New Animal Drugs; Change of Sponsor's Address, 24184-24185 [E7-8322]
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24184
Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Rules and Regulations
PART 246—SPECIAL SUPPLEMENTAL
NUTRITION PROGRAM FOR WOMEN,
INFANTS AND CHILDREN
1. The authority citation for part 246
continues to read as follows:
■
Authority: 42 U.S.C. 1786.
2. In § 246.26, a new paragraph (j) is
added to read as follows:
■
§ 246.26
Other provisions.
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*
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*
(j) Data collection related to local
agencies. (1) Each State agency must
collect data related to local agencies that
have an agreement with the State agency
to participate in the program for each of
Federal fiscal years 2006 through 2009,
including those local agencies that
participated only for part of the fiscal
year. Such data shall include:
(i) The name of each local agency;
(ii) The city in which each local
agency was headquartered and the name
of the state;
(iii) The amount of funds provided to
the participating organization, i.e., the
amount of federal funds provided for
nutrition services and administration to
each participating local agency; and
(iv) The type of participating
organization, e.g., government agency,
educational institution, non-profit
organization/secular, non-profit
organization/faith-based, and ‘‘other.’’
(2) On or before August 31, 2007, and
each subsequent year through 2010,
State agencies must report to FNS data
as specified in paragraph (j)(1) of this
section for the prior Federal fiscal year.
State agencies must submit this data in
a format designated by FNS.
PART 247—COMMODITY
SUPPLEMENTAL FOOD PROGRAM
1. The authority citation for part 247
continues to read as follows:
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Authority: Sec. 5, Pub. L. 93–86, 87 Stat.
249, as added by Sec. 1304(b)(2), Pub. L. 95–
113, 91 Stat. 980 (7 U.S.C. 612c note); sec.
1335, Pub. L. 97–98, 95 Stat. 1293 (7 U.S.C.
612c note); sec. 209, Pub. L. 98–8, 97 Stat.
35 (7 U.S.C. 612c note); sec. 2(8), Pub. L. 98–
92, 97 Stat. 611 (7 U.S.C. 612c note); sec.
1562, Pub. L. 99–198, 99 Stat. 1590 (7 U.S.C.
612c note); sec. 101(k), Pub. L. 100–202; sec.
1771(a), Pub. L. 101–624, 101 Stat. 3806 (7
U.S.C. 612c note); sec. 402(a), Pub. L. 104–
127, 110 Stat. 1028 (7 U.S.C. 612c note); Pub.
L. 107–171.
2. In § 247.29, a new paragraph (d) is
added to read as follows:
■
§ 247.29
Reports and recordkeeping.
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*
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(d) What data must the State agency
collect related to local agencies? (1)
Each State agency must collect data
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02:49 Aug 19, 2011
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related to local agencies that have an
agreement with the State agency to
participate in the program for each of
Federal fiscal years 2006 through 2009;
including those local agencies that
participated only for part of the fiscal
year. Such data shall include:
(i) The name of each local agency;
(ii) The city in which each
participating local agency was
headquartered and the name of the state;
(iii) The amount of funds provided to
the participating organization, i.e., the
amount of federal administrative funds
provided to each participating local
agency; and
(iv) The type of participating
organization, e.g., government agency,
educational institution, non-profit
organization/secular, non-profit
organization/faith-based, and ‘‘other.’’
(2) On or before August 31, 2007, and
each subsequent year through 2010,
State agencies must report to FNS data
as specified in paragraph (d)(1) of this
section for the prior Federal fiscal year.
State agencies must submit this data in
a format designated by FNS.
PART 251—THE EMERGENCY FOOD
ASSISTANCE PROGRAM
1. The authority citation for part 251
continues to read as follows:
■
Authority: 7 U.S.C. 7501–7516.
2. In § 251.10, a new paragraph (i) is
added to read as follows:
■
§ 251.10
Miscellaneous provisions.
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*
(i) Data collection related to eligible
recipient agencies. (1) Each State agency
must collect data related to eligible
recipient agencies that have an
agreement with the State agency to
participate in the program for each of
Federal fiscal years 2006 through 2009,
including those eligible recipient
agencies that participated only for part
of the fiscal year. Such data shall
include:
(i) The name of each eligible recipient
agency;
(ii) The city in which each
participating eligible recipient agency
was headquartered and the name of the
state;
(iii) The amount of funds provided to
the participating organization, i.e., the
sum of the amount of federal
administrative funds plus the value of
the commodities purchased under
Section 214 of the Emergency Food
Assistance Act of 1983 provided to each
participating eligible recipient agency;
and
(iv) The type of participating
organization, e.g., government agency,
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educational institution, non-profit
organization/secular, non-profit
organization/faith-based, and ‘‘other.’’
(2) On or before August 31, 2007, and
each subsequent year through 2010,
State agencies must report to FNS data
as specified in paragraph (i)(1) of this
section for the prior Federal fiscal year.
State agencies must submit this data in
a format designated by FNS.
Dated: April 23, 2007.
Nancy Montanez Johner,
Under Secretary, Food, Nutrition, and
Consumer Services.
[FR Doc. 07–2173 Filed 5–1–07; 8:45 am]
BILLING CODE 3410–30–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s address for
Alpharma, Inc.
DATES: This rule is effective May 2,
2007.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma,
Inc., One Executive Dr., Ft. Lee, NJ
07024, has informed FDA of a change of
address to 440 Rte. 22, Bridgewater, NJ
08807. Accordingly, the agency is
amending the regulations in 21 CFR
510.600(c) to reflect the change.
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 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
■ Therefore, under the Federal Food,
Drug and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
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Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Rules and Regulations
the Center for Veterinary Medicine, 21
CFR part 510 is amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Alpharma, Inc.’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘046573’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*****
Alpharma, Inc., 440 Rte.
22, Bridgewater, NJ
08807.
*****
Drug labeler
code
046573
(2) * * *
List of Subjects in 21 CFR Part 520
Drug labeler
code
Firm name and address
Animal drugs.
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 520 is amended as follows:
■
*****
Alpharma, Inc., 440 Rte.
22, Bridgewater, NJ
08807
*****
046573
improve the accuracy of the animal drug
regulations.
DATES: This rule is effective May 2,
2007.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019, email: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations
in 21 CFR 558.95 to correct an
inadvertent error in the conditions of
use of fenbendazole paste in horses and
cattle. The error in the agency’s
regulations was introduced in a final
rule reflecting the approval of a
supplemental new animal drug
application that published in the
Federal Register on March 9, 2007 (72
FR 10595). This action is being taken to
improve the accuracy of the animal drug
regulations.
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.
Dated: April 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–8322 Filed 5–1–07; 8:45 am]
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
2. Section 520.905c is revised to read
as follows:
■
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 520.905c
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Fenbendazole Paste
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
mmaher on DSK3CLS3C1PROD with $$_JOB
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to correct an
inadvertent error in the conditions of
use of fenbendazole paste in horses and
cattle. This action is being taken to
VerDate Mar 15 2010
02:49 Aug 19, 2011
of body weight. Retreatment at intervals
of 6 to 8 weeks may be required.
(B) For control of arteritis caused by
the fourth-stage larvae of S. vulgaris: 4.6
mg/lb of body weight daily for 5 days.
Treatment should be initiated in the
spring and repeated in 6 months.
(C) For treatment of encysted mucosal
cyathostome (small strongyle) larvae
including early third-stage (hypobiotic),
late third-stage, and fourth-stage larvae:
4.6 mg/lb of body weight daily for 5
consecutive days.
(D) Fenbendazole paste 10 percent
may be used concomitantly with
approved forms of trichlorfon for the
indications provided in paragraph
(e)(1)(i)(A) of this section and for
treating infections of stomach bots as
provided in § 520.2520.
(ii) Limitations. Do not use in horses
intended for human consumption.
(2) Cattle—(i) Amount. 2.3 mg/lb of
body weight. Retreatment may be
needed after 4 to 6 weeks.
(ii) Indications for use. For the
removal and control of lungworms
(Dictyocaulus viviparus), stomach
worms (Haemonchus contortus,
Ostertagia ostertagi, Trichostrongylus
axei), and intestinal worms
(Bunostomum phlebotomum,
Nematodirus helvetianus, Cooperia
punctata, C. oncophora,
Trichostrongylus colubriformis, and
Oesophagostomum radiatum).
(iii) Limitations. Cattle must not be
slaughtered within 8 days following last
treatment.
Dated: April 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–8391 Filed 5–1–07; 8:45 am]
BILLING CODE 4160–01–S
Authority: 21 U.S.C. 360b.
BILLING CODE 4160–01–S
AGENCY:
24185
Jkt 223001
Fenbendazole paste.
(a) Specifications. Each gram of paste
contains 100 milligrams (mg)
fenbendazole (10 percent).
(b) Sponsor. See No. 057926 in §
510.600(c) of this chapter.
(c) Related tolerances. See § 556.275
of this chapter.
(d) Special considerations. See §
500.25 of this chapter.
(e) Conditions of use—(1) Horses—(i)
Indications for use and amounts—(A)
For control of large strongyles
(Strongylus edentatus, S. equinus, S.
vulgaris), small strongyles, pinworms
(Oxyuris equi), and ascarids (Parascaris
equorum): 2.3 mg per pound (/lb) of
body weight, or for foals and weanlings
(less than 18 months of age), 4.6 mg/lb
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[CGD05–06–112]
RIN 1625–AA87
Security Zone; Severn River and
College Creek, Annapolis, MD
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing a permanent security zone
on certain waters of the Severn River
and College Creek. This action is
necessary to ensure the security of highranking public officials and safeguard
E:\FEDREG\02MYR1.LOC
02MYR1
]]>Agencies
[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Rules and Regulations]
[Pages 24184-24185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8322]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's address for Alpharma,
Inc.
DATES: This rule is effective May 2, 2007.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., Ft. Lee,
NJ 07024, has informed FDA of a change of address to 440 Rte. 22,
Bridgewater, NJ 08807. Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c) to reflect the change.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to
[[Page 24185]]
the Center for Veterinary Medicine, 21 CFR part 510 is amended as
follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), revise the entry
for ``Alpharma, Inc.''; and in the table in paragraph (c)(2), revise
the entry for ``046573'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ 046573
08807.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
046573 Alpharma, Inc., 440 Rte. 22, Bridgewater,
NJ 08807
* * * * *
------------------------------------------------------------------------
Dated: April 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-8322 Filed 5-1-07; 8:45 am]
BILLING CODE 4160-01-S
