[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Rules and Regulations]
[Pages 45883-45888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15943]


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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.

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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remove unnecessary or outdated requirements.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regulations on industry and to revise outdated regulations without 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: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://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 http://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 http://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