[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Notices]
[Pages 10862-10863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1837]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Transfer of a 
Premarket Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
12, 2018.

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-New and 
title ``Transfer of a Premarket Notification.'' 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, 
[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.

Transfer of a Premarket Notification

OMB Control Number 0910-New

    The draft guidance ``Transfer of a Premarket Notification (510(k)) 
Clearance--Questions and Answers'' is intended to provide information 
on how to notify FDA of the transfer of a 510(k) clearance from one 
person to another, and the procedures FDA and industry should use 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. The 
proposed information collection seeks to provide information to notify 
FDA of the transfer of a premarket notification (510(k)) clearance.
    The respondents to this collection of information are 510(k) 
holders and parties claiming to be 510(k) holders.
    In the Federal Register of December 22, 2014 (79 FR 76331), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. While FDA received comments on the draft 
guidance document, none were related to the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Voluntary reporting of transfer            4,080               1           4,080            0.25           1,020
 of 510(k) clearance on FDA's
 Unified Registration and
 Listing System (FURLS) (outside
 of annual listing reporting
 requirement)...................
Submission of 510(k) transfer              2,033               1           2,033               4           8,132
 documentation when more than
 one party lists the same 510(k)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           9,152
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that 78 percent of 510(k)s are listed outside of the 
annual registration cycle based on numbers in the FURLS database from 
fiscal year 2009 through fiscal year 2014. Fiscal year 2008 was left 
out of this cohort as it was the first year that registrants were 
required to report the 510(k) number on their listings and, therefore, 
an unusually high number of listings were created. An average of 5,231 
510(k)s have been listed each year since 2008.

[[Page 10863]]

Because listing outside of the annual requirement is voluntary, FDA 
estimates that annually 78 percent of 510(k)s will continue to be 
listed outside of the annual requirement. FDA estimates that 4,080 
510(k)s may be listed outside of the annual registration cycle. 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 
number of unique 510(k) device listings entered in FURLS between fiscal 
years 2009 and 2014 that conflict with a listing already entered by 
another party (5,304), dividing that number by the number of years (6), 
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). The draft guidance identifies potential documentation a party 
could submit to FDA to establish the transfer of a 510(k) clearance. 
FDA estimates it will take a party approximately 4 hours to locate and 
submit information to establish the transfer of the 510(k) clearance, 
resulting in 8,132 burden hours for those 2,033 parties claiming to be 
510(k) holders. FDA reached this estimate based on its expectation of 
the amount of time it will take a party to locate the information, copy 
it, and submit a copy to FDA.
    The burden estimate does not include the maintenance of records 
used to document transferring a premarket notification (510(k)) 
clearance. Based on available information, FDA believes that the 
maintenance of these records is a usual and customary part of normal 
business activities. For example, in the ordinary course of business, 
supporting documents should be kept to verify asset information for 
calculating the annual depreciation or calculating gain or loss on sale 
of an asset on a businesses' tax return. Therefore, this recordkeeping 
requirement creates no additional paperwork burden.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR part 807 (registration and listing) are approved under OMB 
control number 0910-0625; the collections of information in 21 CFR part 
807 subpart E (premarket notification submission) have been approved 
under OMB control number 0910-0120, and collections of information in 
42 CFR 493.17 have been approved under OMB control number 0910-0607.

    Dated: March 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04995 Filed 3-12-18; 8:45 am]
 BILLING CODE 4164-01-P


