[Federal Register Volume 73, Number 222 (Monday, November 17, 2008)]
[Notices]
[Pages 67873-67874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0571]


Agency Information Collection Activities; Proposed Collection; 
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 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 written or electronic comments on the collection of 
information by January 16, 2009.

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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 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.

[[Page 67874]]

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

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                           No. of        No. of Responses  per      Total Annual        Hours Per
                 Section of the Act                     Respondents            Respondent            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.

    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27178 Filed 11-14-08; 8:45 am]
BILLING CODE 4160-01-S