New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Federal Register, Volume 81 Issue 74 (Monday, April 18, 2016)
Federal Register Volume 81, Number 74 (Monday, April 18, 2016)
Rules and Regulations
Pages 22520-22525
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2016-08827
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 524, 529, 556, and 558
Docket No. FDA-2016-N-0002
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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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
Page 22521
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, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
-
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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2016
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21 CFR FOIA
File No. Sponsor Product name Action section summary NEPA review
----------------------------------------------------------------------------------------------------------------
141-444....... Dechra, Ltd., ZYCORTAL Original 522.535 yes......... CE.\1\ \2\
Snaygill Suspension approval for
Industrial (desoxycorticos use as
Estate, terone pivalate replacement
Keighley Rd., injectable therapy for
Skipton, North suspension). mineralocortico
Yorkshire, BD23 id deficiency
2RW United in dogs with
Kingdom. primary
hypoadrenocorti
cism (Addison's
disease).
141-448....... Lloyd, Inc., 604 THYRO-TABS Original 520.1248 yes......... CE.\1\ \2\
W. Thomas Ave., CANINE approval for
Shenandoah, IA (levothyroxine replacement
51601. sodium tablets). therapy for
diminished
thyroid
function in
dogs.
141-452....... Zoetis Inc., 333 SIMPARICA Original 520.2086 yes......... CE.\1\ \2\
Portage St., (sarolaner) approval for
Kalamazoo, MI Chewables. killing adult
49007. fleas, and for
the treatment
and prevention
of flea
infestations
and the
treatment and
control of tick
infestations in
dogs.
141-263....... Zoetis Inc., 333 CERENIA Supplemental 522.1315 yes......... CE.\1\ \2\
Portage St., (maropitant approval
Kalamazoo, MI citrate) providing for
49007. Injectable intravenous
Solution. administration
in dogs and
cats.
141-449....... Intervet, Inc., SAFE-GUARD Supplemental 520.905a, yes......... EA/FONSI.\3\
2 Giralda AquaSol approval for 556.275
Farms, Madison, (fenbendazole the treatment
NJ 07940. oral and control of
suspension) certain
Suspension nematode worms
Concentrate. in swine,
except for
nursing
piglets; and of
a revised
tolerance in
swine liver.
200-600....... ECO LLC, 344 WORMX (pyrantel Original 520.2041 yes......... CE.\1\ \2\
Nassau St., pamoate) approval as a
Princeton, NJ Flavored generic copy of
08540. Tablets. NADA 139-191.
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\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an
environmental assessment or an environmental impact statement because it is of a type that does not have a
significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ 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).
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.
-
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:
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File No. Product name 21 CFR section
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006-391............... S.Q. (sulfaquinoxaline) 40% 558.586
Medicated Feed.
006-677............... S.Q. (sulfaquinoxaline) 20% 520.2325a
Solution.
007-087............... Sulfaquinoxaline Solubilized. 520.2325a
Page 22522
033-157............... SPECTAM Scour Halt 520.2123c
(spectinomycin
dihydrochloride
pentahydrate) Solution.
040-040............... SPECTAM (spectinomycin) 522.2120
Injectable Solution.
048-287............... Oxytetracycline-50 522.1662a
(oxytetracycline
hydrochloride) Injection.
065-110............... PEN-G-MAX (penicillin G 522.1696b
procaine) Injectable
Suspension.
065-498............... DUAL-CILLIN (benzathine 522.1696a
penicillin G and procaine
penicillin G) Injectable
Suspension.
119-142............... PVL Iron Dextran (iron 522.1182
hydrogenated dextran)
Injectable.
128-089............... ZONOMETH (dexamethasone) 522.540
Injectable Solution.
140-270............... SULFASURE SR (sulfamethazine) 520.2260b
Sustained-Release Cattle
Bolus.
200-068............... Oxytetracycline Hydrochloride 522.1662a
100 mg/mL Injection.
200-108............... Dexamethasone Injectable 522.540
Solution.
200-118............... Neomycin (neomycin sulfate) 520.1484
Oral Solution.
200-123............... MAXIM-200 (oxytetracycline) 522.1660a
Injection.
200-147............... GENTA-JECT (gentamicin 522.1044
sulfate) Injectable Solution.
200-153............... NEO 200 (neomycin sulfate) 520.1484
Oral Solution.
200-162............... Tripelennamine Hydrochloride 522.2615
Injection.
200-174............... Gentamicin Sulfate Pig Pump 520.1044b
Oral Solution.
200-177............... Sulfadimethoxine Injection 522.2220
40%.
200-192............... Sulfadimethoxine 12.5% Oral 520.2220a
Solution.
200-219............... Ivermectin Pour-On for Cattle 524.1193
200-463............... Amprolium-P 9.6% Oral 520.100
Solution.
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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.
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File No. Product name 21 CFR section
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038-200............... OXY WS (oxytetracycline) 520.1660d
Soluble Antibiotic.
065-178............... FERMYCIN (chlortetracycline) 520.441
Soluble.
065-496............... Tetracycline Soluble Powder.. 520.2345d
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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-NOX (sulfaquinoxaline) 520.2325a
Soluble Powder.
065-140............... TET-SOL 324 (tetracycline 520.2345d
hydrochloride) Soluble
Powder.
100-094............... POULTRYSULFA (sulfamerazine, 520.2218
sulfamethazine, and
sulfaquinoxaline) Soluble
Powder.
128-686............... BIO-COX (salinomycin) Type A 558.550
Medicated Article.
130-435............... OXY-TET (oxytetracycline 520.1660d
hydrochloride) Soluble
Powder/Solution.
134-284............... BIO-COX/FLAVOMYCIN 558.550
(bambermycins).
200-106............... R-PEN (Penicillin G 520.1696b
potassium) Soluble Powder.
200-130............... NEO-SOL 50 (neomycin sulfate) 520.1484
Soluble Powder.
200-189............... Lincomycin Soluble Powder.... 520.1263c
200-441............... AUREOMYCIN 520.441
(chlortetracycline) Soluble
Powder.
------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.
-
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 Sec. 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, Sec. 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 Sec. 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, Sec. 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
Page 22523
congressional review requirements in 5 U.S.C. 801-808.
List of Subjects
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
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:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.100 Amended
0
2. In Sec. 520.100, remove and reserve paragraph (b)(3).
0
3. In Sec. 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:
Sec. 520.441 Chlortetracycline powder.
* * * * *
(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.
* * * * *
0
4. In Sec. 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:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(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.
Sec. 520.1044b Amended
0
5. In Sec. 520.1044b, in paragraph (b), remove ``000859'' and in its place add ``016592''.
0
6. Add Sec. 520.1248 to read as follows:
Sec. 520.1248 Levothyroxine.
(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 Sec. 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.
0
7. In Sec. 520.1263c, revise paragraph (b) to read as follows:
Sec. 520.1263c Lincomycin powder.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 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.
* * * * *
Sec. 520.1484 Amended
0
8. In Sec. 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''.
Sec. 520.1660d Amended
0
9. In Sec. 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''.
Sec. 520.1696b Amended
0
10. In Sec. 520.1696b, in paragraph (b), in numerical order add ``016592''.
Sec. 520.1705 Amended
0
11. In Sec. 520.1705, in paragraph (a), remove ``pergolide mesylate'' and in its place add ``pergolide (as pergolide mesylate)''.
Sec. 520.2041 Amended
0
12. In Sec. 520.2041, in paragraph (b), remove ``Nos. 017135 and 051311'' and in its place add ``Nos. 017135, 051311, and 066916''.
0
13. Add Sec. 520.2086 to read as follows:
Sec. 520.2086 Sarolaner.
(a) Specifications. Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner.
(b) Sponsor. See No. 054771 in Sec. 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.
Sec. 520.2123c Amended
0
14. In Sec. 520.2123c, in paragraph (b), remove ``000859'' and in its place add ``016592''.
Sec. 520.2218 Amended
0
15. In Sec. 520.2218, in paragraph (b), remove ``054771'' and in its place add ``016592''.
Sec. 520.2220a Amended
0
16. In Sec. 520.2220a, in paragraph (b)(1), remove ``000859'' and in its place add ``016592''.
Sec. 520.2260b Amended
0
17. In Sec. 520.2260b, in paragraph (f)(1), remove ``000859'' and in its place add ``016592''.
Sec. 520.2325a Amended
0
18. In Sec. 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''.
0
19. In Sec. 520.2345d, in paragraph (b)(2), remove ``054628'' and in its place add ``066104''; in paragraph (b)(3),
Page 22524
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:
Sec. 520.2345d Tetracycline powder.
* * * * *
(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.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
20. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
21. Revise Sec. 522.535 to read as follows:
Sec. 522.535 Desoxycorticosterone.
(a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) of desoxycorticosterone pivalate.
(b) Sponsors. See sponsor numbers in Sec. 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.
Sec. 522.540 Amended
0
22. In Sec. 522.540, in paragraphs (a)(2)(i) and (d)(2)(i), remove ``000859'' and in its place add ``016592''.
Sec. 522.1044 Amended
0
23. In Sec. 522.1044, in paragraph (b)(4), remove ``000859'' and in its place add ``016592''.
0
24. Add Sec. 522.1055 to read as follows:
Sec. 522.1055 Gleptoferron.
(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 Sec. 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
Sec. 522.1182 Amended
0
25. In Sec. 522.1182, in paragraph (b)(6), remove ``000859'' and in its place add ``016592''; and remove paragraph (b)(8).
Sec. 522.1315 Amended
0
26. In Sec. 522.1315, in paragraphs (c)(1)(i) and (c)(2)(i), remove ``subcutaneous injection'' and in its place add ``subcutaneous or intravenous injection''.
Sec. 522.1660a Amended
0
27. In Sec. 522.1660a, in paragraph (b), remove ``000859'' and in its place add ``016592''.
Sec. 522.1662a Amended
0
28. In Sec. 522.1662a, in paragraphs (h)(2) and (i)(2), remove ``000859'' and in its place add ``016592''.
Sec. 522.1696a Amended
0
29. In Sec. 522.1696a, in paragraph (b)(2), remove ``000859'' and in its place add ``016592''.
Sec. 522.1696b Amended
0
30. In Sec. 522.1696b, in paragraph (b)(1), remove ``000859'' and in its place add ``016592''.
Sec. 522.2120 Amended
0
31. In Sec. 522.2120, in paragraph (b), remove ``000859'' and in its place add ``016592''.
Sec. 522.2220 Amended
0
32. In Sec. 522.2220, in paragraph (b)(3), remove ``000859'' and in its place add ``016592''.
Sec. 522.2615 Amended
0
33. In Sec. 522.2615, in paragraph (b), remove ``000859'' and in its place add ``016592''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 Amended
0
35. In paragraph (b)(2) of Sec. 522.1193, remove ``000859'' and in its place add ``016592''.
Sec. 524.1484k Amended
0
36. In Sec. 522.1484k, revise the section heading to read: Neomycin and prednisolone suspension.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
37. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1660 Amended
0
38. In Sec. 529.1660, in paragraph (b)(2), remove ``048164, 054771, and 061623'' and in its place add ``054771, 061623, and 069254''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
39. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
40. In Sec. 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:
Sec. 556.275 Fenbendazole.
* * * * *
(b) * * *
Page 22525
(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 Sec. Sec. 520.905a, 520.905c, 520.905d, 520.905e, and 558.258 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
41. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.195 Amended
0
42. Amend Sec. 558.195 as follows:
0
-
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.'';
0
-
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.'';
0
-
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
0
-
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.''
0
43. In Sec. 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:
Sec. 558.340 Maduramicin.
* * * * *
(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.
* * * * *
0
44. In Sec. 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:
Sec. 558.355 Monensin.
* * * * *
(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 Sec. 510.600(c) of this chapter.
(xxv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 4 to 50 grams.
* * * * *
Sec. 558.515 Amended
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45. In Sec. 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.''
Sec. 558.550 Amended
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46. Amend Sec. 558.550 as follows:
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In paragraph (b)(1), remove ``054771'' and in its place add ``016592'';
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Remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2);
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In paragraph (d)(1)(xvi)(c), remove ``Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by Nos. 054771 and 016592 in Sec. 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 Sec. 510.600(c) of this chapter.'';
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In paragraph (d)(1)(xx)(C) and (xxi)(C), remove ``Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in Sec. 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 Sec. 510.600(c) in this chapter.'';
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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 Sec. 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 Sec. 510.600(c) of this chapter.'';
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In paragraph (d)(1)(xxiii)(b), remove ``Salinomycin as provided by Nos. 054771 and 016592; bambermycins by No. 016592 in Sec. 510.600(c) of this chapter.'' and in its place add ``Salinomycin and bambermycins as provided by No. 016592 in Sec. 510.600(c) of this chapter.'';
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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 Sec. 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 Sec. 510.600(c) of this chapter.''; and
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In paragraph (d)(4)(i)(b), remove ``Salinomycin as provided by Nos. 054771 and 016592; oxytetracycline as provided by No. 066104 in Sec. 510.600(c) of this chapter.'' and in its place add ``Salinomycin as provided by No. 016592; oxytetracycline as provided by No. 066104 in Sec. 510.600(c) of this chapter.''
Sec. 558.586 Amended
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47. In Sec. 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.
FR Doc. 2016-08827 Filed 4-15-16; 8:45 am
BILLING CODE 4164-01-P
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