Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment Registration and Device Listing for Manufacturers and Importers of Devices, 7187-7190 [2022-02600]
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Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices
operational improvements associated
with PDUFA implementation. The
commitment goals provide for the
development and issuance of topicspecific guidance. We maintain a
searchable guidance database on our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents. In publishing the
respective notices of availability for
each guidance document, we include an
analysis under the PRA and invite
public comment on the associated
information collection
recommendations. In addition, all
Agency guidance documents are issued
in accordance with our good guidance
practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
In the Federal Register of November
30, 2021 (86 FR 67958), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Prescription drug user fee activity
Total
annual
responses
Average
burden per
response
Total hours
Sections 735 and 736 of the FD&C Act (PDUFA waivers,
not including small business waivers) ..............................
Section 736(d)(1)(C) of the FD&C Act and Form FDA
3971 (small business waivers) .........................................
Reconsideration Requests ...................................................
Appeal Requests ..................................................................
User Fee Cover Sheet Form FDA 3397 ..............................
112
1.68
189
17
3,213
37
6
1
174
1
1.67
1
1
37
10
1
174
2
24
12
0.5 (30
minutes)
74
240
12
87
Total ..............................................................................
........................
........................
411
........................
3626
1 There
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Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency records,
we estimate that the number of initial
waiver requests submitted annually
(excluding small business waiver
requests under section 736(d)(1)(C)) of
the FD&C Act) will be 189, submitted by
112 different applicants; and that 37
respondents annually will each submit
a small business waiver request. We
have included in the burden estimate
the time for preparation and submission
of application fee waivers for small
businesses, including completion of
Form FDA 3971. Small businesses
requesting a waiver must submit
documentation to FDA, including the
number of their employees, as well as
information that the application is the
first human drug application, within the
meaning of the FD&C Act, to be
submitted to the Agency for approval.
We estimate receiving 10 requests for
reconsideration annually (including
small business waiver reconsiderations)
and assume the average burden for
preparing and submitting each request
is 24 hours. In addition, we estimate
receiving 1 request annually for appeal
of user fee waiver determination, and
assume the time needed to prepare an
appeal is 12 hours. We have included in
this estimate both the time needed to
prepare the request for appeal to the
Chief Scientist and User Fee Appeals
Officer within the Office of the
Commissioner, and the time needed to
create and send a copy of the request for
an appeal to the Director Division of
User Fee Management within the Office
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of Management at FDA’s Center for Drug
Evaluation and Research.
We assume 87 hours of burden for
completing and submitting Form FDA
3397 (Prescription Drug User Fee
Coversheet) for submission of a new
drug application or biologics license
application.
The information collection reflects an
overall increase since our last request
for OMB review and approval. We
attribute this to expected fluctuations in
submissions to the Agency.
Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02617 Filed 2–7–22; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
SUMMARY:
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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.
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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
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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-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.
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, PRAStaff@
fda.hhs.gov.
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
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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
Annual
frequency per
response
Number of
respondents
21 CFR section
807.20(a)(5) 3 Initial submittal of manufacturer information
by initial importers ............................................................
807.20(a)(5) 4 Annual submittal of manufacturer information by initial importers .....................................................
807.21(a) 3 Creation of electronic system account ..............
807.21(b) 4 Annual request for waiver from electronic registration & listing ...............................................................
807.21(b) 3 Initial request for waiver from electronic registration & listing ...............................................................
807.22(a) 3 Initial registration & listing .................................
807.22(b)(1) 4 Annual registration ........................................
807.22(b)(2) 4 Other updates of registration ........................
807.22(b)(3) 4 Annual update of listing information .............
807.22(b)(4) Changes to listing information (outside of annual listing requirement period)
Voluntary reporting of transfer of 510(k) clearance
(outside of annual listing requirement period) ..........
Submission of 510(k) transfer documentation when
more than one party lists the same 510(k) ...............
807.26(e) 4 Labeling & advertisement submitted at FDA request .................................................................................
807.34(a) 3 Initial registration & listing when electronic filing waiver granted ............................................................
807.34(a) 4 Annual registration & listing when electronic filing waiver granted ............................................................
807.40(b)(3) 4 Annual update of U.S. agent information .....
807.40(b)(2) 4 U.S. agent responses to FDA requests for
information ........................................................................
807.41(a) 4 Identification by foreign establishments of importers, defined in 21 CFR 807.3, of the establishment’s
devices .............................................................................
807.41(b) 4 Identification of other importers (defined in 21
CFR 807.3(x) and (y)) that facilitate import by foreign
establishments ..................................................................
Total annual
responses
Hours per
response
Total hours 2
4,125
1
4,125
1.75
7,219
4,125
5,355
1
1
4,125
5,355
0.1
0.5
413
2,678
1
1
1
1
1
1
5,355
28,496
2,671
26,871
1
1
1
1
1
1
5,355
28,496
2,671
26,871
1
1
0.5
0.5
0.5
1
5,355
14,248
1,336
13,436
4,080
1
4,080
0.25
1,020
2,033
1
2,033
4
8,132
9
1
9
1
9
1
1
1
1
1
1
6,101
1
1
1
6,101
1
0.5
1
3,051
1,535
1
1,535
0.25
384
14,017
1
14,017
0.5
7,009
14,017
1
14,017
0.5
7,009
Total one-time burden ..................................................
........................
........................
........................
........................
........................
Total recurring burden ...........................................
........................
........................
........................
........................
........................
Hours per
record
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
are rounded to the nearest whole number.
Burden—Firm only provides initially.
4 Recurring Burden—Firm is required to review annually.
2 Totals
3 One-Time
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
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21 CFR section
Annual
frequency
per
recordkeeper
Total annual
records
807.25(d) 2 Labeling & advertisements available for review
807.26 2 List of officers, directors & partners ......................
17,032
33,851
4
1
68,128
33,851
.5
.25
34,064
8,463
Total ..............................................................................
........................
........................
........................
........................
42,527
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 § 807.21(a) are based on
the recent number of owners or
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operators. An owner or operator only
creates an account one time when they
register for the first time (initial
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registration). Once the account is
created, the owner or operator uses the
account as long as the establishment is
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Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices
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 § 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.
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
1 https://www.fda.gov/medical-devices/howstudy-and-market-your-device/device-registrationand-listing.
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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 § 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 § 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 § 807.41 (importrelated 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.
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0294]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Contact
Substance Notification Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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: Submit written comments
(including recommendations) on the
collection of information by March 10,
2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0495. 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, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
Food Contact Substance Notification
Program—21 CFR 170.101, 170.106,
and 171.1
OMB Control Number 0910–0495—
Extension
This information collection supports
FDA regulations regarding Food Contact
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response \2\
----------------------------------------------------------------------------------------------------------------
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.................
-------------------------------------------------------------------------------
Total one-time burden....... .............. .............. .............. .............. ..............
-------------------------------------------------------------------------------
Total recurring burden.. .............. .............. .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents recordkeeper records record
----------------------------------------------------------------------------------------------------------------
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...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 42,527
----------------------------------------------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
---------------------------------------------------------------------------
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
