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2010-09-24
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Prescription Drug User Fee Act (PDUFA) II Five-Year Plan-FY 2000 Update; Availability
Notices
D09002ee1bdfa637e
D09002ee1bdfa640f
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of an internal planning document entitled ``PDUFA II Five- Year Plan: FY 2000 Update.'' The updated plan to achieve PDUFA II goals for the drug review process takes into account changes in revenue projections and workload based on actual revenue and application receipts in fiscal year (FY) 1998 and FY 1999 and updated projections for FY 2000 through FY 2002.
65 FR 46465
https://www.govinfo.gov/app/details/FR-2000-07-28/00-19046
00-19046
fr28jy00-76
4160-01-F
Docket No. 98N-0495
https://www.govinfo.gov/app/details/FR-2000-07-28/00-19046
https://www.govinfo.gov/content/pkg/FR-2000-07-28/html/00-19046.htm
https://www.govinfo.gov/content/pkg/FR-2000-07-28/pdf/00-19046.pdf
2 p.
46465
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65 FR 46465
Prescription Drug User Fee Act (PDUFA) II Five-Year Plan-FY 2000 Update; Availability; Federal Register Vol. 65, Issue
NOTICE
00-19046
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 98N-0495
4160-01-F
00-19046
Notice.
The Food and Drug Administration (FDA) is announcing the availability of an internal planning document entitled ``PDUFA II Five- Year Plan: FY 2000 Update.'' The updated plan to achieve PDUFA II goals for the drug review process takes into account changes in revenue projections and workload based on actual revenue and application receipts in fiscal year (FY) 1998 and FY 1999 and updated projections for FY 2000 through FY 2002.
Submit written comments on the plan at any time. Comments will be considered as the agency makes annual adjustments to the plan in the second quarter of each FY.
Frank P. Claunts, Office of Management Systems (HF-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4427.
Reports and guidance documents; availability, etc.:
Prescription Drug User Fee Act
PDUFA II five-year plan; 2000 FY update,
www.fda.gov/oc/pdufa2/5yrplan.html
Federal Register
Vol. 65, no. 146
Office of the Federal Register, National Archives and Records Administration
2000-07-28
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243 p.
Table of Contents:
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https://www.govinfo.gov/content/pkg/FR-2000-07-28/pdf/FR-2000-07-28.pdf
https://www.govinfo.gov/content/pkg/FR-2000-07-28/xml/FR-2000-07-28.xml
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