New Animal Drugs; Zilpaterol, 53005-53006 [E6-14899]
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Federal Register / Vol. 71, No. 174 / Friday, September 8, 2006 / Rules and Regulations
message in the manner prescribed by
the agency.
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List of Subjects in 20 CFR Part 341
Railroad unemployment insurance,
Reporting and recordkeeping
requirements.
I For the reasons set out in the
preamble, the Railroad Retirement
Board amends title 20, Chapter II,
subchapter C, part 341 of the Code of
Federal Regulations as follows:
Dated: September 5, 2006.
By Authority of the Board.
Beatrice Ezerski,
Secretary to the Board.
[FR Doc. E6–14884 Filed 9–7–06; 8:45 am]
BILLING CODE 7905–01–P
PART 341—STATUTORY LIEN WHERE
SICKNESS BENEFITS PAID
1. The authority citation for part 341
continues to read as follows:
I
Food and Drug Administration
Authority: 45 U.S.C. 362(o).
21 CFR Parts 556 and 558
2. Revise § 341.6(a) introductory text
to read as follows:
I
§ 341.6
New Animal Drugs; Zilpaterol
Report of settlement or judgment.
(a) When a person or company makes
a settlement or must satisfy a final
judgment based on an injury for which
the employee received sickness benefits,
the person or company shall notify the
Board of the settlement or final
judgment. That notice shall be in
writing and submitted within five days
of the settlement or final judgment. A
railroad employer may fulfill the written
notice requirement by sending an
electronic message in the manner
prescribed by the agency. That
notification shall contain:
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I 3. Amend § 341.8 as follows:
I a. Add a new sentence to the end of
paragraph (a);
I b. Revise paragraph (b); and
I c. Amend paragraph (c) by removing
the phrase ‘‘Division of Claims
Operations’’ and adding the phrase
‘‘Sickness and Unemployment Benefits
Section’’ in its place.
I The additions and revisions read as
follows:
rwilkins on PROD1PC63 with RULES
§ 341.8 Termination of sickness benefits
due to a settlement.
(a) * * * A railroad employer may
file the required report by sending an
electronic message in the manner
prescribed by the agency.
(b) A report of settlement shall be
made to the Sickness and
Unemployment Benefits Section and
shall include the information required
in § 341.6. Where the report is an oral
report, and the informant is neither the
employee nor his or her representative,
the informant shall be told that written
confirmation containing the information
called for by § 341.6 must be submitted
to the Board within 5 days from the date
of the oral report. A railroad employer
may fulfill the written report
requirement by sending an electronic
VerDate Aug<31>2005
17:41 Sep 07, 2006
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Intervet
Inc. The NADA provides for use of a
zilpaterol hydrochloride Type A
medicated article to formulate Type B
and Type C medicated feeds for cattle
fed in confinement for slaughter.
DATES: This rule is effective September
8, 2006.
FOR FURTHER INFORMATION CONTACT: Eric
S. Dubbin, Center for Veterinary
Medicine (HFV–120), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301 827–1600, email: eric.dubbin@.fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed NADA 141–
258 for the oral use of ZILMAX
(zilpaterol hydrochloride 4.8%) Type A
medicated article to formulate Type B
(liquid and dry) and Type C medicated
cattle feeds used for increased rate of
weight gain, improved feed efficiency,
and increased carcass leanness in cattle
fed in confinement for slaughter during
the last 20 to 40 days on feed. The
NADA is approved as of August 10,
2006, and the regulations are amended
in part 556 (21 CFR part 556) and part
558 (21 CFR part 558) by adding new
§§ 556.765 and 558.665 and by
amending § 558.4 to reflect the
approval. The basis of approval is
discussed in the freedom of information
summary.
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
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
53005
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.
The agency has carefully considered
the potential environmental impact of
this action and has concluded that the
action will not have a significant impact
on the human environment and that an
environmental impact statement is not
required. FDA’s finding of no significant
impact and the evidence supporting that
finding, contained in an environmental
assessment, may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
marketing exclusivity beginning August
10, 2006.
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 Subjects
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 556 and 558 are amended as
follows:
I
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
1. The authority citation for 21 CFR
part 556 continues to read as follows:
I
Authority: 21 U.S.C. 342, 360b, 371.
I
2. Add § 556.765 to read as follows:
§ 556.765
Zilpaterol.
(a) Acceptable daily intake (ADI). The
ADI for total residues of zilpaterol is
0.083 micrograms per kilogram of body
weight per day.
(b) Tolerances—(1) Cattle—(i) Liver
(the target tissue). The tolerance for
zilpaterol freebase (the marker residue)
is 12 parts per billion (ppb).
(ii) [Reserved]
(2) [Reserved]
E:\FR\FM\08SER1.SGM
08SER1
53006
Federal Register / Vol. 71, No. 174 / Friday, September 8, 2006 / Rules and Regulations
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
4. In paragraph (d) of § 558.4, in the
‘‘Category II’’ table, alphabetically add
an entry for ‘‘Zilpaterol’’ to read as
follows:
I
§ 558.4 Requirement of a medicated feed
mill license.
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(d) * * *
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CATEGORY II
Assay limits percent1 Type A
Drug
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90–110
Zilpaterol
Assay limits percent1 Type B/C2
Type B maximum (100x)
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*
680 g/t (0.075%)
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*
80–110/75–115
1Percent
of labeled amount.
given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a
Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for
the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.
2Values
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5. Add § 558.665 to read as follows:
rwilkins on PROD1PC63 with RULES
§ 558.665
Zilpaterol.
(a) Specifications. Type A medicated
articles containing 21.77 grams (g)
zilpaterol hydrochloride per pound.
(b) Approvals. See No. 057926 in
§ 510.600(c) of this chapter.
(c) Tolerances. See § 556.765 of this
chapter.
(d)Special considerations—(1)
Labeling of Type B and Type C cattle
feeds shall bear the following:
(i) Do not allow horses or other
equines access to feed containing
zilpaterol.
(ii) Not for use in animals intended
for breeding.
(iii) Do not use in veal calves.
(2) Type B Liquid Feeds can be
manufactured containing 68 to 680 g
zilpaterol hydrochloride/ton. The liquid
Type B feeds must be maintained at a
pH of 3.8 to 7.5. For liquid feeds stored
in recirculating tank systems:
Recirculate immediately prior to use for
not less than 10 minutes, moving not
less than 1 percent of the tank contents
per minute from the bottom of the tank
to the top. Recirculate daily as described
even when not used. For liquid feeds
stored in mechanical, air or other
agitation-type tank systems: Agitate
immediately prior to use for not less
than 10 minutes, creating a turbulence
at the bottom of the tank that is visible
at the top. Agitate daily as described
even when not used.
(3) Do not pellet medicated feeds
containing zilpaterol.
(e) Conditions of use in cattle—(1)
Amount. 6.8 g/ton of feed to provide 60
to 90 milligrams zilpaterol
hydrochloride per head per day.
(2) Indications for use. For increased
rate of weight gain, improved feed
efficiency and increased carcass
leanness in cattle fed in confinement for
slaughter during the last 20 to 40 days
on feed.
VerDate Aug<31>2005
17:41 Sep 07, 2006
Jkt 208001
(3) Limitations. Feed continuously as
the sole ration during the last 20 to 40
days on feed. Withdrawal period: 3
days.
Dated: August 29, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–14899 Filed 9–7–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feed; Oxytetracycline
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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
Phibro Animal Health. The
supplemental NADA revises labeling of
oxytetracycline Type A medicated
article with the current genus for the
causative bacteria for American
foulbrood of honeybees.
DATES: This rule is effective September
8, 2006.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Phibro
Animal Health, 65 Challenger Rd., 3d
floor, Ridgefield Park, NJ 07660, filed a
supplement to NADA 95–143 that
provides for use of TERRAMYCIN
100MR (oxytetracycline dihydrate) Type
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
A medicated article for treatment of
various bacterial diseases of livestock.
The supplemental NADA revises
labeling with the current genus for the
causative bacteria for American
foulbrood of honeybees. The
supplemental NADA is approved as of
August 11, 2006, and the regulations in
21 CFR 558.450 are amended 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.
FDA has determined under
§ 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 Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
I 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:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.450
[Amended]
2. In § 558.450, in the table in
paragraph (d)(1)(xiv) in the ‘‘Indications
for use’’ column, remove ‘‘Bacillus’’ and
add in its place ‘‘Paenibacillus’’.
I
E:\FR\FM\08SER1.SGM
08SER1
]]>Agencies
[Federal Register Volume 71, Number 174 (Friday, September 8, 2006)]
[Rules and Regulations]
[Pages 53005-53006]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14899]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
New Animal Drugs; Zilpaterol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by Intervet Inc. The NADA provides for use of a zilpaterol
hydrochloride Type A medicated article to formulate Type B and Type C
medicated feeds for cattle fed in confinement for slaughter.
DATES: This rule is effective September 8, 2006.
FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301 827-1600, e-mail: eric.dubbin@.fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed NADA 141-258 for the oral use of
ZILMAX (zilpaterol hydrochloride 4.8%) Type A medicated article to
formulate Type B (liquid and dry) and Type C medicated cattle feeds
used for increased rate of weight gain, improved feed efficiency, and
increased carcass leanness in cattle fed in confinement for slaughter
during the last 20 to 40 days on feed. The NADA is approved as of
August 10, 2006, and the regulations are amended in part 556 (21 CFR
part 556) and part 558 (21 CFR part 558) by adding new Sec. Sec.
556.765 and 558.665 and by amending Sec. 558.4 to reflect the
approval. The basis of approval is discussed in the freedom of
information summary.
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.
The agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval
qualifies for 5 years of marketing exclusivity beginning August 10,
2006.
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 Subjects
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 556 and
558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
2. Add Sec. 556.765 to read as follows:
Sec. 556.765 Zilpaterol.
(a) Acceptable daily intake (ADI). The ADI for total residues of
zilpaterol is 0.083 micrograms per kilogram of body weight per day.
(b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The
tolerance for zilpaterol freebase (the marker residue) is 12 parts per
billion (ppb).
(ii) [Reserved]
(2) [Reserved]
[[Page 53006]]
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In paragraph (d) of Sec. 558.4, in the ``Category II'' table,
alphabetically add an entry for ``Zilpaterol'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
CATEGORY II
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Assay limits percent\1\ Type A Type B maximum (100x) Assay limits percent\1\ Type B/C\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
Zilpaterol 90-110 680 g/t (0.075%) 80-110/75-115
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Percent of labeled amount.
\2\Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B
medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of
dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.
* * * * *
0
5. Add Sec. 558.665 to read as follows:
Sec. 558.665 Zilpaterol.
(a) Specifications. Type A medicated articles containing 21.77
grams (g) zilpaterol hydrochloride per pound.
(b) Approvals. See No. 057926 in Sec. 510.600(c) of this chapter.
(c) Tolerances. See Sec. 556.765 of this chapter.
(d)Special considerations--(1) Labeling of Type B and Type C cattle
feeds shall bear the following:
(i) Do not allow horses or other equines access to feed containing
zilpaterol.
(ii) Not for use in animals intended for breeding.
(iii) Do not use in veal calves.
(2) Type B Liquid Feeds can be manufactured containing 68 to 680 g
zilpaterol hydrochloride/ton. The liquid Type B feeds must be
maintained at a pH of 3.8 to 7.5. For liquid feeds stored in
recirculating tank systems: Recirculate immediately prior to use for
not less than 10 minutes, moving not less than 1 percent of the tank
contents per minute from the bottom of the tank to the top. Recirculate
daily as described even when not used. For liquid feeds stored in
mechanical, air or other agitation-type tank systems: Agitate
immediately prior to use for not less than 10 minutes, creating a
turbulence at the bottom of the tank that is visible at the top.
Agitate daily as described even when not used.
(3) Do not pellet medicated feeds containing zilpaterol.
(e) Conditions of use in cattle--(1) Amount. 6.8 g/ton of feed to
provide 60 to 90 milligrams zilpaterol hydrochloride per head per day.
(2) Indications for use. For increased rate of weight gain,
improved feed efficiency and increased carcass leanness in cattle fed
in confinement for slaughter during the last 20 to 40 days on feed.
(3) Limitations. Feed continuously as the sole ration during the
last 20 to 40 days on feed. Withdrawal period: 3 days.
Dated: August 29, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-14899 Filed 9-7-06; 8:45 am]
BILLING CODE 4160-01-S
