# [Amended]
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Final rule; technical amendment.
**SUMMARY:**
The Food and Drug Administration (FDA, 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 January and February 2016. FDA is also 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 changes of sponsorship of applications that occurred in January and February.
**DATES:**
This rule is effective April 18, 2016.
**FOR FURTHER INFORMATION CONTACT:**
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, *[email protected]* .
**SUPPLEMENTARY INFORMATION:**
**I. Approval Actions**
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January and February 2016, 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 Division of Dockets Management (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: *http://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: *http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm* .
| File No. | Sponsor | Product name | Action | 21 CFR | FOIA | NEPA |
| --- | --- | --- | --- | --- | --- | --- |
| 141-444 | Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW United Kingdom | ZYCORTAL Suspension (desoxycorticosterone pivalate injectable suspension) | Original approval for use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's disease) | 522.535 | yes | CE. |
| 141-448 | Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 | THYRO-TABS CANINE (levothyroxine sodium tablets) | Original approval for replacement therapy for diminished thyroid function in dogs | 520.1248 | yes | CE. |
| 141-452 | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | SIMPARICA (sarolaner) Chewables | Original approval for killing adult fleas, and for the treatment and prevention of flea infestations and the treatment and control of tick infestations in dogs | 520.2086 | yes | CE. |
| 141-263 | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | CERENIA (maropitant citrate) Injectable Solution | Supplemental approval providing for intravenous administration in dogs and cats | 522.1315 | yes | CE. |
| 141-449 | Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 | SAFE-GUARD AquaSol (fenbendazole oral suspension) Suspension Concentrate | Supplemental approval for the treatment and control of certain nematode worms in swine, except for nursing piglets; and of a revised tolerance in swine liver | 520.905a, 556.275 | yes | EA/FONSI. |
| 200-600 | ECO LLC, 344 Nassau St., Princeton, NJ 08540 | WORMX (pyrantel pamoate) Flavored Tablets | Original approval as a generic copy of NADA 139-191 | 520.2041 | yes | CE. |
Also, FDA is amending the regulations to reflect the approval of several minor supplemental applications that revised classes of food-producing animals in indications and in food safety warnings for decoquinate and robenidine in medicated feeds. A food safety precautionary statement has also been revised for use of monensin in medicated chicken feed.
**II. Changes of Sponsorship**
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee, Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:
| File No. | Product name | 21 CFR section |
| --- | --- | --- |
| 006-391 | S.Q. (sulfaquinoxaline) 40% Medicated Feed | 558.586 |
| 006-677 | S.Q. (sulfaquinoxaline) 20% Solution | 520.2325a |
| 007-087 | Sulfaquinoxaline Solubilized | 520.2325a |
| 033-157 | SPECTAM Scour Halt (spectinomycin dihydrochloride pentahydrate) Solution | 520.2123c |
| 040-040 | SPECTAM (spectinomycin) Injectable Solution | 522.2120 |
| 048-287 | Oxytetracycline-50 (oxytetracycline hydrochloride) Injection | 522.1662a |
| 065-110 | PEN-G-MAX (penicillin G procaine) Injectable Suspension | 522.1696b |
| 065-498 | DUAL-CILLIN (benzathine penicillin G and procaine penicillin G) Injectable Suspension | 522.1696a |
| 119-142 | PVL Iron Dextran (iron hydrogenated dextran) Injectable | 522.1182 |
| 128-089 | ZONOMETH (dexamethasone) Injectable Solution | 522.540 |
| 140-270 | SULFASURE SR (sulfamethazine) Sustained-Release Cattle Bolus | 520.2260b |
| 200-068 | Oxytetracycline Hydrochloride 100 mg/mL Injection | 522.1662a |
| 200-108 | Dexamethasone Injectable Solution | 522.540 |
| 200-118 | Neomycin (neomycin sulfate) Oral Solution | 520.1484 |
| 200-123 | MAXIM-200 (oxytetracycline) Injection | 522.1660a |
| 200-147 | GENTA-JECT (gentamicin sulfate) Injectable Solution | 522.1044 |
| 200-153 | NEO 200 (neomycin sulfate) Oral Solution | 520.1484 |
| 200-162 | Tripelennamine Hydrochloride Injection | 522.2615 |
| 200-174 | Gentamicin Sulfate Pig Pump Oral Solution | 520.1044b |
| 200-177 | Sulfadimethoxine Injection 40% | 522.2220 |
| 200-192 | Sulfadimethoxine 12.5% Oral Solution | 520.2220a |
| 200-219 | Ivermectin Pour-On for Cattle | 524.1193 |
| 200-463 | Amprolium-P 9.6% Oral Solution | 520.100 |
Also, 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 applications to Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666.
| File No. | Product name | 21 CFR section |
| --- | --- | --- |
| 038-200 | OXY WS (oxytetracycline) Soluble Antibiotic | 520.1660d |
| 065-178 | FERMYCIN (chlortetracycline) Soluble | 520.441 |
| 065-496 | Tetracycline Soluble Powder | 520.2345d |
In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:
| File No. | Product name | 21 CFR section |
| --- | --- | --- |
| 006-891 | SUL-Q-NO
(sulfaquinoxaline) Soluble Powder | 520.2325a |
| 065-140 | TET-SOL 324 (tetracycline hydrochloride) Soluble Powder | 520.2345d |
| 100-094 | POULTRYSULFA (sulfamerazine, sulfamethazine, and sulfaquinoxaline) Soluble Powder | 520.2218 |
| 128-686 | BIO-COX (salinomycin) Type A Medicated Article | 558.550 |
| 130-435 | OXY-TET (oxytetracycline hydrochloride) Soluble Powder/Solution | 520.1660d |
| 134-284 | BIO-COX/FLAVOMYCIN (bambermycins) | 558.550 |
| 200-106 | R-PEN (Penicillin G potassium) Soluble Powder | 520.1696b |
| 200-130 | NEO-SOL 50 (neomycin sulfate) Soluble Powder | 520.1484 |
| 200-189 | Lincomycin Soluble Powder | 520.1263c |
| 200-441 | AUREOMYCIN (chlortetracycline) Soluble Powder | 520.441 |
As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.
**III. Technical Amendments**
FDA has noticed that it failed to amend all necessary regulations to reflect the change of sponsorship of an oxytetracycline soluble powder (80 FR 13226, March 13, 2015). At this time, we are amending 21 CFR 529.1660 to include the drug labeler code for the new sponsor. This action is being taken to improve the accuracy of the regulations.
FDA has also noticed that in § 558.355 (21 CFR 558.355) use of bacitracin methylenedisalicylate at 100 to 200 grams/ton in combination with monensin in broiler and replacement chicken feeds was codified in error for NADA 141-140 (66 FR 13236, March 5, 2001). At this time, § 558.355 is amended by removing paragraphs (f)(1)(xxx) and (f)(4)(v). In addition, paragraph (f)(4)(iv), a remnant of a previous technical amendment (79 FR 10963, February 27, 2014), is also being removed. We have also noticed that certain paragraphs describing approved conditions of use were removed in error from § 558.355 during codification of a supplemental application to NADA 138-456 that increased the dose range for monensin used in combination with bacitracin methylenedisalicylate in broiler chicken feed (57 FR 6554, February 26, 1992). At this time, § 558.355 is amended by adding paragraphs (f)(1)(xxiv)( *a* ) and ( *b* ). These actions are being taken to improve the accuracy of the regulations.
FDA has noticed that in error we removed the approved conditions of use for gleptoferron, an injectable iron used to prevent anemia in young piglets. At this time, 21 CFR 522.1055 is being added. This action is being taken to improve the accuracy of the regulations.
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**
Animal drugs.
Animal drugs, Food.
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 522, 524, 529, 556, and 558 are amended as follows:
**21 CFR Part 520**
**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**
1. The authority citation for part 520 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 520**
§ 520.100
2. In § 520.100, remove and reserve paragraph (b)(3).
**21 CFR Part 520**
3. In § 520.441, revise paragraph (b)(1), remove paragraph (b)(2); redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3); and revise newly redesignated paragraph (b)(2).
The revisions read as follows:
§ 520.441
(b) * * *
(1) Nos. 000010, 016592, 054771, and 069254 for use as in paragraph (d) of this section.
(2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section.
**21 CFR Part 520**
4. In § 520.905a, in paragraph (a), remove “paragraph (e)(5)” and in its place add “paragraphs (e)(5) and (6)”; and add paragraph (e)(6) to read as follows:
§ 520.905a
(e) * * *
(6) *Swine, except for nursing piglets* —(i) *Amount.* Administer orally via the drinking water at a daily dose of 2.2 mg/kg of body weight (1.0 mg/lb) for 3 consecutive days.
(ii) *Indications for use.* For the treatment and control of lungworms: Adult *Metastrongylus apri,* adult *M. pudendotectus;* gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms ( *Ascaris suum* ); nodular worms ( *Oesophagostomum dentatum, O. quadrispinulatum* ); small stomach worms ( *Hyostrongylus rubidus* ): Adult and larvae (L2, L3, L4 stages—intestinal mucosal forms) whipworms ( *Trichuris suis* ); and kidney worms: Adult and larvae *Stephanurus dentatus* .
(iii) *Limitations.* Swine intended for human consumption must not be slaughtered within 2 days from the last treatment.
**21 CFR Part 520**
§ 520.1044b
5. In § 520.1044b, in paragraph (b), remove “000859” and in its place add “016592”.
**21 CFR Part 520**
6. Add § 520.1248 to read as follows:
§ 520.1248
(a) *Specifications.* Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.
(b) *Sponsor.* See No. 061690 in § 510.600(c) of this chapter.
(c) *Conditions of use* —(1) *Amount.* Administer by mouth 0.1 mg/10 pounds of body weight (0.022 mg/kilogram) as a single dose every 24 hours or as a divided dose every 12 hours.
(2) *Indications for use.* For replacement therapy for diminished thyroid function in dogs.
(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
**21 CFR Part 520**
7. In § 520.1263c, revise paragraph (b) to read as follows:
§ 520.1263c
(b) *Sponsors.* See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) No. 016592 for use as in paragraph (d) of this section.
(2) Nos. 054925, 061623, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section.
**21 CFR Part 520**
§ 520.1484
8. In § 520.1484, in paragraph (b)(2), remove “054771” and in its place add “016592, 054771,”; and in paragraph (b)(3), remove “000859” and in its place add “016592”.
**21 CFR Part 520**
§ 520.1660d
9. In § 520.1660d, in paragraph (b)(2), remove “054771” and in its place add “016592”; and in paragraph (b)(3), remove “054628” and in its place add “066104”.
**21 CFR Part 520**
§ 520.1696b
10. In § 520.1696b, in paragraph (b), in numerical order add “016592”.
**21 CFR Part 520**
§ 520.1705
11. In § 520.1705, in paragraph (a), remove “pergolide mesylate” and in its place add “pergolide (as pergolide mesylate)”.
**21 CFR Part 520**
§ 520.2041
12. In § 520.2041, in paragraph (b), remove “Nos. 017135 and 051311” and in its place add “Nos. 017135, 051311, and 066916”.
**21 CFR Part 520**
13. Add § 520.2086 to read as follows:
§ 520.2086
(a) *Specifications.* Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner.
(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
(c) *Conditions of use in dogs* —(1) *Amount.* Administer orally once a month at the recommended minimum dosage of 0.9 mg/lb (2 mg/kg).
(2) *Indications for use.* Kills adult fleas, and for the treatment and prevention of flea infestations ( *Ctenocephalides felis* ), and the treatment and control of tick infestations ( *Amblyomma americanum* (lone star tick), *Amblyomma maculatum* (Gulf Coast tick), *Dermacentor variabilis* (American dog tick), and *Rhipicephalus sanguineus* (brown dog tick)) for 1 month in dogs 6 months of age or older and weighing 2.8 pounds or more.
(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
**21 CFR Part 520**
§ 520.2123c
14. In § 520.2123c, in paragraph (b), remove “000859” and in its place add “016592”.
**21 CFR Part 520**
§ 520.2218
15. In § 520.2218, in paragraph (b), remove “054771” and in its place add “016592”.
**21 CFR Part 520**
§ 520.2220a
16. In § 520.2220a, in paragraph (b)(1), remove “000859” and in its place add “016592”.
**21 CFR Part 520**
§ 520.2260b
17. In § 520.2260b, in paragraph (f)(1), remove “000859” and in its place add “016592”.
**21 CFR Part 520**
§ 520.2325a
18. In § 520.2325a, in paragraph (a)(1), remove “000859” and in its place add “016592”; and in paragraph (a)(3), remove “No. 054771” and in its place add “Nos. 016592 and 054771”.
**21 CFR Part 520**
19. In § 520.2345d, in paragraph (b)(2), remove “054628” and in its place add “066104”; in paragraph (b)(3), remove “No. 054771” and in its place add “Nos. 016592 and 054771”; and revise the first sentence in paragraph (d)(1)(iii) and paragraph (d)(2)(iii) to read as follows:
§ 520.2345d
(d) * * *
(1) * * *
(iii) *Limitations.* Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 066104 and within 5 days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.* * *
(2) * * *
(iii) *Limitations.* Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 066104 and within 4 days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.
**21 CFR Part 522**
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
20. The authority citation for part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
21. Revise § 522.535 to read as follows:
§ 522.535
(a) *Specifications.* Each milliliter of suspension contains 25 milligrams (mg) of desoxycorticosterone pivalate.
(b) *Sponsors.* See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and (c)(3) of this section.
(2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section.
(c) *Conditions of use* —(1) *Amount.* (i) Administer an initial dose of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection. Subsequent dosages should be individualized according to label instructions based on patient response to therapy.
(ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.
(2) *Indications for use* —(i) For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's Disease).
(ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.
(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
**21 CFR Part 522**
§ 522.540
22. In § 522.540, in paragraphs (a)(2)(i) and (d)(2)(i), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
§ 522.1044
23. In § 522.1044, in paragraph (b)(4), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
24. Add § 522.1055 to read as follows:
§ 522.1055
(a) *Specifications.* Each milliliter contains the equivalent of 200 milligrams (mg) of elemental iron as gleptoferron (complex of ferric hydroxide and dextran glucoheptonic acid).
(b) *Sponsor.* See No. 059120 in § 510.600(c) of this chapter.
(c) *Conditions of use.* It is used in young piglets as follows:
(1) *Amounts and indications for use* —(i) Administer 200 mg of elemental iron intramuscularly on or before 3 days of age for prevention of iron deficiency anemia.
(ii) Administer 200 mg of elemental iron intramuscularly for treatment of iron deficiency anemia.
(2) [Reserved]
**21 CFR Part 522**
§ 522.1182
25. In § 522.1182, in paragraph (b)(6), remove “000859” and in its place add “016592”; and remove paragraph (b)(8).
**21 CFR Part 522**
§ 522.1315
26. In § 522.1315, in paragraphs (c)(1)(i) and (c)(2)(i), remove “subcutaneous injection” and in its place add “subcutaneous or intravenous injection”.
**21 CFR Part 522**
§ 522.1660a
27. In § 522.1660a, in paragraph (b), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
§ 522.1662a
28. In § 522.1662a, in paragraphs (h)(2) and (i)(2), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
§ 522.1696a
29. In § 522.1696a, in paragraph (b)(2), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
§ 522.1696b
30. In § 522.1696b, in paragraph (b)(1), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
§ 522.2120
31. In § 522.2120, in paragraph (b), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
§ 522.2220
32. In § 522.2220, in paragraph (b)(3), remove “000859” and in its place add “016592”.
**21 CFR Part 522**
§ 522.2615
33. In § 522.2615, in paragraph (b), remove “000859” and in its place add “016592”.
**21 CFR Part 524**
**PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS**
34. The authority citation for part 524 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 524**
§ 524.1193
35. In paragraph (b)(2) of § 522.1193, remove “000859” and in its place add “016592”.
**21 CFR Part 524**
§ 524.1484k
36. In § 522.1484k, revise the section heading to read: *Neomycin and prednisolone suspension.*
**21 CFR Part 529**
**PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS**
37. The authority citation for part 529 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 529**
§ 529.1660
38. In § 529.1660, in paragraph (b)(2), remove “048164, 054771, and 061623” and in its place add “054771, 061623, and 069254”.
**21 CFR Part 556**
**PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD**
39. The authority citation for part 556 continues to read as follows:
**Authority:**
21 U.S.C. 342, 360b, 371.
**21 CFR Part 556**
40. In § 556.275, in paragraph (b)(2)(i), remove “6 ppm” and in its place add “3.2 ppm”; redesignate paragraphs (b)(3) and (4) as paragraphs (b)(4) and (5); and add new paragraph (b)(3) and paragraph (c) to read as follows:
§ 556.275
(b) * * *
(3) *Chickens* —(i) *Liver (the target tissue).* The tolerance for fenbendazole sulfone (the marker residue) is 5.2 ppm.
(ii) [Reserved]
(c) *Related conditions of use.* See §§ 520.905a, 520.905c, 520.905d, 520.905e, and 558.258 of this chapter.
**21 CFR Part 558**
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
41. The authority citation for part 558 continues to read as follows:
**Authority:**
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
**21 CFR Part 558**
§ 558.195
42. Amend § 558.195 as follows:
a. In the table in paragraph (e)(1)(i), in the “Limitations” column, remove “Do not feed to laying chickens.” and in its place add “Do not feed to laying hens producing eggs for human consumption.”;
b. In the table in paragraph (e)(2)(i), in the “Limitations” column, remove “Do not feed to cows producing milk for food.” and in its place add “Do not feed to cows producing milk for human consumption.”;
c. In the table in paragraphs (e)(3)(i)1. and (e)(3)(ii)1., in the “Limitations” column, remove “Do not feed to sheep producing milk for food.” and in its place add “Do not feed to sheep producing milk for human consumption.”; and
d. In the table in paragraphs (e)(3)(i)2. and (e)(3)(ii)2., in the “Limitations” column, remove “Do not feed to goats producing milk for food.” and in its place add “Do not feed to goats producing milk for human consumption.”
**21 CFR Part 558**
43. In § 558.340, redesignate paragraphs (c)(1)(i) and (ii) as paragraphs (c)(2) and (3); and revise newly redesignated paragraph (c)(2) to read as follows:
§ 558.340
(c) * * *
(2) *Indications for use.* Broiler chickens: For prevention of coccidiosis caused by *Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix,* and *E. mivati.*
44. In § 558.355, revise paragraph (f)(1)(xxiv); and revise paragraph (f)(1)(xxv) introductory text and remove and reserve paragraphs (f)(1)(xxx), (f)(4)(iv), and (f)(4)(v).
The revisions read as follows:
§ 558.355
(f) * * *
(1) * * *
(xxiv) *Amount per ton.* Monensin, 90 to 110 grams, plus bacitracin methylenedisalicylate, 4 to 50 grams.
( *a* ) *Indications for use.* For improved feed efficiency; as an aid in the prevention of coccidiosis caused by *Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti,* and *E. mivati.*
( *b* ) *Limitations.* Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter.
(xxv) *Amount per ton.* Monensin, 90 to 110 grams, plus bacitracin zinc, 4 to 50 grams.
**21 CFR Part 558**
§ 558.515
45. In § 558.515, in the table in paragraph (d), in the entry for “30 (0.0033 pct)”, in the first entry under the “Indications for use” column, remove “For broiler and fryer chickens:” and in its place add “Broiler chickens:”; and in the first entry under the “Limitations” column, remove “Do not feed to layers.” and in its place add “Do not feed to chickens producing eggs for food.”
**21 CFR Part 558**
§ 558.550
46. Amend § 558.550 as follows:
a. In paragraph (b)(1), remove “054771” and in its place add “016592”;
b. Remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2);
c. In paragraph (d)(1)(xvi)( *c* ), remove “Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by Nos. 054771 and 016592 in § 510.600(c) of this chapter.” and in its place add “Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.”;
d. In paragraph (d)(1)(xx)(C) and (xxi)(C), remove “Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in § 510.600(c) in this chapter.” and in its place add “Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter.”;
e. In paragraph (d)(1)(xxii)(B), remove “Salinomycin as provided by Nos. 016592 and 054771; tylosin phosphate as provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; tylosin phosphate as provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.”;
f. In paragraph (d)(1)(xxiii)( *b* ), remove “Salinomycin as provided by Nos. 054771 and 016592; bambermycins by No. 016592 in § 510.600(c) of this chapter.” and in its place add “Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.”;
g. In paragraphs (d)(3)(ii)(B), (iii)(B), and (v)(B), remove “Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.”; and
h. In paragraph (d)(4)(i)( *b* ), remove “Salinomycin as provided by Nos. 054771 and 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.”
**21 CFR Part 558**
§ 558.586
47. In § 558.586, in paragraph (b), remove “000859” and in its place add “016592”.
Dated: April 12, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.