[Federal Register Volume 60, Number 78 (Monday, April 24, 1995)]
[Notices]
[Page 20107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10074]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94E-0071]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Zosyn; Correction
AGENCY: Food and Drug Administration.
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 August 30, 1994. The
document announced FDA's determination of the regulatory review period
for purposes of patent extension for Zosyn (tazobactam sodium
and piperacillin sodium). The document was published with some errors.
The document incorrectly stated:
FDA has determined that the applicable regulatory review period
for Zosyn is 1,819 days. Of this time, 1,038 days occurred
during the testing phase of the regulatory review period, while 781
days occurred during the approval phase.
1. The date an exemption under 505(i) of the Federal Food,
Drug, and Cosmetic Act became effective: October 31, 1988. The
applicant claims July 10, 1988, as the date the investigational new
drug application (IND) for Zosyn (IND 31,705) became
effective. However, IND 31,705 was received on June 14, 1988, and it
was placed on clinical hold on July 1, 1988. It was removed from
clinical hold on October 31, 1988, making the IND effective date
October 31, 1988.
It should have stated:
FDA has determined that the applicable regulatory review period
for Zosyn is 1,906 days. Of this time, 1,125 days occurred
during the testing phase of the regulatory review period, while 781
days occurred during the approval phase.
1. The date an exemption under 505(i) of the Federal Food, Drug,
and Cosmetic Act became effective: August 5, 1988. The applicant claims
July 10, 1988, as the date the investigational new drug application
(IND) for Zosyn (IND 31,705) became effective. However, IND
31,705 was received on June 14, 1988, and it was placed on clinical
hold on July 1, 1988. It was removed from clinical hold on August 5,
1988, making the IND effective date August 5, 1988.
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.
SUPPLEMENTARY INFORMATION: In FR Doc. 94-21286, appearing on page 44738
in the Federal Register of August 30, 1994, the following corrections
are made:
On page 44739, in the first column, in the third full paragraph, in
the third line, ``1,819'' is corrected to read ``1,906'' and in the
fourth line, ``1,038'' is corrected to read ``1,125''; in the same
column, in the fourth line from the bottom, ``October 31, 1988'' is
corrected to read ``August 5, 1988''; and in the second column, in the
fifth and sixth lines, ``October 31, 1988'' is corrected to read
``August 5, 1988''.
Dated: April 17, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-10074 Filed 4-21-95; 8:45 am]
BILLING CODE 4160-01-F
