83 FR 15154 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

Page Range		15154-15155
FR Document		2018-07152

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 68 (Monday, April 9, 2018)

[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15154-15155]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0672]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prominent and 
Conspicuous Mark of Manufacturers on Single-Use Devices

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 May 9, 
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 0910-0577. 
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.

Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

OMB Control Number 0910-0577--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 352), among other things, establishes requirements that the 
label or labeling of a medical device must meet so that it is not 
misbranded and subject to regulatory action. Section 301 of the Medical 
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) amended 
section 502 of the FD&C Act to add section 502(u) to require devices 
(both new and reprocessed) to bear prominently and conspicuously the 
name of the manufacturer, a generally recognized abbreviation of such 
name, or a unique and generally recognized symbol identifying the 
manufacturer.
    Section 2(c) of the Medical Device User Fee Stabilization Act of 
2005 (Pub. L. 109-43) amends section 502(u) of the FD&C Act by limiting 
the provision to reprocessed single-use devices (SUDs) and the 
manufacturers who reprocess them. Under the amended provision, if the 
original SUD or an attachment to it prominently and conspicuously bears 
the name of the manufacturer, then the reprocessor of the SUD is 
required to identify itself by name, abbreviation, or symbol in a 
prominent and conspicuous manner on the device or attachment to the 
device. If the original SUD does not prominently and conspicuously bear 
the name of the manufacturer, the manufacturer who reprocesses the SUD 
for reuse may identify itself using a detachable label that is intended 
to be affixed to the patient record.
    The requirements of section 502(u) of the FD&C Act impose a minimal 
burden on industry. This section of the FD&C Act only requires the 
manufacturer, packer, or distributor of a device to include their name 
and address on the labeling of a device. This information is readily 
available to the establishment and easily supplied. From its 
registration and premarket submission database, FDA estimates that 
there are 67 establishments that distribute approximately 427 
reprocessed SUDs. Each response is anticipated to take 0.1 hours (6 
minutes) resulting in a total burden to industry of 43 hours.
    In the Federal Register of December 19, 2017 (82 FR 60207), 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:

[[Page 15155]]



                         Table 1--Estimated Annual Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
      Type of respondent           Number of      disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
Establishments listing fewer                58               2             116  0.1 (6 minutes).              12
 than 10 SUDs.
Establishments listing 10 or                 9              34             306  0.1 (6 minutes).              31
 more SUDs.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................              43
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers have been rounded.

    The burden for this information collection has not changed since 
the last OMB approval.

    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07152 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P

15154 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Type of reporting responses per burden per Total hours
respondents responses
respondent response

Notify FDA when normal reporting is not feasible ............... 500 1 500 8 4,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Hours per
Type of recordkeeping records per Total hours
recordkeepers records record
recordkeeper

Add adverse event reporting plan to COOP ..................... 5,000 1 5,000 50 250,000
Maintain documentation of influenza pandemic conditions
and resultant high absenteeism ..................................... 500 1 500 8 4,000
Maintain records to identify what reports have been
stored and when the reporting process was restored ... 500 1 500 8 4,000

Total ............................................................................ .......................... ........................ ........................ ........................ 258,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 3, 2018. comments should be identified with the FD&C Act by limiting the provision to
Leslie Kux, OMB control number 0910–0577. Also reprocessed single-use devices (SUDs)
Associate Commissioner for Policy. include the FDA docket number found and the manufacturers who reprocess
[FR Doc. 2018–07154 Filed 4–6–18; 8:45 am] in brackets in the heading of this them. Under the amended provision, if
BILLING CODE 4164–01–P
document. the original SUD or an attachment to it
FOR FURTHER INFORMATION CONTACT: prominently and conspicuously bears
Amber Sanford, Office of Operations, the name of the manufacturer, then the
DEPARTMENT OF HEALTH AND Food and Drug Administration, Three reprocessor of the SUD is required to
HUMAN SERVICES White Flint North, 10A–12M, 11601 identify itself by name, abbreviation, or
Landsdown St., North Bethesda, MD symbol in a prominent and conspicuous
Food and Drug Administration 20852, 301–796–8867, PRAStaff@ manner on the device or attachment to
fda.hhs.gov. the device. If the original SUD does not
[Docket No. FDA–2011–N–0672]
prominently and conspicuously bear the
SUPPLEMENTARY INFORMATION: In
Agency Information Collection name of the manufacturer, the
compliance with 44 U.S.C. 3507, FDA
Activities; Submission for Office of manufacturer who reprocesses the SUD
has submitted the following proposed
Management and Budget Review; for reuse may identify itself using a
collection of information to OMB for
Comment Request; Prominent and detachable label that is intended to be
review and clearance.
Conspicuous Mark of Manufacturers affixed to the patient record.
on Single-Use Devices Prominent and Conspicuous Mark of The requirements of section 502(u) of
Manufacturers on Single-Use Devices the FD&C Act impose a minimal burden
AGENCY: Food and Drug Administration, OMB Control Number 0910–0577— on industry. This section of the FD&C
HHS. Extension Act only requires the manufacturer,
ACTION: Notice. packer, or distributor of a device to
Section 502 of the Federal Food, Drug,
include their name and address on the
SUMMARY: The Food and Drug and Cosmetic Act (FD&C Act) (21 U.S.C.
labeling of a device. This information is
Administration (FDA) is announcing 352), among other things, establishes
readily available to the establishment
that a proposed collection of requirements that the label or labeling of
a medical device must meet so that it is and easily supplied. From its
information has been submitted to the registration and premarket submission
Office of Management and Budget not misbranded and subject to
regulatory action. Section 301 of the database, FDA estimates that there are
(OMB) for review and clearance under 67 establishments that distribute
the Paperwork Reduction Act of 1995. Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107– approximately 427 reprocessed SUDs.
DATES: Fax written comments on the Each response is anticipated to take 0.1
250) amended section 502 of the FD&C
collection of information by May 9, hours (6 minutes) resulting in a total
Act to add section 502(u) to require
2018. burden to industry of 43 hours.
devices (both new and reprocessed) to
ADDRESSES: To ensure that comments on bear prominently and conspicuously the In the Federal Register of December
the information collection are received, name of the manufacturer, a generally 19, 2017 (82 FR 60207), FDA published
OMB recommends that written recognized abbreviation of such name, a 60-day notice requesting public
sradovich on DSK3GMQ082PROD with NOTICES

comments be faxed to the Office of or a unique and generally recognized comment on the proposed collection of
Information and Regulatory Affairs, symbol identifying the manufacturer. information. No comments were
OMB, Attn: FDA Desk Officer, Fax: 202– Section 2(c) of the Medical Device received.
395–7285, or emailed to oira_ User Fee Stabilization Act of 2005 (Pub. FDA estimates the burden of this
submission@omb.eop.gov. All L. 109–43) amends section 502(u) of the collection of information as follows:

VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1

Document Created: 2018-04-07 02:39:12
Document Modified: 2018-04-07 02:39:12

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 May 9, 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 15154

83 FR 15154 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration