[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Proposed Rules]
[Pages 45993-45997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15942]



[[Page 45993]]

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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; Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
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remove unnecessary or outdated requirements.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regulations on industry and to revise outdated regulations without 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. This proposed rule is a companion 
to the direct final rule published elsewhere in this issue of the 
Federal Register.

DATES: Submit written or electronic comments by October 30, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0264, by any of the following 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 docket number 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, 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. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule 
published elsewhere in this issue of the Federal Register. This 
companion proposed rule provides the procedural framework to finalize 
the rule in the event that the direct final rule receives any 
significant adverse comments and is withdrawn. The comment period for 
this companion proposed rule runs concurrently with the comment period 
for the direct final rule. Any comments received under this companion 
proposed rule will also be considered as comments regarding the direct 
final rule. We are publishing the direct final rule because the rule is 
noncontroversial, and we do not anticipate that it will receive any 
significant adverse comments.
    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 no significant adverse comment is received in response to the 
direct final rule, no further action will be taken related to this 
proposed rule. Instead, we will publish a confirmation document, before 
the effective date of the direct final rule, confirming that the direct 
final rule will go into effect on February 19, 2008. Additional 
information about direct rulemaking procedures is set forth in a 
guidance published in the Federal Register of November 21, 1997 (62 FR 
62466).

II. Legal Authority

    FDA is proposing to issue 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 Proposed Rule

    FDA is proposing to amend 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 also 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

[[Page 45994]]

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 proposed rule.
    We are proposing to amend 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 proposing this revision to the 
definition.
    We are proposing to amend 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 whether or not the laboratories seek Medicare 
participation. FDA is proposing to amend this regulation to make it 
consistent with updates in the CMS regulations.
    We are proposing to amend 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 
would remain unchanged for Platelets and Red Blood Cells 
Deglycerolized, we are proposing to add 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 would 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 proposing to 
revise 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 
would 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 proposing to revise 
the temporary storage temperature for blood that is transported from 
the donor center to the processing laboratory. We are proposing a range 
between 1 and 10[deg] C until the blood arrives at the processing 
laboratory. We are proposing 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 proposing to revise 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 would 
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 proposing 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 proposing to replace the term donor ``clinic'' with 
donor ``center'' for consistency with Sec.  640.4(b) and current 
terminology.
    We are proposing to remove and reserve Sec.  640.21(b) (21 CFR 
640.21(b)) because this provision is obsolete, as well as proposing to 
remove 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 proposing to amend 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 would clarify that registered facilities 
must follow the suitability requirements for plateletpheresis donors.
    We are proposing to remove and reserve 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 plasmapheresis. Currently, establishments 
may collect Platelets by automated platelet-specific apheresis 
collection procedures. We are proposing to amend 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 biologics license 
application or an approved supplement to a BLA. This revision would 
clarify that registered facilities must follow the collection of source 
material requirements for plateletpheresis donors.
    We are proposing to amend 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 for approved such use by the 
Director, CBER. We are proposing to amend the regulation to provide 
flexibility depending on the type of collecting, processing, and 
storage system used.
    We are proposing to amend 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 proposing to amend 21 CFR 640.30(a) by revising the term 
``product,'' to ``component,'' for consistency with current terminology 
of the proper name. We are also proposing to add 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 proposing this change because

[[Page 45995]]

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 proposing to amend 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 would allow for flexible storage temperatures depending on the 
particular type of system used.
    We are proposing to amend 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 would require that fresh frozen plasma using the 
apheresis procedure be prepared from blood collected by a single 
uninterrupted venipuncture with minimal damage to, and minimal 
manipulation of, the donor's tissue.
    We are proposing to amend 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.'' We are proposing to remove 
this sentence 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 
proposing to amend 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 the FDA for such use by the manufacturer.
    We have also revised the above regulations, where applicable, by 
using ``must'' or ``is'' instead of ``shall,'' 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 proposed 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 proposed 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 proposed rule amendments have no 
compliance costs and do not result in any new requirements, the agency 
certifies that the proposed 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 
proposed 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 proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed 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 proposed 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

    FDA tentatively concludes that this proposed rule contains no 
collection 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.

[[Page 45996]]

21 CFR Part 640

    Blood, Labeling, Reporting and recordkeeping requirements.
    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, it is proposed that 21 CFR parts 606, 
607, 610, and 640 be 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:

    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:


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

    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.
    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 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

    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.
    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

    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.
    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

[[Page 45997]]

component in the directions for use for the blood collecting, 
processing, and storage system approved for such use by the Director, 
CBER.
    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.
    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.
    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.
* * * * *
    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 
system approved for such use by the Director, Center for Biologics 
Evaluation and Research.
* * * * *


Sec.  640.25  [Amended]

    13. Section 640.25 is amended in paragraph (b)(2) by removing 
``6.0'' and adding in its place ``6.2''.
    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.
* * * * *
    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.
* * * * *
    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.
* * * * *
    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. E7-15942 Filed 8-15-07; 8:45 am]
BILLING CODE 4160-01-S