Proposed Requirements for Child-Resistant Packaging; Packages Containing 250 mg or More of Naproxen: Extension of Comment Period

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

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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]

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