New Animal Drugs; Change of Sponsor, 32488-32489 [05-11031]
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32488
Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Rules and Regulations
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.
Steris
Laboratories, Inc., 620 North 51st Ave.,
Phoenix, AZ 85043–4705, has informed
FDA of a change of sponsor’s name to
Watson Laboratories, Inc. 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.
Drug labeler
code
000402
Watson Laboratories, Inc.,
620 North 51st Ave.,
Phoenix, AZ 85043–4705
*
*
*
SUPPLEMENTARY INFORMATION:
Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–11030 Filed 6–2–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Drug labeler
code
Food and Drug Administration,
HHS.
ACTION:
Final rule.
Section
Trade Name
VerDate jul<14>2003
*
17:45 Jun 02, 2005
*
Jkt 205001
520.2261a
Purina Sulfa
097–258
558.485
Purina Ban Worm For Pigs
099–767
558.630
Purina Tylan 40 Plus
Sulfamethazine
113–748
520.1182
Purina Oral Pigemia
558.325
Purina Check-R-Ton LI
135–941
558.485
Check-E-Ton BM
136–116
520.905d
Purina Worm-A-Rest Litter
Pack
520.1840
Purina Bloat Block; Purina
Saf-T-Block BG
013–214
558.274
Purina Hygromix-Swine
520.100a
520.2380a
Purina Horse Wormer Medicated
558.185
Purina 6-Day Worm-Kill
Feed
042–660
558.630
Purina Pork-Plus Medicated
558.625
Purina Hog Plus II
List of Subjects
21 CFR Parts 520 and 522
Purina Liquid Amprol
040–205
Accordingly, the agency is amending
the regulations in parts 520, 522, and
558 (21 CFR parts 520, 522, and 558).
Sections 520.100a, 520.905d, 520.1182,
520.1840, 520.2261a, 520.2380a,
522.940, 558.185, 558.274, 558.325,
558.365, 558.485, 558.625, and 558.630
will reflect the transfer of ownership
and a current format. Sections 520.1182
and 522.940 are being revised to reflect
a current format.
In addition, § 520.2380a is being
revised to correct the citation for the
approved indications for Virbac AH’s
thiabendazole dewormer approved
under NADA 040–205. The citation was
corrected in the Federal Register of
March 3, 1976 (41 FR 9149), but an error
was reintroduced in the 1978 printing of
the Code of Federal Regulations. This
action is being taken to improve the
accuracy of the 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.
Purina Pigemia 100
043–387
Firm name and address
522.940
042–116
*
011–779
013–663
*
(2) * * *
*
Statyl
Food and Drug Administration
No.
*
558.365
BILLING CODE 4160–01–S
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 16 approved new
animal drug applications (NADAs) from
PART 510—NEW ANIMAL DRUGS
Purina Mills, Inc., to Virbac AH, Inc.
DATES: This rule is effective June 3,
I 1. The authority citation for 21 CFR
2005.
part 510 continues to read as follows:
FOR FURTHER INFORMATION CONTACT:
Authority: 21 U.S.C. 321, 331, 351, 352,
David R. Newkirk, Center for Veterinary
353, 360b, 371, 379e.
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
I 2. Section 510.600 is amended in the
table in paragraph (c)(1) by removing the Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.
entry for ‘‘Steris Laboratories, Inc.’’ and
SUPPLEMENTARY INFORMATION: Purina
by alphabetically adding an entry for
Mills, Inc., P.O. Box 66812, St. Louis,
‘‘Watson Laboratories, Inc.’’; and in the
MO 63166–6812, has informed FDA that
table in paragraph (c)(2) by revising the
it has transferred ownership of, and all
entry for ‘‘000402’’ to read as follows:
rights and interest in, the following 16
§ 510.600 Names, addresses, and drug
approved NADAs to Virbac AH, Inc.,
labeler codes of sponsors of approved
3200 Meacham Blvd., Ft. Worth, TX
applications.
76137:
*
*
*
*
*
TABLE 1.
(c) * * *
(1) * * *
NADA
21 CFR
Drug labeler
code
046–700
132–574
*
AGENCY:
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 510 is amended as follows:
*
Trade Name
049–729
*
New Animal Drugs; Change of Sponsor
I
*
000402
21 CFR
Section
21 CFR Parts 520, 522, and 558
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
*
*
Watson Laboratories, Inc.,
620 North 51st Ave.,
Phoenix, AZ 85043–4705
*
*
*
NADA
No.
140–869
List of Subjects in 21 CFR Part 510
Firm name and address
TABLE 1.—Continued
Firm name and address
*
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
Animal drugs.
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 520, 522, and 558 are amended as
follows:
I
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03JNR1
Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Rules and Regulations
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Section 520.100a is amended by
revising paragraph (b) to read as follows:
I
§ 520.100a
Amprolium drinking water.
*
*
*
*
*
(b) Sponsors. See Nos. 050604 and
051311 in § 510.600(c) of this chapter.
*
*
*
*
*
§ 520.905d
[Amended]
3. Section 520.905d is amended in
paragraph (b)(2) by removing ‘‘017800’’
and by adding in its place ‘‘051311’’.
I
4. Section 520.1182 is revised to read
as follows:
I
§ 520.1182
Iron dextran suspension.
(a) Specifications. Each milliliter (mL)
of suspension contains 55.56 milligrams
(mg) iron as ferric hydroxide in complex
with a low molecular weight dextran.
(b) Sponsor. See No. 051311 in
§ 510.600(c) of this chapter.
(c) Conditions of use in swine—(1)
Amount. Administer 100 mg (1.8 mL)
orally by automatic dose dispenser.
(2) Indications for use. For the
prevention of iron deficiency anemia in
baby pigs.
(3) Limitations. Treat each pig within
24 hours of farrowing.
8. The authority citation for 21 CFR
part 522 continues to read as follows:
I
7. Section 520.2380a is amended by
revising the section heading and
paragraph (c) to read as follows:
§ 520.2380a Thiabendazole top dressing
and mineral protein block.
*
*
*
*
*
(c) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
(1) No. 051311 for use as in paragraph
(e)(1)(i) of this section.
(2) No. 050604 for use as in paragraph
(e)(1)(ii) of this section.
(3) No. 021930 for use as in paragraph
(e)(2) of this section.
*
*
*
*
*
VerDate jul<14>2003
17:45 Jun 02, 2005
Jkt 205001
[Amended]
14. Section 558.365 is amended in
paragraph (a) by removing ‘‘017800’’ and
by adding in its place ‘‘No. 051311’’.
I
§ 558.485
[Amended]
9. Section 522.940 is revised to read as
follows:
15. Section 558.485 is amended in
paragraph (b)(5) by removing ‘‘017800’’
and by adding in its place ‘‘051311’’.
§ 522.940
§ 558.625
I
Authority: 21 U.S.C. 360b.
I
Ferric oxide injection.
(a) Specifications. Each milliliter (mL)
contains colloidal ferric oxide
equivalent to 100 milligrams of iron
with a low-viscosity dextrin.
(b) Sponsors. See Nos. 051311 and
053501 in § 510.600(c) of this chapter.
(c) Conditions of use in swine—(1) For
prevention of iron deficiency anemia,
administer 1 mL by intramuscular
injection at 2 to 5 days of age. Dosage
may be repeated at 2 weeks of age.
(2) For treatment of iron deficiency
anemia, administer 1 to 2 mL by
intramuscular injection at 5 to 28 days
of age.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
10. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
11. Section 558.185 is amended by
revising paragraph (b)(2); and by adding
paragraph (b)(3) to read as follows:
I
§ 558.185
Coumaphos.
*
*
*
*
(b) * * *
(2) No. 017800 for use of Type A
§ 520.1840 [Amended]
medicated articles containing 11.2
I 5. Section 520.1840 is amended in
percent coumaphos as in paragraph
paragraph (b)(2) by removing ‘‘017800’’
(e)(1) of this section.
and by adding in its place ‘‘051311’’.
(3) No. 051311 for use of Type A
medicated articles containing 1.12
§ 520.2261a [Amended]
percent coumaphos as in paragraph
(e)(1) of this section.
I 6. Section 520.2261a is amended in
paragraph (a) by removing ‘‘017800’’ and *
*
*
*
*
by adding in its place ‘‘051311’’.
I
§ 558.365
32489
*
[Amended]
16. Section 558.625 is amended in
paragraph (b)(5) by removing ‘‘017800’’
and by adding in its place ‘‘No. 051311’’.
I
§ 558.630
[Amended]
17. Section 558.630 is amended in
paragraph (b)(5) by removing ‘‘017800’’
and by adding in its place ‘‘No. 051311’’.
I
Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–11031 Filed 6–2–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1 and 301
[TD 9194]
RIN 1545–BE22
Residence and Source Rules involving
U.S. Possessions and Other
Conforming Changes; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
SUMMARY: This document corrects
temporary regulations (TD 9194) that
were published in the Federal Register
on Monday, April 11, 2005 (70 FR
18920). The temporary regulations
provide rules under section 937(a) of the
Internal Revenue Code (Code) for
§ 558.274 [Amended]
determining whether an individual is a
bona fide resident of the following U.S.
I 12. Section 558.274 is amended in
possessions: American Samoa, Guam,
paragraph (a)(2) by removing ‘‘043733’’
and by adding in its place ‘‘Nos. 043733 the Northern Mariana Islands, Puerto
Rico, and the United States Virgin
and 051311’’; and in the table in
Islands. The temporary regulations also
paragraph (c)(1)(ii) in the ‘‘Sponsor’’
provide rules under section 937(b) for
column by adding in numerical
determining whether income is derived
sequence ‘‘051311’’.
from sources within a U.S. possession
§ 558.325 [Amended]
and whether income is effectively
connected with the conduct of a trade
I 13. Section 558.325 is amended in
paragraph (a)(13) by removing ‘‘017800’’ or business within a U.S. possession. In
and by adding in its place ‘‘051311’’; and addition, the temporary regulations
provide updated guidance under certain
in paragraphs (d)(2)(ii)(1), (d)(2)(iii)(1),
other Code sections to reflect changes
and (d)(2)(iv) in the table in the
made by the Tax Reform Act of 1986
‘‘Sponsor’’ column by removing
and by the American Jobs Creation Act
‘‘017800’’ and by adding in numerical
of 2004.
sequence ‘‘051311’’.
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
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03JNR1
]]>Agencies
[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Rules and Regulations]
[Pages 32488-32489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 558
New Animal Drugs; Change of Sponsor
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 for 16 approved new
animal drug applications (NADAs) from Purina Mills, Inc., to Virbac AH,
Inc.
DATES: This rule is effective June 3, 2005.
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.gov.
SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St.
Louis, MO 63166-6812, has informed FDA that it has transferred
ownership of, and all rights and interest in, the following 16 approved
NADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:
Table 1.
------------------------------------------------------------------------
NADA No. 21 CFR Section Trade Name
------------------------------------------------------------------------
011-779 522.940 Purina Pigemia 100
------------------------------------------------------------------------
013-214 558.274 Purina Hygromix-Swine
------------------------------------------------------------------------
013-663 520.100a Purina Liquid Amprol
------------------------------------------------------------------------
040-205 520.2380a Purina Horse Wormer Medicated
------------------------------------------------------------------------
042-116 558.185 Purina 6-Day Worm-Kill Feed
------------------------------------------------------------------------
042-660 558.630 Purina Pork-Plus Medicated
------------------------------------------------------------------------
043-387 558.625 Purina Hog Plus II
------------------------------------------------------------------------
046-700 558.365 Statyl
------------------------------------------------------------------------
049-729 520.2261a Purina Sulfa
------------------------------------------------------------------------
097-258 558.485 Purina Ban Worm For Pigs
------------------------------------------------------------------------
099-767 558.630 Purina Tylan 40 Plus
Sulfamethazine
------------------------------------------------------------------------
113-748 520.1182 Purina Oral Pigemia
------------------------------------------------------------------------
132-574 558.325 Purina Check-R-Ton LI
------------------------------------------------------------------------
135-941 558.485 Check-E-Ton BM
------------------------------------------------------------------------
136-116 520.905d Purina Worm-A-Rest Litter Pack
------------------------------------------------------------------------
140-869 520.1840 Purina Bloat Block; Purina Saf-T-
Block BG
------------------------------------------------------------------------
Accordingly, the agency is amending the regulations in parts 520,
522, and 558 (21 CFR parts 520, 522, and 558). Sections 520.100a,
520.905d, 520.1182, 520.1840, 520.2261a, 520.2380a, 522.940, 558.185,
558.274, 558.325, 558.365, 558.485, 558.625, and 558.630 will reflect
the transfer of ownership and a current format. Sections 520.1182 and
522.940 are being revised to reflect a current format.
In addition, Sec. 520.2380a is being revised to correct the
citation for the approved indications for Virbac AH's thiabendazole
dewormer approved under NADA 040-205. The citation was corrected in the
Federal Register of March 3, 1976 (41 FR 9149), but an error was
reintroduced in the 1978 printing of the Code of Federal Regulations.
This action is being taken to improve the accuracy of the 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.
List of Subjects
21 CFR Parts 520 and 522
Animal drugs.
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 520,
522, and 558 are amended as follows:
[[Page 32489]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Section 520.100a is amended by revising paragraph (b) to read as
follows:
Sec. 520.100a Amprolium drinking water.
* * * * *
(b) Sponsors. See Nos. 050604 and 051311 in Sec. 510.600(c) of
this chapter.
* * * * *
Sec. 520.905d [Amended]
0
3. Section 520.905d is amended in paragraph (b)(2) by removing
``017800'' and by adding in its place ``051311''.
0
4. Section 520.1182 is revised to read as follows:
Sec. 520.1182 Iron dextran suspension.
(a) Specifications. Each milliliter (mL) of suspension contains
55.56 milligrams (mg) iron as ferric hydroxide in complex with a low
molecular weight dextran.
(b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in swine--(1) Amount. Administer 100 mg (1.8
mL) orally by automatic dose dispenser.
(2) Indications for use. For the prevention of iron deficiency
anemia in baby pigs.
(3) Limitations. Treat each pig within 24 hours of farrowing.
Sec. 520.1840 [Amended]
0
5. Section 520.1840 is amended in paragraph (b)(2) by removing
``017800'' and by adding in its place ``051311''.
Sec. 520.2261a [Amended]
0
6. Section 520.2261a is amended in paragraph (a) by removing ``017800''
and by adding in its place ``051311''.
0
7. Section 520.2380a is amended by revising the section heading and
paragraph (c) to read as follows:
Sec. 520.2380a Thiabendazole top dressing and mineral protein block.
* * * * *
(c) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
(1) No. 051311 for use as in paragraph (e)(1)(i) of this section.
(2) No. 050604 for use as in paragraph (e)(1)(ii) of this section.
(3) No. 021930 for use as in paragraph (e)(2) of this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
9. Section 522.940 is revised to read as follows:
Sec. 522.940 Ferric oxide injection.
(a) Specifications. Each milliliter (mL) contains colloidal ferric
oxide equivalent to 100 milligrams of iron with a low-viscosity
dextrin.
(b) Sponsors. See Nos. 051311 and 053501 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in swine--(1) For prevention of iron
deficiency anemia, administer 1 mL by intramuscular injection at 2 to 5
days of age. Dosage may be repeated at 2 weeks of age.
(2) For treatment of iron deficiency anemia, administer 1 to 2 mL
by intramuscular injection at 5 to 28 days of age.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
10. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
11. Section 558.185 is amended by revising paragraph (b)(2); and by
adding paragraph (b)(3) to read as follows:
Sec. 558.185 Coumaphos.
* * * * *
(b) * * *
(2) No. 017800 for use of Type A medicated articles containing 11.2
percent coumaphos as in paragraph (e)(1) of this section.
(3) No. 051311 for use of Type A medicated articles containing 1.12
percent coumaphos as in paragraph (e)(1) of this section.
* * * * *
Sec. 558.274 [Amended]
0
12. Section 558.274 is amended in paragraph (a)(2) by removing
``043733'' and by adding in its place ``Nos. 043733 and 051311''; and
in the table in paragraph (c)(1)(ii) in the ``Sponsor'' column by
adding in numerical sequence ``051311''.
Sec. 558.325 [Amended]
0
13. Section 558.325 is amended in paragraph (a)(13) by removing
``017800'' and by adding in its place ``051311''; and in paragraphs
(d)(2)(ii)(1), (d)(2)(iii)(1), and (d)(2)(iv) in the table in the
``Sponsor'' column by removing ``017800'' and by adding in numerical
sequence ``051311''.
Sec. 558.365 [Amended]
0
14. Section 558.365 is amended in paragraph (a) by removing ``017800''
and by adding in its place ``No. 051311''.
Sec. 558.485 [Amended]
0
15. Section 558.485 is amended in paragraph (b)(5) by removing
``017800'' and by adding in its place ``051311''.
Sec. 558.625 [Amended]
0
16. Section 558.625 is amended in paragraph (b)(5) by removing
``017800'' and by adding in its place ``No. 051311''.
Sec. 558.630 [Amended]
0
17. Section 558.630 is amended in paragraph (b)(5) by removing
``017800'' and by adding in its place ``No. 051311''.
Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-11031 Filed 6-2-05; 8:45 am]
BILLING CODE 4160-01-S
