[Federal Register Volume 73, Number 27 (Friday, February 8, 2008)]
[Rules and Regulations]
[Pages 7463-7464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2322]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 606, 607, 610, and 640
[Docket No. FDA-2008-N-0067]
Revisions to the Requirements Applicable to Blood, Blood
Components and Source Plasma; Confirmation of Effective Date and
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date and technical
amendment.
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SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of February 19, 2008, for the direct final rule that
appeared in the Federal Register of August 16, 2007 (72 FR 45883). The
direct final rule amends 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practices in the blood industry and to remove unnecessary or outdated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. In addition, FDA is making technical amendments to the
biologics regulations in response to comments received on the direct
final rule.
DATES: The effective date for the regulation is confirmed as February
19, 2008. The effective date of the technical amendment is also
February 19, 2008.
FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2007
(72 FR 45883), FDA solicited comments concerning the direct final rule
for a 75-day period ending October 30, 2007. FDA stated that the
effective date of the direct final rule would be on February 19, 2008,
6 months after the end of the comment period, unless any significant
adverse comment was submitted to FDA during the comment period. FDA
received several letters of comment on the direct final rule; however,
FDA did not receive any significant adverse comments. Therefore, FDA is
confirming the effective date of the direct final rule and making two
technical amendments in response to comments received. Comments were
received from private industry, an individual, organizations
representing the blood industry, and an employee of the Food and Drug
Administration. The comments received and FDA's responses to the
comments are discussed below as follows:
Two comments stated that under paragraph (c) of 21 CFR 610.53,
there was an error in a temperature listed in the table under Red Blood
Cells Deglycerolized and Red Blood Cells Frozen.
FDA agrees. In the Federal Register of September 24, 2007 (72 FR
54208), FDA issued a notice to correct a typographical error in the
codified section of the direct final rule. The table in paragraph (c)
of section 610.53 was corrected by replacing 65[deg]C with -65[deg]C.
One comment requested clarification of the proposed change in
wording from ``toward'' to ``at'' concerning the specified temperature
range under 21 CFR 640.4(h) because coolers do not have the capacity to
maintain a temperature range between 1 and 10[deg]C.
FDA agrees with the comment and therefore, is revising the
regulation to use ``toward'' rather than ``at''.
One comment requested that under 21 CFR 640.24(d) the pH be revised
from ``not less than 6.0'' to ``not less than 6.2'' to be consistent
with the change in 21 CFR 640.25(b)(2) (Sec. 640.25(b)(2)) and with
industry practice.
Because both of these provisions refer to the same pH requirement,
FDA agrees and is revising 21 CFR 640.24(d) as requested.
One comment agreed with the change in pH under Sec. 640.25(b)(2)
but stated that there was no mention of the number of units that must
meet this requirement and therefore the assumption is that 100 percent
of the units must meet the requirement which they believe is
unachievable.
We believe that the four units we require to be tested for quality
control purposes under Sec. 640.25(b) must meet the criteria listed
under this regulation. However, FDA recently issued a document entitled
``Guidance for Industry and FDA Review Staff: Collection of Platelets
by Automated Methods,'' dated December 2007 (December 17, 2007; 72 FR
71418). In this guidance, we provide recommendations on quality control
monitoring. Therefore, no additional changes are warranted.
Two comments requested that FDA revise the definition under 21 CFR
640.30(a) to include ``for intravenous or further manufacturing use''
to facilitate use of plasma for further manufacturing use that has been
collected concurrently with the collection of another blood component
by apheresis. In addition, the comments requested that 21 CFR 640.34
and other provisions in the regulations be revised and harmonized to
allow interchangeability of the plasma from intravenous use to
manufacturing use after blood collection.
FDA presently has this issue under consideration and may address
this in future rulemaking, if warranted. This comment is beyond the
scope of this rulemaking.
One comment requested that FDA provide the rationale for the
revision to 21 CFR 640.34(b) requiring fresh frozen plasma collected by
an apheresis procedure to be prepared from blood collected by single
uninterrupted venipuncture, and why it was differentiated from other
components collected by apheresis. The comment also questioned whether
the current practice of using a sterile connecting device to attach a
sterile needle in the event of blood flow interruption would be
prohibited in the future.
[[Page 7464]]
The rationale for requiring blood and blood components, including
fresh frozen plasma collected by an apheresis procedure, to be
collected by a single uninterrupted venipuncture is to help ensure
minimal tissue damage which could activate the coagulation cascade.
This is also a requirement for Platelet collection. Under 21 CFR
640.22(d), the regulation states that Platelet phlebotomy shall be
performed by a single uninterrupted venipuncture with minimal damage
to, and minimal manipulation of, the donor's tissue. FDA does not
anticipate, in the near future, any change in the policy for using a
sterile connecting device to attach a sterile needle to a collection
set in the event of a blood flow interruption.
List of Subjects
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 part 640 is amended as follows:
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
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1. 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.
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2. 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 toward
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.
Sec. 640.24 [Amended]
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3. Section 640.24 is amended in the first sentence of paragraph (d) by
removing ``6.0'' and adding in its place ``6.2''.
Dated: February 1, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2322 Filed 2-7-08; 8:45 am]
BILLING CODE 4160-01-S