[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]
BILLING CODE 4160-01-F
