New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N, 14667-14669 [2013-04999]

Download as PDF 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 VerDate Mar<15>2010 14:39 Mar 06, 2013 Jkt 229001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\07MRR1.SGM 07MRR1 Citation in 21 CFR 520.182 529.1003 14668 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. VerDate Mar<15>2010 558.58 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 3. The authority citation for 21 CFR part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. E:\FR\FM\07MRR1.SGM 07MRR1 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: VerDate Mar<15>2010 14:39 Mar 06, 2013 Jkt 229001 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. PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 § 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 E:\FR\FM\07MRR1.SGM 07MRR1

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