[Federal Register Volume 59, Number 72 (Thursday, April 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9045]

[[Page Unknown]]

[Federal Register: April 14, 1994]



Food and Drug Administration

21 CFR Part 331

[Docket No. 93N-0164]
RIN 0905-AA06


Antacid Drug Products for Over-The-Counter Human Use; Proposed 
Amendment of Final Monograph; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

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


SUMMARY: The Food and Drug Administration (FDA) is reopening to May 4, 
1994, the comment period on the notice of proposed rulemaking that 
would require specific indication, warning, and direction statements in 
the labeling of over-the-counter (OTC) antacid drug products containing 
sodium bicarbonate as an active ingredient (February 2, 1994, 59 FR 
5060). FDA is taking this action in response to a request to extend the 
comment period for an additional 30 days to allow more time to comment 
on this proposal. The comment period for these issues closed on April 
4, 1994. This proposal is part of the ongoing review of OTC drug 
products conducted by FDA.

DATES: Written comments by May 4, 1994.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION:  In the Federal Register of February 2, 1994 
(59 FR 5060), FDA issued a notice of proposed rulemaking to amend the 
final monograph for OTC antacid drug products to require specific 
indication, warning, and direction statements in the labeling of 
products containing sodium bicarbonate as an active ingredient 
(hereinafter referred to as the February 1994, proposal). The new 
labeling would be required only for oral dosage forms intended to be 
dissolved in liquid prior to administration, such as powders and 
effervescent granules or tablets. As proposed, no such oral dosage 
forms containing sodium bicarbonate as an active ingredient would be 
allowed to make a claim for ``relief of overindulgence in food and 
drink.'' The proposed warnings would alert consumers to avoid antacid 
drug products containing sodium bicarbonate when the stomach is overly 
full from eating and drinking. The proposed directions would inform 
consumers that sodium bicarbonate should be completely dissolved before 
drinking and that the recommended dose should not be exceeded. FDA 
issued the February 1994, proposal after receiving reports of gastric 
(stomach) rupture following ingestion of sodium bicarbonate to relieve 
gastrointestinal distress. Interested persons were given until April 4, 
1994, to submit comments on the proposal.
    On March 28, 1994, the Nonprescription Drug Manufacturers 
Association (NDMA), a trade association representing the manufacturers 
and distributors of OTC medicines, requested that the comment period be 
extended for at least 30 days. NDMA stated that the extension is 
necessary to provide sufficient time to develop comprehensive comments 
to submit to the agency. NDMA explained that most companies that 
distribute OTC drug products containing sodium bicarbonate as an active 
ingredient were not anticipating changes in the antacid final monograph 
and the February 1994, proposal provided the first opportunity for many 
affected parties to become aware of the agency's concerns and 
intentions for amending the monograph. NDMA stated that interested 
parties have had insufficient time to acquire the reference materials 
cited by FDA, to retrieve relevant product experience reports, and to 
research thoroughly the issues raised in FDA's February 1994, proposal. 
NDMA also mentioned that the time period for the comments includes 
several days on which many company employees will not be working 
because of religious holidays.
    FDA has carefully considered the request and believes that this 
additional time for comment is in the public interest. Accordingly, the 
comment period is reopened to May 4, 1994.
    Interested persons may, on or before May 4, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
OTC antacid drug products containing sodium bicarbonate as an active 
ingredient. 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 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.

    Dated: April 8, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-9045 Filed 4-13-94; 8:45 am]