0910-AF73 200710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use Section 201.307 (21 CFR sec. 201.307) describes a final rule to limit the container size for sodium phosphates oral solution (dibasic sodium phosphate/monobasic sodium phosphate oral solution) to not greater than 90 milliliters (mL) (3 ounces (oz) when used as an over-the-counter (OTC) laxative drug product. FDA limited the container size due to reports of deaths associated with an overdosage of sodium phosphates when packaged in a larger size container and a larger-than-intended dose was ingested inadvertently. In addition, this final rule required warning and direction statements to inform consumers that exceeding the recommended dose of oral and rectal sodium phosphates products in a 24-hour period could be harmful. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 201.307. The purpose of this review is to determine whether the regulation in section 201.307 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in section 201.307; (2) the nature of the complaints or comments received concerning the regulation in section 201.307; (3) the complexity of the regulation in section 201.307; (4) the extent to which the regulation in section 201.307 overlaps, duplicates, or conflicts with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the package size and labeling regulation in section 201.307. The section 610 review has been carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the Agency’s regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President’s priorities and the principles set forth in the Executive order. During the review, FDA received one comment. This comment will be addressed on a future rulemaking. Routine and Frequent Previously Published in The Unified Agenda Completed Actions No No Section 610 Review 21 CFR 201.307 5 USC 610 No Begin Review of Current Regulation 12/01/2006 End Review 09/04/2007 No Local State Yes Not Collected Walter Ellenberg J. 0910 Food and Drug Administration FDA 301 796-2090 301 796-9899 walter.ellenberg@fda.hhs.gov Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue, Silver Spring MD 20993