[Federal Register Volume 63, Number 236 (Wednesday, December 9, 1998)]
[Proposed Rules]
[Page 67817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 334

[Docket No. 78N-036L]
RIN 0910-AA01


Laxative Drug Products for Over-the-Counter Human Use; Partial 
Withdrawal of Proposed Amendment to the Tentative Final Monograph; 
Intent to Repropose

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; withdrawal in part and intent to 
repropose.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing that 
part of the notice of proposed rulemaking that would have amended the 
tentative final monograph for over-the-counter (OTC) laxative drug 
products to include additional professional labeling for oral and 
rectal dibasic sodium phosphate/monobasic sodium phosphate (sodium 
phosphates) drug products. The agency intends to repropose the 
professional labeling for these products in a future issue of the 
Federal Register.

FOR FURTHER INFORMATION CONTACT: Gloria Chang, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 21, 1998 (63 
FR 27886), FDA published an amendment to the tentative final monograph 
for OTC laxative drug products proposing to include additional general 
labeling and expanded professional labeling for oral and rectal sodium 
phosphates drug products. The agency proposed to expand the 
professional labeling for products containing sodium phosphates in 
Sec. 334.80(b)(2) of the tentative final monograph for OTC laxative 
drug products (50 FR 2124 at 2157, January 15, 1985). The agency also 
proposed a new format using specific headings to make the proposed 
professional labeling information clearer and more readable. Interested 
persons were invited to submit written comments or objections by August 
19, 1998.
    The agency plans to further expand the professional labeling in 
proposed Sec. 334.80(b)(2). This notice is to inform interested persons 
that the agency is withdrawing the proposed amendment to the OTC 
laxative tentative final monograph for professional labeling for 
products containing sodium phosphates in Sec. 334.80(b)(2) and will be 
reproposing the professional labeling in a future issue of the Federal 
Register. Further, this partial withdrawal of the proposed amendment to 
the OTC laxative tentative final monograph does not affect the current 
marketing status of sodium phosphates drug products.
    The agency has determined under 21 CFR 25.31(c) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This withdrawal notice is issued under authority of 21 U.S.C. 321, 
351, 352, 353, 355, 360, 371.

    Dated: December 1, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-32642 Filed 12-8-98; 8:45 am]
BILLING CODE 4160-01-F