Listing of Color Additives Exempt From Certification; Bismuth Citrate; Confirmation of Effective Date, 34360-34361 [2010-14598]
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Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Rules and Regulations
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1512
Consumer Product Safety Act: Notice
of Commission Action on the Stay of
Enforcement of Testing and
Certification Requirements
AGENCY: Consumer Product Safety
Commission.
ACTION: Limited extensions of stay of
enforcement.
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SUMMARY: The Consumer Product Safety
Commission (CPSC or Commission) is
extending its stay of enforcement of
certain testing and certification
provisions of section 14 of the
Consumer Product Safety Act (CPSA) as
amended by section 102 of the
Consumer Safety Improvement Act of
2008 (CPSIA). The Commission is
extending the stay for products under 16
CFR part 1512 (bicycles) until August
14, 2010, with two exceptions. First, the
Commission is extending the stay
related to 16 CFR 1512.16 (reflectors)
until November 14, 2010. Second,
bicycles with non-quill-type stems are
excluded from certifying compliance to
16 CFR 1512.6(a) (handlebar stem
insertion mark) until further notice.
DATES: As it pertains to products under
16 CFR part 1512, the stay of
enforcement is extended until August
14, 2010, except for products under 16
CFR 1512.16, for which the stay is
extended until November 14, 2010, and
except for bicycles with non-quill-type
stems, which are excluded from the
certification requirement regarding the
handlebar stem insertion mark at 16
CFR 1512.6(a) until further notice.
FOR FURTHER INFORMATION CONTACT:
Matthew M. Lee, Compliance Officer,
U.S. Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, Maryland 20814; e-mail
mlee@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 14 of the CPSA requires that
every manufacturer of a product (and
the private labeler, if the product bears
a private label) that is subject to a
consumer product safety rule, ban,
standard, or regulation enforced by the
Commission certify, based on testing,
that its product complies with the
applicable safety rule, ban, standard, or
regulation. For nonchildren’s products,
the certification must be based on a test
of each product or a reasonable testing
program. For children’s products, the
certification must be based on testing
conducted by a CPSC-accepted third
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14:49 Jun 16, 2010
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party conformity assessment body
(laboratory). The Commission
announced the criteria and process for
its acceptance of the accreditation of
third party conformity assessment
bodies to test children’s products under
16 CFR part 1512 in a notice of
requirements that appeared in the
Federal Register on September 2, 2009.
74 FR 45428.
On February 9, 2009, the Commission
published a notice in the Federal
Register staying enforcement of the
testing and certification requirements
for many products, including bicycles.
74 FR 6396. The Commission
committed to the stay for one year,
explaining that the stay was necessary
to ‘‘give us the time needed to develop
sound rules and requirements as well as
implement outreach efforts to explain
these [new] requirements of the CPSIA
and their applicability.’’ 74 FR 6396,
6398. On December 28, 2009, the
Commission published a notice in the
Federal Register revising the terms of
the stay. 74 FR 68588. In that notice, the
Commission lifted the stay for some
CPSC regulations and extended the stay
for other CPSC regulations. Relevant for
present purposes, the Commission
stated that it ‘‘plans to keep the stay in
effect for the bicycle regulations (16 CFR
part 1512) as applicable to all bicycles,
both non children’s (sic) and children’s,
until May 17, 2010. With regard to
bicycles, the Commission has
determined that there is insufficient
laboratory capacity for third-party
testing of bicycles at this time * * *.
Should the extension of this stay until
May 17, 2010 prove insufficient, the
bicycle manufacturers and laboratories
must petition the Commission for
additional relief no later than April 1,
2010.’’ 74 FR 68588, 68590.
On April 1, 2010, the Bicycle Product
Suppliers Association (BPSA)
petitioned the Commission for an
extension of the stay of enforcement as
it relates to 16 CFR part 1512, the CPSC
safety regulations for bicycles. The
BPSA contended that laboratory
capacity was still inadequate. It also
asserted that 16 CFR part 1512 is ‘‘out
of date in many respects,’’ and urged the
Commission to revise the regulation.
Finally, BPSA maintained that the
bicycle industry has a good record of
compliance with part 1512 and so
extending the stay would not increase
risk to public health or safety. The CPSC
invited the BPSA to meet to discuss the
petition, and such a meeting was held
on May 3, 2010.
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II. Limited Extensions of Stay of
Enforcement
The Commission has decided to
extend the stay of enforcement of the
testing and certification requirements
imposed by section 14 of the CPSA with
regard to the safety regulations in 16
CFR part 1512 (bicycles) until August
14, 2010, with two exceptions noted
immediately below. As of May 12, 2010,
there are five CPSC-accepted conformity
assessment bodies accredited to test to
some or most of the standards contained
in 16 CFR part 1512. This limited
extension of the stay will provide time
for the development of additional
laboratory capacity for the testing of
children’s bicycles. Nevertheless,
bicycle manufacturers must certify
based on testing that their products,
both nonchildren’s and children’s,
manufactured after August 14, 2010,
comply with 16 CFR part 1512.
There are two exceptions to this
extension of the stay. Because there are
currently no CPSC-accepted conformity
assessment bodies accredited to test to
the bicycle reflector requirements at 16
CFR 1512.16, the Commission is
extending the stay as it relates to bicycle
reflectors and 16 CFR 1512.16 until
November 14, 2010. The Commission is
allowing this additional three-month
period for the development of CPSCaccepted laboratory capacity for bicycle
reflector testing.
In addition, the Commission is aware
that bicycles with non-quill-type stems
may not be able to comply with the
insertion mark requirement of 16 CFR
1512.6(a). Bicycles with non-quill-type
stems are hereby excluded from the
requirement to certify compliance with
the handlebar stem insertion mark
requirement at 16 CFR 1512.6(a).
Dated: June 9, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2010–14328 Filed 6–16–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA–2008–C–0098]
Listing of Color Additives Exempt
From Certification; Bismuth Citrate;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
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Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Rules and Regulations
ACTION: Final rule; confirmation of
effective date.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is confirming the
effective date of April 27, 2010, for the
final rule that appeared in the Federal
Register of March 26, 2010. The final
rule amended the color additive
regulations by increasing the permitted
use level of bismuth citrate as a color
additive in cosmetics intended for
coloring hair on the scalp.
Food and Drug Administration
SUMMARY:
DATES: The effective date for the final
rule published in the Federal Register
of March 26, 2010 (75 FR 14491) is
confirmed as April 27, 2010.
FOR FURTHER INFORMATION CONTACT:
Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1264.
In the
Federal Register of March 26, 2010 (75
FR 14491), FDA amended the color
additive regulations in § 73.2110 (21
CFR 73.2110) by increasing the
permitted use level of bismuth citrate as
a color additive in cosmetics intended
for coloring hair on the scalp.
FDA gave interested persons until
April 26, 2010, to file objections or
requests for a hearing. The agency
received no objections or requests for a
hearing on the final rule. Therefore,
FDA finds that the effective date of the
final rule that published in the Federal
Register of March 26, 2010, should be
confirmed.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs,
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321,
341, 342, 343, 348, 351, 352, 355, 361,
362, 371, 379e) and under authority
delegated to the Commissioner of Food
and Drugs, and redelegated to the
Director, Office of Food Additive Safety,
notice is given that no objections or
requests for a hearing were filed in
response to the March 26, 2010, final
rule. Accordingly, the amendments
issued thereby became effective April
27, 2010.
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■
Dated: June 11, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive
Safety, Center for Food Safety and Applied
Nutrition.
[FR Doc. 2010–14598 Filed 6–16–10; 8:45 am]
21 CFR Part 558
[Docket No. FDA–2010–N–0002]
New Animal Drugs for Use in Animal
Feeds; Florfenicol
AGENCY:
14:49 Jun 16, 2010
ACTION:
Final rule.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.4
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Intervet, Inc. The supplemental NADA
provides for the manufacture of
florfenicol Type B medicated swine
feeds.
DATES:
This rule is effective June 17,
[Amended]
2. In paragraph (d) of § 558.4, in the
‘‘Category II’’ table, in the ‘‘Type B
maximum (100x)’’ column, in the entry
for ‘‘Florfenicol’’, remove ‘‘Swine feed:
n/a’’ and in its place add ‘‘Swine feed:
9.1 g/lb (2.0%)’’.
■
Dated: June 14, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
2010.
[FR Doc. 2010–14611 Filed 6–16–10; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4160–01–S
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, email:
cindy.burnsteel@fda.hhs.gov.
Intervet,
Inc., 56 Livingston Ave., Roseland, NJ
07068, filed a supplement to NADA
141–264 for use of NUFLOR (florfenicol)
Antibiotic Type A Medicated Article for
Swine by veterinary feed directive that
provides for the manufacture of Type B
medicated swine feeds. The
supplemental NADA is approved as of
May 13, 2010, and the regulations are
amended in 21 CFR 558.4 to reflect the
approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33 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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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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 558 is amended as follows:
■
HHS.
BILLING CODE 4160–01–S
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Food and Drug Administration,
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[USCG–2010–0446]
Safety Zone, Milwaukee Harbor,
Milwaukee, WI
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
SUMMARY: The Coast Guard will enforce
the Milwaukee Harbor safety zone
during eight separate periods between
10 p.m. on July 15, 2010 through 10
p.m. on July 25, 2010. This action is
necessary and intended to ensure safety
of life on the navigable waters
immediately prior to, during, and
immediately after fireworks events. This
rule will establish restrictions upon, and
control movement of, vessels in a
specified area immediately prior to,
during, and immediately after fireworks
events. During the enforcement period,
no person or vessel may enter the safety
zones without permission of the Captain
of the Port, Sector Lake Michigan.
DATES: The regulations in 33 CFR
165.935 will be enforced during eight
separate periods between from 10 p.m.
on July 15, 2010 through 10 p.m. on July
25, 2010.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
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]]>Agencies
[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Rules and Regulations]
[Pages 34360-34361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14598]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2008-C-0098]
Listing of Color Additives Exempt From Certification; Bismuth
Citrate; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
[[Page 34361]]
ACTION: Final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of April 27, 2010, for the final rule that appeared in
the Federal Register of March 26, 2010. The final rule amended the
color additive regulations by increasing the permitted use level of
bismuth citrate as a color additive in cosmetics intended for coloring
hair on the scalp.
DATES: The effective date for the final rule published in the Federal
Register of March 26, 2010 (75 FR 14491) is confirmed as April 27,
2010.
FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1264.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 26, 2010
(75 FR 14491), FDA amended the color additive regulations in Sec.
73.2110 (21 CFR 73.2110) by increasing the permitted use level of
bismuth citrate as a color additive in cosmetics intended for coloring
hair on the scalp.
FDA gave interested persons until April 26, 2010, to file
objections or requests for a hearing. The agency received no objections
or requests for a hearing on the final rule. Therefore, FDA finds that
the effective date of the final rule that published in the Federal
Register of March 26, 2010, should be confirmed.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Director, Office of Food Additive Safety, notice is
given that no objections or requests for a hearing were filed in
response to the March 26, 2010, final rule. Accordingly, the amendments
issued thereby became effective April 27, 2010.
Dated: June 11, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2010-14598 Filed 6-16-10; 8:45 am]
BILLING CODE 4160-01-S
