[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Notices]
[Pages 76318-76319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0484]


Agency Information Collection Activities; Proposed Collection; 
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 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 Medical Device Reporting: 
Manufacturer Reporting, Importer Reporting, User Facility Reporting, 
and Distributor Reporting.

DATES: Submit written or electronic comments on the collection of 
information by February 21, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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.

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

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

                                 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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Total                                                                                                     92,545
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 76319]]


                               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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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 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: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7726 Filed 12-22-05; 8:45 am]
BILLING CODE 4160-01-S