New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N, 14667-14669 [2013-04999]
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14667
Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Rules and Regulations
§ 184.1595
[Amended]
37. In § 184.1595, in paragraph (b),
remove ‘‘Office of Premarket Approval
(HFS–200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740’’ and in
its place add ‘‘Office of Food Additive
Safety (HFS–200), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1200’’.
■
§ 184.1866
[Amended]
38. In § 184.1866, in paragraph (b),
remove ‘‘Office of Premarket Approval,
Center for Food Safety and Applied
Nutrition (HFS–200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740’’ and in
its place add ‘‘Office of Food Additive
Safety (HFS–200), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1200’’.
■
§ 184.1914
[Amended]
39. In § 184.1914, in paragraph (b),
remove ‘‘Office of Premarket Approval
(HFS–200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740’’ and in
its place add ‘‘Office of Food Additive
Safety (HFS–200), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1200’’.
■
§ 184.1985
[Amended]
40. In § 184.1985, in paragraph (b),
remove ‘‘Division of Petition Control
(HFS–215), Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 1110 Vermont Ave.
NW., Suite 1200, Washington, DC’’ and
in its place add ‘‘Office of Food
Additive Safety (HFS–200), Center for
Food Safety and Applied Nutrition,
Food and Drug Administration, 5100
■
Paint Branch Pkwy., College Park, MD
20740, 240–402–1200’’.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 189—SUBSTANCES
PROHIBITED FROM USE IN HUMAN
FOOD
Food and Drug Administration
■
its place add ‘‘Office of Food Additive
Safety (HFS–200), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1200’’.
41. The authority citation for 21 CFR
part 189 continues to read as follows:
[Docket No. FDA–2012–N–1167]
Authority: 21 U.S.C. 321, 342, 348, 371,
381.
New Animal Drug Applications;
Alfaprostol; Bicyclohexylammonium
Fumagillin; N-Butyl Chloride;
Competitive Exclusion Culture;
Dichlorophene and Toluene;
Flurogestone Acetate; Isoflurane;
Pyrantel; Tylosin; Tylosin and
Sulfamethazine
§ 189.110
[Amended]
42. In § 189.110, in paragraph (c),
remove ‘‘Division of Food and Color
Additives, Center for Food Safety and
Applied Nutrition (HFS–200), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740’’ and in
its place add ‘‘Office of Food Additive
Safety (HFS–200), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1200’’.
■
§ 189.180
[Amended]
43. In § 189.180, in paragraph (c),
remove ‘‘Division of Food and Color
Additives, Center for Food Safety and
Applied Nutrition (HFS–200), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740’’ and in
its place add ‘‘Office of Food Additive
Safety (HFS–200), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1200’’.
■
Dated: February 1, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2013–04701 Filed 3–6–13; 8:45 am]
BILLING CODE 4160–01–P
21 CFR Parts 510, 520, 522, 529, and
558
AGENCY:
Food and Drug Administration,
HHS.
Final rule, technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal approval of 19 new animal
drug applications (NADAs) and one
abbreviated new animal drug
application (ANADA). The applications
are being withdrawn for lack of
compliance with the reporting
requirements in an FDA regulation.
DATES: This rule is effective March 18,
2013.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855; 240–453–6843;
david.alterman@fda.hhs.gov.
In a notice
published elsewhere in this issue of the
Federal Register, FDA gave notice that
approval of the 19 NADAs and one
ANADA listed in table 1, and all
supplements and amendments thereto,
is withdrawn, effective March 18, 2013,
for lack of compliance with reporting
requirements in 21 CFR 514.80. As
provided in the regulatory text of this
document, the animal drug regulations
are amended to reflect withdrawal of
approval of the following applications
and a current format. Withdrawal of
approval of some applications did not
require amending the regulations.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK67QTVN1PROD with RULES
TABLE 1—NADAS AND ANADA FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Trade name (drug)
Applicant
NADA 009–252 ..............
FUMIDIL B (bicyclohexylammonium fumagillin) ..
NADA 034–601 ..............
SYNCHRO–MATE (flurogestone acetate) ..........
Mid-Continent Agrimarketing, Inc., 8833 Quivira
Rd., Overland Park, KS 66214
G. D. Searle LLC, Pharmacia Corp., 4901
Searle Pkwy., Skokie, IL 60077
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Citation in 21
CFR
520.182
529.1003
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Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Rules and Regulations
TABLE 1—NADAS AND ANADA FOR WHICH APPROVAL IS WITHDRAWN—Continued
Citation in 21
CFR
Application No.
Trade name (drug)
Applicant
NADA 039–284 ..............
NADA 040–920 ..............
Swisher Super Broiler 300–108 (amprolium,
ethopabate, bacitracin zinc, and roxarsone).
Chick Grower Developer Fortified (amprolium) ...
NADA 094–223 ..............
Canine Worm Caps (n-butyl chloride) .................
NADA 098–429 ..............
Medic-Meal-T Premix (tylosin phosphate) ...........
NADA 098–639 ..............
TYLAN Sulfa-G (tylosin phosphate and
sulfamethazine).
TYLAN 10 (tylosin phosphate) ............................
Swisher Feed Division, William Davies Co., Inc.,
P.O. Box 578, Danville, IL 61832
Honeggers and Co., Inc., 201 W. Locust St.,
Fairbury, IL 61739
K. C. Pharmacal, Inc., 8345 Melrose Dr.,
Lenexa, KS 66214
J. C. Feed Mills, 1050 Sheffield, P.O. Box 224,
Waterloo, IA 50704
Bioproducts, Inc., 320 Springside Dr., suite 300,
Fairlawn, OH 44333–2435
Custom Feed Blenders Corp., 540 Hawkeye
Ave., Fort Dodge, IA 50501
Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402
Texas Vitamin Co., P.O. Box 18417, 10695
Aledo St., Dallas, TX 57218
Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363
NADA 106–507 ..............
NADA 110–044 ..............
NADA 117–688 ..............
NADA 120–614 ..............
PRO–TONE Plus Pak GF T–1 (tylosin phosphate).
Dichlorophene and Toluene Capsules ................
NADA 120–671 ..............
TYLAN Sulfa-G (tylosin phosphate and
sulfamethazine).
Pet-Worm-Caps (dichlorophene and toluene) .....
NADA 121–147 ..............
Nutra-Mix TYLAN (tylosin phosphate) .................
NADA 122–522 ..............
TYLAN Sulfa-G (tylosin phosphate and
sulfamethazine).
Nutra-Mix TYLAN-Sulfa Premixes (tylosin phosphate and sulfamethazine).
TYLAN 10 (tylosin phosphate) ............................
NADA 124–391 ..............
NADA 127–195 ..............
NADA 130–092 ..............
Custom Ban Wormer 9.6 Banminth (pyrantel tartrate).
ALFAVET (alfaprostol) .........................................
NADA 141–101 ..............
PREEMPT (competitive exclusion culture) .........
ANADA 200–187 ............
emcdonald on DSK67QTVN1PROD with RULES
NADA 129–415 ..............
Isoflurane, USP ...................................................
Following these withdrawals of
approval, Ag-Mark, Inc.; Bioproducts,
Inc.; Bioscience Division of Milk
Specialties Co.; Custom Feed Blenders
Corp.; G. D. Searle LLC; I.M.S. Inc.; J. C.
Feed Mills; K. C. Pharmacal, Inc.;
Marsam Pharmaceuticals, LLC; MidContinent Agrimarketing, Inc.; Peavey
Co.; Texas Vitamin Co.; Vetem, S.p.A.;
and Webel Feeds, 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. In addition, the entries for Wyeth
Laboratories, Division American Home
Products Corp. are being removed
because that firm is not the sponsor of
an approved NADA.
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.
K. C. Pharmacal, Inc., 8345 Melrose Dr.,
Lenexa, KS 66214
Ag-Mark, Inc., P.O. Box 127, Teachey, NC
28464
Custom Feed Blenders Corp., 540 Hawkeye
Ave., Fort Dodge, IA 50501
Ag-Mark, Inc., P.O. Box 127, Teachey, NC
28464
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE
68137
Custom Feed Blenders Corp., 540 Hawkeye
Ave., Fort Dodge, IA 50501
Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano,
Italy
Bioscience Division, of Milk Specialties Co.,
1902 Tennyson Lane, Madison, WI 53704
Marsam Pharmaceuticals, LLC, Bldg. 31, 24
Olney Ave., Cherry Hill, NJ 08034
List of Subjects
§ 510.600
21 CFR Part 510
14:39 Mar 06, 2013
Jkt 229001
Not codified
520.260
558.625
558.630
558.625
558.625
520.580
558.630
520.580
558.625
558.630
558.630
558.625
558.485
522.46
529.469
529.1186
■
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, and 529
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, 522, 529, and 558
are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Ag-Mark, Inc.’’, ‘‘Bioproducts, Inc.’’,
‘‘Bioscience Division of Milk Specialties
Co.’’, ‘‘Custom Feed Blenders Corp.’’,
‘‘G. D. Searle LLC’’, ‘‘I.M.S. Inc.’’, ‘‘J. C.
Feed Mills’’, ‘‘K. C. Pharmacal, Inc.’’,
‘‘Marsam Pharmaceuticals, LLC’’, ‘‘MidContinent Agrimarketing, Inc.’’, ‘‘Peavey
Co.’’, ‘‘Texas Vitamin Co.’’, ‘‘Vetem,
S.p.A.’’, ‘‘Webel Feeds, Inc.’’, and
‘‘Wyeth Laboratories, Division
American Home Products Corp.’’; and in
the table in paragraph (c)(2), remove the
entries for ‘‘000008’’, ‘‘000014’’,
‘‘000209’’, ‘‘000842’’, ‘‘024174’’,
‘‘028459’’, ‘‘032761’’, ‘‘035098’’,
‘‘038782’’, ‘‘039741’’, ‘‘046987’’,
‘‘050639’’, ‘‘051359’’, ‘‘055882’’, and
‘‘059620’’.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
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558.58
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3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
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Federal Register / Vol. 78, No. 45 / Thursday, March 7, 2013 / Rules and Regulations
§ 520.182
[Removed]
§ 520.580
4. Remove § 520.182.
■ 5. In § 520.260, revise the section
heading and add paragraphs (b)(1)
through (3) to read as follows:
■
§ 520.260
n-Butyl chloride.
emcdonald on DSK67QTVN1PROD with RULES
*
*
*
*
*
(b) * * *
(1) Specifications. Each capsule
contains 221, 272, 442, 816, 884, 1,768
milligrams, or 4.42 grams of n-butyl
chloride.
(2) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section:
(i) No. 000069 for use of 221milligram capsules.
(ii) No. 021091 for use of 272- or 816milligram capsules.
(iii) No. 023851 for use of 221-, 442, 884-, or 1,768-milligram, or 4.42-gram
capsules.
(3) Conditions of use in dogs—(i)
Amount. Administered capsules orally.
Capsules containing 221 milligrams of
n-butyl chloride are administered to
dogs weighing under 5 pounds at a
dosage of 1 capsule per 11⁄4 pounds of
body weight. Capsules containing 442
milligrams of n-butyl chloride are
administered to dogs weighing under 5
pounds at a dosage of 1 capsule per 21⁄2
pounds body weight. Capsules
containing 884 milligrams of n-butyl
chloride are administered to dogs as
follows: Weighing under 5 pounds, 1
capsule; weighing 5 to 10 pounds, 2
capsules; weighing 10 to 20 pounds, 3
capsules; weighing 20 to 40 pounds, 4
capsules; over 40 pounds, 5 capsules.
Capsules containing 1,768 milligrams of
n-butyl chloride are administered at a
dosage level of 1 capsule per dog
weighing 5 to 10 pounds. Capsules
containing 4.42 grams of n-butyl
chloride are administered at a dosage
level of 1 capsule per dog weighing 40
pounds or over.
(ii) Indications for use. For the
removal of ascarids (Toxocara canis and
Toxascaris leonina) and hookworms
(Ancylostoma caninum, Ancylostoma
braziliense, and Uncinaria
stenocephala).
(iii) Limitations. Dogs should not be
fed for 18 to 24 hours before being given
the drug. Administration of the drug
should be followed in 1⁄2 to 1 hour with
a mild cathartic. Normal feeding may be
resumed 4 to 8 hours after treatment.
Animals subject to reinfection may be
retreated in 2 weeks. A veterinarian
should be consulted before using in
severely debilitated dogs.
■ 6. In § 520.580, revise the section
heading and paragraphs (a), (b), and
(d)(1) and (2) to read as follows:
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14:39 Mar 06, 2013
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Dichlorophene and toluene.
(a) Specifications. Each capsule
contains 50 milligrams (mg) of
dichlorophene and 60 mg of toluene, or
multiples thereof.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section:
(1) Nos. 017135, 023851, 051311, and
058670 for use only as a single dose.
(2) Nos. 000010 and 000061 for use in
a single dose or divided-dosage regimen.
*
*
*
*
*
(d) * * *
(1) Amount. Administer as follows:
(i) Single dose: Administer 100 mg of
dicholorophene and 120 mg of toluene
per pound of body weight.
(ii) Divided dose: Administer 100 mg
of dichlorophene and 120 mg of toluene
per 5 pounds of body weight (20 and 24
mg per pound) daily for 6 days.
(2) Indications for use. For the
removal of ascarids (Toxocara canis and
Toxascaris leonina) and hookworms
(Ancylostoma caninum and Uncinaria
stenocephala); and as an aid in
removing tapeworms (Taenia pisiformis,
Dipylidium caninum, and Echinococcus
granulosus) from dogs and cats.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
7. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.46
■
[Removed]
8. Remove § 522.46.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
9. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 529.469
■
10. Remove § 529.469.
§ 529.1003
■
[Removed]
[Removed]
11. Remove § 529.1003.
§ 529.1186
[Amended]
12. In paragraph (b) of § 529.1186,
remove ‘‘000209,’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
13. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
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§ 558.485
14669
[Amended]
14. In § 558.485, in paragraph (b)(6),
remove ‘‘Nos. 034936 and 046987’’ and
add in its place ‘‘No. 034936’’.
■
§ 558.625
[Amended]
15. In § 558.625, remove and reserve
paragraphs (b)(35), (b)(63), (b)(66), and
(b)(77).
■ 16. In § 558.630, add paragraph (b)(5)
to read as follows:
■
§ 558.630
Tylosin and sulfamethazine.
*
*
*
*
*
(b) * * *
(5) Nos. 000986, 012286, 034936, and
046573: 5, 10, 20, or 40 grams per
pound each for use as in paragraph
(e)(2)(ii) of this section.
*
*
*
*
*
Dated: February 27, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–04999 Filed 3–6–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF JUSTICE
28 CFR Part 16
[CPCLO Order No. 002–2013]
Privacy Act of 1974; Implementation
Drug Enforcement
Administration, United States
Department of Justice.
ACTION: Final rule.
AGENCY:
SUMMARY: The Department of Justice
(DOJ or Department), Drug Enforcement
Administration (DEA) is issuing a final
rule for the recently modified system of
records titled ‘‘Investigative Reporting
and Filing System’’ (IRFS), JUSTICE/
DEA–008. This system, which has
already been exempted from particular
subsections of the Privacy Act of 1974,
is now being exempted further.
Information in this system relates to law
enforcement and intelligence matters,
and for the reasons set forth in the rule
these exemptions are necessary to avoid
interference with the law enforcement,
counterterrorism, and national security
functions and responsibilities of the
DEA.
DATES: Effective March 7, 2013.
FOR FURTHER INFORMATION CONTACT: DEA
Headquarters, Attn: Bettie E. Goldman,
Assistant Deputy Chief Counsel (CV),
8701 Morrissette Drive, Springfield, VA
22152, telephone 202–307–8040.
SUPPLEMENTARY INFORMATION:
Background
On April 11, 2012, the Department
published an updated Privacy Act
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]]>Agencies
[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14667-14669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04999]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 529, and 558
[Docket No. FDA-2012-N-1167]
New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium
Fumagillin; N-Butyl Chloride; Competitive Exclusion Culture;
Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel;
Tylosin; Tylosin and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal approval of 19 new animal
drug applications (NADAs) and one abbreviated new animal drug
application (ANADA). The applications are being withdrawn for lack of
compliance with the reporting requirements in an FDA regulation.
DATES: This rule is effective March 18, 2013.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855; 240-453-6843; david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this
issue of the Federal Register, FDA gave notice that approval of the 19
NADAs and one ANADA listed in table 1, and all supplements and
amendments thereto, is withdrawn, effective March 18, 2013, for lack of
compliance with reporting requirements in 21 CFR 514.80. As provided in
the regulatory text of this document, the animal drug regulations are
amended to reflect withdrawal of approval of the following applications
and a current format. Withdrawal of approval of some applications did
not require amending the regulations.
Table 1--NADAs and ANADA for Which Approval Is Withdrawn
----------------------------------------------------------------------------------------------------------------
Application No. Trade name (drug) Applicant Citation in 21 CFR
----------------------------------------------------------------------------------------------------------------
NADA 009-252.................. FUMIDIL B Mid-Continent Agrimarketing, Inc., 520.182
(bicyclohexylammonium 8833 Quivira Rd., Overland Park,
fumagillin). KS 66214
NADA 034-601.................. SYNCHRO-MATE G. D. Searle LLC, Pharmacia Corp., 529.1003
(flurogestone 4901 Searle Pkwy., Skokie, IL
acetate). 60077
[[Page 14668]]
NADA 039-284.................. Swisher Super Broiler Swisher Feed Division, William 558.58
300-108 (amprolium, Davies Co., Inc., P.O. Box 578,
ethopabate, Danville, IL 61832
bacitracin zinc, and
roxarsone).
NADA 040-920.................. Chick Grower Developer Honeggers and Co., Inc., 201 W. Not codified
Fortified (amprolium). Locust St., Fairbury, IL 61739
NADA 094-223.................. Canine Worm Caps (n- K. C. Pharmacal, Inc., 8345 Melrose 520.260
butyl chloride). Dr., Lenexa, KS 66214
NADA 098-429.................. Medic-Meal-T Premix J. C. Feed Mills, 1050 Sheffield, 558.625
(tylosin phosphate). P.O. Box 224, Waterloo, IA 50704
NADA 098-639.................. TYLAN Sulfa-G (tylosin Bioproducts, Inc., 320 Springside 558.630
phosphate and Dr., suite 300, Fairlawn, OH 44333-
sulfamethazine). 2435
NADA 106-507.................. TYLAN 10 (tylosin Custom Feed Blenders Corp., 540 558.625
phosphate). Hawkeye Ave., Fort Dodge, IA 50501
NADA 110-044.................. PRO-TONE Plus Pak GF T- Peavey Co., 730 Second Ave. South, 558.625
1 (tylosin phosphate). Minneapolis, MN 55402
NADA 117-688.................. Dichlorophene and Texas Vitamin Co., P.O. Box 18417, 520.580
Toluene Capsules. 10695 Aledo St., Dallas, TX 57218
NADA 120-614.................. TYLAN Sulfa-G (tylosin Webel Feeds, Inc., R.R. 3, 558.630
phosphate and Pittsfield, IL 62363
sulfamethazine).
NADA 120-671.................. Pet-Worm-Caps K. C. Pharmacal, Inc., 8345 Melrose 520.580
(dichlorophene and Dr., Lenexa, KS 66214
toluene).
NADA 121-147.................. Nutra-Mix TYLAN Ag-Mark, Inc., P.O. Box 127, 558.625
(tylosin phosphate). Teachey, NC 28464
NADA 122-522.................. TYLAN Sulfa-G (tylosin Custom Feed Blenders Corp., 540 558.630
phosphate and Hawkeye Ave., Fort Dodge, IA 50501
sulfamethazine).
NADA 124-391.................. Nutra-Mix TYLAN-Sulfa Ag-Mark, Inc., P.O. Box 127, 558.630
Premixes (tylosin Teachey, NC 28464
phosphate and
sulfamethazine).
NADA 127-195.................. TYLAN 10 (tylosin I.M.S. Inc., 13619 Industrial Rd., 558.625
phosphate). Omaha, NE 68137
NADA 129-415.................. Custom Ban Wormer 9.6 Custom Feed Blenders Corp., 540 558.485
Banminth (pyrantel Hawkeye Ave., Fort Dodge, IA 50501
tartrate).
NADA 130-092.................. ALFAVET (alfaprostol). Vetem, S.p.A., Viale E. Bezzi 24, 522.46
20146 Milano, Italy
NADA 141-101.................. PREEMPT (competitive Bioscience Division, of Milk 529.469
exclusion culture). Specialties Co., 1902 Tennyson
Lane, Madison, WI 53704
ANADA 200-187................. Isoflurane, USP....... Marsam Pharmaceuticals, LLC, Bldg. 529.1186
31, 24 Olney Ave., Cherry Hill, NJ
08034
----------------------------------------------------------------------------------------------------------------
Following these withdrawals of approval, Ag-Mark, Inc.;
Bioproducts, Inc.; Bioscience Division of Milk Specialties Co.; Custom
Feed Blenders Corp.; G. D. Searle LLC; I.M.S. Inc.; J. C. Feed Mills;
K. C. Pharmacal, Inc.; Marsam Pharmaceuticals, LLC; Mid-Continent
Agrimarketing, Inc.; Peavey Co.; Texas Vitamin Co.; Vetem, S.p.A.; and
Webel Feeds, 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. In addition, the entries for Wyeth
Laboratories, Division American Home Products Corp. are being removed
because that firm is not the sponsor of an approved NADA.
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 Parts 520, 522, and 529
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, 522, 529, 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 ``Ag-Mark, Inc.'', ``Bioproducts, Inc.'', ``Bioscience
Division of Milk Specialties Co.'', ``Custom Feed Blenders Corp.'',
``G. D. Searle LLC'', ``I.M.S. Inc.'', ``J. C. Feed Mills'', ``K. C.
Pharmacal, Inc.'', ``Marsam Pharmaceuticals, LLC'', ``Mid-Continent
Agrimarketing, Inc.'', ``Peavey Co.'', ``Texas Vitamin Co.'', ``Vetem,
S.p.A.'', ``Webel Feeds, Inc.'', and ``Wyeth Laboratories, Division
American Home Products Corp.''; and in the table in paragraph (c)(2),
remove the entries for ``000008'', ``000014'', ``000209'', ``000842'',
``024174'', ``028459'', ``032761'', ``035098'', ``038782'', ``039741'',
``046987'', ``050639'', ``051359'', ``055882'', and ``059620''.
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.
[[Page 14669]]
Sec. 520.182 [Removed]
0
4. Remove Sec. 520.182.
0
5. In Sec. 520.260, revise the section heading and add paragraphs
(b)(1) through (3) to read as follows:
Sec. 520.260 n-Butyl chloride.
* * * * *
(b) * * *
(1) Specifications. Each capsule contains 221, 272, 442, 816, 884,
1,768 milligrams, or 4.42 grams of n-butyl chloride.
(2) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section:
(i) No. 000069 for use of 221-milligram capsules.
(ii) No. 021091 for use of 272- or 816-milligram capsules.
(iii) No. 023851 for use of 221-, 442-, 884-, or 1,768-milligram,
or 4.42-gram capsules.
(3) Conditions of use in dogs--(i) Amount. Administered capsules
orally. Capsules containing 221 milligrams of n-butyl chloride are
administered to dogs weighing under 5 pounds at a dosage of 1 capsule
per 1\1/4\ pounds of body weight. Capsules containing 442 milligrams of
n-butyl chloride are administered to dogs weighing under 5 pounds at a
dosage of 1 capsule per 2\1/2\ pounds body weight. Capsules containing
884 milligrams of n-butyl chloride are administered to dogs as follows:
Weighing under 5 pounds, 1 capsule; weighing 5 to 10 pounds, 2
capsules; weighing 10 to 20 pounds, 3 capsules; weighing 20 to 40
pounds, 4 capsules; over 40 pounds, 5 capsules. Capsules containing
1,768 milligrams of n-butyl chloride are administered at a dosage level
of 1 capsule per dog weighing 5 to 10 pounds. Capsules containing 4.42
grams of n-butyl chloride are administered at a dosage level of 1
capsule per dog weighing 40 pounds or over.
(ii) Indications for use. For the removal of ascarids (Toxocara
canis and Toxascaris leonina) and hookworms (Ancylostoma caninum,
Ancylostoma braziliense, and Uncinaria stenocephala).
(iii) Limitations. Dogs should not be fed for 18 to 24 hours before
being given the drug. Administration of the drug should be followed in
\1/2\ to 1 hour with a mild cathartic. Normal feeding may be resumed 4
to 8 hours after treatment. Animals subject to reinfection may be
retreated in 2 weeks. A veterinarian should be consulted before using
in severely debilitated dogs.
0
6. In Sec. 520.580, revise the section heading and paragraphs (a),
(b), and (d)(1) and (2) to read as follows:
Sec. 520.580 Dichlorophene and toluene.
(a) Specifications. Each capsule contains 50 milligrams (mg) of
dichlorophene and 60 mg of toluene, or multiples thereof.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section:
(1) Nos. 017135, 023851, 051311, and 058670 for use only as a
single dose.
(2) Nos. 000010 and 000061 for use in a single dose or divided-
dosage regimen.
* * * * *
(d) * * *
(1) Amount. Administer as follows:
(i) Single dose: Administer 100 mg of dicholorophene and 120 mg of
toluene per pound of body weight.
(ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of
toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for
6 days.
(2) Indications for use. For the removal of ascarids (Toxocara
canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and
Uncinaria stenocephala); and as an aid in removing tapeworms (Taenia
pisiformis, Dipylidium caninum, and Echinococcus granulosus) from dogs
and cats.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.46 [Removed]
0
8. Remove Sec. 522.46.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.469 [Removed]
0
10. Remove Sec. 529.469.
Sec. 529.1003 [Removed]
0
11. Remove Sec. 529.1003.
Sec. 529.1186 [Amended]
0
12. In paragraph (b) of Sec. 529.1186, remove ``000209,''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
13. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.485 [Amended]
0
14. In Sec. 558.485, in paragraph (b)(6), remove ``Nos. 034936 and
046987'' and add in its place ``No. 034936''.
Sec. 558.625 [Amended]
0
15. In Sec. 558.625, remove and reserve paragraphs (b)(35), (b)(63),
(b)(66), and (b)(77).
0
16. In Sec. 558.630, add paragraph (b)(5) to read as follows:
Sec. 558.630 Tylosin and sulfamethazine.
* * * * *
(b) * * *
(5) Nos. 000986, 012286, 034936, and 046573: 5, 10, 20, or 40 grams
per pound each for use as in paragraph (e)(2)(ii) of this section.
* * * * *
Dated: February 27, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-04999 Filed 3-6-13; 8:45 am]
BILLING CODE 4160-01-P
