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

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Federal Register/Vol. 63, No. 98/Thursday, May 21, 1998/Proposed Rules 27886 Federal Register / Vol. 63, No. 98 / Thursday, May 21, 1998 / Proposed Rules (301) 504±0800 or delivered to the allow garments sized for a child nine PART 1616ÐSTANDARD FOR THE Office of the Secretary, Room 501, 4330 months and under and tight-fitting FLAMMABILITY OF CHILDREN'S East-West Highway, Bethesda, Maryland garments in sizes above nine months to SLEEPWEAR: SIZES 7 THROUGH 14 20814. Copies should be submitted in be sold and used as sleepwear. five copies and captioned ``Sleepwear Therefore, the Commission proposes to 1. The authority citation for part 1616 Policy Statement.'' Comments may also modify the policy statements at continues to read as follows: be filed by telefacsimile to (301) 504± 1615.64(d) and 1616.65(d) to provide Authority: Sec. 4, 67 Stat. 112, as 0127 or by e-mail to cpsc [email protected]. that infant garments (defined in the amended, 81 Stat. 569±70; 15 U.S.C. 1193. FOR FURTHER INFORMATION CONTACT: amended sleepwear standard at 16 CFR 2. Section 1616.65 is amended by Patricia Fairall, Program Manager, 1615.1(c)(1) as sized for a child nine revising paragraph (d) introductory text Office of Compliance, Consumer months and under) and ``tight-fitting'' to read as follows: Product Safety Commission, garments (defined in the amended Washington, D.C. 20207; telephone sleepwear standard at 16 CFR 1615.1(o) § 1616.65 Policy scope of the standard. (301) 504±0400, extension 1369. and 1616.2(m)) can be marketed and * * * * * SUPPLEMENTARY INFORMATION: promoted with other sleepwear. (d) Retailers, distributors, and For the reasons stated above and wholesalers, as well as manufacturers, A. Background pursuant to the authority of Section 4 of importers, and other persons (such as The Consumer Product Safety the Flammable Fabrics Act (15 U.S.C. converters) introducing a fabric or Commission enforces two flammability 1193), the Commission proposes to garment into commerce which does not standards for children's sleepwear. The amend 16 CFR 1615.64 and 1616.65 to meet the requirements of the flammability standard for children's read as follows: flammability standards for children's sleepwear in sizes 0 through 6X is sleepwear, have an obligation not to codified at 16 CFR Part 1615. The PART 1615ÐSTANDARD FOR THE promote or sell such fabric or garment flammability standard for children's FLAMMABILITY OF CHILDREN'S for use as an item of children's sleepwear in sizes 7 through 14 is SLEEPWEAR: SIZES 0 THROUGH 6X sleepwear. Also, retailers, distributors, codified at 16 CFR Part 1616. and wholesalers are advised not to On September 9, 1996, the 1. The authority citation for part 1615 advertise, promote, or sell as an item of Commission issued a final rule continues to read as follows: children's sleepwear any item which a amending the flammability standards Authority: Sec. 4, 67 Stat. 112, as manufacturer, importer, or other person for children's sleepwear to exclude from amended, 81 Stat. 569±70; 15 U.S.C. 1193. (such as a converter) introducing the the definition of ``children's sleepwear,'' item into commerce has indicated by codified at 16 CFR 1615.1(a) and 2. Section 1615.64 is amended by label, invoice, or, otherwise, does not 1616.2(a), (1) garments sized for infants revising paragraph (d) introductory text meet the requirements of the children's nine months of age or younger and (2) to read as follows: sleepwear flammability standards and is tight-fitting garments for children older not intended or suitable for use as § 1615.64 Policy to clarify scope of the sleepwear. ``Tight-fitting'' garments as than nine months. 61 FR 47634. The standard. defined by § 1616.2(m) are exempt from Commission found that such tight- * * * * * fitting garments did not present an the standard which requires flame unreasonable risk of injury. Rather, the (d) Retailers, distributors, and resistance. They may be marketed as Commission's information showed that wholesalers, as well as manufacturers, sleepwear for purposes of this section. many severe incidents occurred with importers, and other persons (such as Additionally, retailers are advised: loose-fitting garments such as oversized converters) introducing a fabric or * * * * * t-shirts used inappropriately as garment into commerce which does not Dated: May 12, 1998. sleepwear. The Commission concluded meet the requirements of the Sadye E. Dunn, that garments fitting closely and that flammability standards for children's Secretary, Consumer Product Safety touch the body at key points should be sleepwear, have an obligation not to Commission. exempt from the sleepwear standards promote or sell such fabric or garment [FR Doc. 98±13028 Filed 5±20±98; 8:45 am] because they do not present the same for use as an item of children's BILLING CODE 6355±01±P risk as loose-fitting garments. These sleepwear. Also, retailers, distributors, amendments became effective on and wholesalers are advised not to January 1, 1997. However, the advertise, promote, or sell as an item of DEPARTMENT OF HEALTH AND Commission also issued a stay of children's sleepwear any item which a HUMAN SERVICES enforcement for close-fitting garments manufacturer, importer, or other person which are labeled and promoted as (such as a converter) introducing the Food and Drug Administration underwear. That stay expires on June 9, item into commerce has indicated by 1998. label, invoice, or, otherwise, does not 21 CFR Part 334 meet the requirements of the children's [Docket No. 78N±036L] B. Clarification sleepwear flammability standards and is The Commission has become aware not intended or suitable for use as RIN 0910±AA01 that the garment industry is concerned sleepwear. ``Infant garments'' as defined Laxative Drug Products for Over-the- about the policy statements in 16 CFR by § 1615.1(c) and ``tight-fitting'' Counter Human Use; Proposed 1615.64(d) and 1616.65(d), which garments as defined by § 1615.1(o) are Amendment to the Tentative Final suggest segregation of items covered by exempt from the standard which Monograph the children's sleepwear standards from requires flame resistance. They may be marketed as sleepwear for purposes of all fabrics and garments that are beyond AGENCY: Food and Drug Administration, this section. Additionally, retailers are the scope of the children's sleepwear HHS. standards. The purpose of the advised: ACTION: Notice of proposed rulemaking. September 9, 1996 final rule was to * * * * * Federal Register / Vol. 63, No. 98 / Thursday, May 21, 1998 / Proposed Rules 27887 SUMMARY: The Food and Drug published in the Federal Register of a doctor) in the monograph for OTC Administration (FDA) is amending the January 15, 1985 (50 FR 2124). The laxative drug products. However, that tentative final monograph for over-the- agency also proposed monograph status monograph has not been finalized to counter (OTC) laxative drug products to for sodium phosphates oral solution 3. date. Because of the potential serious include additional general and (See proposed § 334.58(d)(5)(i), 50 FR safety risk involved, elsewhere in this professional labeling for oral and rectal 2124 at 2152 and 2155.) In addition to issue of the Federal Register the agency dibasic sodium phosphate/monobasic its use as an OTC laxative for the relief is finalizing the package size limitation sodium phosphate (sodium phosphates) of occasional constipation, sodium and warning prior to the completion of drug products. FDA is proposing new phosphates oral solution is used as part the final monograph for OTC laxative warnings and directions for these of a bowel cleansing regimen in drug products. The agency is including products and a new time to effect preparing a patient for surgery or for this information in part 201 (21 CFR statement for rectal products based on preparing the colon for x-ray or part 201) at this time and will new data submitted after publication of endoscopic examination. (See proposed incorporate it into the final monograph the tentative final monograph for OTC § 334.80(a)(2), 50 FR 2124 at 2157.) for OTC laxative drug products at a later laxative drug products. This proposal is Sodium phosphates oral solution and date. part of the ongoing review of OTC drug sodium phosphates enema 4, Based on new data submitted since products conducted by FDA. Elsewhere respectively, are the current United the January 15, 1985, and the March 31, in this issue of the Federal Register the States Pharmacopeia (USP) names for 1994, proposals were published, the agency is finalizing the package size the oral and rectal dosage forms of the agency is proposing in this document limitation and warning prior to the combination of sodium phosphates additional general and professional completion of the final monograph for ingredients. labeling for oral and rectal sodium OTC laxative drug products. In the Federal Register of March 31, phosphates products for OTC laxative DATES: Submit written comments or 1994 (59 FR 15139), the agency use. In the Federal Register of February objections by August 19, 1998. proposed to amend the tentative final 27, 1997 (62 FR 9024), FDA proposed to ADDRESSES: Submit written comments monograph for OTC laxative drug establish a standardized format for the to the Dockets Management Branch products to limit the OTC container size labeling of OTC drug products. When (HFA±305), Food and Drug for sodium phosphates oral solution to the agency finalizes that proposal, the Administration, 12420 Parklawn Dr., not greater than 90 milliliters (mL). The agency will also amend the final version rm. 1±23, Rockville, MD 20857. agency noted that the major trade of the rule proposed herein, as needed, FOR FURTHER INFORMATION CONTACT: product containing sodium phosphates to conform to the final labeling rule. Cheryl A. Turner, Center for Drug oral solution was marketed in 45-mL, Copies of previous rulemakings Evaluation and Research (HFD±560), 90-mL, and 240-mL bottles.
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