83 FR 10862 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Transfer of a Premarket Notification

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 49 (March 13, 2018)

Page Range		10862-10863
FR Document		2018-04995

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.

Federal Register, Volume 83 Issue 49 (Tuesday, March 13, 2018)

[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Notices]
[Pages 10862-10863]
From the Federal Register Online  [www.thefederalregister.org]
[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    The draft guidance ``Transfer of a Premarket Notification (510(k)) 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\
----------------------------------------------------------------------------------------------------------------
                                                     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
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 83, No. 49 / Tuesday, March 13, 2018 / Notices 10863

Because listing outside of the annual Dated: March 7, 2018. description of the oral presentation. Only one
requirement is voluntary, FDA estimates Leslie Kux, representative of an organization may be
that annually 78 percent of 510(k)s will Associate Commissioner for Policy. allowed to present oral comments and if
accepted by the committee, presentations
continue to be listed outside of the [FR Doc. 2018–04995 Filed 3–12–18; 8:45 am] may be limited to five minutes. Both printed
annual requirement. FDA estimates that BILLING CODE 4164–01–P and electronic copies are requested for the
4,080 510(k)s may be listed outside of record. In addition, any interested person
the annual registration cycle. FDA may file written comments with the
estimates that it will take approximately DEPARTMENT OF HEALTH AND committee by forwarding their statement to
15 minutes for each listing, for a total HUMAN SERVICES the Contact Person listed on this notice. The
reporting burden of 1,020 hours. statement should include the name, address,
FDA estimates it will have 2,033 National Institutes of Health telephone number and when applicable, the
instances of more than one party business or professional affiliation of the
claiming to be a 510(k) holder for a Office of the Director, National interested person.
Institutes of Health; Notice of Meeting In the interest of security, NIH has
specific device as part of annual instituted stringent procedures for entrance
registration and listing. FDA reached Pursuant to section 10(d) of the onto the NIH campus. All visitor vehicles,
this estimate by identifying the number Federal Advisory Committee Act, as including taxicabs, hotel, and airport shuttles
of unique 510(k) device listings entered amended, notice is hereby given of a will be inspected before being allowed on
in FURLS between fiscal years 2009 and meeting of the Advisory Committee on campus. Visitors will be asked to show one
2014 that conflict with a listing already Research on Women’s Health. form of identification (for example, a
entered by another party (5,304), government-issued photo ID, driver’s license,
The meeting will be open to the or passport) and to state the purpose of their
dividing that number by the number of public as indicated below, with
years (6), and multiplying by the visit.
attendance limited to space available. Information is also available on the
average number of parties claiming to be Individuals who plan to attend and Institute’s/Center’s home page:
the 510(k) holder when there is a need special assistance, such as sign www4.od.nih.gov/orwh/, where an agenda
conflict in the current FURLS database language interpretation or other and any additional information for the
(2.3). The draft guidance identifies reasonable accommodations, should meeting will be posted when available.
potential documentation a party could notify the Contact Person listed below (Catalogue of Federal Domestic Assistance
submit to FDA to establish the transfer in advance of the meeting. Program Nos. 93.14, Intramural Research
of a 510(k) clearance. FDA estimates it A portion of the meeting will be Training Award; 93.22, Clinical Research
will take a party approximately 4 hours closed to the public in accordance with Loan Repayment Program for Individuals
to locate and submit information to from Disadvantaged Backgrounds; 93.232,
the provisions set forth in sections Loan Repayment Program for Research
establish the transfer of the 510(k) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
clearance, resulting in 8,132 burden Generally; 93.39, Academic Research
as amended. The grant applications and Enhancement Award; 93.936, NIH Acquired
hours for those 2,033 parties claiming to the discussions could disclose Immunodeficiency Syndrome Research Loan
be 510(k) holders. FDA reached this confidential trade secrets or commercial Repayment Program; 93.187, Undergraduate
estimate based on its expectation of the property such as patentable material, Scholarship Program for Individuals from
amount of time it will take a party to and personal information concerning Disadvantaged Backgrounds, National
locate the information, copy it, and individuals associated with the grant Institutes of Health, HHS)
submit a copy to FDA. applications, the disclosure of which Dated: March 6, 2018.
The burden estimate does not include
would constitute a clearly unwarranted Michelle Trout,
the maintenance of records used to
invasion of personal privacy. Program Analyst, Office of Federal Advisory
document transferring a premarket
notification (510(k)) clearance. Based on Name of Committee: Advisory Committee Committee Policy.
available information, FDA believes that on Research on Women’s Health. [FR Doc. 2018–04954 Filed 3–12–18; 8:45 am]
Closed: April 17, 2018, 2:30 p.m. to 4:45
the maintenance of these records is a BILLING CODE 4140–01–P
p.m.
usual and customary part of normal Agenda: To evaluate the Sex/Gender
business activities. For example, in the Administrative Supplements program
ordinary course of business, supporting proposed for ORWH’s Strategic Plan. DEPARTMENT OF HEALTH AND
documents should be kept to verify Open: April 18, 2018, 9:00 a.m. to 1:30 HUMAN SERVICES
asset information for calculating the p.m.
annual depreciation or calculating gain Agenda: Opening Remarks, Director’s National Institutes of Health
or loss on sale of an asset on a Report, NIH Legislative Update, Strategic
Plan Update, and Scientific Presentations. Eunice Kennedy Shriver National
businesses’ tax return. Therefore, this Institute of Child Health and Human
Place: National Institutes of Health,
recordkeeping requirement creates no Building 31, 6th Floor, Conference Room 10, Development; Notice of Closed
additional paperwork burden. 31 Center Drive, Bethesda, MD 20892. Meetings
The draft guidance also refers to Contact Person: Elizabeth Spencer, R.N.,
previously approved collections of Deputy Director, Office of Research on Pursuant to section 10(d) of the
information found in FDA regulations. Women’s Health, Executive Secretary, Federal Advisory Committee Act, as
The collections of information in 21 ACRWH, National Institutes of Health, 6707 amended, notice is hereby given of the
CFR part 807 (registration and listing) Democracy Blvd., Room 7W444, Bethesda, following meetings.
are approved under OMB control MD 20817, 301–402–1770 elizabeth.spencer@ The meetings will be closed to the
number 0910–0625; the collections of nih.gov. public in accordance with the
amozie on DSK30RV082PROD with NOTICES

information in 21 CFR part 807 subpart Any member of the public interested in provisions set forth in sections
E (premarket notification submission) presenting oral comments to the committee 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
may notify the Contact Person listed on this
have been approved under OMB control notice at least 10 days in advance of the
as amended. The grant applications and
number 0910–0120, and collections of meeting. Interested individuals and the discussions could disclose
information in 42 CFR 493.17 have been representatives of organizations may submit confidential trade secrets or commercial
approved under OMB control number a letter of intent, a brief description of the property such as patentable material,
0910–0607. organization represented, and a short and personal information concerning

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Document Created: 2018-03-13 01:56:59
Document Modified: 2018-03-13 01:56:59

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by April 12, 2018.
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]
FR Citation		83 FR 10862

83 FR 10862 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Transfer of a Premarket Notification

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 49 (March 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration