[Federal Register Volume 66, Number 198 (Friday, October 12, 2001)]
[Notices]
[Pages 52140-52141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25660]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0277]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Reports of Corrections and Removals

AGENCY: Food and Drug Administration, HHS.

[[Page 52141]]


ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 13, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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.
Reports of Corrections and Removals--21 CFR Part 806 (OMB Control No. 
0910-0359)--Extension
    Section 519(f) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360i(f)) directs FDA to issue regulations to require 
device manufacturers and importers to report promptly to FDA any 
correction or removal of a device undertaken by such manufacturers and 
importers if the correction or removal was undertaken to reduce a risk 
to health posed by the device or to remedy a violation of the act 
caused by the device which may present a risk to health. Under 21 CFR 
806.10 and 806.20(a), FDA requires that each device manufacturer and 
importer shall submit a written report to FDA of any action initiated 
to correct or remove a device to reduce a risk to health posed by the 
device or to remedy a violation of the act caused by the device which 
may present a risk to health within 10 working days of initiating such 
correction or removal. In addition, each manufacturer and importer of a 
device who initiates a correction or removal of a device that is not 
required to be reported to FDA shall keep a record of such correction 
or removal.
    The information collected in the reports of corrections and 
removals will be used by FDA to identify marketed devices that have 
serious problems and to ensure that dangerous and defective devices are 
removed from the market, assuring that FDA has current and complete 
information regarding these corrections and removals and whether recall 
action is adequate. Failure to collect this information prevents FDA 
from receiving timely information about devices that may have a serious 
effect on the health of the users of the devices.
    Respondents to this information collection are businesses or other 
for-profit manufacturers or importers of medical devices who must 
remove or correct medical devices that cause public health risk to the 
general public.
    In the Federal Register of July 6, 2001 (66 FR 35644), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
   21 CFR                          Annual Frequency      Total Annual
   Section    No. of Respondents     per Response          Responses      Hours per Response      Total Hours
----------------------------------------------------------------------------------------------------------------
806.10              880                   1                 880                  10               8,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                           Annual Frequency      Total Annual          Hours per         Total
 21 CFR Section    No. of Recordkeepers    of Recordkeeping         Records          Recordkeeper        Hours
----------------------------------------------------------------------------------------------------------------
806.20(a)                 440                     1                 440                  10               4,400
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The following is an explanation of the burden estimate:

Reporting Burden

    FDA estimates that it would take 10 staff hours to prepare and 
assemble a written report. For the estimated 880 reports, FDA estimates 
that respondents will spend 8,800 hours to prepare, assemble, and send 
the reports.

Recordkeeping Burden

    FDA estimates that it would take 10 staff hours to prepare a 
written record. For the estimated 440 records, the total recordkeeping 
burden is estimated at 4,400 hours per recordkeeper.

    Dated: October 5, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-25660 Filed 10-11-01; 8:45 am]
BILLING CODE 4160-01-S