New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship, 22520-22525 [2016-08827]
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Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Rules and Regulations
‘‘dehumidifier,’’ that delivers cooled,
conditioned air to an enclosed space,
and is powered by single-phase electric
current. It includes a source of
refrigeration and may include additional
means for air circulation and heating.
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[FR Doc. 2016–08891 Filed 4–15–16; 8:45 am]
BILLING CODE 6450–01–P
FEDERAL HOUSING FINANCE
AGENCY
12 CFR Part 1238
[No. 2016–N–05]
Orders: Reporting by Regulated
Entities of Stress Testing Results as of
December 31, 2015; Summary
Instructions and Guidance
Federal Housing Finance
Agency.
ACTION: Orders.
AGENCY:
In this document, the Federal
Housing Finance Agency (FHFA)
provides notice that it issued Orders,
dated March 2, 2016, with respect to
stress test reporting as of December 31,
2015, under section 165(i)(2) of the
Dodd-Frank Wall Street Reform and
Consumer Protection Act (Dodd-Frank
Act). Summary Instructions and
Guidance accompanied the Orders to
provide testing scenarios.
DATES: Effective April 18, 2016. Each
Order is applicable March 2, 2016.
FOR FURTHER INFORMATION CONTACT: Naa
Awaa Tagoe, Senior Associate Director,
Office of Financial Analysis, Modeling
and Simulations, (202) 649–3140,
naaawaa.tagoe@fhfa.gov; Stefan
Szilagyi, Examination Manager,
FHLBank Modeling, FHLBank Risk
Modeling Branch (202) 649–3515,
stefan.szilagyi@fhfa.gov; Karen Heidel,
Senior Counsel, Office of General
Counsel, (202) 649–3073, karen.heidel@
fhfa.gov; or Mark D. Laponsky, Deputy
General Counsel, Office of General
Counsel, (202) 649–3054,
mark.laponsky@fhfa.gov. The telephone
number for the Telecommunications
Device for the Hearing Impaired is (800)
877–8339.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
FHFA is responsible for ensuring that
the regulated entities operate in a safe
and sound manner, including the
maintenance of adequate capital and
internal controls, that their operations
and activities foster liquid, efficient,
competitive, and resilient national
housing finance markets, and that they
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carry out their public policy missions
through authorized activities. See 12
U.S.C. 4513. These Orders are being
issued under 12 U.S.C. 4516(a), which
authorizes the Director of FHFA to
require by Order that the regulated
entities submit regular or special reports
to FHFA and establishes remedies and
procedures for failing to make reports
required by Order. The Orders, through
the accompanying Summary
Instructions and Guidance, prescribe for
the regulated entities the scenarios to be
used for stress testing. The Summary
Instructions and Guidance also provides
to the regulated entities advice
concerning the content and format of
reports required by the Orders and the
rule.
II. Orders, Summary Instructions and
Guidance
For the convenience of the affected
parties and the public, the text of the
Orders follows below in its entirety.
You may access these Orders and the
Summary Instructions and Guidance
from FHFA’s Web site at https://www.
fhfa.gov/SupervisionRegulation/Dodd
FrankActStressTests. The Orders and
Summary Instructions and Guidance
also will be available for public
inspection and copying at the Federal
Housing Finance Agency, Eighth Floor,
400 Seventh St. SW., Washington, DC
20219. To make an appointment call
(202) 649–3804.
The text of the Orders is as follows:
and supplemented on February 4, 2016;
and
Whereas, section 1314 of the Safety
and Soundness Act, 12 U.S.C. 4514(a)
authorizes the Director of FHFA to
require regulated entities, by general or
specific order, to submit such reports on
their management, activities, and
operation as the Director considers
appropriate.
Now Therefore, it is hereby Ordered
as follows:
Each regulated entity shall report to
FHFA and to the Board of Governors of
the Federal Reserve System the results
of the stress testing as required by 12
CFR 1238, in the form and with the
content described therein and in the
Summary Instructions and Guidance,
with Appendices 1 through 12 thereto,
accompanying this Order and dated
March 2, 2016.
It Is So Ordered, this the 2nd day of
March, 2016.
This Order is effective immediately.
Signed at Washington, DC, this 2nd
day of March, 2016.
Melvin L. Watt,
Director, Federal Housing Finance
Agency.
Dated: April 12, 2016.
Melvin L. Watt,
Director, Federal Housing Finance Agency.
[FR Doc. 2016–08903 Filed 4–15–16; 8:45 am]
BILLING CODE 8070–01–P
Federal Housing Finance Agency
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Order Nos. 2016–OR–B–1, 2016–OR–
FNMA–1, and 2016–OR–FHLMC–1
Food and Drug Administration
REPORTING BY REGULATED
ENTITIES OF STRESS TESTING
RESULTS AS OF DECEMBER 31, 2015
Whereas, section 165(i)(2) of the
Dodd-Frank Wall Street Reform and
Consumer Protection Act (‘‘Dodd-Frank
Act’’) requires certain financial
companies with total consolidated
assets of more than $10 billion, and
which are regulated by a primary
Federal financial regulatory agency, to
conduct annual stress tests to determine
whether the companies have the capital
necessary to absorb losses as a result of
adverse economic conditions;
Whereas, FHFA’s rule implementing
section 165(i)(2) of the Dodd-Frank Act
is codified as 12 CFR 1238 and requires
that ‘‘[e]ach regulated entity must file a
report in the manner and form
established by FHFA.’’ 12 CFR
1238.5(b);
Whereas, The Board of Governors of
the Federal Reserve System issued stress
testing scenarios on January 28, 2016
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21 CFR Parts 520, 522, 524, 529, 556,
and 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA, 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 January
and February 2016. FDA is also
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
SUMMARY:
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Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Rules and Regulations
amended to reflect changes of
sponsorship of applications that
occurred in January and February.
DATES: This rule is effective April 18,
2016.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
January and February 2016, 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 Division
of Dockets Management (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/Officeof
Foods/CVM/CVMFOIAElectronic
ReadingRoom/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/Approved
AnimalDrugProducts/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2016
File No.
Sponsor
Product name
141–444 ...
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd.,
Skipton, North Yorkshire,
BD23 2RW United Kingdom.
ZYCORTAL Suspension
(desoxycorticosterone
pivalate injectable suspension).
141–448 ...
Lloyd, Inc., 604 W. Thomas
Ave., Shenandoah, IA
51601.
THYRO–TABS CANINE
(levothyroxine sodium
tablets).
141–452 ...
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
SIMPARICA (sarolaner)
Chewables.
141–263 ...
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
CERENIA (maropitant citrate) Injectable Solution.
141–449 ...
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
SAFE–GUARD AquaSol
(fenbendazole oral suspension) Suspension
Concentrate.
200–600 ...
ECO LLC, 344 Nassau St.,
Princeton, NJ 08540.
WORMX (pyrantel pamoate)
Flavored Tablets.
21 CFR
section
Action
Original approval for use as
replacement therapy for
mineralocorticoid deficiency in dogs with primary hypoadrenocorticism
(Addison’s disease).
Original approval for replacement therapy for diminished thyroid function
in dogs.
Original approval for killing
adult fleas, and for the
treatment and prevention
of flea infestations and
the treatment and control
of tick infestations in dogs.
Supplemental approval providing for intravenous administration in dogs and
cats.
Supplemental approval for
the treatment and control
of certain nematode
worms in swine, except
for nursing piglets; and of
a revised tolerance in
swine liver.
Original approval as a generic copy of NADA 139–
191.
FOIA
summary
NEPA
review
522.535
yes ........
CE.1 2
520.1248
yes ........
CE.1 2
520.2086
yes ........
CE.1 2
522.1315
yes ........
CE.1 2
520.905a,
556.275
yes ........
EA/FONSI.3
520.2041
yes ........
CE.1 2
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1 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or
an environmental impact statement because it is of a type that does not have a significant effect on the human environment.
2 CE granted under 21 CFR 25.33(d)(1).
3 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).
Also, FDA is amending the
regulations to reflect the approval of
several minor supplemental
applications that revised classes of foodproducing animals in indications and in
food safety warnings for decoquinate
and robenidine in medicated feeds. A
food safety precautionary statement has
also been revised for use of monensin in
medicated chicken feed.
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee,
Mission, KS 66201 has informed FDA
that it has transferred ownership of, and
all rights and interest in, the following
approved applications to Huvepharma
AD, 5th Floor, 3A Nikolay Haitov Str.,
1113 Sofia, Bulgaria:
File No.
Product name
006–391 ...
006–677 ...
007–087 ...
S.Q. (sulfaquinoxaline) 40% Medicated Feed ........................................................................................................
S.Q. (sulfaquinoxaline) 20% Solution .....................................................................................................................
Sulfaquinoxaline Solubilized ....................................................................................................................................
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21 CFR section
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558.586
520.2325a
520.2325a
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File No.
033–157
040–040
048–287
065–110
065–498
119–142
128–089
140–270
200–068
200–108
200–118
200–123
200–147
200–153
200–162
200–174
200–177
200–192
200–219
200–463
Product name
...
...
...
...
...
...
...
...
...
...
...
...
...
...
...
...
...
...
...
...
21 CFR section
SPECTAM Scour Halt (spectinomycin dihydrochloride pentahydrate) Solution .....................................................
SPECTAM (spectinomycin) Injectable Solution ......................................................................................................
Oxytetracycline-50 (oxytetracycline hydrochloride) Injection ..................................................................................
PEN-G-MAX (penicillin G procaine) Injectable Suspension ...................................................................................
DUAL-CILLIN (benzathine penicillin G and procaine penicillin G) Injectable Suspension .....................................
PVL Iron Dextran (iron hydrogenated dextran) Injectable ......................................................................................
ZONOMETH (dexamethasone) Injectable Solution ................................................................................................
SULFASURE SR (sulfamethazine) Sustained-Release Cattle Bolus .....................................................................
Oxytetracycline Hydrochloride 100 mg/mL Injection ...............................................................................................
Dexamethasone Injectable Solution ........................................................................................................................
Neomycin (neomycin sulfate) Oral Solution ............................................................................................................
MAXIM-200 (oxytetracycline) Injection ....................................................................................................................
GENTA-JECT (gentamicin sulfate) Injectable Solution ..........................................................................................
NEO 200 (neomycin sulfate) Oral Solution .............................................................................................................
Tripelennamine Hydrochloride Injection ..................................................................................................................
Gentamicin Sulfate Pig Pump Oral Solution ...........................................................................................................
Sulfadimethoxine Injection 40% ..............................................................................................................................
Sulfadimethoxine 12.5% Oral Solution ...................................................................................................................
Ivermectin Pour-On for Cattle .................................................................................................................................
Amprolium-P 9.6% Oral Solution ............................................................................................................................
Also, 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 applications to Phibro Animal
Health Corp., GlenPointe Centre East, 3d
floor, 300 Frank W. Burr Blvd., Suite 21,
Teaneck, NJ 07666.
File No.
Product name
038–200 ...
065–178 ...
065–496 ...
OXY WS (oxytetracycline) Soluble Antibiotic ..........................................................................................................
FERMYCIN (chlortetracycline) Soluble ...................................................................................................................
Tetracycline Soluble Powder ...................................................................................................................................
In addition, Zoetis, Inc., 333 Portage
St., Kalamazoo, MI 49007 has informed
FDA that it has transferred ownership
006–891
065–140
100–094
128–686
130–435
134–284
200–106
200–130
200–189
200–441
...
...
...
...
...
...
...
...
...
...
FDA has noticed that it failed to
amend all necessary regulations to
reflect the change of sponsorship of an
oxytetracycline soluble powder (80 FR
13226, March 13, 2015). At this time, we
are amending 21 CFR 529.1660 to
include the drug labeler code for the
new sponsor. This action is being taken
to improve the accuracy of the
regulations.
FDA has also noticed that in § 558.355
(21 CFR 558.355) use of bacitracin
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21 CFR section
SUL-Q-NOX (sulfaquinoxaline) Soluble Powder .....................................................................................................
TET-SOL 324 (tetracycline hydrochloride) Soluble Powder ...................................................................................
POULTRYSULFA (sulfamerazine, sulfamethazine, and sulfaquinoxaline) Soluble Powder ..................................
BIO-COX (salinomycin) Type A Medicated Article .................................................................................................
OXY-TET (oxytetracycline hydrochloride) Soluble Powder/Solution ......................................................................
BIO-COX/FLAVOMYCIN (bambermycins) ..............................................................................................................
R-PEN (Penicillin G potassium) Soluble Powder ...................................................................................................
NEO-SOL 50 (neomycin sulfate) Soluble Powder ..................................................................................................
Lincomycin Soluble Powder ....................................................................................................................................
AUREOMYCIN (chlortetracycline) Soluble Powder ................................................................................................
III. Technical Amendments
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methylenedisalicylate at 100 to 200
grams/ton in combination with
monensin in broiler and replacement
chicken feeds was codified in error for
NADA 141–140 (66 FR 13236, March 5,
2001). At this time, § 558.355 is
amended by removing paragraphs
(f)(1)(xxx) and (f)(4)(v). In addition,
paragraph (f)(4)(iv), a remnant of a
previous technical amendment (79 FR
10963, February 27, 2014), is also being
removed. We have also noticed that
certain paragraphs describing approved
conditions of use were removed in error
from § 558.355 during codification of a
supplemental application to NADA
138–456 that increased the dose range
for monensin used in combination with
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520.1660d
520.441
520.2345d
Huvepharma AD, 5th Floor, 3A Nikolay
Haitov Str., 1113 Sofia, Bulgaria:
Product name
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
changes of sponsorship.
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21 CFR section
of, and all rights and interest in, the
following approved applications to
File No.
520.2123c
522.2120
522.1662a
522.1696b
522.1696a
522.1182
522.540
520.2260b
522.1662a
522.540
520.1484
522.1660a
522.1044
520.1484
522.2615
520.1044b
522.2220
520.2220a
524.1193
520.100
520.2325a
520.2345d
520.2218
558.550
520.1660d
558.550
520.1696b
520.1484
520.1263c
520.441
bacitracin methylenedisalicylate in
broiler chicken feed (57 FR 6554,
February 26, 1992). At this time,
§ 558.355 is amended by adding
paragraphs (f)(1)(xxiv)(a) and (b). These
actions are being taken to improve the
accuracy of the regulations.
FDA has noticed that in error we
removed the approved conditions of use
for gleptoferron, an injectable iron used
to prevent anemia in young piglets. At
this time, 21 CFR 522.1055 is being
added. This action is being taken to
improve the accuracy of the regulations.
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
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congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Parts 520, 522, 524, and 529
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 and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 520, 522, 524, 529, 556, and
558 are amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.100
[Amended]
2. In § 520.100, remove and reserve
paragraph (b)(3).
■ 3. In § 520.441, revise paragraph
(b)(1), remove paragraph (b)(2);
redesignate paragraphs (b)(3) and (4) as
paragraphs (b)(2) and (3); and revise
newly redesignated paragraph (b)(2).
The revisions read as follows:
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§ 520.441
Chlortetracycline powder.
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(b) * * *
(1) Nos. 000010, 016592, 054771, and
069254 for use as in paragraph (d) of
this section.
(2) No. 066104 for use as in
paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and
(d)(4)(ii) through (d)(4)(iv) of this
section.
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■ 4. In § 520.905a, in paragraph (a),
remove ‘‘paragraph (e)(5)’’ and in its
place add ‘‘paragraphs (e)(5) and (6)’’;
and add paragraph (e)(6) to read as
follows:
§ 520.905a
Fenbendazole suspension.
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(e) * * *
(6) Swine, except for nursing piglets—
(i) Amount. Administer orally via the
drinking water at a daily dose of 2.2 mg/
kg of body weight (1.0 mg/lb) for 3
consecutive days.
(ii) Indications for use. For the
treatment and control of lungworms:
Adult Metastrongylus apri, adult M.
pudendotectus; gastrointestinal worms:
Adult and larvae (L3, L4 stages, liver,
lung, intestinal forms) large
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roundworms (Ascaris suum); nodular
worms (Oesophagostomum dentatum,
O. quadrispinulatum); small stomach
worms (Hyostrongylus rubidus): Adult
and larvae (L2, L3, L4 stages—intestinal
mucosal forms) whipworms (Trichuris
suis); and kidney worms: Adult and
larvae Stephanurus dentatus.
(iii) Limitations. Swine intended for
human consumption must not be
slaughtered within 2 days from the last
treatment.
§ 520.1044b
[Amended]
Levothyroxine.
(a) Specifications. Each tablet
contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,
0.8, or 1.0 milligrams (mg)
levothyroxine sodium.
(b) Sponsor. See No. 061690 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer by mouth 0.1 mg/10 pounds
of body weight (0.022 mg/kilogram) as
a single dose every 24 hours or as a
divided dose every 12 hours.
(2) Indications for use. For
replacement therapy for diminished
thyroid function in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 7. In § 520.1263c, revise paragraph (b)
to read as follows:
§ 520.1263c
Lincomycin powder.
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(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter as follows:
(1) No. 016592 for use as in paragraph
(d) of this section.
(2) Nos. 054925, 061623, and 076475
for use as in paragraphs (d)(1) and (d)(2)
of this section.
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[Amended]
11. In § 520.1705, in paragraph (a),
remove ‘‘pergolide mesylate’’ and in its
place add ‘‘pergolide (as pergolide
mesylate)’’.
■
§ 520.2041
[Amended]
12. In § 520.2041, in paragraph (b),
remove ‘‘Nos. 017135 and 051311’’ and
in its place add ‘‘Nos. 017135, 051311,
and 066916’’.
■ 13. Add § 520.2086 to read as follows:
■
§ 520.2086
5. In § 520.1044b, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■ 6. Add § 520.1248 to read as follows:
■
§ 520.1248
§ 520.1705
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Sarolaner.
(a) Specifications. Each chewable
tablet contains 5, 10, 20, 40, 80, or 120
milligrams (mg) sarolaner.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally once a
month at the recommended minimum
dosage of 0.9 mg/lb (2 mg/kg).
(2) Indications for use. Kills adult
fleas, and for the treatment and
prevention of flea infestations
(Ctenocephalides felis), and the
treatment and control of tick
infestations (Amblyomma americanum
(lone star tick), Amblyomma maculatum
(Gulf Coast tick), Dermacentor variabilis
(American dog tick), and Rhipicephalus
sanguineus (brown dog tick)) for 1
month in dogs 6 months of age or older
and weighing 2.8 pounds or more.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.2123c
[Amended]
14. In § 520.2123c, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
§ 520.2218
[Amended]
15. In § 520.2218, in paragraph (b),
remove ‘‘054771’’ and in its place add
‘‘016592’’.
■
§ 520.2220a
[Amended]
16. In § 520.2220a, in paragraph (b)(1),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
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§ 520.1484
[Amended]
8. In § 520.1484, in paragraph (b)(2),
remove ‘‘054771’’ and in its place add
‘‘016592, 054771,’’; and in paragraph
(b)(3), remove ‘‘000859’’ and in its place
add ‘‘016592’’.
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§ 520.1660d
[Amended]
9. In § 520.1660d, in paragraph (b)(2),
remove ‘‘054771’’ and in its place add
‘‘016592’’; and in paragraph (b)(3),
remove ‘‘054628’’ and in its place add
‘‘066104’’.
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§ 520.1696b
[Amended]
10. In § 520.1696b, in paragraph (b), in
numerical order add ‘‘016592’’.
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§ 520.2260b
[Amended]
17. In § 520.2260b, in paragraph (f)(1),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
§ 520.2325a
[Amended]
18. In § 520.2325a, in paragraph (a)(1),
remove ‘‘000859’’ and in its place add
‘‘016592’’; and in paragraph (a)(3),
remove ‘‘No. 054771’’ and in its place
add ‘‘Nos. 016592 and 054771’’.
■ 19. In § 520.2345d, in paragraph
(b)(2), remove ‘‘054628’’ and in its place
add ‘‘066104’’; in paragraph (b)(3),
■
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remove ‘‘No. 054771’’ and in its place
add ‘‘Nos. 016592 and 054771’’; and
revise the first sentence in paragraph
(d)(1)(iii) and paragraph (d)(2)(iii) to
read as follows:
§ 520.2345d
Tetracycline powder.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Administer for 3 to 5
days; do not slaughter animals for food
within 4 days of treatment for No.
066104 and within 5 days of treatment
for Nos. 016592, 054771, 054925,
057561, 059130, and 061623; prepare a
fresh solution daily; use as the sole
source of tetracycline.* * *
(2) * * *
(iii) Limitations. Administer for 3 to 5
days; do not slaughter animals for food
within 7 days of treatment for No.
066104 and within 4 days of treatment
for Nos. 016592, 054771, 054925,
057561, 059130, and 061623; prepare a
fresh solution daily; use as the sole
source of tetracycline.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
20. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
21. Revise § 522.535 to read as
follows:
■
mstockstill on DSK4VPTVN1PROD with RULES
§ 522.535
Desoxycorticosterone.
(a) Specifications. Each milliliter of
suspension contains 25 milligrams (mg)
of desoxycorticosterone pivalate.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter.
(1) No. 043264 for use as in
paragraphs (c)(1)(i), (c)(2)(i), and (c)(3)
of this section.
(2) No. 058198 for use as in
paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3)
of this section.
(c) Conditions of use—(1) Amount. (i)
Administer an initial dose of 2.2 mg/
kilogram (1 mg/lb) of body weight by
subcutaneous injection. Subsequent
dosages should be individualized
according to label instructions based on
patient response to therapy.
(ii) Dosage requirements are variable
and must be individualized on the basis
of the response of the patient to therapy.
Initial dose of 1 milligram per pound
(0.45 kilogram) of body weight every 25
days, intramuscularly. Usual dose is
0.75 to 1.0 milligram per pound of body
weight every 21 to 30 days.
(2) Indications for use—(i) For use as
replacement therapy for
mineralocorticoid deficiency in dogs
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Jkt 238001
with primary hypoadrenocorticism
(Addison’s Disease).
(ii) For use as replacement therapy for
the mineralocorticoid deficit in dogs
with primary adrenocortical
insufficiency.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 522.1696b
§ 522.540
§ 522.2220
[Amended]
[Amended]
30. In § 522.1696b, in paragraph (b)(1),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
§ 522.2120
[Amended]
31. In § 522.2120, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
22. In § 522.540, in paragraphs (a)(2)(i)
and (d)(2)(i), remove ‘‘000859’’ and in
its place add ‘‘016592’’.
§ 522.1044
[Amended]
■
§ 522.2615
■
[Amended]
23. In § 522.1044, in paragraph (b)(4),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■ 24. Add § 522.1055 to read as follows:
■
§ 522.1055
Gleptoferron.
(a) Specifications. Each milliliter
contains the equivalent of 200
milligrams (mg) of elemental iron as
gleptoferron (complex of ferric
hydroxide and dextran glucoheptonic
acid).
(b) Sponsor. See No. 059120 in
§ 510.600(c) of this chapter.
(c) Conditions of use. It is used in
young piglets as follows:
(1) Amounts and indications for use—
(i) Administer 200 mg of elemental iron
intramuscularly on or before 3 days of
age for prevention of iron deficiency
anemia.
(ii) Administer 200 mg of elemental
iron intramuscularly for treatment of
iron deficiency anemia.
(2) [Reserved]
§ 522.1182
[Amended]
25. In § 522.1182, in paragraph (b)(6),
remove ‘‘000859’’ and in its place add
‘‘016592’’; and remove paragraph (b)(8).
32. In § 522.2220, in paragraph (b)(3),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
33. In § 522.2615, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
34. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1193
[Amended]
26. In § 522.1315, in paragraphs
(c)(1)(i) and (c)(2)(i), remove
‘‘subcutaneous injection’’ and in its
place add ‘‘subcutaneous or intravenous
injection’’.
■
§ 522.1660a
[Amended]
27. In § 522.1660a, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
§ 522.1662a
35. In paragraph (b)(2) of § 522.1193,
remove ‘‘000859’’ and in its place add
‘‘016592’’.
§ 524.1484k
28. In § 522.1662a, in paragraphs
(h)(2) and (i)(2), remove ‘‘000859’’ and
in its place add ‘‘016592’’.
[Amended]
29. In § 522.1696a, in paragraph (b)(2),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
[Amended]
36. In § 522.1484k, revise the section
heading to read: Neomycin and
prednisolone suspension.
■
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
37. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 529.1660
[Amended]
38. In § 529.1660, in paragraph (b)(2),
remove ‘‘048164, 054771, and 061623’’
and in its place add ‘‘054771, 061623,
and 069254’’.
■
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
39. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
40. In § 556.275, in paragraph (b)(2)(i),
remove ‘‘6 ppm’’ and in its place add
‘‘3.2 ppm’’; redesignate paragraphs
(b)(3) and (4) as paragraphs (b)(4) and
(5); and add new paragraph (b)(3) and
paragraph (c) to read as follows:
■
[Amended]
■
§ 522.1696a
[Amended]
■
■
§ 522.1315
[Amended]
§ 556.275
*
Fenbendazole.
*
*
(b) * * *
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*
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(3) Chickens—(i) Liver (the target
tissue). The tolerance for fenbendazole
sulfone (the marker residue) is 5.2 ppm.
(ii) [Reserved]
*
*
*
*
*
(c) Related conditions of use. See
§§ 520.905a, 520.905c, 520.905d,
520.905e, and 558.258 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
41. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.195
[Amended]
42. Amend § 558.195 as follows:
a. In the table in paragraph (e)(1)(i), in
the ‘‘Limitations’’ column, remove ‘‘Do
not feed to laying chickens.’’ and in its
place add ‘‘Do not feed to laying hens
producing eggs for human
consumption.’’;
■ b. In the table in paragraph (e)(2)(i), in
the ‘‘Limitations’’ column, remove ‘‘Do
not feed to cows producing milk for
food.’’ and in its place add ‘‘Do not feed
to cows producing milk for human
consumption.’’;
■ c. In the table in paragraphs (e)(3)(i)1.
and (e)(3)(ii)1., in the ‘‘Limitations’’
column, remove ‘‘Do not feed to sheep
producing milk for food.’’ and in its
place add ‘‘Do not feed to sheep
producing milk for human
consumption.’’; and
■ d. In the table in paragraphs (e)(3)(i)2.
and (e)(3)(ii)2., in the ‘‘Limitations’’
column, remove ‘‘Do not feed to goats
producing milk for food.’’ and in its
place add ‘‘Do not feed to goats
producing milk for human
consumption.’’
■ 43. In § 558.340, redesignate
paragraphs (c)(1)(i) and (ii) as
paragraphs (c)(2) and (3); and revise
newly redesignated paragraph (c)(2) to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES
■
■
(f) * * *
(1) * * *
(xxiv) Amount per ton. Monensin, 90
to 110 grams, plus bacitracin
methylenedisalicylate, 4 to 50 grams.
(a) Indications for use. For improved
feed efficiency; as an aid in the
prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E.
acervulina, E. maxima, E. brunetti, and
E. mivati.
(b) Limitations. Do not feed to laying
chickens; feed continuously as sole
ration; in the absence of coccidiosis, the
use of monensin with no withdrawal
period may limit feed intake resulting in
reduced weight gain; as bacitracin
methylenedisalicylate provided by No.
054771 in § 510.600(c) of this chapter.
(xxv) Amount per ton. Monensin, 90
to 110 grams, plus bacitracin zinc, 4 to
50 grams.
*
*
*
*
*
§ 558.515
[Amended]
45. In § 558.515, in the table in
paragraph (d), in the entry for ‘‘30
(0.0033 pct)’’, in the first entry under
the ‘‘Indications for use’’ column,
remove ‘‘For broiler and fryer
chickens:’’ and in its place add ‘‘Broiler
chickens:’’; and in the first entry under
the ‘‘Limitations’’ column, remove ‘‘Do
not feed to layers.’’ and in its place add
‘‘Do not feed to chickens producing eggs
for food.’’
■
§ 558.550
[Amended]
46. Amend § 558.550 as follows:
a. In paragraph (b)(1), remove
‘‘054771’’ and in its place add
‘‘016592’’;
■ b. Remove paragraph (b)(2) and
redesignate paragraph (b)(3) as
paragraph (b)(2);
■ c. In paragraph (d)(1)(xvi)(c), remove
‘‘Chlortetracycline as provided by Nos.
054771 and 069254; salinomycin as
provided by Nos. 054771 and 016592 in
§ 510.600(c) of this chapter.’’ and in its
place add ‘‘Chlortetracycline as
§ 558.340 Maduramicin.
provided by Nos. 054771 and 069254;
*
*
*
*
*
salinomycin as provided by No. 016592
(c) * * *
in § 510.600(c) of this chapter.’’;
(2) Indications for use. Broiler
■ d. In paragraph (d)(1)(xx)(C) and
chickens: For prevention of coccidiosis
caused by Eimeria acervulina, E. tenella, (xxi)(C), remove ‘‘Salinomycin as
provided by 054771; bacitracin
E. brunetti, E. maxima, E. necatrix, and
methylene disalicylate as provided by
E. mivati.
054771 in § 510.600(c) in this chapter.’’
*
*
*
*
*
and in its place add ‘‘Salinomycin as
■ 44. In § 558.355, revise paragraph
provided by No. 016592; bacitracin
(f)(1)(xxiv); and revise paragraph
(f)(1)(xxv) introductory text and remove methylenedisalicylate as provided by
No. 054771 in § 510.600(c) in this
and reserve paragraphs (f)(1)(xxx),
chapter.’’;
(f)(4)(iv), and (f)(4)(v).
■ e. In paragraph (d)(1)(xxii)(B), remove
The revisions read as follows:
‘‘Salinomycin as provided by Nos.
§ 558.355 Monensin.
016592 and 054771; tylosin phosphate
as provided by Nos. 000986 and 016592
*
*
*
*
*
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16:20 Apr 15, 2016
Jkt 238001
■
■
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
22525
in § 510.600(c) of this chapter.’’ and in
its place add ‘‘Salinomycin as provided
by No. 016592; tylosin phosphate as
provided by Nos. 000986 and 016592 in
§ 510.600(c) of this chapter.’’;
■ f. In paragraph (d)(1)(xxiii)(b), remove
‘‘Salinomycin as provided by Nos.
054771 and 016592; bambermycins by
No. 016592 in § 510.600(c) of this
chapter.’’ and in its place add
‘‘Salinomycin and bambermycins as
provided by No. 016592 in § 510.600(c)
of this chapter.’’;
■ g. In paragraphs (d)(3)(ii)(B), (iii)(B),
and (v)(B), remove ‘‘Salinomycin as
provided by 054771; bacitracin
methylene disalicylate as provided by
054771 in § 510.600(c) of this chapter.’’
and in its place add ‘‘Salinomycin as
provided by No. 016592; bacitracin
methylenedisalicylate as provided by
No. 054771 in § 510.600(c) of this
chapter.’’; and
■ h. In paragraph (d)(4)(i)(b), remove
‘‘Salinomycin as provided by Nos.
054771 and 016592; oxytetracycline as
provided by No. 066104 in § 510.600(c)
of this chapter.’’ and in its place add
‘‘Salinomycin as provided by No.
016592; oxytetracycline as provided by
No. 066104 in § 510.600(c) of this
chapter.’’
§ 558.586
[Amended]
47. In § 558.586, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘016592’’.
■
Dated: April 12, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 2016–08827 Filed 4–15–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2011–N–0650]
Cardiovascular Devices;
Reclassification of External Pacemaker
Pulse Generator Devices;
Reclassification of Pacing System
Analyzers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is issuing a final
order to reclassify external pacemaker
pulse generator (EPPG) devices, which
are currently preamendments class III
devices (regulated under product code
SUMMARY:
E:\FR\FM\18APR1.SGM
18APR1
]]>Agencies
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Rules and Regulations]
[Pages 22520-22525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08827]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, 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 January and February 2016. FDA is also
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
[[Page 22521]]
amended to reflect changes of sponsorship of applications that occurred
in January and February.
DATES: This rule is effective April 18, 2016.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during January and February 2016, 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
Division of Dockets Management (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 January and February 2016
----------------------------------------------------------------------------------------------------------------
21 CFR FOIA
File No. Sponsor Product name Action section summary NEPA review
----------------------------------------------------------------------------------------------------------------
141-444....... Dechra, Ltd., ZYCORTAL Original 522.535 yes......... CE.\1\ \2\
Snaygill Suspension approval for
Industrial (desoxycorticos use as
Estate, terone pivalate replacement
Keighley Rd., injectable therapy for
Skipton, North suspension). mineralocortico
Yorkshire, BD23 id deficiency
2RW United in dogs with
Kingdom. primary
hypoadrenocorti
cism (Addison's
disease).
141-448....... Lloyd, Inc., 604 THYRO-TABS Original 520.1248 yes......... CE.\1\ \2\
W. Thomas Ave., CANINE approval for
Shenandoah, IA (levothyroxine replacement
51601. sodium tablets). therapy for
diminished
thyroid
function in
dogs.
141-452....... Zoetis Inc., 333 SIMPARICA Original 520.2086 yes......... CE.\1\ \2\
Portage St., (sarolaner) approval for
Kalamazoo, MI Chewables. killing adult
49007. fleas, and for
the treatment
and prevention
of flea
infestations
and the
treatment and
control of tick
infestations in
dogs.
141-263....... Zoetis Inc., 333 CERENIA Supplemental 522.1315 yes......... CE.\1\ \2\
Portage St., (maropitant approval
Kalamazoo, MI citrate) providing for
49007. Injectable intravenous
Solution. administration
in dogs and
cats.
141-449....... Intervet, Inc., SAFE-GUARD Supplemental 520.905a, yes......... EA/FONSI.\3\
2 Giralda AquaSol approval for 556.275
Farms, Madison, (fenbendazole the treatment
NJ 07940. oral and control of
suspension) certain
Suspension nematode worms
Concentrate. in swine,
except for
nursing
piglets; and of
a revised
tolerance in
swine liver.
200-600....... ECO LLC, 344 WORMX (pyrantel Original 520.2041 yes......... CE.\1\ \2\
Nassau St., pamoate) approval as a
Princeton, NJ Flavored generic copy of
08540. Tablets. NADA 139-191.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an
environmental assessment or an environmental impact statement because it is of a type that does not have a
significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ 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).
Also, FDA is amending the regulations to reflect the approval of
several minor supplemental applications that revised classes of food-
producing animals in indications and in food safety warnings for
decoquinate and robenidine in medicated feeds. A food safety
precautionary statement has also been revised for use of monensin in
medicated chicken feed.
II. Changes of Sponsorship
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390,
Shawnee, Mission, KS 66201 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113
Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
006-391............... S.Q. (sulfaquinoxaline) 40% 558.586
Medicated Feed.
006-677............... S.Q. (sulfaquinoxaline) 20% 520.2325a
Solution.
007-087............... Sulfaquinoxaline Solubilized. 520.2325a
[[Page 22522]]
033-157............... SPECTAM Scour Halt 520.2123c
(spectinomycin
dihydrochloride
pentahydrate) Solution.
040-040............... SPECTAM (spectinomycin) 522.2120
Injectable Solution.
048-287............... Oxytetracycline-50 522.1662a
(oxytetracycline
hydrochloride) Injection.
065-110............... PEN-G-MAX (penicillin G 522.1696b
procaine) Injectable
Suspension.
065-498............... DUAL-CILLIN (benzathine 522.1696a
penicillin G and procaine
penicillin G) Injectable
Suspension.
119-142............... PVL Iron Dextran (iron 522.1182
hydrogenated dextran)
Injectable.
128-089............... ZONOMETH (dexamethasone) 522.540
Injectable Solution.
140-270............... SULFASURE SR (sulfamethazine) 520.2260b
Sustained-Release Cattle
Bolus.
200-068............... Oxytetracycline Hydrochloride 522.1662a
100 mg/mL Injection.
200-108............... Dexamethasone Injectable 522.540
Solution.
200-118............... Neomycin (neomycin sulfate) 520.1484
Oral Solution.
200-123............... MAXIM-200 (oxytetracycline) 522.1660a
Injection.
200-147............... GENTA-JECT (gentamicin 522.1044
sulfate) Injectable Solution.
200-153............... NEO 200 (neomycin sulfate) 520.1484
Oral Solution.
200-162............... Tripelennamine Hydrochloride 522.2615
Injection.
200-174............... Gentamicin Sulfate Pig Pump 520.1044b
Oral Solution.
200-177............... Sulfadimethoxine Injection 522.2220
40%.
200-192............... Sulfadimethoxine 12.5% Oral 520.2220a
Solution.
200-219............... Ivermectin Pour-On for Cattle 524.1193
200-463............... Amprolium-P 9.6% Oral 520.100
Solution.
------------------------------------------------------------------------
Also, 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
applications to Phibro Animal Health Corp., GlenPointe Centre East, 3d
floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666.
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
038-200............... OXY WS (oxytetracycline) 520.1660d
Soluble Antibiotic.
065-178............... FERMYCIN (chlortetracycline) 520.441
Soluble.
065-496............... Tetracycline Soluble Powder.. 520.2345d
------------------------------------------------------------------------
In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following approved applications to Huvepharma AD, 5th
Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
006-891............... SUL-Q-NOX (sulfaquinoxaline) 520.2325a
Soluble Powder.
065-140............... TET-SOL 324 (tetracycline 520.2345d
hydrochloride) Soluble
Powder.
100-094............... POULTRYSULFA (sulfamerazine, 520.2218
sulfamethazine, and
sulfaquinoxaline) Soluble
Powder.
128-686............... BIO-COX (salinomycin) Type A 558.550
Medicated Article.
130-435............... OXY-TET (oxytetracycline 520.1660d
hydrochloride) Soluble
Powder/Solution.
134-284............... BIO-COX/FLAVOMYCIN 558.550
(bambermycins).
200-106............... R-PEN (Penicillin G 520.1696b
potassium) Soluble Powder.
200-130............... NEO-SOL 50 (neomycin sulfate) 520.1484
Soluble Powder.
200-189............... Lincomycin Soluble Powder.... 520.1263c
200-441............... AUREOMYCIN 520.441
(chlortetracycline) Soluble
Powder.
------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these changes of sponsorship.
III. Technical Amendments
FDA has noticed that it failed to amend all necessary regulations
to reflect the change of sponsorship of an oxytetracycline soluble
powder (80 FR 13226, March 13, 2015). At this time, we are amending 21
CFR 529.1660 to include the drug labeler code for the new sponsor. This
action is being taken to improve the accuracy of the regulations.
FDA has also noticed that in Sec. 558.355 (21 CFR 558.355) use of
bacitracin methylenedisalicylate at 100 to 200 grams/ton in combination
with monensin in broiler and replacement chicken feeds was codified in
error for NADA 141-140 (66 FR 13236, March 5, 2001). At this time,
Sec. 558.355 is amended by removing paragraphs (f)(1)(xxx) and
(f)(4)(v). In addition, paragraph (f)(4)(iv), a remnant of a previous
technical amendment (79 FR 10963, February 27, 2014), is also being
removed. We have also noticed that certain paragraphs describing
approved conditions of use were removed in error from Sec. 558.355
during codification of a supplemental application to NADA 138-456 that
increased the dose range for monensin used in combination with
bacitracin methylenedisalicylate in broiler chicken feed (57 FR 6554,
February 26, 1992). At this time, Sec. 558.355 is amended by adding
paragraphs (f)(1)(xxiv)(a) and (b). These actions are being taken to
improve the accuracy of the regulations.
FDA has noticed that in error we removed the approved conditions of
use for gleptoferron, an injectable iron used to prevent anemia in
young piglets. At this time, 21 CFR 522.1055 is being added. This
action is being taken to improve the accuracy of the regulations.
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
[[Page 22523]]
congressional review requirements in 5 U.S.C. 801-808.
List of Subjects
21 CFR Parts 520, 522, 524, and 529
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 and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
522, 524, 529, 556, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.100 [Amended]
0
2. In Sec. 520.100, remove and reserve paragraph (b)(3).
0
3. In Sec. 520.441, revise paragraph (b)(1), remove paragraph (b)(2);
redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3); and
revise newly redesignated paragraph (b)(2).
The revisions read as follows:
Sec. 520.441 Chlortetracycline powder.
* * * * *
(b) * * *
(1) Nos. 000010, 016592, 054771, and 069254 for use as in paragraph
(d) of this section.
(2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B),
and (d)(4)(ii) through (d)(4)(iv) of this section.
* * * * *
0
4. In Sec. 520.905a, in paragraph (a), remove ``paragraph (e)(5)'' and
in its place add ``paragraphs (e)(5) and (6)''; and add paragraph
(e)(6) to read as follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(e) * * *
(6) Swine, except for nursing piglets--(i) Amount. Administer
orally via the drinking water at a daily dose of 2.2 mg/kg of body
weight (1.0 mg/lb) for 3 consecutive days.
(ii) Indications for use. For the treatment and control of
lungworms: Adult Metastrongylus apri, adult M. pudendotectus;
gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung,
intestinal forms) large roundworms (Ascaris suum); nodular worms
(Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms
(Hyostrongylus rubidus): Adult and larvae (L2, L3, L4 stages--
intestinal mucosal forms) whipworms (Trichuris suis); and kidney worms:
Adult and larvae Stephanurus dentatus.
(iii) Limitations. Swine intended for human consumption must not be
slaughtered within 2 days from the last treatment.
Sec. 520.1044b [Amended]
0
5. In Sec. 520.1044b, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
0
6. Add Sec. 520.1248 to read as follows:
Sec. 520.1248 Levothyroxine.
(a) Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5,
0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.
(b) Sponsor. See No. 061690 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer by mouth 0.1 mg/10
pounds of body weight (0.022 mg/kilogram) as a single dose every 24
hours or as a divided dose every 12 hours.
(2) Indications for use. For replacement therapy for diminished
thyroid function in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
7. In Sec. 520.1263c, revise paragraph (b) to read as follows:
Sec. 520.1263c Lincomycin powder.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter as follows:
(1) No. 016592 for use as in paragraph (d) of this section.
(2) Nos. 054925, 061623, and 076475 for use as in paragraphs (d)(1)
and (d)(2) of this section.
* * * * *
Sec. 520.1484 [Amended]
0
8. In Sec. 520.1484, in paragraph (b)(2), remove ``054771'' and in its
place add ``016592, 054771,''; and in paragraph (b)(3), remove
``000859'' and in its place add ``016592''.
Sec. 520.1660d [Amended]
0
9. In Sec. 520.1660d, in paragraph (b)(2), remove ``054771'' and in
its place add ``016592''; and in paragraph (b)(3), remove ``054628''
and in its place add ``066104''.
Sec. 520.1696b [Amended]
0
10. In Sec. 520.1696b, in paragraph (b), in numerical order add
``016592''.
Sec. 520.1705 [Amended]
0
11. In Sec. 520.1705, in paragraph (a), remove ``pergolide mesylate''
and in its place add ``pergolide (as pergolide mesylate)''.
Sec. 520.2041 [Amended]
0
12. In Sec. 520.2041, in paragraph (b), remove ``Nos. 017135 and
051311'' and in its place add ``Nos. 017135, 051311, and 066916''.
0
13. Add Sec. 520.2086 to read as follows:
Sec. 520.2086 Sarolaner.
(a) Specifications. Each chewable tablet contains 5, 10, 20, 40,
80, or 120 milligrams (mg) sarolaner.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally once a
month at the recommended minimum dosage of 0.9 mg/lb (2 mg/kg).
(2) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis), and the
treatment and control of tick infestations (Amblyomma americanum (lone
star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor
variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog
tick)) for 1 month in dogs 6 months of age or older and weighing 2.8
pounds or more.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.2123c [Amended]
0
14. In Sec. 520.2123c, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Sec. 520.2218 [Amended]
0
15. In Sec. 520.2218, in paragraph (b), remove ``054771'' and in its
place add ``016592''.
Sec. 520.2220a [Amended]
0
16. In Sec. 520.2220a, in paragraph (b)(1), remove ``000859'' and in
its place add ``016592''.
Sec. 520.2260b [Amended]
0
17. In Sec. 520.2260b, in paragraph (f)(1), remove ``000859'' and in
its place add ``016592''.
Sec. 520.2325a [Amended]
0
18. In Sec. 520.2325a, in paragraph (a)(1), remove ``000859'' and in
its place add ``016592''; and in paragraph (a)(3), remove ``No.
054771'' and in its place add ``Nos. 016592 and 054771''.
0
19. In Sec. 520.2345d, in paragraph (b)(2), remove ``054628'' and in
its place add ``066104''; in paragraph (b)(3),
[[Page 22524]]
remove ``No. 054771'' and in its place add ``Nos. 016592 and 054771'';
and revise the first sentence in paragraph (d)(1)(iii) and paragraph
(d)(2)(iii) to read as follows:
Sec. 520.2345d Tetracycline powder.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 4 days of treatment for No. 066104 and within 5
days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and
061623; prepare a fresh solution daily; use as the sole source of
tetracycline.* * *
(2) * * *
(iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 7 days of treatment for No. 066104 and within 4
days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and
061623; prepare a fresh solution daily; use as the sole source of
tetracycline.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
20. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
21. Revise Sec. 522.535 to read as follows:
Sec. 522.535 Desoxycorticosterone.
(a) Specifications. Each milliliter of suspension contains 25
milligrams (mg) of desoxycorticosterone pivalate.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and
(c)(3) of this section.
(2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and
(c)(3) of this section.
(c) Conditions of use--(1) Amount. (i) Administer an initial dose
of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection.
Subsequent dosages should be individualized according to label
instructions based on patient response to therapy.
(ii) Dosage requirements are variable and must be individualized on
the basis of the response of the patient to therapy. Initial dose of 1
milligram per pound (0.45 kilogram) of body weight every 25 days,
intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body
weight every 21 to 30 days.
(2) Indications for use--(i) For use as replacement therapy for
mineralocorticoid deficiency in dogs with primary hypoadrenocorticism
(Addison's Disease).
(ii) For use as replacement therapy for the mineralocorticoid
deficit in dogs with primary adrenocortical insufficiency.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.540 [Amended]
0
22. In Sec. 522.540, in paragraphs (a)(2)(i) and (d)(2)(i), remove
``000859'' and in its place add ``016592''.
Sec. 522.1044 [Amended]
0
23. In Sec. 522.1044, in paragraph (b)(4), remove ``000859'' and in
its place add ``016592''.
0
24. Add Sec. 522.1055 to read as follows:
Sec. 522.1055 Gleptoferron.
(a) Specifications. Each milliliter contains the equivalent of 200
milligrams (mg) of elemental iron as gleptoferron (complex of ferric
hydroxide and dextran glucoheptonic acid).
(b) Sponsor. See No. 059120 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. It is used in young piglets as follows:
(1) Amounts and indications for use--(i) Administer 200 mg of
elemental iron intramuscularly on or before 3 days of age for
prevention of iron deficiency anemia.
(ii) Administer 200 mg of elemental iron intramuscularly for
treatment of iron deficiency anemia.
(2) [Reserved]
Sec. 522.1182 [Amended]
0
25. In Sec. 522.1182, in paragraph (b)(6), remove ``000859'' and in
its place add ``016592''; and remove paragraph (b)(8).
Sec. 522.1315 [Amended]
0
26. In Sec. 522.1315, in paragraphs (c)(1)(i) and (c)(2)(i), remove
``subcutaneous injection'' and in its place add ``subcutaneous or
intravenous injection''.
Sec. 522.1660a [Amended]
0
27. In Sec. 522.1660a, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Sec. 522.1662a [Amended]
0
28. In Sec. 522.1662a, in paragraphs (h)(2) and (i)(2), remove
``000859'' and in its place add ``016592''.
Sec. 522.1696a [Amended]
0
29. In Sec. 522.1696a, in paragraph (b)(2), remove ``000859'' and in
its place add ``016592''.
Sec. 522.1696b [Amended]
0
30. In Sec. 522.1696b, in paragraph (b)(1), remove ``000859'' and in
its place add ``016592''.
Sec. 522.2120 [Amended]
0
31. In Sec. 522.2120, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Sec. 522.2220 [Amended]
0
32. In Sec. 522.2220, in paragraph (b)(3), remove ``000859'' and in
its place add ``016592''.
Sec. 522.2615 [Amended]
0
33. In Sec. 522.2615, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 [Amended]
0
35. In paragraph (b)(2) of Sec. 522.1193, remove ``000859'' and in its
place add ``016592''.
Sec. 524.1484k [Amended]
0
36. In Sec. 522.1484k, revise the section heading to read: Neomycin
and prednisolone suspension.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
37. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1660 [Amended]
0
38. In Sec. 529.1660, in paragraph (b)(2), remove ``048164, 054771,
and 061623'' and in its place add ``054771, 061623, and 069254''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
39. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
40. In Sec. 556.275, in paragraph (b)(2)(i), remove ``6 ppm'' and in
its place add ``3.2 ppm''; redesignate paragraphs (b)(3) and (4) as
paragraphs (b)(4) and (5); and add new paragraph (b)(3) and paragraph
(c) to read as follows:
Sec. 556.275 Fenbendazole.
* * * * *
(b) * * *
[[Page 22525]]
(3) Chickens--(i) Liver (the target tissue). The tolerance for
fenbendazole sulfone (the marker residue) is 5.2 ppm.
(ii) [Reserved]
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.905a, 520.905c,
520.905d, 520.905e, and 558.258 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
41. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.195 [Amended]
0
42. Amend Sec. 558.195 as follows:
0
a. In the table in paragraph (e)(1)(i), in the ``Limitations'' column,
remove ``Do not feed to laying chickens.'' and in its place add ``Do
not feed to laying hens producing eggs for human consumption.'';
0
b. In the table in paragraph (e)(2)(i), in the ``Limitations'' column,
remove ``Do not feed to cows producing milk for food.'' and in its
place add ``Do not feed to cows producing milk for human
consumption.'';
0
c. In the table in paragraphs (e)(3)(i)1. and (e)(3)(ii)1., in the
``Limitations'' column, remove ``Do not feed to sheep producing milk
for food.'' and in its place add ``Do not feed to sheep producing milk
for human consumption.''; and
0
d. In the table in paragraphs (e)(3)(i)2. and (e)(3)(ii)2., in the
``Limitations'' column, remove ``Do not feed to goats producing milk
for food.'' and in its place add ``Do not feed to goats producing milk
for human consumption.''
0
43. In Sec. 558.340, redesignate paragraphs (c)(1)(i) and (ii) as
paragraphs (c)(2) and (3); and revise newly redesignated paragraph
(c)(2) to read as follows:
Sec. 558.340 Maduramicin.
* * * * *
(c) * * *
(2) Indications for use. Broiler chickens: For prevention of
coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E.
maxima, E. necatrix, and E. mivati.
* * * * *
0
44. In Sec. 558.355, revise paragraph (f)(1)(xxiv); and revise
paragraph (f)(1)(xxv) introductory text and remove and reserve
paragraphs (f)(1)(xxx), (f)(4)(iv), and (f)(4)(v).
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(1) * * *
(xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
methylenedisalicylate, 4 to 50 grams.
(a) Indications for use. For improved feed efficiency; as an aid in
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously
as sole ration; in the absence of coccidiosis, the use of monensin with
no withdrawal period may limit feed intake resulting in reduced weight
gain; as bacitracin methylenedisalicylate provided by No. 054771 in
Sec. 510.600(c) of this chapter.
(xxv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
zinc, 4 to 50 grams.
* * * * *
Sec. 558.515 [Amended]
0
45. In Sec. 558.515, in the table in paragraph (d), in the entry for
``30 (0.0033 pct)'', in the first entry under the ``Indications for
use'' column, remove ``For broiler and fryer chickens:'' and in its
place add ``Broiler chickens:''; and in the first entry under the
``Limitations'' column, remove ``Do not feed to layers.'' and in its
place add ``Do not feed to chickens producing eggs for food.''
Sec. 558.550 [Amended]
0
46. Amend Sec. 558.550 as follows:
0
a. In paragraph (b)(1), remove ``054771'' and in its place add
``016592'';
0
b. Remove paragraph (b)(2) and redesignate paragraph (b)(3) as
paragraph (b)(2);
0
c. In paragraph (d)(1)(xvi)(c), remove ``Chlortetracycline as provided
by Nos. 054771 and 069254; salinomycin as provided by Nos. 054771 and
016592 in Sec. 510.600(c) of this chapter.'' and in its place add
``Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin
as provided by No. 016592 in Sec. 510.600(c) of this chapter.'';
0
d. In paragraph (d)(1)(xx)(C) and (xxi)(C), remove ``Salinomycin as
provided by 054771; bacitracin methylene disalicylate as provided by
054771 in Sec. 510.600(c) in this chapter.'' and in its place add
``Salinomycin as provided by No. 016592; bacitracin
methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) in
this chapter.'';
0
e. In paragraph (d)(1)(xxii)(B), remove ``Salinomycin as provided by
Nos. 016592 and 054771; tylosin phosphate as provided by Nos. 000986
and 016592 in Sec. 510.600(c) of this chapter.'' and in its place add
``Salinomycin as provided by No. 016592; tylosin phosphate as provided
by Nos. 000986 and 016592 in Sec. 510.600(c) of this chapter.'';
0
f. In paragraph (d)(1)(xxiii)(b), remove ``Salinomycin as provided by
Nos. 054771 and 016592; bambermycins by No. 016592 in Sec. 510.600(c)
of this chapter.'' and in its place add ``Salinomycin and bambermycins
as provided by No. 016592 in Sec. 510.600(c) of this chapter.'';
0
g. In paragraphs (d)(3)(ii)(B), (iii)(B), and (v)(B), remove
``Salinomycin as provided by 054771; bacitracin methylene disalicylate
as provided by 054771 in Sec. 510.600(c) of this chapter.'' and in its
place add ``Salinomycin as provided by No. 016592; bacitracin
methylenedisalicylate as provided by No. 054771 in Sec. 510.600(c) of
this chapter.''; and
0
h. In paragraph (d)(4)(i)(b), remove ``Salinomycin as provided by Nos.
054771 and 016592; oxytetracycline as provided by No. 066104 in Sec.
510.600(c) of this chapter.'' and in its place add ``Salinomycin as
provided by No. 016592; oxytetracycline as provided by No. 066104 in
Sec. 510.600(c) of this chapter.''
Sec. 558.586 [Amended]
0
47. In Sec. 558.586, in paragraph (b), remove ``000859'' and in its
place add ``016592''.
Dated: April 12, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-08827 Filed 4-15-16; 8:45 am]
BILLING CODE 4164-01-P
