[Federal Register Volume 74, Number 95 (Tuesday, May 19, 2009)]
[Notices]
[Pages 23413-23414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0075]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 (the PRA).

DATES: Fax written comments on the collection of information by June 
18, 2009.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0437. 
Also include the FDA 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.

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

    Section 519(a)(1) of 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.
    In the Federal Register of February 25, 2009 (74 FR 8547), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received one non-related PRA comment that 
did not require a response.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 23414]]



                                                     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 803.32                    .................                393                     2                777                1.0                777
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803.33                                           3,419                393                     1                393                  1                393
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803.40 and 803.42                    .................                 73                    37              2,682                1.0              2,682
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803.50 and 803.52                    .................              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 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                 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 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 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 adverse events 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 Code of Federal Regulations 
(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 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: May 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning./SUPLINF>
[FR Doc. E9-11625 Filed 5-18-09; 8:45 am]
BILLING CODE 4160-01-S