Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date, 42451 [C1-2013-15111]
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Federal Register / Vol. 78, No. 136 / Tuesday, July 16, 2013 / Rules and Regulations
By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2013–17015 Filed 7–15–13; 8:45 am]
BILLING CODE 8011–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket Nos. FDA–2011–C–0344 and FDA–
2011–C–0463]
Listing of Color Additives Exempt
From Certification; Reactive Blue 246
and Reactive Blue 247 Copolymers;
Confirmation of Effective Date
Correction
In rule document 2013–15111,
appearing on pages 37962–37963 in the
issue of Tuesday, June 25, 2013, make
the following correction:
On page 37962, in the section titled
SUPPLEMENTARY INFORMATION, the first
paragraph is corrected to read as set
forth below:
In the Federal Register of April 1,
2013, we amended the color additive
regulations in §§ 73.3100 and 73.3106
(21 CFR 73.3100 and 73.3106),
respectively, to provide for the safe use
of additional copolymers of 1,4-bis[(2hydroxyethyl)amino]-9,10anthracenedione bis(2-methyl-2propenoic)ester (C.I. Reactive Blue 247)
and additional copolymers of 1,4-bis[4(2-methacryloxyethyl)phenylamino]
anthraquinone (C.I. Reactive Blue 246),
as color additives in contact lenses. We
also corrected the nomenclature for
Reactive Blue 247 by inserting ‘‘2methyl’’ before ‘‘2-propenoic.’’
[FR Doc. C1–2013–15111 Filed 7–15–13; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 500
[Docket No. FDA–2013–N–0253]
mstockstill on DSK4VPTVN1PROD with RULES
Animal Feeds Contaminated With
Salmonella Microorganisms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule; removal.
The Food and Drug
Administration (FDA or Agency) is
revoking an advisory opinion on animal
SUMMARY:
VerDate Mar<15>2010
18:29 Jul 15, 2013
Jkt 229001
feeds contaminated with Salmonella
microorganisms. This action is being
taken because that advisory opinion is
being superseded by the current FDA
enforcement strategy articulated in a
final compliance policy guide (CPG) on
Salmonella in food for animals.
DATES: This rule is effective July 16,
2013.
FOR FURTHER INFORMATION CONTACT: Kim
Young, Center for Veterinary Medicine
(HFV–230), 7519 Standish Pl., MPN–4,
Rm. 106, Rockville, MD 20855, 240–
276–9207, kim.young@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 15, 1967, (32
FR 4058), FDA issued an advisory
opinion (the 1967 advisory opinion)
codified at § 500.35 (21 CFR 500.35),
which found that processed fish meal,
poultry meal, meat meal, tankage, or
other animal byproducts intended for
use in animal feed may be contaminated
with Salmonella bacteria, an organism
pathogenic to man and animals. FDA
found in the 1967 advisory opinion that
contamination of these products may
occur through inadequate heat treatment
of the product during its processing or
through recontamination of the heattreated product during a time of
improper storage or handling
subsequent to processing. FDA also
found in the 1967 advisory opinion that
Salmonella contamination of such
animal feeds having the potential for
producing infection and disease in
animals must be regarded as an
adulterant within the meaning of
section 402(a) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 342(a)).
FDA then articulated its intention to
regard as adulterated within the
meaning of section 402(a) of the FD&C
Act shipments of the following when
intended for animal feed and
encountered in interstate commerce and
found upon examination to be
contaminated with Salmonella
microorganisms: Bone meal, blood meal,
crab meal, feather meal, fish meal, fish
solubles, meat scraps, poultry meat
meal, tankage, or other similar animal
byproducts, or blended mixtures of
these.
Elsewhere in this issue of the Federal
Register, FDA announced a final
guidance for FDA staff entitled
‘‘Compliance Policy Guide Sec. 690.800
Salmonella in Food for Animals’’ (the
CPG), that revises the criteria FDA staff
should consider in deciding whether to
recommend seizure or import detention
of an animal feed or feed ingredient due
to adulteration resulting from
contamination with Salmonella.
Because the policy in the 1967 advisory
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42451
opinion is being superseded by the CPG,
the 1967 advisory opinion codified at 21
CFR 500.35 is hereby revoked.
FDA is removing § 500.35 without
prior opportunity for comment in
accordance with 21 CFR 10.85(g), which
states ‘‘An advisory opinion may be
amended or revoked at any time after it
has been issued. Notice of amendment
or revocation will be given in the same
manner as notice of the advisory
opinion was originally given or in the
Federal Register. . .’’ As the advisory
opinion at § 500.35 was published and
codified on March 15, 1967, without
prior opportunity for comment, this
removal of § 500.35 is published in the
Federal Register in the same manner.
List of Subjects in 21 CFR Part 500
Animal drugs, Animal feeds, Cancer,
Labeling, Packaging and containers,
Polychlorinated biphenyls (PCBs).
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 500 is amended as follows:
PART 500—GENERAL
1. The authority citation for 21 CFR
part 500 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 342, 343,
348, 351, 352, 353, 360b, 371, 379e.
§ 500.35
■
[Removed]
2. Remove § 500.35.
Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16971 Filed 7–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2012–0403]
RIN 1625–AA08
Special Local Regulations; Marine
Events; Annual Bayview Mackinac
Race
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
the special local regulation for the
annual Bayview Mackinac Race, from 9
a.m. to 5 p.m. on July 20, 2013. This
special local regulated is necessary to
SUMMARY:
E:\FR\FM\16JYR1.SGM
16JYR1
]]>Agencies
[Federal Register Volume 78, Number 136 (Tuesday, July 16, 2013)]
[Rules and Regulations]
[Page 42451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: C1-2013-15111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463]
Listing of Color Additives Exempt From Certification; Reactive
Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective
Date
Correction
In rule document 2013-15111, appearing on pages 37962-37963 in the
issue of Tuesday, June 25, 2013, make the following correction:
On page 37962, in the section titled SUPPLEMENTARY INFORMATION, the
first paragraph is corrected to read as set forth below:
In the Federal Register of April 1, 2013, we amended the color
additive regulations in Sec. Sec. 73.3100 and 73.3106 (21 CFR 73.3100
and 73.3106), respectively, to provide for the safe use of additional
copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione
bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) and additional
copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone
(C.I. Reactive Blue 246), as color additives in contact lenses. We also
corrected the nomenclature for Reactive Blue 247 by inserting ``2-
methyl'' before ``2-propenoic.''
[FR Doc. C1-2013-15111 Filed 7-15-13; 8:45 am]
BILLING CODE 1505-01-D
