[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Notices]
[Page 76318-76319]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de05-85]
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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://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: 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]
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