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Federal Register/Vol. 63, No. 98/Thursday, May 21, 1998/Rules and Regulations

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Federal Register/Vol. 63, No. 98/Thursday, May 21, 1998/Rules and Regulations 27836 Federal Register / Vol. 63, No. 98 / Thursday, May 21, 1998 / Rules and Regulations concludes that the proposed use of the (address above) between 9 a.m. and 4 document. Any objections received in additive is safe, that the additive will p.m., Monday through Friday. response to the regulation may be seen achieve its intended technical effect, Any person who will be adversely in the Dockets Management Branch and therefore, that the regulations in affected by this regulation may at any between 9 a.m. and 4 p.m., Monday § 178.2010 should be amended as set time on or before June 22, 1998, file through Friday. forth below. with the Dockets Management Branch List of Subjects in 21 CFR Part 178 In accordance with § 171.1(h) (21 CFR (address above) written objections thereto. Each objection shall be Food additives, Food packaging. 171.1(h)), the petition and the Therefore, under the Federal Food, documents that FDA considered and separately numbered, and each numbered objection shall specify with Drug, and Cosmetic Act and under relied upon in reaching its decision to authority delegated to the Commissioner approve the petition are available for particularity the provisions of the regulation to which objection is made of Food and Drugs and redelegated to inspection at the Center for Food Safety the Director, Center for Food Safety and and Applied Nutrition by appointment and the grounds for the objection. Each numbered objection on which a hearing Applied Nutrition, 21 CFR part 178 is with the information contact person amended as follows: listed above. As provided in § 171.1(h), is requested shall specifically so state. the agency will delete from the Failure to request a hearing for any PART 178ÐINDIRECT FOOD documents any materials that are not particular objection shall constitute a ADDITIVES: ADJUVANTS, available for public disclosure before waiver of the right to a hearing on that PRODUCTION AIDS, AND SANITIZERS objection. Each numbered objection for making the documents available for which a hearing is requested shall 1. The authority citation for 21 CFR inspection. include a detailed description and part 178 continues to read as follows: The agency has carefully considered analysis of the specific factual Authority: 21 U.S.C. 321, 342, 348, 379e. the potential environmental effects of information intended to be presented in 2. Section 178.2010 is amended in the this action. FDA has concluded that the support of the objection in the event table in paragraph (b) by alphabetically action will not have a significant impact that a hearing is held. Failure to include adding a new entry under the headings on the human environment, and that an such a description and analysis for any ``Substances'' and ``Limitations'' to read environmental impact statement is not particular objection shall constitute a as follows: required. The agency's finding of no waiver of the right to a hearing on the significant impact and the evidence objection. Three copies of all documents § 178.2010 Antioxidants and/or stabilizers supporting that finding, contained in an shall be submitted and shall be for polymers. environmental assessment, may be seen identified with the docket number * * * * * in the Dockets Management Branch found in brackets in the heading of this (b) * * * Substances Limitations ******* 1, 11-(3, 6, 9-Trioxaundecyl) bis-3-(dodecylthio) propionate (CAS Reg. For use only as provided in § 175.300(b)(3)(xxxi) of this chapter at 4.0 No. 64253±30±1). parts per 100 parts rubber. ******* Dated: May 11, 1998. DEPARTMENT OF HEALTH AND sodium phosphate oral solution) to not L. Robert Lake, HUMAN SERVICES greater than 90 milliliters (mL) (3 Director, Office of Policy, Planning and ounces (oz)) when used as an over-the- Strategic Initiatives, Center for Food Safety Food and Drug Administration counter (OTC) laxative drug product. and Applied Nutrition. FDA is limiting the container size 21 CFR Part 201 [FR Doc. 98±13469 Filed 5±20±98; 8:45 am] because of reports of deaths associated BILLING CODE 4160±01±F [Docket No. 78N±036L] with an overdosage of sodium RIN 0910±AA01 phosphates oral solution when the product was packaged in a larger-size Package Size Limitation for Sodium container and a larger than intended Phosphates Oral Solution and Warning dose was ingested inadvertently. The and Direction Statements for Oral and agency is also requiring warning and Rectal Sodium Phosphates for Over- direction statements to inform the-Counter Laxative Use consumers that exceeding the AGENCY: Food and Drug Administration, recommended dose of oral and rectal HHS. sodium phosphates products in a 24- ACTION: Final rule. hour period can be harmful. This final rule is part of the ongoing review of SUMMARY: The Food and Drug OTC drug products conducted by FDA. Administration (FDA) is issuing a final DATES: rule to limit the container size for The regulation is effective June sodium phosphates oral solution 22, 1998, however compliance with (dibasic sodium phosphate/monobasic Federal Register / Vol. 63, No. 98 / Thursday, May 21, 1998 / Rules and Regulations 27837 § 201.307(b)(2) and (b)(3) is not regimen in preparing a patient for sodium phosphates oral solution creates mandatory until September 18, 1998. surgery or for preparing the colon for x- a potential safety risk, particularly for FOR FURTHER INFORMATION CONTACT: ray or endoscopic examination. (See elderly persons who are likely to use the Cheryl A. Turner, Center for Drug proposed § 334.80(a)(2), 50 FR 2124 at product for bowel cleansing prior to Evaluation and Research (HFD±560), 2157.) Sodium phosphates oral solution surgery or a diagnostic procedure Food and Drug Administration, 5600 and sodium phosphates enema 3, involving the colon. Because of the Fishers Lane, Rockville, MD 20857, respectively, are the current United reported cases of accidental overdosing 301±827±2222. States Pharmacopeia (USP) names for and the confusion that has occurred SUPPLEMENTARY INFORMATION: the oral and rectal dosage forms of the between 240-mL and 90-mL container combination of sodium phosphates sizes, the agency proposed that the 240- I. Background ingredients. mL size container of sodium phosphates In the Federal Register of March 21, In the Federal Register of March 31, oral solution should no longer remain in 1975 (40 FR 12902), FDA published, 1994 (59 FR 15139), the agency the OTC marketplace. In the interest of under § 330.10(a)(6) (21 CFR proposed to amend the tentative final safety, the agency proposed to limit the 330.10(a)(6)), an advance notice of monograph for OTC laxative drug maximum OTC container size for this proposed rulemaking to establish a products to limit the OTC container size product to 90 mL. monograph for OTC laxative, for sodium phosphates oral solution to The agency proposed to include the antidiarrheal, emetic, and antiemetic not greater than 90 mL. The agency also package size limitation and warning in drug products, together with the proposed a warning for all oral and the monograph for OTC laxative drug recommendations of the Advisory rectal dosage forms of sodium products. However, that monograph has Review Panel on OTC Laxative, phosphates products to inform not been finalized to date. Because of Antidiarrheal, Emetic, and Antiemetic consumers not to exceed the the potential safety risk involved, the Drug Products (the Panel), which was recommended dosage unless directed by agency has decided to finalize both the the Advisory Review Panel responsible a doctor. Interested persons were package size limitation and several new for evaluating data on the active invited to submit written comments on warning and direction statements prior ingredients in these classes. The Panel the proposed regulation and on the to completion of the final monograph recommended monograph status for agency's economic impact for OTC laxative drug products. The phosphate salts, such as sodium determination by May 31, 1994. agency has decided to include this phosphates oral solution (40 FR 12902 In response to the proposal, two information in part 201 (21 CFR part at 12940), but did not recommend any manufacturers of laxative drug products 201) at this time and to incorporate it container size limitations. submitted comments. Neither comment into the final monograph for OTC The agency's proposed regulation, in addressed the agency's economic impact laxative drug products at a later date. the form of a tentative final monograph, determination. Copies of these In the Federal Register of February for OTC laxative drug products was comments are on public display in the 27, 1997 (62 FR 9024), FDA proposed to published in the Federal Register of Dockets Management Branch (HFA± establish a standardized format for the January 15, 1985 (50 FR 2124). The 305), Food and Drug Administration, labeling of OTC drug products. Until the agency also proposed monograph status 12420 Parklawn Dr., rm. 1±23, proposal is finalized, manufacturers, for sodium phosphates oral solution (50 Rockville, MD 20857. Additional distributors, and packagers must comply FR 2124 at 2152 and 2155), but did not information that has come to the with the final rule published herein and recommend any container size agency's attention since publication of all other currently applicable labeling limitations. The agency proposed the the proposal is also on public display in regulations. The agency will eventually following dosage for sodium phosphates the Dockets Management Branch. use the final labeling rule to incorporate oral solution for adults and children 12 In the proposal, the agency discussed the information included herein in part years of age and over: 3.42 to 7.56 grams its reasons for limiting the package size 201 into the final monograph for OTC (g) of dibasic sodium phosphate and 9.1 for sodium phosphates oral solution (59 laxative drug products.
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