[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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]
BILLING CODE 4160-01-F