New Animal Drugs For Use in Animal Feeds; Decoquinate, 2567-2568 [05-789]
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2567
Federal Register / Vol. 70, No. 10 / Friday, January 14, 2005 / Rules and Regulations
paragraphs (e)(1)(i) and (e)(1)(ii) in the
‘‘Sponsor’’ column by adding in
numerical sequence ‘‘021641’’ to read as
follows:
§ 558.342
Melengestrol.
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(b) Approvals. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
(1) No. 000009 for use of products
described in paragraph (a) of this
section.
(2) No. 021641 for use of product
described in paragraph (a)(2) of this
section.
*
*
*
*
*
Dated: December 29, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–761 Filed 1–13–05; 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
Feeds; Decoquinate
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 two supplemental new
animal drug applications (NADAs) filed
by Alpharma Inc. The supplemental
NADAs provide for the use of singleingredient decoquinate and
Decoquinate in
grams/ton
Combination in
grams/ton
*
Indications for use
*
(ii) 12.9 to 90.8
VerDate jul<14>2003
chlortetracycline Type A medicated
articles to make two-way Type B and
Type C medicated feeds for cattle at a
broader range of concentrations.
DATES: This rule is effective January 14,
2005.
FOR FURTHER INFORMATION CONTACT:
Janis R. Messenheimer, Center for
Veterinary Medicine (HFV–135), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301–827–
7578, e-mail:
janis.messenheimer@fda.gov.
SUPPLEMENTARY INFORMATION: Alpharma
Inc., One Executive Drive, P.O. Box
1399, Fort Lee, NJ 07024, filed a
supplement to NADA 141–147 for use of
DECCOX (decoquinate) and
CHLORMAX (chlortetracycline) Type A
medicated articles to make two-way
Type B and Type C medicated feeds for
cattle at the broader range of
concentrations. Alpharma Inc. also filed
a supplement to NADA 141–185 for use
of DECCOX and AUREOMYCIN
(chlortetracycline) Type A medicated
articles for the same revised conditions
of use. The supplemental applications
are approved as of December 16, 2004,
and the regulations are amended in 21
CFR 558.195 to reflect the approval. The
basis of approval is discussed in the
freedom of information summaries.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii),
summaries of safety and effectiveness
data and information submitted to
support approval of these applications
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.
*
Chlortetracycline
500 to 4,000.
13:05 Jan 13, 2005
Jkt 205001
*
Frm 00007
Fmt 4700
List of Subjects in 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
part 558 is amended as follows:
I
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.
2. Section 558.195 is amended by
redesignating paragraphs (e)(2)(ii),
(e)(2)(iii), and (e)(2)(iv) as paragraphs
(e)(2)(vi), (e)(2)(iv), and (e)(2)(iii)
respectively; and by adding new
paragraphs (e)(2)(ii) and (e)(2)(vii) to
read as follows:
I
§ 558.195
Decoquinate.
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*
(e) * * *
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(2) Cattle.
*
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Limitations
Calves, beef, and nonlactating
dairy cattle: As in paragraph
(e)(2)(i) of this section; for treatment of bacterial enteritis
caused by Escherichia coli; and
for treatment of bacterial pneumonia caused by Pasteurella
multocida organisms susceptible to chlortetracycline.
PO 00000
The agency has determined under 21
CFR 25.33(a)(1) that these actions are of
a type that do not individually or
cumulatively have a significant effect on
the human environment. Therefore,
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.
*
Sponsor
*
Feed Type C feed to provide 22.7 mg decoquinate
and 1 gram chlortetracycline per 100 lb body
weight per day for not more than 5 days. When
consumed, feed 22.7 mg decoquinate per 100 lb
body weight/day for a total of 28 days to prevent
coccidiosis. Withdraw 24 hours prior to slaughter
when manufactured from CTC (chlortetracycline)
Type A medicated articles under NADA 141–
147. Zero withdrawal time when manufactured
from AUREOMYCIN (chlortetracycline) Type A
medicated articles under NADA 141–185. A
withdrawal period has not been established for
this product in preruminating calves. Do not use
in calves to be processed for veal. Do not feed
to animals producing milk for food. Chlortetracycline as provided by No. 046573 in
§ 510.600(c) of this chapter.
Sfmt 4700
E:\FR\FM\14JAR1.SGM
14JAR1
*
046573
2568
Federal Register / Vol. 70, No. 10 / Friday, January 14, 2005 / Rules and Regulations
Decoquinate in
grams/ton
Combination in
grams/ton
*
*
(vii) 90.9 to 535.7
*
*
Indications for use
*
*
Chlortetracycline
4,000 to
20,000.
*
*
BILLING CODE 4160–01–S
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Parts 4022 and 4044
Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets
in Single-Employer Plans; Interest
Assumptions for Valuing and Paying
Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
SUMMARY: The Pension Benefit Guaranty
Corporation’s regulations on Benefits
Payable in Terminated Single-Employer
Plans and Allocation of Assets in
Single-Employer Plans prescribe interest
assumptions for valuing and paying
benefits under terminating singleemployer plans. This final rule amends
the regulations to adopt interest
assumptions for plans with valuation
dates in February 2005. Interest
assumptions are also published on the
PBGC’s Web site https://www.pbgc.gov.
EFFECTIVE DATE: February 1, 2005.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion, Acting Assistant
General Counsel, Office of the General
Counsel, Pension Benefit Guaranty
Corporation, 1200 K Street, NW.,
Washington, DC 20005, (202) 326–4024.
13:05 Jan 13, 2005
Jkt 205001
*
Calves, beef, and nonlactating
dairy cattle: As in paragraph
(e)(2)(i) of this section; for treatment of bacterial enteritis
caused by Escherichia coli; and
for treatment of bacterial pneumonia caused by Pasteurella
multocida organisms susceptible to chlortetracycline.
Dated: January 7, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–789 Filed 1–13–05; 8:45 am]
VerDate jul<14>2003
Limitations
*
Frm 00008
Fmt 4700
*
Feed Type C medicated feed supplements as a
top dress or mix into the daily ration to provide
22.7 mg decoquinate and 1 gram chlortetracycline per 100 lb body weight per day for not
more than 5 days. When consumed, feed 22.7
mg decoquinate per 100 lb body weight per day
for a total of 28 days to prevent coccidiosis.
Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline) Type A
medicated articles under NADA 141–147. Zero
withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated
articles under NADA 141–185. A withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be
processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 046573 in § 510.600(c) of this
chapter.
(TTY/TDD users may call the Federal
relay service toll-free at 1–800–877–
8339 and ask to be connected to (202)
326–4024.)
SUPPLEMENTARY INFORMATION: The
PBGC’s regulations prescribe actuarial
assumptions—including interest
assumptions—for valuing and paying
plan benefits of terminating singleemployer plans covered by title IV of
the Employee Retirement Income
Security Act of 1974. The interest
assumptions are intended to reflect
current conditions in the financial and
annuity markets.
Three sets of interest assumptions are
prescribed: (1) A set for the valuation of
benefits for allocation purposes under
section 4044 (found in Appendix B to
Part 4044), (2) a set for the PBGC to use
to determine whether a benefit is
payable as a lump sum and to determine
lump-sum amounts to be paid by the
PBGC (found in Appendix B to Part
4022), and (3) a set for private-sector
pension practitioners to refer to if they
wish to use lump-sum interest rates
determined using the PBGC’s historical
methodology (found in Appendix C to
Part 4022).
Accordingly, this amendment (1) adds
to Appendix B to Part 4044 the interest
assumptions for valuing benefits for
allocation purposes in plans with
valuation dates during February 2005,
(2) adds to Appendix B to Part 4022 the
interest assumptions for the PBGC to
use for its own lump-sum payments in
plans with valuation dates during
February 2005, and (3) adds to
Appendix C to Part 4022 the interest
assumptions for private-sector pension
practitioners to refer to if they wish to
use lump-sum interest rates determined
PO 00000
Sponsor
Sfmt 4700
*
046573
using the PBGC’s historical
methodology for valuation dates during
February 2005.
For valuation of benefits for allocation
purposes, the interest assumptions that
the PBGC will use (set forth in
Appendix B to part 4044) will be 4.00
percent for the first 20 years following
the valuation date and 4.75 percent
thereafter. These interest assumptions
represent a decrease (from those in
effect for January 2005) of 0.10 percent
for the first 20 years following the
valuation date and are otherwise
unchanged.
The interest assumptions that the
PBGC will use for its own lump-sum
payments (set forth in Appendix B to
part 4022) will be 3.00 percent for the
period during which a benefit is in pay
status and 4.00 percent during any years
preceding the benefit’s placement in pay
status. These interest assumptions are
unchanged from those in effect for
January 2005.
For private-sector payments, the
interest assumptions (set forth in
Appendix C to part 4022) will be the
same as those used by the PBGC for
determining and paying lump sums (set
forth in Appendix B to part 4022).
The PBGC has determined that notice
and public comment on this amendment
are impracticable and contrary to the
public interest. This finding is based on
the need to determine and issue new
interest assumptions promptly so that
the assumptions can reflect, as
accurately as possible, current market
conditions.
Because of the need to provide
immediate guidance for the valuation
and payment of benefits in plans with
valuation dates during February 2005,
the PBGC finds that good cause exists
E:\FR\FM\14JAR1.SGM
14JAR1
]]>Agencies
[Federal Register Volume 70, Number 10 (Friday, January 14, 2005)]
[Rules and Regulations]
[Pages 2567-2568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-789]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; Decoquinate
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 two supplemental new animal
drug applications (NADAs) filed by Alpharma Inc. The supplemental NADAs
provide for the use of single-ingredient decoquinate and
chlortetracycline Type A medicated articles to make two-way Type B and
Type C medicated feeds for cattle at a broader range of concentrations.
DATES: This rule is effective January 14, 2005.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail:
janis.messenheimer@fda.gov.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Drive, P.O. Box
1399, Fort Lee, NJ 07024, filed a supplement to NADA 141-147 for use of
DECCOX (decoquinate) and CHLORMAX (chlortetracycline) Type A medicated
articles to make two-way Type B and Type C medicated feeds for cattle
at the broader range of concentrations. Alpharma Inc. also filed a
supplement to NADA 141-185 for use of DECCOX and AUREOMYCIN
(chlortetracycline) Type A medicated articles for the same revised
conditions of use. The supplemental applications are approved as of
December 16, 2004, and the regulations are amended in 21 CFR 558.195 to
reflect the approval. The basis of approval is discussed in the freedom
of information summaries.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and
effectiveness data and information submitted to support approval of
these applications 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)(1) that these
actions are of a type that do not individually or cumulatively have a
significant effect on the human environment. Therefore, 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
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. Section 558.195 is amended by redesignating paragraphs (e)(2)(ii),
(e)(2)(iii), and (e)(2)(iv) as paragraphs (e)(2)(vi), (e)(2)(iv), and
(e)(2)(iii) respectively; and by adding new paragraphs (e)(2)(ii) and
(e)(2)(vii) to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(e) * * *
* * * * *
(2) Cattle.
----------------------------------------------------------------------------------------------------------------
Decoquinate in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(ii) 12.9 to 90.8 Chlortetracyclin Calves, beef, and Feed Type C feed to provide 22.7 mg 046573
e 500 to 4,000. nonlactating dairy decoquinate and 1 gram
cattle: As in paragraph chlortetracycline per 100 lb body
(e)(2)(i) of this weight per day for not more than 5
section; for treatment days. When consumed, feed 22.7 mg
of bacterial enteritis decoquinate per 100 lb body weight/
caused by Escherichia day for a total of 28 days to
coli; and for treatment prevent coccidiosis. Withdraw 24
of bacterial pneumonia hours prior to slaughter when
caused by Pasteurella manufactured from CTC
multocida organisms (chlortetracycline) Type A
susceptible to medicated articles under NADA 141-
chlortetracycline. 147. Zero withdrawal time when
manufactured from AUREOMYCIN
(chlortetracycline) Type A
medicated articles under NADA 141-
185. A withdrawal period has not
been established for this product
in preruminating calves. Do not
use in calves to be processed for
veal. Do not feed to animals
producing milk for food.
Chlortetracycline as provided by
No. 046573 in Sec. 510.600(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
[[Page 2568]]
* * * * * * *
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(vii) 90.9 to Chlortetracyclin Calves, beef, and Feed Type C medicated feed 046573
535.7 e 4,000 to nonlactating dairy supplements as a top dress or mix
20,000. cattle: As in paragraph into the daily ration to provide
(e)(2)(i) of this 22.7 mg decoquinate and 1 gram
section; for treatment chlortetracycline per 100 lb body
of bacterial enteritis weight per day for not more than 5
caused by Escherichia days. When consumed, feed 22.7 mg
coli; and for treatment decoquinate per 100 lb body weight
of bacterial pneumonia per day for a total of 28 days to
caused by Pasteurella prevent coccidiosis. Withdraw 24
multocida organisms hours prior to slaughter when
susceptible to manufactured from CTC
chlortetracycline. (chlortetracycline) Type A
medicated articles under NADA 141-
147. Zero withdrawal time when
manufactured from AUREOMYCIN
(chlortetracycline) Type A
medicated articles under NADA 141-
185. A withdrawal period has not
been established for this product
in preruminating calves. Do not
use in calves to be processed for
veal. Do not feed to animals
producing milk for food.
Chlortetracycline as provided by
No. 046573 in Sec. 510.600(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: January 7, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-789 Filed 1-13-05; 8:45 am]
BILLING CODE 4160-01-S
