Human drugs: Laxative products (OTC) Oral and rectal sodium phosphate products; tentative final monograph; partial withdrawal,
[Federal Register: December 9, 1998 (Volume 63, Number 236)]
[Proposed Rules]
[Page 67817]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de98-21]
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.
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. 98-32642Filed12-8-98; 8:45 am]
BILLING CODE 4160-01-F
