New Animal Drugs for Use in Animal Feeds; Semduramicin; Virginiamycin, 41631-41632 [E9-19738]
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41631
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Rules and Regulations
living. So, 50% of the death gratuity
will be paid to his spouse and the
remaining 50% of the death gratuity
paid under this subpart would be paid
to John Smith. This means the surviving
spouse will receive $10,000 and John
Smith will receive $10,000.
(2) Example Two. Employee dies in
circumstances that would qualify her for
payment of the gratuity under this
subpart; her agency has paid the
$10,000 death gratuity pursuant to
Public Law 104–208. The employee had
not completed any designation form.
The FECA death gratuity is reduced by
the $10,000 death gratuity and
employee’s spouse receives $90,000.
(3) Example Three. An employee of
the Foreign Service whose annual salary
is $75,000 dies in circumstances that
would qualify for payment of both the
Foreign Service Act death gratuity and
the death gratuity under this subpart.
Before his death, the employee
designated that 40% of the death
gratuity under this subpart be paid to
his cousin Jane Smith, pursuant to the
alternate beneficiary designation
provision at section 10.908 and that
10% be paid to his uncle John Doe who
has since died. At the time of his death,
the employee had no surviving spouse,
children, parents, or siblings. Therefore,
the Foreign Service Act death gratuity
will not be paid, because no eligible
survivors according to the Foreign
Service Act provision exist. The death
gratuity under this subpart would equal
$100,000, because no other death
gratuity has been paid, and Jane would
receive $40,000 according to the
employee’s designation. As John Doe is
deceased, no death gratuity may be paid
pursuant to the designation of a share of
the death gratuity to him.
Signed at Washington, DC, this 29th day of
July 2009.
Shelby S. Hallmark,
Acting Assistant Secretary for Employment
Standards Administration.
[FR Doc. E9–18523 Filed 8–17–09; 8:45 am]
BILLING CODE 4510–CF–P
Semduramicin in grams
per ton
*
cprice-sewell on DSKDVH8Z91PROD with RULES
(2) 22.7
VerDate Nov<24>2008
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2009–N–0665]
New Animal Drugs for Use in Animal
Feeds; Semduramicin; Virginiamycin
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 an original new animal drug
application (NADA) filed by Phibro
Animal Health. The NADA provides for
use of single-ingredient Type A
medicated articles containing
semduramyicin (as semduramicin
sodium biomass) and virginiamycin to
manufacture 2-way combination drug
Type C medicated feeds for use in
broiler chickens.
DATES: This rule is effective August 18,
2009.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116, email: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Phibro
Animal Health, 65 Challenger Rd., 3d
floor, Ridgefield Park, NJ 07660, filed
NADA 141–289 that provides for the use
of AVIAX II (semduramicin sodium
biomass) and STAFAC (virginiamycin)
Type A medicated articles to
manufacture 2-way combination drug
Type C medicated feeds for broiler
chickens. The NADA is approved as of
July 13, 2009, and the regulations are
amended in 21 CFR 558.555 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
Combination in grams per
ton
*
14:34 Aug 17, 2009
Jkt 217001
PO 00000
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:
■
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.
2. In § 558.555, add paragraphs (e)(2)
through (e)(4) to read as follows:
■
§ 558.555
*
*
Fmt 4700
Sfmt 4700
*
*
Limitations
*
Broiler chickens: As in paragraph
(e)(1) of this section; for increased rate of weight gain and
improved feed efficiency.
Frm 00051
Semduramicin.
*
*
(e) * * *
Indications for use
*
Virginiamycin 5
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 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.
*
Feed continuously as sole ration.
Withdraw 1 day before slaughter. Do not feed to laying hens.
Virginiamycin provided by No.
066104 in § 510.600(c) of this
chapter.
E:\FR\FM\18AUR1.SGM
18AUR1
Sponsor
*
066104
41632
Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Rules and Regulations
Semduramicin in grams
per ton
Combination in grams per
ton
Indications for use
Limitations
Sponsor
(3) 22.7
Virginiamycin 5 to 15
Broiler chickens: As in paragraph
(e)(1) of this section; for increased rate of weight gain.
Feed continuously as sole ration.
Withdraw 1 day before slaughter. Do not feed to laying hens.
Virginiamycin provided by No.
066104 in § 510.600(c) of this
chapter.
066104
(4) 22.7
Virginiamycin 20
Broiler chickens: As in paragraph
(e)(1) of this section; for prevention of necrotic enteritis caused
by C. perfringens susceptible to
virginiamycin.
Feed continuously as sole ration.
Withdraw 1 day before slaughter. Do not feed to laying hens.
Virginiamycin provided by No.
066104 in § 510.600(c) of this
chapter.
066104
Dated: August 12, 2009.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. E9–19738 Filed 8–17–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
e-mail Kay Wade, Bridge
Administration Branch, Coast Guard;
telephone 504–671–2128, e-mail
kay.b.wade@uscg.mil. If you have
questions on viewing the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
[Docket No. USCG–2009–0101]
Regulatory Information
RIN 1625–AA09
On March 26, 2009, we published a
notice of proposed rulemaking (NPRM)
entitled Drawbridge Operation
Regulation; Sabine River, Echo, TX in
the Federal Register (74 FR 13164). We
received 2 comments on the proposed
rule. No public meeting was requested,
and none was held.
Drawbridge Operation Regulation;
Sabine River, Echo, TX
Coast Guard, DHS.
Final rule.
AGENCY:
cprice-sewell on DSKDVH8Z91PROD with RULES
ACTION:
SUMMARY: The Coast Guard is changing
the regulation governing the operation
of the Union Pacific Railroad Swing
Span Bridge across the Sabine River,
mile 19.3, at Echo, Orange County, TX.
The bridge currently opens on signal
with 24 hours advance notice but
because of the limited number of
requests for openings, the bridge owner
requested an increase in the length of
notification time required to open the
bridge.
DATES: This rule is effective September
17, 2009.
ADDRESSES: Comments and related
materials received from the public, as
well as documents mentioned in this
preamble as being available in the
docket, are part of docket USCG–2009–
0101 and are available online by going
to https://www.regulations.gov, inserting
USCG–2009–0101 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ This
material is also available for inspection
or copying at the Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
VerDate Nov<24>2008
14:34 Aug 17, 2009
Jkt 217001
Background and Purpose
Due to a lack of bridge openings
requested by mariners, Union Pacific
Railroad Company, the bridge owner,
requested a change in the operating
regulation governing the Union Pacific
railroad swing span bridge across the
Sabine River, mile 19.3 at Echo, Texas
from 24 hours advance notice to open
the bridge to 14 days advance notice to
open the bridge. This change allows the
bridge owner to open the bridge for the
passage of vessels while minimizing his
requirements to staff and maintain the
bridge. The bridge has a vertical
clearance of 7.9 feet above Mean High
Water (MHW), elevation 2.18 feet NGVD
in the closed-to-navigation position and
unlimited in the open-to-navigation
position. In accordance with 33 CFR
117.493(a), the bridge is currently
required to open on signal for the
passage of marine vessels if at least 24
hours of advanced notice is given.
Bridge tender logs indicate no requests
for bridge openings in several years.
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
Discussion of Comments and Changes
The Coast Guard received a total of
two comments in response to the
NPRM. The comments were from
Federal and State agencies having no
objections to the proposal. Therefore, no
change was made to the regulatory text.
Regulatory Analyses
We developed this rule after
considering numerous statutes and
executive orders related to rulemaking.
Below we summarize our analyses
based on 13 of these statutes or
executive orders.
Regulatory Planning and Review
This rule is not a significant
regulatory action under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
Budget has not reviewed it under that
Order.
We expect the economic impact of
this rule to be so minimal that a full
Regulatory Evaluation is unnecessary.
The public will need to notify the
bridge owner of a required opening 14
days in advance rather than 24 hours in
advance. There is no change in the
regulatory text published in the NPRM.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we have considered
whether this rule would have a
significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have
a significant economic impact on a
substantial number of small entities.
E:\FR\FM\18AUR1.SGM
18AUR1
]]>Agencies
[Federal Register Volume 74, Number 158 (Tuesday, August 18, 2009)]
[Rules and Regulations]
[Pages 41631-41632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19738]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Semduramicin;
Virginiamycin
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 an original new animal drug
application (NADA) filed by Phibro Animal Health. The NADA provides for
use of single-ingredient Type A medicated articles containing
semduramyicin (as semduramicin sodium biomass) and virginiamycin to
manufacture 2-way combination drug Type C medicated feeds for use in
broiler chickens.
DATES: This rule is effective August 18, 2009.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d
floor, Ridgefield Park, NJ 07660, filed NADA 141-289 that provides for
the use of AVIAX II (semduramicin sodium biomass) and STAFAC
(virginiamycin) Type A medicated articles to manufacture 2-way
combination drug Type C medicated feeds for broiler chickens. The NADA
is approved as of July 13, 2009, and the regulations are amended in 21
CFR 558.555 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 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.
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. In Sec. 558.555, add paragraphs (e)(2) through (e)(4) to read as
follows:
Sec. 558.555 Semduramicin.
* * * * *
(e) * * *
------------------------------------------------------------------------
Semduramicin Combination
in grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
(2) 22.7 Virginiamyci Broiler Feed 066104
n 5 chickens: As continuously
in paragraph as sole
(e)(1) of ration.
this section; Withdraw 1
for increased day before
rate of slaughter. Do
weight gain not feed to
and improved laying hens.
feed Virginiamycin
efficiency. provided by
No. 066104 in
Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
[[Page 41632]]
(3) 22.7 Virginiamyci Broiler Feed 066104
n 5 to 15 chickens: As continuously
in paragraph as sole
(e)(1) of ration.
this section; Withdraw 1
for increased day before
rate of slaughter. Do
weight gain. not feed to
laying hens.
Virginiamycin
provided by
No. 066104 in
Sec.
510.600(c) of
this chapter.
------------------------------------------------------------------------
(4) 22.7 Virginiamyci Broiler Feed 066104
n 20 chickens: As continuously
in paragraph as sole
(e)(1) of ration.
this section; Withdraw 1
for day before
prevention of slaughter. Do
necrotic not feed to
enteritis laying hens.
caused by C. Virginiamycin
perfringens provided by
susceptible No. 066104 in
to Sec.
virginiamycin 510.600(c) of
. this chapter.
------------------------------------------------------------------------
Dated: August 12, 2009.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E9-19738 Filed 8-17-09; 8:45 am]
BILLING CODE 4160-01-S
