Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, 45883-45888 [E7-15943]
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Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Rules and Regulations
Backfit Analysis
The NRC has determined that the
backfit rule (10 CFR 72.62) does not
apply to this direct final rule because
this amendment does not involve any
provisions that would impose backfits
as defined in 10 CFR Chapter I.
Therefore, a backfit analysis is not
required.
Congressional Review Act
Under the Congressional Review Act
of 1996, the NRC has determined that
this action is not a major rule and has
verified this determination with the
Office of Information and Regulatory
Affairs, Office of Management and
Budget.
Section 72.44(g) also issued under secs.
142(b) and 148(c), (d), Pub. L. 100–203, 101
Stat. 1330–232, 1330–236 (42 U.S.C.
10162(b), 10168(c), (d)). Section 72.46 also
issued under sec. 189, 68 Stat. 955 (42 U.S.C.
2239); sec. 134, Pub. L. 97–425, 96 Stat. 2230
(42 U.S.C. 10154). Section 72.96(d) also
issued under sec. 145(g), Pub. L. 100–203,
101 Stat. 1330–235 (42 U.S.C. 10165(g)).
Subpart J also issued under secs. 2(2), 2(15),
2(19), 117(a), 141(h), Pub. L. 97–425, 96 Stat.
2202, 2203, 2204, 2222, 2244 (42 U.S.C.
10101, 10137(a), 10161(h)). Subparts K and L
are also issued under sec. 133, 98 Stat. 2230
(42 U.S.C. 10153) and sec. 218(a), 96 Stat.
2252 (42 U.S.C. 10198).
2. In § 72.214, Certificate of
Compliance 1027 is revised to read as
follows:
I
List of Subjects in 10 CFR Part 72
§ 72.214 List of approved spent fuel
storage casks.
Administrative practice and
procedure, Criminal penalties,
Manpower training programs, Nuclear
materials, Occupational safety and
health, Penalties, Radiation protection,
Reporting and recordkeeping
requirements, Security measures, Spent
fuel, Whistleblowing.
*
For the reasons set out in the
preamble and under the authority of the
Atomic Energy Act of 1954, as amended;
the Energy Reorganization Act of 1974,
as amended; the Nuclear Waste Policy
Act of 1982, as amended; and 5 U.S.C.
552 and 553; the NRC is adopting the
following amendments to 10 CFR part
72.
I
PART 72—LICENSING
REQUIREMENTS FOR THE
INDEPENDENT STORAGE OF SPENT
NUCLEAR FUEL, HIGH-LEVEL
RADIOACTIVE WASTE, AND
REACTOR-RELATED GREATER THAN
CLASS C WASTE
1. The authority citation for part 72
continues to read as follows:
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I
17:52 Aug 15, 2007
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Dated at Rockville, Maryland, this 31st day
of July, 2007.
For the Nuclear Regulatory Commission.
Martin J. Virgilio,
Acting Executive Director for Operations.
[FR Doc. E7–16134 Filed 8–15–07; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Authority: Secs. 51, 53, 57, 62, 63, 65, 69,
81, 161, 182, 183, 184, 186, 187, 189, 68 Stat.
929, 930, 932, 933, 934, 935, 948, 953, 954,
955, as amended, sec. 234, 83 Stat. 444, as
amended (42 U.S.C. 2071, 2073, 2077, 2092,
2093, 2095, 2099, 2111, 2201, 2232, 2233,
2234, 2236, 2237, 2238, 2282); sec. 274, Pub.
L. 86–373, 73 Stat. 688, as amended (42
U.S.C. 2021); sec. 201, as amended, 202, 206,
88 Stat. 1242, as amended, 1244, 1246 (42
U.S.C. 5841, 5842, 5846); Pub. L. 95–601, sec.
10, 92 Stat. 2951 as amended by Pub. L. 102–
486, sec. 7902, 106 Stat. 3123 (42 U.S.C.
5851); sec. 102, Pub. L. 91–190, 83 Stat. 853
(42 U.S.C. 4332); secs. 131, 132, 133, 135,
137, 141, Pub. L. 97–425, 96 Stat. 2229, 2230,
2232, 2241, sec. 148, Pub. L. 100–203, 101
Stat. 1330–235 (42 U.S.C. 10151, 10152,
10153, 10155, 10157, 10161, 10168); sec.
1704, 112 Stat. 2750 (44 U.S.C. 3504 note);
sec. 651(e), Pub. L. 109–58, 119 Stat. 806–10
(42 U.S.C. 2014, 2021, 2021b, 2111).
VerDate Aug<31>2005
*
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Certificate Number: 1027.
Initial Certificate Effective Date: May
30, 2000.
Amendment Number 1 Effective Date:
October 30, 2007.
SAR Submitted by: Transnuclear, Inc.
SAR Title: Final Safety Analysis
Report for the TN–68 Dry Storage Cask.
Docket Number: 72–1027.
Certificate Expiration Date: May 28,
2020.
Model Number: TN–68.
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21 CFR Parts 606, 607, 610, and 640
[Docket No. 2007N–0264]
Revisions to the Requirements
Applicable to Blood, Blood
Components and Source Plasma
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Direct final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
biologics regulations by removing,
revising, or updating specific
regulations applicable to blood, blood
components and Source Plasma to be
more consistent with current practices
in the blood industry and to remove
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unnecessary or outdated requirements.
We are taking this action as part of our
continuing effort to reduce the burden
of unnecessary regulations on industry
and to revise outdated regulations
without diminishing public health
protection.
Elsewhere in this issue of the Federal
Register, we are publishing a
companion proposed rule under our
usual procedures for notice and
comment in the event that we receive
any significant adverse comments on
the direct final rule. If we receive any
significant adverse comments that
warrant terminating the direct final rule,
we will consider such comments on the
proposed rule in developing the final
rule.
DATES: This direct final rule is effective
February 19, 2008. Submit written or
electronic comments by October 30,
2007. If we receive no significant
adverse comments during the specified
comment period, we intend to publish
a confirmation document on or before
the effective date of this direct final rule
confirming that the direct final rule will
go into effect on February 19, 2008. If
we receive any significant adverse
comments during the comment period,
we intend to withdraw this direct final
rule before its effective date by a notice
published in the Federal Register.
ADDRESSES: You may submit comments,
identified by Docket No. 2007N–0264,
by any of the folllowing methods:
Electronic Submissions
Submit electronic comments in the
following ways:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD-ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, FDA is no longer accepting
comments submitted to the agency by email. FDA encourages you to continue
to submit electronic comments by using
the Federal eRulemaking Portal or the
agency Web site, as described
previously, in the ADDRESSES portion of
this document under Electronic
Submissions.
Instructions: All submissions received
must include the agency name and
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Federal Register / Vol. 72, No. 158 / Thursday, August 16, 2007 / Rules and Regulations
Docket No(s). and Regulatory
Information Number (RIN) (if a RIN
number has been assigned) for this
rulemaking. All comments received may
be posted without change to https://
www.fda.gov/ohrms/dockets/
default.htm, including any personal
information provided. For additional
information on submitting comments,
see the ‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
number(s), found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Stephen M. Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
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I. Direct Final Rulemaking
In the Federal Register of November
21, 1997 (62 FR 62466), FDA described
its procedures on when and how the
agency will employ direct final
rulemaking. We have determined that
this rule is appropriate for direct final
rulemaking because we believe that it is
noncontroversial and we anticipate no
significant adverse comments.
Consistent with our procedures on
direct final rulemaking, FDA is
publishing elsewhere in this issue of the
Federal Register a companion proposed
rule on the same subject matter. The
companion proposed rule provides a
procedural framework within which the
rule may be finalized in the event that
the direct final rule is withdrawn
because of any significant adverse
comment. The comment period for the
direct final rule runs concurrently with
the companion proposed rule. Any
comments received in response to the
companion proposed rule will be
considered as comments regarding the
direct final rule.
We are providing a comment period
on the direct final rule of 75 days after
the date of publication in the Federal
Register. If we receive any significant
adverse comments, we intend to
withdraw this direct final rule before its
effective date by publication of a notice
in the Federal Register. A significant
adverse comment is defined as a
comment that explains why the rule
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would be inappropriate, including
challenges to the rule’s underlying
premise or approach, or would be
ineffective or unacceptable without a
change. In determining whether an
adverse comment is significant and
warrants terminating a direct final
rulemaking, we will consider whether
the comment raises an issue serious
enough to warrant a substantive
response in a notice-and-comment
process in accordance with section 553
of the Administrative Procedure Act (5
U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the
scope of the rule will not be considered
significant or adverse under this
procedure. A comment recommending a
regulation change in addition to those in
the rule would not be considered a
significant adverse comment unless the
comment states why the rule would be
ineffective without additional change.
In addition, if a significant adverse
comment applies to an amendment,
paragraph, or section of this rule and
that provision can be severed from the
remainder of the rule, we may adopt as
final those provisions of the rule that are
not the subject of a significant adverse
comment.
If any significant adverse comments
are received during the comment
period, FDA will publish, before the
effective date of this direct final rule, a
document withdrawing the direct final
rule. If we withdraw the direct final
rule, any comments received will be
applied to the proposed rule and will be
considered in developing a final rule
using the usual notice-and-comment
procedures.
If FDA receives no significant adverse
comments during the specified
comment period, FDA intends to
publish a document, before the effective
date of the direct final rule, confirming
the effective date.
II. Legal Authority
FDA is issuing this new rule under
the biological products and
communicable diseases provisions of
the Public Health Service Act (PHS
Act)(42 U.S.C. 262–264), and the drugs,
devices, and general administrative
provisions of the Federal Food, Drug,
and Cosmetic Act (the act)(21 U.S.C.
321, 331, 351–353, 355, 360, 360j, 371,
and 374). Under these provisions of the
PHS Act and the act, we have the
authority to issue and enforce
regulations designed to ensure that
biological products are safe, pure,
potent, and properly labeled, and to
prevent the introduction, transmission,
and spread of communicable disease.
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III. Highlights of the Direct Final Rule
FDA is amending the biologics
regulations by removing, revising, or
updating specific regulations applicable
to blood, blood components, and Source
Plasma to be more consistent with
current practices in the blood industry
and to remove unnecessary or outdated
requirements. We are issuing these
amendments as a direct final rule
because we have concluded that they
are noncontroversial and that there is
little likelihood that there will be
comments opposing the rule. Any
comment recommending additional
changes to these regulations will not be
considered to be a ‘‘significant adverse
comment’’ unless the comment
demonstrates that the change being
made in the direct final rule represents
a major departure from current
regulations or accepted industry
standards, or cannot be implemented
without additional amendments to the
regulation. Below we identify each of
the changes included in this direct final
rule.
We are amending 21 CFR 606.3(i) by
revising the definition of ‘‘processing’’
to mean any procedure employed after
collection and before ‘‘or after’’
compatibility testing of blood. The
current regulation states that processing
means any procedure employed after
collection and before compatibility
testing of blood. Because blood
components occasionally are further
processed after compatibility testing has
been performed, we are revising this
definition.
We are amending 21 CFR 607.65(f) by
removing the words ‘‘approved for
Medicare reimbursement and’’ and
replacing with the words ‘‘that is
certified under the Clinical Laboratory
Improvement Amendments of 1988 (42
U.S.C. 263a) and 42 CFR part 493 or has
met equivalent requirements as
determined by the Centers for Medicare
and Medicaid Services and which are’’.
As a result of the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) and the implementing
regulations adopted by the Centers for
Medicaid and Medicare Services (CMS),
the inspection regime relied on in a
1983 Memorandum of Understanding
(MOU) between FDA and the Health
Care Financing Administration (HCFA),
now CMS, will be modified. Under the
CLIA program, clinical laboratories
must be surveyed by CMS (either
directly or through a State survey
agency), unless they are located in a
CLIA-approved State, or are accredited
by a CMS-approved accreditation
organization. CLIA regulations apply to
clinical laboratories regardless of
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whether or not the laboratories seek
Medicare participation. FDA is
amending this regulation to make it
consistent with updates in the CMS
regulations.
We are amending 21 CFR 610.53(c) by
revising the dating period in the table
for Platelets, Red Blood Cells
Deglycerolized, and Red Blood Cells
Frozen. Although the current
recommended dating period will remain
unchanged for Platelets and Red Blood
Cells Deglycerolized, we are adding that
a different dating period could apply for
these products if so specified in the
directions for use for the blood
collecting, processing, and storage
system approved for such use by the
Director, Center for Biologics Evaluation
and Research (CBER). This change will
allow for flexible dating periods
depending on the type of collecting,
processing, and storage system used. In
addition, under Red Blood Cells Frozen,
we are revising the dating period from
3 years to 10 years, or as specified in the
directions for use for the blood
collecting, processing, and storage
system approved for such use by the
Director, CBER. This change will allow
for flexible dating periods depending on
the type of collecting, processing, and
storage system used.
Under § 640.4(h) (21 CFR 640.4(h)),
we are revising the temporary storage
temperature for blood that is transported
from the donor center to the processing
laboratory. We are revising the range to
between 1 and 10 ° C until the blood
arrives at the processing laboratory. We
are making this revision to be consistent
with 21 CFR 600.15 which allows for
shipping temperatures of Whole Blood
to be from 1 to 10 ° C, and for
consistency with current industry
practice. In addition, we are revising the
applicability of this requirement to
Whole Blood unless it is to be further
processed into another component, such
as Platelets or Red Blood Cells
Leukocytes Reduced. The current
regulation applies only to Whole Blood
unless the blood is to be used as a
source for Platelets. This change will
clarify that processing Whole Blood into
other components, in addition to
Platelets, is acceptable. For Whole
Blood that is to be processed into
another component, we are revising this
regulation to state that the blood must
be stored in an environment maintained
at a temperature range that is specified
for that component in the directions for
use for the blood collecting, processing,
and storage system approved for such
use by the Director, CBER. We are also
amending the term donor ‘‘clinic’’ to
donor ‘‘center’’ for consistency with
§ 640.4(b) and current terminology.
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We are removing and reserving
§ 640.21(b) (21 CFR 640.21(b)) because
this provision is obsolete, as well as
removing the reference to
plasmapheresis in 21 CFR 640.20(b).
Improvements in technology now allow
establishments to collect Platelets by
automated methods eliminating the
need for the collection of platelets by
manual plasmapheresis. Currently,
establishments may collect Platelets by
automated platelet-specific apheresis
collection procedures. We are amending
§ 640.21(c) by adding that
plateletpheresis donors must meet the
criteria for suitability as prescribed in
21 CFR 640.3 and 640.63(c)(6), or as
described in an approved biologics
license application (BLA) or an
approved supplement to a BLA, and that
informed consent must be obtained as
prescribed in 21 CFR 640.61. This
revision will clarify that registered
facilities must follow the suitability
requirements for plateletpheresis
donors.
We are removing and reserving
§ 640.22(b) (21 CFR 640.22(b)) because
this regulation is obsolete. As
previously mentioned, improvements in
technology now allow establishments to
collect Platelets by automated methods,
eliminating the need for the collection
of platelets by manual plasmapheresis.
Currently, establishments may collect
Platelets by automated platelet-specific
apheresis collection procedures. We are
amending § 640.22(c) by adding that if
plateletpheresis is used, the procedure
for collection must be as prescribed in
21 CFR 640.62 - Medical supervision; 21
CFR 640.64 - Collection of blood for
Source Plasma; and 21 CFR 640.65 Plasmapheresis, or as described in an
approved BLA or an approved
supplement to a BLA. This revision will
clarify that registered facilities must
follow the collection of source material
requirements for plateletpheresis
donors.
We are amending 21 CFR 640.24(a) to
allow Platelets to be pooled under
certain circumstances. That is, Platelets
may be pooled if such processing is
specified in the directions for use for the
blood collecting, processing, and storage
system approved for such use by the
Director, CBER. We are amending the
regulation to provide flexibility
depending on the type of collecting,
processing, and storage system used.
We are amending 21 CFR 640.25(b)(2)
by revising the pH level from ‘‘6.0’’ to
‘‘6.2’’ for consistency with current
industry practice. Studies have shown
that a lower pH may adversely affect
platelet function (Refs. 1 and 2).
We are amending 21 CFR 640.30(a) by
revising the term ‘‘product,’’ to
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‘‘component,’’ for consistency with
current terminology of the proper name.
We are also adding an alternative
definition of Plasma, namely, ‘‘The fluid
portion of human blood intended for
intravenous use which is prepared by
apheresis methods as specified in the
directions for use for the blood
collecting, processing, and storage
system including closed and open
systems.’’ We are making this change
because Plasma is now collected by
other methods, such as apheresis
collection, in addition to being collected
as a byproduct of Whole Blood
collection.
We are amending 21 CFR 640.32(a) to
add that a different storage temperature
may be used for Whole Blood intended
for further manufacturing into Plasma,
Fresh Frozen Plasma, or Liquid Plasma.
Any different storage temperature
would be specified in the directions for
use for the blood collecting, processing,
and storage system. This change will
allow for flexible storage temperatures
depending on the particular type of
system used.
We are amending 21 CFR 640.34(b) by
adding the phrase ‘‘or collected by an
apheresis procedure’’ in the second
sentence to clarify that this section also
applies to plasma collected by aphersis
procedures. We require that fresh frozen
plasma using the apheresis procedure
also be prepared from blood collected
by a single uninterrupted venipuncture
with minimal damage to, and minimal
manipulation of, the donor’s tissue.
We are amending § 640.64(b) (21 CFR
640.64(b)) by removing the second
sentence that states, ‘‘The amount of
anticoagulant required for the quantity
of blood to be collected shall be in the
blood container when it is sterilized.’’
This sentence is being removed because
of technological advances. Now, the
anticoagulant does not always have to
be in the collection set. The
anticoagulant can be connected by a
‘‘sterile docking’’ procedure or attached
separately, as is the case with automated
apheresis collection. We are also
amending § 640.64(c) by removing the
specific anticoagulant solution formulas
and indicating that the anticoagulant
solutions must be compounded and
used according to a formula approved
by the Director, CBER. We have
determined that it is unnecessary to
provide specific formulae for
anticoagulant solutions in the
regulations, and that manufacturers
should be able to use any anticoagulant
approved by FDA for such use by the
manufacturer.
We have also revised the previous
regulations, where applicable, by using
‘‘must’’ or ‘‘is’’ instead of ‘‘shall’’,
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depending on the circumstances. We
have made these revisions for plain
language purposes. These editorial
changes are for clarity only and do not
change the substance of the
requirements. We will continue to make
these changes in other applicable
regulations as they are revised in future
rulemakings. In addition, we will
continue to make the change from
‘‘product’’ to ‘‘component’’ in other
applicable regulations as they are
revised in future rulemakings.
IV. Analysis of Impacts
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A. Review Under Executive Order
12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Act of
1995
FDA has examined the impacts of the
direct 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 direct final rule is not
a significant regulatory action as defined
by 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. Because the direct final rule
amendments have no compliance costs
and do not result in any new
requirements, the agency certifies that
the direct final rule will not have a
significant economic 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 $122
million, using the most current (2005)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this direct final rule to result in any 1–
year expenditure that would meet or
exceed this amount.
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B. Environmental Impact
List of Subjects
The agency has determined, under 21
CFR 25.31(h), 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.
21 CFR Part 606
C. Federalism
Biologics, Labeling, Reporting and
recordkeeping requirements.
FDA has analyzed this direct final
rule in accordance with the principles
set forth in Executive Order 13132. FDA
has determined that the direct final 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. Accordingly, the
agency has concluded that the direct
final 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.
V. Paperwork Reduction Act of 1995
This direct final rule contains no
collections of information. Therefore,
clearance by OMB under the Paperwork
Reduction Act of 1995 is not required.
Blood, Labeling, Laboratories,
Reporting and recordkeeping
requirements.
21 CFR Part 607
Blood.
21 CFR Part 610
21 CFR Part 640
Blood, Labeling, Reporting and
recordkeeping requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act, and under authority
delegated by the Commissioner of Food
and Drugs, 21 CFR parts 606, 607, 610,
and 640 are amended as follows:
PART 606—CURRENT GOOD
MANUFACTURING PRACTICE FOR
BLOOD AND BLOOD COMPONENTS
1. The authority citation for 21 CFR
part 606 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
355, 360, 360j, 371, 374; 42 U.S.C. 216, 262,
263a, 264.
2. Section 606.3 is amended by
revising paragraph (i) to read as follows:
I
§ 606.3
Definitions.
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VI. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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(i) Processing means any procedure
employed after collection, and before or
after compatibility testing of blood, and
includes the identification of a unit of
donor blood, the preparation of
components from such unit of donor
blood, serological testing, labeling and
associated recordkeeping.
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PART 607—ESTABLISHMENT
REGISTRATION AND PRODUCT
LISTING FOR MANUFACTURERS OF
HUMAN BLOOD AND BLOOD
PRODUCTS
3. The authority citation for 21 CFR
part 607 continues to read as follows:
VII. References
I
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
Authority: 21 U.S.C. 321, 331, 351, 352,
355, 360, 371, 374, 381, 393; 42 U.S.C. 262,
264, 271.
1. Scott Murphy, ‘‘Platelet Storage for
Transfusion,’’ Seminars in Hematology,
22(3): 165–177, July 1985.
2. L. Dumont and T. VandenBroeke,
‘‘Seven-Day Storage of Apheresis Platelets
Report of an In Vitro Study,’’ 43: 143–150,
Transfusion, February 2003.
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Frm 00008
Fmt 4700
Sfmt 4700
4. Section 607.65 is amended by
revising the first sentence in paragraph
(f) to read as follows:
I
§ 607.65 Exemptions for blood product
establishments.
*
*
*
*
*
(f) Transfusion services which are a
part of a facility that is certified under
the Clinical Laboratory Improvement
E:\FR\FM\16AUR1.SGM
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Amendments of 1988 (42 U.S.C. 263a)
and 42 CFR part 493 or has met
equivalent requirements as determined
by the Centers for Medicare and
Medicaid Services and which are
engaged in the compatibility testing and
transfusion of blood and blood
components, but which neither
routinely collect nor process blood and
blood components.* * *
A
6. Section 610.53 is amended in
paragraph (c) in the table by revising the
entries for Platelets, Red Blood Cells
Deglycerolized, and Red Blood Cells
Frozen to read as follows:
I
PART 610—GENERAL BIOLOGICAL
PRODUCTS STANDARDS
5. The authority citation for 21 CFR
part 610 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360c, 360d, 360h, 360i, 371,
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
§ 610.53 Dating periods for licensed
biological products.
*
*
*
(c) * * *
*
*
B
*
D
Manufacturer’s storage
period 1 to 5 °C (unless otherwise stated).
Product
C
Manufacturer’s storage
period 0 °C or colder
(unless otherwise
stated).
Dating period after leaving manufacturer’s storage when stored at
2 to 8 °C (unless otherwise stated)
*
Platelets
*
Not applicable .............
*
*
*
*
do ................................
*
*
*
72 hours from time of collection of source blood, provided labeling
recommends storage at 20 to 24°C or between 1 and 6°C, or as
specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluation and Research (CBER).
*
*
*
*
Red Blood Cells
Deglycerolized
do ................................
do ................................
24 hours after removal from storage at 65°C or colder, provided
labeling recommends storage between 1 and 6°C, or as specified in the directions for use for the blood collecting, processing,
and storage system approved for such use by the Director,
CBER.
Red Blood Cells Frozen
do ................................
do ................................
10 years from date of collection of source blood, provided labeling
recommends storage at 65°C or colder, or as specified in the directions for use for the blood collecting, processing, and storage
system approved for such use by the Director, CBER.
*
*
*
*
*
PART 640—ADDITIONAL STANDARDS
FOR HUMAN BLOOD AND BLOOD
PRODUCTS
7. The authority citation for 21 CFR
part 640 continues to read as follows:
I
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371; 42 U.S.C. 216, 262, 263, 263a,
264.
8. Section 640.4 is amended by
revising paragraph (h) to read as
follows:
I
§ 640.4
mstockstill on PROD1PC66 with RULES
§ 640.20
*
*
*
*
(h) Storage. Whole Blood must be
placed in storage at a temperature
between 1 and 6°C immediately after
collection unless the blood is to be
further processed into another
component or the blood must be
transported from the donor center to the
processing laboratory. If transported, the
blood must be placed in temporary
storage having sufficient refrigeration
capacity to cool the blood continuously
at a temperature range between 1 and
10°C until arrival at the processing
laboratory. At the processing laboratory,
VerDate Aug<31>2005
16:47 Aug 15, 2007
Jkt 211001
Platelets.
*
Collection of the blood.
*
the blood must be stored at a
temperature between 1 and 6°C. Blood
from which a component is to be
prepared must be held in an
environment maintained at a
temperature range specified for that
component in the directions for use for
the blood collecting, processing, and
storage system approved for such use by
the Director, CBER.
I 9. Section 640.20 is amended by
revising paragraph (b) to read as follows:
*
*
*
*
(b) Source. The source material for
Platelets is plasma which may be
obtained by whole blood collection or
by plateletpheresis.
I 10. Section 640.21 is amended by
removing and reserving paragraph (b)
and revising paragraph (c) to read as
follows:
§ 640.21
Suitability of donors.
*
*
*
*
*
(b) [Reserved]
(c) Plateletpheresis donors must meet
the criteria for suitability as prescribed
in §§ 640.3 and 640.63(c)(6) or as
described in an approved biologics
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
license application (BLA) or an
approved supplement to a BLA.
Informed consent must be obtained as
prescribed in § 640.61.
I 11. Section 640.22 is amended by
removing and reserving paragraph (b)
and revising paragraph (c) to read as
follows:
§ 640.22
Collection of source material.
*
*
*
*
*
(b) [Reserved]
(c) If plateletpheresis is used, the
procedure for collection must be as
prescribed in §§ 640.62, 640.64 (except
paragraph (c)), and 640.65, or as
described in an approved biologics
license application (BLA) or an
approved supplement to a BLA.
*
*
*
*
*
I 12. Section 640.24 is amended by
revising paragraph (a) to read as follows:
§ 640.24
Processing.
(a) Separation of plasma and platelets
and resuspension of the platelets must
be in a closed system. Platelets must not
be pooled during processing unless the
platelets are pooled as specified in the
directions for use for the blood
collecting, processing, and storage
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system approved for such use by the
Director, Center for Biologics Evaluation
and Research.
*
*
*
*
*
§ 640.25
[Amended]
13. Section 640.25 is amended in
paragraph (b)(2) by removing ‘‘6.0’’ and
adding in its place ‘‘6.2’’.
I
14. Section 640.30 is amended by
revising paragraph (a) to read as follows:
I
§ 640.30
Plasma.
(a) Proper name and definition. The
proper name of this component is
Plasma. The component is defined as:
(1) The fluid portion of one unit of
human blood intended for intravenous
use which is collected in a closed
system, stabilized against clotting, and
separated from the red cells; or
(2) The fluid portion of human blood
intended for intravenous use which is
prepared by apheresis methods as
specified in the directions for use for the
blood collecting, processing, and storage
system including closed and open
systems.
*
*
*
*
*
15. Section 640.32 is amended by
revising paragraph (a) to read as follows:
I
§ 640.32
Collection of source material.
(a) Whole Blood must be collected,
transported, and stored as prescribed in
§ 640.4. When whole blood is intended
for Plasma, Fresh Frozen Plasma, and
Liquid Plasma, until the plasma is
removed, the whole blood must be
maintained at a temperature between 1
and 6 °C or as specified in the directions
for use for the blood collecting,
processing, and storage system
approved for such use by the Director,
Center for Biologics Evaluations and
Research. Whole blood intended for
Platelet Rich Plasma must be
maintained as prescribed in § 640.24
until the plasma is removed. The red
blood cells must be placed in storage at
a temperature between 1 and 6 °C
immediately after the plasma is
separated.
*
*
*
*
*
16. Section 640.34 is amended by
revising the second sentence in
paragraph (b) to read as follows:
I
§ 640.34
Processing.
mstockstill on PROD1PC66 with RULES
*
*
*
*
*
(b) Fresh Frozen Plasma. * * * The
plasma must be separated from the red
blood cells or collected by an apheresis
procedure, and placed in a freezer
within 8 hours or within the timeframe
specified in the directions for use for the
VerDate Aug<31>2005
16:47 Aug 15, 2007
Jkt 211001
blood collecting, processing, and storage
system, and stored at -18 °C or colder.
*
*
*
*
*
I 17. Section 640.64 is amended by
revising paragraphs (b) and (c) to read
as follows:
§ 640.64
plasma.
Collection of blood for source
*
*
*
*
*
(b) Blood containers. Blood containers
and donor sets must be pyrogen-free,
sterile, and identified by lot number.
(c) The anticoagulant solution. The
anticoagulant solution must be sterile
and pyrogen-free. Anticoagulant
solutions must be compounded and
used according to a formula that has
been approved for the applicant by the
Director, Center for Biologics Evaluation
and Research.
*
*
*
*
*
Dated: July 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15943 Filed 8–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Parts 22 and 51
[Public Notice: 5888]
RIN 1400–AC39
Passport Procedures—Amendment to
Expedited Passport Processing
Regulation
Department of State.
Interim final rule.
AGENCY:
ACTION:
SUMMARY: This interim final rule
changes the definition of ‘‘expedited
passport processing’’ from the 3business day period to a number of
business days as may be published from
time to time on the Department’s Web
site, https://www.travel.state.gov. This
change is meant to ensure that the
Department can continue to offer this
service consistent with its regulations,
despite increases in demand for it. It is
also meant to ensure that the public can
easily determine the current standards
for expedited passport processing.
Further, this interim final rule makes a
conforming amendment to the Schedule
of Fees for Consular Services.
DATES: Effective date: This interim final
rule becomes effective August 16, 2007.
Comment date: The Department of
State will accept written comments from
interested persons up to October 15,
2007.
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
Interested parties may
submit comments at any time by any of
the following methods:
• Mail (paper, disk, or CD–ROM
submissions): Comments by mail are to
be addressed to the Office of Legal
Affairs and Law Enforcement, U.S.
Department of State, 2100 Pennsylvania
Ave., NW., Suite 300, Washington, DC
20037.
• Internet: Comments by Internet are
to be sent to https://www.regulations.gov.
This notice can also be viewed from this
Internet address.
• Electronically: You may submit
electronic comments to
ExpediteRuleComments@state.gov. You
must include the RIN in the subject line
of your message. Attachments must be
in Microsoft Word.
Instructions: All submissions must
include the agency name and docket
number. All comments will be posted
without change to https://
www.regulations.gov, including any
personal information sent with each
comment.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
regarding this regulatory amendment
should be directed to Susan M. Bozinko,
Bureau of Consular Affairs, Passport
Services, Division of Legal Affairs, U.S.
Department of State, Washington, DC
20037, who may be reached at 202–663–
2491 or e-mailed at
BozinkoSM@state.gov.
SUPPLEMENTARY INFORMATION: Section
7209 of the Intelligence Reform and
Terrorism Prevention Act (IRTPA),
enacted on December 17, 2004, requires
the Secretary of Homeland Security, in
consultation with the Secretary of State,
to develop expeditiously a plan to
require most U.S. citizens and certain
other categories of individuals to
present a passport or other
documentation of identity and
citizenship deemed sufficient by the
Secretary of Homeland Security when
entering the United States.
The Department of State’s Office of
Passport Services (Passport Services)
began planning for increased passport
demand even before Congress passed
IRTPA. It planned for a sharp increase
in passport applications and anticipated
the need for increased staff to handle
the demand. Recognizing the
uncertainty of passport demand and the
need for reliable information to guide its
planning efforts, Passport Services
contracted for a passport demand study
in 2005, and used the data from this
study to initiate a program of resource
upgrades for meeting demand.
Beginning in February 2007, it
became apparent that passport demand
ADDRESSES:
E:\FR\FM\16AUR1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Rules and Regulations]
[Pages 45883-45888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15943]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 606, 607, 610, and 640
[Docket No. 2007N-0264]
Revisions to the Requirements Applicable to Blood, Blood
Components and Source Plasma
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
biologics regulations by removing, revising, or updating specific
regulations applicable to blood, blood components and Source Plasma to
be more consistent with current practices in the blood industry and to
remove unnecessary or outdated requirements. We are taking this action
as part of our continuing effort to reduce the burden of unnecessary
regulations on industry and to revise outdated regulations without
diminishing public health protection.
Elsewhere in this issue of the Federal Register, we are publishing
a companion proposed rule under our usual procedures for notice and
comment in the event that we receive any significant adverse comments
on the direct final rule. If we receive any significant adverse
comments that warrant terminating the direct final rule, we will
consider such comments on the proposed rule in developing the final
rule.
DATES: This direct final rule is effective February 19, 2008. Submit
written or electronic comments by October 30, 2007. If we receive no
significant adverse comments during the specified comment period, we
intend to publish a confirmation document on or before the effective
date of this direct final rule confirming that the direct final rule
will go into effect on February 19, 2008. If we receive any significant
adverse comments during the comment period, we intend to withdraw this
direct final rule before its effective date by a notice published in
the Federal Register.
ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0264, by any of the folllowing methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and
[[Page 45884]]
Docket No(s). and Regulatory Information Number (RIN) (if a RIN number
has been assigned) for this rulemaking. All comments received may be
posted without change to https://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
I. Direct Final Rulemaking
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
described its procedures on when and how the agency will employ direct
final rulemaking. We have determined that this rule is appropriate for
direct final rulemaking because we believe that it is noncontroversial
and we anticipate no significant adverse comments. Consistent with our
procedures on direct final rulemaking, FDA is publishing elsewhere in
this issue of the Federal Register a companion proposed rule on the
same subject matter. The companion proposed rule provides a procedural
framework within which the rule may be finalized in the event that the
direct final rule is withdrawn because of any significant adverse
comment. The comment period for the direct final rule runs concurrently
with the companion proposed rule. Any comments received in response to
the companion proposed rule will be considered as comments regarding
the direct final rule.
We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comments, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register. A significant adverse comment is defined as a
comment that explains why the rule would be inappropriate, including
challenges to the rule's underlying premise or approach, or would be
ineffective or unacceptable without a change. In determining whether an
adverse comment is significant and warrants terminating a direct final
rulemaking, we will consider whether the comment raises an issue
serious enough to warrant a substantive response in a notice-and-
comment process in accordance with section 553 of the Administrative
Procedure Act (5 U.S.C. 553). Comments that are frivolous,
insubstantial, or outside the scope of the rule will not be considered
significant or adverse under this procedure. A comment recommending a
regulation change in addition to those in the rule would not be
considered a significant adverse comment unless the comment states why
the rule would be ineffective without additional change. In addition,
if a significant adverse comment applies to an amendment, paragraph, or
section of this rule and that provision can be severed from the
remainder of the rule, we may adopt as final those provisions of the
rule that are not the subject of a significant adverse comment.
If any significant adverse comments are received during the comment
period, FDA will publish, before the effective date of this direct
final rule, a document withdrawing the direct final rule. If we
withdraw the direct final rule, any comments received will be applied
to the proposed rule and will be considered in developing a final rule
using the usual notice-and-comment procedures.
If FDA receives no significant adverse comments during the
specified comment period, FDA intends to publish a document, before the
effective date of the direct final rule, confirming the effective date.
II. Legal Authority
FDA is issuing this new rule under the biological products and
communicable diseases provisions of the Public Health Service Act (PHS
Act)(42 U.S.C. 262-264), and the drugs, devices, and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(the act)(21 U.S.C. 321, 331, 351-353, 355, 360, 360j, 371, and 374).
Under these provisions of the PHS Act and the act, we have the
authority to issue and enforce regulations designed to ensure that
biological products are safe, pure, potent, and properly labeled, and
to prevent the introduction, transmission, and spread of communicable
disease.
III. Highlights of the Direct Final Rule
FDA is amending the biologics regulations by removing, revising, or
updating specific regulations applicable to blood, blood components,
and Source Plasma to be more consistent with current practices in the
blood industry and to remove unnecessary or outdated requirements. We
are issuing these amendments as a direct final rule because we have
concluded that they are noncontroversial and that there is little
likelihood that there will be comments opposing the rule. Any comment
recommending additional changes to these regulations will not be
considered to be a ``significant adverse comment'' unless the comment
demonstrates that the change being made in the direct final rule
represents a major departure from current regulations or accepted
industry standards, or cannot be implemented without additional
amendments to the regulation. Below we identify each of the changes
included in this direct final rule.
We are amending 21 CFR 606.3(i) by revising the definition of
``processing'' to mean any procedure employed after collection and
before ``or after'' compatibility testing of blood. The current
regulation states that processing means any procedure employed after
collection and before compatibility testing of blood. Because blood
components occasionally are further processed after compatibility
testing has been performed, we are revising this definition.
We are amending 21 CFR 607.65(f) by removing the words ``approved
for Medicare reimbursement and'' and replacing with the words ``that is
certified under the Clinical Laboratory Improvement Amendments of 1988
(42 U.S.C. 263a) and 42 CFR part 493 or has met equivalent requirements
as determined by the Centers for Medicare and Medicaid Services and
which are''. As a result of the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) and the implementing regulations adopted by
the Centers for Medicaid and Medicare Services (CMS), the inspection
regime relied on in a 1983 Memorandum of Understanding (MOU) between
FDA and the Health Care Financing Administration (HCFA), now CMS, will
be modified. Under the CLIA program, clinical laboratories must be
surveyed by CMS (either directly or through a State survey agency),
unless they are located in a CLIA-approved State, or are accredited by
a CMS-approved accreditation organization. CLIA regulations apply to
clinical laboratories regardless of
[[Page 45885]]
whether or not the laboratories seek Medicare participation. FDA is
amending this regulation to make it consistent with updates in the CMS
regulations.
We are amending 21 CFR 610.53(c) by revising the dating period in
the table for Platelets, Red Blood Cells Deglycerolized, and Red Blood
Cells Frozen. Although the current recommended dating period will
remain unchanged for Platelets and Red Blood Cells Deglycerolized, we
are adding that a different dating period could apply for these
products if so specified in the directions for use for the blood
collecting, processing, and storage system approved for such use by the
Director, Center for Biologics Evaluation and Research (CBER). This
change will allow for flexible dating periods depending on the type of
collecting, processing, and storage system used. In addition, under Red
Blood Cells Frozen, we are revising the dating period from 3 years to
10 years, or as specified in the directions for use for the blood
collecting, processing, and storage system approved for such use by the
Director, CBER. This change will allow for flexible dating periods
depending on the type of collecting, processing, and storage system
used.
Under Sec. 640.4(h) (21 CFR 640.4(h)), we are revising the
temporary storage temperature for blood that is transported from the
donor center to the processing laboratory. We are revising the range to
between 1 and 10 [deg] C until the blood arrives at the processing
laboratory. We are making this revision to be consistent with 21 CFR
600.15 which allows for shipping temperatures of Whole Blood to be from
1 to 10 [deg] C, and for consistency with current industry practice. In
addition, we are revising the applicability of this requirement to
Whole Blood unless it is to be further processed into another
component, such as Platelets or Red Blood Cells Leukocytes Reduced. The
current regulation applies only to Whole Blood unless the blood is to
be used as a source for Platelets. This change will clarify that
processing Whole Blood into other components, in addition to Platelets,
is acceptable. For Whole Blood that is to be processed into another
component, we are revising this regulation to state that the blood must
be stored in an environment maintained at a temperature range that is
specified for that component in the directions for use for the blood
collecting, processing, and storage system approved for such use by the
Director, CBER. We are also amending the term donor ``clinic'' to donor
``center'' for consistency with Sec. 640.4(b) and current terminology.
We are removing and reserving Sec. 640.21(b) (21 CFR 640.21(b))
because this provision is obsolete, as well as removing the reference
to plasmapheresis in 21 CFR 640.20(b). Improvements in technology now
allow establishments to collect Platelets by automated methods
eliminating the need for the collection of platelets by manual
plasmapheresis. Currently, establishments may collect Platelets by
automated platelet-specific apheresis collection procedures. We are
amending Sec. 640.21(c) by adding that plateletpheresis donors must
meet the criteria for suitability as prescribed in 21 CFR 640.3 and
640.63(c)(6), or as described in an approved biologics license
application (BLA) or an approved supplement to a BLA, and that informed
consent must be obtained as prescribed in 21 CFR 640.61. This revision
will clarify that registered facilities must follow the suitability
requirements for plateletpheresis donors.
We are removing and reserving Sec. 640.22(b) (21 CFR 640.22(b))
because this regulation is obsolete. As previously mentioned,
improvements in technology now allow establishments to collect
Platelets by automated methods, eliminating the need for the collection
of platelets by manual plasmapheresis. Currently, establishments may
collect Platelets by automated platelet-specific apheresis collection
procedures. We are amending Sec. 640.22(c) by adding that if
plateletpheresis is used, the procedure for collection must be as
prescribed in 21 CFR 640.62 - Medical supervision; 21 CFR 640.64 -
Collection of blood for Source Plasma; and 21 CFR 640.65 -
Plasmapheresis, or as described in an approved BLA or an approved
supplement to a BLA. This revision will clarify that registered
facilities must follow the collection of source material requirements
for plateletpheresis donors.
We are amending 21 CFR 640.24(a) to allow Platelets to be pooled
under certain circumstances. That is, Platelets may be pooled if such
processing is specified in the directions for use for the blood
collecting, processing, and storage system approved for such use by the
Director, CBER. We are amending the regulation to provide flexibility
depending on the type of collecting, processing, and storage system
used.
We are amending 21 CFR 640.25(b)(2) by revising the pH level from
``6.0'' to ``6.2'' for consistency with current industry practice.
Studies have shown that a lower pH may adversely affect platelet
function (Refs. 1 and 2).
We are amending 21 CFR 640.30(a) by revising the term ``product,''
to ``component,'' for consistency with current terminology of the
proper name. We are also adding an alternative definition of Plasma,
namely, ``The fluid portion of human blood intended for intravenous use
which is prepared by apheresis methods as specified in the directions
for use for the blood collecting, processing, and storage system
including closed and open systems.'' We are making this change because
Plasma is now collected by other methods, such as apheresis collection,
in addition to being collected as a byproduct of Whole Blood
collection.
We are amending 21 CFR 640.32(a) to add that a different storage
temperature may be used for Whole Blood intended for further
manufacturing into Plasma, Fresh Frozen Plasma, or Liquid Plasma. Any
different storage temperature would be specified in the directions for
use for the blood collecting, processing, and storage system. This
change will allow for flexible storage temperatures depending on the
particular type of system used.
We are amending 21 CFR 640.34(b) by adding the phrase ``or
collected by an apheresis procedure'' in the second sentence to clarify
that this section also applies to plasma collected by aphersis
procedures. We require that fresh frozen plasma using the apheresis
procedure also be prepared from blood collected by a single
uninterrupted venipuncture with minimal damage to, and minimal
manipulation of, the donor's tissue.
We are amending Sec. 640.64(b) (21 CFR 640.64(b)) by removing the
second sentence that states, ``The amount of anticoagulant required for
the quantity of blood to be collected shall be in the blood container
when it is sterilized.'' This sentence is being removed because of
technological advances. Now, the anticoagulant does not always have to
be in the collection set. The anticoagulant can be connected by a
``sterile docking'' procedure or attached separately, as is the case
with automated apheresis collection. We are also amending Sec.
640.64(c) by removing the specific anticoagulant solution formulas and
indicating that the anticoagulant solutions must be compounded and used
according to a formula approved by the Director, CBER. We have
determined that it is unnecessary to provide specific formulae for
anticoagulant solutions in the regulations, and that manufacturers
should be able to use any anticoagulant approved by FDA for such use by
the manufacturer.
We have also revised the previous regulations, where applicable, by
using ``must'' or ``is'' instead of ``shall'',
[[Page 45886]]
depending on the circumstances. We have made these revisions for plain
language purposes. These editorial changes are for clarity only and do
not change the substance of the requirements. We will continue to make
these changes in other applicable regulations as they are revised in
future rulemakings. In addition, we will continue to make the change
from ``product'' to ``component'' in other applicable regulations as
they are revised in future rulemakings.
IV. Analysis of Impacts
A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Act of 1995
FDA has examined the impacts of the direct 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 direct final rule is not a significant regulatory action as
defined by 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. Because the direct final rule amendments have no
compliance costs and do not result in any new requirements, the agency
certifies that the direct final rule will not have a significant
economic 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 $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
direct final rule to result in any 1-year expenditure that would meet
or exceed this amount.
B. Environmental Impact
The agency has determined, under 21 CFR 25.31(h), 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.
C. Federalism
FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the direct final 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. Accordingly,
the agency has concluded that the direct final 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.
V. Paperwork Reduction Act of 1995
This direct final rule contains no collections of information.
Therefore, clearance by OMB under the Paperwork Reduction Act of 1995
is not required.
VI. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
VII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Scott Murphy, ``Platelet Storage for Transfusion,'' Seminars
in Hematology, 22(3): 165-177, July 1985.
2. L. Dumont and T. VandenBroeke, ``Seven-Day Storage of
Apheresis Platelets Report of an In Vitro Study,'' 43: 143-150,
Transfusion, February 2003.
List of Subjects
21 CFR Part 606
Blood, Labeling, Laboratories, Reporting and recordkeeping
requirements.
21 CFR Part 607
Blood.
21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 640
Blood, Labeling, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated by the
Commissioner of Food and Drugs, 21 CFR parts 606, 607, 610, and 640 are
amended as follows:
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS
0
1. The authority citation for 21 CFR part 606 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371,
374; 42 U.S.C. 216, 262, 263a, 264.
0
2. Section 606.3 is amended by revising paragraph (i) to read as
follows:
Sec. 606.3 Definitions.
* * * * *
(i) Processing means any procedure employed after collection, and
before or after compatibility testing of blood, and includes the
identification of a unit of donor blood, the preparation of components
from such unit of donor blood, serological testing, labeling and
associated recordkeeping.
* * * * *
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR
MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
0
3. The authority citation for 21 CFR part 607 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374,
381, 393; 42 U.S.C. 262, 264, 271.
0
4. Section 607.65 is amended by revising the first sentence in
paragraph (f) to read as follows:
Sec. 607.65 Exemptions for blood product establishments.
* * * * *
(f) Transfusion services which are a part of a facility that is
certified under the Clinical Laboratory Improvement
[[Page 45887]]
Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493 or has met
equivalent requirements as determined by the Centers for Medicare and
Medicaid Services and which are engaged in the compatibility testing
and transfusion of blood and blood components, but which neither
routinely collect nor process blood and blood components.* * *
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
0
5. The authority citation for 21 CFR part 610 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
0
6. Section 610.53 is amended in paragraph (c) in the table by revising
the entries for Platelets, Red Blood Cells Deglycerolized, and Red
Blood Cells Frozen to read as follows:
Sec. 610.53 Dating periods for licensed biological products.
* * * * *
(c) * * *
----------------------------------------------------------------------------------------------------------------
A B C D
----------------------------------------------------------------------------------------------------------------
Product Manufacturer's storage Manufacturer's storage Dating period after leaving
period 1 to 5 [deg]C period 0 [deg]C or manufacturer's storage when stored at 2
(unless otherwise colder (unless to 8 [deg]C (unless otherwise stated)
stated). otherwise stated).
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Platelets Not applicable......... do..................... 72 hours from time of collection of
source blood, provided labeling
recommends storage at 20 to 24[deg]C or
between 1 and 6[deg]C, or as specified
in the directions for use for the blood
collecting, processing, and storage
system approved for such use by the
Director, Center for Biologics
Evaluation and Research (CBER).
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Red Blood Cells do..................... do..................... 24 hours after removal from storage at
Deglycerolized 65[deg]C or colder, provided labeling
recommends storage between 1 and
6[deg]C, or as specified in the
directions for use for the blood
collecting, processing, and storage
system approved for such use by the
Director, CBER.
----------------------------------------------------------------------------------------------------------------
Red Blood Cells do..................... do..................... 10 years from date of collection of
Frozen source blood, provided labeling
recommends storage at 65[deg]C or
colder, or as specified in the
directions for use for the blood
collecting, processing, and storage
system approved for such use by the
Director, CBER.
----------------------------------------------------------------------------------------------------------------
* * * * *
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
0
7. The authority citation for 21 CFR part 640 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.
0
8. Section 640.4 is amended by revising paragraph (h) to read as
follows:
Sec. 640.4 Collection of the blood.
* * * * *
(h) Storage. Whole Blood must be placed in storage at a temperature
between 1 and 6[deg]C immediately after collection unless the blood is
to be further processed into another component or the blood must be
transported from the donor center to the processing laboratory. If
transported, the blood must be placed in temporary storage having
sufficient refrigeration capacity to cool the blood continuously at a
temperature range between 1 and 10[deg]C until arrival at the
processing laboratory. At the processing laboratory, the blood must be
stored at a temperature between 1 and 6[deg]C. Blood from which a
component is to be prepared must be held in an environment maintained
at a temperature range specified for that component in the directions
for use for the blood collecting, processing, and storage system
approved for such use by the Director, CBER.
0
9. Section 640.20 is amended by revising paragraph (b) to read as
follows:
Sec. 640.20 Platelets.
* * * * *
(b) Source. The source material for Platelets is plasma which may
be obtained by whole blood collection or by plateletpheresis.
0
10. Section 640.21 is amended by removing and reserving paragraph (b)
and revising paragraph (c) to read as follows:
Sec. 640.21 Suitability of donors.
* * * * *
(b) [Reserved]
(c) Plateletpheresis donors must meet the criteria for suitability
as prescribed in Sec. Sec. 640.3 and 640.63(c)(6) or as described in
an approved biologics license application (BLA) or an approved
supplement to a BLA. Informed consent must be obtained as prescribed in
Sec. 640.61.
0
11. Section 640.22 is amended by removing and reserving paragraph (b)
and revising paragraph (c) to read as follows:
Sec. 640.22 Collection of source material.
* * * * *
(b) [Reserved]
(c) If plateletpheresis is used, the procedure for collection must
be as prescribed in Sec. Sec. 640.62, 640.64 (except paragraph (c)),
and 640.65, or as described in an approved biologics license
application (BLA) or an approved supplement to a BLA.
* * * * *
0
12. Section 640.24 is amended by revising paragraph (a) to read as
follows:
Sec. 640.24 Processing.
(a) Separation of plasma and platelets and resuspension of the
platelets must be in a closed system. Platelets must not be pooled
during processing unless the platelets are pooled as specified in the
directions for use for the blood collecting, processing, and storage
[[Page 45888]]
system approved for such use by the Director, Center for Biologics
Evaluation and Research.
* * * * *
Sec. 640.25 [Amended]
0
13. Section 640.25 is amended in paragraph (b)(2) by removing ``6.0''
and adding in its place ``6.2''.
0
14. Section 640.30 is amended by revising paragraph (a) to read as
follows:
Sec. 640.30 Plasma.
(a) Proper name and definition. The proper name of this component
is Plasma. The component is defined as:
(1) The fluid portion of one unit of human blood intended for
intravenous use which is collected in a closed system, stabilized
against clotting, and separated from the red cells; or
(2) The fluid portion of human blood intended for intravenous use
which is prepared by apheresis methods as specified in the directions
for use for the blood collecting, processing, and storage system
including closed and open systems.
* * * * *
0
15. Section 640.32 is amended by revising paragraph (a) to read as
follows:
Sec. 640.32 Collection of source material.
(a) Whole Blood must be collected, transported, and stored as
prescribed in Sec. 640.4. When whole blood is intended for Plasma,
Fresh Frozen Plasma, and Liquid Plasma, until the plasma is removed,
the whole blood must be maintained at a temperature between 1 and 6
[deg]C or as specified in the directions for use for the blood
collecting, processing, and storage system approved for such use by the
Director, Center for Biologics Evaluations and Research. Whole blood
intended for Platelet Rich Plasma must be maintained as prescribed in
Sec. 640.24 until the plasma is removed. The red blood cells must be
placed in storage at a temperature between 1 and 6 [deg]C immediately
after the plasma is separated.
* * * * *
0
16. Section 640.34 is amended by revising the second sentence in
paragraph (b) to read as follows:
Sec. 640.34 Processing.
* * * * *
(b) Fresh Frozen Plasma. * * * The plasma must be separated from
the red blood cells or collected by an apheresis procedure, and placed
in a freezer within 8 hours or within the timeframe specified in the
directions for use for the blood collecting, processing, and storage
system, and stored at -18 [deg]C or colder.
* * * * *
0
17. Section 640.64 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 640.64 Collection of blood for source plasma.
* * * * *
(b) Blood containers. Blood containers and donor sets must be
pyrogen-free, sterile, and identified by lot number.
(c) The anticoagulant solution. The anticoagulant solution must be
sterile and pyrogen-free. Anticoagulant solutions must be compounded
and used according to a formula that has been approved for the
applicant by the Director, Center for Biologics Evaluation and
Research.
* * * * *
Dated: July 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15943 Filed 8-15-07; 8:45 am]
BILLING CODE 4160-01-S
