[Federal Register Volume 71, Number 59 (Tuesday, March 28, 2006)]
[Notices]
[Pages 15419-15420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0484]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device 
Reporting: Manufacturer Reporting, Importer Reporting, User Facility 
Reporting, and Distributor Reporting

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 April 
27, 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 written 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: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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.

Medical Device Reporting: Manufacturer Reporting, Importer Reporting, 
User Facility Reporting, and Distributor Reporting--21 CFR Part 803 
(OMB Control Number 0910-0437)--Extension

    Section 519(a), (b), and (c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360i(a), (b), and (c)) requires user 
facilities, manufacturers, and importers of medical devices to report 
adverse events involving medical devices to FDA. On December 11, 1995 
(60 FR 63578 at 63597), FDA issued part 803 (21 CFR part 803) that 
implemented section 519 of the act. The regulation was amended to 
conform to the changes reflected in the FDA Modernization Act of 1997.
    Information from these reports will be used to evaluate risks 
associated with medical devices and to enable FDA to take appropriate 
regulatory measures to protect the public health.
    Respondents to this collection of information are businesses or 
other for profit and nonprofit organizations including user facilities, 
manufacturers, and importers of medical devices.
    In the Federal Register of December 23, 2005 (70 FR 76318), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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803.19                                                                 55                     4                220                  3                660
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803.30                                                                700                     5              3,500                  1              3,500
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803.33, FDA Form 3419                                                 700                     1                700                  1                700
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803.40                                                                 40                    17                680                  1                680
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803.50                                                              1,465                    57             83,505                  1             83,505
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803.55, FDA Form 3417                                                 700                     5              3,500                  1              3,500
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Total                                                                                                                                             92,545
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
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803.17                                                                220                     1                220                3.3                726
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803.18(c) and (d)                                                  30,000                     1             30,000                1.5             45,000
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Total                                                                                                                                             45,726
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Part 803 requires user facilities to report to the device 
manufacturer, and to FDA in the case of a death, incidents where a 
medical device caused or contributed to a death or serious injury. 
Manufacturers of medical devices are required to report to FDA when 
they become aware of information indicating that one of their devices 
may have

[[Page 15420]]

caused or contributed to death or serious injury or has malfunctioned 
in such a way that should the malfunction recur, it would be likely to 
cause or contribute to a death or serious injury. Device importers 
report deaths and serious injuries to the manufacturers and FDA. 
Importers report malfunctions only to the manufacturers, unless they 
are unknown, then the reports are sent to FDA.
    The number of respondents for each CFR section in table 1 of this 
document is based upon the number of respondents entered into FDA's 
internal databases. FDA estimates, based on its experience and 
interaction with the medical device community, that all reporting CFR 
sections are expected to take 1 hour to complete, with the exception of 
Sec.  803.19. Section 803.19 is expected to take approximately 3 hours 
to complete, but is only required for reporting the summarized data 
quarterly to FDA. By summarizing events, the total time used to report 
for this section is reduced because the respondents do not submit a 
full report for each event they report in a quarterly summary report.
    The agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the medical device 
reporting (MDR) requirements as part of their internal quality control 
system. There are an estimated 30,000 medical device distributors. 
Although they do not submit MDR reports, they must maintain records of 
complaints, under Sec.  803.18(d).
    The agency has estimated that on average, 220 user facilities, 
importers, and manufacturers would annually be required to establish 
new procedures, or revise existing procedures, in order to comply with 
this provision.
    Therefore, FDA estimates the one-time burden to respondents for 
establishing or revising procedures to be 2,200 hours (220 respondents 
x 10 hours). For those entities, a one-time burden of 10 hours is 
estimated for establishing written MDR procedures. The remaining 
manufacturers, user facilities, and importers, not required to revise 
their written procedures to comply with this provision, are excluded 
from the burden because the recordkeeping activities needed to comply 
with this provision are considered ``usual and customary'' under 5 CFR 
1320.3(b)(2).
    The annual burden for recordkeeping to respondents follows. Under 
Sec.  803.17, FDA estimates 220 respondents will spend approximately 
3.3 hours to complete the requirements for this section. The number of 
respondents was estimated by consolidating the total of all new 
reporting entities together. The 3.3 hours was estimated by FDA, as 
this section deals with a respondent creating new MDR procedures and is 
a one-time function. The ``total hours'' for this section equals 
approximately 726 hours.
    Under Sec.  803.18, 30,000 respondents represent distributors, 
importers, and other respondents to this information collection. FDA 
estimates that it should take them approximately 1 1/2 hours to 
complete the recordkeeping requirement for this section. Total hours 
for this section equal 45,000 hours.

    Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4426 Filed 3-27-06; 8:45 am]
BILLING CODE 4160-01-S