Document ID: FDA-2016-N-0002-0034
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Approval of New Animal Drug 
Applications
Posted Date: 2016-12-27T05:00Z

[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 94987-94991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
george.haibel@fda.hhs.gov.

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