Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period, 6875-6877 [2022-02472]
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<![CDATA[
6875
Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
25.40(a) and (c) ...................................................................
9
1
9
2,160
19,440
Total ..............................................................................
........................
........................
........................
........................
22,860
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VI. Estimated Annual Reporting Burden
for Tobacco Products
Under sections 905, 910, and 911 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 387e, 387j, and 387k),
product applications and supplements,
premarket tobacco applications
(PMTAs), substantial equivalences
(SEs), exemption from SEs, and
modified risk tobacco product
applications (MRTPAs) must contain a
claim for categorical exclusion or an EA.
The majority of the EA burden for
tobacco products is covered under
already existing information collections.
The burden for SEs is currently
approved under OMB control number
0910–0673; the burden for PMTAs are
currently approved under OMB control
number 0910–0768; and the burden for
SE exemptions are currently approved
under OMB control number 0910–0684.
FDA’s estimates are based on actual
report data from fiscal year (FY) 2018 to
FY 2020. On average, FDA estimated it
received approximately 14 MRTPAs
from 14 respondents. Based on updated
data for this collection, FDA estimates
14 EAs from 14 respondents. A total of
14 respondents will submit an average
of 1 application for environmental
assessment. Based on FDA’s experience,
previous information provided by
potential sponsors and knowledge that
part of the EA information has already
been produced in one of the tobacco
product applications, FDA estimates
that it takes approximately 80 hours to
prepare an EA. Based on recent MRTPA
numbers, we now estimate a total of 14
annual responses and 1,120 hours for
Tobacco Products (a decrease of 13
responses and 1,040 hours).
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.40(a) and (c) ...................................................................
14
1
14
80
1,120
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval, we have
adjusted our burden estimate. We
estimate the total burden for this
information collection to be 30,315
annual responses, and 314,736 hours.
These estimates reflect an overall
increase of 13,463 responses and 94,078
hours. We attribute the adjustments to
expected fluctuations in the number of
responses the various centers in FDA
have received over the last few years.
Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02475 Filed 2–4–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0053]
Notifying the Food and Drug
Administration of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the Federal Food,
Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability that appeared in
the Federal Register of January 11,
2022. In the notice of availability, FDA
requested comments on draft guidance
for industry and FDA staff entitled
‘‘Notifying the Food and Drug
Administration of a Permanent
Discontinuance or Interruption in
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
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17:36 Feb 04, 2022
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Manufacturing of a Device Under
Section 506J of the Federal Food, Drug,
and Cosmetic Act.’’ The Agency is
taking this action in response to a
request for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the document published
January 11, 2022 (87 FR 1417). Submit
either electronic or written comments
on the draft guidance by April 11, 2022,
to ensure that the Agency considers
your comment on this draft guidance
before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
E:\FR\FM\07FEN1.SGM
07FEN1
6876
Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES1
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–
2022–D–0053 for ‘‘Notifying the Food
and Drug Administration of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the
Federal Food, Drug, and Cosmetic Act.’’
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
VerDate Sep<11>2014
17:36 Feb 04, 2022
Jkt 256001
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
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Notifying the Food
and Drug Administration of a
Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the
Federal Food, Drug, and Cosmetic Act’’
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 or the
Center for Biologics Evaluation and
Research, Office of Communication,
Outreach, and Development, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Brittany Caldwell, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5556, Silver Spring,
MD 20993–0002, 301–796–5900 or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 11,
2022, FDA published a notice of
availability with a 60-day comment
period to request comments on draft
guidance for industry and FDA staff
entitled ‘‘Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the Federal Food, Drug,
and Cosmetic Act.’’
The Agency has received a request for
an extension of the comment period.
The request conveyed concern that the
current 60-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response.
FDA has considered the request and
is extending the comment period for the
notice of availability for 30 days, until
April 11, 2022. The Agency believes
that a 30-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying guidance on these important
issues.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the Federal Food, Drug,
and Cosmetic Act.’’ 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 draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft
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 ‘‘Notifying FDA of
a Permanent Discontinuance or
Interruption in Manufacturing of a
Device Under Section 506J of the
Federal Food, Drug, and Cosmetic Act’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
E:\FR\FM\07FEN1.SGM
07FEN1
Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
use the document number 21003 and
complete title to identify the guidance
you are requesting.
Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02472 Filed 2–4–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0080]
Formal Meetings Between the Food
and Drug Administration and Sponsors
or Requestors of Over-the-Counter
Monograph Drugs; Draft 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 draft
guidance for industry entitled ‘‘Formal
Meetings Between FDA and Sponsors or
Requestors of Over-the-Counter
Monograph Drugs.’’ This draft guidance
provides recommendations to industry
on formal meetings between FDA and
sponsors or requestors of over-thecounter (OTC) monograph drugs.
DATES: Submit either electronic or
written comments on the draft guidance
by April 8, 2022 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:
jspears on DSK121TN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:36 Feb 04, 2022
Jkt 256001
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–
2022–D–0080 for ‘‘Formal Meetings
Between FDA and Sponsors or
Requestors of Over-the-Counter
Monograph Drugs.’’ 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
PO 00000
Frm 00039
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6877
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.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research (HFD–600), Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–402–7945.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Formal Meetings Between FDA and
Sponsors or Requestors of Over-theCounter Monograph Drugs.’’ This draft
guidance provides recommendations to
industry on formal meetings between
FDA and sponsors or requestors of
nonprescription drugs without
approved new drug applications that are
governed by section 505G of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355h) (hereafter referred
to as OTC monograph drugs).
Section 505G of the FD&C Act was
added by the Coronavirus Aid, Relief,
and Economic Security Act (CARES
Act) (Pub. L. 116–136), which was
enacted on March 27, 2020. As required
by section 505G(l) of the FD&C Act, this
draft guidance, when finalized, will
discuss the procedures and principles
for formal meetings between FDA and
sponsors or requestors for an OTC
monograph drug (hereafter referred to
collectively as meeting requesters). In
doing so, and as required by section
505G(h) of the FD&C Act, this draft
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6875-6877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0053]
Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
appeared in the Federal Register of January 11, 2022. In the notice of
availability, FDA requested comments on draft guidance for industry and
FDA staff entitled ``Notifying the Food and Drug Administration of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act.'' The
Agency is taking this action in response to a request for an extension
to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the document published
January 11, 2022 (87 FR 1417). Submit either electronic or written
comments on the draft guidance by April 11, 2022, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any
[[Page 6876]]
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-2022-D-0053 for ``Notifying the Food and Drug Administration of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act.''
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 draft guidance document entitled
``Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act'' 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 or the Center for Biologics Evaluation and
Research, Office of Communication, Outreach, and Development, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993. Send one
self-addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: Brittany Caldwell, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5556, Silver Spring, MD 20993-0002, 301-
796-5900 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 11, 2022, FDA published a notice
of availability with a 60-day comment period to request comments on
draft guidance for industry and FDA staff entitled ``Notifying FDA of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act.''
The Agency has received a request for an extension of the comment
period. The request conveyed concern that the current 60-day comment
period does not allow sufficient time to develop a meaningful or
thoughtful response.
FDA has considered the request and is extending the comment period
for the notice of availability for 30 days, until April 11, 2022. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Notifying
FDA of a Permanent Discontinuance or Interruption in Manufacturing of a
Device Under Section 506J of the Federal Food, Drug, and Cosmetic
Act.'' 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 draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft 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 ``Notifying FDA of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please
[[Page 6877]]
use the document number 21003 and complete title to identify the
guidance you are requesting.
Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02472 Filed 2-4-22; 8:45 am]
BILLING CODE 4164-01-P
