[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





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Food and Drug Administration



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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

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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