1834 Federal Register / Vol. 66, No. 7 / Wednesday, January 10, 2001 / Rules and Regulations

§ 558.355 [Amended]

3. Section 558.355 Monensin is

amended in paragraph (f)(7) by adding

‘‘alone or with tylosin’’ after

‘‘decoquinate’’.

4. Section 558.625 is amended by

redesignating paragraphs (f)(2)(i)

through (f)(2)(v) as (f)(2)(ii) through

(f)(2)(vi), and by adding paragraph

(f)(2)(i) to read as follows:

§ 558.625 Tylosin.

* * * * *

(f) * * *

(2) * * *

(i) Decoquinate and monensin as in

§ 558.195.

* * * * *

Dated: December 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–628 Filed 1–9–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 606 and 640

[Docket No. 98N–0673]

Revisions to the Requirements

Applicable to Blood, Blood

Components, and Source Plasma;

Confirmation in Part and Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule; confirmation in

part and technical amendment.

SUMMARY: The Food and Drug

Administration (FDA) is confirming in

part the direct final rule issued in the

Federal Register of August 19, 1999.

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unnecessary or outdated requirements.

FDA is confirming the provisions for

which no significant adverse comments

were received. The agency received

significant adverse comments on certain

provisions and is amending Title 21

Code of Federal Regulations to reinstate

the former provisions.

DATES: The effective date for the

amendments to the sections published

in the Federal Register of August 19,

1999 (64 FR 45366), and listed in table

1 of this document, is confirmed as

February 11, 2000. The amendments

listed in table 2 of this document are

effective January 10, 2001.

FOR FURTHER INFORMATION CONTACT:

Joseph L. Okrasinski, 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: Written

comments concerning the direct final

rule were to be submitted on or before

December 3, 1999. FDA stated that the

effective date of the direct final rule

would be February 11, 2000. If no

timely significant comments were

submitted to FDA during the comment

period, FDA intended to publish a

document in the Federal Register

within 30 days after the comment

period ended, confirming the effective

date of the final rule. If timely

significant comments were received, the

agency intended to publish a document

in the Federal Register withdrawing the

direct final rule before its effective date.

Because of complex issues related to

this rulemaking and because of

competing priorities, FDA did not issue

a document either confirming or

withdrawing the direct final rule before

its effective date. Therefore the Code of

Federal Regulations was revised as of

April 1, 2000, to codify the regulations

in the direct final rule.

The agency received significant

comments to the docket. If a significant

adverse comment applies to an

amendment, paragraph, or section of the

rule and that provision can be severed

from the remainder of the rule, FDA

may adopt as final those provisions of

the rule that are not subjects of

significant adverse comments.

Thus, FDA is confirming in part the

direct final rule (sections listed in table

1 of this document) effective February

11, 2000.

The agency is making technical

amendments to 21 CFR 640.25(c),

640.56(c), and 640.71(a) by replacing

‘‘Clinical Laboratories Improvement Act

of 1967 (CLIA)’’ with ‘‘Clinical

Laboratories Improvement Amendments

of 1988 (CLIA).’’ This action is

necessary for consistency when

referring to CLIA in the regulations.

TABLE 1.—AMENDMENTS EFFECTIVE FEBRUARY 11, 2000

21 CFR Section Action

606.3(c), (e), and (f) ...................................................................................... Revised.

606.100(b) and (d) ......................................................................................... Revised introductory text.

606.100(b)(7) and (b)(18) .............................................................................. Revised.

606.121(a), (d)(2), and (e)(1)(ii) .................................................................... Revised.

606.122(f) and (n)(4) ..................................................................................... Revised.

606.151(e) ...................................................................................................... Revised.

606.160(b)(2)(v) ............................................................................................. Revised.

606.170(b) ...................................................................................................... Revised.

640.2(b) and (d) ............................................................................................. Removed.

640.2(c), (e), and (f) ...................................................................................... Redesignated as (b), (c), and (d).

640.2(c)(2) ..................................................................................................... Revised.

640.3(b) .......................................................................................................... Revised introductory text.

640.3(b)(3), (c)(2), and (c)(3) ........................................................................ Revised.

640.3(e) .......................................................................................................... Removed and reserved.

640.4(d)(1) through (d)(4), and (h) ................................................................ Removed.

640.4(i) ........................................................................................................... Redesignated as paragraph (h).

640.4(b) and (d) ............................................................................................. Revised.

640.6(c) .......................................................................................................... Removed.

640.13(a) ........................................................................................................ Revised.

640.16(b) ........................................................................................................ Revised.

640.22(a) ........................................................................................................ Revised.

640.25(c) ........................................................................................................ Nomenclature change.

640.31(c) ........................................................................................................ Removed.

Federal Register / Vol. 66, No. 7 / Wednesday, January 10, 2001 / Rules and Regulations 1835

TABLE 1.—AMENDMENTS EFFECTIVE FEBRUARY 11, 2000—Continued

21 CFR Section Action

640.32(a) ........................................................................................................ Revised.

640.34(e)(2), (e)(3), and (g)(2) ...................................................................... Revised.

640.51(c) ........................................................................................................ Removed.

640.52(a) ........................................................................................................ Revised.

640.56(c) ........................................................................................................ Nomenclature change.

640.63(c)(3), (c)(5), (c)(12), and (c)(13) ........................................................ Revised.

640.65(b)(4) and (b)(5) .................................................................................. Revised.

640.65(b)(8) ................................................................................................... Added.

640.69(d) ........................................................................................................ Revised.

640.71(a) ........................................................................................................ Nomenclature change.

640.72(a)(1) ................................................................................................... Revised.

FDA received significant adverse

comments on certain provisions of the

rule, listed in table 2 of this document.

Accordingly in this rulemaking, because

these provisions became effective on

February 11, 2000, the agency is

amending these sections identified in

table 2 of this document to reinstate the

former provisions.

TABLE 2.—AMENDMENTS EFFECTIVE JANUARY 10, 2001

21 CFR Section Action

606.3(j) ........................................................................................................... Revised.

606.151(b) and (c) ......................................................................................... Revised.

640.2(b) .......................................................................................................... Revised.

640.3(c)(1) ..................................................................................................... Revised.

640.4(g) .......................................................................................................... Revised introductory text.

640.4(g)(1), (g)(2), (g)(4), and (g)(5) ............................................................. Revised.

640.5 .............................................................................................................. Revised introductory text.

640.5(c) .......................................................................................................... Revised.

640.15 ............................................................................................................ Revised.

640.16(a) ........................................................................................................ Revised.

640.23(a) ........................................................................................................ Revised.

640.24(b) ........................................................................................................ Revised.

640.25(c) introductory text ............................................................................. Amended.

640.34(a) through (e)(1) ................................................................................ Revised.

640.54(a)(2) ................................................................................................... Revised.

640.56(c) introductory text ............................................................................. Revised.

640.62 ............................................................................................................ Revised.

640.63(c)(11) ................................................................................................. Revised.

640.71(a) ........................................................................................................ Amended.

Comments received by the agency

regarding the reinstated portions of the

rule will be applied to the

corresponding portion of the companion

proposed rule (64 FR 45375, August 19,

1999), and will be considered in

developing a final rule using the usual

Administrative Procedure Act notice

and comment procedures.

List of Subjects

21 CFR Part 606

Blood, Labeling, Laboratories,

Reporting and recordkeeping

requirements.

21 CFR Part 640

Blood, Labeling, Reporting and

recordkeeping requirements.

Therefore under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, and authority

delegated by the Commissioner of Food

and Drugs, the direct final rule

published on August 19, 1999 (64 FR

45366), is confirmed in part and 21 CFR

parts 606 and 640 are amended as

follows:

PART 606—CURRENT GOOD

MANUFACTURING PRACTICE FOR

BLOOD AND BLOOD COMPONENTS

1. The authority citation for 21 CFR

part 606 continues to read as follows:

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 (j) to read as follows:

§ 606.3 Definitions.

* * * * *

(j) Compatibility testing means the in

vitro serological tests performed on

donor and recipient blood samples to

establish the serological matching of a

donor’s blood or blood components

with that of a potential recipient.

3. Section 606.151 is amended by

revising paragraphs (b) and (c) to read

as follows:

§ 606.151 Compatibility testing.

* * * * *

(b) The use of fresh recipient serum

samples less than 48 hours old for all

pretransfusion testing.

(c) The testing of the donor’s cells

with the recipient’s serum (major

crossmatch) by a method that will

demonstrate agglutinating, coating, and

hemolytic antibodies, which shall

include the antiglobulin method.

* * * * *

PART 640—ADDITIONAL STANDARDS

FOR HUMAN BLOOD AND BLOOD

PRODUCTS

4. 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.

1836 Federal Register / Vol. 66, No. 7 / Wednesday, January 10, 2001 / Rules and Regulations

5. Section 640.2 is amended by

revising paragraph (b) to read as follows:

§ 640.2 General requirements.

* * * * *

(b) Final container. The original blood

container shall be the final container

and shall not be entered prior to issue

for any purpose except for blood

collection. Such container shall be

uncolored and transparent to permit

visual inspection of the contents and

any closure shall be such as will

maintain an hermetic seal and prevent

contamination of the contents. The

container material shall not interact

with the contents under customary

conditions of storage and use, in such a

manner as to have an adverse effect

upon the safety, purity, or potency of

the blood.

* * * * *

6. Section 640.3 is amended by

revising paragraph (c)(1) to read as

follows:

§ 640.3 Suitability of donor.

* * * * *

(c) * * *

(1) A history of viral hepatitis;

* * * * *

7. Section 640.4 is amended by

revising the introductory text of

paragraph (g) and by revising

paragraphs (g)(1), (g)(2), (g)(4) and (g)(5)

to read as follows:

§ 640.4 Collection of the blood.

* * * * *

(g) Pilot samples for laboratory tests.

Pilot samples for laboratory tests shall

meet the following standards:

(1) One or more pilot samples shall be

provided with each unit of blood when

issued or reissued except as provided in

§ 640.2(c)(2) and all pilot samples shall

be from the donor who is the source of

the unit of blood.

(2) All samples for laboratory tests

performed by the manufacturer and all

pilot samples accompanying a unit of

blood shall be collected at the time of

filling the final container by the person

who collects the unit of blood.

* * * * *

(4) All containers for pilot samples

accompanying a unit of blood shall be

attached to the whole blood container

before blood collection in a tamperproof

manner that will conspicuously indicate

removal and reattachment.

(5) When CPDA–1 is used, pilot

samples for compatibility testing shall

contain blood mixed with CPDA–1.

* * * * *

8. Section 640.5 is amended by

revising the introductory text and

paragraph (c) to read as follows:

§ 640.5 Testing the blood.

All laboratory tests shall be made on

a pilot sample specimen of blood taken

from the donor at the time of collecting

the unit of blood, and these tests shall

include the following:

* * * * *

(c) Determination of the Rh factors.

Each container of Whole Blood shall be

classified as to Rh type on the basis of

tests done on the pilot sample. The label

shall indicate the extent of typing and

the results of all tests performed. If the

test, using Anti-D Blood Grouping

Reagent, is positive, the container may

be labeled ‘‘Rh Positive’’. If this test is

negative, the results shall be confirmed

by further testing which may include

tests for the Rho variant (Du) and for

other Rh-Hr factors. Blood may be

labeled ‘‘Rh Negative’’ if negative to

tests for the Rho (D) and Rho variant (Du)

factors. If the test using Anti-D Blood

Grouping Reagent is negative, but not

tested for the Rho variant (Du), the label

must indicate that this test was not

done. Only Anti-Rh Blood Grouping

Reagents licensed under, or that

otherwise meet the requirements of, the

regulations of this subchapter shall be

used, and the technique used shall be

that for which the serum is specifically

designed to be effective.

* * * * *

9. Section 640.15 is revised to read as

follows:

§ 640.15 Pilot samples.

Pilot samples collected in integral

tubing or in separate pilot tubes shall

meet the following standards:

(a) One or more pilot samples of

either the original blood or of the Red

Blood Cells being processed shall be

provided with each unit of Red Blood

Cells when issued or reissued.

(b) Before they are filled, all pilot

sample tubes shall be marked or

identified so as to relate them to the

donor of that unit of red cells.

(c) Before the final container is filled

or at the time the final product is

prepared, the pilot sample tubes to

accompany a unit of cells shall be

attached securely to the final container

in a tamper proof manner that will

conspicuously indicate removal and

reattachment.

(d) All pilot sample tubes

accompanying a unit of Red Blood Cells

shall be filled at the time the blood is

collected or at the time the final product

is prepared, in each instance by the

person who performs the collection or

preparation.

10. Section 640.16 is amended by

revising paragraph (a) to read as follows:

§ 640.16 Processing.

(a) Separation. Within 21 days from

date of blood collection (within 35 days

from date of blood collection when

CPDA–1 solution is used as the

anticoagulant), Red Blood Cells may be

prepared either by centrifugation done

in a manner that will not tend to

increase the temperature of the blood or

by normal undisturbed sedimentation.

A portion of the plasma sufficient to

insure optimal cell preservation shall be

left with the red blood cells except

when a cryoprotective substance is

added for prolonged storage.

* * * * *

11. Section 640.23 is amended by

revising paragraph (a) to read as follows:

§ 640.23 Testing the blood.

(a) Blood from which plasma is

separated for the preparation of Platelets

shall be tested as prescribed in

§§ 610.40 and 610.45 of this chapter and

§ 640.5 (a), (b), and (c).

* * * * *

12. Section 640.24 is amended by

revising paragraph (b) to read as follows:

§ 640.24 Processing.

* * * * *

(b) Immediately after collection, the

whole blood or plasma shall be held in

storage between 20 and 24 °C, unless it

must be transported from the donor

clinic to the processing laboratory.

During such transport, all reasonable

methods shall be used to maintain the

temperature as close as possible to a

range between 20 and 24 °C until it

arrives at the processing laboratory

where it shall be held between 20 and

24 °C until the platelets are separated.

The platelet concentrate shall be

separated within 4 hours after the

collection of the unit of whole blood or

plasma.

* * * * *

§ 640.25 [Amended]

13. Section 640.25 General

requirements is amended in the

introductory text of paragraph (c) by

removing ‘‘Clinical Laboratories

Improvement Act of 1967’’ and by

adding in its place ‘‘Clinical

Laboratories Improvement Amendments

of 1988.’’

14. Section 640.34 is amended by

revising paragraphs (a) through (e)(1) to

read as follows:

§ 640.34 Processing.

(a) Plasma. Plasma shall be separated

from the red blood cells within 26 days

after phlebotomy (within 40 days after

phlebotomy when CPDA–1 solution is

used as the anticoagulant), and shall be

Federal Register / Vol. 66, No. 7 / Wednesday, January 10, 2001 / Rules and Regulations 1837

1Section 125(f) provides that the following are

not qualified benefits (even though they are

generally excludable from gross income under an

express provision of the Internal Revenue Code:

Products advertised, marketed, or offered as longterm care insurance; medical savings accounts

under section 106(b); qualified scholarships under

section 117; educational assistance programs under

section 127; and fringe benefits under section 132.

2 49 FR 19321 (May 7, 1984) and 54 FR 9460

(March 7, 1989), respectively.

stored at -18 °C or colder within 6 hours

after transfer to the final container,

unless the product is to be stored as

Liquid Plasma.

(b) Fresh Frozen Plasma. Fresh Frozen

Plasma shall be prepared from blood

collected by a single uninterrupted

venipuncture with minimal damage to

and minimal manipulation of the

donor’s tissue. The plasma shall be

separated from the red blood cells,

frozen solid within 6 hours after

phlebotomy and stored at -18 °C or

colder.

(c) Liquid Plasma. Liquid Plasma

shall be separated from the red blood

cells within 26 days after phlebotomy

(within 40 days after phlebotomy when

CPDA–1 solution is used as the

anticoagulant), and shall be stored at a

temperature of 1 to 6 °C within 4 hours

after filling the final container.

(d) Platelet Rich Plasma. Platelet Rich

Plasma shall be prepared from blood

collected by a single uninterrupted

venipuncture with minimal damage to

and manipulation of the donor’s tissue.

The plasma shall be separated from the

red blood cells by centrifugation within

4 hours after phlebotomy. The time and

speed of centrifugation shall have been

shown to produce a product with at

least 250,000 platelets per microliter.

The plasma shall be stored at a

temperature between 20 to 24 °C or

between 1 and 6 °C, immediately after

filling the final container. A gentle and

continuous agitation of the product

shall be maintained throughout the

storage period, if stored at a temperature

of 20 to 24 °C.

(e) Modifications of Plasma. It is

possible to separate Platelets and/or

Cryoprecipitated AHF from Plasma.

When these components are to be

separated, the plasma shall be collected

as described in § 640.32 for Plasma.

(1) Platelets shall be separated as

prescribed in subpart C of part 640,

prior to freezing the plasma. The

remaining plasma may be labeled as

Fresh Frozen Plasma, if frozen solid

within 6 hours after phlebotomy.

* * * * *

15. Section 640.54 is amended by

revising paragraph (a)(2) to read as

follows:

§ 640.54 Processing.

(a) * * *

(2) The plasma shall be frozen solid

within 6 hours after blood collection. A

combination of dry ice and organic

solvent may be used for freezing:

Provided, That the procedure has been

shown not to cause the solvent to

penetrate the container or leach

plasticizer from the container into the

plasma.

* * * * *

§ 640.56 [Amended]

16. Section 640.56 Quality control test

for potency is amended in the

introductory text of paragraph (c) by

removing ‘‘Clinical Laboratories

Improvement Act of 1988’’ and by

adding in its place ‘‘Clinicial

Laboratories Improvement Amendments

of 1988’’.

17. Section 640.62 is revised to read

as follows:

§ 640.62 Medical supervision.

A qualified licensed physician shall

be on the premises when donor

suitability is being determined,

immunizations are being made, whole

blood is being collected, and red blood

cells are being returned to the donor.

18. Section 640.63 is amended by

revising paragraph (c)(11) to read as

follows:

§ 640.63 Suitability of donor.

* * * * *

(c) * * *

(11) Freedom from a history of viral

hepatitis;

* * * * *

§ 640.71 [Amended]

19. Section 640.71 Manufacturing

responsibility is amended in the

introductory text of paragraph (a) by

removing ‘‘Clinical Laboratories

Improvement Act of 1988’’ and by

adding in its place ‘‘Clinicial

Laboratories Improvement Amendments

of 1988’’.

Dated: December 29, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–533 Filed 1–9–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8921]

RIN 1545–AY23

Tax Treatment of Cafeteria Plans

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations.

SUMMARY: This document contains final

regulations relating to section 125

cafeteria plans. The final regulations

clarify the circumstances under which a

cafeteria plan may permit an employee

to change his or her cafeteria plan

election with respect to accident or

health coverage, group-term life

insurance coverage, dependent care

assistance and adoption assistance

during the plan year.

DATES: Effective Date: These regulations

are effective January 10, 2001.

Applicability Date: See the Scope of

Regulations and Effective Date portion

of this preamble.

FOR FURTHER INFORMATION CONTACT:

Christine L. Keller or Janet A. Laufer at

(202) 622–6080 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

This document contains amendments

to the Income Tax Regulations (26 CFR

part 1) under section 125 of the Internal

Revenue Code (Code). Section 125

generally provides that an employee in

a cafeteria plan will not have an amount

included in gross income solely because

the employee may choose among two or

more benefits consisting of cash and

qualified benefits. A qualified benefit

generally is any benefit that is

excludable from gross income under an

express provision of the Code, including

coverage under an employer-provided

accident or health plan under sections

105 and 106, group-term life insurance

under section 79, elective contributions

under a qualified cash or deferred

arrangement within the meaning of

section 401(k), dependent care

assistance under section 129, and

adoption assistance under section 137.1

Qualified benefits can be provided

under a cafeteria plan either through

insured arrangements or arrangements

that are not insured.

In 1984 and 1989, proposed

regulations were published relating to

cafeteria plans.2 In general, the 1984

and 1989 proposed regulations require

that, for benefits to be provided on a

pre-tax basis under section 125, an

employee may make changes during a

plan year only in certain circumstances.

Specifically, Q&A–8 of § 1.125–1 and

Q&A–6(b), (c), and (d) of § 1.125–2

permit participants to make benefit

election changes during a plan year

pursuant to changes in cost or coverage,