[Federal Register Volume 60, Number 1 (Tuesday, January 3, 1995)]
[Notices]
[Pages 129-130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32242]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94E-0234]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ZemuronTM Injection; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting the 
notice that appeared in the Federal Register of September 15, 1994. The 
document announced FDA's determination of the regulatory review period 
for purposes of patent extension for ZeuronTM Injection 
(rocuronium bromide). The document was published with some errors. The 
document incorrectly stated: ``1. The date an exemption under section 
505(i) of the Federal Food, Drug, and Cosmetic Act became effective: 
January 15, 1994. The applicant claims January 14, 1989, as 
[[Page 130]] the date the investigational new drug application (IND) 
became effective. However, FDA records indicate that the IND effective 
date was January 15, 1994, which was 30 days after FDA receipt of the 
IND.'' The document should have stated: ``1. The date an exemption 
under section 505(i) of the Federal Food, Drug, and Cosmetic Act became 
effective: January 15, 1989. The applicant claims January 14, 1989, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was January 15, 1989, which was 30 days after FDA receipt of the IND.'' 
This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

    In FR Doc. 94-22760, appearing on page 47341 in the Federal 
Register of September 15, 1994, the following corrections are made:
    On page 47341, in the second column, in the third paragraph, in the 
fourth and ninth lines, ``January 15, 1994'' is corrected to read 
``January 15, 1989''.

    Dated: December 21, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-32242 Filed 12-30-94; 8:45 am]
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