[Federal Register: August 5, 1998 (Volume 63, Number 150)]
[Rules and Regulations]               
[Page 41718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au98-9]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. 97N-0449]

 
Revisions to the General Safety Test Requirements for Biological 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule: Confirmation in part and withdrawal in part.

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SUMMARY: The Food and Drug Administration (FDA) is confirming in part 
and withdrawing in part the provisions in the direct final rule that 
published in the Federal Register of April 20, 1998, to revise the 
general safety test (GST) requirements for biological products. FDA is 
confirming the part of the rule about which no significant adverse 
comment was received and withdrawing the part about which significant 
adverse comment was received.

DATES: The effective date for the revision of Sec. 610.11(g)(1) 
published at 63 FR 19403 (April 20, 1998) is confirmed as September 2, 
1998. The revision of Sec. 610.11(g)(2) published at 63 FR 19403 (April 
20, 1998) is withdrawn as of August 5, 1998.

FOR FURTHER INFORMATION CONTACT: Dano B. Murphy, 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 published a direct final rule on April 
20, 1998 (63 FR 19399), that was intended to revise the GST 
requirements set forth in Sec. 610.11 (21 CFR 610.11). In response to 
the direct final rule, the agency received significant adverse comment 
about Sec. 610.11(g)(2), the provision of the rule that provides the 
administrative procedures for requesting an exemption from the GST 
requirements. The agency received no significant adverse comment about 
the addition of ``cellular therapy products'' to the list of products 
excepted from the GST in Sec. 610.11(g)(1).
    Under FDA's direct final rule procedures, the receipt of any 
significant adverse comment will result in the withdrawal of the direct 
final rule; however, FDA may adopt as final any part of a direct final 
rule that can be severed and is not subject to significant adverse 
comment. Thus, the part of this direct final rule that received 
significant adverse comment can be severed and is being withdrawn, 
effective immediately. Comments received by the agency regarding the 
withdrawn portion of the rule will be applied to the corresponding 
portion of the companion proposed rule (63 FR 19431) and will be 
considered in developing a final rule using the usual Administrative 
Procedure Act notice-and-comment procedures.
     FDA is confirming Sec. 610.11(g)(1) of the direct final rule and 
adding ``cellular therapy products'' to the list of products excepted 
from the GST, effective September 2, 1998.
    For the reasons set forth in the preamble, the revision of 
Sec. 610.11(g)(2), published at 63 FR 19403 (April 20, 1998), is 
withdrawn and paragraph (g)(2) is reserved.

    Dated: July 29, 1998.
William K. Hubbard.
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20823 Filed 8-4-98; 8:45 am]
BILLING CODE 4160-01-F