New Animal Drugs For Use in Animal Feed; Zilpaterol, 16754-16755 [E8-6601]
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Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Rules and Regulations
19 CFR Part 163
Administrative practice and
procedure, Customs duties and
inspection, Exports, Imports, Reporting
and recordkeeping requirements, Trade
agreements.
19 CFR Part 178
Administrative practice and
procedure, Exports, Imports, Reporting
and recordkeeping requirements.
Amendments to the CBP Regulations
Accordingly, the interim rule
amending Parts 10, 163, and 178 of the
CBP regulations (19 CFR parts 10, 163,
and 178), which was published at 72 FR
35154 on June 27, 2007, is adopted as
a final rule without change.
I
W. Ralph Basham,
Commissioner, U.S. Customs and Border
Protection.
Approved: March 25, 2008.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. E8–6511 Filed 3–28–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Penicillin G
Benzathine and Penicillin G Procaine
Suspension
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 IVX
Animal Health, Inc. The supplemental
NADA provides for changing scientific
nomenclature for a bovine pathogen on
labeling for penicillin G benzathine and
penicillin G procaine injectable
suspension.
DATES:
This rule is effective March 31,
2008.
jlentini on PROD1PC65 with RULES
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
IVX
Animal Health, Inc., 3915 South 48th
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
15:59 Mar 28, 2008
Jkt 214001
Street Ter., St. Joseph, MO 64503, filed
a supplement to NADA 65–498 for PEN
BP–48 (penicillin G benzathine and
penicillin G procaine) injectable
suspension used for the treatment of
animal diseases associated with several
bacterial pathogens. The supplemental
NADA provides for changing a bovine
pathogen name from Corynebacterium
pyogenes to Actinomyces pyogenes on
product labeling. The supplemental
NADA is approved as of February 22,
2008, and the regulations in 21 CFR
522.1696a 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.
The agency 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 Subjects 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
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 522.1696a
[Amended]
2. In § 522.1696a, in paragraph
(d)(2)(ii)(A), remove ‘‘Corynebacterium
pyogenes’’ and ‘‘(C. pyogenes)’’ and in
their places add ‘‘Actinomyces
pyogenes’’ and ‘‘(A. pyogenes)’’.
I
Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–6603 Filed 3–28–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feed; 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
approved, single-ingredient Type A
medicated articles containing zilpaterol
hydrochloride and melengestrol acetate
in two-way combination Type B and
Type C medicated feeds for heifers fed
in confinement for slaughter.
DATES: This rule is effective March 31,
2008.
FOR FURTHER INFORMATION CONTACT:
Gerald L. Rushin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8103, email: gerald.rushin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed NADA 141–
284 that provides for use of ZILMAX
(zilpaterol hydrochloride) and MGA
(melengestrol acetate) Type A
medicated articles to make dry and
liquid two-way combination Type B and
Type C medicated feeds used for
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness; and for suppression of estrus
(heat) in heifers fed in confinement for
slaughter during the last 20 to 40 days
on feed. The NADA is approved as of
February 29, 2008, and the regulations
in 21 CFR 558.665 are amended 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.
The agency has determined under 21
CFR 25.33(a)(2) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
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16755
Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Rules and Regulations
neither an environmental assessment
nor 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
(2) 6.8 to provide 60 to 90 mg/
head/day
Zilpaterol.
*
*
(e) * * *
*
*
*
*
*
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Part 41
[T.D. TTB–68; Re: T.D. ATF–444 and Notice
No. 912]
RIN 1513–AB38
Puerto Rican Tobacco Products and
Cigarette Papers and Tubes Shipped
From Puerto Rico to the United States
(2007R–368P)
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Final rule (Treasury decision).
AGENCY:
SUMMARY: The Alcohol and Tobacco Tax
and Trade Bureau is adopting as a final
rule, with some clarifying changes and
editorial corrections, the temporary
regulations set forth in T.D. ATF–444.
These temporary regulations eliminated
the onsite preshipment inspection of,
and the requirement to complete several
ATF forms for, shipments to the United
States of tobacco products and cigarette
papers and tubes manufactured in
Puerto Rico.
DATES: Effective Date: March 31, 2008.
FOR FURTHER INFORMATION CONTACT:
Amy R. Greenberg, Regulations and
Rulings Division, Alcohol and Tobacco
*
Background
Chapter 52 of the Internal Revenue
Code of 1986 (IRC) pertains to the
Federal excise tax on tobacco products
and cigarette papers and tubes. Section
5701 of the IRC (26 U.S.C. 5701)
imposes a tax on such products
manufactured in, or imported into, the
United States. Section 7652(a) of the IRC
(26 U.S.C. 7652(a)) imposes the same
tax, with certain exceptions not
pertinent here, on articles of
merchandise of Puerto Rican
manufacture coming into the United
States and withdrawn for consumption
or sale. The Alcohol and Tobacco Tax
and Trade Bureau (TTB) is responsible
for administering the provisions of
chapter 52 and section 7652(a) of the
IRC as they pertain to the tax on tobacco
products and cigarette papers and tubes,
including promulgating regulations
concerning payment and collection of
the tax and other requirements that
protect the revenue. Prior to January 24,
2003, our predecessor agency, the
Bureau of Alcohol, Tobacco and
Firearms (ATF) administered these
regulations.
On March 8, 2001, ATF published in
the Federal Register (66 FR 13849) a
temporary rule, T.D. ATF–444,
amending the regulations in 27 CFR part
275 to eliminate certain regulatory
requirements related to the shipment of
tobacco products and cigarette papers
and tubes of Puerto Rican manufacture
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Sponsor
*
As in paragraph (e)(1) of this section; see paragraph §§ 558.342(d)
of this chapter. Melengestrol acetate as provided by No. 000009 in
§ 510.600(c) of this chapter.
Tax and Trade Bureau, 1310 G Street,
NW., Suite 200E, Washington, DC
20220; telephone 202–927–8210; or email Amy.Greenberg@ttb.gov.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF THE TREASURY
Jkt 214001
*
Limitations
Heifers fed in confinement for
slaughter: As in paragraph (e)(1)
of this section; and for suppression
of estrus (heat).
*
BILLING CODE 4160–01–S
jlentini on PROD1PC65 with RULES
*
Melengestrol acetate
to provide 0.25 to 0.5
mg/ head/day
*
15:59 Mar 28, 2008
§ 558.665
Indications for use
*
Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–6601 Filed 3–28–08; 8:45 am]
VerDate Aug<31>2005
2. In § 558.665, add paragraph (e)(2) to
read as follows:
I
1. The authority citation for 21 CFR
part 558 continues to read as follows:
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
Combination in
grams/ton
Zilpaterol in grams/ton
*
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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:
Authority: 21 U.S.C. 360b, 371.
I
*
057926
*
from Puerto Rico to the United States.
Specifically, ATF amended §§ 275.105,
275.106, 275.110, and 275.111 to
eliminate the requirement that persons
who ship tobacco products and cigarette
papers and tubes of Puerto Rican
manufacture from Puerto Rico to the
United States notify ATF prior to the
shipment, and to eliminate the
requirements that an ATF officer: (1)
Inspect each shipment of such articles;
(2) certify that the amount of tax on the
articles has been calculated correctly;
and (3) release each shipment. The
amended regulations set forth
recordkeeping requirements in place of
the former processes of notification,
physical inspection, certification, and
release. Under the temporary rule,
persons who ship Puerto Rican tobacco
products and cigarette papers and tubes
to the United States must keep and
maintain records to show that the
amount of tax is correctly calculated,
paid (where applicable), and recorded
for audit and examination purposes.
The temporary rule amendments to
§§ 275.106, 275.110, and 275.111 also
eliminated the requirements for the
completion of four specific forms. Two
forms, ATF forms 2987 (5210.8) and
3075 (5200.9), were required to be
submitted to ATF by the company
shipping the products to the United
States, and contained information
readily available from common
commercial records. The elimination of
these forms was intended to relieve the
taxpayer of a duplicative recordkeeping
requirement. The other two forms, ATF
forms 2989 and 3074 (5200.6), were
certificates which were prepared by
ATF officers and affixed to the outside
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[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Rules and Regulations]
[Pages 16754-16755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6601]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feed; 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 approved,
single-ingredient Type A medicated articles containing zilpaterol
hydrochloride and melengestrol acetate in two-way combination Type B
and Type C medicated feeds for heifers fed in confinement for
slaughter.
DATES: This rule is effective March 31, 2008.
FOR FURTHER INFORMATION CONTACT: Gerald L. Rushin, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8103, e-mail:
gerald.rushin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed NADA 141-284 that provides for use of
ZILMAX (zilpaterol hydrochloride) and MGA (melengestrol acetate) Type A
medicated articles to make dry and liquid two-way combination Type B
and Type C medicated feeds used for increased rate of weight gain,
improved feed efficiency, and increased carcass leanness; and for
suppression of estrus (heat) in heifers fed in confinement for
slaughter during the last 20 to 40 days on feed. The NADA is approved
as of February 29, 2008, and the regulations in 21 CFR 558.665 are
amended 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.
The agency has determined under 21 CFR 25.33(a)(2) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore,
[[Page 16755]]
neither an environmental assessment nor 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.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
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
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In Sec. 558.665, add paragraph (e)(2) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
------------------------------------------------------------------------
Zilpaterol in Combination in Indications
grams/ton grams/ton for use Limitations Sponsor
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(2) 6.8 to Melengestrol Heifers fed As in 057926
provide 60 acetate to in paragraph
to 90 mg/ provide 0.25 confinement (e)(1) of
head/day to 0.5 mg/ for this
head/day slaughter: section; see
As in paragraph
paragraph Sec. Sec.
(e)(1) of 558.342(d)
this of this
section; and chapter.
for Melengestrol
suppression acetate as
of estrus provided by
(heat). No. 000009
in Sec.
510.600(c)
of this
chapter.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6601 Filed 3-28-08; 8:45 am]
BILLING CODE 4160-01-S
