[Federal Register Volume 60, Number 226 (Friday, November 24, 1995)]
[Rules and Regulations]
[Page 57927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28600]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 310, 355, and 369
[Docket No. 80N-0042]
RIN 0910-AA01
Anticaries Drug Products for Over-The-Counter Human Use; Final
Monograph; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of October 6, 1995 (60 FR
52474). The document established conditions under which over-the-
counter (OTC) anticaries drug products (products that aid in the
prevention of dental cavities) are generally recognized as safe and
effective and not misbranded. The document was published with some
errors. This document corrects those errors.
EFFECTIVE DATE: October 7, 1996.
FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for
Drug Evaluation and Research (HFD-560), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-2304.
SUPPLEMENTARY INFORMATION: In FR Doc. 95-24693, appearing on page 52474
in the Federal Register of Friday, October 6, 1995, the following
corrections are made:
-1. On page 52484, in the first column, in the first full
paragraph, beginning in the 12th line from the bottom, the phrase ``as
the following: `anticavity fluoride' (select one of the following'' is
corrected to read ``as: (select one or both of the following:
`anticavity' or `fluoride' ''.
-2. On page 52504, in the table, in the entry for ``Sodium
monofluorophosphate (1,500 ppm):'', the designation ``NM'' is removed.
Sec. 355.50 [Corrected]
3. One page 52508, in the third column, in Sec. 355.50 Labeling
of anticaries drug products, in paragraph (a), beginning in line 4, the
phrase ``as the following: `anticavity fluoride' (select one of the
following'' is corrected to read ``as: (select one or both of the
following: `anticavity' or `fluoride')''.
Dated: November 16, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-28600 Filed 11-22-95; 8:45 am]
BILLING CODE 4160-01-F
