[Federal Register Volume 62, Number 49 (Thursday, March 13, 1997)]
[Rules and Regulations]
[Page 11769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600 and 601

[Docket No. 95N-0411]
RIN 0910-AA71


Elimination of Establishment License Application for Specified 
Biotechnology and Specified Synthetic Biological Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of May 14, 1996 (61 FR 
24227). The document amended the biologics regulations to eliminate the 
establishment license application (ELA) requirement for certain 
biotechnology and synthetic biological products subject to licensing 
under the Public Health Service Act (PHS Act); exempted these 
biotechnology and synthetic biological products from certain biologics 
regulations; and harmonized the requirements applicable to these 
products with those applicable to similar drug products which are 
approved under the Federal Food, Drug, and Cosmetic Act (the act). The 
document referenced certain regulations that were later removed from 
Title 21 of the Code of Federal Regulations (CFR). This document 
removes those references to ensure the consistency and accuracy of the 
CFR.

EFFECTIVE DATE: March 13, 1997.
FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, suite 400S, Rockville, MD 20852-
1448, 301-594-3074.

    In FR Doc. 96-12144, appearing on page 24227, in the Federal 
Register of Tuesday, May 14, 1996, the following corrections are made:
    1. On page 24230, in the 2d column, in the 4th full paragraph, in 
the 8th line, remove ``; 601.30 to 601.33;'' and add ``, 601.33;'' in 
their place.


Sec. 601.2  [Corrected]

    2. On page 24233, in the 2d column, Sec. 601.2(c)(3) is corrected 
by removing ``, 601.30, 601.31, 601.32''.

    Dated: March 6, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6359 Filed 3-12-97; 8:45 am]
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