Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications, 74652-74653 [05-24104]
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74652
Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Rules and Regulations
introductory text, and the first sentence
of paragraph (e)(i), remove ‘‘duplicate or
corrected’’ and add in its place
‘‘replacement.’’
I b. In the third and fourth sentences of
paragraph (a), the first sentence of
paragraph (d) introductory text, and the
first sentence of paragraph (g), remove
‘‘,duplicate, or corrected’’ and add in its
place ‘‘or replacement.’’
I 4. Section 422.110 is revised to read
as follows:
§ 422.110 Individual’s request for change
in record.
(a) Form SS–5. If you wish to change
the name or other personal identifying
information you previously submitted
in connection with an application for a
social security number card, you must
complete and sign a Form SS–5 except
as provided in paragraph (b) of this
section. You must prove your identity,
and you may be required to provide
other evidence. (See § 422.107 for
evidence requirements.) You may obtain
a Form SS–5 from any local Social
Security office or from one of the
sources noted in § 422.103(b). You may
submit a completed request for change
in records to any Social Security office,
or, if you are outside the U.S., to the
Department of Veterans Affairs Regional
Office, Manila, Philippines, or to any
U.S. Foreign Service post or U.S.
military post. If your request is for a
change of name on the card, we may
issue you a replacement card bearing
the same number and the new name. We
will grant an exception from the
limitations specified in § 422.103(e)(2)
for replacement social security number
cards representing a change in name or,
if you are an alien, a change to a
restrictive legend shown on the card.
(See § 422.103(e)(3) for the definition of
a change to a restrictive legend.)
(b) Assisting in enumeration. We may
enter into an agreement with officials of
the Department of State and the
Department of Homeland Security to
assist us by collecting, as part of the
immigration process, information to
change the name or other personal
identifying information you previously
submitted in connection with an
application or request for a social
security number card. If your request is
to change a name on the card or to
correct the restrictive legend on the card
to reflect a change in alien status, we
may issue you a replacement card
bearing the same number and the new
name or legend. We will grant an
exception from the limitations specified
in § 422.103(e)(2) for replacement social
security number cards representing a
change of name or, if you are an alien,
a change to a restrictive legend shown
on the card. (See § 422.103(e)(3) for the
definition of a change to a restrictive
legend.)
[FR Doc. 05–23962 Filed 12–15–05; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
New Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of 15
new animal drug applications (NADAs)
because the products are no longer
manufactured or marketed. In a notice
published elsewhere in this issue of the
Federal Register, FDA is withdrawing
approval of the NADAs.
DATES: This rule is effective December
27, 2005.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–212), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9067, e-mail: pesposit@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: The
following sponsors have requested that
FDA withdraw approval of the 15
NADAs listed in table 1 of this
document because the products are no
longer manufactured or marketed:
TABLE 1.
Sponsor
21 CFR Section
Affected (Sponsor
Drug Labeler
Code)
NADA Number, Product (Drug)
Bioproducts, Inc., 320 Springside Dr., Suite 300,
Fairlawn, OH 44333–2435
NADA 119–063, Pyrantel Tartrate Ton Pack (pyrantel tartrate)
558.485 (051359)
Farmland Industries, Inc., Kansas City, MO
64116
NADA 138–656, BN Wormer—19.2 BANMINTH Premix (pyrantel tartrate)
558.485 (021676)
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE
68137
NADA 129–395, HYGROMIX 0.6 Premix (hygromycin B)
558.274 (050639)
NADA 129–646, TYLAN 10 Sulfa-G (tylosin, sulfamethazine)
NADA 136–601, Swine Guard BN (pyrantel tartrate)
558.630 (050639)
558.485 (050639)
J. & R. Specialty Supply Co., 310 Second Ave.,
SW., P.O. Box 506, Waseca, MN 56093
NADA 96–780, TYLAN 10; TYLAN 40 (tylosin)
n/a (049768)
Kerber Milling Co., Box 152, 1817 E. Main St.,
Emmetsburg, IA 50536
NADA 98–687, Hy-Test Hy-Boost TY 5 Medicated (tylosin)
558.625 (029341)
M & M Livestock Products Co., Eagle Grove, IA
50533
NADA 96–837, M & M Tylosin Premix (tylosin)
558.625 (026282)
Nutra-Blend Corp., P.O. Box 485, Neosho, MO
64850
NADA 129–161, Nutra-Blend TYLAN 10 Sulfa Premix (tylosin,
sulfamethazine)
NADA 136–384, Swine Wormer-BN BANMINTH (pyrantel tartrate)
558.630 (050568)
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558.485 (050568)
Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Rules and Regulations
74653
TABLE 1.—Continued
Sponsor
21 CFR Section
Affected (Sponsor
Drug Labeler
Code)
NADA Number, Product (Drug)
South St. Paul Feeds, Inc., 500 Farwell Ave.,
South St. Paul, MN 55075
NADA 136–369, Custom Ban Wormer 9.6 (pyrantel tartrate)
558.485 (001800)
Stockton Hay & Grain Co.
NADA 49–462, Rainbrook Broiler Premix No. 1 (ampolium, arsanilic
acid, ethopabate, penicillin G procaine, streptomycin)
NADA 91–646, Rainbow Broiler Base Concentrate (ampolium, bacitracin zinc, ethopabate)
NADA 91–647, Rainbow Broiler Base Concentrate (ampolium, chlortetracycline, ethopabate)
n/a (036541)
n/a (036541)
NADA 131–146, FLAVOMYCIN 0.4 (bambermycins)
558.95 (011490)
Triple ‘‘F’’, Inc., 10104 Douglas Ave., Des
Moines, IA 50322
Following the withdrawal of approval
of these NADAs, Kerber Milling Co., M
& M Livestock Products Co., NutraBlend Corp., and South St. Paul Feeds,
Inc., are no longer sponsors of an
approved application. Therefore, we are
removing entries for these four sponsors
from 21 CFR 510.600(c).
As provided below, the animal drug
regulations are amended to reflect the
withdrawal of approvals.
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.
paragraph (c)(2) by removing the entries
for ‘‘001800’’, ‘‘026282’’, ‘‘029341’’, and
‘‘050568’’.
DEPARTMENT OF JUSTICE
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
21 CFR Parts 1300 and 1308
Authority: 21 U.S.C. 360b, 371.
§ 558.95
[Amended]
4. Section 558.95 is amended by
removing and reserving paragraph (a)(3).
I
§ 558.274
[Amended]
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 558
§ 558.485
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 510 and 558 are amended as
follows:
I
PART 510—NEW ANIMAL DRUGS
I
I
1. The authority citation for 21 CFR
part 510 continues to read as follows:
§ 558.630
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. Section 510.600 is amended in the
table in paragraph (c)(1) by removing
the entries for ‘‘Kerber Milling Co.’’, ‘‘M
& M Livestock Products Co.’’, ‘‘NutraBlend Corp.’’, and ‘‘South St. Paul
Feeds, Inc.’’; and in the table in
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16:21 Dec 15, 2005
Jkt 208001
[Amended]
8. Section 558.630 is amended in
paragraph (b)(10) by removing ‘‘,
050568, 050639’’.
I
[Amended]
I
[Amended]
7. Section 558.625 is amended by
removing and reserving paragraphs
(b)(22), (b)(31), (b)(52), and (b)(79).
I
§ 510.600
[Amended]
6. Section 558.485 is amended by
removing and reserving paragraphs
(b)(2) and (b)(4); and in paragraph (b)(3)
by removing ‘‘, 049685, 050568, 050639,
and 051359’’ and by adding in its place
‘‘and 049685’’.
§ 558.625
Dated: December 7, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–24104 Filed 12–15–05; 8:45 am]
BILLING CODE 4160–01–S
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RIN 1117–AA95
Implementation of the Anabolic Steroid
Control Act of 2004
5. Section 558.274 is amended in
paragraph (a)(4) by removing ‘‘, 043733,
and 050639’’ and by adding in its place
‘‘and 043733’’; and in the table in
paragraphs (c)(1)(i) and (c)(1)(ii) in the
‘‘Sponsor’’ column by removing ‘‘,
050639’’.
21 CFR Part 510
Drug Enforcement Administration
[Docket No. DEA–264]
3. The authority citation for 21 CFR
part 558 continues to read as follows:
I
I
List of Subjects
n/a (036541)
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
SUMMARY: The purpose of this
rulemaking is to conform the Drug
Enforcement Administration’s (DEA)
regulations to the provisions of the
Anabolic Steroid Control Act of 2004.
Effective January 20, 2005, the Act
amended the Controlled Substances Act
(CSA) and replaced the existing
definition of ‘‘anabolic steroid’’ with a
new definition. This new definition
altered the basis for all future
administrative scheduling actions
relating to the control of anabolic
steroids as Schedule III controlled
substances by eliminating the
requirement to prove muscle growth.
Additionally, the Act lists 59 specific
substances as being anabolic steroids.
As such, these substances and their
salts, esters and ethers are Schedule III
controlled substances. This rulemaking
amends 21 CFR Parts 1300 and 1308 to
reflect these changes.
The Act also amends the CSA by
revising the language requiring
exclusion of certain over the counter
products from regulation as controlled
substances. The Act clarifies that the
exclusionary language in 21 U.S.C.
811(g)(1) pertains only to non-narcotic
‘‘drugs’’ that may, under the Federal
Food, Drug, and Cosmetic Act (FDCA),
E:\FR\FM\16DER1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Rules and Regulations]
[Pages 74652-74653]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24104]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of New Animal Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of 15
new animal drug applications (NADAs) because the products are no longer
manufactured or marketed. In a notice published elsewhere in this issue
of the Federal Register, FDA is withdrawing approval of the NADAs.
DATES: This rule is effective December 27, 2005.
FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail:
pesposit@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the 15 NADAs listed in table 1 of this
document because the products are no longer manufactured or marketed:
Table 1.
----------------------------------------------------------------------------------------------------------------
21 CFR Section
Affected (Sponsor
Sponsor NADA Number, Product (Drug) Drug Labeler
Code)
----------------------------------------------------------------------------------------------------------------
Bioproducts, Inc., 320 Springside NADA 119-063, Pyrantel Tartrate Ton Pack (pyrantel 558.485 (051359)
Dr., Suite 300, Fairlawn, OH 44333- tartrate)
2435
----------------------------------------------------------------------------------------------------------------
Farmland Industries, Inc., Kansas NADA 138-656, BN Wormer--19.2 BANMINTH Premix 558.485 (021676)
City, MO 64116 (pyrantel tartrate)
----------------------------------------------------------------------------------------------------------------
I.M.S. Inc., 13619 Industrial Rd., NADA 129-395, HYGROMIX 0.6 Premix (hygromycin B) 558.274 (050639)
Omaha, NE 68137
NADA 129-646, TYLAN 10 Sulfa-G (tylosin, 558.630 (050639)
sulfamethazine)
NADA 136-601, Swine Guard BN (pyrantel tartrate) 558.485 (050639)
----------------------------------------------------------------------------------------------------------------
J. & R. Specialty Supply Co., 310 NADA 96-780, TYLAN 10; TYLAN 40 (tylosin) n/a (049768)
Second Ave., SW., P.O. Box 506,
Waseca, MN 56093
----------------------------------------------------------------------------------------------------------------
Kerber Milling Co., Box 152, 1817 E. NADA 98-687, Hy-Test Hy-Boost TY 5 Medicated (tylosin) 558.625 (029341)
Main St., Emmetsburg, IA 50536
----------------------------------------------------------------------------------------------------------------
M & M Livestock Products Co., Eagle NADA 96-837, M & M Tylosin Premix (tylosin) 558.625 (026282)
Grove, IA 50533
----------------------------------------------------------------------------------------------------------------
Nutra-Blend Corp., P.O. Box 485, NADA 129-161, Nutra-Blend TYLAN 10 Sulfa Premix 558.630 (050568)
Neosho, MO 64850 (tylosin, sulfamethazine)
NADA 136-384, Swine Wormer-BN BANMINTH (pyrantel 558.485 (050568)
tartrate)
----------------------------------------------------------------------------------------------------------------
[[Page 74653]]
South St. Paul Feeds, Inc., 500 NADA 136-369, Custom Ban Wormer 9.6 (pyrantel 558.485 (001800)
Farwell Ave., South St. Paul, MN tartrate)
55075
----------------------------------------------------------------------------------------------------------------
Stockton Hay & Grain Co. NADA 49-462, Rainbrook Broiler Premix No. 1 (ampolium, n/a (036541)
arsanilic acid, ethopabate, penicillin G procaine,
streptomycin)
NADA 91-646, Rainbow Broiler Base Concentrate n/a (036541)
(ampolium, bacitracin zinc, ethopabate)
NADA 91-647, Rainbow Broiler Base Concentrate n/a (036541)
(ampolium, chlortetracycline, ethopabate)
----------------------------------------------------------------------------------------------------------------
Triple ``F'', Inc., 10104 Douglas NADA 131-146, FLAVOMYCIN 0.4 (bambermycins) 558.95 (011490)
Ave., Des Moines, IA 50322
----------------------------------------------------------------------------------------------------------------
Following the withdrawal of approval of these NADAs, Kerber Milling
Co., M & M Livestock Products Co., Nutra-Blend Corp., and South St.
Paul Feeds, Inc., are no longer sponsors of an approved application.
Therefore, we are removing entries for these four sponsors from 21 CFR
510.600(c).
As provided below, the animal drug regulations are amended to
reflect the withdrawal of approvals.
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 Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 and
558 are 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.
Sec. 510.600 [Amended]
0
2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entries for ``Kerber Milling Co.'', ``M & M Livestock
Products Co.'', ``Nutra-Blend Corp.'', and ``South St. Paul Feeds,
Inc.''; and in the table in paragraph (c)(2) by removing the entries
for ``001800'', ``026282'', ``029341'', and ``050568''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.95 [Amended]
0
4. Section 558.95 is amended by removing and reserving paragraph
(a)(3).
Sec. 558.274 [Amended]
0
5. Section 558.274 is amended in paragraph (a)(4) by removing ``,
043733, and 050639'' and by adding in its place ``and 043733''; and in
the table in paragraphs (c)(1)(i) and (c)(1)(ii) in the ``Sponsor''
column by removing ``, 050639''.
Sec. 558.485 [Amended]
0
6. Section 558.485 is amended by removing and reserving paragraphs
(b)(2) and (b)(4); and in paragraph (b)(3) by removing ``, 049685,
050568, 050639, and 051359'' and by adding in its place ``and 049685''.
Sec. 558.625 [Amended]
0
7. Section 558.625 is amended by removing and reserving paragraphs
(b)(22), (b)(31), (b)(52), and (b)(79).
Sec. 558.630 [Amended]
0
8. Section 558.630 is amended in paragraph (b)(10) by removing ``,
050568, 050639''.
Dated: December 7, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-24104 Filed 12-15-05; 8:45 am]
BILLING CODE 4160-01-S
