[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7187-7190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

[[Page 7188]]

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-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 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.

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, 
[email protected].

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

[[Page 7189]]

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\ https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
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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