Document ID: FDA-2015-N-0002-0059
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
Posted Date: 2015-12-22T05:00Z

[Federal Register Volume 80, Number 245 (Tuesday, December 22, 2015)]
[Rules and Regulations]
[Pages 79474-79476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32000]

[[Page 79474]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2015-N-0002]

New Animal Drugs for Use in Animal Feeds; Bacitracin 
Methylenedisalicylate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Pharmgate LLC for the use of a Type A 
medicated article containing bacitracin methylenedisalicylate to 
manufacture Type B and Type C medicated feeds for chickens, turkeys, 
pheasants, quail, and feedlot cattle. This supplemental approval 
reflects FDA's effectiveness conclusions that relied on the National 
Academy of Sciences/National Research Council Drug Efficacy Study 
Group's evaluation of the effectiveness of this drug as well 
indications for use not subject to this review.

DATES: This rule is effective December 22, 2015.

FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0589, email: matthew.lucia@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2003 
(68 FR 47332), as corrected October 7, 2003 (68 FR 57911), as part of 
the Drug Efficacy Study Implementation (DESI) program, the Center for 
Veterinary Medicine (CVM) announced the effective conditions of use for 
several drug products and use combinations that were listed in 21 CFR 
558.15. CVM proposed to withdraw the NADAs for those products or use 
combinations lacking substantial evidence of effectiveness following a 
90-day opportunity to supplement the NADAs with labeling conforming to 
the relevant findings of effectiveness.
    In response to that notice of opportunity for a hearing (NOOH), 
Pennfield Oil Co. (Pennfield), 14040 Industrial Rd., Omaha, NE 68144, 
filed a hearing request for its approved, non-DESI finalized NADA 141-
137 for a bacitracin methylenedisalicylate Type A medicated article.
    In March 2015, Pennfield transferred sponsorship of NADA 141-137 to 
Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 
(Pharmgate) (80 FR 13226, March 13, 2015). Subsequently, Pharmgate 
filed a supplement to NADA 141-137 for PENNITRACIN MD 50G (bacitracin 
Type A medicated article) with labeling conforming to the findings of 
effectiveness in the 2003 NOOH. In addition, the submitted labeling 
included indications for use approved by FDA that were not subject to 
DESI findings of effectiveness (34 FR 7906, May 20, 1969).
    The supplemental NADA provides for use of a Type A medicated 
article containing bacitracin methylenedisalicylate to manufacture Type 
B and Type C medicated feeds for several production and therapeutic 
indications in broiler and replacement chickens, growing turkeys, 
growing pheasants, growing quail, and beef steers and heifers fed in 
confinement for slaughter. The supplemental NADA is approved as of 
October 6, 2015, and the regulations are amended in 21 CFR 558.76 to 
reflect the approval. Pharmgate, as successor to Pennfield, has since 
withdrawn the hearing request for NADA 141-137.
    Approval of this supplemental NADA did not require review of any 
new safety or effectiveness data. Therefore, a freedom of information 
summary was not prepared.
    The DESI evaluation was concerned only with the effectiveness of 
the drug products and use combinations. Nothing in this document 
constitutes a bar to further proceedings with respect to questions of 
safety of the subject drugs in treated animals or of the drugs or their 
metabolites in food products derived from treated animals.
    Products that comply with FDA's findings of effectiveness are 
eligible for copying, as described in the ``Generic Animal Drug and 
Patent Term Restoration Act; Eighth Policy Letter,'' August 21, 1991 
(56 FR 41561). Accordingly, sponsors may now obtain approval of 
abbreviated NADAs for this Type A medicated article.
    The Agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

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

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

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

0
2. Amend Sec.  558.76 as follows:
0
a. Revise the section heading and paragraph (a);
0
b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and 
(e);
0
c. Add new paragraph (b); and
0
d. Revise newly redesignated paragraph (e)(1).
    The revisions and addition read as follows:

Sec.  558.76  Bacitracin methylenedisalicylate.

    (a) Specifications. (1) Type A medicated articles containing 10, 
25, 30, 40, 50, 60, or 75 grams bacitracin methylenedisalicylate per 
pound.
    (2) Type A medicated article containing 50 grams bacitracin 
methylenedisalicylate per pound.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 054771 for use of products in paragraph (a)(1) of this 
section as in paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v) through 
(xiii), and (e)(1)(xv) of this section.
    (2) No. 069254 for use of products in paragraph (a)(2) of this 
section as in paragraphs (e)(1)(ii), (e)(1)(iv), (e)(1)(xiv), and 
(e)(1)(xvi) of this section.
* * * * *
    (e) * * *
    (1) It is used as follows:

[[Page 79475]]

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                                  Combination in
          Bacitracin            grams per ton (g/    Indications for use        Limitations           Sponsor
 methylenedisalicylate amount          ton)
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(i) 4 to 50 g/ton.............  .................  Chickens, turkeys, and  .....................          054771
                                                    pheasants: For
                                                    increased rate of
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
(ii) 4 to 50 g/ton............  .................  Broiler and             .....................          069254
                                                    replacement chickens,
                                                    growing turkeys, and
                                                    growing pheasants:
                                                    For increased rate of
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
(iii) 5 to 20 g/ton...........  .................  Quail not over 5 weeks  .....................          054771
                                                    of age: For increased
                                                    rate of weight gain
                                                    and improved feed
                                                    efficiency.
(iv) 5 to 20 g/ton............  .................  Growing quail: For      For use in quail not           069254
                                                    increased rate of       over 5 weeks of age.
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
(v) 10 to 25 g/ton............  .................  Chickens: For           For first 7 months of          054771
                                                    increased egg           production.
                                                    production and
                                                    improved feed
                                                    efficiency for egg
                                                    production.
(vi) 10 to 30 g/ton...........  .................  Swine: For increased    For growing and                054771
                                                    rate of weight gain     finishing swine.
                                                    and improved feed
                                                    efficiency.
(vii) 10 to 30 g/ton..........  Chlortetracycline  Swine: For increased    Feed for not more              054771
                                 approximately      rate of weight gain     than 14 days;                 069254
                                 400, varying       and improved feed       bacitracin
                                 with body weight   efficiency; for         methylenedisalicylat
                                 and food           treatment of            e provided by No.
                                 consumption to     bacterial enteritis     054771;
                                 provide 10         caused by Escherichia   chlortetracycline
                                 milligrams (mg)    coli and Salmonella     provided by Nos.
                                 per pound of       choleraesuis and        054771 and 069254 in
                                 body weight per    bacterial pneumonia     Sec.   510.600(c) of
                                 day.               caused by Pasteurella   this chapter.
                                                    multocida susceptible
                                                    to chlortetracycline.
(viii) 10 to 30 g/ton.........  .................  Swine: For control of   Feed for not more              054771
                                                    porcine proliferative   than 14 days;
                                                    enteropathies           chlortetracycline
                                                    (ileitis) caused by     and bacitracin
                                                    Lawsonia                methylenedisalicylat
                                                    intracellularis         e as provided by No.
                                                    susceptible to          054771 in Sec.
                                                    chlortetracycline.      510.600(c) of this
                                                                            chapter.
(ix) 50 g/ton.................  .................  Broiler chickens: As    Feed continuously as           054771
                                                    an aid in the           sole ration.
                                                    prevention of
                                                    necrotic enteritis
                                                    caused or complicated
                                                    by Clostridium spp.
                                                    or other organisms
                                                    susceptible to
                                                    bacitracin.
                                                    Replacement chickens:
                                                    As an aid in the
                                                    prevention of
                                                    necrotic enteritis
                                                    caused or complicated
                                                    by Clostridium spp.
                                                    or other organisms
                                                    susceptible to
                                                    bacitracin.
(x) 100 to 200 g/ton..........  .................  Broiler chickens: As    Feed continuously as           054771
                                                    an aid in the control   sole ration. Start
                                                    of necrotic enteritis   at first clinical
                                                    caused or complicated   signs of disease,
                                                    by Clostridium spp.     vary dosage based on
                                                    or other organisms      severity of
                                                    susceptible to          infection,
                                                    bacitracin.             administer
                                                    Replacement chickens:   continuously for 5
                                                    As an aid in the        to 7 days or as long
                                                    control of necrotic     as clinical signs
                                                    enteritis caused or     persist, then reduce
                                                    complicated by          medication to
                                                    Clostridium spp. or     prevention level (50
                                                    other organisms         g/ton).
                                                    susceptible to
                                                    bacitracin.
(xi) 200 g/ton................  .................  Turkeys: As an aid in   Feed continuously as           054771
                                                    the control of          the sole ration.
                                                    transmissible
                                                    enteritis in growing
                                                    turkeys complicated
                                                    by organisms
                                                    susceptible to
                                                    bacitracin
                                                    methylenedisalicylate
                                                    . Quail: For the
                                                    prevention of
                                                    ulcerative enteritis
                                                    in growing quail due
                                                    to Clostridium
                                                    colinum susceptible
                                                    to bacitracin
                                                    methylenedisalicylate.
(xii) 250 g/ton...............  .................  1. Growing/finishing    As the sole ration.            054771
                                                    swine: For control of   Not for use in swine
                                                    swine dysentery         weighing more than
                                                    Treponema               250 pounds.
                                                    hyodysenteriae on       Diagnosis should be
                                                    premises with history   confirmed by a
                                                    of swine dysentery      veterinarian a when
                                                    but where signs of      results are not
                                                    the disease have not    satisfactory.
                                                    yet occurred; or
                                                    following an approved
                                                    treatment of the
                                                    disease condition.

[[Page 79476]]

 
                                                   2. Pregnant sows: For   As the sole ration.
                                                    control of              Feed to sows from 14
                                                    clostridial enteritis   days before through
                                                    caused by C.            21 days after
                                                    perfringens in          farrowing on
                                                    suckling piglets.       premises with a
                                                                            history of
                                                                            clostridial scours.
                                                                            Diagnosis should be
                                                                            confirmed by
                                                                            veterinarian when
                                                                            results are not
                                                                            satisfactory.
(xiii) To provide 70 mg per     .................  Feedlot beef cattle:    Administer                     054771
 head per day.                                      For reduction in the    continuously
                                                    number of liver         throughout the
                                                    condemnations due to    feeding period.
                                                    abscesses.
(xiv) To provide 70 mg per      .................  Beef steers and         Administer                     069254
 head per day.                                      heifers fed in          continuously
                                                    confinement for         throughout the
                                                    slaughter: For          feeding period.
                                                    reduction in the
                                                    number of liver
                                                    condemnations due to
                                                    abscesses.
(xv) To provide 250 mg per      .................  Feedlot beef cattle:    Administer                     054771
 head per day.                                      For reduction in the    continuously for 5
                                                    number of liver         days then
                                                    condemnations due to    discontinue for
                                                    abscesses.              subsequent 25 days,
                                                                            repeat the pattern
                                                                            during the feeding
                                                                            period.
(xvi) To provide 250 mg per     .................  Beef steers and         Administer                     069254
 head per day.                                      heifers fed in          continuously for 5
                                                    confinement for         days then
                                                    slaughter: For          discontinue for
                                                    reduction in the        subsequent 25 days,
                                                    number of liver         repeat the pattern
                                                    condemnations due to    during the feeding
                                                    abscesses.              period.
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* * * * *

    Dated: December 16, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-32000 Filed 12-21-15; 8:45 am]
BILLING CODE 4164-01-P