Document ID: FDA-2014-N-0002-0027
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid;
Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address
Posted Date: 2014-07-02T04:00Z

[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37617-37621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15276]

 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules 
and Regulations  

[[Page 37617]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 529, 556, and 558

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; 
Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; 
Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change 
of Sponsor's Address

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 April and May 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 remove an obsolete entry for a 
drug for which approval was withdrawn in 1996.

DATES: This rule is effective July 2, 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 April and May 
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 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 regulations are being amended in 21 CFR 510.600 to 
reflect a change of address for Dechra, Ltd.; in 21 CFR 522.313a to 
reflect the previous approval of revised food safety warnings for 
ceftiofur sodium powder for injection; and in 21 CFR 558.4 to remove a 
listing for niclosamide which remained codified, in error, following 
the voluntary withdrawal of approval of the sole NADA for a niclosamide 
medicated feed (61 FR 34727, July 3, 1996). These amendments are 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.

                                 Table 1--Original and Supplemental NADAs and ANADAs Approved During April and May 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            New animal drug
           NADA/ ANADA                    Sponsor            product name             Action        21 CFR section   FOIA summary        NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-421..........................  Merial Ltd., 3239     DUOCARE (ivermectin   Original approval          520.1198  yes...........  CE.1 2
                                    Satellite Blvd.,      1.87% and             for the treatment
                                    Bldg. 500, Duluth,    praziquantel          and control of
                                    GA 30096-4640.        23.38%) Paste.        gastrointestinal
                                                                                nematodes,
                                                                                cestodes, and
                                                                                tapeworms
                                                                                parasites in
                                                                                horses over 5
                                                                                months of age.
141-423..........................  Axcentive SARL,       HALAMID               Original approval           510.600  yes...........  EA/FONSI.\3\
                                    Chemin de             (chloramine[dash]T    for control of             529.382
                                    Champouse, Quartier   powder for            mortality in               556.118
                                    Violesi, 13320 Bouc   immersion) Aqua.      certain freshwater
                                    Bel Air, France.                            fish due to
                                                                                Flavobacterium spp.

[[Page 37618]]

 
141-426..........................  Intervet, Inc., 556   BRAVECTO              Original approval           520.998  yes...........  CE.1 2
                                    Morris Ave.,          (fluralaner)          for the treatment
                                    Summit, NJ 07901.     Chewable Tablets      and prevention of
                                                          for Dogs.             flea infestations,
                                                                                and the treatment
                                                                                and control of
                                                                                tick infestations
                                                                                in dogs and
                                                                                puppies.
141-427..........................  Dechra, Ltd.,         OSPHOS (clodronate    Original approval           522.454  yes...........  CE.1 2
                                    Snaygill Industrial   injection).           for the control of
                                    Estate, Keighley                            clinical signs
                                    Road, Skipton,                              associated with
                                    North Yorkshire,                            navicular syndrome
                                    BD23 2RW, United                            in horses.
                                    Kingdom.
013-076 \4\......................  Elanco Animal         TYLAN (tylosin        Supplemental               520.2640  no............  CE.1 5
                                    Health, A Division    tartrate) Soluble     approval of a
                                    of Eli Lilly & Co.,   Powder.               change in
                                    Lilly Corporate                             marketing status
                                    Center,                                     from over-the-
                                    Indianapolis, IN                            counter (OTC) to
                                    46285.                                      by veterinary
                                                                                prescription (Rx).
141-327..........................  Merial Ltd., 3239     LONGRANGE             Supplemental                522.814  yes...........  CE.1 5
                                    Satellite Blvd.,      (eprinomectin)        approval adding
                                    Bldg. 500, Duluth,    Extended-Release      treatment and
                                    GA 30096-4640.        Injectable            control of a
                                                          Parasiticide.         gastrointestinal
                                                                                roundworm with 150
                                                                                days of persistent
                                                                                effectiveness.
141-406..........................  Merial Ltd., 3239     NEXGARD (afoxolaner)  Supplemental                 520.43  yes...........  CE.1 2
                                    Satellite Blvd.,      Chewable Tablets.     approval for the
                                    Bldg. 500, Duluth,                          treatment and
                                    GA 30096-4640.                              control of two
                                                                                additional species
                                                                                of tick in dogs
                                                                                and puppies.
200-513..........................  Norbrook              ENROFLOX              Original approval           522.812  yes...........  CE.1 5
                                    Laboratories, Ltd.,   (enrofloxacin)        as a generic copy
                                    Station Works,        Injection for Dogs    of NADA 140-913.
                                    Newry BT35 6JP,       2.27%.
                                    Northern Ireland.
200-530..........................  Huvepharma AD, 5th    TYLOVET 100 (tylosin  Original approval           558.500  yes...........  CE.1 6
                                    Floor, 3A Nikolay     phosphate) plus       as a generic copy
                                    Haytov Str., 1113     PAYLEAN               of NADA 141-172.
                                    Sophia, Bulgaria.     (ractopamine HCl)
                                                          Type B and C
                                                          medicated feeds.
200-558..........................  Zoetis Inc., 333      ENGAIN 9 and 45       Original approval       New 522.500  yes...........  CE.1 6
                                    Portage St.,          (ractopamine HCl)     as a generic copy
                                    Kalamazoo, MI 49007.  plus TYLAN 100        of NADA 141-172.
                                                          (tylosin phosphate)
                                                          Type B and C
                                                          medicated feeds.
200-561..........................  Zoetis Inc., 333      ACTOGAIN 45           Original approval           558.500  yes...........  CE.1 6
                                    Portage St.,          (ractopamine HCl),    as a generic copy
                                    Kalamazoo, MI 49007.  RUMENSIN              of NADA 141-224.
                                                          (monensin), and
                                                          TYLAN 100 (tylosin
                                                          phosphate) Type B
                                                          and C medicated
                                                          feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 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.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ The Agency has carefully considered an EA of the potential environmental impact of this action and has made a finding of no significant impact
  (FONSI).
\4\ The NADA listed was identified as being 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.
\5\ CE granted under 21 CFR 25.33(a)(1).
\6\ CE granted under 21 CFR 25.33(a)(2).

[[Page 37619]]

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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 510, 
520, 522, 529, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Axcentive SARL'' and revise the entry for ``Dechra, 
Ltd.''; and in the table in paragraph (c)(2), revise the entry for 
``043264'' and numerically add an entry for ``086009'' to read as 
follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                                * * * * *
Axcentive SARL, Chemin de Champouse, Quartier Violesi,            086009
 13320 Bouc Bel Air, France.............................
 
                                * * * * *
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd.,           043264
 Skipton, North Yorkshire, BD23 2RW, United Kingdom.....
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
             Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
043264....................................  Dechra, Ltd., Snaygill
                                             Industrial Estate, Keighley
                                             Rd., Skipton, North
                                             Yorkshire, BD23 2RW, United
                                             Kingdom
 
                                * * * * *
086009....................................  Axcentive SARL, Chemin de
                                             Champouse, Quartier
                                             Violesi, 13320 Bouc Bel
                                             Air, France
 
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
4. In Sec.  520.43, revise paragraph (c)(2) to read as follows:

Sec.  520.43  Afoxolaner.

* * * * *
    (c) * * *
    (2) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis); and for the 
treatment and control of black-legged tick (Ixodes scapularis), 
American Dog tick (Dermacentor variabilis), and lone star tick 
(Amblyomma americanum) infestations in dogs and puppies 8 weeks of age 
and older, weighing 4 lb of body weight or greater, for 1 month.
* * * * *

0
5. Section 520.998 is added to read as follows:

Sec.  520.998  Fluralaner.

    (a) Specifications. Each chewable tablet contains 112.5, 250, 500, 
1000, or 1400 milligrams (mg) fluralaner.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally as a 
single dose every 12 weeks according to the label dosage schedule to 
provide a minimum dose of 11.4 mg per pound (/lb) (25 mg per kilogram) 
body weight. May be administered every 8 weeks in case of potential 
exposure to Amblyomma americanum ticks.
    (2) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations [Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and 
Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and 
puppies 6 months of age and older, and weighing 4.4 lb or greater; for 
the treatment and control of A. americanum (lone star tick) 
infestations for 8 weeks in dogs and puppies 6 months of age and older, 
and weighing 4.4 lb or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
6. In Sec.  520.1198, add paragraphs (a)(3), (b)(3), and (d)(1)(iii); 
and revise paragraph (d)(2) to read as follows:

Sec.  520.1198  Ivermectin and praziquantel paste.

    (a) * * *
    (3) 0.0187 mg (1.87 percent) ivermectin and 0.2338 mg (23.38 
percent) praziquantel.
    (b) * * *
    (3) No. 050604 for use of products described in paragraph (a)(3) of 
this section as in paragraphs (d)(1)(iii), (d)(2)(iii) and (d)(3) of 
this section.
* * * * *
    (d) * * *
    (1) * * *
    (iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel 
(1.14 mg/lb).
    (2) Indications for use--(i) For treatment and control of the 
following parasites: Tapeworms--Anoplocephala perfoliata; Large 
Strongyles (adults)--Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, 
Triodontophorus spp. including T. brevicauda and T. serratus, and 
Craterostomum acuticaudatum; Small Strongyles (adults, including those 
resistant to some benzimidazole class compounds)--Coronocyclus spp. 
including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. 
including C. catinatum and C. pateratum; Cylicocyclus spp. including C. 
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; 
Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. 
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; 
Small Strongyles--fourth-stage larvae; Pinworms (adults and fourth-
stage larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus 
axei; Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral 
and gastric stages)--Gasterophilus spp.

[[Page 37620]]

including G. intestinalis and G. nasalis; Lungworms (adults and fourth-
stage larvae)--Dictyocaulus arnfieldi; Intestinal Threadworms 
(adults)--Strongyloides westeri; Summer Sores caused by Habronema and 
Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck 
threadworm microfilariae of Onchocerca sp.
    (ii) For treatment and control of the following parasites: 
Tapeworms--Anoplocephala perfoliata; Large Strongyles (adults)--
Strongylus vulgaris (also early forms in blood vessels), S. edentatus 
(also tissue stages), S. equinus, Triodontophorus spp.; Small 
Strongyles (adults, including those resistant to some benzimidazole 
class compounds)--Cyathostomum spp.; Cylicocyclus spp.; Cylicostephanus 
spp., Cylicodontophorus spp.; Small Strongyles--fourth-stage larvae; 
Pinworms (adults and fourth-stage larvae)--Oxyuris equi; Ascarids 
(adults and third- and fourth-stage larvae)--Parascaris equorum; 
Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach Worms 
(adults)--Habronema muscae; Bots (oral and gastric stages)--
Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)--
Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--Strongyloides 
westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous 
third-stage larvae; Dermatitis caused by neck threadworm microfilariae, 
Onchocerca sp.
    (iii) For treatment and control of the following parasites in 
horses over 5 months of age: Tapeworms--Anoplocephala perfoliata; Large 
Strongyles (adults)--Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, 
Triodontophorus spp. including T. brevicauda and T. serratus, and 
Craterostomum acuticaudatum; Small Strongyles (adults, including those 
resistant to some benzimidazole class compounds)--Coronocyclus spp. 
including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. 
including C. catinatum and C. pateratum; Cylicocyclus spp. including C. 
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; 
Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. 
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; 
Small Strongyles--fourth-stage larvae; Pinworms (adults and fourth-
stage larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus 
axei; Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral 
and gastric stages)--Gasterophilus spp. including G. intestinalis and 
G. nasalis; Lungworms (adults and fourth-stage larvae)--Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults)--Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-
stage larvae; Dermatitis caused by neck threadworm microfilariae of 
Onchocerca sp.
* * * * *

0
7. Amend Sec.  520.2640 as follows:
0
a. Revise paragraph (b);
0
b. Redesignate paragraph (d) as (e);
0
c. Add new paragraph (d); and
0
d. Revise newly designated paragraph (e)(2)(ii).
    The addition and revisions 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) Nos. 016592 and 061623 for use as in paragraphs (e)(1), 
(e)(2)(i), (e)(2)(ii)(B), (e)(2)(iii), (e)(3), and (e)(4) of this 
section.
* * * * *
    (d) Special considerations. For No. 000986, labeling shall bear 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''
    (e) * * *
    (2) * * *
    (ii) Indications for use--(A) For the reduction in severity of 
effects of infectious sinusitis associated with Mycoplasma 
gallisepticum.
    (B) For maintaining weight gain and feed efficiency in the presence 
of infectious sinusitis associated with Mycoplasma gallisepticum 
sensitive to tylosin.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
9. In 522.313a, remove paragraph (d); redesignate paragraph (e) as 
paragraph (d); and revise newly redesignated paragraphs (d)(1)(iii), 
(d)(2)(iii), and (d)(3)(iii) to read as follows:

Sec.  522.313a  Ceftiofur crystalline free acid.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Following label use as a single treatment, a 14-
day pre-slaughter withdrawal period is required. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian. Federal 
law prohibits extra-label use of this drug in swine for disease 
prevention purposes; at unapproved doses, frequencies, durations, or 
routes of administration; and in unapproved, major food-producing 
species/production classes.
    (2) * * *
    (iii) Limitations. Following label use as either a single-dose or 
2-dose regimen, a 13-day pre-slaughter withdrawal period is required 
after the last treatment. A withdrawal period has not been established 
in preruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian. Federal law prohibits extra-label use of this drug in 
cattle for disease prevention purposes; at unapproved doses, 
frequencies, durations, or routes of administration; and in unapproved, 
major food-producing species/production classes.
    (3) * * *
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

0
10. Add Sec.  522.454 to read as follows:

Sec.  522.454  Clodronate.

    (a) Specifications. Each milliliter of solution contains 60 
milligrams (mg) clodronate disodium.
    (b) Sponsor. See No. 043264 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1.8 mg per 
kilogram of body weight by intramuscular injection up to a maximum dose 
of 900 mg per horse.
    (2) Indications for use. For the control of clinical signs 
associated with navicular syndrome.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

0
11. In Sec.  522.812, revise paragraph (b)(2) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (2) No. 055529 for use of product described in paragraph (a)(1) as 
in paragraph (e)(1), and use of product described in paragraph (a)(2) 
as in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i), 
(e)(3)(ii)(B), and (e)(3)(iii) of this section.
* * * * *

0
12. In Sec.  522.814, revise paragraphs (d)(2) and (3) to read as 
follows:

[[Page 37621]]

Sec.  522.814  Eprinomectin.

* * * * *
    (d) * * *
    (2) Indications for use. For the treatment and control of the 
following internal and external parasites: Gastrointestinal roundworms 
(adults and fourth-stage larvae) Bunostomum phlebotomum, Cooperia 
oncophora, C. punctata, C. surnabada, Trichostrongylus axei, Ostertagia 
ostertagi (including inhibited stage); (adults) Haemonchus placei, 
Oesophagostomum radiatum, O. lyrata, T. colubriformis; lungworms 
(adults) Dictyocaulus viviparus; cattle grubs Hypoderma bovis; mites 
Sarcoptes scabiei var. bovis. Prevents reinfection with C. oncophora, 
C. punctata, and T. axei for 100 days following treatment; H. placei, 
O. radiatum, O. lyrata, and O. ostertagi for 120 days following 
treatment; and B. phlebotomum and D. viviparus for 150 days following 
treatment.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Animals intended for human 
consumption must not be slaughtered within 48 days of the last 
treatment. This drug product is not approved 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. A withdrawal period has not been established for pre-
ruminating calves. Do not use in calves to be processed for veal.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
13. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
14. Add 529.382 to read as follows:

Sec.  529.382  Chloramine-T.

    (a) Specifications. Chloramine-T trihydrate powder for solution.
    (b) Sponsor. See No. 086009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.118 of this chapter.
    (d) Conditions of use--(1) Freshwater-reared salmonids--(i) Amount. 
12 to 20 milligrams per liter (mg/L) water in a continuous flow water 
supply or as a static bath once per day for 60 minutes on consecutive 
or alternative days for three treatments.
    (ii) Indications for use. For the control of mortality in 
freshwater-reared salmonids due to bacterial gill disease associated 
with Flavobacterium spp.
    (2) Walleye--(i) Amount. 10 to 20 mg/L water in a continuous flow 
water supply or as a static bath once per day for 60 minutes on 
consecutive or alternative days for three treatments.
    (ii) Indications for use. For the control of mortality in walleye 
due to external columnaris disease associated with Flavobacterium 
columnare.
    (3) Freshwater-reared warmwater finfish--(i) Amount. 20 mg/L water 
in a continuous flow water supply or as a static bath once per day for 
60 minutes on consecutive or alternative days for three treatments.
    (ii) Indications for use. For the control of mortality in 
freshwater-reared warmwater finfish due to external columnaris disease 
associated with F. columnare.

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

0
15. The authority citation for 21 CFR part 556 continues to read as 
follows:

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

0
16. Add Sec.  556.118 to read as follows:

Sec.  556.118  Chloramine-T.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of 
chloramine-T is 5 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Fish--(i) Muscle/skin (target tissue). The 
tolerance for para-toluenesulfonamide (marker residue) is 0.90 parts 
per million.
    (ii) [Reserved]
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  529.382 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
17. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec.  558.4  [Amended]

0
18. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, 
remove the entry for ``Niclosamide''.

Sec.  558.500  [Amended]

0
19. Amend Sec.  558.500 as follows:
0
a. In the table in paragraphs (e)(1)(ii), (iii), and (iv), in the 
``Limitations'' column, add at the end of the entry ``Ractopamine as 
provided by No. 000986 with tylosin as provided by Nos. 000986 or 
016592 in Sec.  510.600(c) of this chapter; or ractopamine as provided 
by No. 054771 with tylosin as provided by No. 000986 in Sec.  
510.600(c) of this chapter.'' and in the ``Sponsor'' column, remove 
``000986'' and in its place add ``000986, 016592, 054771'';
0
b. In the table in paragraph (e)(2)(viii), in the ``Limitations'' 
column, remove ``No. 054771'' and in its place add ``Nos. 000986 and 
054771'';
0
c. In the table in paragraph (e)(2)(x), in the ``Limitations'' column, 
remove ``Nos. 054771 and 021641'' and in its place add ``Nos. 000986 
and 054771''; and
0
d. In the table in paragraphs (e)(2)(ix) and (xiii), in the 
``Limitations'' column, add at the end of the entry ``Ractopamine as 
provided by Nos. 000986 or 054771 with tylosin as provided by No. 
000986 in Sec.  510.600(c) of this chapter.'' and in the ``Sponsor'' 
column, remove ``000986'' and in its place add ``000986, 054771''.

    Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-15276 Filed 6-30-14; 11:15 am]
BILLING CODE 4164-01-P