[Federal Register Volume 61, Number 141 (Monday, July 22, 1996)]
[Rules and Regulations]
[Page 38046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18437]
[[Page 38045]]
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Part VIII
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 201 and 331
Drug Labeling; Sodium Labelling for Over-the-Counter Drugs; and
Labelling of Orally Ingested Over-the-Counter Drug Products Containing
Calcium, Magnesium, and Potassium; Extension of Comment Periods; Final
and Proposed Rules
Federal Register / Vol. 61, No. 141 / Monday, July 22, 1996 / Rules
and Regulations
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[[Page 38046]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201 and 331
[Docket No. 90N-0309]
RIN 0910-AA63
Drug Labeling; Sodium Labeling for Over-the-Counter Drugs;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to
September 20, 1996, the period for comments on amending the final rule
for sodium labeling for over-the-counter (OTC) drug products that was
published in the Federal Register of April 22, 1996. In the document,
FDA asked for comments on whether the final rule should be amended to
include sodium content labeling for OTC rectal laxative, vaginal,
dentifrice, mouthwash, and mouth rinse drug products. FDA is taking
this action in response to a request to extend the period for comments
to allow interested persons additional time to comment on this matter.
DATES: Written comments 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 17798), FDA issued a final rule on sodium labeling for OTC drug
products with opportunity for comments on whether the final rule should
be amended to include sodium content labeling for OTC rectal laxative,
vaginal, dentifrice, mouthwash, and mouth rinse drug products.
Interested persons were given until July 22, 1996, to submit comments
on labeling for those products. The final rule amends the general
labeling provisions for OTC drug products to: (1) Require that the
sodium content of all OTC drug products intended for oral ingestion be
included in labeling when the product contains 5 milligrams (mg) or
more sodium per a single dose; (2) require that all OTC drug products
intended for oral ingestion containing more than 140 mg sodium in the
labeled maximum daily dose bear a general warning that persons who are
on a sodium-restricted diet should not take the product unless directed
by a doctor; and (3) provide for the voluntary use of certain terms
(``sodium free,'' ``very low sodium,'' and ``low sodium'') relating to
an OTC drug product's sodium content per labeled maximum daily dose.
FDA issued the final rule in order to provide uniform sodium content
labeling for all OTC drug products intended for oral ingestion (whether
marketed under an OTC drug monograph, an approved application, or no
application), and to provide for the voluntary use in OTC drug product
labeling of the same terms used to describe sodium content in food
labeling.
On June 18, 1996, Nonprescription Drug Manufacturers Association
(NDMA), a trade association of nonprescription drug manufacturers,
requested a 60-day extension to file comments and new information. NDMA
stated that to fully address the issue of sodium labeling for OTC
rectal laxative, vaginal, dentifrice, mouthwash, and mouth rinse drug
products, its members needed this additional time because six different
task groups needed to look at these drug classes in coordination with
task groups from the Cosmetic, Toiletry and Fragrance Association. NDMA
also raised a number of questions on the final rule, which FDA has
answered in a recent feedback letter (Ref. 1).
FDA has carefully considered the request and acknowledges the broad
scope of the proposal. The agency considers an extension of time for
comments to be in the public interest. This will allow all interested
persons additional time to evaluate whether products other than those
intended for oral ingestion should be covered by the sodium labeling
regulation. The agency is therefore extending the time for comment for
an additional 60 days.
-Interested persons may, on or before September 20, 1996, submit to
the Dockets Management Branch (address above) written comments
regarding sodium labeling for OTC rectal laxative, vaginal, dentifrice,
mouthwash, and mouth rinse drug products. 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.
Reference
The following reference has been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(1) Letter from D. Bowen, FDA, to R. W. Soller, NDMA, July 15,
1996, in Docket No. 90N-0309 Dockets Management Branch.
Dated: July 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-18437 Filed 7-19-96; 8:45 am]
BILLING CODE 4160-01-F
