelerated aging can also be used to
develop test articles at the end of the
proposed shelf-life; and when
procedural modifications or options
should be justified in the test report. In
addition, FDA made editorial changes to
the guidance for clarity.
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 ‘‘Mouse Embryo
Assay for Assisted Reproduction
Technology 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.
I. Background
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
Center for Devices and Radiological
Health 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 and at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download
an electronic copy of ‘‘Mouse Embryo
Assay for Assisted Reproduction
Technology 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 16015 and complete title to
identify the guidance you are
requesting.
The majority of assisted reproduction
technology (ART) devices directly or
indirectly contact gametes and/or
embryos during use. The mouse embryo
assay (MEA) is used to assess the
potential for embryotoxicity of devices
that contact gametes and/or embryos.
Several classification regulations under
part 884 (21 CFR part 884) include
special controls that require MEA
testing or information. MEA may also be
used by sponsors to support premarket
submissions for other devices that are
intended to contact gametes and/or
embryos during their use. However,
there are no voluntary consensus
standards that describe how to conduct
the MEA. This guidance provides
recommendations for conducting the
MEA to support premarket submissions
and lot release for ART devices that are
intended to contact gametes and/or
embryos and to comply with the special
controls for those devices classified
under part 884 that require MEA testing
or information.
A notice of availability of the draft
guidance appeared in the Federal
Register of June 13, 2019 (84 FR 27637).
FDA considered comments received and
revised the guidance as appropriate in
response to the comments, including
minor technical edits and clarifications.
Specifically, the final guidance includes
revisions to recommend that liquidbased test articles should be prepared
per the instructions for use; clarify
FDA’s recommended exposure time for
test articles depending on their clinical
use duration; include additional
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
II. Electronic Access
III. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
E:\FR\FM\05JAN1.SGM
05JAN1
314
Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices
Topic
807, subpart E ............................................................................
800, 801, and 809 ......................................................................
Premarket Notification ................................................................
Medical Device Labeling Regulations ........................................
Dated: December 28, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–29081 Filed 1–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2199]
Investigational New Drug Submissions
for Individualized Antisense
Oligonucleotide Drug Products:
Administrative and Procedural
Recommendations; Draft Guidance for
Sponsor-Investigators; 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 draft
guidance for industry entitled ‘‘IND
Submissions for Individualized
Antisense Oligonucleotide Drug
Products: Administrative and
Procedural Recommendations.’’ FDA is
publishing this draft guidance to help
sponsor-investigators (hereafter referred
to as sponsors) developing
individualized antisense
oligonucleotide (ASO) drug products for
a severely debilitating or life-threatening
genetic disease. Most often, individuals
with such diseases will not have
adequate alternative therapy available
for treating their disease. This draft
guidance is intended to help sponsors of
such development programs, who may
be relatively unfamiliar with FDA
regulations, processes, and practices,
with the administrative and procedural
aspects of interacting with FDA,
including seeking feedback from FDA
on their development programs and
making regulatory submissions related
to these development programs.
DATES: Submit either electronic or
written comments on the draft guidance
by March 8, 2021 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:
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
OMB control
No.
21 CFR part
VerDate Sep<11>2014
17:09 Jan 04, 2021
Jkt 253001
Electronic Submission
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–
2020–D–2199 for ‘‘IND Submissions for
Individualized Antisense
Oligonucleotide Drug Products:
Administrative and Procedural
Recommendations.’’ 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, 240–402–7500.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
0910–0120
0910–0485
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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 draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. 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.
E:\FR\FM\05JAN1.SGM
05JAN1
]]>Agencies
[Federal Register Volume 86, Number 2 (Tuesday, January 5, 2021)]
[Notices]
[Pages 312-314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2105]
Mouse Embryo Assay for Assisted Reproduction Technology 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 ``Mouse Embryo Assay for
Assisted Reproduction Technology Devices.'' This guidance document
provides recommendations on conducting the mouse embryo assay to
support premarket submissions and lot release of assisted reproduction
technology devices.
DATES: The announcement of the guidance is published in the Federal
Register on January 5, 2021.
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.''
[[Page 313]]
Instructions: All submissions received must include the Docket No.
FDA-2019-D-2105 for ``Mouse Embryo Assay for Assisted Reproduction
Technology 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, 240-
402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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
``Mouse Embryo Assay for Assisted Reproduction Technology Devices'' to
the Office of Policy, 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: Pei-Hsuan (Chris) Hung, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2647, Silver Spring, MD 20993-0002,
240-402-5928.
SUPPLEMENTARY INFORMATION:
I. Background
The majority of assisted reproduction technology (ART) devices
directly or indirectly contact gametes and/or embryos during use. The
mouse embryo assay (MEA) is used to assess the potential for
embryotoxicity of devices that contact gametes and/or embryos. Several
classification regulations under part 884 (21 CFR part 884) include
special controls that require MEA testing or information. MEA may also
be used by sponsors to support premarket submissions for other devices
that are intended to contact gametes and/or embryos during their use.
However, there are no voluntary consensus standards that describe how
to conduct the MEA. This guidance provides recommendations for
conducting the MEA to support premarket submissions and lot release for
ART devices that are intended to contact gametes and/or embryos and to
comply with the special controls for those devices classified under
part 884 that require MEA testing or information.
A notice of availability of the draft guidance appeared in the
Federal Register of June 13, 2019 (84 FR 27637). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including minor technical edits and clarifications.
Specifically, the final guidance includes revisions to recommend that
liquid-based test articles should be prepared per the instructions for
use; clarify FDA's recommended exposure time for test articles
depending on their clinical use duration; include additional
specificity on the number of embryos that should be used; discuss how
accelerated aging can also be used to develop test articles at the end
of the proposed shelf-life; and when procedural modifications or
options should be justified in the test report. In addition, FDA made
editorial changes to the guidance for clarity.
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 ``Mouse Embryo Assay for Assisted
Reproduction Technology 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.
II. 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 Center for Devices and Radiological Health 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 and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Mouse Embryo Assay for Assisted
Reproduction Technology Devices'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 16015 and complete title to identify the
guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations have been approved by
OMB as listed in the following table:
[[Page 314]]
------------------------------------------------------------------------
OMB control
21 CFR part Topic No.
------------------------------------------------------------------------
807, subpart E.................... Premarket 0910-0120
Notification.
800, 801, and 809................. Medical Device 0910-0485
Labeling
Regulations.
------------------------------------------------------------------------
Dated: December 28, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29081 Filed 1-4-21; 8:45 am]
BILLING CODE 4164-01-P
