[Federal Register: January 11, 1995] ======================================================================= ----------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1700 Proposed Requirements for Child-Resistant Packaging; Packages Containing 250 mg or More of Naproxen: Extension of Comment Period AGENCY: Consumer Product Safety Commission. ACTION: Notice of extension of comment period. ----------------------------------------------------------------------- SUMMARY: On November 14, 1994, the Commission issued a proposed rule under the Poison Prevention Packaging Act to require child-resistant packaging for naproxen preparations containing 250 mg or more of naproxen per package. The Commission had specified that comments should be submitted by January 30, 1995. After receiving a request to extend the comment period, the Commission has decided to do so, and it will permit comments until March 1, 1995. DATES: Comments on the proposal should be submitted not later than March 1, 1995. ADDRESSES: Comments should be mailed to the Office of the Secretary, Consumer Product Safety Commission, Washington, DC 20207-0001, or delivered to the Office of the Secretary, Consumer Product Safety Commission, room 502, 4330 East West Highway, Bethesda, Maryland 20814, telephone (301) 504-0800. FOR FURTHER INFORMATION CONTACT: Jacqueline Ferrante, Ph.D., Directorate for Health Sciences, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-0477 ext. 1199. SUPPLEMENTARY INFORMATION: The Commission recently published in the Federal Register proposed requirements for special packaging (also known as child resistant packaging) for naproxen preparations containing 250 mg or more of naproxen per package. 59 FR 56445. These proposed requirements were issued under the authority of the Poison Prevention Packaging Act (PPPA), 15 U.S.C. 1471-1476. The PPPA authorizes the Commission to establish standards for the special packaging of any household substance if (1) the degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance and (2) the special packaging is technically feasible, practicable, and appropriate for the substance. 15 U.S.C. 1472(a). The November 14, 1994, Federal Register notice provides details concerning toxicity, dosage, and packaging of naproxen. The notice also discusses findings that the PPPA requires the Commission to make concerning (1) the hazard to children presented by the substances; (2) the technical feasibility, practicability, and appropriateness of special packaging; and (3) the reasonableness of the proposed standard. The Commission received a request from the Syntex Corporation (``Syntex'') asking for an extension of the comment period allowed for the proposed requirements. Syntex and Proctor & Gamble jointly have three years exclusivity to manufacture and market the only over-the- counter naproxen product. Syntex stated that since it has recently been acquired by Hoffmann-La Roche, Ltd., additional time is necessary for preparation and review of comments by the new management. Syntex [[Page 2717]] requested a 30 day extension to the comment period.The Commission believes that this extension will allow a more complete response to the proposed requirements. It will permit the Commission to receive a more in depth response from a company that has a significant interest in the proposed rule. Granting a 30-day extension of the comment period should not increase the risk of young children being poisoned by naproxen because the two companies marketing naproxen preparations are voluntarily using child-resistant packaging. Dated: January 6, 1995. Sadye E. Dunn, Secretary, Consumer Product Safety Commission. [FR Doc. 95-705 Filed 1-10-95; 8:45 am] BILLING CODE 6355-01-P