[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Notices]
[Pages 5812-5813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2555]
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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.
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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 March
7, 2012.
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 oira_submission@omb.eop.gov. 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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. Thus, the name for this information collection activity
has been changed to more accurately describe the information collection
content.
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 10 establishments that distribute approximately 1,000
reprocessed SUDs. Each response is anticipated to take 0.1 hours
resulting in a total burden to industry of 100 hours.
In the Federal Register of September 27, 2011 (76 FR 59704), 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 5813]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FD&C Act section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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502(u).......................... 10 100 1,000 .1 100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2555 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P