Unique Device Identification System: Form and Content of the Unique Device Identifier; Guidance for Industry and Food and Drug Administration Staff; Availability, 35802-35803 [2021-14462]
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35802
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
Authority: 22 U.S.C. 7105(b).
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’’).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–14448 Filed 7–6–21; 8:45 am]
BILLING CODE 4184–47–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1853]
Unique Device Identification System:
Form and Content of the Unique
Device Identifier; 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, Agency, or we) is
announcing the availability of a final
guidance entitled ‘‘Unique Device
Identification System: Form and
Content of the Unique Device Identifier
(UDI).’’ This document describes the
requirements for, and FDA’s
recommendations regarding, the form
and content of the UDI to help ensure
that the UDIs developed under systems
for the issuance of UDIs meet the
objectives of the Unique Device
Identification System Final Rule.
DATES: The announcement of the
guidance is published in the Federal
Register on July 7, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD 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
VerDate Sep<11>2014
17:44 Jul 06, 2021
Jkt 253001
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–
2016–D–1853 for ‘‘Unique Device
Identification System: Form and
Content of the Unique Device Identifier
(UDI).’’ 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 00074
Fmt 4703
Sfmt 4703
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 guidance
document entitled ‘‘Unique Device
Identification System: Form and
Content of the Unique Device Identifier
(UDI)’’ 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:
Christopher Diamant, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3210, Silver Spring,
MD 20993–0002, 301–796–5995 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
This document is intended to assist
labelers, as defined in 21 CFR 801.3,
and FDA-accredited issuing agencies, as
defined in 21 CFR 830.3, in complying
with UDI labeling requirements,
including by clarifying FDA’s
interpretation of certain requirements
under 21 CFR 801.40. Specifically, this
guidance describes the requirements for,
and FDA’s recommendations regarding,
the form and content of the UDI to help
ensure that the UDIs developed under
systems for the issuance of UDIs meet
the objectives of the Unique Device
Identification System Final Rule, 78 FR
E:\FR\FM\07JYN1.SGM
07JYN1
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
58786 (September 24, 2013). In this
guidance, we describe the two forms of
a UDI, clarify the content of the UDI,
and address the use of data delimiters
that identify specific data elements
within the UDI. The guidance also
addresses the recommended order of the
data in the easily readable plain text
form of a UDI carrier. This guidance
does not apply to universal product
codes.
A notice of availability of the draft
guidance appeared in the Federal
Register of July 26, 2016 (81 FR 48814).
FDA considered the comments received
and revised the guidance as appropriate
in response to the comments.
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 ‘‘Unique Device
Identification System: Form and
Content of the Unique Device Identifier
(UDI).’’ It does not establish any rights
for any person and is not binding on
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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances. Persons unable to
download an electronic copy of
‘‘Unique Device Identification System:
Form and Content of the Unique Device
Identifier (UDI)’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1500035 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:
OMB Control
No.
21 CFR part
Topic
801 subpart B and 830 ...............................................................
Unique Device Identification .......................................................
Dated: July 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14462 Filed 7–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–2223]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BARHEMSYS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BARHEMSYS and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
VerDate Sep<11>2014
17:44 Jul 06, 2021
Jkt 253001
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by September 7, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
January 3, 2022. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 7,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 7, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
35803
0910–0720
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
Submission’’ 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
E:\FR\FM\07JYN1.SGM
07JYN1
Agencies
[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35802-35803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14462]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1853]
Unique Device Identification System: Form and Content of the
Unique Device Identifier; 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, Agency, or we) is
announcing the availability of a final guidance entitled ``Unique
Device Identification System: Form and Content of the Unique Device
Identifier (UDI).'' This document describes the requirements for, and
FDA's recommendations regarding, the form and content of the UDI to
help ensure that the UDIs developed under systems for the issuance of
UDIs meet the objectives of the Unique Device Identification System
Final Rule.
DATES: The announcement of the guidance is published in the Federal
Register on July 7, 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.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-1853 for ``Unique Device Identification System: Form and
Content of the Unique Device Identifier (UDI).'' 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
``Unique Device Identification System: Form and Content of the Unique
Device Identifier (UDI)'' 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: Christopher Diamant, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 3210, Silver Spring, MD 20993-0002,
301-796-5995 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
This document is intended to assist labelers, as defined in 21 CFR
801.3, and FDA-accredited issuing agencies, as defined in 21 CFR 830.3,
in complying with UDI labeling requirements, including by clarifying
FDA's interpretation of certain requirements under 21 CFR 801.40.
Specifically, this guidance describes the requirements for, and FDA's
recommendations regarding, the form and content of the UDI to help
ensure that the UDIs developed under systems for the issuance of UDIs
meet the objectives of the Unique Device Identification System Final
Rule, 78 FR
[[Page 35803]]
58786 (September 24, 2013). In this guidance, we describe the two forms
of a UDI, clarify the content of the UDI, and address the use of data
delimiters that identify specific data elements within the UDI. The
guidance also addresses the recommended order of the data in the easily
readable plain text form of a UDI carrier. This guidance does not apply
to universal product codes.
A notice of availability of the draft guidance appeared in the
Federal Register of July 26, 2016 (81 FR 48814). FDA considered the
comments received and revised the guidance as appropriate in response
to the comments.
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 ``Unique Device Identification System: Form
and Content of the Unique Device Identifier (UDI).'' 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download
an electronic copy of ``Unique Device Identification System: Form and
Content of the Unique Device Identifier (UDI)'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 1500035 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:
------------------------------------------------------------------------
OMB Control
21 CFR part Topic No.
------------------------------------------------------------------------
801 subpart B and 830............. Unique Device 0910-0720
Identification.
------------------------------------------------------------------------
Dated: July 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14462 Filed 7-6-21; 8:45 am]
BILLING CODE 4164-01-P