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