[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]
=======================================================================
-----------------------------------------------------------------------
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
