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11990 Federal Register / Vol. 70, No.

46 / Thursday, March 10, 2005 / Notices

DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION section for brackets in the heading of this
HUMAN SERVICES electronic access to the draft guidance document. A copy of the draft guidance
document. and received comments are available for
Food and Drug Administration Submit written comments on the draft public examination in the Division of
guidance to the Division of Dockets Dockets Management between 9 a.m.
[Docket No. 2005D–0019]
Management (HFA–305), Food and Drug and 4 p.m., Monday through Friday.
Draft Guidance for Industry and Food Administration, 5630 Fishers Lane, rm. III. The Paperwork Reduction Act of
and Drug Administration Staff on Class 1061, Rockville, MD 20852. Submit 1995
II Special Controls Guidance electronic comments to http://
www.fda.gov/dockets/ecomments. The draft guidance document
Document: Automated Blood Cell
contains information collection
Separator Device Operating by FOR FURTHER INFORMATION CONTACT:
provisions that are subject to review by
Centrifugal or Filtration Separation Kathleen E. Swisher, Center for
the Office of Management and Budget
Principle; Availability Biologics Evaluation and Research
(OMB) under the Paperwork Reduction
(HFM–17), Food and Drug
AGENCY: Food and Drug Administration, Act of 1995 (the PRA) (44 U.S.C. 3501–
Administration, suite 200N, 1401
HHS. 3520). Under the PRA, Federal agencies
Rockville Pike, Rockville, MD 20852–
ACTION: Notice. must obtain approval from OMB for
1448, 301–827–6210.
each collection of information they
SUPPLEMENTARY INFORMATION: conduct or sponsor. ‘‘Collection of
SUMMARY: The Food and Drug
Administration (FDA) is announcing the I. Background information’’ is defined in 44 U.S.C.
availability of a draft document entitled 3502(3) and 5 CFR 1320.3(c) and
FDA is announcing the availability of includes agency requests or
‘‘Class II Special Controls Guidance
a draft document entitled ‘‘Class II requirements that members of the public
Document: Automated Blood Cell
Special Controls Guidance Document: submit reports, keep records, or provide
Separator Device Operating by
Automated Blood Cell Separator Device information to a third party. Section
Centrifugal or Filtration Separation
Operating by Centrifugal or Filtration 3506(c)(2)(A) of the PRA (44 U.S.C.
Principle’’ dated January 2005. The draft
Separation Principle’’ dated January 3506(c)(2)(A)) requires Federal agencies
guidance document serves as the special
2005. This special control guidance to provide a 60-day notice in the
control to support the reclassification
identifies the relevant classification Federal Register concerning each
from class III to class II of the automated
regulation, which provides a description proposed collection of information
blood cell separator device operating on
of the applicable automated blood cell before submitting the collection to OMB
a centrifugal or filtration separation
separator. In addition, other sections of for approval. To comply with this
principle intended for the routine
this special control guidance list the requirement, FDA is publishing notice
collection of blood and blood
risks to health identified by FDA and of the proposed collection of
components. This draft guidance
describe measures that, if followed by information set forth in this document.
document describes a means by which
manufacturers and combined with With respect to the following
the automated blood cell separator
general controls, will ordinarily address collection of information, FDA invites
device operating by centrifugal or
the risks associated with these comments on the following topics: (1)
filtration separation principle may
automated blood cell separators. Whether the proposed collection of
comply with the requirement of special
The draft guidance is being issued information is necessary for the proper
controls for class II devices. Elsewhere
consistent with FDA’s good guidance performance of FDA’s functions,
in this issue of the Federal Register,
practices regulation (21 CFR 10.115). including whether the information will
FDA is publishing a proposed rule to
The draft guidance, when finalized, will have practical utility; (2) the accuracy of
reclassify these device types into class
represent the agency’s current thinking FDA’s estimate of the burden of the
II (special controls).
on this topic. It does not create or confer proposed collection of information,
DATES: Submit written or electronic any rights for or on any person and does including the validity of the
comments on the draft guidance by June not operate to bind FDA or the public. methodology and assumptions used; (3)
8, 2005 to ensure their adequate An alternative approach may be used if ways to enhance the quality, utility, and
consideration in preparation of the final such approach satisfies the requirement clarity of the information to be
guidance. General comments on agency of the applicable statutes and collected; and (4) ways to minimize the
guidance documents are welcome at any regulations. burden of the collection of information
time. Submit written comments on the on respondents, including through the
information collection burden by May 9, II. Comments
use of automated collection techniques,
2005. The draft guidance document is being when appropriate, and other forms of
ADDRESSES: Submit written requests for distributed for comment purposes only information technology.
single copies of the draft guidance to the and is not intended for implementation
Office of Communication, Training, and at this time. Interested persons may Draft Guidance for Industry—Class II
Manufacturers Assistance (HFM–40), submit to the Division of Dockets Special Controls Guidance Document:
Center for Biologics Evaluation and Management (see ADDRESSES) written or Automated Blood Cell Separator Device
Research, Food and Drug electronic comments regarding the draft Operating by Centrifugal or Filtration
Administration, 1401 Rockville Pike, guidance. Submit written or electronic Separation Principle
Rockville, MD 20852–1448. Send one comments to ensure adequate Under the Safe Medical Devices Act
self-addressed adhesive label to assist consideration in preparation of the final of 1990 (Public Law 101–629, 104 Stat.
the office in processing your requests. guidance. Submit a single copy of 4511), FDA may establish special
The draft guidance may also be obtained electronic comments or two paper controls, including performance
by mail by calling the Center for copies of any mailed comments, except standards, postmarket surveillance,
Biologics Evaluation and Research that individuals may submit one paper patient registries, guidelines, and other
Voice Information System at 1–800– copy. Comments are to be identified appropriate actions it believes necessary
835–4709 or 301–827–1800. See the with the docket number found in the to provide reasonable assurance of the

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Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices 11991

safety and effectiveness of the device. blood components, should comply with recommends that manufacturers of these
This draft guidance document serves as the same general and special controls. devices file with FDA an annual report
the special control to support the The annual report should include, at for three consecutive years, this would
reclassification from class III to class II a minimum, a summary of anticipated be less burdensome than the current
of the automated blood cell separator and unanticipated donor adverse device postapproval requirements under part
device operating on a centrifugal events that have occurred, such as those 814, subpart E (21 CFR part 814, subpart
separation principle intended for the required under (§ 606.160(b)(1)(iii) 21 E), including the submission of periodic
routine collection of blood and blood CFR 606.160(b)(1)(iii))1 to be recorded reports under § 814.84.
components; and, serves as the special and maintained by the facility using the
Collecting or transfusing facilities,
control for the filtration-based device device to collect blood and blood
and manufacturers have certain
with the same intended use reclassified components, and that might not be
reported by manufacturers under responsibilities under the CFR. Among
as class II in the Federal Register of
Medical Device Reporting (MDR). Also, others, collecting or transfusing
February 28, 2003 (68 FR 9530).
For currently marketed products not equipment failures, including software, facilities are required to maintain
approved under the premarket approval hardware, and disposable item failures’ records of any reports of complaints of
(PMA) process, the manufacturer should should be reported. The reporting of adverse reactions (§ 606.170), while the
file with FDA for 3 consecutive years an adverse device events summarized in an manufacturer is responsible for
annual report on the anniversary date of annual report will alert FDA to trends conducting an investigation of each
the device reclassification from Class III or clusters of events that might be a event that is reasonably known to the
to Class II or, on the anniversary date of safety issue otherwise unreported under manufacturer and evaluating the cause
the 510(k) clearance. Any subsequent the MDR regulation. of the event § 803.50(b)(2) (21 CFR
change to the device requiring the Reclassification of this device from 803.50(b)(2)). In the draft guidance
submission of a premarket notification class III to class II for the intended use document, we recommend that
in accordance with section 510(k) of the of routine collection of blood and blood manufacturers include in their three
Federal Food, Drug, and Cosmetic Act components will relieve manufacturers annual reports a summary of adverse
(the act) (21 U.S.C. 360) should be of the burden of complying with the reactions maintained by the collecting
included in the annual report. Also, a premarket approval requirements of or transfusing facility or similar reports
manufacturer of a device determined to section 515 of the act (21 U.S.C. 360e), of adverse events collected in addition
be substantially equivalent to the and may permit small potential to those required under the MDR
centrifugal or filtration-based automated competitors to enter the marketplace by regulation.
blood cell separator device intended for reducing the burden. Although the FDA estimates the burden of this
the routine collection of blood and special control guidance document collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Annual Frequency per Total Annual Re-
Number of Respondents Hours per Response Total Hours
Response sponses

Annual Report 4 1 4 5 20
1There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA records, there are evaluating the cause of the event http://www.fda.gov/cber/guidelines.htm
approximately four manufacturers of (§ 803.50(b)(2)). or http://www.fda.gov/ohrms/dockets/
automated blood cell separator devices. The reporting recommended in the default.htm.
We estimate that the manufacturers will special control guidance document Dated: March 1, 2005.
spend approximately 5 hours preparing broadens the information to be reported Jeffrey Shuren,
and submitting the annual report. The by manufacturers to FDA. Although the Assistant Commissioner for Policy.
total annual burden of this collection of manufacturer’s reporting burden is [FR Doc. 05–4764 Filed 3–9–05; 8:45 am]
information is estimated at increased, the collection burden BILLING CODE 4160–01–S
approximately 20 hours. remains unchanged. We are
Other burden hours required for recommending that the manufacturer
proposed 21 CFR 864.9245 are already submit annually, for 3 consecutive DEPARTMENT OF HEALTH AND
years, a summary of all adverse events, HUMAN SERVICES
reported and approved under OMB
including those reported under part 803.
control number 0910–0120 (premarket
The Mandatory MedWatch Reporting Office of Inspector General
notification submission 510(k), 21 CFR Form 3500A: Codes Manual, contains a
part 807, subpart E), and OMB control comprehensive list of adverse events Program Exclusions: February 2005
number 0910–0437 (MDR). Currently, associated with device use, including
manufacturers of medical devices are AGENCY: Office of Inspector General,
most of those events that we HHS.
required to submit to FDA individual recommend summarizing in the annual
adverse event reports of death, serious ACTION: Notice of program exclusions.
report.
injury, and malfunctions (§§ 803.50 and During the month of February 2005,
803.53). The manufacturer is IV. Electronic Access
the HHS Office of Inspector General
responsible for conducting an Persons with access to the Internet imposed exclusions in the cases set
investigation of each event and may obtain the draft guidance at either forth below. When an exclusions is

1 21 CFR 606.160(b) ‘‘Records shall be maintained when applicable: * * * (1)(iii) Donor adverse reaction complaints and reports, inlcuding results
that include, but are not limited to, the following of all investigations and followup.’’

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