[Federal Register Volume 60, Number 7 (Wednesday, January 11, 1995)]
[Proposed Rules]
[Pages 2716-2717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-705]


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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.

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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