[Federal Register: October 1, 2002 (Volume 67, Number 190)]
[Notices]
[Page 61638-61639]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc02-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0405]
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 information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for 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 December 2, 2002.
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.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
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: (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
[[Page 61639]]
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 (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 63597), FDA issued part 803 (21 CFR part 803) that implemented
section 519 of the act. The regulation was amended to conform with the
changes reflected in the 1997 FDA Modernization Act.
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 non-profit organizations including user
facilities, manufacturers, and importers of medical devices.
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section No. of [chyph]Frequency Total Annual Hours per Total
[chyph]Respondents per Response [chyph]Responses [chyph]Response Hours
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803.19 25 1 25 3 75
803.30 1,000 3 3,000 1 3,000
803.33 FDA Form 3419 1,000 1 1,000 1 1,000
803.40 50 10 500 1 500
803.50 1,500 34 51,000 1 51,000
803.55 FDA Form 3417 700 5 3,500 1 3,500
TOTALS .................. ................ ................ ............... 59,075
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\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual
No. of Frequency Total Annual Hours per Total
21 CFR Section [chyph]Respondents per [chyph]Responses [chyph]Response Hours
Response
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803.17 3,200 1 3,200 3.3 10,560
803.18\2\ 39,000 1 39,000 1.5 58,500
TOTAL .................. .......... ................ ............... 69,060
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\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
information.
\2\ Include an estimated 35,000 medical device distributors. Although they do not submit MDR reports, they must
maintain records of complaints.
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.
Part 803 requires user facilities to report incidents where a
medical device caused or contributed to a death or serious injury to
the device manufacturer and to FDA (in case of death). 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 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. If the
manufacturer is unknown, the importer sends the reports to FDA.
The agency has estimated that on average, 1,800 entities annually
would be required to establish new procedures or revise existing
procedures in order to comply with medical device report (MDR)
provisions. For those entities, a one-time burden of 10 hours is
estimated for establishing written MDR procedures. The remaining
manufacturers, user facilities, and importers which are 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).
Dated: September 24, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-24811 Filed 9-30-02; 8:45 am]
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