[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78445-78446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30511]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prominent and Conspicuous Mark of Manufacturers on 
Single-Use Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reprocessed, single-use device 
labeling.

DATES: Submit either electronic or written comments on the collection 
of information by March 2, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of

[[Page 78446]]

information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
extension of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (the 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.
    FDA estimates the burden of this collection of information as 
follows:

                         Table 1--Estimated Annual Third-Party Disclosure Burden \1\ \2\
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                                                   Number of
      Type of respondent           Number of      disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per disclosure
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Establishments listing less                 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.
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    Total.....................  ..............  ..............  ..............  ................              43
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers have been rounded.


    Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30511 Filed 12-29-14; 8:45 am]
BILLING CODE 4164-01-P