[Federal Register Volume 65, Number 50 (Tuesday, March 14, 2000)]
[Rules and Regulations]
[Pages 13678-13679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6170]



Food and Drug Administration

21 CFR Part 640

[Docket No. 98N-0608]

Revision of Requirements Applicable to Albumin (Human), Plasma 
Protein Fraction (Human), and Immune Globulin (Human); Confirmation in 
Part and Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation in part and technical 


SUMMARY: The Food and Drug Administration (FDA) is confirming in part 
the direct final rule that appeared in the Federal Register of May 14, 
1999 (64 FR 26282). The direct final rule amends the biologics 
regulations by removing, revising, or updating specific regulations 
applicable to blood derivative products to be more consistent with 
current practices and to remove unnecessary or outdated requirements.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 hereby amending Title 21 Code of 
Federal Regulations to reinstate the former provisions. In addition, 
FDA is correcting the precision of the value for protein concentration 
that was inadvertently omitted from the codified section of the direct 
final rule.

DATES: The effective date for the amendments to the sections published 
in the Federal Register of May 14, 1999 (64 FR 26282), and listed in 
table 1 of this document, is confirmed as September 27, 1999. The 
amendments to Secs. 640.81(e) and (f), 640.92(a), and 640.102(e) are 
effective March 14, 2000.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, 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: FDA solicited comments concerning the direct 
final rule for a 75-day period ending July 28, 1999. FDA stated that 
the effective date of the direct final rule would be September 27, 
1999, 60 days after the end of the comment period, unless any 
significant adverse comment was submitted to FDA during the comment 
period. FDA also stated that 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 September 27, 1999.

                                 Table 1
               21 CFR                               Action
640.80(a) and (b)                    Revised
640.81(c)                            Revised
640.82(a) and (c)                    Revised heading
640.82(d) and (e)                    Revised
640.84                               Revised introductory paragraph
640.84(a)                            Removed introductory text
640.84(b)                            Removed
640.84(a)(1) through (a)(4)          Redesignated as paragraphs (a)
                                      through (d)
640.84 new paragraphs (a) and (d)    Revised
640.90(a) and (b)                    Revised
640.91(b)(2), (c), (e), and (f)      Revised
640.92(a)                            Revised
640.92(c)                            Revised heading
640.92(d) and (e)                    Revised

[[Page 13679]]

640.94(a)                            Revised
640.100(a), (b), and (c)             Revised
640.101(b)                           Revised heading
640.101(e)(3), (e)(4), and (f)       Removed
640.103(b)                           Revised
640.104(b)(2), (b)(3), (c)(1), and   Revised

    Secondly, FDA received significant adverse comments on three 
provisions of the rule, 21 CFR 640.81(e) and (f) and 640.102(e). 
Therefore, the agency is amending these sections to reinstate the 
former provisions. 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 26344, May 14, 1999), and 
will be considered in developing a final rule using the usual 
Administrative Procedure Act notice-and-comment procedures.
    Finally, FDA is amending Sec. 640.92(a) to include a revision of 
range for protein concentration. This change was discussed in the 
preamble to the Direct final rule (section III.G (64 FR 26282 at 
26284)), but was inadvertently omitted from the codified section of the 

List of Subjects in 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 to the 
Commissioner of Food and Drugs, the direct final rule published on May 
14, 1999 (64 FR 26282), is confirmed in part and 21 CFR part 640 is 
amended as follows:


    1. The authority citation for 21 CFR part 640 continues to read as 

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 
U.S.C. 216, 262, 263, 263a, 264.

    2. Section 640.81 is amended by revising the last sentence in 
paragraph (e) and paragraph (f) to read as follows:

Sec. 640.81  Processing.

* * * * *
    (e) * * * Heat treatment shall be conducted so that the solution is 
heated for not less than 10 or more than 11 hours at an attained 
temperature of 60;deg;0.5  deg.C.
    (f) Stabilizer. Either 0.16 millimole sodium acetyltryptophanate, 
or 0.08 millimole sodium acetyltryptophanate and 0.08 millimole sodium 
caprylate shall be added per gram of albumin as a stabilizer.
* * * * *

Sec. 640.92  [Amended]

    3. Section 640.92 Tests on final product is amended in paragraph 
(a) by removing ``5.00.3'' and adding in its place 

    4. Section 640.102 is amended by revising the last sentence of 
paragraph (e) to read as follows:

Sec. 640.102  Manufacture of Immune Globulin (Human).

* * * * *
    (e) * * * At no time during processing shall the product be exposed 
to temperatures above 45  deg.C and after sterilization the product 
shall not be exposed to temperatures above 30 to 32  deg.C for more 
than 72 hours.

    Dated: March 8, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-6170 Filed 3-13-00; 8:45 am]