[Federal Register: June 2, 2006 (Volume 71, Number 106)]
[Notices]
[Page 32101-32102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn06-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0019]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry and Food and Drug Administration Staff on Class II Special
Controls Guidance Document: Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration Separation Principle
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.
DATES: Fax written comments on the collection of information by July 3,
2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
Draft Guidance for Industry and FDA Staff on Class II Special Controls
Guidance Document: Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle
Under the Safe Medical Devices Act of 1990 (Public Law 101-629, 104
Stat. 4511), FDA may establish special controls, including performance
standards, postmarket surveillance, patient registries, guidelines, and
other appropriate actions it believes necessary to provide reasonable
assurance of the safety and effectiveness of the device. This draft
guidance document serves as the special control to support the
reclassification from class III to class II
[[Page 32102]]
of the automated blood cell separator device operating on a centrifugal
separation principle intended for the routine collection of blood and
blood components (see proposed rule of March 10, 2005, 70 FR 11887),
and serves as the special control for the filtration-based device with
the same intended use reclassified as class II in the Federal Register
of February 28, 2003 (68 FR 9530). The final rule for the automated
blood cell separator device operating on a centrifugal separation
principle will be published in conjunction with the special controls
guidance document.
For currently marketed products not approved under the premarket
approval (PMA) process, the manufacturer should file with FDA for 3
consecutive years an annual report on the anniversary date of the
device reclassification from class III to class II, or on the
anniversary date of the 510(k) clearance. Any subsequent change to the
device requiring the submission of a premarket notification in
accordance with section 510(k) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360(k)) should be included in the annual
report. Also, a manufacturer of a device determined to be substantially
equivalent to the centrifugal or filtration-based automated blood cell
separator device intended for the routine collection of blood and blood
components, should comply with the same general and special controls.
The annual report should include, at a minimum, a summary of
anticipated and unanticipated donor adverse device events that have
occurred, such as those required under Sec. 606.160(b)(1)(iii) (21 CFR
606.160(b)(1)(iii))\1\ to be recorded and maintained by the facility
using the device to collect blood and blood components, and that might
not be reported by manufacturers under Medical Device Reporting (MDR).
Also, equipment failures, including software, hardware, and disposable
item failures' should be reported. The reporting of adverse device
events summarized in an annual report will alert FDA to trends or
clusters of events that might be a safety issue otherwise unreported
under the MDR regulation.
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\1\Section 606.160(b)--``Records shall be maintained that
include, but are not limited to, the following when applicable: * *
* (1)(iii) Donor adverse reaction complaints and reports, including
results of all investigations and followup.''
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Reclassification of this device from class III to class II for the
intended use of routine collection of blood and blood components will
relieve manufacturers of the burden of complying with PMA requirements
of section 515 of the act (21 U.S.C. 360e), and may permit small
potential competitors to enter the marketplace by reducing the burden.
Although the special control guidance document recommends that
manufacturers of these devices file with FDA an annual report for 3
consecutive years, this would be less burdensome than the current
postapproval requirements under part 814, subpart E (21 CFR part 814,
subpart E), including the submission of periodic reports under Sec.
814.84.
Collecting or transfusing facilities and manufacturers have certain
responsibilities under the CFR. Among others, collecting or transfusing
facilities are required to maintain records of any reports of
complaints of adverse reactions (Sec. 606.170), while the manufacturer
is responsible for conducting an investigation of each event that is
reasonably known to the manufacturer and evaluating the cause of the
event under part 803 (21 CFR part 803), specifically in Sec.
803.50(b)(2). In the draft guidance document, we recommend that
manufacturers include in their three annual reports a summary of
adverse reactions maintained by the collecting or transfusing facility
or similar reports of adverse events collected in addition to those
required under the MDR regulation.
In the Federal Register of March 10, 2005 (70 FR 11990), FDA
published a 60-day notice requesting public comment on the information
collection provisions. One public comment was received but it did not
relate to the collection of information.
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Respondent Total Hours
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Annual Report 4 1 4 5 20
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are an estimated four manufacturers of
automated blood cell separator devices. We estimate that the
manufacturers will spend approximately 5 hours preparing and submitting
the annual report. The total annual burden of this collection of
information is estimated at approximately 20 hours.
Other burden hours associated with proposed 21 CFR 864.9245 are
already reported and approved under OMB control number 0910-0120
(premarket notification submission in accordance with section 510(k) of
the act, and 21 CFR part 807, subpart E), and OMB control number 0910-
0437 (MDR). Currently, manufacturers of medical devices are required to
submit to FDA individual adverse event reports of death, serious
injury, and malfunctions (Sec. Sec. 803.50 and 803.53). The
manufacturer is responsible for conducting an investigation of each
event and evaluating the cause of the event (Sec. 803.50(b)(2)).
The reporting recommended in the special control guidance document
broadens the information to be reported by manufacturers to FDA. We are
recommending that the manufacturer submit annually, for 3 consecutive
years, a summary of all adverse events, including those reported under
part 803. The MedWatch medical device reporting code instructions
(http://www.fda.gov/cdrh/mdr/373.html), contains a comprehensive list
of adverse events associated with device use, including most of those
events that we recommend summarizing in the annual report.
Dated: May 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8571 Filed 6-1-06; 8:45 am]
BILLING CODE 4160-01-S