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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.

DATES:

This rule is effective March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2017, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofFoods/​CVM/​CVMFOIAElectronicReadingRoom/​default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/​AnimalVeterinary/​Products/​ApprovedAnimalDrugProducts/​default.htm.

Table 1—Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2017

Approval dateFile No.SponsorProduct nameSpeciesEffect of the actionPublic documents
July 21, 2017141-450Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940BANAMINE Transdermal (flunixin transdermal solution) SolutionCattleOriginal approval for the control of pyrexia associated with bovine respiratory disease and the control of pain associated with foot rot in steers, beef heifers, beef cows, beef bulls intended for slaughter, and replacement dairy heifers under 20 months of ageFOI Summary; EA/FONSI.1
Start Printed Page 13633
July 19, 2017141-336ECO LLC, 344 Nassau St., Princeton, NJ 08540AIVLOSIN (tylvalosin tartrate) Water Soluble GranulesSwineSupplemental approval for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and Streptococcus suis in groups of swine in buildings experiencing an outbreak of SRDFOI Summary.
July 14, 2017200-620Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009ALTREN (altrenogest) SolutionHorsesOriginal approval as a generic copy of NADA 131-310FOI Summary.
July 14, 2017200-621Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009SWINEMATE (altrenogest) SolutionSwineOriginal approval as a generic copy of NADA 141-222FOI Summary.
September 15, 2017141-250Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007Chlortetracycline and lasalocid Type B and Type C medicated feedsCattleSupplemental approval of revised representative labeling making technical amendments
September 28, 2017141-333Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137SENTINEL SPECTRUM (milbemycin oxime/lufenuron/praziquantel)DogsSupplemental approval for the treatment and control of the adult tapeworm Dipylidium caninumFOI Summary.
1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI).

II. Change of Sponsorship

SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe, KS 66061-1304 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:

File No.Product name21 CFR Section
200-348ECOMECTIN (ivermectin) Topical Solution524.1193

Following this withdrawal of approval, SmartVet USA, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)).

Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

File No.Product name21 CFR Section
109-305Oxytocin Injection522.1680

The animal drug regulations are being amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

The following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:

File No.SponsorProduct name21 CFR Section
047-055Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880Chorionic Gonadotropin Powder for Injection522.1081
104-606Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880Dexamethasone Sodium Phosphate Injection522.540
Start Printed Page 13634
139-633Wildlife Laboratories, Inc., 1230 W. Ash St., Suite D, Windsor, CO 80550WILDNIL (carfentanil citrate) Injection522.300

Following this withdrawal of approval, Watson Laboratories, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c).

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is withdrawn, effective April 9, 2018. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

IV. Technical Amendments

Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has informed FDA that it has changed its name and address to Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has changed its name to ADM Animal Nutrition, Inc. Accordingly, we are amending § 510.600(c) to reflect these changes.

We are also making technical amendments to update the scientific name of a pathogenic bacterium, to accurately list the concentrations of ingredients in a combination new animal drug, and to correctly list the assay limits and maximum drug concentration in Type B medicated feeds for a combination new animal drug used in feed. These actions are being taken to improve the accuracy of the regulations.

V. Legal Authority

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document 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. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Start List of Subjects

List of Subjects

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Parts 520, 522, and 524

  • Animal drugs

21 CFR Part 556

  • Animal drugs
  • Food

21 CFR Part 558

  • Animal drugs
  • Animal feeds
End List of Subjects

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 556, and 558 are amended as follows:

Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for part 510 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority Start Amendment Part

2. In § 510.600, in the table in paragraph (c)(1), remove the entries for “ADM Alliance Nutrition, Inc.”, “SmartVet USA, Inc.” and “Western Chemical, Inc.”, and add entries for “ADM Animal Nutrition, Inc.” and “Syndel USA” in alphabetical order; and in the table in paragraph (c)(2), remove the entry for “086001” and revise the entries for “012286” and “050378” to read as follows:

End Amendment Part
Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*         *         *         *         *         *         *
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115012286
*         *         *         *         *         *         *
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248050378
*         *         *         *         *         *         *

(2) * * *

Drug labeler codeFirm name and address
*         *         *         *         *         *         *
012286ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.
Start Printed Page 13635
*         *         *         *         *         *         *
050378Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
*         *         *         *         *         *         *
Start Amendment Part

3. Effective April 9, 2018,” in § 510.600, in the table in paragraph (c)(1), remove the entry for “Watson Laboratories, Inc.”; and in the table in paragraph (c)(2), remove the entry for “000402”.

End Amendment Part Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

4. The authority citation for part 520 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority
[Amended]
Start Amendment Part

5. In § 520.48, in paragraph (b), remove “000061 and 061623” and in its place add “000061, 051072, and 061623”.

End Amendment Part
[Amended]
Start Amendment Part

6. In § 520.1447, in paragraph (d)(1)(ii), remove “( Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)” and in its place add “(Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, and E. granulosus)”.

End Amendment Part Start Amendment Part

7. In § 520.2645, revise paragraphs (d)(1) and (2) to read as follows:

End Amendment Part
Tylvalosin.
* * * * *

(d) * * *

(1) Amount. Administer 50 parts per million (ppm) tylvalosin continuously in drinking water for 5 consecutive days.

(2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and Streptococcus suis in groups of swine in buildings experiencing an outbreak of SRD.

* * * * *
Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

8. The authority citation for part 522 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority
[Removed]
Start Amendment Part

9. Effective April 9, 2018, remove § 522.300.

End Amendment Part Start Amendment Part

10. Effective April 9, 2018, in § 522.540, revise paragraphs (b)(2) and (c)(2) to read as follows:

End Amendment Part
Dexamethasone solution.
* * * * *

(b) * * *

(2) Sponsor. See No. 061623 in § 510.600(c) of this chapter.

* * * * *

(c) * * *

(2) Sponsor. See No. 061623 in § 510.600(c) of this chapter.

* * * * *
[Amended]
Start Amendment Part

11. Effective April 9, 2018, in § 522.1081, in paragraph (b)(1), remove “Nos. 000402 and 054771” and in its place add “No. 054771”.

End Amendment Part
[Amended]
Start Amendment Part

12. In § 522.1662a, in paragraph (h)(3)(ii), remove “ Spherophorus necrophorus” and in its place add “Fusobacterium necrophorum”.

End Amendment Part
[Amended]
Start Amendment Part

13. In § 522.1680, in paragraph (b), remove “054628,”.

End Amendment Part Start Part

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

14. The authority citation for part 524 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 360b.

End Authority Start Amendment Part

15. Add § 524.970 to read as follows:

End Amendment Part
Flunixin.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine).

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.286 of this chapter.

(d) Conditions of use—(1) Amount. Apply only once at a dose of 3.3 mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically in a narrow strip along the dorsal midline from the withers to the tailhead.

(2) Indications for use. For the control of pyrexia associated with bovine respiratory disease and the control of pain associated with foot rot in steers, beef heifers, beef cows, beef bulls intended for slaughter, and replacement dairy heifers under 20 months of age.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cattle must not be slaughtered for human consumption within 8 days of the last treatment. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in suckling beef calves, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

Start Amendment Part

16. In § 524.1132, revise paragraph (a) to read as follows:

End Amendment Part
Hydrocortisone, miconazole, and gentamicin otic suspension.

(a) Specifications. Each milliliter (mL) of suspension contains 1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).

* * * * *
[Amended]
Start Amendment Part

17. In § 524.1193, in paragraph (b)(2), remove “086001” and in its place add “058005”.

End Amendment Part Start Part

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

End Part Start Amendment Part

18. The authority citation for part 556 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 342, 360b, 371.

End Authority
[Amended]
Start Amendment Part

19. In § 556.286, in paragraph (c), remove “§§ 522.956 and 522.970” and in its place add “§§ 522.956, 522.970, and 524.970”.

End Amendment Part Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

20. The authority citation for part 558 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

End Authority Start Amendment Part

21. In § 558.4, in paragraph (d), in the “Category II” table, revise the row entries for “Neomycin” through “Pyrantel tartrate” to read as follows:

End Amendment Part
Start Printed Page 13636
Requirement of a medicated feed mill license.
* * * * *

(d) * * *

Category II

DrugAssay limits percent 1 Type A 1Type B maximum (100×)Assay limits percent 1 Type B/C 2
*         *         *         *         *         *         *
Neomycin80-12020 g/lb (4.4%)70-125
Oxytetracycline80-12020 g/lb (4.4%)65-135
Neomycin sulfate80-120100 g/lb (22.0%)70-125
Nicarbazin (granular)90-1105.675 g/lb (1.25%)85-115/75-125
Narasin90-1105.675 g/lb (1.25%)85-115/75-125
Nicarbazin (powder)98-1065.675 g/lb (1.25%)85-115/80-120
Novobiocin85-11517.5 g/lb (3.85%)80-120
Pyrantel tartrate90-11036 g/lb (7.9%)75-125
*         *         *         *         *         *         *
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.
* * * * *
Start Amendment Part

22. In § 558.128, revise paragraphs (e)(3)(vi), (e)(4)(ix), and (e)(4)(xxvi) to read as follows:

End Amendment Part
Chlortetracycline.
* * * * *

(e) * * *

(3) * * *

Chlortetracycline amountCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(vi) 10 mg/lb of body weightTiamulin hydrogen fumarate, 35For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by P. multocida sensitive to chlortetracyclineFeed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254 in § 510.600(c) of this chapter058198 069254

(4) * * *

Chlortetracycline amountCombination in grams/tonIndications for useLimitationsSponsor
Start Printed Page 13637
*         *         *         *         *         *         *
(ix) 500 to 4,000 to provide 10 mg/lb of body weight dailyLasalocid, 30 to 600Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gainFeed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter054771
*         *         *         *         *         *         *
(xxvi) 500 to 4,000 to provide 10 mg/head/dayLasalocid, 30 to 181.8Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuerniiHand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter054771
* * * * *
Start Amendment Part

23. In § 558.325, revise paragraph (d)(2) to read as follows:

End Amendment Part
Lincomycin.
* * * * *

(d) * * *

(2) The expiration date of VFDs for lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled.

* * * * *
[Amended]
Start Amendment Part

24. In § 558.575, in paragraph (e)(2)(ii) remove “and bacterial infections due to H. galmaxima,”.

End Amendment Part Start Signature

Dated: March 21, 2018.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2018-06358 Filed 3-29-18; 8:45 am]

BILLING CODE 4164-01-P