[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9354]

[[Page Unknown]]

[Federal Register: April 19, 1994]



Food and Drug Administration

21 CFR Part 343

[Docket No. 77N-094U]
RIN 0905-AA06


Internal Analgesic, Antipyretic, and Antirheumatic Drug Products 
for Over-the-Counter Human Use; Proposed Amendment to Tentative 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 
pertaining to combinations of over-the-counter (OTC) internal analgesic 
and antacid ingredients, specifically sodium bicarbonate used as an 
antacid active ingredient (February 2, 1994, 59 FR 5068). 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 5068), FDA issued a notice of proposed rulemaking to amend the 
tentative final monograph for OTC internal analgesic, antipyretic, and 
antirheumatic drug products (hereinafter referred to as the February 
1994, proposal). This proposal affected combinations of internal 
analgesic and antacid ingredients, specifically sodium bicarbonate used 
as an antacid active ingredient. As proposed, combination drug products 
intended to be dissolved in liquid prior to administration, such as 
powders and effervescent granules or tablets, would not be allowed to 
make a claim for ``relief of overindulgence in food and drink'' or a 
claim for ``relief of hangover.'' 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 internal analgesic, 
antipyretic, and antirheumatic tentative 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 tentative final 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 internal analgesic, antipyretic, and antirheumatic drug products 
containing sodium bicarbonate as an antacid 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 13, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-9354 Filed 4-18-94; 8:45 am]