Poison Prevention Packaging; Notice of Lifing of Stay of Enforcement for Lidoderm® Patch, 36836 [05-12673]
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36836
Federal Register / Vol. 70, No. 122 / Monday, June 27, 2005 / Rules and Regulations
Issued in Renton, Washington, on June 14,
2005.
Kevin M. Mullin,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 05–12509 Filed 6–24–05; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1700
Poison Prevention Packaging; Notice
of Lifing of Stay of Enforcement for
Lidoderm Patch
Consumer Product Safety
Commission.
ACTION: Lifting Stay of Enforcement.
AGENCY:
SUMMARY: This notice announces the
Commission’s decision to lift a stay
enforcement of special packaging
requirements for the drug Lidoderm.
The Commission issued the stay in
August of 2001. The manufacturer of
Lidoderm is now using packaging that
complies with special packaging
requirements.
The action will be effective on
June 27, 2005.
FOR FURTHER INFORMATION CONTACT: Geri
Smith, Office of Compliance, Consumer
Product Safety Commission,
Washington, DC 20207; telephone (301)
504–7529.
SUPPLEMENTARY INFORMATION: In 1995,
the Commission issued a regulation
under the Poison Prevention Packaging
Act (‘‘PPPA’’) requiring child resistant
(‘‘CR’’) packaging for lidocaine products
with more than 5 milligrams (mg) of
lidocaine in a single package. 16 CFR
1700.14 (a)(23).
Lidoderm is a single-use dermal
patch that contains lidocaine.
Lidoderm is prescribed to treat postherpetic neuralgia (‘‘PHN’’), a rare,
chronic condition that results from
nerve injury caused by shingles. Each
Lidoderm patch contains 700 mg
lidocaine. Under the PPPA, if a product
requires special packaging, the
immediate container of the product
must be CR. This means that for
Lidoderm to comply with the PPPA,
each patch must be packaged in an
individual CR pouch, or multiple
patches that are not packaged in
individual CR pouches must be
packaged together in a single resealable
CR pouch without envelopes.
On August 14, 2000, the manufacturer
of Lidoderm, Endo Pharmaceuticals
Inc. (‘‘Endo’’), petitioned the
Commission for a partial exemption for
DATES:
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16:46 Jun 24, 2005
Jkt 205001
Lidoderm from special packaging
requirements stating that ‘‘it is not
practicable to market each Lidoderm
patch in a child-resistant envelope.’’ At
that time, Lidoderm was marketed in
the form of five patches inside a non-CR
resealable envelope. One non-CR carton
of Lidoderm contained six envelopes
(each envelope contained five patches)
for a total of 30 patches per carton. Endo
asserted that placing each patch in a CR
envelope would be cost prohibitive and
would force it to discontinue
production of Lidoderm.
The Commission declined to issue the
exemption that Endo requested because,
as explained in the August 30, 2001 stay
notice, under the PPPA, the expense of
special packaging cannot be the basis for
an exemption. 66 FR 45842. However,
the Commission did agree to stay
enforcement of the special packaging
requirements for Lidoderm under
certain conditions specified in the
notice of the stay. Id.
Endo has informed the Commission
that it is now packaging Lidoderm
patches in CR packaging in full
compliance with the PPPA requirements
(each single-use patch is packaged in an
individual CR pouch). Because the stay
of enforcement is no longer necessary,
the Commission has decided to lift the
stay. This means that Lidoderm, like
any other item requiring special
packaging under the Commission’s
PPPA regulations, must comply with all
PPPA special packaging requirements.
Dated: June 22, 2005.
Todd Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 05–12673 Filed 6–24–05; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[CGD13–05–022]
RIN 1625–AA00
Safety Zones: Fireworks Displays in
the Captain of the Port Portland Zone
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing safety zones on the waters
of the Suislaw, Willamette, Columbia,
Coos, and Chehalis Rivers, located in
the Area of Responsibility of the Captain
of the Port, Portland, Oregon, during
fireworks displays. The Captain of the
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
Port, Portland, Oregon, is taking this
action to safeguard watercraft and their
occupants from safety hazards
associated with these displays. Entry
into these safety zones is prohibited
unless authorized by the Captain of the
Port.
DATES: This rule is effective from 9:30
p.m. on July 2, 2005 until 11 p.m. on
July 23, 2005.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket (CGD13–05–
022) and are available for inspection or
copying at the U.S. Coast Guard MSO/
Group Portland, 6767 N. Basin Ave,
Portland, Oregon 97217 between 7 a.m.
and 4 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Petty Officer Charity Keuter, c/o Captain
of the Port, Portland 6767 N. Basin
Avenue, Portland, Oregon 97217, (503)
240–2590.
SUPPLEMENTARY INFORMATION:
Regulatory Information
We did not publish a notice of
proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B) and
5 U.S.C. 553(d)(3), the Coast Guard finds
that good cause exists for not publishing
an NPRM and for making this rule
effective less than 30 days after
publication in the Federal Register.
Publishing a NPRM would be contrary
to public interest since immediate
action is necessary to ensure the safety
of vessels and spectators gathering in
the vicinity of the various fireworks
launching barges and displays. If normal
notice and comment procedures were
followed, this rule would not become
effective until after the dates of the
events. For this reason, publishing an
NPRM and making this rule effective
less than 30 days after publication in the
Federal Register in this case would be
impracticable and contrary to the public
interest.
Background and Purpose
The Coast Guard is establishing
temporary safety zones to allow for safe
fireworks displays. All events occur
within the Captain of the Port, Portland,
OR, Area of Responsibility (AOR). These
events may result in a number of vessels
congregating near fireworks launching
barges and sites. The safety zones are
needed to protect watercraft and their
occupants from safety hazards
associated with fireworks displays. This
safety zone will be enforced by
representatives of the Captain of the
Port, Portland, Oregon. The Captain of
the Port may be assisted by other Fderal
and local agencies.
E:\FR\FM\27JNR1.SGM
27JNR1
]]>Agencies
[Federal Register Volume 70, Number 122 (Monday, June 27, 2005)]
[Rules and Regulations]
[Page 36836]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12673]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Poison Prevention Packaging; Notice of Lifing of Stay of
Enforcement for Lidoderm[reg] Patch
AGENCY: Consumer Product Safety Commission.
ACTION: Lifting Stay of Enforcement.
-----------------------------------------------------------------------
SUMMARY: This notice announces the Commission's decision to lift a stay
enforcement of special packaging requirements for the drug
Lidoderm[reg]. The Commission issued the stay in August of 2001. The
manufacturer of Lidoderm[reg] is now using packaging that complies with
special packaging requirements.
DATES: The action will be effective on June 27, 2005.
FOR FURTHER INFORMATION CONTACT: Geri Smith, Office of Compliance,
Consumer Product Safety Commission, Washington, DC 20207; telephone
(301) 504-7529.
SUPPLEMENTARY INFORMATION: In 1995, the Commission issued a regulation
under the Poison Prevention Packaging Act (``PPPA'') requiring child
resistant (``CR'') packaging for lidocaine products with more than 5
milligrams (mg) of lidocaine in a single package. 16 CFR 1700.14
(a)(23).
Lidoderm[reg] is a single-use dermal patch that contains lidocaine.
Lidoderm[reg] is prescribed to treat post-herpetic neuralgia (``PHN''),
a rare, chronic condition that results from nerve injury caused by
shingles. Each Lidoderm[reg] patch contains 700 mg lidocaine. Under the
PPPA, if a product requires special packaging, the immediate container
of the product must be CR. This means that for Lidoderm[reg] to comply
with the PPPA, each patch must be packaged in an individual CR pouch,
or multiple patches that are not packaged in individual CR pouches must
be packaged together in a single resealable CR pouch without envelopes.
On August 14, 2000, the manufacturer of Lidoderm[reg], Endo
Pharmaceuticals Inc. (``Endo''), petitioned the Commission for a
partial exemption for Lidoderm[reg] from special packaging requirements
stating that ``it is not practicable to market each Lidoderm[reg] patch
in a child-resistant envelope.'' At that time, Lidoderm[reg] was
marketed in the form of five patches inside a non-CR resealable
envelope. One non-CR carton of Lidoderm[reg] contained six envelopes
(each envelope contained five patches) for a total of 30 patches per
carton. Endo asserted that placing each patch in a CR envelope would be
cost prohibitive and would force it to discontinue production of
Lidoderm[reg].
The Commission declined to issue the exemption that Endo requested
because, as explained in the August 30, 2001 stay notice, under the
PPPA, the expense of special packaging cannot be the basis for an
exemption. 66 FR 45842. However, the Commission did agree to stay
enforcement of the special packaging requirements for Lidoderm[reg]
under certain conditions specified in the notice of the stay. Id.
Endo has informed the Commission that it is now packaging
Lidoderm[reg] patches in CR packaging in full compliance with the PPPA
requirements (each single-use patch is packaged in an individual CR
pouch). Because the stay of enforcement is no longer necessary, the
Commission has decided to lift the stay. This means that Lidoderm[reg],
like any other item requiring special packaging under the Commission's
PPPA regulations, must comply with all PPPA special packaging
requirements.
Dated: June 22, 2005.
Todd Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 05-12673 Filed 6-24-05; 8:45 am]
BILLING CODE 6355-01-P
