[Federal Register: September 29, 2005 (Volume 70, Number 188)]
[Page 56910-56911]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 56910]]



Food and Drug Administration

[Docket No. 2005N-0389]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reprocessed Single-Use Device Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 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 November 28, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 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.

Reprocessed Single-Use Device Labeling (21 U.S.C. 352(u))

    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. The Medical Device User 
Fee and Modernization Act of 2002 (MDUFMA) (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. 
Section 2(c) of The Medical Device User Fee Stabilization Act of 2005 
(MDUFSA) (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. MDUFSA was enacted on August 1, 
2005, and becomes self-implementing on August 1, 2006.
    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 3 establishments that distribute approximately 300 
reprocessed SUDs. Each response is anticipated to take 0.1 hours 
resulting in a total burden to industry of 30 hours.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                              No. of         Annual Responses       Total Annual        Hours per
                  Section of the act                       Respondents        Per Respondent         Responses           Response         Total Hours
502(u)                                                                  3                   100                300                0.1                 30
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 56911]]

    Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19509 Filed 9-28-05; 8:45 am]