[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