Notice2022-02600
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment Registration and Device Listing for Manufacturers and Importers of Devices
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Published
February 8, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 establishment registration and device listing for manufacturers and importers of devices.
Full Text
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<title>Federal Register, Volume 87 Issue 26 (Tuesday, February 8, 2022)</title>
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[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7187-7190]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02600]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3815]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishment Registration and Device Listing for
Manufacturers and Importers of Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 establishment registration and device listing for
manufacturers and importers of devices.
DATES: Submit either electronic or written comments on the collection
of information by April 11, 2022.
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 April 11, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 11, 2022. 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.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
[[Page 7188]]
Comments submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2015-N-3815 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Establishment Registration and
Device Listing for Manufacturers and Importers of Devices.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St, North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#83d3d1c2d0f7e2e5e5c3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="e1b1b3a0b295808787a1878580cf898992cf868e97">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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.
Establishment Registration and Device Listing for Manufacturers and
Importers of Devices--21 CFR Part 807, Subparts A Through D
OMB Control Number 0910-0625--Extension
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part
807, subparts A through D), medical device establishment owners and
operators are required to electronically submit establishment
registration and device listing information.
Complete and accurate registration and listing information is
necessary to accomplish a number of statutory and regulatory
objectives, such as: (1) Identification of establishments producing
marketed medical devices, (2) identification of establishments
producing a specific device when that device is in short supply or is
needed for national emergency, (3) facilitation of recalls for devices
marketed by owners and operators of device establishments, (4)
identification and cataloging of marketed devices, (5) administering
postmarketing surveillance programs for devices, (6) identification of
devices marketed in violation of the law, (7) identification and
control of devices imported into the country from foreign
establishments, and (8) scheduling and planning inspections of
registered establishments under section 704 of the FD&C Act (21 U.S.C.
374).
Respondents to this information collection are owners or operators
of establishments that engage in the manufacturing, preparation,
propagation, compounding, or processing of a device or devices, who
must register their establishments and submit listing information for
each of their devices in commercial distribution. Notwithstanding
certain
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exceptions, foreign device establishments that manufacture, prepare,
propagate, compound, or process a device that is imported or offered
for import into the United States must also comply with the
registration and listing requirements. The number of respondents is
based on data from the FDA Unified Registration and Listing System
(FURLS). Burden estimates are based on recent experience with the
medical device registration and listing program, electronic system
operating experience, and previous data estimates.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response \2\
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807.20(a)(5) \3\ Initial 4,125 1 4,125 1.75 7,219
submittal of manufacturer
information by initial
importers......................
807.20(a)(5) \4\ Annual 4,125 1 4,125 0.1 413
submittal of manufacturer
information by initial
importers......................
807.21(a) \3\ Creation of 5,355 1 5,355 0.5 2,678
electronic system account......
807.21(b) \4\ Annual request for 1 1 1 1 1
waiver from electronic
registration & listing.........
807.21(b) \3\ Initial request 1 1 1 1 1
for waiver from electronic
registration & listing.........
807.22(a) \3\ Initial 5,355 1 5,355 1 5,355
registration & listing.........
807.22(b)(1) \4\ Annual 28,496 1 28,496 0.5 14,248
registration...................
807.22(b)(2) \4\ Other updates 2,671 1 2,671 0.5 1,336
of registration................
807.22(b)(3) \4\ Annual update 26,871 1 26,871 0.5 13,436
of listing information.........
807.22(b)(4) Changes to listing
information (outside of annual
listing requirement period)
Voluntary reporting of 4,080 1 4,080 0.25 1,020
transfer of 510(k)
clearance (outside of
annual listing requirement
period)....................
Submission of 510(k) 2,033 1 2,033 4 8,132
transfer documentation when
more than one party lists
the same 510(k)............
807.26(e) \4\ Labeling & 9 1 9 1 9
advertisement submitted at FDA
request........................
807.34(a) \3\ Initial 1 1 1 1 1
registration & listing when
electronic filing waiver
granted........................
807.34(a) \4\ Annual 1 1 1 1 1
registration & listing when
electronic filing waiver
granted........................
807.40(b)(3) \4\ Annual update 6,101 1 6,101 0.5 3,051
of U.S. agent information......
807.40(b)(2) \4\ U.S. agent 1,535 1 1,535 0.25 384
responses to FDA requests for
information....................
807.41(a) \4\ Identification by 14,017 1 14,017 0.5 7,009
foreign establishments of
importers, defined in 21 CFR
807.3, of the establishment's
devices........................
807.41(b) \4\ Identification of 14,017 1 14,017 0.5 7,009
other importers (defined in 21
CFR 807.3(x) and (y)) that
facilitate import by foreign
establishments.................
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Total one-time burden....... .............. .............. .............. .............. ..............
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Total recurring burden.. .............. .............. .............. .............. ..............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals are rounded to the nearest whole number.
\3\ One-Time Burden--Firm only provides initially.
\4\ Recurring Burden--Firm is required to review annually.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents recordkeeper records record
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807.25(d) \2\ Labeling & 17,032 4 68,128 .5 34,064
advertisements available for
review.........................
807.26 \2\ List of officers, 33,851 1 33,851 .25 8,463
directors & partners...........
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Total....................... .............. .............. .............. .............. 42,527
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Recurring burden--Firm is required to keep records.
The estimates for creation of new user accounts under Sec.
807.21(a) are based on the recent number of owners or operators. An
owner or operator only creates an account one time when they register
for the first time (initial registration). Once the account is created,
the owner or operator uses the account as long as the establishment is
[[Page 7190]]
registered. If an owner or operator changes, the new owner or operator
creates a new owner or operator account and transfers the ownership of
the establishment to their owner or operator account. Once they create
an owner or operator account, they use the account for as long as the
company is registered. Under Sec. 807.22(b)(4), changes to listing
information may be made at times outside of the annual listing
requirement period, such as when a change is made to a previously
listed device.
The draft guidance document entitled ``Transfer of a Premarket
Notification (510(k)) Clearance--Questions and Answers'' (December
2014), which contained instructions for the proposed voluntary
information collection, has recently been withdrawn. While notification
of transfer of ownership information is not currently required, our
medical device registration and listing website \1\ communicates
procedures for notifying FDA of the transfer of a premarket
notification (510(k)) clearance from one person to another. The
notification is used to ensure public information in FDA's databases
about the current 510(k) holder for a specific device(s) is accurate
and up to date. Although submission of information regarding the
transfer of a 510(k) clearance is not required under the regulations,
we regularly receive such notifications from respondents.
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\1\ <a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing">https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing</a>.
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FDA estimates that annually 78 percent of 510(k)s may be initially
listed or updated outside of the annual registration requirement (about
4,080 510(k)s per year). FDA estimates that it will take approximately
15 minutes for each listing, for a total reporting burden of 1,020
hours.
FDA estimates it will have 2,033 instances of more than one party
claiming to be a 510(k) holder for a specific device as part of annual
registration and listing. FDA reached this estimate by identifying the
average number of unique 510(k) device listings entered in FURLS
between fiscal years 2017 and 2019 that conflict with a listing already
entered by another party (5,304), dividing that number by the number of
years (3) and multiplying by the average number of parties claiming to
be the 510(k) holder when there is a conflict in the current FURLS
database (2.3), then dividing the result by 2 (because only one company
per listing will submit the appropriate documentation to show that they
are the current 510(k) holder).
The registration and listing website identifies potential
documentation a party could submit to FDA to establish the transfer of
a 510(k) clearance to a new owner or operator. Based on the amount of
time to locate the information, copy it, and submit a copy, FDA
estimates it will take respondents approximately 4 hours to establish
the transfer of a 510(k) clearance.
The estimate for Sec. 807.25(d) in table 2 of this document
(recordkeeping burden) reflects the requirement that owners or
operators maintain a historical file containing the labeling and
advertisements in use. The estimate for Sec. 807.26 reflects the
requirement that owners or operators keep a list of officers,
directors, and partners for each establishment. Owners or operators
will need to provide this information only when requested by FDA.
However, it is assumed that some effort will need to be expended to
keep such records current.
The recurring burden for the data collection under Sec. 807.41
(import-related information provided by foreign companies exporting to
the United States) was estimated based on data from previous years.
Foreign companies identify one importer and one person who imports or
offers for import with readily available contact information at the
time of registration. After completing their initial registration, they
are required to review the importer information annually. When they
review the importer information annually, they simply verify the
importer information is accurate. If it is and no changes are needed,
the foreign establishment's official correspondent checks the
certification and submits the annual registration. If they need to make
changes to the importer information, they can do so at any time and use
a spreadsheet to update more than one importer at a time to their
registration. The use of the spreadsheet reduces the burden to the
official correspondent of the foreign establishment.
Our estimated burden for the information collection reflects an
overall increase of 10,880 hours and a corresponding increase of 28,430
responses/records. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.
Additionally, we have included non-substantive changes, incorporating
the burden previously approved under OMB control number 0910-0852 into
OMB control number 0910-0625, as approved by OMB in May 2021.
Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02600 Filed 2-7-22; 8:45 am]
BILLING CODE 4164-01-P
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