[Federal Register Volume 61, Number 200 (Tuesday, October 15, 1996)]
[Notices]
[Page 53748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94E-0099]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; NeutrexinTM; 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 August 30, 1994 (59 FR 
44737). The document announced FDA's determination of the regulatory 
review period for purposes of patent extension for NeutrexinTM 
(trimetrexate glucuronate). The document was published with an error in 
one of the dates stated as part of the regulatory review period and 
requires additional clarification between the patent extension 
applicant's records and FDA's records.

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. 94-21280, appearing on page 44737 in the Federal 
Register of Tuesday, August 30, 1994, the following corrections are 
made:
    On page 44737, in the second column, in the second complete 
paragraph, in the fourth line, ``1,934'' is corrected to read 
``1,931''; and in the sixth line, ``317'' is corrected to read ``320''; 
in the same column, in the third complete paragraph, in the eighth 
line, ``However,'' is removed; in the eleventh line, ``March 10, 1987. 
FDA'' is corrected to read ``March 10, 1987. The applicant has 
documentation to suggest that an FDA official orally removed IND 29,796 
from clinical hold on September 2, 1987. However, FDA''; in the 
fourteenth line, ``clinical hold'' is corrected to read ``clinical hold 
via letter''; and in the same column, in the last paragraph, beginning 
in the fifth line, ``February 4, 1993'' is corrected to read: 
``February 1, 1993''; and the last two sentences are corrected to read: 
``FDA has verified the applicant's claim that the new drug application 
(NDA) for NeutrexinTM (NDA 20-326) was initially submitted on 
February 1, 1993.''

    Dated: October 8, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-26301 Filed 10-11-96; 8:45 am]
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