Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 6993-6994 [E9-2941]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Rules and Regulations
the Federal Hazardous Substances Act.
15 U.S.C. 1261n.
F. Effective Date
The Administrative Procedure Act
(APA) requires that a substantive rule
must be published not less than 30 days
before its effective date, unless it grants
an exemption. 5 U.S.C. 553(d)(1).
Because this interim final rule grants
exemptions from the existing
requirements, the effective date is
February 10, 2009.
G. Request for Comments
The interim final rule will become
effective without prior notice and
comment. Notice and comment
procedures are not required under the
APA when the agency for good cause
finds that notice and comment is
impracticable, unnecessary or contrary
to the public interest. 5 U.S.C. 553(b)(B).
The Commission finds that the public
notice and comment before the issuance
of this interim final rule would have
been impracticable given the statutory
requirement imposed in the CPSIA that
the lead limits go into effect on February
10, 2009, six months after the enactment
of the CPSIA, and the inapplicability of
the Commission’s stay of certain testing
certification requirements to lead
content limits imposed on these
products.
Interested persons are invited to
submit comment on the interim final
rule. The Commission will consider
these comments before issuing final
regulations. In addition, comments
previously submitted in response to the
notice of proposed rulemaking will be
considered along with the comments to
the interim final rule in this proceeding.
Comments should be submitted by
March 16, 2009. Comments should be emailed to
Sec101ElectronicDevices@cpsc.gov.
Comments should be captioned
‘‘Section 101 Electronic Devices Interim
Rule.’’ Comments may also be mailed,
preferably in five copies, to the Office of
the Secretary, Consumer Product Safety
Commission, Room 502, 4330 East West
Highway, Bethesda, Maryland 20814, or
delivered to the same address
(telephone (301) 504–7923). Comments
also may be filed by facsimile to (301)
504–0127.
mstockstill on PROD1PC66 with RULES
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous
materials, Hazardous substances,
Imports, Infants and children, Labeling,
Law enforcement, and Toys.
■ For the reasons stated above, the
Commission amends 16 CFR part 1500
as follows:
VerDate Nov<24>2008
16:07 Feb 11, 2009
Jkt 217001
PART 1500—HAZARDOUS
SUBSTANCES AND ARTICLES:
ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority citation for part 1500
is revised to read as follows:
■
Authority: 15 U.S.C. 1261–1278, 122 Stat.
3016.
2. Add a new § 1500.88 to read as
follows:
■
§ 1500.88 Exemptions from lead limits
under section 101 of the Consumer Product
Safety Improvement Act for Certain
Electronic Devices.
(a) The Consumer Product Safety
Improvement Act (CPSIA) provides for
specific lead limits in children’s
products. Section 101(a) of the CPSIA
provides that by February 10, 2009,
products designed or intended primarily
for children 12 and younger may not
contain more than 600 ppm of lead.
After August 14, 2009, products
designed or intended primarily for
children 12 and younger cannot contain
more than 300 ppm of lead. On August
14, 2011, the limit may be further
reduced to 100 ppm, unless the
Commission determines that it is not
technologically feasible to have this
lower limit. Paint, coatings or
electroplating may not be considered a
barrier that would make the lead
content of a product inaccessible to a
child.
(b) Section 101(b)(4) of the CPSIA
provides that if the Commission
determines that it is not technologically
feasible for certain electronic devices to
comply with the lead limits, the
Commission must issue requirements by
regulation to eliminate or minimize the
potential for exposure to and
accessibility of lead in such electronic
devices and establish a compliance
schedule unless the Commission
determines that full compliance is not
technologically feasible.
(c) Certain lead-containing component
parts in children’s electronic devices
unable to meet the lead limits set forth
in paragraph (a) of this section due to
technological infeasibility are granted
the exemptions that follow in paragraph
(d) of this section, provided that use of
lead is necessary for the proper
functioning of the component part and
it is not technologically feasible for the
component part to meet the lead content
limits set forth in paragraph (a) of this
section.
(d) Exemptions for lead as used in
certain component parts in children’s
electronic devices include:
(1) Lead blended into the glass of
cathode ray tubes, electronic
components and fluorescent tubes.
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
6993
(2) Lead used as an alloying element
in steel. The maximum amount of lead
shall be less than 0.35% by weight
(3500 ppm).
(3) Lead used in the manufacture of
aluminum. The maximum amount of
lead shall be less than 0.4% by weight
(4,000 ppm).
(4) Lead used in copper-based alloys.
The maximum amount of lead shall be
less than 4% by weight (40,000 ppm).
(5) Lead used in lead-bronze bearing
shells and bushings.
(6) Lead used in compliant pin
connector systems.
(7) Lead used in optical and filter
glass.
(8) Lead oxide in plasma display
panels (PDP) and surface conduction
electron emitter displays (SED) used in
structural elements; notably in the front
and rear glass dielectric layer, the bus
electrode, the black stripe, the address
electrode, the barrier ribs, the seal frit
and frit ring as well as in print pastes.
(9) Lead oxide in the glass envelope
of Black Light Blue (BLB) lamps.
(e) Components of electronic devices
that are removable or replaceable such
as battery packs and light bulbs that are
inaccessible when the product is
assembled in functional form or are
otherwise granted an exemption are not
subject to the lead limits in paragraph
(a) of this section.
(f) Commission staff is directed to
reevaluate and report to the Commission
on the technological feasibility of
compliance with the lead limits in
paragraph (a) of this section for
children’s electronic devices, including
the technological feasibility of making
accessible component parts
inaccessible, and the status of the
exemptions, no less than every five
years after publication of a final rule in
the Federal Register on children’s
electronic devices.
Dated: February 9, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. E9–3025 Filed 2–11–09; 8:45 am]
BILLING CODE 6335–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2008–N–0039]
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\12FER1.SGM
12FER1
6994
ACTION:
Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Rules and Regulations
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Cross Vetpharm Group Ltd. The
supplemental ANADA provides for the
veterinary prescription use of flunixin
meglumine solution by intravenous
injection in dairy cattle for control of
pyrexia associated with acute bovine
mastitis.
This rule is effective February
12, 2009.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
supplemental ANADA 200–387 that
provides for veterinary prescription use
of FLUNAZINE (flunixin meglumine)
Injectable Solution intravenously in
dairy cattle for control of pyrexia
associated with acute bovine mastitis.
The supplemental ANADA is approved
as of December 18, 2008, and the
regulations are amended in 21 CFR
522.970 to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
FDA has determined under 21 CFR
25.33(a)(1) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
mstockstill on PROD1PC66 with RULES
DATES:
List of Subject in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
■
VerDate Nov<24>2008
16:07 Feb 11, 2009
Jkt 217001
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 522.970, revise paragraphs
(b)(2) and (b)(4) to read as follows:
■
§ 522.970
Flunixin.
*
*
*
*
*
(b) * * *
(2) See No. 057561 for use as in
paragraphs (e)(1), (e)(2)(i)(A),
(e)(2)(ii)(A), and (e)(2)(iii) of this
section.
*
*
*
*
*
(4) See Nos. 055529, 059130, and
061623 for use as in paragraphs (e)(1)
and (e)(2) of this section.
*
*
*
*
*
Dated: February 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–2941 Filed 2–11–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 105
[Docket Nos. TSA–2006–24191; USCG–
2006–24196]
Transportation Worker Identification
Credential (TWIC) Implementation in
the Maritime Sector; Hazardous
Materials Endorsement for a
Commercial Driver’s License
AGENCY:
United States Coast Guard;
DHS.
ACTION: Notice of extension of
compliance date, American Samoa,
Captain of the Port Zone Honolulu.
SUMMARY: This document informs
owners and operators of facilities
located on the island of American
Samoa within Captain of the Port Zone
Honolulu that the date by which they
must implement access control
procedures utilizing TWIC has been
extended to no later than April 14, 2009.
This extension is due to the fact that a
large percentage of the maritime
workforce in American Samoa is not
native to the island, and do not need to
comply with United States immigration
laws.
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
DATES: The new compliance date for the
TWIC regulations found in 33 CFR part
105 for the island of American Samoa in
Captain of the Port Zone Honolulu is
April 14, 2009.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this document
as being available in the docket, are part
of dockets TSA–2006–24191 and
USCG–2006–24196, and are available
for inspection or copying at the Docket
Management Facility, U.S. Department
of Transportation, West Building
Ground Floor, Room W12–140, 1200
New Jersey Avenue, SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays. You may also find this docket
on the Internet at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this document,
call LCDR Jonathan Maiorine, telephone
1–877–687–2243. If you have questions
on viewing the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–493–0402.
SUPPLEMENTARY INFORMATION:
I. Regulatory History
On May 22, 2006, the Department of
Homeland Security (DHS), through the
United States Coast Guard (Coast Guard)
and the Transportation Security
Administration (TSA), published a joint
notice of proposed rulemaking entitled
‘‘Transportation Worker Identification
Credential (TWIC) Implementation in
the Maritime Sector; Hazardous
Materials Endorsement for a
Commercial Driver’s License’’ in the
Federal Register (71 FR 29396). This
was followed by a 45-day comment
period and four public meetings. The
Coast Guard and TSA issued a joint
final rule, under the same title, on
January 25, 2007 (72 FR 3492)
(hereinafter referred to as the original
TWIC final rule). The preamble to that
final rule contains a discussion of all the
comments received on the NPRM, as
well as a discussion of the provisions
found in the original TWIC final rule,
which became effective on March 26,
2007.
On May 7, 2008, the Coast Guard and
TSA issued a final rule to realign the
compliance date for implementation of
the Transportation Worker
Identification Credential (73 FR 25562).
The date by which mariners need to
obtain a TWIC, and by which owners
and operators of vessels and outer
continental shelf facilities must
implement access control procedures
utilizing TWIC, is April 15, 2009.
Owners and operators of facilities that
E:\FR\FM\12FER1.SGM
12FER1
]]>Agencies
[Federal Register Volume 74, Number 28 (Thursday, February 12, 2009)]
[Rules and Regulations]
[Pages 6993-6994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2941]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2008-N-0039]
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
AGENCY: Food and Drug Administration, HHS.
[[Page 6994]]
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The
supplemental ANADA provides for the veterinary prescription use of
flunixin meglumine solution by intravenous injection in dairy cattle
for control of pyrexia associated with acute bovine mastitis.
DATES: This rule is effective February 12, 2009.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed supplemental ANADA 200-387 that
provides for veterinary prescription use of FLUNAZINE (flunixin
meglumine) Injectable Solution intravenously in dairy cattle for
control of pyrexia associated with acute bovine mastitis. The
supplemental ANADA is approved as of December 18, 2008, and the
regulations are amended in 21 CFR 522.970 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA has determined under 21 CFR 25.33(a)(1) that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subject in 21 CFR Part 522
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.970, revise paragraphs (b)(2) and (b)(4) to read as
follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(2) See No. 057561 for use as in paragraphs (e)(1), (e)(2)(i)(A),
(e)(2)(ii)(A), and (e)(2)(iii) of this section.
* * * * *
(4) See Nos. 055529, 059130, and 061623 for use as in paragraphs
(e)(1) and (e)(2) of this section.
* * * * *
Dated: February 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-2941 Filed 2-11-09; 8:45 am]
BILLING CODE 4160-01-S
