[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13801-13802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05744]


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

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 April 
14, 2016.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 (the 
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 the economic analysis for the final rule 
entitled ``Implementation of Device Registration and Listing 
Requirements Enacted in the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, the Medical Device User Fee and 
Modernization Act of 2002, and Title II of the Food and Drug 
Administration Amendments Act of 2007.''
    In the Federal Register of October 27, 2015 (80 FR 65779), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of
             21 CFR Section                FDA Form No.      Number of     responses per   Total annual     Average burden per response     Total hours
                                                            respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.20(a)(5) \2\--Submittal of                      3673           8,594               1           8,594  1.75..........................          15,040
 manufacturer information by initial
 importers.
807.20(a)(5) \3\--Submittal of                      3673           8,594               3          25,782  .1............................           2,578
 manufacturer information by initial                                                                      (6 minutes)...................
 importers.

[[Page 13802]]

 
807.21(a) \3\--Creation of electronic               3673           3,559               1           3,559  .5............................           1,780
 system account.                                                                                          (30 minutes)..................
807.21(b) \2\--Annual request for waiver  ..............              14               1              14  1.............................              14
 from electronic registration and
 listing.
807.21(b) \3\--Initial request for        ..............               4               1               4  1.............................               4
 waiver from electronic registration and
 listing.
807.22(a) \3\--Initial registration and             3673           3,539               1           3,539  .5............................           1,770
 listing.                                                                                                 (30 minutes)..................
807.22(b)(1) \3\--Annual registration...            3673          20,355               1          20,355  .75...........................          15,266
                                                                                                          (45 minutes)..................
807.22(b)(2) \3\--Other updates of                  3673           4,176               1           4,176  .5............................           2,088
 registration.                                                                                            (30 minutes)..................
807.22(b)(3) \3\--Annual update of                  3673          19,875               1          19,875  1.............................          19,875
 listing information.
807.26(e) \3\--Labeling and               ..............              71               1              71  1.............................              71
 advertisement submitted at FDA request.
807.34(a) \2\--Initial registration and   ..............              14               1              14  1.............................              14
 listing when electronic filing waiver
 granted.
807.34(a) \3\--Annual registration and    ..............               4               1               4  1.............................               4
 listing when electronic filing waiver
 granted.
807.40(b)(2) \3\--Annual update of U.S.             3673           1,615               1           1,615  .5............................             808
 agent information.                                                                                       (30 minutes)..................
807.40(b)(3) \3\--U.S. agent responses              3673           1,535               1           1,535  .25...........................             384
 to FDA requests for information.                                                                         (15 minutes)..................
807.41(a) \3\--Identification of initial            3673          10,329               1          10,329  .5............................           5,165
 importers by foreign establishments.                                                                     (30 minutes)..................
807.41(b) \3\--Identification of other              3673          10,329               1          10,329  .5............................           5,165
 parties that facilitate import by                                                                        (30 minutes)..................
 foreign establishments.
                                         ---------------------------------------------------------------------------------------------------------------
    Total one-time burden...............  ..............  ..............  ..............  ..............  ..............................          15,068
                                         ---------------------------------------------------------------------------------------------------------------
    Total recurring burden..............  ..............  ..............  ..............  ..............  ..............................          54,958
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One-time burden.
\3\ Recurring burden.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
       21 CFR Section            Number of      records per    Total annual   Average burden per    Total hours
                               recordkeepers   recordkeeper       records        recordkeeping
----------------------------------------------------------------------------------------------------------------
807.25(d) \2\--List of                23,806               1          23,806  .25...............           5,952
 officers, directors and                                                      (30 minutes)......
 partners.
807.26 \2\--Labeling and              11,746               4          46,984  .5................          23,492
 advertisements available                                                     (30 minutes)......
 for review.
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ..................          29,444
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Recurring burden.


    Dated: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05744 Filed 3-14-16; 8:45 am]
BILLING CODE 4164-01-P