New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate, 79474-79476 [2015-32000]
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79474
Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Rules and Regulations
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.
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
rmajette on DSK2TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:05 Dec 21, 2015
Jkt 238001
Industrial Rd., Omaha, NE 68144, filed
a hearing request for its approved, nonDESI 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
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
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
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.
2. Amend § 558.76 as follows:
a. Revise the section heading and
paragraph (a);
■ b. Redesignate paragraphs (b), (c), and
(d) as paragraphs (c), (d), and (e);
■ c. Add new paragraph (b); and
■ d. Revise newly redesignated
paragraph (e)(1).
The revisions and addition read as
follows:
■
■
§ 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
§ 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:
E:\FR\FM\22DER1.SGM
22DER1
Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Rules and Regulations
Combination in
grams per ton
(g/ton)
(i) 4 to 50 g/ton .................
..............................
(ii) 4 to 50 g/ton .................
..............................
(iii) 5 to 20 g/ton ................
..............................
(iv) 5 to 20 g/ton ................
..............................
(v) 10 to 25 g/ton ..............
..............................
(vi) 10 to 30 g/ton ..............
..............................
(vii) 10 to 30 g/ton .............
(viii) 10 to 30 g/ton ............
Chlortetracycline
approximately
400, varying
with body
weight and food
consumption to
provide 10 milligrams (mg) per
pound of body
weight per day.
..............................
(ix) 50 g/ton .......................
..............................
(x) 100 to 200 g/ton ..........
..............................
(xi) 200 g/ton .....................
..............................
(xii) 250 g/ton ....................
rmajette on DSK2TPTVN1PROD with RULES
Bacitracin
methylenedisalicylate
amount
..............................
VerDate Sep<11>2014
15:05 Dec 21, 2015
Jkt 238001
79475
Indications for use
Limitations
Chickens, turkeys, and pheasants:
For increased rate of weight gain
and improved feed efficiency.
Broiler and replacement chickens,
growing turkeys, and growing
pheasants: For increased rate of
weight gain and improved feed efficiency.
Quail not over 5 weeks of age: For
increased rate of weight gain and
improved feed efficiency.
Growing quail: For increased rate of
weight gain and improved feed efficiency.
Chickens: For increased egg production and improved feed efficiency
for egg production.
Swine: For increased rate of weight
gain and improved feed efficiency.
Swine: For increased rate of weight
gain and improved feed efficiency;
for treatment of bacterial enteritis
caused by Escherichia coli and
Salmonella choleraesuis and bacterial pneumonia caused by
Pasteurella multocida susceptible
to chlortetracycline.
............................................................
054771
............................................................
069254
............................................................
054771
For use in quail not over 5 weeks of
age.
069254
For first 7 months of production ........
054771
For growing and finishing swine ........
054771
Feed for not more than 14 days;
bacitracin
methylenedisalicylate
provided by No. 054771; chlortetracycline provided by Nos.
054771
and
069254
in
§ 510.600(c) of this chapter.
054771
069254
Feed for not more than 14 days;
chlortetracycline and bacitracin
methylenedisalicylate as provided
by No. 054771 in § 510.600(c) of
this chapter.
Feed continuously as sole ration ......
054771
Swine: For control of porcine proliferative
enteropathies
(ileitis)
caused by Lawsonia intracellularis
susceptible to chlortetracycline.
Broiler chickens: As an aid in the
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.
Broiler chickens: As an aid in the
control of necrotic enteritis caused
or complicated by Clostridium spp.
or other organisms susceptible to
bacitracin. Replacement chickens:
As an aid in the control of necrotic
enteritis caused or complicated by
Clostridium spp. or other organisms susceptible to bacitracin.
Turkeys: As an aid in the control of
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.
1. Growing/finishing swine: For control of swine dysentery Treponema
hyodysenteriae on premises with
history of swine dysentery but
where signs of the disease have
not yet occurred; or following an
approved treatment of the disease
condition.
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
Sponsor
054771
Feed continuously as sole ration.
Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long
as clinical signs persist, then reduce medication to prevention
level (50 g/ton).
054771
Feed continuously as the sole ration
054771
As the sole ration. Not for use in
swine weighing more than 250
pounds. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory.
054771
E:\FR\FM\22DER1.SGM
22DER1
79476
Federal Register / Vol. 80, No. 245 / Tuesday, December 22, 2015 / Rules and Regulations
Bacitracin
methylenedisalicylate
amount
Combination in
grams per ton
(g/ton)
..............................
(xiv) To provide 70 mg per
head per day.
..............................
(xv) To provide 250 mg
per head per day.
..............................
(xvi) To provide 250 mg
per head per day.
..............................
*
*
*
*
*
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
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Part 4044
Allocation of Assets in SingleEmployer Plans; Interest Assumptions
for Valuing Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
This final rule amends the
Pension Benefit Guaranty Corporation’s
regulation on Allocation of Assets in
Single-Employer Plans to prescribe
interest assumptions under the asset
allocation regulation for valuation dates
in the first quarter of 2016. The interest
assumptions are used for valuing
benefits under terminating singleemployer plans covered by the pension
insurance system administered by
PBGC. As discussed below, PBGC has
published a separate final rule
document dealing with interest
assumptions under its regulation on
Benefits Payable in Terminated SingleEmployer Plans for January 2016.
DATES: Effective January 1, 2016.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion (Klion.Catherine@
PBGC.gov), Assistant General Counsel
rmajette on DSK2TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:05 Dec 21, 2015
Jkt 238001
Limitations
2. Pregnant sows: For control of
clostridial enteritis caused by C.
perfringens in suckling piglets.
(xiii) To provide 70 mg per
head per day.
Indications for use
As the sole ration. Feed to sows
from 14 days before through 21
days after farrowing on premises
with a history of clostridial scours.
Diagnosis should be confirmed by
veterinarian when results are not
satisfactory.
Administer continuously throughout
the feeding period.
Feedlot beef cattle: For reduction in
the number of liver condemnations
due to abscesses.
Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses.
Feedlot beef cattle: For reduction in
the number of liver condemnations
due to abscesses.
Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses.
Frm 00018
Fmt 4700
Sfmt 4700
054771
Administer continuously throughout
the feeding period.
069254
Administer continuously for 5 days
then discontinue for subsequent 25
days, repeat the pattern during the
feeding period.
Administer continuously for 5 days
then discontinue for subsequent 25
days, repeat the pattern during the
feeding period.
054771
for Regulatory Affairs, Office of the
General Counsel, Pension Benefit
Guaranty Corporation, 1200 K Street
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: PBGC’s
regulation on Allocation of Assets in
Single-Employer Plans (29 CFR part
4044) prescribes actuarial
assumptions—including interest
assumptions—for valuing plan benefits
under terminating single-employer
plans covered by title IV of the
Employee Retirement Income Security
Act of 1974. The interest assumptions in
the regulation are also published on
PBGC’s Web site (https://www.pbgc.gov).
The interest assumptions in Appendix
B to Part 4044 are used to value benefits
for allocation purposes under ERISA
section 4044. Assumptions under the
asset allocation regulation are updated
quarterly and are intended to reflect
current conditions in the financial and
annuity markets. This final rule updates
the asset allocation interest assumptions
for the first quarter (January through
March) of 2016.
The first quarter 2016 interest
assumptions under the allocation
regulation will be 2.82 percent for the
first 20 years following the valuation
date and 2.95 percent thereafter. In
comparison with the interest
assumptions in effect for the fourth
quarter of 2015, these interest
assumptions represent no change in the
select period (the period during which
the select rate (the initial rate) applies),
PO 00000
Sponsor
069254
an increase of 0.36 percent in the select
rate, and a decrease of 0.03 percent in
the ultimate rate (the final rate).
PBGC has determined that notice and
public comment on this amendment are
impracticable and contrary to the public
interest. This finding is based on the
need to determine and issue new
interest assumptions promptly so that
the assumptions can reflect current
market conditions as accurately as
possible.
Because of the need to provide
immediate guidance for the valuation of
benefits under plans with valuation
dates during the first quarter of 2016,
PBGC finds that good cause exists for
making the assumptions set forth in this
amendment effective less than 30 days
after publication.
PBGC has determined that this action
is not a ‘‘significant regulatory action’’
under the criteria set forth in Executive
Order 12866.
Because no general notice of proposed
rulemaking is required for this
amendment, the Regulatory Flexibility
Act of 1980 does not apply. See 5 U.S.C.
601(2).
List of Subjects in 29 CFR Part 4044
Employee benefit plans, Pension
insurance, Pensions.
In consideration of the foregoing, 29
CFR part 4044 is amended as follows:
PART 4044—ALLOCATION OF
ASSETS IN SINGLE-EMPLOYER
PLANS
1. The authority citation for part 4044
continues to read as follows:
■
E:\FR\FM\22DER1.SGM
22DER1
]]>Agencies
[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]]
----------------------------------------------------------------------------------------------------------------
Combination in
Bacitracin grams per ton (g/ Indications for use Limitations Sponsor
methylenedisalicylate amount ton)
----------------------------------------------------------------------------------------------------------------
(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.
----------------------------------------------------------------------------------------------------------------
* * * * *
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
