Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin, 11330-11331 [2011-4546]
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations
instituted and their existence has been
made public, unless one of the
exceptions in section 301(ll)(1) to (ll)(4)
applies. In our review of this petition,
FDA did not consider whether section
301(ll) of the FD&C Act or any of its
exemptions apply to food containing
this additive. Accordingly, this final
rule should not be construed to be a
statement that a food containing this
additive, if introduced or delivered for
introduction into interstate commerce,
would not violate section 301(ll) of the
FD&C Act. Furthermore, this language is
included in all food additive final rules
and therefore should not be construed to
be a statement of the likelihood that
section 301(ll) of the FD&C Act applies.
List of Subjects in 21 CFR Part 173
Food additives, Incorporation by
reference.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Director, Center for Food Safety and
Applied Nutrition, 21 CFR part 173 is
amended as follows:
PART 173—SECONDARY DIRECT
FOOD ADDITIVES PERMITTED IN
FOOD FOR HUMAN CONSUMPTION
1. The authority citation for 21 CFR
part 173 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
2. Section 173.356 is added to subpart
D to read as follows:
■
§ 173.356
Hydrogen peroxide.
Hydrogen peroxide (CAS Reg. No.
7722–84–1) may be safely used to treat
food in accordance with the following
conditions:
(a) The additive meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 496 and 497,
which is incorporated by reference. The
Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Center for Food Safety
and Applied Nutrition’s Library, Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–2163, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030, or go to: https://
www.archives.gov/federal_register/
code_of_federal regulations/
ibr_locations.html.
(b) The additive is used as an
antimicrobial agent in the production of
modified whey (including, but not
limited to, whey protein concentrates
and whey protein isolates) by
ultrafiltration methods, at a level not to
exceed 0.001 percent by weight of the
whey, providing that residual hydrogen
peroxide is removed by appropriate
chemical or physical means during the
processing of the modified whey.
Dated: February 16, 2011.
Susan M. Bernard,
Acting Director, Office of Regulations, Policy
and Social Services, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2011–4497 Filed 3–1–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
[Docket No. FDA–2011–N–0003]
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of a
New Animal Drug Applications;
Phenylbutazone; Pyrantel; Tylosin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of
eight new animal drug applications
(NADAs). In a notice published
elsewhere in this issue of the Federal
Register, FDA is withdrawing approval
of these NADAs.
SUMMARY:
DATES:
This rule is effective March 14,
2011.
John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079,
e-mail: john.bartkowiak@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
sponsors have requested that FDA
withdraw approval of the three NADAs
listed in table 1 of this document
because the products are no longer
manufactured or marketed:
SUPPLEMENTARY INFORMATION:
TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF THREE NADAS
Sponsor
NADA No. product
(established name of drug)
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123
NADA
48–647;
Phenylbutazone
Boluses
(phenylbutazone).
NADA 96–161; Hy-Con TYLAN Premix (tylosin phosphate).
NADA 119–062; Cadco-BN-10 BANMINTH Premix
(pyrantel tartrate).
Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247 ...
WReier-Aviles on DSKGBLS3C1PROD with RULES
Triple ‘‘F’’, Inc., 10104 Douglas Ave., Des Moines, IA
50322.
Truow Nutrition, Inc., 1590 Todd
Farm Dr., Elgin, IL 60123 (Truow) has
informed FDA that it is the owner of
five feed premix NADAs previously
owned by milling companies which it
has purchased. NADA 100–352 was
owned by NutriBasics Co., last doing
VerDate Mar<15>2010
15:24 Mar 01, 2011
Jkt 223001
business at P.O. Box 1014, Wilmar, MN
56201. NADA 107–002 and NADA 123–
000 were owned by Seeco, Inc., also last
doing business at P.O. Box 1014,
Wilmar, MN 56201. NADA 133–833 and
NADA 135–243 were owned by
Southern Micro-Blenders, Inc., last
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
21 CFR section affected
(sponsor drug labeler code)
§ 520.1720a (058829).
§ 558.625 (035369).
§ 558.485 (011490).
doing business at 3801 N. Hawthorne
St., Chattanooga, TN 37406. Truow has
requested that FDA withdraw approval
of the five NADAs in table 2 of this
document because they are no longer
manufactured or marketed:
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02MRR1
Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations
11331
TABLE 2—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF FIVE NADAS BY TRUOW NUTRITION, INC.
Previous sponsor
NADA No. product
(established name of drug)
NutriBasics Co., P.O. Box 1014, Wilmar, MN 56201 ......
NADA 100–352; Seeco T–10 Premix (tylosin phosphate).
NADA 107–002; Seeco TYLAN-Sulfa 10 Premix (tylosin
phosphate and sulfamethazine).
NADA
123–000;
Super
Swine
Wormer
B–9
BANMINTH(pyrantel tartrate).
NADA 133–833; TYLAN 10 Premix (tylosin phosphate)
Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 .............
Seeco, Inc., P.O. Box 1014, Wilmar, MN 56201 .............
Southern Micro-Blenders, Inc., 3801 N. Hawthorne St.,
Chattanooga, TN 37406.
Southern Micro-Blenders, Inc., 3801 N. Hawthorne St.,
Chattanooga, TN 37406.
In a notice published elsewhere in
this issue of the Federal Register, FDA
gave notice that approval of NADA 48–
647, 96–161, 100–352, 107–002, 119–
062, 123–000, 133–833, and 135–243,
and all supplements and amendments
thereto, is withdrawn, effective March
14, 2011. As provided in the regulatory
text of this document, the animal drug
regulations are amended to reflect these
withdrawals of approval.
Following these changes of
sponsorship, Yoder Feed, Division of
Yoder, Inc., Triple ‘‘F’’, Inc., NutriBasics
Co., Seeco, Inc., and Southern MicroBlenders, Inc., are no longer the sponsor
of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove the entries for these
firms.
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.
WReier-Aviles on DSKGBLS3C1PROD with RULES
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Triple ‘‘F’’, Inc.’’ and ‘‘Yoder Feed,
Division of Yoder, Inc.’’; and in the table
in paragraph (c)(2), remove the entries
for ‘‘011490’’, ‘‘011749’’, ‘‘035369’’,
‘‘049685’’, and ‘‘053740’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
4. In § 520.1720a, revise paragraph
(b)(6) to read as follows:
■
§ 520.1720a
boluses.
Phenylbutazone tablets and
*
*
*
*
(b) * * *
(6) No. 058829 for use of 100-mg or
1-g tablets in dogs and horses.
*
*
*
*
*
5. The authority citation for 21 CFR
part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
6. In § 558.485, revise the section
heading and paragraph (b)(3) to read 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.
Jkt 223001
Pyrantel.
*
*
*
*
*
(b) * * *
(3) Nos. 010439, 012286, 016968, and
017790: 9.6 and 19.2 grams per pound
for use as in paragraphs (e)(1)(i) through
(e)(1)(iii) of this section.
*
*
*
*
*
§ 558.625
[Amended]
7. In § 558.625, remove and reserve
paragraphs (b)(8), (b)(38), and (b)(80).
■
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
Not codified.
§ 558.485 (011749).
§ 558.625 (049685).
§ 558.485 (049685).
Dated: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011–4546 Filed 3–1–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 516
[Docket No. FDA–2010–N–0534]
New Animal Drugs for Minor Use and
Minor Species; Confirmation of
Effective Date
AGENCY:
*
§ 558.485
§ 558.625 (053740).
RIN 0910–AG58
Authority: 21 U.S.C. 360b.
■
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 510, 520, and 558 are
amended as follows:
15:24 Mar 01, 2011
NADA 135–243; Swine Guard-BN BANMINTH Premix
(pyrantel tartrate).
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
21 CFR Part 520
Animal drugs.
VerDate Mar<15>2010
§ 510.600
21 CFR section affected
(sponsor drug labeler code)
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of March 30, 2011, for the
final rule that appeared in the Federal
Register of November 15, 2010 (75 FR
69586). The direct final rule amends the
regulations regarding new animal drugs
for minor use and minor species
(MUMS) to update language and clarify
the intent of the regulations consistent
with the preambles to the proposed and
final rules. This document confirms the
effective date of the direct final rule.
DATES: Effective date confirmed: March
30, 2011.
FOR FURTHER INFORMATION CONTACT: Meg
Oeller, Center for Veterinary Medicine
(HFV–50), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9005,
e-mail: margaret.oeller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 15, 2010
(75 FR 69586), FDA solicited comments
concerning the direct final rule for a
75-day period ending January 31, 2011.
FDA stated that the effective date of the
SUMMARY:
E:\FR\FM\02MRR1.SGM
02MRR1
]]>Agencies
[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11330-11331]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4546]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
[Docket No. FDA-2011-N-0003]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin
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
eight new animal drug applications (NADAs). In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of these NADAs.
DATES: This rule is effective March 14, 2011.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The sponsors have requested that FDA
withdraw approval of the three NADAs listed in table 1 of this document
because the products are no longer manufactured or marketed:
Table 1--Voluntary Requests for Withdrawal of Approval of Three NADAs
----------------------------------------------------------------------------------------------------------------
NADA No. product 21 CFR section affected (sponsor drug
Sponsor (established name of drug) labeler code)
----------------------------------------------------------------------------------------------------------------
First Priority, Inc., 1590 Todd Farm NADA 48-647; Sec. 520.1720a (058829).
Dr., Elgin, IL 60123. Phenylbutazone Boluses
(phenylbutazone).
Yoder Feed, Division of Yoder, Inc., NADA 96-161; Hy-Con TYLAN Sec. 558.625 (035369).
Kalona, IA 52247. Premix (tylosin
phosphate).
Triple ``F'', Inc., 10104 Douglas Ave., NADA 119-062; Cadco-BN-10 Sec. 558.485 (011490).
Des Moines, IA 50322. BANMINTH Premix (pyrantel
tartrate).
----------------------------------------------------------------------------------------------------------------
Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 (Truow)
has informed FDA that it is the owner of five feed premix NADAs
previously owned by milling companies which it has purchased. NADA 100-
352 was owned by NutriBasics Co., last doing business at P.O. Box 1014,
Wilmar, MN 56201. NADA 107-002 and NADA 123-000 were owned by Seeco,
Inc., also last doing business at P.O. Box 1014, Wilmar, MN 56201. NADA
133-833 and NADA 135-243 were owned by Southern Micro-Blenders, Inc.,
last doing business at 3801 N. Hawthorne St., Chattanooga, TN 37406.
Truow has requested that FDA withdraw approval of the five NADAs in
table 2 of this document because they are no longer manufactured or
marketed:
[[Page 11331]]
Table 2--Voluntary Requests for Withdrawal of Approval of Five NADAs by Truow Nutrition, Inc.
----------------------------------------------------------------------------------------------------------------
NADA No. product 21 CFR section affected (sponsor drug
Previous sponsor (established name of drug) labeler code)
----------------------------------------------------------------------------------------------------------------
NutriBasics Co., P.O. Box 1014, Wilmar, NADA 100-352; Seeco T-10 Sec. 558.625 (053740).
MN 56201. Premix (tylosin
phosphate).
Seeco, Inc., P.O. Box 1014, Wilmar, MN NADA 107-002; Seeco TYLAN- Not codified.
56201. Sulfa 10 Premix (tylosin
phosphate and
sulfamethazine).
Seeco, Inc., P.O. Box 1014, Wilmar, MN NADA 123-000; Super Swine Sec. 558.485 (011749).
56201. Wormer B-9
BANMINTH(pyrantel
tartrate).
Southern Micro-Blenders, Inc., 3801 N. NADA 133-833; TYLAN 10 Sec. 558.625 (049685).
Hawthorne St., Chattanooga, TN 37406. Premix (tylosin
phosphate).
Southern Micro-Blenders, Inc., 3801 N. NADA 135-243; Swine Guard- Sec. 558.485 (049685).
Hawthorne St., Chattanooga, TN 37406. BN BANMINTH Premix
(pyrantel tartrate).
----------------------------------------------------------------------------------------------------------------
In a notice published elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADA 48-647, 96-161, 100-
352, 107-002, 119-062, 123-000, 133-833, and 135-243, and all
supplements and amendments thereto, is withdrawn, effective March 14,
2011. As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these withdrawals of approval.
Following these changes of sponsorship, Yoder Feed, Division of
Yoder, Inc., Triple ``F'', Inc., NutriBasics Co., Seeco, Inc., and
Southern Micro-Blenders, Inc., are no longer the sponsor of an approved
application. Accordingly, 21 CFR 510.600(c) is being amended to remove
the entries for these firms.
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 520
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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 parts 510,
520, 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. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Triple ``F'', Inc.'' and ``Yoder Feed, Division of Yoder,
Inc.''; and in the table in paragraph (c)(2), remove the entries for
``011490'', ``011749'', ``035369'', ``049685'', and ``053740''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.1720a, revise paragraph (b)(6) to read as follows:
Sec. 520.1720a Phenylbutazone tablets and boluses.
* * * * *
(b) * * *
(6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
6. In Sec. 558.485, revise the section heading and paragraph (b)(3) to
read as follows:
Sec. 558.485 Pyrantel.
* * * * *
(b) * * *
(3) Nos. 010439, 012286, 016968, and 017790: 9.6 and 19.2 grams per
pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this
section.
* * * * *
Sec. 558.625 [Amended]
0
7. In Sec. 558.625, remove and reserve paragraphs (b)(8), (b)(38), and
(b)(80).
Dated: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-4546 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P
