[Federal Register Volume 69, Number 80 (Monday, April 26, 2004)]
[Notices]
[Page 22540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-0529]


Guidance for Industry on Changes to an Approved New Drug 
Application or Abbreviated New Drug Application; Availability; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of April 8, 2004 (69 FR 18768). 
The document announced the availability of a revised guidance for 
industry entitled ``Changes to an Approved NDA or ANDA.'' The document 
was published with inadvertent errors. This document corrects those 
errors.

FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy and 
Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: In FR Doc. 04-7533, appearing on page 18768 
in the Federal Register of Thursday, April 8, 2004, the following 
corrections are made:
    1. On page 18768, in the first column, under the FOR FURTHER 
INFORMATION CONTACT section, the contact information is corrected to 
read ``David J. Cummings, Center for Drug Evaluation and Research (HFD-
357), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-5187.''
    2. On page 18768, in the third column, the second full paragraph is 
removed.

    Dated: April 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9324 Filed 4-23-04; 8:45 am]
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