[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63768-63770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22340]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1853]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Unique Device Identification System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with the Unique Device Identification System.
DATES: Submit either electronic or written comments on the collection
of information by November 15, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Unique Device Identification
System.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this
[[Page 63769]]
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Unique Device Identification System--21 CFR Parts 16, 801, 803, 806,
810, 814, 820, 821, 822 and 830--OMB Control Number 0910-0720--
Extension
In accordance with the collection of information entitled ``Unique
Device Identification System (UDI),'' medical device labelers, unless
excepted, are required to design and use medical device labels and
device packages that bear a UDI, present dates on labels in a
particular format, and submit data concerning each version or model of
a device to the Global Unique Device Identification Database (GUDID) no
later than the date the label of the device must bear a UDI. Once a
device becomes subject to UDI requirements, respondents will be
required to update the information reported whenever the information
changes.
The recordkeeping, reporting, and third-party disclosure
requirements referenced in this document are imposed on any person who
causes a label to be applied to a device, or who causes the label to be
modified, with the intent that the device will be commercially
distributed without any subsequent replacement or modification of the
label. In most instances, the labeler would be the device manufacturer,
but other types of labelers include a specification developer, a
single-use device reprocessor, a convenience kit assembler, a
repackager, or a relabeler. Respondents may also include any private
organization that applies for accreditation by FDA as an issuing
agency.
FDA has identified the following requirements as having burdens
that must be accounted for under the PRA; the burdens associated with
these requirements are summarized in the table that follows:
Section 801.18 requires that whenever a labeler of a medical device
includes an expiration date, a date of manufacture, or any other date
intended to be brought to the attention of the user of the device, the
labeler must present the date on the label in a format that meets the
requirements of this section.
Section 801.20 requires every medical device label and package to
bear a UDI.
Under Sec. 801.35, any labeler of a device that is not required to
bear a UDI on its label may include a UDI on the label of that device
and utilize the GUDID.
Under Sec. 801.45, any device that has to be labeled with a UDI
also has to bear a permanent marking providing the UDI on the device
itself if the device is intended for more than one use and intended to
be reprocessed before each use.
Section 801.50 requires stand-alone software to comply with
specific labeling requirements that identify the software.
Section 801.55 authorizes additional, case-by-case, labeling
exceptions and alternatives to standard UDI labeling requirements.
If a labeler relabels or modifies a label of a device that is
required to bear a UDI, under Sec. 830.60 it has to keep a record
showing the relationship of the original device identifier to the new
device identifier.
Section 830.110 requires an applicant seeking initial FDA
accreditation as a UDI-issuing agency to furnish FDA an application
containing certain information, materials, and supporting
documentation.
Under Sec. 830.120, an FDA-accredited issuing agency is required
to disclose information concerning its system for the assignment of
UDIs; maintain a list of labelers that use its system for the
assignment of UDIs, and provide FDA a copy of such list; and upon
request, provide FDA with information concerning a labeler that is
employing the issuing agency's system for assignment of UDIs.
Sections 830.310 and 830.320 require the labeler to provide certain
information to the GUDID concerning the labeler and each version or
model of a device required to be labeled with a UDI, unless the labeler
obtains a waiver.
Section 830.360 requires each labeler to retain records showing all
UDIs used to identify devices that must be labeled with a UDI and the
particular version or model associated with each device identifier,
until 3 years after it ceases to market a version or model of a device.
Respondents who are required to submit data to the Agency under
certain other approved information collections (listed below) are
required to include UDI data elements for the device that is the
subject of such information collection. Addition of the UDI data
elements is included in this burden estimate for the conforming
amendments in the following 21 CFR parts:
Part 803--Medical Device Reporting (OMB control number 0910-
0437)
Part 806--Medical Devices; Reports of Corrections and Removals
(OMB control number 0910-0359)
Part 814--Premarket Approval of Medical Devices (OMB control
number 0910-0231)
Part 820--Quality System Regulation (OMB control number 0910-
0073)
Part 821--Medical Device Tracking Requirements (OMB control
number 0910-0442)
Part 822--Postmarket Surveillance (OMB control number 0910-
0449)
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Burden \1\
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Number of Number of Average burden
respondents responses per Total annual per response (in Total hours
\2\ respondent \3\ responses \4\ hours) \5\ \6\
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Reporting..................... 6,199 51 316,149 0.023 [1 minute] 7,271
Recordkeeping................. 5,987 51 305,337 0.989 [59 301,978
minutes].
Third-Party Disclosure........ 5,987 51 305,337 0.885 [53 270,223
minutes].
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory
requirements within the category may involve fewer respondents.
\3\ Maximum No. of Responses for any regulatory requirement within each category. Individual regulatory
requirements within the category may involve fewer responses.
[[Page 63770]]
\4\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory
requirements within the category may involve fewer total annual responses.
\5\ Rounded to three decimals. Total Hours reflects a more precise, non-rounded Average Burden per Response. An
approximate (non-rounded) conversion to minutes is shown in square brackets.
\6\ Total Hours is based on a more precise Burden per Response than the rounded value shown in this table.
Dated: September 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22340 Filed 9-15-16; 8:45 am]
BILLING CODE 4164-01-P