[Federal Register Volume 61, Number 161 (Monday, August 19, 1996)]
[Proposed Rules]
[Pages 42826-42827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 331

[Docket No. 95N-0254]
RIN 0910-AA63


Labeling of Orally Ingested Over-the-Counter Drug Products 
Containing Calcium, Magnesium, and Potassium; Correction

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
of proposed rulemaking that appeared in the Federal Register of April 
22, 1996 (61 FR 17807). The document proposed to amend the general 
labeling provisions for over-the-counter (OTC) drug products intended 
for oral ingestion to require the content per dosage unit and warning 
labeling when the product contains certain levels of calcium, 
magnesium, or potassium. The document was published with some errors. 
This document corrects those errors.
DATES: Written comments by July 22, 1996. Written comments on the 
agency's economic impact determination by July 22, 1996. The agency is 
proposing that any final rule based on this proposal be effective 12 
months after the date of its publication in the Federal Register.
FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-105),- Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2304.
    In FR Doc. 96-9734, appearing on page 17807 in the Federal Register 
of Monday, April 22, 1996, the following corrections are made:
    1. On page 17808, in the third column, in the third full paragraph, 
in the seventh line, ``vitamin E'' is corrected to read ``vitamin A.''
    2. On page 17809, in the first column, in the first full paragraph, 
in the second line, ``vitamin E'' is corrected to read ``vitamin A,'' 
and in the same

[[Page 42827]]

paragraph, beginning in the twelfth line, the two last sentences are 
removed and a new sentence is added to read ``Thus, for foods 
containing less than 20 mg of calcium or less than 8 mg of magnesium 
per serving, the content may be declared as zero or as less than 2 
percent of the Daily Value, except that magnesium need not be declared 
unless a claim is made about the nutrient.''
    3. On page 17809, in the first column, in the third full paragraph, 
in the eleventh line, after the word ``amount.'', the following 
sentence is added: ``In the Federal Register of December 21, 1995 (60 
FR 66206), FDA published a proposal entitled `Food Labeling: Nutrient 
Content Claims, General Principles; Health Claims, General Requirements 
and Other Specific Requirements for Individual Health Claims' that 
would revise this requirement. (See 60 FR 66206 at 66225.) Comments on 
the revision will be addressed in that rulemaking proceeding.''

    Dated: July 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-21049 Filed 8-16-96; 8:45 am]
BILLING CODE 4160-01-F