81_FR_95235 81 FR 94987 - Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications

81 FR 94987 - Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 248 (December 27, 2016)

Page Range94987-94991
FR Document2016-31084

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.

Federal Register, Volume 81 Issue 248 (Tuesday, December 27, 2016) 
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 94987-94991]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31084]



[[Page 94987]]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 529

[Docket No. FDA-2016-N-0002]


Oral Dosage Form New Animal Drugs; Approval of New Animal Drug 
Applications

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 of 43 supplemental new animal drug 
applications (NADAs) and 52 supplemental abbreviated new animal drug 
applications (ANADAs) for revised labeling reflecting a change in 
marketing status from over-the-counter (OTC) to prescription (Rx) for 
antimicrobial drugs of importance to human medicine administered to 
food-producing animals in medicated drinking water. These applications 
were submitted in voluntary compliance with the goals of the FDA Center 
for Veterinary Medicine's (CVM's) Judicious Use Initiative.

DATES: This rule is effective December 31, 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: FDA is amending the animal drug regulations 
to reflect approval of 43 supplemental NADAs and 52 supplemental ANADAs 
for revised labeling reflecting a change in marketing status from OTC 
to Rx for antimicrobial drugs of importance to human medicine 
administered to food-producing animals in medicated drinking water. 
These applications were 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 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their 
change to Rx marketing status is consistent with the FDA CVM's 
initiative for the Judicious Use of Antimicrobials. The affected 
applications follow:

------------------------------------------------------------------------
          File No.             Animal drug product         Sponsor
------------------------------------------------------------------------
006-084.....................  SULMET                Huvepharma EOOD, 5th
                               (sulfamethazine)      Floor, 3A Nikolay
                               Drinking Water        Haytov Str., 1113
                               Solution.             Sophia, Bulgaria
                                                     (Huvepharma EOOD).
006-677.....................  S.Q.                  Huvepharma EOOD.
                               (sulfaquinoxaline)
                               20% Solution.
006-707.....................  SULQUIN 6-50          Zoetis Inc., 333
                               (Sulfaquinoxaline).   Portage St.,
                                                     Kalamazoo, MI 49007
                                                     (Zoetis Inc.).
006-891.....................  SUL-Q-NOX             Huvepharma EOOD.
                               (sulfaquinoxaline)
                               Solution.
007-087.....................  Sulfaquinoxaline      Huvepharma EOOD.
                               Solubilized
                               (Powder).
008-622.....................  TERRAMYCIN            Zoetis Inc.
                               (oxytetracycline)
                               Soluble Powder.
011-315.....................  NEOMIX 325            Zoetis Inc.
                               (neomycin) Soluble
                               Powder.
015-160.....................  Sodium                Zoetis Inc.
                               Sulfachloropyrazine
                               Solution.
031-205.....................  AGRIBON               Zoetis Inc.
                               (sulfadimethoxine)
                               12.5% Drinking
                               Water Solution.
031-553.....................  ESB 3                 Zoetis Inc.
                               (sulfachloropyrazin
                               e) Soluble Powder/
                               Solution.
032-946.....................  MAGNA TERRAMYCIN      Zoetis Inc.
                               (oxytetracycline
                               and carbomycin)
                               Soluble Powder.
033-373.....................  VETSULID SP           Huvepharma EOOD.
                               (sulfachloropyridaz
                               ine) Soluble Powder.
035-157.....................  GALLIMYCIN            Cross Vetpharm Group
                               (erythromycin)        Ltd., Broomhill
                               Soluble Powder.       Rd., Tallaght,
                                                     Dublin 24, Ireland
                                                     (Cross Vetpharm
                                                     Group Ltd.).
038-200.....................  MEDAMYCIN             Phibro Animal Health
                               (oxytetracycline)     Corp., GlenPointe
                               Soluble Powder.       Centre East, 3d
                                                     floor, 300 Frank W.
                                                     Burr Blvd., suite
                                                     21, Teaneck, NJ
                                                     07666 (Phibro
                                                     Animal Health
                                                     Corp.).
038-661.....................  SPECTOGARD            Cross Vetpharm Group
                               (spectinomycin)       Ltd.
                               Water Soluble
                               Powder.
046-109.....................  L-S 50 (lincomycin    Zoetis Inc.
                               and spectinomycin)
                               Water Soluble
                               Powder.
046-285.....................  AGRIBON               Zoetis Inc.
                               (sulfadimethoxine)
                               Soluble Powder.
055-012.....................  CHLORONEX SULMET      Huvepharma EOOD.
                               (chlortetracycline
                               bisulfate and
                               sulfamethazine)
                               Soluble Powder.
055-020.....................  AUREOMYCIN            Zoetis Inc.
                               (chlortetracycline)
                               Soluble Powder.
055-060.....................  Penicillin G          Zoetis Inc.
                               Potassium, USP.
065-071.....................  AUREOMYCIN            Huvepharma EOOD.
                               (chlortetracycline)
                               Soluble Powder.
065-123.....................  Tetracycline Soluble  Zoetis Inc.
                               Powder.
065-140.....................  TET-SOL 324           Huvepharma EOOD.
                               (tetracycline)
                               Soluble Powder.
065-178.....................  FERMYCIN              Phibro Animal Health
                               (chlortetracycline)   Corp.
                               Soluble.
065-256.....................  CHLORO-SOLUBLE-O      Pharmgate LLC, 1015
                               (chlortetracycline)   Ashes Dr., suite
                               Soluble Powder.       102, Wilmington, NC
                                                     28405 (Pharmgate
                                                     LLC).
065-269.....................  POLYOTIC              Huvepharma EOOD.
                               (tetracycline)
                               Soluble Powder.
065-410.....................  TETRA-SAL             Zoetis Inc.
                               (tetracycline)
                               Soluble Powder.
065-440.....................  CHLORONEX             Huvepharma EOOD.
                               (chlortetracycline)
                               Soluble Powder.
065-441.....................  POLYOTIC              Zoetis Inc.
                               (tetracycline)
                               Soluble Powder
                               Concentrate.
065-480.....................  Chlortetracycline     Pharmgate LLC.
                               Soluble Powder.
065-486.....................  Chlortetracycline     Strategic Veterinary
                               Bisulfate Soluble     Pharmaceuticals,
                               Powder.               Inc., 100 NW.
                                                     Airport Rd., St.
                                                     Joseph, MO 64503
                                                     (Strategic Vet.
                                                     Pharm., Inc.).
065-496.....................  Tetracycline Soluble  Phibro Animal Health
                               Powder.               Corp.
091-191.....................  GENTOCIN              Intervet, Inc., 2
                               (gentamicin) Oral     Giralda Farms,
                               Solution.             Madison, NJ 07940
                                                     (Intervet, Inc.).
100-094.....................  POULTRY SULFA         Huvepharma EOOD.
                               (sulfamerazine,
                               sulfamethazine, and
                               sulfaquinoxaline)
                               Soluble Powder.
106-964.....................  APRALAN (apramycin)   Elanco US Inc.
                               Soluble Powder.
111-636.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)
                               Soluble Powder.

[[Page 94988]]

 
122-272.....................  SULMET                Huvepharma EOOD.
                               (sulfamethazine)
                               Soluble Powder.
130-435.....................  OXY-TET               Huvepharma EOOD.
                               (oxytetracycline)
                               Soluble Powder.
133-836.....................  GARACIN (gentamicin)  Intervet, Inc.
                               Soluble Powder.
140-578.....................  SOLU-TET 324          Zoetis Inc.
                               (tetracycline)
                               Soluble Powder.
200-026.....................  PENNOX 343            Pharmgate LLC.
                               (oxytetracycline).
200-030.....................  Sulfadimethoxine      Agri Laboratories,
                               12.5% Oral Solution.  Ltd., P.O. Box
                                                     3103, St. Joseph,
                                                     MO 64503 (Agri
                                                     Laboratories,
                                                     Ltd.).
200-031.....................  Sulfadimethoxine      Agri Laboratories,
                               Antibacterial         Ltd.
                               Soluble Powder.
200-046.....................  Neomycin Soluble      Zoetis Inc.
                               Powder.
200-049.....................  Tetracycline          Agri Laboratories,
                               Hydrochloride         Ltd.
                               Soluble Powder-324.
200-050.....................  NEOMED (neomycin)     Cross Vetpharm Group
                               Soluble Powder.       Ltd.
200-066.....................  AGRIMYCIN-343         Agri Laboratories,
                               (oxytetracycline)     Ltd.
                               Soluble Powder.
200-103.....................  PENAQUA SOL-G         Cross Vetpharm Group
                               (penicillin G         Ltd.
                               potassium) Soluble
                               Powder.
200-106.....................  R-PEN (penicillin G   Huvepharma EOOD.
                               potassium) Soluble
                               Powder.
200-113.....................  BIOSOL[supreg]        Zoetis Inc.
                               (neomycin) Liquid.
200-118.....................  Neomycin Oral         Huvepharma EOOD.
                               Solution.
200-122.....................  SOLU-PEN (penicillin  Zoetis Inc.
                               G potassium)
                               Soluble Powder.
200-130.....................  NEO-SOL 50            Zoetis Inc.
                               (neomycin) Soluble
                               Powder.
200-136.....................  Tetracycline          Quo Vademus, LLC,
                               Hydrochloride         277 Faison McGowan
                               Soluble Powder-324.   Rd., Kenansville,
                                                     NC 28349 (Quo
                                                     Vademus, LLC).
200-144.....................  Oxytetracycline HCl   Cross Vetpharm Group
                               Soluble Powder.       Ltd.
200-146.....................  TETROXY 25            Cross Vetpharm Group
                               (oxytetracycline).    Ltd.
200-153.....................  NEO 200 (neomycin)    Huvepharma EOOD.
                               Oral Solution.
200-165.....................  SDM                   Strategic Vet.
                               (sulfadimethoxine)    Pharm., Inc.
                               12.5% Oral Solution.
200-185.....................  GEN-GARD (Gentamicin  Agri Laboratories,
                               sulfate) Soluble      Ltd.
                               Powder.
200-189.....................  Lincomycin Soluble..  Huvepharma EOOD.
200-190.....................  GENTORAL (gentamicin  Med-Pharmex, Inc.,
                               sulfate) Oral         2727 Thompson Creek
                               Solution.             Rd., Pomona, CA
                                                     91767-1861 (Med-
                                                     Pharmex, Inc.).
200-192.....................  Sulfadimethoxine      Huvepharma EOOD.
                               12.5% Oral Solution.
200-197.....................  Streptomycin Oral     Huvepharma EOOD.
                               Solution w/STREP
                               SOL (RLNAD 065-252).
200-233.....................  LINCO (lincomycin)    Zoetis Inc.
                               Soluble Powder.
200-234.....................  TETRASOL              Med-Pharmex, Inc.
                               (tetracycline)
                               Soluble Powder.
200-235.....................  NEOSOL (neomycin)     Med-Pharmex, Inc.
                               Soluble Powder.
200-236.....................  Chlortetracycline     Quo Vademus, LLC.
                               HCL Soluble Powder.
200-238.....................  SULFASOL              Med-Pharmex, Inc.
                               (sulfadimethoxine)
                               Soluble Powder.
200-241.....................  LINCOSOL              Med-Pharmex, Inc.
                               (lincomycin)
                               Soluble Powder.
200-247.....................  TETROXY 343           Cross Vetpharm Group
                               (oxytetracycline)     Ltd.
                               Soluble Powder.
200-251.....................  SULFORAL              Med-Pharmex, Inc.
                               (Sulfadimethoxine)
                               Soluble Powder.
200-258.....................  Sulfadimethoxine      Phibro Animal Health
                               Soluble Powder.       Corp.
200-289.....................  NEOSOL-ORAL           Med-Pharmex, Inc.
                               (neomycin) Soluble
                               Powder.
200-295.....................  PENNCHLOR 64          Pharmgate LLC.
                               (chlortetracycline)
                               Soluble Powder.
200-303.....................  Lincomycin            Quo Vademus, LLC.
                               Hydrochloride
                               Soluble Powder.
200-345.....................  Lincomycin-           Phibro Animal Health
                               Spectinomycin         Corp.
                               Soluble Powder.
200-347.....................  Penicillin G          Quo Vademus, LLC.
                               Potassium USP.
200-372.....................  HAN-PEN (penicillin   G.C. Hanford
                               G potassium)          Manufacturing Co.,
                               Soluble Powder.       P.O. Box 1017,
                                                     Syracuse, NY 13201
                                                     (G.C. Hanford Mfg.
                                                     Co.).
200-374.....................  TETRAMED 324 HCA      Cross Vetpharm Group
                               (tetracycline)        Ltd.
                               Soluble Powder.
200-376.....................  SULFAMED-G            Cross Vetpharm Group
                               (sulfadimethoxine)    Ltd.
                               Soluble Powder.
200-377.....................  LINXMED-SP            Cross Vetpharm Group
                               (lincomycin and       Ltd.
                               spectinomycin)
                               Soluble Powder.
200-378.....................  Neomycin Sulfate 325  Sparhawk
                               Soluble Powder.       Laboratories, Inc.,
                                                     12340 Santa Fe
                                                     Trail Dr., Lenexa,
                                                     KS 66215 (Sparhawk
                                                     Laboratories,
                                                     Inc.).
200-379.....................  Neomycin Liquid.....  Sparhawk
                                                     Laboratories, Inc.
200-380.....................  SPECLINX-50           Cross Vetpharm Group
                               (lincomycin and       Ltd.
                               spectinomycin)
                               Soluble Powder.
200-407.....................  Lincomycin-           Agri Laboratories,
                               Spectinomycin Water   Ltd.
                               Soluble Powder.
200-434.....................  SMZ-MED 454           Cross Vetpharm Group
                               (sulfamethazine)      Ltd.
                               Soluble Powder.
200-441.....................  AUREOMYCIN            Huvepharma EOOD.
                               (chlortetracycline)
                               Soluble Powder.
200-443.....................  Sulfadimethoxine      First Priority,
                               Soluble Powder.       Inc., 1590 Todd
                                                     Farm Dr., Elgin, IL
                                                     60123.
200-460.....................  TETROXY AQUATIC       Cross Vetpharm Group
                               (oxytetracycline)     Ltd.
                               Soluble Powder.
200-494.....................  GENTAMED              Cross Vetpharm Group
                               (gentamicin)          Ltd.
                               Soluble Powder.
------------------------------------------------------------------------

    The animal drug regulations are also being amended to reflect 
several non-substantive changes in format. These technical amendments 
are being made to improve the consistency and readability of the 
regulations.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect approval of similar supplemental 
NADAs and ANADAs changing the marketing status of antimicrobial drugs 
administered to food-producing animals in medicated feed.
    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 in 21 CFR Parts 520 and 529

    Animal drugs.

    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 and 
529 are amended as follows:

[[Page 94989]]

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.  520.110  [Amended]

0
2. In Sec.  520.110, in paragraph (d)(3), remove ``Prepare fresh 
medicated water daily.'' and as the last sentence add ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''


Sec.  520.441  [Amended]

0
3. In Sec.  520.441, in paragraphs (d)(1)(i)(A)(2), (d)(2)(i)(A)(2), 
(d)(4)(i)(A)(2), (d)(4)(i)(B)(2), (d)(4)(ii)(A)(2), (d)(4)(ii)(B)(2), 
(d)(4)(iii)(C), (d)(4)(iv)(C), (d)(5)(i)(A)(2), (d)(5)(ii)(A)(2), 
(d)(5)(iii)(C), and (d)(5)(iv)(C), as the last sentence add ``Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.''


Sec.  520.445  [Amended]

0
4. In Sec.  520.445, in paragraph (d)(3), as the last sentence add 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''

0
5. In Sec.  520.823, revise paragraphs (d)(1)(i), (d)(1)(iii), 
(d)(2)(i), (d)(2)(iii), (d)(3)(i), and (d)(3)(iii) to read as follows:


Sec.  520.823  Erythromycin.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Administer 0.500 gram per gallon for 5 days.
* * * * *
    (iii) Limitations. Do not use in replacement pullets over 16 weeks 
of age. Do not use in chickens producing eggs for human consumption. 
Withdraw 1 day before slaughter. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. Administer 0.500 gram per gallon for 7 days.
* * * * *
    (iii) Limitations. Do not use in replacement pullets over 16 weeks 
of age. Do not use in chickens producing eggs for human consumption. 
Withdraw 1 day before slaughter. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (3) * * *
    (i) Amount. Administer 0.500 gram per gallon for 7 days.
* * * * *
    (iii) Limitations. Do not use in turkeys producing eggs for human 
consumption. Withdraw 1 day before slaughter. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

0
6. In Sec.  520.1044a, revise paragraph (d)(3) to read as follows:


Sec.  520.1044a  Gentamicin sulfate oral solution.

* * * * *
    (d) * * *
    (3) Limitations. Do not slaughter treated swine for food for at 
least 3 days following treatment. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
7. In Sec.  520.1044c, remove paragraph (d)(4) and revise paragraph 
(d)(3) to read as follows:


Sec.  520.1044c  Gentamicin sulfate powder.

* * * * *
    (d) * * *
    (3) Limitations. Withdrawal period: 10 days. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.


Sec.  520.1263c  [Amended]

0
8. In Sec.  520.1263c, in paragraph (b)(1), remove ``No. 016592'' and 
in its place add ``Nos. 016592 and 054771''; in paragraph (d)(1)(iii), 
remove ``051259'' and in its place add ``054925'', and as the last 
sentence add ``Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.''; and in paragraphs (d)(2)(iii) and 
(d)(3)(iii), add ``Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.''

0
9. In Sec.  520.1265, add paragraph (d)(3) to read as follows:


Sec.  520.1265  Lincomycin and spectinomycin powder.

* * * * *
    (d) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
10. In Sec.  520.1484, revise paragraphs (e)(1)(iii) and (e)(2)(iii) to 
read as follows:


Sec.  520.1484  Neomycin.

* * * * *
    (e) * * **
    (1) * * *
    (iii) Limitations. Discontinue treatment prior to slaughter as 
follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) * * *
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
11. In Sec.  520.1660a, revise the section heading and paragraphs 
(e)(1) and (e)(3) to read as follows:


Sec.  520.1660a  Oxytetracycline and carbomycin.

* * * * *
    (e) * * *
    (1) Amount. Administer 1.0 gram of oxytetracycline and 1.0 gram 
carbomycin per gallon for not more than 5 days.
* * * * *
    (3) Limitations. Not for use in chickens producing eggs for human 
consumption. Withdraw 24 hours before slaughter. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

0
12. In Sec.  520.1660d, revise paragraphs (d)(1)(i)(A)(1), 
(d)(1)(i)(A)(3), (d)(1)(i)(B)(1), (d)(1)(i)(B)(3), (d)(1)(ii)(A)(1), 
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(1), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(1), 
(d)(1)(ii)(C)(3), (d)(1)(iii)(A), (d)(1)(iii)(C), (d)(1)(iv)(A), 
(d)(1)(iv)(C), (d)(1)(v)(A), (d)(1)(v)(C), (d)(2)(i), and (d)(2)(iii) 
to read as follows:


Sec.  520.1660d  Oxytetracycline powder.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (A) * * *
    (1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 
days. Not to be used for more than 14 consecutive days.
* * * * *
    (3) Do not use in birds producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (B) * * *
    (1) Amount. Administer 400 to 800 milligrams/gallon for 7 to 14 
days. Not to be used for more than 14 consecutive days.
* * * * *
    (3) Do not use in birds producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (ii) * * *
    (A) * * *
    (1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 
days. Not to be used for more than 14 consecutive days.
* * * * *
    (3) Do not use in birds producing eggs for human consumption. 
Withdraw 5 days prior to slaughter those products sponsored by Nos. 
054771 and 061623 in Sec.  510.600(c) of this chapter. Withdraw 4 days 
prior to slaughter

[[Page 94990]]

those products sponsored by No. 054628. Zero-day withdrawal for those 
products sponsored by Nos. 057561 and 069254. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (B) * * *
    (1) Amount. Administer 400 milligrams/gallon for 7 to 14 days. Not 
to be used for more than 14 consecutive days.
* * * * *
    (3) Do not use in birds producing eggs for human consumption. 
Withdraw 5 days prior to slaughter those products sponsored by Nos. 
054771 and 061623 in Sec.  510.600(c) of this chapter. Withdraw 4 days 
prior to slaughter those products sponsored by No. 054628. Zero-day 
withdrawal for those products sponsored by Nos. 057561 and 069254. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (C) * * *
    (1) Amount. Administer 25 milligrams per pound of body weight daily 
for 7 to 14 days. Not to be used for more than 14 consecutive days.
* * * * *
    (3) Do not use in birds producing eggs for human consumption. 
Withdraw 5 days prior to slaughter those products sponsored by Nos. 
054771 and 061623 in Sec.  510.600(c) of this chapter. Withdraw 4 days 
prior to slaughter those products sponsored by No. 054628. Zero-day 
withdrawal for those products sponsored by Nos. 057561 and 069254. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (iii) * * *
    (A) Amount. Administer 10 milligrams per pound of body weight daily 
for up to 14 days. Do not use for more than 14 consecutive days.
* * * * *
    (C) Withdraw zero days prior to slaughter those products sponsored 
by Nos. 054771, 057561, 061623, and 069254 in Sec.  510.600(c) of this 
chapter. Withdraw 4 days prior to slaughter those products sponsored by 
No. 054628. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (iv) * * *
    (A) Amount. Administer 10 milligrams per pound of body weight daily 
for up to 14 days. Do not use for more than 14 consecutive days.
* * * * *
    (C) Withdraw 5 days prior to slaughter. A milk discard period has 
not been established for this product in lactating dairy cattle. Do not 
use in female dairy cattle 20 months of age or older. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (v) * * *
    (A) Amount. Administer 10 milligrams per pound of body weight daily 
for up to 14 days. Not to be used for more than 14 consecutive days.
* * * * *
    (C) Withdraw 5 days prior to slaughter. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. 200 milligrams per colony, administered via either a 
1:1 sugar syrup (equal parts of sugar and water weight to weight) or 
dusting with a powdered sugar mixture. The drug is administered in 3 
applications of sugar syrup or 3 dustings at 4- to 5-day intervals.
* * * * *
    (iii) The drug should be fed early in the spring or fall and 
consumed by the bees before main honey flow begins to avoid 
contamination of production honey. Remove at least 6 weeks prior to 
main honey flow. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

0
13. In Sec.  520.1696b, redesignate paragraph (c) as paragraph (d) and 
add new paragraph (c), and revise redesignated paragraph (d)(3) to read 
as follows:


Sec.  520.1696b  Penicillin G powder.

* * * * *
    (c) Related tolerances. See Sec.  556.510 of this chapter.
* * * * *
    (d) * * *
    (3) Limitations. Discontinue treatment at least 1 day prior to 
slaughter. Not for use in turkeys producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.


Sec.  520.2123b  [Amended]

0
14. In Sec.  520.2123b, remove paragraph (d)(1)(i); redesignate 
paragraphs (d)(1)(ii) and (iii) as paragraphs (d)(1)(i) and (ii); and 
in paragraph (d)(2), as the last sentence add ``Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.''


Sec.  520.2184  [Amended]

0
15. In Sec.  520.2184, in paragraph (d)(3), remove the first sentence, 
and as the last sentence add ``Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.''


Sec.  520.2200  [Amended]

0
16. In Sec.  520.2200, in paragraphs (d)(1)(iii) and (d)(2)(iii), as 
the last sentence add ``Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.''


Sec.  520.2218   [Amended]

0
17. In Sec.  520.2218, in paragraphs (d)(1)(ii) and (d)(2)(ii), remove 
the first sentence, and as the last sentence add ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''

0
18. In Sec.  520.2220a, revise the section heading and paragraphs 
(d)(1)(iii), (d)(2)(iii), and (d)(3)(iii) to read as follows:


Sec.  520.2220a  Sulfadimethoxine oral solution and soluble powder.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Withdraw 5 days before slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) * * *
    (iii) Limitations. Withdraw 5 days before slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) * * *
    (iii) Limitations. Withdraw 7 days before slaughter. A withdrawal 
period has not been established for this product 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 the extralabel use of this product 
in lactating dairy cattle.


Sec.  520.2261a  [Amended]

0
19. In Sec.  520.2261a, in paragraph (d)(3), as the last sentence add 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''


Sec.  520.2261b  [Amended]

0
20. In Sec.  520.2261b, in paragraphs (d)(1)(iii), (d)(2)(iii), 
(d)(3)(iii), and (d)(4)(iii), as the last sentence add ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''


Sec.  520.2325a  [Amended]

0
21. In Sec.  520.2325a, in paragraph (d), remove the first sentence, 
and as the last sentence add ``Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.''


Sec.  520.2345d   [Amended]

0
22. In Sec.  520.2345d, in paragraphs (d)(1)(iii), (d)(2)(iii), 
(d)(3)(iii), and (d)(4)(iii), as the last sentence add ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''

[[Page 94991]]

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
23. The authority citation for part 529 continues to read as follows:

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

0
24. In Sec.  529.1660, add paragraph (d)(3) to read as follows:


Sec.  529.1660   Oxytetracycline.

* * * * *
    (d) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31084 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 94987 DEPARTMENT OF HEALTH AND revised labeling reflecting a change in for revised labeling reflecting a change HUMAN SERVICES marketing status from over-the-counter in marketing status from OTC to Rx for (OTC) to prescription (Rx) for antimicrobial drugs of importance to Food and Drug Administration antimicrobial drugs of importance to human medicine administered to food- human medicine administered to food- producing animals in medicated 21 CFR Parts 520 and 529 producing animals in medicated drinking water. These applications were [Docket No. FDA–2016–N–0002] drinking water. These applications were identified as being affected by guidance submitted in voluntary compliance with for industry (GFI) #213, ‘‘New Animal Oral Dosage Form New Animal Drugs; the goals of the FDA Center for Drugs and New Animal Drug Approval of New Animal Drug Veterinary Medicine’s (CVM’s) Combination Products Administered in Applications Judicious Use Initiative. or on Medicated Feed or Drinking Water DATES: This rule is effective December of Food-Producing Animals: AGENCY: Food and Drug Administration, 31, 2016. HHS. Recommendations for Drug Sponsors for FOR FURTHER INFORMATION CONTACT: Voluntarily Aligning Product Use Final rule; technical ACTION: George K. Haibel, Center for Veterinary Conditions with GFI #209,’’ December amendment. Medicine (HFV–6), Food and Drug 2013 (http://www.fda.gov/downloads/ SUMMARY: The Food and Drug Administration, 7519 Standish Pl., AnimalVeterinary/GuidanceCompliance Administration (FDA) is amending the Rockville, MD 20855, 240–402–5689, Enforcement/GuidanceforIndustry/ animal drug regulations to reflect george.haibel@fda.hhs.gov. UCM299624.pdf). Their change to Rx approval of 43 supplemental new SUPPLEMENTARY INFORMATION: FDA is marketing status is consistent with the animal drug applications (NADAs) and amending the animal drug regulations to FDA CVM’s initiative for the Judicious 52 supplemental abbreviated new reflect approval of 43 supplemental Use of Antimicrobials. The affected animal drug applications (ANADAs) for NADAs and 52 supplemental ANADAs applications follow: File No. Animal drug product Sponsor 006–084 ...... SULMET (sulfamethazine) Drinking Water Solution ................... Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 006–677 ...... S.Q. (sulfaquinoxaline) 20% Solution .......................................... Huvepharma EOOD. 006–707 ...... SULQUIN 6–50 (Sulfaquinoxaline) .............................................. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 006–891 ...... SUL–Q–NOX (sulfaquinoxaline) Solution .................................... Huvepharma EOOD. 007–087 ...... Sulfaquinoxaline Solubilized (Powder) ........................................ Huvepharma EOOD. 008–622 ...... TERRAMYCIN (oxytetracycline) Soluble Powder ....................... Zoetis Inc. 011–315 ...... NEOMIX 325 (neomycin) Soluble Powder .................................. Zoetis Inc. 015–160 ...... Sodium Sulfachloropyrazine Solution .......................................... Zoetis Inc. 031–205 ...... AGRIBON (sulfadimethoxine) 12.5% Drinking Water Solution ... Zoetis Inc. 031–553 ...... ESB 3 (sulfachloropyrazine) Soluble Powder/Solution ............... Zoetis Inc. 032–946 ...... MAGNA TERRAMYCIN (oxytetracycline and carbomycin) Solu- Zoetis Inc. ble Powder. 033–373 ...... VETSULID SP (sulfachloropyridazine) Soluble Powder ............. Huvepharma EOOD. 035–157 ...... GALLIMYCIN (erythromycin) Soluble Powder ............................ Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.). 038–200 ...... MEDAMYCIN (oxytetracycline) Soluble Powder ......................... Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 038–661 ...... SPECTOGARD (spectinomycin) Water Soluble Powder ............ Cross Vetpharm Group Ltd. 046–109 ...... L–S 50 (lincomycin and spectinomycin) Water Soluble Powder Zoetis Inc. 046–285 ...... AGRIBON (sulfadimethoxine) Soluble Powder ........................... Zoetis Inc. 055–012 ...... CHLORONEX SULMET (chlortetracycline bisulfate and Huvepharma EOOD. sulfamethazine) Soluble Powder. 055–020 ...... AUREOMYCIN (chlortetracycline) Soluble Powder .................... Zoetis Inc. 055–060 ...... Penicillin G Potassium, USP ....................................................... Zoetis Inc. 065–071 ...... AUREOMYCIN (chlortetracycline) Soluble Powder .................... Huvepharma EOOD. 065–123 ...... Tetracycline Soluble Powder ....................................................... Zoetis Inc. 065–140 ...... TET–SOL 324 (tetracycline) Soluble Powder ............................. Huvepharma EOOD. 065–178 ...... FERMYCIN (chlortetracycline) Soluble ....................................... Phibro Animal Health Corp. 065–256 ...... CHLORO–SOLUBLE–O (chlortetracycline) Soluble Powder ...... Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 (Pharmgate LLC). 065–269 ...... POLYOTIC (tetracycline) Soluble Powder .................................. Huvepharma EOOD. 065–410 ...... TETRA–SAL (tetracycline) Soluble Powder ................................ Zoetis Inc. 065–440 ...... CHLORONEX (chlortetracycline) Soluble Powder ...................... Huvepharma EOOD. 065–441 ...... POLYOTIC (tetracycline) Soluble Powder Concentrate .............. Zoetis Inc. 065–480 ...... Chlortetracycline Soluble Powder ................................................ Pharmgate LLC. asabaliauskas on DSK3SPTVN1PROD with RULES 065–486 ...... Chlortetracycline Bisulfate Soluble Powder ................................. Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 (Strategic Vet. Pharm., Inc.). 065–496 ...... Tetracycline Soluble Powder ....................................................... Phibro Animal Health Corp. 091–191 ...... GENTOCIN (gentamicin) Oral Solution ....................................... Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 (Intervet, Inc.). 100–094 ...... POULTRY SULFA (sulfamerazine, sulfamethazine, and Huvepharma EOOD. sulfaquinoxaline) Soluble Powder. 106–964 ...... APRALAN (apramycin) Soluble Powder ..................................... Elanco US Inc. 111–636 ...... LINCOMIX (lincomycin) Soluble Powder ..................................... Zoetis Inc. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00079 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

94988 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations File No. Animal drug product Sponsor 122–272 ...... SULMET (sulfamethazine) Soluble Powder ................................ Huvepharma EOOD. 130–435 ...... OXY–TET (oxytetracycline) Soluble Powder ............................... Huvepharma EOOD. 133–836 ...... GARACIN (gentamicin) Soluble Powder ..................................... Intervet, Inc. 140–578 ...... SOLU–TET 324 (tetracycline) Soluble Powder ........................... Zoetis Inc. 200–026 ...... PENNOX 343 (oxytetracycline) ................................................... Pharmgate LLC. 200–030 ...... Sulfadimethoxine 12.5% Oral Solution ........................................ Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 (Agri Laboratories, Ltd.). 200–031 ...... Sulfadimethoxine Antibacterial Soluble Powder .......................... Agri Laboratories, Ltd. 200–046 ...... Neomycin Soluble Powder .......................................................... Zoetis Inc. 200–049 ...... Tetracycline Hydrochloride Soluble Powder-324 ........................ Agri Laboratories, Ltd. 200–050 ...... NEOMED (neomycin) Soluble Powder ........................................ Cross Vetpharm Group Ltd. 200–066 ...... AGRIMYCIN–343 (oxytetracycline) Soluble Powder ................... Agri Laboratories, Ltd. 200–103 ...... PENAQUA SOL–G (penicillin G potassium) Soluble Powder ..... Cross Vetpharm Group Ltd. 200–106 ...... R–PEN (penicillin G potassium) Soluble Powder ....................... Huvepharma EOOD. 200–113 ...... BIOSOL® (neomycin) Liquid ........................................................ Zoetis Inc. 200–118 ...... Neomycin Oral Solution ............................................................... Huvepharma EOOD. 200–122 ...... SOLU–PEN (penicillin G potassium) Soluble Powder ................ Zoetis Inc. 200–130 ...... NEO–SOL 50 (neomycin) Soluble Powder ................................. Zoetis Inc. 200–136 ...... Tetracycline Hydrochloride Soluble Powder-324 ........................ Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 (Quo Vademus, LLC). 200–144 ...... Oxytetracycline HCl Soluble Powder ........................................... Cross Vetpharm Group Ltd. 200–146 ...... TETROXY 25 (oxytetracycline) ................................................... Cross Vetpharm Group Ltd. 200–153 ...... NEO 200 (neomycin) Oral Solution ............................................. Huvepharma EOOD. 200–165 ...... SDM (sulfadimethoxine) 12.5% Oral Solution ............................. Strategic Vet. Pharm., Inc. 200–185 ...... GEN–GARD (Gentamicin sulfate) Soluble Powder ..................... Agri Laboratories, Ltd. 200–189 ...... Lincomycin Soluble ...................................................................... Huvepharma EOOD. 200–190 ...... GENTORAL (gentamicin sulfate) Oral Solution .......................... Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861 (Med-Pharmex, Inc.). 200–192 ...... Sulfadimethoxine 12.5% Oral Solution ........................................ Huvepharma EOOD. 200–197 ...... Streptomycin Oral Solution w/STREP SOL (RLNAD 065–252) .. Huvepharma EOOD. 200–233 ...... LINCO (lincomycin) Soluble Powder ........................................... Zoetis Inc. 200–234 ...... TETRASOL (tetracycline) Soluble Powder .................................. Med-Pharmex, Inc. 200–235 ...... NEOSOL (neomycin) Soluble Powder ........................................ Med-Pharmex, Inc. 200–236 ...... Chlortetracycline HCL Soluble Powder ....................................... Quo Vademus, LLC. 200–238 ...... SULFASOL (sulfadimethoxine) Soluble Powder ......................... Med-Pharmex, Inc. 200–241 ...... LINCOSOL (lincomycin) Soluble Powder .................................... Med-Pharmex, Inc. 200–247 ...... TETROXY 343 (oxytetracycline) Soluble Powder ....................... Cross Vetpharm Group Ltd. 200–251 ...... SULFORAL (Sulfadimethoxine) Soluble Powder ........................ Med-Pharmex, Inc. 200–258 ...... Sulfadimethoxine Soluble Powder ............................................... Phibro Animal Health Corp. 200–289 ...... NEOSOL–ORAL (neomycin) Soluble Powder ............................. Med-Pharmex, Inc. 200–295 ...... PENNCHLOR 64 (chlortetracycline) Soluble Powder ................. Pharmgate LLC. 200–303 ...... Lincomycin Hydrochloride Soluble Powder ................................. Quo Vademus, LLC. 200–345 ...... Lincomycin-Spectinomycin Soluble Powder ................................ Phibro Animal Health Corp. 200–347 ...... Penicillin G Potassium USP ........................................................ Quo Vademus, LLC. 200–372 ...... HAN–PEN (penicillin G potassium) Soluble Powder .................. G.C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 (G.C. Hanford Mfg. Co.). 200–374 ...... TETRAMED 324 HCA (tetracycline) Soluble Powder ................. Cross Vetpharm Group Ltd. 200–376 ...... SULFAMED–G (sulfadimethoxine) Soluble Powder ................... Cross Vetpharm Group Ltd. 200–377 ...... LINXMED–SP (lincomycin and spectinomycin) Soluble Powder Cross Vetpharm Group Ltd. 200–378 ...... Neomycin Sulfate 325 Soluble Powder ....................................... Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 (Sparhawk Laboratories, Inc.). 200–379 ...... Neomycin Liquid .......................................................................... Sparhawk Laboratories, Inc. 200–380 ...... SPECLINX–50 (lincomycin and spectinomycin) Soluble Powder Cross Vetpharm Group Ltd. 200–407 ...... Lincomycin-Spectinomycin Water Soluble Powder ..................... Agri Laboratories, Ltd. 200–434 ...... SMZ–MED 454 (sulfamethazine) Soluble Powder ...................... Cross Vetpharm Group Ltd. 200–441 ...... AUREOMYCIN (chlortetracycline) Soluble Powder .................... Huvepharma EOOD. 200–443 ...... Sulfadimethoxine Soluble Powder ............................................... First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. 200–460 ...... TETROXY AQUATIC (oxytetracycline) Soluble Powder ............. Cross Vetpharm Group Ltd. 200–494 ...... GENTAMED (gentamicin) Soluble Powder ................................. Cross Vetpharm Group Ltd. The animal drug regulations are also ANADAs changing the marketing status List of Subjects in 21 CFR Parts 520 and being amended to reflect several non- of antimicrobial drugs administered to 529 substantive changes in format. These food-producing animals in medicated asabaliauskas on DSK3SPTVN1PROD with RULES Animal drugs. technical amendments are being made feed. to improve the consistency and Therefore, under the Federal Food, This rule does not meet the definition Drug, and Cosmetic Act and under readability of the regulations. of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because authority delegated to the Commissioner Elsewhere in this issue of the Federal it is a rule of ‘‘particular applicability.’’ of Food and Drugs and redelegated to Register, FDA is amending the animal Therefore, it is not subject to the the Center for Veterinary Medicine, 21 drug regulations to reflect approval of congressional review requirements in 5 CFR parts 520 and 529 are amended as similar supplemental NADAs and U.S.C. 801–808. follows: VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00080 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 94989 PART 520—ORAL DOSAGE FORM Withdraw 1 day before slaughter. ■ 11. In § 520.1660a, revise the section NEW ANIMAL DRUGS Federal law restricts this drug to use by heading and paragraphs (e)(1) and (e)(3) or on the order of a licensed to read as follows: ■ 1. The authority citation for part 520 veterinarian. continues to read as follows: § 520.1660a Oxytetracycline and ■ 6. In § 520.1044a, revise paragraph carbomycin. Authority: 21 U.S.C. 360b. (d)(3) to read as follows: * * * * * § 520.110 [Amended] § 520.1044a Gentamicin sulfate oral (e) * * * solution. (1) Amount. Administer 1.0 gram of ■ 2. In § 520.110, in paragraph (d)(3), * * * * * oxytetracycline and 1.0 gram remove ‘‘Prepare fresh medicated water (d) * * * carbomycin per gallon for not more than daily.’’ and as the last sentence add (3) Limitations. Do not slaughter 5 days. ‘‘Federal law restricts this drug to use by or on the order of a licensed treated swine for food for at least 3 days * * * * * veterinarian.’’ following treatment. Federal law (3) Limitations. Not for use in restricts this drug to use by or on the chickens producing eggs for human § 520.441 [Amended] order of a licensed veterinarian. consumption. Withdraw 24 hours before ■ 3. In § 520.441, in paragraphs ■ 7. In § 520.1044c, remove paragraph slaughter. Federal law restricts this drug (d)(1)(i)(A)(2), (d)(2)(i)(A)(2), (d)(4) and revise paragraph (d)(3) to read to use by or on the order of a licensed (d)(4)(i)(A)(2), (d)(4)(i)(B)(2), as follows: veterinarian. (d)(4)(ii)(A)(2), (d)(4)(ii)(B)(2), ■ 12. In § 520.1660d, revise paragraphs § 520.1044c Gentamicin sulfate powder. (d)(4)(iii)(C), (d)(4)(iv)(C), (d)(5)(i)(A)(2), (d)(1)(i)(A)(1), (d)(1)(i)(A)(3), (d)(5)(ii)(A)(2), (d)(5)(iii)(C), and * * * * * (d)(1)(i)(B)(1), (d)(1)(i)(B)(3), (d)(5)(iv)(C), as the last sentence add (d) * * * (d)(1)(ii)(A)(1), (d)(1)(ii)(A)(3), ‘‘Federal law restricts this drug to use by (3) Limitations. Withdrawal period: 10 (d)(1)(ii)(B)(1), (d)(1)(ii)(B)(3), or on the order of a licensed days. Federal law restricts this drug to (d)(1)(ii)(C)(1), (d)(1)(ii)(C)(3), veterinarian.’’ use by or on the order of a licensed (d)(1)(iii)(A), (d)(1)(iii)(C), (d)(1)(iv)(A), veterinarian. (d)(1)(iv)(C), (d)(1)(v)(A), (d)(1)(v)(C), § 520.445 [Amended] (d)(2)(i), and (d)(2)(iii) to read as § 520.1263c [Amended] ■ 4. In § 520.445, in paragraph (d)(3), as follows: the last sentence add ‘‘Federal law ■ 8. In § 520.1263c, in paragraph (b)(1), restricts this drug to use by or on the remove ‘‘No. 016592’’ and in its place § 520.1660d Oxytetracycline powder. order of a licensed veterinarian.’’ add ‘‘Nos. 016592 and 054771’’; in * * * * * paragraph (d)(1)(iii), remove ‘‘051259’’ (d) * * * ■ 5. In § 520.823, revise paragraphs and in its place add ‘‘054925’’, and as (1) * * * (d)(1)(i), (d)(1)(iii), (d)(2)(i), (d)(2)(iii), the last sentence add ‘‘Federal law (d)(3)(i), and (d)(3)(iii) to read as (i) * * * restricts this drug to use by or on the (A) * * * follows: order of a licensed veterinarian.’’; and in (1) Amount. Administer 200 to 400 § 520.823 Erythromycin. paragraphs (d)(2)(iii) and (d)(3)(iii), add milligrams/gallon for 7 to 14 days. Not * * * * * ‘‘Federal law restricts this drug to use by to be used for more than 14 consecutive (d) * * * or on the order of a licensed days. (1) * * * veterinarian.’’ * * * * * (i) Amount. Administer 0.500 gram ■ 9. In § 520.1265, add paragraph (d)(3) (3) Do not use in birds producing eggs per gallon for 5 days. to read as follows: for human consumption. Federal law * * * * * restricts this drug to use by or on the § 520.1265 Lincomycin and spectinomycin (iii) Limitations. Do not use in powder. order of a licensed veterinarian. replacement pullets over 16 weeks of (B) * * * * * * * * (1) Amount. Administer 400 to 800 age. Do not use in chickens producing (d) * * * eggs for human consumption. Withdraw milligrams/gallon for 7 to 14 days. Not (3) Limitations. Federal law restricts 1 day before slaughter. Federal law to be used for more than 14 consecutive this drug to use by or on the order of restricts this drug to use by or on the days. a licensed veterinarian. order of a licensed veterinarian. * * * * * ■ 10. In § 520.1484, revise paragraphs (2) * * * (3) Do not use in birds producing eggs (i) Amount. Administer 0.500 gram (e)(1)(iii) and (e)(2)(iii) to read as for human consumption. Federal law per gallon for 7 days. follows: restricts this drug to use by or on the * * * * * § 520.1484 Neomycin. order of a licensed veterinarian. (iii) Limitations. Do not use in * * * * * (ii) * * * replacement pullets over 16 weeks of (e) * * ** (A) * * * age. Do not use in chickens producing (1) * * * (1) Amount. Administer 200 to 400 eggs for human consumption. Withdraw (iii) Limitations. Discontinue milligrams/gallon for 7 to 14 days. Not 1 day before slaughter. Federal law treatment prior to slaughter as follows: to be used for more than 14 consecutive asabaliauskas on DSK3SPTVN1PROD with RULES restricts this drug to use by or on the Cattle, 1 day; sheep, 2 days; swine and days. order of a licensed veterinarian. goats, 3 days. Federal law restricts this * * * * * (3) * * * drug to use by or on the order of a (3) Do not use in birds producing eggs (i) Amount. Administer 0.500 gram licensed veterinarian. for human consumption. Withdraw 5 per gallon for 7 days. (2) * * * days prior to slaughter those products * * * * * (iii) Limitations. Federal law restricts sponsored by Nos. 054771 and 061623 (iii) Limitations. Do not use in turkeys this drug to use by or on the order of in § 510.600(c) of this chapter. producing eggs for human consumption. a licensed veterinarian. Withdraw 4 days prior to slaughter VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00081 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

94990 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations those products sponsored by No. older. Federal law restricts this drug to sentence add ‘‘Federal law restricts this 054628. Zero-day withdrawal for those use by or on the order of a licensed drug to use by or on the order of a products sponsored by Nos. 057561 and veterinarian. licensed veterinarian.’’ 069254. Federal law restricts this drug (v) * * * to use by or on the order of a licensed (A) Amount. Administer 10 § 520.2218 [Amended] veterinarian. milligrams per pound of body weight ■ 17. In § 520.2218, in paragraphs (B) * * * daily for up to 14 days. Not to be used (d)(1)(ii) and (d)(2)(ii), remove the first (1) Amount. Administer 400 for more than 14 consecutive days. sentence, and as the last sentence add milligrams/gallon for 7 to 14 days. Not * * * * * ‘‘Federal law restricts this drug to use by to be used for more than 14 consecutive (C) Withdraw 5 days prior to or on the order of a licensed days. slaughter. Federal law restricts this drug veterinarian.’’ * * * * * to use by or on the order of a licensed ■ 18. In § 520.2220a, revise the section (3) Do not use in birds producing eggs veterinarian. heading and paragraphs (d)(1)(iii), for human consumption. Withdraw 5 (2) * * * (d)(2)(iii), and (d)(3)(iii) to read as days prior to slaughter those products (i) Amount. 200 milligrams per follows: sponsored by Nos. 054771 and 061623 colony, administered via either a 1:1 in § 510.600(c) of this chapter. sugar syrup (equal parts of sugar and § 520.2220a Sulfadimethoxine oral Withdraw 4 days prior to slaughter water weight to weight) or dusting with solution and soluble powder. those products sponsored by No. a powdered sugar mixture. The drug is * * * * * 054628. Zero-day withdrawal for those administered in 3 applications of sugar (d) * * * products sponsored by Nos. 057561 and syrup or 3 dustings at 4- to 5-day (1) * * * intervals. (iii) Limitations. Withdraw 5 days 069254. Federal law restricts this drug * * * * * before slaughter. Federal law restricts to use by or on the order of a licensed (iii) The drug should be fed early in this drug to use by or on the order of veterinarian. (C) * * * the spring or fall and consumed by the a licensed veterinarian. (1) Amount. Administer 25 milligrams bees before main honey flow begins to (2) * * * avoid contamination of production (iii) Limitations. Withdraw 5 days per pound of body weight daily for 7 to honey. Remove at least 6 weeks prior to before slaughter. Federal law restricts 14 days. Not to be used for more than main honey flow. Federal law restricts this drug to use by or on the order of 14 consecutive days. this drug to use by or on the order of a licensed veterinarian. * * * * * (3) * * * (3) Do not use in birds producing eggs a licensed veterinarian. ■ 13. In § 520.1696b, redesignate (iii) Limitations. Withdraw 7 days for human consumption. Withdraw 5 before slaughter. A withdrawal period days prior to slaughter those products paragraph (c) as paragraph (d) and add new paragraph (c), and revise has not been established for this product sponsored by Nos. 054771 and 061623 in preruminating calves. Do not use in in § 510.600(c) of this chapter. redesignated paragraph (d)(3) to read as follows: calves to be processed for veal. Federal Withdraw 4 days prior to slaughter law restricts this drug to use by or on those products sponsored by No. § 520.1696b Penicillin G powder. the order of a licensed veterinarian. 054628. Zero-day withdrawal for those Federal law prohibits the extralabel use * * * * * products sponsored by Nos. 057561 and (c) Related tolerances. See § 556.510 of this product in lactating dairy cattle. 069254. Federal law restricts this drug of this chapter. to use by or on the order of a licensed § 520.2261a [Amended] veterinarian. * * * * * (d) * * * ■ 19. In § 520.2261a, in paragraph (d)(3), (iii) * * * as the last sentence add ‘‘Federal law (3) Limitations. Discontinue treatment (A) Amount. Administer 10 restricts this drug to use by or on the at least 1 day prior to slaughter. Not for milligrams per pound of body weight order of a licensed veterinarian.’’ use in turkeys producing eggs for daily for up to 14 days. Do not use for human consumption. Federal law more than 14 consecutive days. § 520.2261b [Amended] restricts this drug to use by or on the * * * * * order of a licensed veterinarian. ■ 20. In § 520.2261b, in paragraphs (C) Withdraw zero days prior to (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and slaughter those products sponsored by § 520.2123b [Amended] (d)(4)(iii), as the last sentence add Nos. 054771, 057561, 061623, and ■ 14. In § 520.2123b, remove paragraph ‘‘Federal law restricts this drug to use by 069254 in § 510.600(c) of this chapter. (d)(1)(i); redesignate paragraphs or on the order of a licensed Withdraw 4 days prior to slaughter (d)(1)(ii) and (iii) as paragraphs (d)(1)(i) veterinarian.’’ those products sponsored by No. and (ii); and in paragraph (d)(2), as the 054628. Federal law restricts this drug § 520.2325a [Amended] last sentence add ‘‘Federal law restricts to use by or on the order of a licensed this drug to use by or on the order of ■ 21. In § 520.2325a, in paragraph (d), veterinarian. a licensed veterinarian.’’ remove the first sentence, and as the last (iv) * * * sentence add ‘‘Federal law restricts this (A) Amount. Administer 10 § 520.2184 [Amended] drug to use by or on the order of a milligrams per pound of body weight ■ 15. In § 520.2184, in paragraph (d)(3), licensed veterinarian.’’ asabaliauskas on DSK3SPTVN1PROD with RULES daily for up to 14 days. Do not use for remove the first sentence, and as the last more than 14 consecutive days. § 520.2345d [Amended] sentence add ‘‘Federal law restricts this * * * * * drug to use by or on the order of a ■ 22. In § 520.2345d, in paragraphs (C) Withdraw 5 days prior to licensed veterinarian.’’ (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and slaughter. A milk discard period has not (d)(4)(iii), as the last sentence add been established for this product in § 520.2200 [Amended] ‘‘Federal law restricts this drug to use by lactating dairy cattle. Do not use in ■ 16. In § 520.2200, in paragraphs or on the order of a licensed female dairy cattle 20 months of age or (d)(1)(iii) and (d)(2)(iii), as the last veterinarian.’’ VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00082 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 94991 PART 529—CERTAIN OTHER DOSAGE animal drug applications (ANADAs) for supplemental NADAs and 35 FORM NEW ANIMAL DRUGS revised labeling reflecting a change in supplemental ANADAs for revised marketing status from over-the-counter labeling reflecting a change in marketing ■ 23. The authority citation for part 529 (OTC) use to use by veterinary feed status from OTC use to use by VFD for continues to read as follows: directive (VFD) for antimicrobial drugs antimicrobial drugs of importance to Authority: 21 U.S.C. 360b. of importance to human medicine human medicine administered to food- ■ 24. In § 529.1660, add paragraph (d)(3) administered to food-producing animals producing animals in medicated feed. to read as follows: in medicated feed. Where applicable, Where applicable, FDA is also FDA is also withdrawing approval of withdrawing approval of those parts of § 529.1660 Oxytetracycline. those parts of the NADAs that pertain to the NADAs that pertain to use of these * * * * * use of these antimicrobial drugs for antimicrobial drugs for growth (d) * * * growth promotion indications. These actions are being taken at the sponsors’ promotion indications. These actions (3) Limitations. Federal law restricts requests because these particular are being taken at the sponsors’ requests this drug to use by or on the order of a licensed veterinarian. medicated feeds will no longer be because these particular medicated manufactured or marketed. These feeds will no longer be manufactured or Dated: December 20, 2016. marketed. applications were submitted in Tracey H. Forfa, voluntary compliance with the goals of These applications were identified as Deputy Director, Center for Veterinary FDA Center for Veterinary Medicine’s Medicine. being affected by guidance for industry (CVM’s) Judicious Use Initiative. In (GFI) #213, ‘‘New Animal Drugs and [FR Doc. 2016–31084 Filed 12–23–16; 8:45 am] addition, the animal drug regulations New Animal Drug Combination BILLING CODE 4164–01–P are being amended to reflect the Products Administered in or on voluntary withdrawal of approval of Medicated Feed or Drinking Water of certain entire NADAs and ANADAs that Food-Producing Animals: DEPARTMENT OF HEALTH AND were affected by this initiative. The HUMAN SERVICES Recommendations for Drug Sponsors for animal drug regulations are also being Voluntarily Aligning Product Use amended to reflect several non- Food and Drug Administration Conditions with GFI #209’’, December substantive changes in format. These technical amendments are being made 2013 (http://www.fda.gov/downloads/ 21 CFR Parts 556 and 558 AnimalVeterinary/ to improve the consistency and [Docket No. FDA–2016–N–0002] readability of the regulations. GuidanceComplianceEnforcement/ DATES: This rule is effective December GuidanceforIndustry/UCM299624.pdf). New Animal Drugs for Use in Animal 30, 2016. Their change to VFD marketing status is Feed; Approval of New Animal Drug consistent with FDA CVM’s initiative FOR FURTHER INFORMATION CONTACT: Applications; Withdrawal of Approval for the Judicious Use of Antimicrobials. George K. Haibel, Center for Veterinary of New Animal Drug Applications Medicine (HFV–6), Food and Drug The animal drug regulations for AGENCY: Food and Drug Administration, Administration, 7519 Standish Pl., medicated feeds are also being amended HHS. Rockville, MD 20855, 240–402–5689, to reflect several non-substantive Final rule; technical ACTION: george.haibel@fda.hhs.gov. changes in format. These technical amendment. SUPPLEMENTARY INFORMATION: amendments are being made to improve I. Supplemental Approval of Revised the consistency and readability of the SUMMARY: The Food and Drug regulations. Administration (FDA) is amending the Labeling and Withdrawal of Approval animal drug regulations to reflect of Portions of NADAs Pertaining to The affected applications for Type A approval of 71 supplemental new Production Indications medicated articles for which animal drug applications (NADAs) and FDA is amending the animal drug supplemental applications with revised 35 supplemental abbreviated new regulations to reflect approval of 71 labeling were approved follow: File No. Animal drug product Sponsor 006–391 ........ S.Q. 40% (sulfaquinoxaline) Type A Medicated Article ............. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 008–804 ........ TM–50 or TM–100 (oxytetracycline) Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 010–092 ........ GALLIMYCIN–100P (erythromycin) Type A Medicated Article .. Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.). 010–918 ........ HYGROMIX 8 (hygromycin B) Type A Medicated Article .......... Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). 012–491 ........ TYLAN (tylosin) Type A Medicated Article ................................. Elanco US Inc. 033–950 ........ Sulfamerazine In Fish Grade ...................................................... Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). asabaliauskas on DSK3SPTVN1PROD with RULES 035–688 ........ AUREOMIX S 40/40 (chlortetracycline and sulfamethazine) Zoetis Inc. Granular Type A Medicated Article. 035–805 ........ AUREO S 700 (chlortetracycline and sulfamethazine) Granular Zoetis Inc. Type A Medicated Article. 038–439 ........ TERRAMYCIN 200 (oxytetracycline) for Fish Type A Medi- Phibro Animal Health Corp. cated Article. 040–209 ........ ROFENAID 40 (sulfadimethoxine and ormetoprim) Type A Zoetis Inc. Medicated Article. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00083 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1


Document Created: 2018-02-14 09:13:37
Document Modified: 2018-02-14 09:13:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesThis rule is effective December 31, 2016.
ContactGeorge K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation81 FR 94987 
CFR Citation21 CFR 520
21 CFR 529
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