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2010-09-23
article
Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph
Part III
Proposed Rules
D09002ee1bdec064b
D09002ee1bdec07a1
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 issuing an advance notice of proposed rulemaking that would establish conditions under which over-the-counter (OTC) drug products for the reduction or prevention of dental plaque and gingivitis are generally recognized as safe and effective and not misbranded. This notice is based on the recommendations of the Dental Plaque Subcommittee of the Nonprescription Drugs Advisory Committee (NDAC) and is part of FDA's ongoing review of OTC drug products.
68 FR 32232
https://www.govinfo.gov/app/details/FR-2003-05-29/03-12783
03-12783
fr29my03-35
RIN 0910-AA01
4160-01-S
Docket No. 81N-033P
https://www.govinfo.gov/app/details/FR-2003-05-29/03-12783
https://www.govinfo.gov/content/pkg/FR-2003-05-29/html/03-12783.htm
https://www.govinfo.gov/content/pkg/FR-2003-05-29/pdf/03-12783.pdf
56 p.
32232
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68 FR 32232
Code of Federal Regulations
Title 21 Part 356
21 CFR Part 356
Regulation Identification Number 0910-AA01
RIN 0910-AA01
Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph; Federal Register Vol. 68, Issue
PRORULE
03-12783
III
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2003-08-27
Docket No. 81N-033P
4160-01-S
03-12783
Advance notice of proposed rulemaking.
The Food and Drug Administration (FDA) is issuing an advance notice of proposed rulemaking that would establish conditions under which over-the-counter (OTC) drug products for the reduction or prevention of dental plaque and gingivitis are generally recognized as safe and effective and not misbranded. This notice is based on the recommendations of the Dental Plaque Subcommittee of the Nonprescription Drugs Advisory Committee (NDAC) and is part of FDA's ongoing review of OTC drug products.
Submit written or electronic comments by August 27, 2003. Submit reply comments by October 27, 2003.
Robert L. Sherman, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.
Human drugs:
Oral health care products (OTC)
Antigingivitis/antiplaque products; monograph establishment,
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 68, no. 103
Office of the Federal Register, National Archives and Records Administration
2003-05-29
continuing
daily
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396 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2003-05-29
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https://www.govinfo.gov/app/details/FR-2003-05-29
https://www.govinfo.gov/content/pkg/FR-2003-05-29/pdf/FR-2003-05-29.pdf
https://www.govinfo.gov/content/pkg/FR-2003-05-29/xml/FR-2003-05-29.xml
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