Notice2022-13522
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment Registration and Device Listing for Manufacturers and Importers of Devices
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 87 Issue 121 (Friday, June 24, 2022)</title>
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[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37859-37861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13522]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3815]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
25, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#3a5553485b65494f58575349495355547a555758145f554a145d554c"><span class="__cf_email__" data-cfemail="d6b9bfa4b789a5a3b4bbbfa5a5bfb9b896b9bbb4f8b3b9a6f8b1b9a0">[email protected]</span></a>. All
comments should be identified with the OMB control number 0910-0625.
Also include the FDA docket number found in brackets in the heading of
this document.
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#85d5d7c4d6f1e4e3e3c5e3e1e4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="df8f8d9e8cabbeb9b99fb9bbbef1b7b7acf1b8b0a9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 implementing regulations in 21 CFR part 807,
subparts A through D (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
[[Page 37860]]
submit listing information for each of their devices in commercial
distribution. Notwithstanding certain 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.
In the Federal Register of February 8, 2022 (87 FR 7187), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Annual
21 CFR section; activity Number of frequency per Total annual Hours per response Total hours
respondents response responses \2\
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807.20(a)(5); \3\ Initial submittal of 4,125 1 4,125 1.75................................... 7,219
manufacturer information by initial importers.
807.20(a)(5); \4\ Annual submittal of 4,125 1 4,125 0.1 (6 minutes)........................ 413
manufacturer information by initial importers.
807.21(a); \3\ Creation of electronic system 5,355 1 5,355 0.5 (30 minutes)....................... 2,678
account.
807.21(b); \4\ Annual request for waiver from 1 1 1 1...................................... 1
electronic registration & listing.
807.21(b); \3\ Initial request for waiver from 1 1 1 1...................................... 1
electronic registration & listing.
807.22(a); \3\ Initial registration & listing.. 5,355 1 5,355 1...................................... 5,355
807.22(b)(1); \4\ Annual registration.......... 28,496 1 28,496 0.5 (30 minutes)....................... 14,248
807.22(b)(2); \4\ Other updates of registration 2,671 1 2,671 0.5 (30 minutes)....................... 1,336
807.22(b)(3); \4\ Annual update of listing 26,871 1 26,871 0.5 (30 minutes)....................... 13,436
information.
807.22(b)(4) Changes to listing information
(outside of annual listing requirement
period):
Voluntary reporting of transfer of 510(k) 4,080 1 4,080 0.25 (15 minutes)...................... 1,020
clearance (outside of annual listing
requirement period).
Submission of 510(k) transfer documentation 2,033 1 2,033 4...................................... 8,132
when more than one party lists the same
510(k).
807.26(e); \4\ Labeling & advertisement 9 1 9 1...................................... 9
submitted at FDA request.
807.34(a); \3\ Initial registration & listing 1 1 1 1...................................... 1
when electronic filing waiver granted.
807.34(a); \4\ Annual registration & listing 1 1 1 1...................................... 1
when electronic filing waiver granted.
807.40(b)(3); \4\ Annual update of U.S. agent 6,101 1 6,101 0.5 (30 minutes)....................... 3,051
information.
807.40(b)(2); \4\ U.S. agent responses to FDA 1,535 1 1,535 0.25 (15 minutes)...................... 384
requests for information.
807.41(a); \4\ Identification by foreign 14,017 1 14,017 0.5 (30 minutes)....................... 7,009
establishments of importers, defined in 807.3,
of the establishment's devices.
807.41(b); \4\ Identification of other 14,017 1 14,017 0.5 (30 minutes)....................... 7,009
importers (defined in 807.3(x)-(y)) that
facilitate import by foreign establishments.
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Total.................................. .............. .............. .............. ....................................... 71,303
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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 record Total hours
respondents recordkeeper records
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807.25(d); \2\ Labeling and advertisements 17,032 4 68,128 0.5 (30 minutes)....................... 34,064
available for review.
807.26; \2\ List of officers, directors, and 33,851 1 33,851 .25 (15 minutes)....................... 8,463
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.
Our estimates for creating 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
[[Page 37861]]
registration). Once the account is created, the owner or operator uses
the account as long as the establishment is 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 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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We estimate 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). We assume it will take 15 minutes for each
listing, for a total reporting burden of 1,020 hours.
We estimate 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. We determined our 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, we assume
it takes respondents an average of 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 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 3 years.
Dated: June 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13522 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P
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