[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
amendment.
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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current practices and to remove unnecessary or outdated requirements.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
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21 CFR Action
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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
(c)(2)
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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
document.
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:
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
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.
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
``5.00.30''.
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]
BILLING CODE 4160-01-F