[Federal Register Volume 59, Number 187 (Wednesday, September 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24014]


[Federal Register: September 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. 77N-0094]
RIN 0905-AA06


Drug Products for the Treatment and/or Prevention of Nocturnal 
Leg Muscle Cramps for Over-The-Counter Human Use; 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 August 22, 1994 (59 FR 
43234). The document established that any over-the-counter (OTC) drug 
product for the treatment and/or prevention of nocturnal leg muscle 
cramps is not generally recognized as safe and effective and is 
misbranded. The document was published with some typographical errors. 
This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2994.
    In FR Doc. 94-20449, appearing on page 43234, the following 
corrections are made:
    1. On page 43239, in the third column, in reference 3, line 5, and 
in reference 4, line 2, the word ``Q-VELR'' is corrected to read ``Q-
VEL''.
    2. On page 43242, in the second column, line 21, and in the first 
full paragraph, line 19, the number ``106'' is corrected to read 
``106''.
    3. On page 43245, in the second column, in reference 4, line 2, and 
in reference 5, line 4, the word ``Q-VELR'' is corrected to read ``Q-
VEL''.
    4. On page 43249, in the second column, in reference 1, line 2, and 
in reference 2, line 4, the word ``Q-VELR'' is corrected to read ``Q-
VEL''.
    5. On page 43250, in the third column, in reference 1, line 2, and 
in reference 2, line 4, the word ``Q-VELR'' is corrected to read ``Q-
VEL''.
    6. On page 43252, in the first column, in the second paragraph, in 
line 2, ``regulatuion'' is corrected to read ``regulation''; and in 
line 7, the word ``agencies'' is corrected to read ``agency's''; and in 
line 8, the word ``substances'' is corrected to read ``substance''.

    Dated: September 21, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-24014 Filed 9-27-94; 8:45 am]
BILLING CODE 4160-01-F