[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20138-20140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09412]


-----------------------------------------------------------------------

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; Electronic Submission 
of Medical Device Registration and Listing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 June 7, 
2019.

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 oira_submission@omb.eop.gov. 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, 
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.

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

[[Page 20139]]

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.
    In the Federal Register of December 4, 2018 (83 FR 62583), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Annual
                     21 CFR section                        FDA form No.      Number of     frequency per   Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
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............
                                                         -----------------------------------------------------------------------------------------------
    Total One Time Burden...............................  ..............  ..............  ..............  ..............  ..............          14,975
                                                         -----------------------------------------------------------------------------------------------
    Total Recurring Burden..............................  ..............  ..............  ..............  ..............  ..............          39,173
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.


[[Page 20140]]


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Annual
        21 CFR Section             Number of     frequency per   Total annual   Hours per record    Total hours
                                  respondents    recordkeeper       records
----------------------------------------------------------------------------------------------------------------
807.25(d) \2\--List of                  22,338               1          22,338  0.25 (15                   5,585
 Officers, Directors, and                                                        minutes).
 Partners.
807.26 \2\--Labeling and                17,032               4          68,128  0.5 (30 minutes)          34,064
 Advertisements Available for
 Review.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          39,649
----------------------------------------------------------------------------------------------------------------
\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: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09412 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P


