Document ID: FDA-2017-N-0002-0011
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor’s Name and Address
Posted Date: 2018-03-30T04:00Z

[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13632-13637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06358]

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

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 556, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Changes of 
Sponsorship; Change of a Sponsor's Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during July, August, and September 2017. FDA is 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. The 
animal drug regulations are also being amended to reflect the 
withdrawal of approval of applications, changes of sponsorship of 
applications, and a change of a sponsor's name and address, and to make 
technical amendments to improve the accuracy of the regulations.

DATES: This rule is effective March 30, 2018, except for amendatory 
instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 
522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during July, August, and September 2017, 
as listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., 
Monday through Friday. Persons with access to the internet may obtain 
these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and 
patent information may be accessed in FDA's publication, Approved 
Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Approval date        File No.        Sponsor              Product name               Species          Effect of the action     Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 21, 2017...........    141-450  Intervet, Inc., 2    BANAMINE Transdermal      Cattle..............  Original approval for    FOI Summary; EA/
                                      Giralda Farms,       (flunixin transdermal                           the control of pyrexia   FONSI.\1\
                                      Madison, NJ 07940.   solution) Solution.                             associated with bovine
                                                                                                           respiratory disease
                                                                                                           and the control of
                                                                                                           pain associated with
                                                                                                           foot rot in steers,
                                                                                                           beef heifers, beef
                                                                                                           cows, beef bulls
                                                                                                           intended for
                                                                                                           slaughter, and
                                                                                                           replacement dairy
                                                                                                           heifers under 20
                                                                                                           months of age.

[[Page 13633]]

 
July 19, 2017...........    141-336  ECO LLC, 344 Nassau  AIVLOSIN (tylvalosin      Swine...............  Supplemental approval    FOI Summary.
                                      St., Princeton, NJ   tartrate) Water Soluble                         for control of swine
                                      08540.               Granules.                                       respiratory disease
                                                                                                           (SRD) associated with
                                                                                                           Bordetella
                                                                                                           bronchiseptica,
                                                                                                           Haemophilus parasuis,
                                                                                                           Pasteurella multocida,
                                                                                                           and Streptococcus suis
                                                                                                           in groups of swine in
                                                                                                           buildings experiencing
                                                                                                           an outbreak of SRD.
July 14, 2017...........    200-620  Aurora               ALTREN (altrenogest)      Horses..............  Original approval as a   FOI Summary.
                                      Pharmaceutical,      Solution.                                       generic copy of NADA
                                      LLC, 1196 Highway                                                    131-310.
                                      3 South,
                                      Northfield, MN
                                      55057-3009.
July 14, 2017...........    200-621  Aurora               SWINEMATE (altrenogest)   Swine...............  Original approval as a   FOI Summary.
                                      Pharmaceutical,      Solution.                                       generic copy of NADA
                                      LLC, 1196 Highway                                                    141-222.
                                      3 South,
                                      Northfield, MN
                                      55057-3009.
September 15, 2017......    141-250  Zoetis Inc., 333     Chlortetracycline and     Cattle..............  Supplemental approval    .....................
                                      Portage St.,         lasalocid Type B and                            of revised
                                      Kalamazoo, MI        Type C medicated feeds.                         representative
                                      49007.                                                               labeling making
                                                                                                           technical amendments.
September 28, 2017......    141-333  Virbac AH, Inc.,     SENTINEL SPECTRUM         Dogs................  Supplemental approval    FOI Summary.
                                      3200 Meacham         (milbemycin oxime/                              for the treatment and
                                      Blvd., Ft. Worth,    lufenuron/praziquantel).                        control of the adult
                                      TX 76137.                                                            tapeworm Dipylidium
                                                                                                           caninum.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Change of Sponsorship

    SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe, 
KS 66061-1304 has informed FDA that it has transferred ownership of, 
and all rights and interest in, the following application to Sparhawk 
Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:

------------------------------------------------------------------------
            File No.                  Product name        21 CFR Section
------------------------------------------------------------------------
200-348........................  ECOMECTIN (ivermectin)        524.1193
                                  Topical Solution.
------------------------------------------------------------------------

Following this withdrawal of approval, SmartVet USA, Inc. is no longer 
the sponsor of an approved application. Accordingly, it will be removed 
from the list of sponsors of approved applications in Sec.  510.600(c) 
(21 CFR 510.600(c)).
    Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., 
St. Joseph, MO 64503 has informed FDA that it has transferred ownership 
of, and all rights and interest in, the following application to Cross 
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

------------------------------------------------------------------------
            File No.                  Product name        21 CFR Section
------------------------------------------------------------------------
109-305........................  Oxytocin Injection....        522.1680
------------------------------------------------------------------------

The animal drug regulations are being amended to reflect these changes 
of sponsorship.

III. Withdrawals of Approval

    The following sponsors requested that FDA withdraw approval of the 
NADAs listed in the following table because the products are no longer 
manufactured or marketed:

----------------------------------------------------------------------------------------------------------------
              File No.                           Sponsor                    Product name          21 CFR Section
----------------------------------------------------------------------------------------------------------------
047-055.............................  Watson Laboratories, Inc.,    Chorionic Gonadotropin              522.1081
                                       311 Bonnie Circle, Corona,    Powder for Injection.
                                       CA 92880.
104-606.............................  Watson Laboratories, Inc.,    Dexamethasone Sodium                 522.540
                                       311 Bonnie Circle, Corona,    Phosphate Injection.
                                       CA 92880.

[[Page 13634]]

 
139-633.............................  Wildlife Laboratories, Inc.,  WILDNIL (carfentanil                 522.300
                                       1230 W. Ash St., Suite D,     citrate) Injection.
                                       Windsor, CO 80550.
----------------------------------------------------------------------------------------------------------------

    Following this withdrawal of approval, Watson Laboratories, Inc. is 
no longer the sponsor of an approved application. Accordingly, it will 
be removed from the list of sponsors of approved applications in Sec.  
510.600(c).
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 047-055, 104-606, and 139-633, and all 
supplements and amendments thereto, is withdrawn, effective April 9, 
2018. As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect these actions.

IV. Technical Amendments

    Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has 
informed FDA that it has changed its name and address to Syndel USA, 
1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc., 
1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has 
changed its name to ADM Animal Nutrition, Inc. Accordingly, we are 
amending Sec.  510.600(c) to reflect these changes.
    We are also making technical amendments to update the scientific 
name of a pathogenic bacterium, to accurately list the concentrations 
of ingredients in a combination new animal drug, and to correctly list 
the assay limits and maximum drug concentration in Type B medicated 
feeds for a combination new animal drug used in feed. These actions are 
being taken to improve the accuracy of the regulations.

V. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires 
Federal Register publication of ``notice[s] . . . effective as a 
regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
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. 
Likewise, this is not a rule subject to Executive Order 12866, which 
defines a rule as ``an agency statement of general applicability and 
future effect, which the agency intends to have the force and effect of 
law, that is designed to implement, interpret, or prescribe law or 
policy or to describe the procedure or practice requirements of an 
agency.''

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 520, 522, 524, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

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

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``ADM Alliance Nutrition, Inc.'', ``SmartVet USA, Inc.'' 
and ``Western Chemical, Inc.'', and add entries for ``ADM Animal 
Nutrition, Inc.'' and ``Syndel USA'' in alphabetical order; and in the 
table in paragraph (c)(2), remove the entry for ``086001'' and revise 
the entries for ``012286'' and ``050378'' to read as follows:

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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy,          012286
 IL 62305-3115..........................................
 
                              * * * * * * *
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.......          050378
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
             Drug labeler code                                                          Firm name and address
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
012286.....................................  ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.
 

[[Page 13635]]

 
                                                                      * * * * * * *
050378.....................................  Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
3. Effective April 9, 2018,'' in Sec.  510.600, in the table in 
paragraph (c)(1), remove the entry for ``Watson Laboratories, Inc.''; 
and in the table in paragraph (c)(2), remove the entry for ``000402''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for part 520 continues to read as follows:

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

Sec.  520.48  [Amended]

0
5. In Sec.  520.48, in paragraph (b), remove ``000061 and 061623'' and 
in its place add ``000061, 051072, and 061623''.

Sec.  520.1447  [Amended]

0
6. In Sec.  520.1447, in paragraph (d)(1)(ii), remove ``(Taenia 
pisiformis, Echinococcus multilocularis, and E. granulosus)'' and in 
its place add ``(Dipylidium caninum, Taenia pisiformis, Echinococcus 
multilocularis, and E. granulosus)''.

0
7. In Sec.  520.2645, revise paragraphs (d)(1) and (2) to read as 
follows:

Sec.  520.2645  Tylvalosin.

* * * * *
    (d) * * *
    (1) Amount. Administer 50 parts per million (ppm) tylvalosin 
continuously in drinking water for 5 consecutive days.
    (2) Indications for use. For control of porcine proliferative 
enteropathy (PPE) associated with Lawsonia intracellularis infection in 
groups of swine in buildings experiencing an outbreak of PPE; and for 
control of swine respiratory disease (SRD) associated with Bordetella 
bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and 
Streptococcus suis in groups of swine in buildings experiencing an 
outbreak of SRD.
* * * * *

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

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

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

Sec.  522.300  [Removed]

0
9. Effective April 9, 2018, remove Sec.  522.300.

0
10. Effective April 9, 2018, in Sec.  522.540, revise paragraphs (b)(2) 
and (c)(2) to read as follows:

Sec.  522.540  Dexamethasone solution.

* * * * *
    (b) * * *
    (2) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
* * * * *
    (c) * * *
    (2) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  522.1081  [Amended]

0
11. Effective April 9, 2018, in Sec.  522.1081, in paragraph (b)(1), 
remove ``Nos. 000402 and 054771'' and in its place add ``No. 054771''.

Sec.  522.1662a  [Amended]

0
12. In Sec.  522.1662a, in paragraph (h)(3)(ii), remove ``Spherophorus 
necrophorus'' and in its place add ``Fusobacterium necrophorum''.

Sec.  522.1680  [Amended]

0
13. In Sec.  522.1680, in paragraph (b), remove ``054628,''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
14. The authority citation for part 524 continues to read as follows:

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

0
15. Add Sec.  524.970 to read as follows:

Sec.  524.970  Flunixin.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine).
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.286 of this chapter.
    (d) Conditions of use--(1) Amount. Apply only once at a dose of 3.3 
mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically 
in a narrow strip along the dorsal midline from the withers to the 
tailhead.
    (2) Indications for use. For the control of pyrexia associated with 
bovine respiratory disease and the control of pain associated with foot 
rot in steers, beef heifers, beef cows, beef bulls intended for 
slaughter, and replacement dairy heifers under 20 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Cattle must not be slaughtered 
for human consumption within 8 days of the last treatment. Not for use 
in female dairy cattle 20 months of age or older, including dry dairy 
cows; use in these cattle may cause drug residues in milk and/or in 
calves born to these cows or heifers. Not for use in suckling beef 
calves, dairy calves, and veal calves. A withdrawal period has not been 
established for this product in pre-ruminating calves.

0
16. In Sec.  524.1132, revise paragraph (a) to read as follows:

Sec.  524.1132  Hydrocortisone, miconazole, and gentamicin otic 
suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 
1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole 
nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).
* * * * *

Sec.  524.1193  [Amended]

0
17. In Sec.  524.1193, in paragraph (b)(2), remove ``086001'' and in 
its place add ``058005''.

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

0
18. The authority citation for part 556 continues to read as follows:

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

Sec.  556.286  [Amended]

0
19. In Sec.  556.286, in paragraph (c), remove ``Sec. Sec.  522.956 and 
522.970'' and in its place add ``Sec. Sec.  522.956, 522.970, and 
524.970''.

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

0
20. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
21. In Sec.  558.4, in paragraph (d), in the ``Category II'' table, 
revise the row entries for ``Neomycin'' through ``Pyrantel tartrate'' 
to read as follows:

[[Page 13636]]

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                               Assay limits                                       Assay limits
                    Drug                        percent \1\        Type B maximum (100x)        percent \1\ Type
                                                Type A \1\                                          B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Neomycin....................................          80-120  20 g/lb (4.4%).................             70-125
Oxytetracycline.............................          80-120  20 g/lb (4.4%).................             65-135
Neomycin sulfate............................          80-120  100 g/lb (22.0%)...............             70-125
Nicarbazin (granular).......................          90-110  5.675 g/lb (1.25%).............      85-115/75-125
Narasin.....................................          90-110  5.675 g/lb (1.25%).............      85-115/75-125
Nicarbazin (powder).........................          98-106  5.675 g/lb (1.25%).............      85-115/80-120
Novobiocin..................................          85-115  17.5 g/lb (3.85%)..............             80-120
Pyrantel tartrate...........................          90-110  36 g/lb (7.9%).................             75-125
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.

* * * * *

0
22. In Sec.  558.128, revise paragraphs (e)(3)(vi), (e)(4)(ix), and 
(e)(4)(xxvi) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
    Chlortetracycline amount          grams/ton        Indications for use         Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(vi) 10 mg/lb of body weight...  Tiamulin hydrogen   For control of swine    Feed chlortetracycline       058198
                                  fumarate, 35.       dysentery associated    at approximately 400        069254
                                                      with Brachyspira        g/ton of feed,
                                                      (formerly Serpulina     varying with body
                                                      or Treponema)           weight and food
                                                      hyodysenteriae          consumption, to
                                                      susceptible to          provide 10 mg/lb of
                                                      tiamulin and for        body weight. Feed
                                                      treatment of swine      continuously as the
                                                      bacterial enteritis     sole ration for 14
                                                      caused by E. coli and   days. Withdraw
                                                      Salmonella              medicated feed 2 days
                                                      choleraesuis            before slaughter.
                                                      sensitive to            Tiamulin as provided
                                                      chlortetracycline and   by Nos. 058198 or
                                                      treatment of            069254 in Sec.
                                                      bacterial pneumonia     510.600(c) of this
                                                      caused by P.            chapter.
                                                      multocida sensitive
                                                      to chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
    Chlortetracycline amount          grams/ton        Indications for use         Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
 

[[Page 13637]]

 
                                                  * * * * * * *
(ix) 500 to 4,000 to provide 10  Lasalocid, 30 to    Pasture cattle          Feed continuously on a       054771
 mg/lb of body weight daily.      600.                (slaughter, stocker,    hand-fed basis for
                                                      feeder cattle, dairy    not more than 5 days
                                                      and beef replacement    to provide 10 mg
                                                      heifers): For           chlortetracycline per
                                                      treatment of            lb. body weight per
                                                      bacterial enteritis     day and not less than
                                                      caused by E. coli and   60 mg or more than
                                                      bacterial pneumonia     300 mg lasalocid per
                                                      caused by P.            head per day in at
                                                      multocida organisms     least 1 pound of
                                                      susceptible to          feed. Daily lasalocid
                                                      chlortetracycline;      intakes in excess of
                                                      and for increased       200 mg/head/day in
                                                      rate of weight gain.    pasture cattle have
                                                                              not been shown to be
                                                                              more effective than
                                                                              200 mg lasalocid/head/
                                                                              day. Do not allow
                                                                              horses or other
                                                                              equines access to
                                                                              feeds containing
                                                                              lasalocid. No
                                                                              withdrawal period is
                                                                              required. A
                                                                              withdrawal period has
                                                                              not been established
                                                                              for this product in
                                                                              pre-ruminating
                                                                              calves. Do not use in
                                                                              calves to be
                                                                              processed for veal.
                                                                              See Sec.   558.311(d)
                                                                              of this chapter.
                                                                              Lasalocid as provided
                                                                              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                              chapter.
 
                                                  * * * * * * *
(xxvi) 500 to 4,000 to provide   Lasalocid, 30 to    Cattle weighing up to   Hand feed continuously       054771
 10 mg/head/day.                  181.8.              800 pounds: For the     for not more than 5
                                                      treatment of            days at a rate of 10
                                                      bacterial enteritis     mg chlortetracycline
                                                      caused by E. coli and   and 1 mg lasalocid
                                                      bacterial pneumonia     per 2.2 lb. body
                                                      caused by P.            weight daily to
                                                      multocida susceptible   cattle with a maximum
                                                      to chlortetracycline;   of 360 mg of
                                                      and for the control     lasalocid per head
                                                      of coccidiosis caused   per day. Do not allow
                                                      by Eimeria bovis and    horses or other
                                                      E. zuernii.             equines access to
                                                                              feeds containing
                                                                              lasalocid. No
                                                                              withdrawal period is
                                                                              required. A
                                                                              withdrawal period has
                                                                              not been established
                                                                              for this product in
                                                                              pre-ruminating
                                                                              calves. Do not use in
                                                                              calves to be
                                                                              processed for veal.
                                                                              See Sec.   558.311(d)
                                                                              of this chapter.
                                                                              Lasalocid as provided
                                                                              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
23. In Sec.  558.325, revise paragraph (d)(2) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (d) * * *
    (2) The expiration date of VFDs for lincomycin medicated feeds must 
not exceed 6 months from the date of issuance. VFDs for lincomycin 
shall not be refilled.
* * * * *

Sec.  558.575  [Amended]

0
24. In Sec.  558.575, in paragraph (e)(2)(ii) remove ``and bacterial 
infections due to H. galmaxima,''.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06358 Filed 3-29-18; 8:45 am]
 BILLING CODE 4164-01-P