New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
Federal Register, Volume 79 Issue 173 (Monday, September 8, 2014)
Federal Register Volume 79, Number 173 (Monday, September 8, 2014)
Rules and Regulations
Pages 53134-53138
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-20325
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 558
Docket No. FDA-2014-N-0002
New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
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 approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2014. 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 add a cross reference to a tolerance.
DATES: This rule is effective September 8, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July 2014, 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 Center for Veterinary Medicine (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.
Also, the animal drug regulations are being amended in 21 CFR 522.955 to add a cross reference to a tolerance for an inactive vehicle in an injectable dosage form product. This amendment is being made 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.
Page 53135
Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
013-076 \1\............ Elanco Animal Health, TYLAN (tylosin Supplemental approval 520.2640 yes............... EA/FONSI \2\
A Division of Eli tartrate) Soluble for the control of
Lilly & Co., Lilly Powder. mortality caused by
Corporate Center, necrotic enteritis
Indianapolis, IN associated with
46285. Clostridium
perfringens in
broiler chickens.
141-207................ Zoetis Inc., 333 ADVOCIN (danofloxacin Supplemental approval 522.522 yes............... CE \3\ \4\
Portage St., injection) Sterile for control of
Kalamazoo, MI 49007. Injectable Solution. bovine respiratory
disease (BRD) in
beef cattle at high
risk of developing
BRD associated with
Mannheimia
haemolytica and
Pasteurella
multocida.
141-431................ Bioniche Animal Health FOLLTROPIN (porcine Original approval for 522.1002 yes............... CE \3\ \5\
USA, Inc., 119 Rowe pituitary-derived the induction of
Rd., Athens, GA 30601. follicle stimulating superovulation in
hormone for beef and dairy
injection). heifers and cows.
141-434................ Abbott Laboratories, SIMBADOL Original approval for 522.230 yes............... CE \3\ \6\
North Chicago, IL (buprenorphine control of
60064. injection). postoperative pain
associated with
surgical procedures
in cats.
200-520................ Norbrook Laboratories, CARPRIEVE (carprofen) Original approval as 522.304 yes............... CE \3\ \7\
Ltd., Station Works, Injection. a generic copy of
Newry BT35 6JP, NADA 141-199.
Northern Ireland.
200-559................ Zoetis Inc., 333 ACTOGAIN 45 Original approval as 558.500 yes............... CE \3\ \7\
Portage St., (ractopamine HCl) a generic copy of
Kalamazoo, MI 49007. plus RUMENSIN NADA 141-225.
(monensin) Type B
and C medicated
feeds.
200-566 \1\............ Huvepharma AD, 5th OPTAFLEXX 45 Original approval as 558.500 yes............... CE \3\ \7\
Floor, 3A Nikolay (ractopamine HCl) a generic copy of
Haytov Str., 1113 plus RUMENSIN NADA 141-224.
Sophia, Bulgaria. (monensin) plus
TYLOVET (tylosin
phosphate) Type B
and C medicated
feeds.
200-567 \1\............ Huvepharma AD, 5th OPTAFLEXX 45 Original approval as 558.500 yes............... CE \3\ \7\
Floor, 3A Nikolay (ractopamine HCl) a generic copy of
Haytov Str., 1113 plus RUMENSIN NADA 141-233.
Sophia, Bulgaria. (monensin) plus
TYLOVET (tylosin
phosphate) plus MGA
(melengestrol
acetate) Type B and
C medicated feeds.
200-569 \1\............ Huvepharma AD, 5th TYLAN (tylosin Original approval as 558.550 yes............... CE \3\ \7\
Floor, 3A Nikolay phosphate) plus a generic copy of
Haytov Str., 1113 SACOX (salinomycin NADA 141-198.
Sophia, Bulgaria. sodium) Type C
medicated feeds.
200-570 \1\............ Huvepharma AD, 5th TYLOVET (tylosin Original approval as 558.550 yes............... CE \3\ \7\
Floor, 3A Nikolay phosphate) plus BIO- a generic copy of
Haytov Str., 1113 COX (salinomycin NADA 141-198.
Sophia, Bulgaria. sodium) Type C
medicated feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The listed application is affected by guidance for industry (GFI) 213, ``New Animal Drugs and New Animal Drug Combination Products
Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product
Use Conditions with GFI 209'', December 2013.
\2\ 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).
\3\ The Agency has determined under 21 CFR 25.33 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 individually or cumulatively have a significant effect on the
human environment.
\4\ CE granted under 21 CFR 25.33(d)(5).
\5\ CE granted under 21 CFR 25.33(c).
\6\ CE granted under 21 CFR 25.33(d)(1).
\7\ CE granted under 21 CFR 25.33(a)(1).
Page 53136
List of Subjects
21 CFR Parts 520 and 522
Animal drugs.
21 CFR Part 558
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, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.2640, revise paragraphs (b) and (e)(1) to read as follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) Sponsors. (1) No. 000986 for use as in paragraphs (e)(1), (e)(2)(i), (e)(2)(ii)(A), (e)(2)(iii), (e)(3), and (e)(4) of this section.
(2) No. 016592 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2)(i), (e)(2)(ii)(A), (e)(2)(iii), (e)(3), and (e)(4) of this section.
(3) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2)(i), (e)(2)(ii)(B), (e)(2)(iii), (e)(3), and (e)(4) of this section.
* * * * *
(e) * * *
(1) Chickens--(i) Amounts and indications for use.--(A) Administer 2 grams per gallon (528 parts per million (ppm)) for 1 to 5 days as an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum in broiler and replacement chickens. For the control of CRD associated with M. gallisepticum at time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae in broiler chickens. Treated chickens should consume enough medicated drinking water to provide 50 milligrams (mg) tylosin per pound of body weight per day.
(B) Administer 851 to 1,419 mg/gallon (225 to 375 ppm) for 5 days for the control of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens.
(ii) Limitations. Do not use in layers producing eggs for human consumption. Do not administer within 24 hours of slaughter.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. Add Sec. 522.230 to read as follows:
Sec. 522.230 Buprenorphine.
(a) Specifications. Each milliliter of solution contains 1.8 milligrams (mg) buprenorphine.
(b) Sponsor. See No. 000044 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Administer 0.24 mg per kilogram (0.11 mg per pound) by subcutaneous injection once daily, for up to 3 days. Administer the first dose approximately 1 hour prior to surgery.
(2) Indications for use. For the control of postoperative pain associated with surgical procedures in cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Sec. 522.304 Amended
0
5. In Sec. 522.304, paragraph (b), remove ``No. 054771'' and in its place add ``Nos. 054771 and 055529''.
0
6. In Sec. 522.522, remove paragraph (d)(2); redesignate paragraph (d)(3) as paragraph (d)(2); and revise paragraph (d)(1) to read as follows:
Sec. 522.522 Danofloxacin.
* * * * *
(d) * * *
(1) Amount and indications for use. Administer by subcutaneous injection either:
(i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours, for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida; or
(ii) 8 mg/kg of body weight as a single dose for the treatment of BRD associated with M. haemolytica and P. multocida and for the control of BRD in beef cattle at high risk of developing BRD associated with M. haemolytica and P. multocida.
* * * * *
0
7. In Sec. 522.955, revise paragraph (c) to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(c) Related tolerances. See Sec. Sec. 500.1410 and 556.283 of this chapter.
* * * * *
0
8. In Sec. 522.1002, add paragraph (c) to read as follows:
Sec. 522.1002 Follicle stimulating hormone.
* * * * *
(c)(1) Specifications. Each package contains 2 vials. One vial contains 700 international units (IU) porcine-pituitary derived follicle stimulating hormone (FSH) equivalent to 400 milligrams NIH-
FSH-P1, as a dry powder. The other vial contains 20 milliliters (mL) of bacteriostatic sodium chloride injection. When reconstituted, each milliliter of constituted solution contains 35 IU FSH.
(2) Sponsor. See No. 064847 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Dosage. Administer 2.5 mL (87.5 IU) intramuscularly, twice daily at 12-hour intervals, for 4 consecutive days. In conjunction with the 6th dose, administer an approved prostaglandin product for cattle (cloprostenol sodium or dinoprost tromethamine), using the labeled dosage and administration instructions to cause luteolysis and induce estrus. See Sec. 522.460 for use of cloprostenol sodium or Sec. 522.690 for use of dinoprost tromethamine.
(ii) Indications for use. For the induction of superovulation in beef and dairy heifers and cows.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
9. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
0
10. In Sec. 558.500, revise paragraphs (e)(2)(ii), (e)(2)(iv), (e)(2)(vii), (e)(2)(ix), (e)(2)(x), (e)(2)(xii), and (e)(2)(xiii), to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
Page 53137
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Ractopamine in grams/ton grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 8.2 to 24.6............... Monensin 10 to 40 Cattle fed in As in paragraph 000986, 054771
to provide 0.14 confinement for (e)(2)(i) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see paragraph
body weight, (e)(2)(i) of Sec. Sec.
depending on this section; 558.355(d) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine as
challenge, up to coccidiosis due provided by Nos.
480 mg/head/day. to Eimeria bovis 000986 or 054771
and E zuernii. in Sec.
510.600(c) of
this chapter;
monensin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
* * * * * * *
(iv) 8.2 to 24.6............... Monensin 10 to 40 Cattle fed in As in paragraph 000986, 016592, 054771
to provide 0.14 confinement for (e)(2)(i) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see Sec. Sec.
body weight, (e)(2)(i) of 558.355(d) and
depending on this section; 558.625(c) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine as
challenge, up to coccidiosis due provided by No.
480 mg/head/day, to Eimeria bovis 000986 with
plus tylosin 8 and E zuernii; tylosin as
to 10. and for provided by Nos.
reduction of 000986 or 016592
incidence of in Sec.
liver abscesses 510.600(c) of
caused by this chapter; or
Fusobacterium ractopamine as
necrophorum and provided by No.
Arcanobacterium 054771 with
(Actinomyces) tylosin as
pyogenes. provided by No.
000986 in Sec.
510.600(c) of
this chapter.
* * * * * * *
(vii) 9.8 to 24.6.............. Monensin 10 to 40 Cattle fed in As in paragraph 000986, 054771
to provide 0.14 confinement for (e)(2)(vi) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see paragraph
body weight, (e)(2)(vi) of Sec. Sec.
depending on this section; 558.355(d) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine as
challenge, up to coccidiosis due provided by Nos.
480 mg/head/day. to Eimeria bovis 000986 or 054771
and E zuernii. in Sec.
510.600(c) of
this chapter;
monensin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
* * * * * * *
(ix) 9.8 to 24.6............... Monensin 10 to 40 Cattle fed in As in paragraph 000986, 016592, 054771
to provide 0.14 confinement for (e)(2)(vi) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see Sec. Sec.
body weight, (e)(2)(vi) of 558.355(d) and
depending on this section; 558.625(c) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine and
challenge, up to coccidiosis due monensin as
480 mg/head/day, to Eimeria bovis provided by No.
plus tylosin 8 and E zuernii; 000986 with
to 10. and for tylosin as
reduction of provided by Nos.
incidence of 000986 or 016592
liver abscesses in Sec.
caused by 510.600(c) of
Fusobacterium this chapter; or
necrophorum and ractopamine as
Arcanobacterium provided by No.
(Actinomyces) 054771 with
pyogenes. monensin and
tylosin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
Page 53138
(x) 9.8 to 24.6................ Monensin 10 to 40 Heifers fed in As in paragraph 000986, 016592, 054771
to provide 0.14 confinement for (e)(2)(vi) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see paragraphs
body weight, (e)(2)(vi) of Sec. Sec.
depending on this section; 558.342(d),
severity of for prevention 558.355(d) and
coccidiosis and control of 558.625(c) of
challenge, up to coccidiosis due this chapter.
480 mg/head/day, to Eimeria bovis Ractopamine,
plus tylosin 8 and E zuernii; monensin, and
to 10, plus for reduction of tylosin as
melengestrol incidence of provided by No.
acetate to liver abscesses 000986 with
provide 0.25 to caused by melengestrol
0.5 mg/head/day. Fusobacterium acetate as
necrophorum and provided by Nos.
Arcanobacterium 000986 or 054771
(Actinomyces) in Sec.
pyogenes; and 510.600(c) of
for suppression this chapter; or
of estrus (heat). ractopamine and
monensin as
provided by No.
000986 with
tylosin as
provided by Nos.
000986 or 016592
and melengestrol
acetate as
provided by No.
054771 in Sec.
510.600(c) of
this chapter; or
ractopamine as
provided by No.
054771 with
monensin and
tylosin as
provided by No.
000986 and
melengestrol
acetate provided
by No. 054771 in
Sec.
510.600(c) of
this chapter.
* * * * * * *
(xii) Not to exceed 800; to Monensin 10 to 40 Cattle fed in Top dress 000986, 054771
provide 70 to 400 mg/head/day. to provide 0.14 confinement for ractopamine in a
to 0.42 mg slaughter: As in minimum of 1.0
monensin/lb of paragraph lb of medicated
body weight, (e)(2)(i) of feed during the
depending on this section; last 28 to 42
severity of for prevention days on feed.
coccidiosis and control of Not for animals
challenge, up to coccidiosis due intended for
480 mg/head/day. to Eimeria bovis breeding. See
and E zuernii. Sec.
558.355(d).
Ractopamine as
provided by Nos.
000986 or 054771
in Sec.
510.600(c) of
this chapter;
monensin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
(xiii) Not to exceed 800; to Monensin 10 to 40 Cattle fed in Top dress 000986, 016592, 054771
provide 70 to 400 mg/head/day. to provide 0.14 confinement for ractopamine in a
to 0.42 mg slaughter: As in minimum of 1.0
monensin/lb of paragraph lb of medicated
body weight, (e)(2)(i) of feed during the
depending on this section; last 28 to 42
severity of for prevention days on feed.
coccidiosis and control of Not for animals
challenge, up to coccidiosis due intended for
480 mg/head/day, to Eimeria bovis breeding. See
plus tylosin 8 and E zuernii; Sec. Sec.
to 10. and for 558.355(d) and
reduction of 558.625(c).
incidence of Ractopamine and
liver abscesses monensin as
caused by provided by No.
Fusobacterium 000986 with
necrophorum and tylosin as
Arcanobacterium provided by Nos.
(Actinomyces) 000986 or 016592
pyogenes. in Sec.
510.600(c) of
this chapter; or
ractopamine as
provided by No.
054771 with
monensin and
tylosin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
11. In Sec. 558.550, revise the last sentence in paragraph (d)(1)(xxii)(B) to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(d) * * *
(1) * * *
(xxii) * * *
(B) * * * 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.
* * * * *
Dated: August 21, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
FR Doc. 2014-20325 Filed 9-5-14; 8:45 am
BILLING CODE 4164-01-P
