Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment, 7463-7464 [E8-2322]

Download as PDF Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Rules and Regulations Riverton, WY, Riverton Regional, ILS OR LOC RWY 28, Amdt 1B Martinsburg, WV, Eastern WV Regional/ Shepherd, LOC/DME BC RWY 8, Amdt 6, CANCELLED The FAA published an Amendment in Docket No. 30587, Amdt No. 3251 to Part 97 of the Federal Aviation Regulations (Vol. 73, FR No. 16, Page 4073 dated Thursday, January 24, 2008) under section 97.29 effective March 13, 2008, which is hereby corrected to read as follows: Waterville, ME, ILS OR LOC RWY 5, Amdt 2B The FAA published an Amendment in Docket No. 30587, Amdt No. 3251 to Part 97 of the Federal Aviation Regulations (Vol. 73, FR No. 16, Page 4073 dated Thursday, January 24, 2008) under section 97.29 effective April 10, 2008, which is hereby rescinded: Burlington, VT, Burlington Intl, ILS OR LOC/ DME RWY 33, Amdt 1 The FAA published an Amendment in Docket No. 30587, Amdt No. 3251 to Part 97 of the Federal Aviation Regulations (Vol. 73, FR No. 16, Page 4073 dated Thursday, January 24, 2008) under section 97.29 effective February 14, 2008, which is hereby corrected to read as follows: Omaha, NE, Epply Airfield, ILS OR LOC RWY 32L, Amdt 1 Omaha, NE, Epply Airfield, ILS OR LOC/ DME RWY 14L, Amdt 1 Omaha, NE, Epply Airfield, ILS OR LOC/ DME RWY 14R, ILS RWY 14R (CAT II), ILS RWY 14R (CAT III), Amdt 4 Omaha, NE, Epply Airfield, RNAV (GPS) RWY 14L, Amdt 1 Omaha, NE, Epply Airfield, Takeoff Minimums and Obstacle DP, Amdt 5 [FR Doc. 08–535 Filed 2–7–08; 8:45 am] BILLING CODE 4910–13–M 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. Direct final rule; confirmation of effective date and technical amendment. jlentini on PROD1PC65 with RULES ACTION: 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, VerDate Aug<31>2005 17:26 Feb 07, 2008 Jkt 214001 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. The effective date for the regulation is confirmed as February 19, 2008. The effective date of the technical amendment is also February 19, 2008. DATES: 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. In the Federal Register of August 16, 2007 (72 FR 45883), FDA solicited comments concerning the direct final rule for a 75day 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°C with -65°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°C. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 7463 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) (§ 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 § 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 § 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. E:\FR\FM\08FER1.SGM 08FER1 7464 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Rules and Regulations 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. the blood collecting, processing, and storage system approved for such use by the Director, CBER. § 640.24 [Amended] 3. Section 640.24 is amended in the first sentence of paragraph (d) by removing ‘‘6.0’’ and adding in its place ‘‘6.2’’. I 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 DEPARTMENT OF THE TREASURY Internal Revenue Service List of Subjects 26 CFR Part 1 21 CFR Part 640 [TD 9379] 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 part 640 is amended as follows: RIN 1545–BG35 PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS SUMMARY: This document contains a temporary regulation that provides the time and manner for making an election to treat the sale or exchange of musical compositions or copyrights in musical works created by the taxpayer (or received by the taxpayer from the works’ creator in a transferred basis transaction) as the sale or exchange of a capital asset. The regulation reflects changes to the law made by the Tax Increase Prevention and Reconciliation Act of 2005 and the Tax Relief and Health Care Act of 2006. The regulation affects taxpayers making the election under section 1221(b)(3) of the Internal Revenue Code (Code) to treat gain or loss from such a sale or exchange as capital gain or loss. The text of this temporary regulation also serves as the text of the proposed regulation (REG– 153589–06) set forth in the Proposed Rules section of this issue of the Federal Register. DATES: Effective Date: This regulation is effective on February 8, 2008. Applicability Dates: For dates of applicability, see § 1.1221–3T(d). FOR FURTHER INFORMATION CONTACT: Jamie Kim, (202) 622–4950 (not a tollfree number). SUPPLEMENTARY INFORMATION: 1. 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. 2. Section 640.4 is amended by revising paragraph (h) to read as follows: I § 640.4 Collection of the blood. jlentini on PROD1PC65 with RULES * * * * * (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 toward a temperature range between 1 and 10 °C until arrival at the processing laboratory. At the processing laboratory, 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 VerDate Aug<31>2005 17:26 Feb 07, 2008 Jkt 214001 Time and Manner for Electing Capital Asset Treatment for Certain SelfCreated Musical Works Internal Revenue Service (IRS), Treasury. ACTION: Temporary regulation. AGENCY: Background Section 1221(a) of the Internal Revenue Code (Code) generally provides PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 that capital assets include all property held by a taxpayer with certain specified exclusions. Section 1221(a)(1) excludes from the definition of a capital asset inventory property or property held by a taxpayer primarily for sale to customers in the ordinary course of the taxpayer’s trade or business. Section 1221(a)(3) excludes from the definition of a capital asset copyrights, literary, musical, or artistic compositions, letters or memoranda, or similar property held by a taxpayer whose personal efforts created the property (or held by a taxpayer whose basis in the property is determined by reference to the basis of such property in the hands of the taxpayer whose personal efforts created the property). Section 1221(b)(3) of the Code, added by section 204 of the Tax Increase Prevention and Reconciliation Act of 2005 (Public Law 109–222, 120 Stat. 345) and amended by section 412 of the Tax Relief and Health Care Act of 2006 (Public Law 109–432, 120 Stat. 2922), provides that, at the election of a taxpayer, the section 1221(a)(1) and (a)(3) exclusions from capital asset status do not apply to musical compositions or copyrights in musical works sold or exchanged by a taxpayer described in section 1221(a)(3). Thus, if a taxpayer who owns a musical composition or copyright in a musical work created by the taxpayer (or transferred to the taxpayer by the work’s creator in a section 1221(a)(3)(C) transferred basis transaction) elects the application of this provision, gain or loss from the sale or exchange of the musical composition or copyright is treated as capital gain or loss. Explanation of Provisions This temporary regulation provides rules regarding the time and manner for making an election under section 1221(b)(3) to treat gain or loss from the sale or exchange of certain musical compositions or copyrights in musical works as gain or loss from the sale or exchange of a capital asset. Special Analyses It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to this regulation. For application of the Regulatory Flexibility Act (5 U.S.C. Chapter 6) please refer to the cross reference notice of proposed rulemaking published elsewhere in this issue of the Federal Register. Pursuant to section E:\FR\FM\08FER1.SGM 08FER1

Agencies

[Federal Register Volume 73, Number 27 (Friday, February 8, 2008)]
[Rules and Regulations]
[Pages 7463-7464]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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

0
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.

0
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]

0
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

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