[Federal Register Volume 61, Number 141 (Monday, July 22, 1996)]
[Proposed Rules]
[Page 38047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18438]



  Federal Register / Vol. 61, No. 141 / Monday, July 22, 1996 / 
Proposed Rules  

[[Page 38047]]



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; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
September 20, 1996, the comment period on the notice of proposed 
rulemaking 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 notice of 
proposed rulemaking was published in the Federal Register of April 22, 
1996 (61 FR 17807). FDA is taking this action in response to a request 
for extension of the comment period to allow interested persons 
additional time to comment on the notice of proposed rulemaking.
DATES: Written comments by September 20, 1996. Written comments on the 
agency's economic impact determination by September 20, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 22, 1996 
(61 FR 17807), FDA published a notice of proposed rulemaking to amend 
the general labeling provisions for OTC drug products to require that 
the labeling of all OTC drug products intended for oral ingestion 
include: (1) The calcium content per dosage unit when the product 
contains 20 milligrams (mg) or more per single dose; (2) a warning 
statement that persons with kidney stones and persons on a calcium-
restricted diet should not take the product unless directed by a doctor 
when the product contains more than 3.2 grams of calcium in the labeled 
maximum daily dose; (3) the magnesium content per dosage unit when the 
product contains 8 mg or more per single dose; (4) a warning statement 
that persons with kidney disease and persons on a magnesium-restricted 
diet should not take the product unless directed by a doctor if the 
product contains more than 600 mg magnesium in the labeled maximum 
daily dose; (5) the potassium content per dosage unit when the product 
contains 5 mg or more per single dose; and (6) a warning statement that 
persons with kidney disease and persons on a potassium-restricted diet 
should not take the product unless directed by a doctor if the product 
contains more than 975 mg potassium in the labeled maximum daily dose. 
FDA issued the notice of proposed rulemaking in order to provide 
uniform calcium, magnesium, and potassium content and warning labeling 
for all OTC drug products intended for oral ingestion whether marketed 
under an OTC drug monograph, an approved application, or no 
application.
    On June 18, 1996, Nonprescription Drug Manufacturers Association 
(NDMA), a trade association of nonprescription drug manufacturers, 
requested a 60-day extension in which to file comments and new 
information. NDMA noted FDA's request for comments on recent scientific 
information to consider in setting requirements for OTC drug product 
labeling for products containing these ingredients (cations), the 
potential far-reaching nature of the proposal, and what NDMA termed 
``possible substantial economic impact'' as a basis for its request for 
an extension of the comment period. NDMA also had a number of questions 
on a related final rule for sodium labeling for OTC drug products 
published in the Federal Register of April 22, 1996 (61 FR 17798), 
which FDA has addressed in a recent feedback letter (Ref. 1).
    FDA has carefully considered the request and acknowledges the broad 
scope of the notice of proposed rulemaking, which would affect products 
in several therapeutic categories. Manufacturers may require additional 
time to obtain information, including scientific information, and 
comment on the notice of proposed rulemaking. Although the agency has a 
policy of generally not extending such comment periods, FDA considers 
an extension of time for comments in this case to be in the public 
interest and is therefore extending the comment period for an 
additional 60 days.
    Interested persons may, on or before September 20, 1996, submit to 
the Dockets Management Branch (address above) written comments on the 
notice of proposed rulemaking. Three copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in the brackets in the 
heading of this document. Received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.

Reference

    -1. Letter from Debra Bowen, FDA, to R. W. Soller, NDMA, July 
15, 1996, in Docket No. 95N-0254, Dockets Management Branch.

    Dated: July 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-18438 Filed 7-19-96; 8:45 am]
BILLING CODE 4160-01-F