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2010-09-23
article
Withdrawal of Approval of 128 Suitability Petitions; Correction
Notices
D09002ee1bdd86095
D09002ee1bdd86133
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 correcting a notice that appeared in the Federal Register of February 23, 2007 (72 FR 8184). The notice announced that FDA was withdrawing approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (PREA). FDA has determined that approval of the suitability petition submitted by Roxane Laboratories, Inc. (Roxane), for lorazepam oral solution, 1 milligram (mg)/10 milliliters (mL) (Docket No. FDA- 1994-P-0017),\1\ should not have been withdrawn and therefore retroactively reinstates its approval of that petition. This document also corrects errors in the petition numbers for two of the suitability petitions listed in the notice. ---------------------------------------------------------------------------
73 FR 58606
https://www.govinfo.gov/app/details/FR-2008-10-07/E8-23721
E8-23721
fr07oc08-83
4160-01-S
Docket No. FDA-2004-P-0474
https://www.govinfo.gov/app/details/FR-2008-10-07/E8-23721
https://www.govinfo.gov/content/pkg/FR-2008-10-07/html/E8-23721.htm
https://www.govinfo.gov/content/pkg/FR-2008-10-07/pdf/E8-23721.pdf
1 p.
58606
58606
73 FR 58606
Withdrawal of Approval of 128 Suitability Petitions; Correction; Federal Register Vol. 73, Issue
NOTICE
E8-23721
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2004-P-0474
4160-01-S
E8-23721
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 23, 2007 (72 FR 8184). The notice announced that FDA was withdrawing approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (PREA). FDA has determined that approval of the suitability petition submitted by Roxane Laboratories, Inc. (Roxane), for lorazepam oral solution, 1 milligram (mg)/10 milliliters (mL) (Docket No. FDA- 1994-P-0017),\1\ should not have been withdrawn and therefore retroactively reinstates its approval of that petition. This document also corrects errors in the petition numbers for two of the suitability petitions listed in the notice. ---------------------------------------------------------------------------
Cecelia M. Parise,Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration,5600
Withdrawal of Approval of 128 Suitability Petitions; Correction,
http://www.Regulations.gov
Federal Register
Vol. 73, no. 195
Office of the Federal Register, National Archives and Records Administration
2008-10-07
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https://www.govinfo.gov/app/details/FR-2008-10-07
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https://www.govinfo.gov/app/details/FR-2008-10-07
https://www.govinfo.gov/content/pkg/FR-2008-10-07/pdf/FR-2008-10-07.pdf
https://www.govinfo.gov/content/pkg/FR-2008-10-07/xml/FR-2008-10-07.xml
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