Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle, 67640-67644 [E7-23285]
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Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Rules and Regulations
seq.). Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity).
Under the Regulatory Flexibility Act,
if a rule has a significant economic
impact on a substantial number of small
entities, an agency must analyze
regulatory options that would minimize
any significant impact of the rule on
small entities. Section 202(a) of the
Unfunded Mandates Reform Act of 1995
requires that agencies prepare a written
statement of anticipated costs and
benefits before proposing any rule that
may result in an expenditure in any 1
year by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
(adjusted annually for inflation).
FDA has determined that this final
rule is consistent with the principles set
out in Executive Order 12866 and in
these two statutes. The final rule is not
a significant regulatory action as defined
by the Executive order and so is not
subject to review under the Executive
order. As explained later in this
document, the final rule will not have
a significant economic impact on a
substantial number of small entities.
The Unfunded Mandates Reform Act
does not require FDA to prepare a
statement of costs and benefits for this
final rule, because the rule is not
expected to result in any 1-year
expenditure that would exceed $100
million adjusted for inflation. The
current inflation adjusted statutory
threshold is about $127 million using
the most current (2006) Implicit Price
Deflator for the Gross Domestic Product.
The purpose of this final rule is to
remove the exemption in
§ 310.201(a)(20) for carbetapentane
citrate from the prescription-dispensing
requirements of section 503(b)(1)(B) of
the act and to remove two entries for
carbetapentane citrate in § 369.21. FDA
has reviewed its Drug Listing System
and determined that there currently are
no marketed OTC drug products that
contain carbetapentane citrate.
Therefore, FDA certifies that this final
rule will not have a significant
economic impact on a substantial
number of small entities. No further
analysis is required under the
Regulatory Flexibility Act (5 U.S.C.
605(b)).
IV. Paperwork Reduction Act of 1995
This final rule contains no collections
of information. Therefore, clearance by
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the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
V. Environmental Impact
§ 310.201
[Amended]
2. In § 310.201 remove and reserve
paragraph (a)(20).
I
PART 369—INTERPRETATIVE
STATEMENTS RE WARNINGS ON
DRUGS AND DEVICES FOR OVERTHE-COUNTER SALE
FDA has determined under 21 CFR
25.31(a) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
I
VI. Federalism
§ 369.21
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that this rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Any effect on the
States, on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government occurred in 1987
when FDA classified carbetapentane
citrate as not generally recognized as
safe and effective for OTC antitussive
use. States had the opportunity to
comment at the time that final rule was
published (52 FR 30042, August 12,
1987). Accordingly, FDA has concluded
that this rule does not contain policies
that have federalism implications as
defined in the Executive order and,
consequently, a federalism summary
impact statement is not required.
4. In § 369.21 remove the following
entries:
‘‘CARBETAPENTANE CITRATE
PREPARATIONS. (See Cough-Due-toCold Preparations.)’’
‘‘‘COUGH-DUE-TOCOLD’PREPARATIONS
(CARBETAPENTANE CITRATE). (See
§ 310.201(a)(20) of this chapter.)
‘Keep out of reach of children. In case
of overdose, get medical help or contact
a Poison Control Center right away.’’’
List of Subjects
21 CFR Part 310
Administrative practice and
procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping
requirements.
21 CFR Part 369
Labeling, Medical devices, Over-thecounter drugs.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 310
and 369 are amended as follows:
PART 310—NEW DRUGS
1. The authority citation for 21 CFR
part 310 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360b–360f, 360j, 361(a), 371, 374,
375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b–263n.
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3. The authority citation for 21 CFR
part 369 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 371.
[Amended]
I
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23207 Filed 11–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 864
[Docket No. 2005N–0017]
Medical Devices; Hematology and
Pathology Devices: Reclassification of
Automated Blood Cell Separator
Device Operating by Centrifugal
Separation Principle
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is reclassifying
from class III to class II the automated
blood cell separator device operating by
centrifugal separation principle and
intended for the routine collection of
blood and blood components. FDA is
taking this action on its own initiative
based on new information. Elsewhere in
this issue of the Federal Register, FDA
is announcing the availability of a
guidance document that will serve as
the special controls for this device, as
well as the special controls for the
device with the same intended use but
operating on a filtration separation
principle.
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Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Rules and Regulations
This rule is effective December
31, 2007. The reclassification date is
November 30, 2007.
FOR FURTHER INFORMATION CONTACT:
Nathaniel L. Geary, Center for Biologics
Evaluation and Research, Food and
Drug Administration (HFM–17), 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
DATES:
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I. Background
The Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 301 et seq.), as
amended by the Medical Device
Amendments of 1976 (the 1976
amendments) (Public Law 94–295), the
Safe Medical Devices Act (SMDA)
(Public Law 101–629), the Food and
Drug Administration Modernization Act
(FDAMA) (Public Law 105–115), and
the Medical Device User Fee and
Modernization Act (Public Law 107–
250) established a comprehensive
system for the regulation of medical
devices intended for human use.
Section 513 of the act (21 U.S.C. 360c)
established three categories (classes) of
devices, depending on the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are as follows:
• Class I (general controls),
• Class II (special controls), and
• Class III (premarket approval).
Under the 1976 amendments, class II
devices were defined as devices for
which there was insufficient
information to show that general
controls themselves would provide
reasonable assurance of safety and
effectiveness, but for which there was
sufficient information to establish
performance standards to provide such
assurance. SMDA broadened the
definition of class II devices to mean
those devices for which the general
controls by themselves are insufficient
to provide reasonable assurance of
safety and effectiveness, but for which
there is sufficient information to
establish special controls to provide
such assurance, including performance
standards, post-market surveillance,
patient registries, development and
dissemination of guidelines,
recommendations, and other
appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the
act).
Under section 513 of the act, devices
that were in commercial distribution
before May 28, 1976 (the date of
enactment of the 1976 amendments),
generally referred to as preamendment
devices, are classified after FDA:
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1. Receives a recommendation from a
device classification panel (an FDA
advisory committee);
2. Publishes the panel’s
recommendation for comment, along
with a proposed regulation classifying
the device; and
3. Publishes a final regulation
classifying the device.
FDA has classified most
preamendments devices under these
procedures.
1. Devices that were not in
commercial distribution before May 28,
1976, generally referred to as
postamendments devices, are classified
automatically by statute (section 513(f)
of the act) (21 U.S.C. 360c(f)) into class
III without any FDA rulemaking
process. Those devices remain in class
III and require premarket approval
unless and until FDA reclassifies the
device into class I or class II.
2. FDA issues an order classifying the
device into class I or II in accordance
with new section 513(f)(2) of the act, as
amended by FDAMA; or
3. FDA issues an order finding the
device to be substantially equivalent,
under section 513(i) of the act (21 U.S.C.
360c(i)), to a predicate device that does
not require premarket approval.
The agency determines whether new
devices are substantially equivalent to
previously offered devices by means of
premarket notification procedures in
section 510(k) of the act (21 U.S.C.
360(k)) and part 807 of the regulations
(21 CFR part 807).
A preamendments device that has
been classified into class III may be
marketed through premarket
notification procedures, without
submission of a premarket approval
application (PMA) until FDA issues a
final regulation under section 515(b) of
the act (21 U.S.C. 360e(b)) requiring
premarket approval.
Section 513(e) of the act governs
reclassification of classified
preamendments devices. This section
provides that FDA may, by rulemaking,
reclassify a device (in a proceeding that
parallels the initial classification
proceeding) based upon ‘‘new
information.’’ FDA can initiate a
reclassification under section 513(e) or
an interested person may petition FDA
to reclassify a preamendments device.
The term ‘‘new information,’’ as used in
section 513(e)(1) of the act, includes
information developed as a result of a
reevaluation of the data before the
agency when the device was originally
classified, as well as information not
presented, not available, or not
developed at that time. (See, e.g.,
Holland Rantos v. United States
Department of Health, Education, and
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Welfare, 587 F.2d 1173, 1174 n.1 (D.C.
Cir. 1978); Upjohn v. Finch, 422 F.2d
944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966)).
Reevaluation of the data previously
before the agency is an appropriate basis
for subsequent regulatory action where
the reevaluation is made in light of
newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at
181; Ethicon, Inc. v. FDA, 762 F.Supp.
382, 389–91 (D.D.C. 1991)), or in light
of changes in ‘‘medical science.’’ (See
Upjohn v. Finch, supra, 422 F.2d at
951). Regardless of whether data before
the agency are past or new data, the
‘‘new information’’ to support
reclassification under section 513(e)(1)
of the act must be ‘‘valid scientific
evidence,’’ as defined in section
513(a)(3) of the act and 21 CFR
860.7(c)(2). (See, e.g., General Medical
Co. v. FDA, 770 F.2d 214 (D.C. Cir.
1985); Contact Lens Assoc. v. FDA, 766
F.2d 592 (D.C. Cir.), cert. denied, 474
U.S. 1062 (1985)). FDA relies upon
‘‘valid scientific evidence’’ in the
classification process to determine the
level of regulation for devices. To be
considered in the reclassification
process, the valid scientific evidence
upon which FDA relies must be
publicly available. Publicly available
information excludes trade secret and/or
confidential commercial information,
e.g., the contents of a pending PMA.
(See section 520(c) of the act (21 U.S.C.
360j(c)).
Section 510(m) of the act (21 U.S.C.
360(m)) provides that FDA exempt a
class II device from the premarket
notification requirements under section
510(k) of the act if FDA determines that
premarket notification is not necessary
to provide reasonable assurance of the
safety and effectiveness of the device.
FDA believes that an automated blood
cell separator device operating by
centrifugal separation principle should
not be exempt from premarket
notification under section 510(m) of the
act because premarket notification is
necessary to provide reasonable
assurance of the safety and effectiveness
of the device.
II. Regulatory History of the Device
The automated blood cell separator
device operating by centrifugal
separation principle intended for the
routine collection of blood and blood
components is a preamendments device
classified into class III.
In the Federal Register of March 10,
2005 (70 FR 11887), based on new
information with respect to the device,
FDA proposed, on its own initiative, to
reclassify from class III to class II the
automated blood cell separator device
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operating by centrifugal separation
principle, when the intended use of the
device is for the routine collection of
blood and blood components. Interested
persons were invited to comment on the
proposed rule by June 8, 2005. FDA
received one comment on the proposed
rule and draft guidance and that
comment was considered as the rule
and guidance were finalized.
Also, FDA is correcting a regulatory
citation in the proposed rule of March
10, 2005 (70 FR 11887), on page 11892,
in the first column, starting in the
second line; ‘‘21 CFR 803.50(b)(2)’’ is
corrected to read ‘‘21 CFR
803.50(b)(3))’’.
FDA also identified the draft guidance
entitled ‘‘Guidance for Industry and
FDA Staff: Class II Special Controls
Guidance Document: Automated Blood
Cell Separator Device Operating by
Centrifugal or Filtration Separation
Principle’’ as the proposed special
controls capable of providing reasonable
assurance of safety and effectiveness for
these devices.
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III. Summary of Final Rule
Under section 513(e) of the act and
§ 860.130 (21 CFR 860.130), based on
new information and on its own
initiative, FDA is reclassifying from
class III to class II (special controls) the
automated blood cell separator device
operating by centrifugal separation
principle and intended for the routine
collection of blood and blood
components. The special controls in
conjunction with general controls will
provide reasonable assurance of the
safety and effectiveness of the device.
For all other uses, including therapeutic
apheresis, the device remains in its
current classification as class III. All
therapeutic apheresis (blood cell
separator) devices are regulated by the
Center for Devices and Radiological
Health and are not part of § 864.9245 (21
CFR 864.9245).
The automated blood cell separator
device operating by centrifugal
separation principle is assigned the
generic name, automated blood cell
separator. It is identified as a device that
automatically withdraws whole blood
from a donor, separates the blood into
components, retains one or more
components, and returns the remainder
of the blood to the donor. This final rule
removes reference in § 864.9245, to the
words that were in parentheses,
specifically, red blood cells, white blood
cells, plasma, and platelets. The
components obtained are transfused or
used for further manufacturing. The
separation bowls of centrifugal blood
cell separators may be reusable or
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disposable, as specified by the device
manufacturer.
Also in this rule, we are removing
from § 864.9245(b), the list of special
controls for the class II automated blood
cell separator device operating by
filtration separation principle and
intended for the routine collection of
blood and blood components. The
special controls guidance entitled
‘‘Guidance for Industry and FDA Staff:
Class II Special Controls Guidance
Document: Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Principle’’ will
provide the special controls for both
filtration- and centrifugal-based
automated blood cell separator devices
intended for the routine collection of
blood and blood components. The
availability of this guidance is
announced elsewhere in this issue of
the Federal Register.
The special controls guidance
document recommends that the
manufacturer file with FDA for 3
consecutive years an annual report on
the anniversary date of the final rule for
reclassification or on the anniversary
date of 510(k) clearance. Each annual
report should include, at a minimum,
the following information:
• A summary of anticipated and
unanticipated donor adverse events that
have occurred and that are not required
to be reported by manufacturers under
part 803 (21 CFR part 803) Medical
Device Reporting (MDR);
• Any subsequent change to the
device requiring the submission of a
premarket notification in accordance
with section 510(k) of the act;
• Any subsequent change to the
preamendments class III device
requiring a 30-day notice in accordance
with § 814.39(f) (21 CFR 814.39(f)).
For this type of device, FDA has
determined that premarket notification
is necessary to provide reasonable
assurance of the safety and effectiveness
of the device and, therefore, the type of
device is not exempt from premarket
notification requirements. Prior to
marketing the device, persons must
submit to FDA a premarket notification
containing information about the
automated blood cell separator device
they intend to market. Following the
effective date of this final rule, any firm
submitting a 510(k) premarket
notification for an automated blood cell
separator device operating by filtration
or centrifugal separation principle and
intended for the routine collection of
blood and blood components will need
to address the issues covered in the
special controls guidance. However, the
firm need only show that its device
meets the recommendations of the
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guidance or in some other way provides
equivalent assurance of safety and
effectiveness.
IV. Analysis of Comments on the
Proposed Rule and FDA’s Response
FDA received one comment on the
proposed rule. The comment supported
the reclassification of the automated
blood cell separator device operating by
centrifugal separation principle and
intended for the routine collection of
blood and blood components. In
addition, the comment provided
specific questions about the reporting
requirements in the special controls
guidance document and asked FDA to
clarify these reporting requirements.
We first provide a general response to
the comment and then respond to the
questions submitted in the comment. To
make it easier to identify the questions
provided in the comment and our
responses, the word ‘‘Comment,’’ in
parentheses, will appear before the
description of the question, and the
word ‘‘Response,’’ in parentheses, will
appear before our response. We
numbered the comments to distinguish
the questions.
When the device is reclassified, all
manufacturers of currently marketed
automated blood cell separators
operating by centrifugal separation
principle not approved under the
premarket approval process should file
annual reports for 3 consecutive years
on the anniversary date of
reclassification of the device from class
III to class II, or on the anniversary date
of the 510(k) clearance. Within the 3year reporting period, any subsequent
change to the device requiring a 510(k)
should be included in the annual report.
The criteria for reporting changes to the
device and its labeling under 510(k) are
delineated in FDA’s guidance ‘‘Deciding
When to Submit a 510(k) for a Change
to an Existing Device,’’ January 10,
1997.
However, manufacturers of automated
blood cell separator devices operating
by filtration separation principle that
were classified into class II (68 FR 9530,
February 28, 2003) were subject to the
special controls of § 864.9245 issued in
2003, requiring 3 consecutive years of
submitting annual reports. These
devices are not required to initiate
another cycle of annual reports as a
result of the change of special controls
for those devices codified by this rule.
Under §§ 606.160(b)(1)(iii) and
606.170 (21 CFR 606.160(b)(1)(iii) and
606.170), the facility using the device to
collect blood and blood components is
required to keep records of donor
adverse reaction complaints and reports,
including results of all investigations
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and followup. Under § 803.50(b)(3),
manufacturers are responsible for
conducting an investigation of each
event and evaluating the cause of the
event. The special controls would have
the manufacturer summarize this
information and submit it to FDA in the
annual report.
Specific questions submitted in the
comment and FDA’s responses:
(Comment 1) Do you intend to request
3-year annual reporting only for the
initial 510(k) clearance for the
automated blood cell separator device?
(Response) Yes. The 3-year annual
reporting described in the special
controls guidance document
recommends annual reporting only for
the initial 510(k) clearance. Any
subsequent change to the device within
this 3-year reporting period requiring
the submission of a premarket
notification in accordance with section
510(k) of the act should be included in
the annual report. However, the
submission of this 510(k) information
concerning a change to the device
would not restart the 3-year reporting
period.
(Comment 2) Is it correct that for a
device originally approved under the
PMA process, then switched to a 510(k),
annual reporting would not be required?
(Response) Yes, this is correct, if an
automated blood cell separator device
intended for the routine collection of
blood and blood components was
originally approved under the PMA
process.
(Comment 3) Does this reporting
requirement apply to all automated
blood cell separator devices operating
by centrifugal or filtration separation
principle intended for the routine
collection of blood and blood
components regardless of when the
original clearance was granted? Would
any preamendments devices be
‘‘grandfathered’’ in so that the reporting
would not be required?
(Response) The reporting
recommended in the special controls
guidance applies to currently marketed
products not approved under the PMA
process. The 3-year annual reporting for
these products should begin on the
anniversary date of the device
reclassification from class III to class II,
or, on the anniversary date of 510(k)
clearance.
In this rulemaking, we are
reclassifying the automated blood cell
separator device operating by
centrifugal separation principle from
class III to class II. Therefore, the
reclassification date from class III to
class II for the automated blood cell
separator device operating by
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centrifugal separation principle and
intended for the routine collection of
blood and blood components is the date
of publication in the Federal Register of
this final rule (see DATES). The
reclassification date from class III to
class II for the automated blood cell
separator device operating by filtration
separation principle and intended for
the routine collection of blood and
blood components is February 28, 2003.
Devices in commercial distribution
before May 28, 1976, are also referred to
as preamendments devices. On
September 12, 1980 (45 FR 60643), FDA
issued a final rule classifying these
preamendment automated blood cell
separator devices as class III (premarket
approval). The 1976 amendments did
not immediately subject preamendment
devices classified in class III to the
preamendment process. In the
regulation (§ 864.9245), FDA did not set
a deadline for the submission of
premarket approval applications for the
device. That regulation is amended in
this rulemaking to reclassify the device
from class III to class II. Therefore,
preamendments devices are subject to
this rulemaking, and the special
controls guidance document as of the
anniversary date of device
reclassification from class III to class II.
V. FDA’s Conclusion
Therefore, under section 513 of the
act, FDA is adopting the summary of
reasons for the Panel’s recommendation
and the summary of data upon which
the Panel’s recommendation is based
(70 FR 11887 at 11890). FDA is also
adopting the risks to public health
stated in the proposed rule (70 FR 11887
at 11891). Furthermore, FDA is issuing
a final rule that revises § 864.9245,
thereby, reclassifying the generic type of
device, automated blood cell separator
operated by centrifugal separation
principle and intended for the routine
collection of blood and blood
components from class III into class II.
VI. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is not a
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67643
significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. The reclassification of
automated blood cell separator devices
from class III to class II will relieve
manufacturers of the cost of complying
with the premarket approval
requirements in section 515 of the act.
Although the special controls guidance
document recommends that
manufacturers of these devices file with
FDA an annual report for 3 consecutive
years, this is less burdensome than the
current premarket approval
requirements, including the submission
of periodic reports (21 CFR 814.84). By
eliminating the need for premarket
approval applications, reclassification
will reduce regulatory costs with respect
to these devices, impose no significant
economic impact on any small entities,
and may permit small potential
competitors to enter the marketplace by
lowering their costs. The agency
therefore certifies that this final rule
will not have a significant impact on a
substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $127
million, using the most current (2006)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
VII. Environmental Impact
The agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
VIII. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
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Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
IX. Paperwork Reduction Act of 1995
This final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) is not required. FDA
concludes that the special controls
guidance document contains
information collection provisions that
are subject to review and clearance by
OMB under the PRA. Elsewhere in this
issue of the Federal Register, FDA is
publishing a notice announcing the
availability of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Automated Blood
Cell Separator Device Operating by
Centrifugal of Filtration Separation
Principle.’’ The notice contains an
analysis of the paperwork burden for the
guidance.
List of Subjects in 21 CFR Part 864
Blood, Medical devices, Packaging
and containers.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 864 is
amended as follows:
PART 864—HEMATOLOGY AND
PATHOLOGY DEVICES
1. The authority citation for 21 CFR
part 864 continues to read as follows:
I
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 864.9245 is revised to read
as follows:
I
rwilkins on PROD1PC63 with RULES
§ 864.9245
separator.
Automated blood cell
(a) Identification. An automated blood
cell separator is a device that uses a
centrifugal or filtration separation
principle to automatically withdraw
whole blood from a donor, separate the
whole blood into blood components,
collect one or more of the blood
components, and return to the donor the
remainder of the whole blood and blood
components. The automated blood cell
separator device is intended for routine
collection of blood and blood
components for transfusion or further
manufacturing use.
VerDate Aug<31>2005
16:09 Nov 29, 2007
Jkt 214001
(b) Classification. Class II (special
controls). The special control for this
device is a guidance for industry and
FDA staff entitled ‘‘Class II Special
Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle.’’
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23285 Filed 11–29–07; 8:45 am]
BILLING CODE 4160–01–S
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Part 4022
Benefits Payable in Terminated SingleEmployer Plans
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
SUMMARY: This rule amends Appendix D
to the Pension Benefit Guaranty
Corporation’s regulation on Benefits
Payable in Terminated Single-Employer
Plans by adding the maximum
guaranteeable pension benefit that may
be paid by the PBGC with respect to a
plan participant in a single-employer
pension plan that terminates in 2008.
The amendment is necessary because
the maximum guarantee amount
changes each year, based on changes in
the contribution and benefit base under
section 230 of the Social Security Act.
The effect of the amendment is to advise
plan administrators, participants and
beneficiaries of the increased maximum
guarantee amount for 2008.
DATES: Effective Date: January 1, 2008.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion, Manager, Regulatory
and Policy Division, Legislative and
Regulatory Department, Pension Benefit
Guaranty Corporation, 1200 K Street,
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll-free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: Section
4022(b) of the Employee Retirement
Income Security Act of 1974 provides
for certain limitations on benefits
guaranteed by the PBGC in terminating
single-employer pension plans covered
under Title IV of ERISA. One of the
limitations, set forth in section
4022(b)(3)(B), is a dollar ceiling on the
amount of the monthly benefit that may
be paid to a plan participant (in the
form of a life annuity beginning at age
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
65) by the PBGC. The ceiling is equal to
‘‘$750 multiplied by a fraction, the
numerator of which is the contribution
and benefit base (determined under
section 230 of the Social Security Act)
in effect at the time the plan terminates
and the denominator of which is such
contribution and benefit base in effect in
calendar year 1974 [$13,200].’’ This
formula is also set forth in § 4022.22(b)
of the PBGC’s regulation on Benefits
Payable in Terminated Single-Employer
Plans (29 CFR part 4022). Appendix D
to part 4022 lists, for each year
beginning with 1974, the maximum
guaranteeable benefit payable by the
PBGC to participants in single-employer
plans that have terminated in that year.
Section 230(d) of the Social Security
Act (42 U.S.C. 430(d)) provides special
rules for determining the contribution
and benefit base for purposes of ERISA
section 4022(b)(3)(B). Each year the
Social Security Administration
determines, and notifies the PBGC of,
the contribution and benefit base to be
used by the PBGC under these
provisions, and the PBGC publishes an
amendment to Appendix D to part 4022
to add the guarantee limit for the
coming year.
The PBGC has been notified by the
Social Security Administration that,
under section 230 of the Social Security
Act, $75,900 is the contribution and
benefit base that is to be used to
calculate the PBGC maximum
guaranteeable benefit for 2008.
Accordingly, the formula under section
4022(b)(3)(B) of ERISA and 29 CFR
4022.22(b) is: $750 multiplied by
$75,900/$13,200. Thus, the maximum
monthly benefit guaranteeable by the
PBGC in 2008 is $4,312.50 per month in
the form of a life annuity beginning at
age 65. This amendment updates
Appendix D to part 4022 to add this
maximum guaranteeable amount for
plans that terminate in 2008. (If a
benefit is payable in a different form or
begins at a different age, the maximum
guaranteeable amount is the actuarial
equivalent of $4,312.50 per month.)
General notice of proposed
rulemaking is unnecessary. The
maximum guaranteeable benefit is
determined according to the formula in
section 4022(b)(3)(B) of ERISA, and
these amendments make no change in
its method of calculation but simply list
2008 maximum guaranteeable benefit
amounts for the information of the
public.
The PBGC has determined that this
action is not a ‘‘significant regulatory
action’’ under the criteria set forth in
Executive Order 12866.
Because no general notice of proposed
rulemaking is required for this
E:\FR\FM\30NOR1.SGM
30NOR1
]]>Agencies
[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Rules and Regulations]
[Pages 67640-67644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23285]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 864
[Docket No. 2005N-0017]
Medical Devices; Hematology and Pathology Devices:
Reclassification of Automated Blood Cell Separator Device Operating by
Centrifugal Separation Principle
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reclassifying from
class III to class II the automated blood cell separator device
operating by centrifugal separation principle and intended for the
routine collection of blood and blood components. FDA is taking this
action on its own initiative based on new information. Elsewhere in
this issue of the Federal Register, FDA is announcing the availability
of a guidance document that will serve as the special controls for this
device, as well as the special controls for the device with the same
intended use but operating on a filtration separation principle.
[[Page 67641]]
DATES: This rule is effective December 31, 2007. The reclassification
date is November 30, 2007.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research, Food and Drug Administration (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act (SMDA)
(Public Law 101-629), the Food and Drug Administration Modernization
Act (FDAMA) (Public Law 105-115), and the Medical Device User Fee and
Modernization Act (Public Law 107-250) established a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the act (21 U.S.C. 360c) established three categories
(classes) of devices, depending on the regulatory controls needed to
provide reasonable assurance of their safety and effectiveness. The
three categories of devices are as follows:
Class I (general controls),
Class II (special controls), and
Class III (premarket approval).
Under the 1976 amendments, class II devices were defined as devices
for which there was insufficient information to show that general
controls themselves would provide reasonable assurance of safety and
effectiveness, but for which there was sufficient information to
establish performance standards to provide such assurance. SMDA
broadened the definition of class II devices to mean those devices for
which the general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but for which there
is sufficient information to establish special controls to provide such
assurance, including performance standards, post-market surveillance,
patient registries, development and dissemination of guidelines,
recommendations, and other appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the act).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendment devices, are
classified after FDA:
1. Receives a recommendation from a device classification panel (an
FDA advisory committee);
2. Publishes the panel's recommendation for comment, along with a
proposed regulation classifying the device; and
3. Publishes a final regulation classifying the device.
FDA has classified most preamendments devices under these
procedures.
1. Devices that were not in commercial distribution before May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) (21 U.S.C.
360c(f)) into class III without any FDA rulemaking process. Those
devices remain in class III and require premarket approval unless and
until FDA reclassifies the device into class I or class II.
2. FDA issues an order classifying the device into class I or II in
accordance with new section 513(f)(2) of the act, as amended by FDAMA;
or
3. FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the act (21 U.S.C. 360c(i)), to a
predicate device that does not require premarket approval.
The agency determines whether new devices are substantially
equivalent to previously offered devices by means of premarket
notification procedures in section 510(k) of the act (21 U.S.C. 360(k))
and part 807 of the regulations (21 CFR part 807).
A preamendments device that has been classified into class III may
be marketed through premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Section 513(e) of the act governs reclassification of classified
preamendments devices. This section provides that FDA may, by
rulemaking, reclassify a device (in a proceeding that parallels the
initial classification proceeding) based upon ``new information.'' FDA
can initiate a reclassification under section 513(e) or an interested
person may petition FDA to reclassify a preamendments device. The term
``new information,'' as used in section 513(e)(1) of the act, includes
information developed as a result of a reevaluation of the data before
the agency when the device was originally classified, as well as
information not presented, not available, or not developed at that
time. (See, e.g., Holland Rantos v. United States Department of Health,
Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978);
Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966)).
Reevaluation of the data previously before the agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951). Regardless of
whether data before the agency are past or new data, the ``new
information'' to support reclassification under section 513(e)(1) of
the act must be ``valid scientific evidence,'' as defined in section
513(a)(3) of the act and 21 CFR 860.7(c)(2). (See, e.g., General
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc.
v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)).
FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which FDA relies must be publicly available. Publicly
available information excludes trade secret and/or confidential
commercial information, e.g., the contents of a pending PMA. (See
section 520(c) of the act (21 U.S.C. 360j(c)).
Section 510(m) of the act (21 U.S.C. 360(m)) provides that FDA
exempt a class II device from the premarket notification requirements
under section 510(k) of the act if FDA determines that premarket
notification is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. FDA believes that an automated
blood cell separator device operating by centrifugal separation
principle should not be exempt from premarket notification under
section 510(m) of the act because premarket notification is necessary
to provide reasonable assurance of the safety and effectiveness of the
device.
II. Regulatory History of the Device
The automated blood cell separator device operating by centrifugal
separation principle intended for the routine collection of blood and
blood components is a preamendments device classified into class III.
In the Federal Register of March 10, 2005 (70 FR 11887), based on
new information with respect to the device, FDA proposed, on its own
initiative, to reclassify from class III to class II the automated
blood cell separator device
[[Page 67642]]
operating by centrifugal separation principle, when the intended use of
the device is for the routine collection of blood and blood components.
Interested persons were invited to comment on the proposed rule by June
8, 2005. FDA received one comment on the proposed rule and draft
guidance and that comment was considered as the rule and guidance were
finalized.
Also, FDA is correcting a regulatory citation in the proposed rule
of March 10, 2005 (70 FR 11887), on page 11892, in the first column,
starting in the second line; ``21 CFR 803.50(b)(2)'' is corrected to
read ``21 CFR 803.50(b)(3))''.
FDA also identified the draft guidance entitled ``Guidance for
Industry and FDA Staff: Class II Special Controls Guidance Document:
Automated Blood Cell Separator Device Operating by Centrifugal or
Filtration Separation Principle'' as the proposed special controls
capable of providing reasonable assurance of safety and effectiveness
for these devices.
III. Summary of Final Rule
Under section 513(e) of the act and Sec. 860.130 (21 CFR 860.130),
based on new information and on its own initiative, FDA is
reclassifying from class III to class II (special controls) the
automated blood cell separator device operating by centrifugal
separation principle and intended for the routine collection of blood
and blood components. The special controls in conjunction with general
controls will provide reasonable assurance of the safety and
effectiveness of the device. For all other uses, including therapeutic
apheresis, the device remains in its current classification as class
III. All therapeutic apheresis (blood cell separator) devices are
regulated by the Center for Devices and Radiological Health and are not
part of Sec. 864.9245 (21 CFR 864.9245).
The automated blood cell separator device operating by centrifugal
separation principle is assigned the generic name, automated blood cell
separator. It is identified as a device that automatically withdraws
whole blood from a donor, separates the blood into components, retains
one or more components, and returns the remainder of the blood to the
donor. This final rule removes reference in Sec. 864.9245, to the
words that were in parentheses, specifically, red blood cells, white
blood cells, plasma, and platelets. The components obtained are
transfused or used for further manufacturing. The separation bowls of
centrifugal blood cell separators may be reusable or disposable, as
specified by the device manufacturer.
Also in this rule, we are removing from Sec. 864.9245(b), the list
of special controls for the class II automated blood cell separator
device operating by filtration separation principle and intended for
the routine collection of blood and blood components. The special
controls guidance entitled ``Guidance for Industry and FDA Staff: Class
II Special Controls Guidance Document: Automated Blood Cell Separator
Device Operating by Centrifugal or Filtration Principle'' will provide
the special controls for both filtration- and centrifugal-based
automated blood cell separator devices intended for the routine
collection of blood and blood components. The availability of this
guidance is announced elsewhere in this issue of the Federal Register.
The special controls guidance document recommends that the
manufacturer file with FDA for 3 consecutive years an annual report on
the anniversary date of the final rule for reclassification or on the
anniversary date of 510(k) clearance. Each annual report should
include, at a minimum, the following information:
A summary of anticipated and unanticipated donor adverse
events that have occurred and that are not required to be reported by
manufacturers under part 803 (21 CFR part 803) Medical Device Reporting
(MDR);
Any subsequent change to the device requiring the
submission of a premarket notification in accordance with section
510(k) of the act;
Any subsequent change to the preamendments class III
device requiring a 30-day notice in accordance with Sec. 814.39(f) (21
CFR 814.39(f)).
For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device and, therefore, the type of device is
not exempt from premarket notification requirements. Prior to marketing
the device, persons must submit to FDA a premarket notification
containing information about the automated blood cell separator device
they intend to market. Following the effective date of this final rule,
any firm submitting a 510(k) premarket notification for an automated
blood cell separator device operating by filtration or centrifugal
separation principle and intended for the routine collection of blood
and blood components will need to address the issues covered in the
special controls guidance. However, the firm need only show that its
device meets the recommendations of the guidance or in some other way
provides equivalent assurance of safety and effectiveness.
IV. Analysis of Comments on the Proposed Rule and FDA's Response
FDA received one comment on the proposed rule. The comment
supported the reclassification of the automated blood cell separator
device operating by centrifugal separation principle and intended for
the routine collection of blood and blood components. In addition, the
comment provided specific questions about the reporting requirements in
the special controls guidance document and asked FDA to clarify these
reporting requirements.
We first provide a general response to the comment and then respond
to the questions submitted in the comment. To make it easier to
identify the questions provided in the comment and our responses, the
word ``Comment,'' in parentheses, will appear before the description of
the question, and the word ``Response,'' in parentheses, will appear
before our response. We numbered the comments to distinguish the
questions.
When the device is reclassified, all manufacturers of currently
marketed automated blood cell separators operating by centrifugal
separation principle not approved under the premarket approval process
should file annual reports for 3 consecutive years on the anniversary
date of reclassification of the device from class III to class II, or
on the anniversary date of the 510(k) clearance. Within the 3-year
reporting period, any subsequent change to the device requiring a
510(k) should be included in the annual report. The criteria for
reporting changes to the device and its labeling under 510(k) are
delineated in FDA's guidance ``Deciding When to Submit a 510(k) for a
Change to an Existing Device,'' January 10, 1997.
However, manufacturers of automated blood cell separator devices
operating by filtration separation principle that were classified into
class II (68 FR 9530, February 28, 2003) were subject to the special
controls of Sec. 864.9245 issued in 2003, requiring 3 consecutive
years of submitting annual reports. These devices are not required to
initiate another cycle of annual reports as a result of the change of
special controls for those devices codified by this rule.
Under Sec. Sec. 606.160(b)(1)(iii) and 606.170 (21 CFR
606.160(b)(1)(iii) and 606.170), the facility using the device to
collect blood and blood components is required to keep records of donor
adverse reaction complaints and reports, including results of all
investigations
[[Page 67643]]
and followup. Under Sec. 803.50(b)(3), manufacturers are responsible
for conducting an investigation of each event and evaluating the cause
of the event. The special controls would have the manufacturer
summarize this information and submit it to FDA in the annual report.
Specific questions submitted in the comment and FDA's responses:
(Comment 1) Do you intend to request 3-year annual reporting only
for the initial 510(k) clearance for the automated blood cell separator
device?
(Response) Yes. The 3-year annual reporting described in the
special controls guidance document recommends annual reporting only for
the initial 510(k) clearance. Any subsequent change to the device
within this 3-year reporting period requiring the submission of a
premarket notification in accordance with section 510(k) of the act
should be included in the annual report. However, the submission of
this 510(k) information concerning a change to the device would not
restart the 3-year reporting period.
(Comment 2) Is it correct that for a device originally approved
under the PMA process, then switched to a 510(k), annual reporting
would not be required?
(Response) Yes, this is correct, if an automated blood cell
separator device intended for the routine collection of blood and blood
components was originally approved under the PMA process.
(Comment 3) Does this reporting requirement apply to all automated
blood cell separator devices operating by centrifugal or filtration
separation principle intended for the routine collection of blood and
blood components regardless of when the original clearance was granted?
Would any preamendments devices be ``grandfathered'' in so that the
reporting would not be required?
(Response) The reporting recommended in the special controls
guidance applies to currently marketed products not approved under the
PMA process. The 3-year annual reporting for these products should
begin on the anniversary date of the device reclassification from class
III to class II, or, on the anniversary date of 510(k) clearance.
In this rulemaking, we are reclassifying the automated blood cell
separator device operating by centrifugal separation principle from
class III to class II. Therefore, the reclassification date from class
III to class II for the automated blood cell separator device operating
by centrifugal separation principle and intended for the routine
collection of blood and blood components is the date of publication in
the Federal Register of this final rule (see DATES). The
reclassification date from class III to class II for the automated
blood cell separator device operating by filtration separation
principle and intended for the routine collection of blood and blood
components is February 28, 2003.
Devices in commercial distribution before May 28, 1976, are also
referred to as preamendments devices. On September 12, 1980 (45 FR
60643), FDA issued a final rule classifying these preamendment
automated blood cell separator devices as class III (premarket
approval). The 1976 amendments did not immediately subject preamendment
devices classified in class III to the preamendment process. In the
regulation (Sec. 864.9245), FDA did not set a deadline for the
submission of premarket approval applications for the device. That
regulation is amended in this rulemaking to reclassify the device from
class III to class II. Therefore, preamendments devices are subject to
this rulemaking, and the special controls guidance document as of the
anniversary date of device reclassification from class III to class II.
V. FDA's Conclusion
Therefore, under section 513 of the act, FDA is adopting the
summary of reasons for the Panel's recommendation and the summary of
data upon which the Panel's recommendation is based (70 FR 11887 at
11890). FDA is also adopting the risks to public health stated in the
proposed rule (70 FR 11887 at 11891). Furthermore, FDA is issuing a
final rule that revises Sec. 864.9245, thereby, reclassifying the
generic type of device, automated blood cell separator operated by
centrifugal separation principle and intended for the routine
collection of blood and blood components from class III into class II.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The reclassification of automated blood cell
separator devices from class III to class II will relieve manufacturers
of the cost of complying with the premarket approval requirements in
section 515 of the act. Although the special controls guidance document
recommends that manufacturers of these devices file with FDA an annual
report for 3 consecutive years, this is less burdensome than the
current premarket approval requirements, including the submission of
periodic reports (21 CFR 814.84). By eliminating the need for premarket
approval applications, reclassification will reduce regulatory costs
with respect to these devices, impose no significant economic impact on
any small entities, and may permit small potential competitors to enter
the marketplace by lowering their costs. The agency therefore certifies
that this final rule will not have a significant impact on a
substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National
[[Page 67644]]
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
the agency has concluded that the rule does not contain policies that
have federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
IX. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) is not required. FDA concludes
that the special controls guidance document contains information
collection provisions that are subject to review and clearance by OMB
under the PRA. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice announcing the availability of the guidance
document entitled ``Class II Special Controls Guidance Document:
Automated Blood Cell Separator Device Operating by Centrifugal of
Filtration Separation Principle.'' The notice contains an analysis of
the paperwork burden for the guidance.
List of Subjects in 21 CFR Part 864
Blood, Medical devices, Packaging and containers.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
864 is amended as follows:
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
0
1. The authority citation for 21 CFR part 864 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 864.9245 is revised to read as follows:
Sec. 864.9245 Automated blood cell separator.
(a) Identification. An automated blood cell separator is a device
that uses a centrifugal or filtration separation principle to
automatically withdraw whole blood from a donor, separate the whole
blood into blood components, collect one or more of the blood
components, and return to the donor the remainder of the whole blood
and blood components. The automated blood cell separator device is
intended for routine collection of blood and blood components for
transfusion or further manufacturing use.
(b) Classification. Class II (special controls). The special
control for this device is a guidance for industry and FDA staff
entitled ``Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Separation
Principle.''
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23285 Filed 11-29-07; 8:45 am]
BILLING CODE 4160-01-S
