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2010-09-23
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Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs
Proposed Rules
D09002ee1bde27e33
D09002ee1bde27eb6
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.
70 FR 75988
https://www.govinfo.gov/app/details/FR-2005-12-22/E5-7646
E5-7646
fr22de05-18
RIN 0910-AF34
RIN 0910-AF45
4160-01-S
Docket Nos. 1976N-0052N (formerly 1976N-052N) and 1981N-0022 (formerly 81N-0022)
https://www.govinfo.gov/app/details/FR-2005-12-22/E5-7646
https://www.govinfo.gov/content/pkg/FR-2005-12-22/html/E5-7646.htm
https://www.govinfo.gov/content/pkg/FR-2005-12-22/pdf/E5-7646.pdf
11 p.
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70 FR 75988
Code of Federal Regulations
Title 21 Part 310
21 CFR Part 310
Code of Federal Regulations
Title 21 Part 341
21 CFR Part 341
Code of Federal Regulations
Title 21 Part 357
21 CFR Part 357
Regulation Identification Number 0910-AF34
RIN 0910-AF34
Regulation Identification Number 0910-AF45
RIN 0910-AF45
Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs; Federal Register Vol. 70, Issue
PRORULE
E5-7646
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2006-03-22
Docket Nos. 1976N-0052N (formerly 1976N-052N) and 1981N-0022 (formerly 81N-0022)
4160-01-S
E5-7646
Notice of proposed rule.
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.
Submit written and electronic comments and new data by March 22, 2006. Written and electronic comments on the agency's economic impact determination by March 22, 2006. Please see section X of this document for the effective date of any final rule that may be published based on this proposal.
Gerald M. Rachanow or Robert L. Sherman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5426, Silver Spring, MD 20993, 301-796-2090.
Human drugs:
Phenylpropanolamine-containing products (OTC); tentative final monographs,
http://www.census.gov/statab/freq/00s0768.txt
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
http://www.regulations.gov
http://www.whitehouse.gov/omb/memoranda/index.html
Federal Register
Vol. 70, no. 245
Office of the Federal Register, National Archives and Records Administration
2005-12-22
continuing
daily
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born digital
210 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2005-12-22
P0b002ee180995aef
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0042-1219
0364-1406
769-004-00000-9
000582072
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https://www.govinfo.gov/app/details/FR-2005-12-22
https://www.govinfo.gov/content/pkg/FR-2005-12-22/pdf/FR-2005-12-22.pdf
https://www.govinfo.gov/content/pkg/FR-2005-12-22/xml/FR-2005-12-22.xml
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FR-2005-12-22
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