[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6895-6896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2902]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0571]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Compliance With the Medical
Device User Fee and Modernization Act of 2002, as Amended: Prominent
and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly
``Reprocessed Single-Use Device Labeling'')
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
13, 2009.
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: 202-395-6974, or e-mailed 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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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.
Guidance for Industry and Food and Drug Administration Staff;
Compliance With Section 301 of the Medical Device User Fee and
Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark
of Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-
Use Device Labeling'') (Federal Food, Drug and Cosmetic Act, Section
502(u)) (OMB Control Number 0910-0577)--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (the 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 (Public Law 107-250)
amended section 502 of the 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
[[Page 6896]]
more accurately describe the information collection content.
Section 2(c) of The Medical Device User Fee Stabilization Act of
2005 (Public Law 109-43) amends section 502(u) of the 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 act impose a minimal
burden on industry. This section of the 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 November 17, 2008 (73 FR 67873), FDA
published a 60-day notice requesting public comment on the information
collection provisions. The agency received one comment in support of
the collection of information stating that it is necessary to help
reprocessors of SUDs comply with section 502(u) of the act. The comment
further stated that the estimated reporting burden did not appear
excessive.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
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Section of the No. of Annual Frequency Total Annual Hours per
Act Respondents per Response Responses Response Total Hours
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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: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2902 Filed 2-10-09; 8:45 am]
BILLING CODE 4160-01-S