[Federal Register: December 15, 2005 (Volume 70, Number 240)]
[Page 74324]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0389]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reprocessed Single-
Use Device Labeling

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


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 
January 17, 2006..

ADDRESSES:  OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    In the Federal Register of September 29, 2005 (70 FR 56910), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

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

    Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-24041 Filed 12-14-05; 8:45 am]