[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Notices]
[Pages 32101-32102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8571]


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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of Management and Budget Review; Comment Request; Draft Guidance for 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Draft Guidance for Industry and FDA Staff on Class II Special Controls 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 This draft 
guidance document serves as the special control to support the 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