[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Pages 8547-8549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4057]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0075]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting: Manufacturer, Importer, User
Facility, 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
(MDR); manufacturer, importer, user facility, and distributor
reporting.
DATES: Submit written or electronic comments on the collection of
information by April 27, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. 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, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
[[Page 8548]]
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, Importer, User Facility, and
Distributor Reporting--21 CFR Part 803 (OMB Control Number 0910-0437)--
Extension
Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to
report ``whenever the manufacturer or importer receives or otherwise
becomes aware of information that reasonably suggests that one of its
marketed devices: (A) May have caused or contributed to a death or
serious injury, or (B) has malfunctioned and that such device or a
similar device marketed by the manufacturer or importer would be likely
to cause or contribute to a death or serious injury if the malfunction
were to recur * * *.''
Section 519(b)(1)(A) of the act requires ``whenever a device user
facility receives or otherwise becomes aware of information that
reasonably suggests that a device has or may have caused or contributed
to the death of a patient of the facility, the facility shall, as soon
as practicable but not later than 10 working days after becoming aware
of the information, report the information to the Secretary and, if the
identity of the manufacturer is known, to the manufacturer of the
device.''
Section 519(b)(1)(B) of the act requires ``whenever a device user
facility receives or otherwise becomes aware of: (i) Information that
reasonably suggests that a device has or may have caused or contributed
to the serious illness of, or serious injury to, a patient of the
facility * * *, shall, as soon as practicable but not later than 10
working days after becoming aware of the information, report the
information to the manufacturer of the device or to the Secretary if
the identity of the manufacturer is not known.''
Complete, accurate, and timely adverse event information is
necessary for the identification of emerging device problems.
Information from these reports will be used to evaluate risks
associated with medical devices which will enable FDA to take
appropriate regulatory measures in protection of the public health
under section 519 of the act. Thus FDA is requesting approval for these
information collection requirements which are being implemented under
part 803 (21 CFR part 803).
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 FDA Form No. Respondents per Response Responses Response Total Hours
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803.19 ................. 57 4 228 3.0 684
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803.30 and .32 ................. 393 2 777 1.0 777
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803.33 3419 393 1 393 1 393
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803.40 and .42 ................. 73 37 2,682 1.0 2,682
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803.50 and .52 ................. 1,601 104 166,271 1.0 166,271
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803.56 ................. 1,200 63 76,186 1.0 76,186
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Total ................. ................. .................... 246,537 ................. 246,993
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden
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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 10 2,200
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803.18 (a) through (d) 30,000 1 30,000 1.5 45,000
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Total 47,200
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
[[Page 8549]]
Part 803 requires user facilities to report to the device
manufacturer and to FDA in case of a death, incidents where a medical
device caused or contributed to a death or serious injury.
Additionally, user facilities are required to annually submit the
number and summary of advents reported during the calendar year, using
FDA Form 3419. 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 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 under Sec. 803.17 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).
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 1.5 hours to complete
the recordkeeping requirement for this section. Total hours for this
section equal 45,000 hours.
Dated: February 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4057 Filed 2-24-09; 8:45 am]
BILLING CODE 4160-01-S