[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62583-62585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26303]


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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; Electronic Submission of Medical Device Registration 
and Listing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 
electronic submission of medical device registration and listing.

DATES: Submit either electronic or written comments on the collection 
of information by February 4, 2019.

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 February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 4, 2019. 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. 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; Electronic Submission of Medical 
Device Registration and Listing.'' 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.
     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

[[Page 62584]]

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.gpo.gov/fdsys/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.

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. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this 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.

Electronic Submission of Medical Device Registration and Listing--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 cataloguing 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, (8) and 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 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.
    Burden estimates are based on recent experience with the existing 
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                        FDA form No.      Number of    frequency  per   Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
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807.20(a)(5) \2\--Submittal of Manufacturer Information             3673           5,736               1           5,736            1.75          10,038
 by Initial Importers...................................
807.20(a)(5) \3\--Submittal of Manufacturer Information             3673           5,736               1           5,736             0.1             574
 by Initial Importers...................................
807.21(a) \2\--Creation of Electronic System Account....            3673           2,937               1           2,937             0.5           1,469
807.21(b) \3\--Annual Request for Waiver from Electronic  ..............               1               1               1               1               1
 Registration and Listing...............................
807.21(b) \2\--Initial Request for Waiver from            ..............               1               1               1               1               1
 Electronic Registration and Listing for................
807.22(a) \2\--Initial Registration and Listing.........            3673           3,467               1           3,467               1           3,467
807.22(b)(1) \3\--Annual Registration...................            3673          23,403               1          23,403             0.5          11,702

[[Page 62585]]

 
807.22(b)(2) \3\--Other Updates of Registration.........            3673           2,687               1           2,687             0.5           1,344
807.22(b)(3) \3\--Annual Update of Listing Information..            3673          22,607               1          22,607             0.5          11,304
807.26(e) \3\--Labeling and Advertisement Submitted at    ..............              71               1              71               1              71
 FDA Request............................................
807.34(a) \2\--Initial Registration and Listing when      ..............               1               1               1               1               1
 Electronic Filing Waiver Granted.......................
807.34(a) \3\--Annual Registration and Listing when       ..............               1               1               1               1               1
 Electronic Filing Waiver Granted.......................
807.40(b)(2) \3\--Annual Update of US Agent Information.            3673           1,615               1           1,615             0.5             808
807.40(b)(3) \3\--US Agent Responses to FDA Requests for            3673           1,535               1           1,535            0.25             384
 Information............................................
807.41(a) \3\--Identification of Initial Importers by               3673          12,983               1          12,983             0.5           6,492
 Foreign Establishments.................................
807.41(b) \3\--Identification of Other Parties that                 3673          12,983               1          12,983             0.5           6,492
 Facilitate Import by Foreign Establishments............
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    Total One Time Burden...............................  ..............  ..............  ..............  ..............  ..............          14,975
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        Total Recurring Burden..........................  ..............  ..............  ..............  ..............  ..............          39,173
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\1\ Totals are rounded to the nearest whole number.
\2\ One-Time Burden--Firm only provides initially.
\3\ 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\--List of Officers,          22,338               1          22,338             .25           5,585
 Directors, and Partners........                                                    (15 minutes)
807.26 \2\--Labeling and                  17,032               4          68,128              .5          34,064
 Advertisements Available for                                                       (30 minutes)
 Review.........................
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    Total.......................  ..............  ..............  ..............  ..............          39,649
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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 following adjustments and program changes resulted in a 5,672-
hour decrease to the overall total hour burden estimate for this 
information collection request.
     We adjusted the number of respondents based on updated 
registration and listing data.
     In the reporting burden table, we corrected the table 
footnotes to accurately indicate whether the information collection 
(IC) is a one-time or reoccurring burden.
     We also adjusted some of the IC descriptions in the table 
for increased clarity.
     We updated our estimate of Hours per Response for 
``807.22(a) Initial Registration and Listing'' (+ 0.5 hours), 
``807.22(b)(1) Annual Registration'' (- 0.25 hours), and ``807.22(b)(3) 
Annual Update of Listing Information'' (- 0.25 hours). Based on our 
review of the program, we believe these changes to the burden estimate 
will more accurately reflect the current preparation time for these 
ICs.

    Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26303 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P