[Federal Register Volume 66, Number 78 (Monday, April 23, 2001)]
[Rules and Regulations]
[Pages 20402-20403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 660

[Docket No. 00N-1586]


Revision to Requirements for Licensed Anti-Human Globulin and 
Blood Grouping Reagents; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of June 11, 2001, for the direct final rule that 
appeared in the Federal Register of December 12, 2000 (65 FR 77497). 
The direct final rule rule amends the biologics regulations applicable 
to microbiological controls for licensed Anti-Human Globulin and Blood 
Grouping Reagents by removing the requirement that these products be 
sterile. This document confirms the effective date of the direct final 
rule.

DATES: Effective date confirmed: June 11, 2001.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 12, 2000 
(65 FR 77497), FDA solicited comments concerning the direct final rule 
for a 75-

[[Page 20403]]

day period ending February 26, 2001. FDA stated that the effective date 
of the direct final rule would be on June 11, 2001, unless any 
significant adverse comment was submitted to FDA during the comment 
period. FDA did not receive any significant adverse comments.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, the 
amendments issued thereby will go into effect on June 11, 2001.

    Dated: April 13, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-9873 Filed 4-20-01; 8:45 am]
BILLING CODE 4160-01-S