New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address, 14584-14588 [2018-06961]
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Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Rules and Regulations
expressed as ‘‘Estimated Energy Cost’’ in
dollars and based on usage of 3 hours
per day and 11 cents ($0.11) per kWh.
(2) Principal display panel format.
The light output (brightness) and energy
cost shall appear in that order and with
equal clarity and conspicuousness on
the principal display panel of the
product package. The format, terms,
specifications, and minimum sizes shall
follow the specifications and minimum
sizes displayed in Prototype Label 5 in
appendix L of this part.
(3) Lighting Facts label content. The
side or rear display panel of the product
package shall be labeled clearly and
conspicuously with a Lighting Facts
label that contains the following
information in the following order:
(i) The light output of each lamp
included in the package, expressed as
‘‘Brightness’’ in average initial lumens
rounded to the nearest five;
(ii) The estimated annual energy cost
of each lamp included in the package
based on the average initial wattage, a
usage rate of 3 hours per day and 11
cents ($0.11) per kWh and explanatory
text as illustrated in Prototype Label 6
in appendix L of this part;
(iii) The life, as defined in § 305.2(w),
of each lamp included in the package,
expressed in years rounded to the
nearest tenth (based on 3 hours
operation per day);
(iv) The correlated color temperature
of each lamp included in the package,
as measured in degrees Kelvin and
expressed as ‘‘Light Appearance’’ and
by a number and a marker in the form
of a scale as illustrated in Prototype
Label 6 to appendix L of this part placed
proportionately on the scale where the
left end equals 2,600 K and the right end
equals 6,600 K;
(v) The wattage, as defined in
§ 305.2(hh), for each lamp included in
the package, expressed as energy used
in average initial wattage;
(vi) The ENERGY STAR logo as
illustrated in Prototype Label 6 to
appendix L of this part for certified
products, if desired by the manufacturer
or private labeler. Only manufacturers
or private labelers that have signed a
Memorandum of Understanding with
the Department of Energy or the
Environmental Protection Agency may
add the ENERGY STAR logo to labels on
certified covered products; such
manufacturers or private labelers may
add the ENERGY STAR logo to labels
only on those products that are covered
by the Memorandum of Understanding;
(vii) The design voltage of each lamp
included in the package, if other than
120 volts;
(viii) For any general service lamp
containing mercury, the following
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statement: ‘‘Contains Mercury For more
on clean up and safe disposal, visit
epa.gov/cfl.’’ The manufacturer may
also print an ‘‘Hg[Encircled]’’ symbol on
the label after the term ‘‘Contains
Mercury’’; and
(ix) No marks or information other
than that specified in this part shall
appear on the Lighting Facts label.
(4) Standard Lighting Facts label
format. Except as provided in paragraph
(b)(5) of this section, information
specified in paragraph (b)(3) of this
section shall be presented on covered
lamp packages in the format, terms,
explanatory text, specifications, and
minimum sizes as shown in Prototype
Labels 6 in appendix L of this part and
consistent in format and orientation
with Sample Labels 10, 11, or 12 in
appendix L. The text and lines shall be
all black or one color type, printed on
a white or other neutral contrasting
background whenever practical.
(i) The Lighting Facts information
shall be set off in a box by use of
hairlines and shall be all black or one
color type, printed on a white or other
neutral contrasting background
whenever practical.
(ii) All information within the
Lighting Facts label shall utilize:
(A) Arial or an equivalent type style;
(B) Upper and lower case letters;
(C) Leading as indicated in Prototype
Label 6 in appendix L of this part;
(D) Letters that never touch;
(E) The box and hairlines separating
information as illustrated in Prototype
Labels 6 in appendix L of this part; and
(F) The minimum font sizes and line
thicknesses as illustrated in Prototype
Label 6 in appendix L of this part.
(5) Lighting Facts format for small
packages. If the total surface area of the
product package available for labeling is
less than 24 square inches and the
package shape or size cannot
accommodate the standard label
required by paragraph (b)(4) of this
section, manufacturers may provide the
information specified in paragraph
(b)(3) of this section using a smaller,
linear label following the format, terms,
explanatory text, specifications, and
minimum sizes illustrated in Prototype
Label 7 in appendix L of this part.
(6) Bilingual labels. The information
required by paragraphs (b)(1) through
(5) of this section may be presented in
a second language either by using
separate labels for each language or in
a bilingual label with the English text in
the format required by this section
immediately followed by the text in the
second language. Sample Label 13 in
appendix L of this part provides an
example of a bilingual Lighting Facts
label. All required information must be
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included in both languages. Numeric
characters that are identical in both
languages need not be repeated.
(7) Product labeling. Any general
service lamp shall be labeled legibly on
the product with the following
information:
(i) The lamp’s average initial lumens,
expressed as a number rounded to the
nearest five, adjacent to the word
‘‘lumens,’’ both provided in minimum 8
point font; and
(ii) For general service lamps
containing mercury, the following
statement: ‘‘Mercury disposal: epa.gov/
cfl’’ in minimum 8 point font.
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By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–06694 Filed 4–4–18; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, and
558
[Docket No. FDA–2017–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship; Change of a Sponsor’s
Name and Address
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during October,
November, and December 2017. FDA is
informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to reflect changes of
sponsorship of applications and a
change of a sponsor’s name and address.
DATES: This rule is effective April 5,
2018.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
October, November, and December
2017, as listed in table 1. In addition,
FDA is informing the public of the
availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act and, for
actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOI Summaries)
under the Freedom of Information Act
(FOIA). These public documents may be
seen in the Dockets Management Staff
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday. Persons with access to the
internet may obtain these documents at
14585
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/ApprovedAnimalDrug
Products/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING
OCTOBER, NOVEMBER, AND DECEMBER 2017
Approval
date
File No.
Sponsor
Product name
Species
Effect of the action
Original approval for use of INTREPITY
(avilamycin) and MONTEBAN (narasin) Type
A medicated articles to manufacture Type C
medicated broiler chicken feeds for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens,
and the prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
Original approval for use of INTREPITY
(avilamycin) and MAXIBAN (narasin and
nicarbazin) Type A medicated articles to manufacture Type C medicated broiler chicken
feeds for the prevention of mortality caused
by necrotic enteritis associated with Clostridium perfringens, and the prevention of coccidiosis caused by Eimeria necatrix, E.
tenella, E. acervulina, E. brunetti, E. mivati,
and E. maxima.
Supplemental approval for intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic.
Supplemental approval for the control of mortality caused by necrotic enteritis associated
with Clostridium perfringens in broiler chickens.
Supplemental approval for use of LINCOMIX
(lincomycin) Type A medicated articles to
manufacture Type B and Type C medicated
swine feeds for reduction in the severity of
the effects of respiratory disease associated
with Mycoplasma hyopneumoniae.
Original approval of a soft chewable tablet to
prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae
(Dirofilaria immitis) for a month (30 days) after
infection and for the treatment and control of
roundworm (Toxocara canis, Toxascaris
leonina), hookworm (Ancylostoma caninum,
Uncinaria
stenocephala,
Ancylostoma
braziliense), and tapeworm (Dipylidium
caninum, Taenia pisiformis) infections.
Original approval for use of DERACIN (chlortetracycline) and BOVATEC (lasalocid) Type
A medicated articles to manufacture Type B
and Type C medicated cattle feeds as a generic copy of NADA 141–250.
October 27,
2017.
141–467
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Avilamycin and narasin
Type C medicated
feeds.
Chickens ....
October 27,
2017.
141–466
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Avilamycin, narasin, and
nicarbazin Type C
medicated feeds.
Chickens ....
November 9,
2017.
106–111
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
TELAZOL (tiletamine and
zolazepam for injection).
Dogs ...........
November
21, 2017.
200–473
TYLOVET (tylosin tartrate) Soluble Powder.
Chickens ....
November
30, 2017.
097–505
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str., 1113
Sofia, Bulgaria.
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
Lincomycin Type B and
Type C medicated
feeds.
Swine .........
December
11, 2017.
141–441
Virbac AH, Inc., 3200
Meacham Blvd., Ft.
Worth, TX 76137.
IVERHART MAX
(ivermectin, pyrantel
pamoate, praziquantel)
Soft Chew.
Dogs ...........
December
12, 2017.
200–617
Pharmgate LLC, 1800 Sir
Tyler Dr., Wilmington,
NC 28405.
Chlortetracycline and
lasalocid Type B and
Type C medicated
feeds.
Cattle ..........
Public
documents
FOI Summary;
EA/FONSI. 1
FOI Summary;
EA/FONSI. 1
FOI Summary.
FOI Summary.
FOI Summary.
amozie on DSK30RV082PROD with RULES
1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI).
II. Changes of Sponsorship
Aratana Therapeutics, Inc., 11400
Tomahawk Creek Pkwy., Leawood, KS
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66211 has informed FDA that it has
transferred ownership of, and all rights
and interest in, the following
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application to Elanco US, Inc., 2500
Innovation Way, Greenfield, IN 46140:
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21 CFR
section
File No.
Product name
141–455 ....................................................
GALLIPRANT (grapiprant) Tablets ..............................................................................
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 HQ Specialty Pharma
Corp., 120 Rte. 17 North, suite 130,
Paramus, NJ 07652:
21 CFR
section
File No.
Product name
055–097 ....................................................
DRY–MAST (pen G procaine/dihydrostreptomycin sulfate) Infusion ..........................
Ridley Block Operations Inc., 424
North Riverfront Dr., P.O. Box 8500,
Mankato, MN 56002–8500 has informed
FDA that it has transferred ownership
of, and all rights and interest in, the
following applications to Ridley USA,
21 CFR
section
Product name
141–187 ....................................................
CRYSTALYX IONO–LYX (lasalocid) Type C Medicated Protein Block ......................
it has transferred ownership of, and all
rights and interest in, the following
application to Ridley USA, Inc., 111 W
21 CFR
section
Product name
033–733 ....................................................
SWEETLIX BLOAT–GUARD (poloxalene) Pressed Block ..........................................
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III. Legal Authority
This final rule is issued under section
512(i) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21
U.S.C.360b(i)), which requires Federal
Register publication of ‘‘notice[s] . . .
effective as a regulation,’’ of the
conditions of use of approved new
animal drugs. This rule sets forth
technical amendments to the regulations
to codify recent actions on approved
new animal drug applications and
corrections to improve the accuracy of
the regulations, and as such does not
impose any burden on regulated
entities.
Although denominated a rule
pursuant to the FD&C Act, this
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document does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a ‘‘rule of particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808. Likewise, this is not a
rule subject to Executive Order 12866,
which defines a rule as ‘‘an agency
statement of general applicability and
future effect, which the agency intends
to have the force and effect of law, that
is designed to implement, interpret, or
prescribe law or policy or to describe
the procedure or practice requirements
of an agency.’’
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, and 526
Animal drugs.
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Animal drugs, Animal feeds.
Frm 00022
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520.1840
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
520, 522, 526, and 558 are amended as
follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Ridley Block Operations, Inc.’’ and
revise the entry for ‘‘Ridley U.S.
Holdings, Inc.’’; and in the table in
paragraph (c)(2), remove the entry for
‘‘068287’’ and revise the entry for
‘‘067949’’.
The revisions read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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21 CFR Part 558
558.311
Cherry St., suite 500, Mankato, MN
56001:
File No.
Accordingly, the animal drug
regulations are being amended to reflect
these changes of sponsorship. Following
these withdrawals of approval, neither
Ridley Block Operations, Inc. nor Ridley
U.S. Holdings, Inc. is the sponsor of an
approved application. Accordingly,
these firms will be removed from the list
of sponsors of approved applications in
§ 510.600(c) (21 CFR 510.600(c)).
526.1696b
Inc., 111 W Cherry St., suite 500,
Mankato, MN 56001:
File No.
Ridley U.S. Holdings, Inc., 424 North
Riverfront Dr., P.O. Box 8500, Mankato,
MN 56002–8500 has informed FDA that
520.1084
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(c) * * *
(1) * * *
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Firm name and address
Drug labeler code
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Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 ................................................................................
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067949
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(2) * * *
Drug labeler code
Firm name and address
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067949 .................................................................................................................................................................................
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Ridley USA, Inc., 111 W
Cherry St., Suite 500,
Mankato, MN 56001.
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PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.1084
[Amended]
4. In § 520.1084, in paragraph (b),
remove ‘‘086026’’ and in its place add
‘‘058198’’.
■
§ 520.1199
[Amended]
5. In § 520.1199, in paragraph (a)
introductory text, remove ‘‘chewable
tablet’’ and in its place add ‘‘chewable
tablet or soft chewable tablet’’; and in
paragraph (c)(2), remove ‘‘Prevents’’ and
in its place add ‘‘To prevent’’.
■ 6. In § 520.2640, revise paragraphs
(b)(1) and (2) to read as follows:
■
§ 520.2640
Tylosin.
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(b) * * *
(1) Nos. 016592 and 058198 for use as
in paragraph (e) of this section.
(2) No. 061623 for use as in
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2),
(e)(3), and (e)(4) of this section.
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PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
7. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
8. In § 522.2470, revise paragraphs (b)
and (c) to read as follows:
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§ 522.2470
injection.
Tiletamine and zolazepam for
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(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter:
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(1) No. 054771 for use as in paragraph
(c) of this section.
(2) Nos. 026637 and 051311 for use as
in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A),
(c)(1)(iii) and (c)(2) of this section.
(c) Conditions of use—(1) Dogs—(i)
Amount. Expressed as milligrams of the
drug combination:
(A) An initial intramuscular dosage of
3 to 4.5 milligrams per pound (mg/lb) of
body weight for diagnostic purposes; 4.5
to 6 mg/lb of body weight for minor
procedures of short duration such as
repair of lacerations and wounds,
castrations, and other procedures
requiring mild to moderate analgesia.
Supplemental doses when required
should be less than the initial dose and
the total dose given should not exceed
12 mg/lb of body weight. The maximum
total safe dose is 13.6 mg/lb of body
weight.
(B) Administer intravenously at 1 to 2
mg/lb (2.2 to 4.4 mg/kg) body weight to
effect for induction of anesthesia
followed by maintenance with an
inhalant anesthetic.
(ii) Indications for use. (A)
Intramuscular administration in dogs for
restraint and minor procedures of short
duration (30 minutes average) requiring
mild to moderate analgesia.
(B) Intravenous administration in
dogs for induction of anesthesia
followed by maintenance with an
inhalant anesthetic.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. An initial
intramuscular dosage of 4.4 to 5.4 mg/
lb of body weight is recommended for
such procedures as dentistry, treatment
of abscesses, foreign body removal, and
related types of surgery; 4.8 to 5.7 mg/
lb of body weight for minor procedures
requiring mild to moderate analgesia,
such as repair of lacerations, castrations,
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and other procedures of short duration.
Initial dosages of 6.5 to 7.2 mg/lb of
body weight are recommended for
ovariohysterectomy and onychectomy.
When supplemental doses are required,
such individual supplemental doses
should be given in increments that are
less than the initial dose and the total
dose given (initial dose plus
supplemental doses) should not exceed
the maximum allowable safe dose of
32.7 mg/lb of body weight.
(ii) Indications for use. For restraint or
for anesthesia combined with muscle
relaxation.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
9. The authority citation for part 526
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 526.1696b
[Amended]
10. In § 526.1696b, in paragraph (b),
remove ‘‘054628’’ and in its place add
‘‘042791’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
11. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
12. In § 558.68, add paragraphs
(e)(1)(iii) and (iv) to read as follows:
■
§ 558.68
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Avilamycin.
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(e) * * *
(1) * * *
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Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Rules and Regulations
Avilamycin in grams/
ton
Combination in
grams/ton
Indications for use
Limitations
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(iii) 13.6 to 40.9 ..........
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Narasin, .....................
54 to 90 .....................
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Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with
Clostridium perfringens; and
for the prevention of coccidiosis
caused
by
Eimeria
necatrix,
E.
tenella,
E.
acervulina, E. brunetti, E.
mivati, and E. maxima.
(iv) 13.6 to 40.9 ..........
Narasin ......................
27 to 45; ....................
nicarbazin ..................
27 to 45 .....................
Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with
Clostridium perfringens; and
for the prevention of coccidiosis
caused
by
Eimeria
necatrix,
E.
tenella,
E.
acervulina, E. brunetti, E.
mivati, and E. maxima.
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Feed as the sole ration for 21 consecutive
days to chickens that are at risk of developing, but not yet showing clinical signs
of, necrotic enteritis associated with Clostridium perfringens. To assure responsible
antimicrobial drug use in broiler chickens,
treatment administration must begin on or
before 10 days of age. Do not allow adult
turkeys, horses, or other equines access
to narasin formulations. Ingestion of
narasin by these species has been fatal.
Narasin as provided by No. 058198 in
§ 510.600(c) of this chapter.
Feed as the sole ration for 21 consecutive
days to chickens that are at risk of developing, but not yet showing clinical signs
of, necrotic enteritis associated with Clostridium perfringens. To assure responsible
antimicrobial drug use in broiler chickens,
treatment administration must begin on or
before 10 days of age. Do not allow adult
turkeys, horses, or other equines access
to narasin formulations. Ingestion of
narasin by these species has been fatal.
Do not feed to laying hens. Withdraw 5
days before slaughter. Narasin and
nicarbazin as provided by No. 058198 in
§ 510.600(c) of this chapter.
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§ 558.128
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§ 558.311
13. In § 558.128, in paragraph (e)(4),
in the ‘‘Sponsor’’ column, numerically
add ‘‘069254’’ to paragraphs (e)(4)(ii),
(vii), (viii), (ix), and (xviii) through
(xxvi).
Lincomycin grams/ton
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(xiv) 100 to 200 ..........
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14. In § 558.311, in paragraph (b)(9)
and in paragraph (e)(1)(xix), in the
‘‘Sponsor’’ column, remove ‘‘068287’’
and in its place add ‘‘067949’’.
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Office of the Secretary
32 CFR Part 182
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Defense Support of Civilian Law
Enforcement Agencies
Under Secretary of Defense for
Policy, DoD.
ACTION: Final rule.
AGENCY:
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Sponsors
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054771
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This final rule removes the
Department of Defense (DoD) regulation
concerning defense support of civilian
law enforcement agencies. This part
establishes DoD policy, assigns
responsibilities, and provides
procedures to key DoD individuals who
provide support to Federal, State,
Tribal, and local civilian law
enforcement agencies within the United
States, including the District of
Columbia, the Commonwealth of Puerto
Rico, the U.S. Virgin Islands, Guam,
American Samoa, the Commonwealth of
the Northern Mariana Islands, and any
territory or possession of the United
SUMMARY:
[Docket ID: DOD–2017–OS–0052]
Jkt 244001
*
*
*
*
*
For reduction in the severity of the effects Feed as sole ration for 21 days
of respiratory disease associated with
Mycoplasma hyopneumoniae.
RIN 0790–AK04
17:47 Apr 04, 2018
*
Limitations
[FR Doc. 2018–06961 Filed 4–4–18; 8:45 am]
VerDate Sep<11>2014
058198
Lincomycin.
*
*
(e) * * *
(2) * * *
Indications for use
DEPARTMENT OF DEFENSE
BILLING CODE 4164–01–P
058198
15. In § 558.325 revise paragraph
(e)(2)(xiv) to read as follows:
*
Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
*
■
Combination in
grams/ton
*
§ 558.325
■
[Amended]
■
*
[Amended]
Sponsor
E:\FR\FM\05APR1.SGM
05APR1
]]>Agencies
[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Rules and Regulations]
[Pages 14584-14588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06961]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, and 558
[Docket No. FDA-2017-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship; Change of a Sponsor's Name and Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during October, November, and December 2017. FDA
is informing the public of the availability of summaries of the basis
of approval and of environmental review documents, where applicable.
The animal drug regulations are also being amended to reflect changes
of sponsorship of applications and a change of a sponsor's name and
address.
DATES: This rule is effective April 5, 2018.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 14585]]
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during October, November, and December
2017, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act and, for
actions requiring review of safety or effectiveness data, summaries of
the basis of approval (FOI Summaries) under the Freedom of Information
Act (FOIA). These public documents may be seen in the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to the internet may obtain these
documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be
accessed in FDA's publication, Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During
October, November, and December 2017
----------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action Public documents
----------------------------------------------------------------------------------------------------------------
October 27, 141-467 Elanco US Inc., Avilamycin and Chickens...... Original FOI Summary; EA/
2017. 2500 Innovation narasin Type C approval for FONSI. \1\
Way, medicated feeds. use of
Greenfield, IN INTREPITY
46140. (avilamycin)
and MONTEBAN
(narasin) Type
A medicated
articles to
manufacture
Type C
medicated
broiler
chicken feeds
for the
prevention of
mortality
caused by
necrotic
enteritis
associated
with
Clostridium
perfringens,
and the
prevention of
coccidiosis
caused by
Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
mivati, and E.
maxima.
October 27, 141-466 Elanco US Inc., Avilamycin, Chickens...... Original FOI Summary; EA/
2017. 2500 Innovation narasin, and approval for FONSI. \1\
Way, nicarbazin Type use of
Greenfield, IN C medicated INTREPITY
46140. feeds. (avilamycin)
and MAXIBAN
(narasin and
nicarbazin)
Type A
medicated
articles to
manufacture
Type C
medicated
broiler
chicken feeds
for the
prevention of
mortality
caused by
necrotic
enteritis
associated
with
Clostridium
perfringens,
and the
prevention of
coccidiosis
caused by
Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
mivati, and E.
maxima.
November 9, 106-111 Zoetis Inc., 333 TELAZOL Dogs.......... Supplemental FOI Summary.
2017. Portage St., (tiletamine and approval for
Kalamazoo, MI zolazepam for intravenous
49007. injection). administration
in dogs for
induction of
anesthesia
followed by
maintenance
with an
inhalant
anesthetic.
November 21, 200-473 Huvepharma EOOD, TYLOVET (tylosin Chickens...... Supplemental FOI Summary.
2017. 5th Floor, 3A tartrate) approval for
Nikolay Haytov Soluble Powder. the control of
Str., 1113 mortality
Sofia, Bulgaria. caused by
necrotic
enteritis
associated
with
Clostridium
perfringens in
broiler
chickens.
November 30, 097-505 Zoetis Inc., 333 Lincomycin Type Swine......... Supplemental ................
2017. Portage St., B and Type C approval for
Kalamazoo, MI medicated feeds. use of
49007. LINCOMIX
(lincomycin)
Type A
medicated
articles to
manufacture
Type B and
Type C
medicated
swine feeds
for reduction
in the
severity of
the effects of
respiratory
disease
associated
with
Mycoplasma
hyopneumoniae.
December 11, 141-441 Virbac AH, Inc., IVERHART MAX Dogs.......... Original FOI Summary.
2017. 3200 Meacham (ivermectin, approval of a
Blvd., Ft. pyrantel soft chewable
Worth, TX 76137. pamoate, tablet to
praziquantel) prevent canine
Soft Chew. heartworm
disease by
eliminating
the tissue
stage of
heartworm
larvae
(Dirofilaria
immitis) for a
month (30
days) after
infection and
for the
treatment and
control of
roundworm
(Toxocara
canis,
Toxascaris
leonina),
hookworm
(Ancylostoma
caninum,
Uncinaria
stenocephala,
Ancylostoma
braziliense),
and tapeworm
(Dipylidium
caninum,
Taenia
pisiformis)
infections.
December 12, 200-617 Pharmgate LLC, Chlortetracyclin Cattle........ Original ................
2017. 1800 Sir Tyler e and lasalocid approval for
Dr., Type B and Type use of DERACIN
Wilmington, NC C medicated (chlortetracyc
28405. feeds. line) and
BOVATEC
(lasalocid)
Type A
medicated
articles to
manufacture
Type B and
Type C
medicated
cattle feeds
as a generic
copy of NADA
141-250.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact
of this action and has made a finding of no significant impact (FONSI).
II. Changes of Sponsorship
Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS
66211 has informed FDA that it has transferred ownership of, and all
rights and interest in, the following application to Elanco US, Inc.,
2500 Innovation Way, Greenfield, IN 46140:
[[Page 14586]]
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
141-455........................ GALLIPRANT (grapiprant) 520.1084
Tablets.
------------------------------------------------------------------------
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 HQ
Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ
07652:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
055-097........................ DRY-MAST (pen G 526.1696b
procaine/
dihydrostreptomycin
sulfate) Infusion.
------------------------------------------------------------------------
Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following
applications to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato,
MN 56001:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
141-187........................ CRYSTALYX IONO-LYX 558.311
(lasalocid) Type C
Medicated Protein
Block.
------------------------------------------------------------------------
Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box
8500, Mankato, MN 56002-8500 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following application
to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
033-733........................ SWEETLIX BLOAT-GUARD 520.1840
(poloxalene) Pressed
Block.
------------------------------------------------------------------------
Accordingly, the animal drug regulations are being amended to
reflect these changes of sponsorship. Following these withdrawals of
approval, neither Ridley Block Operations, Inc. nor Ridley U.S.
Holdings, Inc. is the sponsor of an approved application. Accordingly,
these firms will be removed from the list of sponsors of approved
applications in Sec. 510.600(c) (21 CFR 510.600(c)).
III. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 526
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 526, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Ridley Block Operations, Inc.'' and revise the entry for ``Ridley
U.S. Holdings, Inc.''; and in the table in paragraph (c)(2), remove the
entry for ``068287'' and revise the entry for ``067949''.
The revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 14587]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Ridley USA, Inc., 111 W Cherry St., Suite 500, 067949
Mankato, MN 56001............................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
067949........................................ Ridley USA, Inc., 111 W
Cherry St., Suite 500,
Mankato, MN 56001.
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1084 [Amended]
0
4. In Sec. 520.1084, in paragraph (b), remove ``086026'' and in its
place add ``058198''.
Sec. 520.1199 [Amended]
0
5. In Sec. 520.1199, in paragraph (a) introductory text, remove
``chewable tablet'' and in its place add ``chewable tablet or soft
chewable tablet''; and in paragraph (c)(2), remove ``Prevents'' and in
its place add ``To prevent''.
0
6. In Sec. 520.2640, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) * * *
(1) Nos. 016592 and 058198 for use as in paragraph (e) of this
section.
(2) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii),
(e)(2), (e)(3), and (e)(4) of this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
8. In Sec. 522.2470, revise paragraphs (b) and (c) to read as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) No. 054771 for use as in paragraph (c) of this section.
(2) Nos. 026637 and 051311 for use as in paragraphs (c)(1)(i)(A),
(c)(1)(ii)(A), (c)(1)(iii) and (c)(2) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Expressed as
milligrams of the drug combination:
(A) An initial intramuscular dosage of 3 to 4.5 milligrams per
pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of
body weight for minor procedures of short duration such as repair of
lacerations and wounds, castrations, and other procedures requiring
mild to moderate analgesia. Supplemental doses when required should be
less than the initial dose and the total dose given should not exceed
12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of
body weight.
(B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg)
body weight to effect for induction of anesthesia followed by
maintenance with an inhalant anesthetic.
(ii) Indications for use. (A) Intramuscular administration in dogs
for restraint and minor procedures of short duration (30 minutes
average) requiring mild to moderate analgesia.
(B) Intravenous administration in dogs for induction of anesthesia
followed by maintenance with an inhalant anesthetic.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. An initial intramuscular dosage of 4.4 to 5.4
mg/lb of body weight is recommended for such procedures as dentistry,
treatment of abscesses, foreign body removal, and related types of
surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring
mild to moderate analgesia, such as repair of lacerations, castrations,
and other procedures of short duration. Initial dosages of 6.5 to 7.2
mg/lb of body weight are recommended for ovariohysterectomy and
onychectomy. When supplemental doses are required, such individual
supplemental doses should be given in increments that are less than the
initial dose and the total dose given (initial dose plus supplemental
doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb
of body weight.
(ii) Indications for use. For restraint or for anesthesia combined
with muscle relaxation.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 526.1696b [Amended]
0
10. In Sec. 526.1696b, in paragraph (b), remove ``054628'' and in its
place add ``042791''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
11. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
12. In Sec. 558.68, add paragraphs (e)(1)(iii) and (iv) to read as
follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
[[Page 14588]]
----------------------------------------------------------------------------------------------------------------
Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 13.6 to 40.9.............. Narasin,........... Broiler chickens: Feed as the sole ration 058198
54 to 90........... For the prevention for 21 consecutive
of mortality days to chickens that
caused by necrotic are at risk of
enteritis developing, but not
associated with yet showing clinical
Clostridium signs of, necrotic
perfringens; and enteritis associated
for the prevention with Clostridium
of coccidiosis perfringens. To assure
caused by Eimeria responsible
necatrix, E. antimicrobial drug use
tenella, E. in broiler chickens,
acervulina, E. treatment
brunetti, E. administration must
mivati, and E. begin on or before 10
maxima. days of age. Do not
allow adult turkeys,
horses, or other
equines access to
narasin formulations.
Ingestion of narasin
by these species has
been fatal. Narasin as
provided by No. 058198
in Sec. 510.600(c)
of this chapter.
(iv) 13.6 to 40.9............... Narasin............ Broiler chickens: Feed as the sole ration 058198
27 to 45;.......... For the prevention for 21 consecutive
nicarbazin......... of mortality days to chickens that
27 to 45........... caused by necrotic are at risk of
enteritis developing, but not
associated with yet showing clinical
Clostridium signs of, necrotic
perfringens; and enteritis associated
for the prevention with Clostridium
of coccidiosis perfringens. To assure
caused by Eimeria responsible
necatrix, E. antimicrobial drug use
tenella, E. in broiler chickens,
acervulina, E. treatment
brunetti, E. administration must
mivati, and E. begin on or before 10
maxima. days of age. Do not
allow adult turkeys,
horses, or other
equines access to
narasin formulations.
Ingestion of narasin
by these species has
been fatal. Do not
feed to laying hens.
Withdraw 5 days before
slaughter. Narasin and
nicarbazin as provided
by No. 058198 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.128 [Amended]
0
13. In Sec. 558.128, in paragraph (e)(4), in the ``Sponsor'' column,
numerically add ``069254'' to paragraphs (e)(4)(ii), (vii), (viii),
(ix), and (xviii) through (xxvi).
Sec. 558.311 [Amended]
0
14. In Sec. 558.311, in paragraph (b)(9) and in paragraph (e)(1)(xix),
in the ``Sponsor'' column, remove ``068287'' and in its place add
``067949''.
0
15. In Sec. 558.325 revise paragraph (e)(2)(xiv) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Lincomycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(xiv) 100 to 200............... .................. For reduction in the Feed as sole 054771
severity of the ration for 21
effects of respiratory days.
disease associated
with Mycoplasma
hyopneumoniae.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06961 Filed 4-4-18; 8:45 am]
BILLING CODE 4164-01-P
