[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