[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: [email protected].
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:
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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