New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor, 34276-34279 [2015-14734]
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Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations
individually or cumulatively have a
significant effect on the human
environment such that neither an
environmental assessment nor an
environmental impact statement is
required. We have not received any new
information or comments that would
affect that determination.
VII. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
asabaliauskas on DSK5VPTVN1PROD with RULES
VIII. Objections
If you will be adversely affected by
one or more provisions of this
regulation, you may file with the
Division of Dockets Management (see
ADDRESSES) either electronic or written
objections. You must separately number
each objection, and within each
numbered objection you must specify
with particularity the provision(s) to
which you object, and the grounds for
your objection. Within each numbered
objection, you must specifically state
whether you are requesting a hearing on
the particular provision that you specify
in that numbered objection. If you do
not request a hearing for any particular
objection, you waive the right to a
hearing on that objection. If you request
a hearing, your objection must include
a detailed description and analysis of
the specific factual information you
intend to present in support of the
objection in the event that a hearing is
held. If you do not include such a
description and analysis for any
particular objection, you waive the right
to a hearing on the objection.
It is only necessary to send one set of
documents. Identify documents with the
docket number found in brackets in the
heading of this document. Any
objections received in response to the
regulation may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IX. Section 301(ll) of the Federal Food,
Drug, and Cosmetic Act
Our review of this petition was
limited to section 409 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348). This final
rule is not a statement regarding
compliance with other sections of the
FD&C Act. For example, the Food and
Drug Administration Amendments Act
of 2007, which was signed into law on
September 27, 2007, amended the FD&C
Act to, among other things, add section
301(ll) of the FD&C Act (21 U.S.C.
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331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery
for introduction into interstate
commerce of any food that contains a
drug approved under section 505 of the
FD&C Act (21 U.S.C. 355), a biological
product licensed under section 351 of
the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for
which substantial clinical investigations
have been instituted and their existence
has been made public, unless one of the
exemptions in section 301(ll)(1) to (4) of
the FD&C Act applies. In our review of
this petition, we did not consider
whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food
containing this additive. Accordingly,
this final rule should not be construed
to be a statement that a food containing
this additive, if introduced or delivered
for introduction into interstate
commerce, would not violate section
301(ll) of the FD&C Act. Furthermore,
this language is included in all food
additive final rules and therefore should
not be construed to be a statement of the
likelihood that section 301(ll) of the
FD&C Act applies.
X. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. FDA Memorandum from H. Lee, to E.
Anderson, June 18, 2014.
2. FDA Memorandum from A. Khan to E.
Anderson, August 6, 2014.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by
reference, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Director, Center for Food Safety and
Applied Nutrition, 21 CFR part 172 is
amended as follows:
PART 172—FOOD ADDITIVES
PERMITTED FOR DIRECT ADDITION
TO FOOD FOR HUMAN
CONSUMPTION
1. The authority citation for 21 CFR
part 172 continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
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■
2. Amend § 172.185 as follows:
a. Revise paragraph (a);
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b. Redesignate paragraphs (b) and (c)
as paragraphs (c) and (d), respectively;
and
■ c. Add new paragraph (b).
The revision and addition read as
follows:
■
§ 172.185
TBHQ.
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(a) The food additive has a melting
point of not less than 126.5 °C.
(b) The percentage of TBHQ in the
food additive is not less than 99.0
percent when tested by the assay
described in the Food Chemicals Codex,
9th ed. (2014), pp. 1192–1194, which is
incorporated by reference, or an
equivalent method. The Director of the
Office of the Federal Register approves
this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address:
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
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Dated: June 9, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2015–14704 Filed 6–15–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, and
528
[Docket No. FDA–2015–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
application-related actions for new
animal drug applications (NADAs) and
SUMMARY:
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abbreviated new animal drug
applications (ANADAs) during March
and April 2015. 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 amended to
reflect several nonsubstantive changes.
These technical amendments are being
made to improve the accuracy of the
regulations.
DATES: This rule is effective June 16,
2015.
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.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during March and April 2015,
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),
SUPPLEMENTARY INFORMATION:
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 MARCH AND APRIL 2015
Sponsor
New animal drug product name
Action
200–557 .....
Putney, Inc., One Monument Sq.,
suite 400, Portland, ME 04101.
Original approval as a generic
copy of NADA 106–111.
522.2470
yes ..
CE 1 2.
200–578 .....
Belcher Pharmaceuticals, LLC,
6911 Bryan Dairy Rd., Largo,
FL 33777.
´
Ceva Sante Animale, 10 Avenue
`
de
la
Ballastiere,
33500
Libourne, France.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
Tiletamine-Zolazepam Injectable
Solution (tiletamine HCl and
zolazepam HCl).
Carprofen
Flavored
Tablets
(carprofen).
Original approval as a generic
copy of NADA 141–053.
520.304
yes ..
CE 1 2.
Altrenogest Solution (altrenogest)
Original approval as a generic
copy of NADA 141–222.
520.48
yes ..
CE 1 2.
SPECTRAMAST LC (ceftiofur
intramammary
suspension)
Sterile Suspension.
Supplemental approval for treatment of diagnosed subclinical
mastitis
associated
with
coagulase-negative
staphylococci
and
Streptococcus dysgalactiae in lactating
dairy cattle.
Supplemental approval under section 512(b)(1) of the FD&C Act
for use with cloprostenol injection to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows.
526.313
yes ..
CE 1 3.
522.1077
yes ..
EA/FONSI 4.
200–579 .....
141–238 .....
200–134 .....
Intervet, Inc., 2 Giralda Farms,
Madison, NJ 07940.
FERTAGYL (gonadorelin) Sterile
Solution.
21 CFR
sections
FOIA
summary
NADA/
ANADA
NEPA review
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(a)(1).
3 CE granted under 21 CFR 25.33(d)(5).
4 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).
In addition during March and April
2015, ownership of, and all rights and
interest in, the following approved
applications have been transferred as
follows:
NADA/
ANADA
Previous sponsor
140–883 .....
Bayer HealthCare LLC, Animal
Health Division, P.O. Box 390,
Shawnee, Mission, KS 66201.
Bayer HealthCare LLC, Animal
Health Division, P.O. Box 390,
Shawnee, Mission, KS 66201.
rEVO Biologics, 175 Crossing Blvd.,
Framingham, MA 01702.
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141–188 .....
141–294 .....
At this time, the regulations are being
amended to reflect these changes of
sponsorship.
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New animal drug product name
LEGEND
(hyaluronate
Injectable Solution.
New sponsor
sodium)
Merial, Inc., 3239 Satellite Blvd.,
Bldg. 500, Duluth, GA 30096.
522.1145
MARQUIS (ponazuril) Antiprotozoal
Oral Paste.
Merial, Inc., 3239 Satellite Blvd.,
Bldg. 500, Duluth, GA 30096.
520.1855
Bc6 rDNA construct in GTC 155–92
goats.
LFB USA, Inc., 175 Crossing Blvd.,
Framingham, MA 01702.
528.1070
Following these changes of
sponsorship, LFB USA, Inc., is now the
sponsor of an approved application.
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21 CFR
section
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Accordingly, § 510.600 (21 CFR
510.600) is being amended to add this
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firm to the list of sponsors of approved
applications.
The animal drug regulations are also
being amended to reflect several nonsubstantive changes. These technical
amendments are being made 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
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
1. The authority citation for 21 CFR
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
‘‘Abbott Laboratories’’ and add in
alphabetical order an entry for ‘‘LFB
USA, Inc.’’; and in the table in
paragraph (c)(2), remove the entry for
000044 and add in numerical order an
entry for ‘‘086047’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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(2) * * *
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PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
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Altrenogest.
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(b) Sponsors. See Nos. 000061 and
013744 in § 510.600(c) of this chapter.
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§ 520.88g
[Amended]
5. In § 520.88g, in paragraph (c)(2)(i),
remove ‘‘(1 milliliter)’’.
■ 6. In § 520.154a:
■ a. Revise the section heading;
■ b. In paragraphs (d)(1)(ii), (d)(2)(i)(A),
(d)(2)(ii)(A), and (d)(4)(ii), remove
‘‘bacitracin methylene disalicylate’’ and
in its place add ‘‘bacitracin
methylenedisalicylate’’; and
■ c. In paragraph (d)(3)(ii), remove
‘‘Treponema hyodysenteriae’’ and in its
place add ‘‘Brachyspira
hyodysenteriae’’.
The revision reads as follows:
■
§ 520.154a Bacitracin
methylenedisalicylate.
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§ 520.304
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[Amended]
7. In § 520.304, in paragraph (b)(3),
remove ‘‘No. 026637’’ and in its place
add ‘‘Nos. 026637 and 062250’’.
■
[Amended]
8. In § 520.804, redesignate
paragraphs (c)(i), (c)(ii), and (c)(iii), as
paragraphs (c)(1), (c)(2), and (c)(3).
■ 9. In § 520.1660d, revise paragraph
(a)(4) to read as follows:
Drug labeler
code
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§ 520.1660d
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Firm name and address
16:14 Jun 15, 2015
Oxytetracycline powder.
(a) * * *
(4) Each 2.73 grams of powder
086047 contains 1 gram of OTC HCl (packets:
2.46 and 9.87 oz, 3.09 and 3.91 lb; pail:
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3.09 lb).
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§ 520.1855
Drug labeler
code
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LFB USA, Inc., 175 Crossing
Blvd., Framingham, MA
01702 ................................
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§ 520.804
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Firm name and address
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§ 520.48
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LFB USA, Inc., 175 Crossing
Blvd., Framingham, MA
01702
4. In § 520.48, revise paragraph (b) to
read as follows:
PART 510—NEW ANIMAL DRUGS
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086047 ..........
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21 CFR Parts 520, 522, 526, and 528
Animal drugs.
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 510, 520, 522, 526, and 528
are amended as follows:
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(c) * * *
(1) * * *
Firm name and address
Authority: 21 U.S.C. 360b.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
Drug labeler
code
Jkt 235001
§ 520.2218 Sulfamerazine, sulfamethazine,
and sulfaquinoxaline powder.
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(d) * * *
(1) * * *
(i) * * *
(A) As an aid in the control of
coccidiosis caused by Eimeria tenella
and E. necatrix susceptible to
sulfamerazine, sulfamethazine, and
sulfaquinoxaline: Provide medicated
water (0.04 percent solution) for 2 to 3
days, then plain water for 3 days, then
medicated water (0.025 percent
solution) for 2 days. If bloody droppings
appear, repeat at 0.025 percent level for
2 more days. Do not change litter.
(B) As an aid in the control of acute
fowl cholera caused by Pasteurella
multocida susceptible to sulfamerazine,
sulfamethazine, and sulfaquinoxaline:
Provide medicated water (0.04 percent
solution) for 2 to 3 days. If disease
recurs, repeat treatment.
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(2) * * *
(i) * * *
(A) As an aid in the control of
coccidiosis caused by Eimeria
meleagrimitis and E. adenoeides
susceptible to sulfamerazine,
sulfamethazine, and sulfaquinoxaline:
Provide medicated water (0.025 percent
solution) for 2 days, then plain water for
3 days, then medicated water (0.025
percent solution) for 2 days, then plain
water for 3 days, then medicated water
(0.025 percent solution) for 2 days.
Repeat if necessary. Do not change litter.
(B) As an aid in the control of acute
fowl cholera caused by Pasteurella
multocida susceptible to sulfamerazine,
sulfamethazine, and sulfaquinoxaline:
Provide medicated water (0.04 percent
solution) for 2 to 3 days. If disease
recurs, repeat treatment.
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§ 520.2640
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
13. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
10. In § 520.1855, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘050604’’.
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[Amended]
12. In § 520.2640, in paragraphs
(e)(2)(iii) and (e)(3)(iii), remove the first
sentence.
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[Amended]
■
PO 00000
11. In § 520.2218, revise paragraphs
(d)(1)(i)(A) and (B), and paragraphs
(d)(2)(i)(A) and (B) to read as follows:
■
§§ 522.1073 and 522.1075
[Removed]
14. Remove §§ 522.1073 and
522.1075.
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15. Revise § 522.1077 to read as
follows:
■
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§ 522.1077
Gonadorelin.
(a) Specifications. Each milliliter (mL)
of solution contains:
(1) 43 micrograms (mg) of gonadorelin
as gonadorelin acetate;
(2) 100 mg of gonadorelin as
gonadorelin acetate;
(3) 50 mg of gonadorelin as
gonadorelin diacetate tetrahydrate; or
(4) 50 mg of gonadorelin as
gonadorelin hydrochloride.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter.
(1) No. 000061 for use of the 43-mg/
mL product described in paragraph
(a)(1) as in paragraphs (d)(1)(i),
(d)(1)(iv), and (d)(2) of this section.
(2) No. 068504 for use of the 100-mg/
mL product described in paragraph
(a)(2) as in paragraphs (d)(1)(ii),
(d)(1)(v), and (d)(2) of this section.
(3) Nos. 000859 and 050604 for use of
the 50-mg/mL product described in
paragraph (a)(3) as in paragraphs
(d)(1)(ii) and (d)(2) of this section.
(4) No. 054771 for use of the 50-mg/
mL product described in paragraph
(a)(4) as in paragraphs (d)(1)(iii),
(d)(1)(vi), and (d)(2) of this section.
(c) Special considerations. Concurrent
luteolytic drug use is approved as
follows:
(1) Cloprostenol injection for use as in
paragraph (d)(1)(iv) of this section as
provided by No. 000061 in § 510.600(c)
of this chapter.
(2) Cloprostenol injection for use as in
paragraph (d)(1)(v) of this section as
provided by No. 000061 or No. 068504
in § 510.600(c) of this chapter.
(3) Dinoprost injection for use as in
paragraph (d)(1)(vi) of this section as
provided by No. 054771 in § 510.600(c)
of this chapter.
(d) Conditions of use in cattle—(1)
Indications for use and amounts—(i)
For the treatment of ovarian follicular
cysts in dairy cattle: Administer 86 mg
gonadorelin by intramuscular or
intravenous injection.
(ii) For the treatment of ovarian
follicular cysts in dairy cattle:
Administer 100 mg gonadorelin by
intramuscular or intravenous injection.
(iii) For the treatment of ovarian
follicular cysts in cattle: Administer 100
mg gonadorelin by intramuscular
injection.
(iv) For use with cloprostenol
injection to synchronize estrous cycles
to allow for fixed-time artificial
insemination (FTAI) in lactating dairy
cows: Administer to each cow 86 mg
gonadorelin by intramuscular injection,
followed 6 to 8 days later by 500 mg
cloprostenol by intramuscular injection,
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Jkt 235001
followed 30 to 72 hours later by 86 mg
gonadorelin by intramuscular injection.
(v) For use with cloprostenol injection
to synchronize estrous cycles to allow
for fixed-time artificial insemination
(FTAI) in lactating dairy cows and beef
cows: Administer to each cow 100 mg
gonadorelin by intramuscular injection,
followed 6 to 8 days later by 500 mg
cloprostenol by intramuscular injection,
followed 30 to 72 hours later by 100 mg
gonadorelin by intramuscular injection.
(vi) For use with dinoprost injection
to synchronize estrous cycles to allow
fixed-time artificial insemination (FTAI)
in lactating dairy cows: Administer to
each cow 100 to 200 mg gonadorelin by
intramuscular injection, followed 6 to 8
days later by 25 mg dinoprost by
intramuscular injection, followed 30 to
72 hours later by 100 to 200 mg
gonadorelin by intramuscular injection.
(2) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 522.1145
[Amended]
34279
coagulase-negative staphylococci and S.
dysgalactiae.
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PART 528—NEW ANIMAL DRUGS IN
GENETICALLY ENGINEERED
ANIMALS
21. The authority citation for 21 CFR
part 528 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 528.1070
[Amended]
22. In § 528.1070, in paragraph (b),
remove ‘‘042976’’ and in its place add
‘‘086047’’.
■
Dated: June 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–14734 Filed 6–15–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
16. In § 520.1145, in paragraph
(e)(2)(i), remove ‘‘000859’’ and in its
place add ‘‘050604’’.
■ 17. In § 522.2470, revise paragraph (b)
to read as follows:
■
§ 522.2470
injection.
Tiletamine and zolazepam for
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(b) Sponsors. See Nos. 026637 and
054771 in § 510.600(c) of this chapter.
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■ 18. In § 522.2483, revise paragraph (b)
to read as follows:
§ 522.2483
Triamcinolone.
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(b) Sponsors. See Nos. 000010 and
054628 in § 510.600(c) of this chapter.
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PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
19. The authority citation for 21 CFR
part 526 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
20. In § 526.313, revise paragraph
(d)(1)(ii) to read as follows:
■
§ 526.313
Ceftiofur.
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(d) * * *
(1) * * *
(ii) Indications for use. For use in
lactating dairy cattle:
(A) For the treatment of clinical
mastitis associated with coagulasenegative staphylococci, Streptococcus
dysgalactiae, and Escherichia coli; and
(B) For the treatment of diagnosed
subclinical mastitis associated with
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26 CFR Parts 20, 25, and 602
[TD 9725]
RIN 1545–BK74
Portability of a Deceased Spousal
Unused Exclusion Amount
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
AGENCY:
This document contains final
regulations that provide guidance under
sections 2010 and 2505 of the Internal
Revenue Code on the estate and gift tax
applicable exclusion amount, in general,
as well as on the applicable
requirements for electing portability of a
deceased spousal unused exclusion
(DSUE) amount to the surviving spouse
and on the applicable rules for the
surviving spouse’s use of this DSUE
amount. The statutory provisions
underlying the portability rules were
enacted as part of the Tax Relief,
Unemployment Insurance
Reauthorization, and Job Creation Act of
2010, and these provisions were made
permanent by the American Taxpayer
Relief Act of 2012. The portability rules
affect the estates of married decedents
dying on or after January 1, 2011, and
the surviving spouses of those
decedents.
SUMMARY:
DATES:
Effective Date. These regulations are
effective on June 12, 2015.
Applicability Dates: For specific dates
of applicability of the final regulations,
E:\FR\FM\16JNR1.SGM
16JNR1
]]>Agencies
[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Rules and Regulations]
[Pages 34276-34279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14734]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, and 528
[Docket No. FDA-2015-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect application-related actions for new animal
drug applications (NADAs) and
[[Page 34277]]
abbreviated new animal drug applications (ANADAs) during March and
April 2015. 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
amended to reflect several nonsubstantive changes. These technical
amendments are being made to improve the accuracy of the regulations.
DATES: This rule is effective June 16, 2015.
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: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during March and April
2015, 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 March and April 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug product 21 CFR
NADA/ANADA Sponsor name Action sections FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
200-557........... Putney, Inc., One Tiletamine-Zolazepam Original approval as a 522.2470 yes................ CE \1\ \2\.
Monument Sq., suite 400, Injectable Solution generic copy of NADA
Portland, ME 04101. (tiletamine HCl and 106-111.
zolazepam HCl).
200-578........... Belcher Pharmaceuticals, Carprofen Flavored Original approval as a 520.304 yes................ CE \1\ \2\.
LLC, 6911 Bryan Dairy Tablets (carprofen). generic copy of NADA
Rd., Largo, FL 33777. 141-053.
200-579........... Ceva Sant[eacute] Altrenogest Solution Original approval as a 520.48 yes................ CE \1\ \2\.
Animale, 10 Avenue de la (altrenogest). generic copy of NADA
Ballasti[egrave]re, 141-222.
33500 Libourne, France.
141-238........... Zoetis Inc., 333 Portage SPECTRAMAST LC Supplemental approval 526.313 yes................ CE \1\ \3\.
St., Kalamazoo, MI 49007. (ceftiofur intramammary for treatment of
suspension) Sterile diagnosed subclinical
Suspension. mastitis associated
with coagulase-negative
staphylococci and
Streptococcus
dysgalactiae in
lactating dairy cattle.
200-134........... Intervet, Inc., 2 Giralda FERTAGYL (gonadorelin) Supplemental approval 522.1077 yes................ EA/FONSI \4\.
Farms, Madison, NJ 07940. Sterile Solution. under section 512(b)(1)
of the FD&C Act for use
with cloprostenol
injection to
synchronize estrous
cycles to allow for
fixed time artificial
insemination (FTAI) in
lactating dairy cows.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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(a)(1).
\3\ CE granted under 21 CFR 25.33(d)(5).
\4\ 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).
In addition during March and April 2015, ownership of, and all
rights and interest in, the following approved applications have been
transferred as follows:
----------------------------------------------------------------------------------------------------------------
New animal drug product 21 CFR
NADA/ANADA Previous sponsor name New sponsor section
----------------------------------------------------------------------------------------------------------------
140-883........... Bayer HealthCare LLC, LEGEND (hyaluronate Merial, Inc., 3239 522.1145
Animal Health Division, sodium) Injectable Satellite Blvd., Bldg.
P.O. Box 390, Shawnee, Solution. 500, Duluth, GA 30096.
Mission, KS 66201.
141-188........... Bayer HealthCare LLC, MARQUIS (ponazuril) Merial, Inc., 3239 520.1855
Animal Health Division, Antiprotozoal Oral Paste. Satellite Blvd., Bldg.
P.O. Box 390, Shawnee, 500, Duluth, GA 30096.
Mission, KS 66201.
141-294........... rEVO Biologics, 175 Bc6 rDNA construct in GTC LFB USA, Inc., 175 528.1070
Crossing Blvd., 155-92 goats. Crossing Blvd.,
Framingham, MA 01702. Framingham, MA 01702.
----------------------------------------------------------------------------------------------------------------
At this time, the regulations are being amended to reflect these
changes of sponsorship.
Following these changes of sponsorship, LFB USA, Inc., is now the
sponsor of an approved application. Accordingly, Sec. 510.600 (21 CFR
510.600) is being amended to add this
[[Page 34278]]
firm to the list of sponsors of approved applications.
The animal drug regulations are also being amended to reflect
several non-substantive changes. These technical amendments are being
made 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 congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 526, and 528
Animal drugs.
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 510,
520, 522, 526, and 528 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR 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 ``Abbott Laboratories'' and add in alphabetical order an entry for
``LFB USA, Inc.''; and in the table in paragraph (c)(2), remove the
entry for 000044 and add in numerical order an entry for ``086047'' to
read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702. 086047
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
086047................................. LFB USA, Inc., 175 Crossing
Blvd., Framingham, MA 01702
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.48, revise paragraph (b) to read as follows:
Sec. 520.48 Altrenogest.
* * * * *
(b) Sponsors. See Nos. 000061 and 013744 in Sec. 510.600(c) of
this chapter.
* * * * *
Sec. 520.88g [Amended]
0
5. In Sec. 520.88g, in paragraph (c)(2)(i), remove ``(1 milliliter)''.
0
6. In Sec. 520.154a:
0
a. Revise the section heading;
0
b. In paragraphs (d)(1)(ii), (d)(2)(i)(A), (d)(2)(ii)(A), and
(d)(4)(ii), remove ``bacitracin methylene disalicylate'' and in its
place add ``bacitracin methylenedisalicylate''; and
0
c. In paragraph (d)(3)(ii), remove ``Treponema hyodysenteriae'' and in
its place add ``Brachyspira hyodysenteriae''.
The revision reads as follows:
Sec. 520.154a Bacitracin methylenedisalicylate.
* * * * *
Sec. 520.304 [Amended]
0
7. In Sec. 520.304, in paragraph (b)(3), remove ``No. 026637'' and in
its place add ``Nos. 026637 and 062250''.
Sec. 520.804 [Amended]
0
8. In Sec. 520.804, redesignate paragraphs (c)(i), (c)(ii), and
(c)(iii), as paragraphs (c)(1), (c)(2), and (c)(3).
0
9. In Sec. 520.1660d, revise paragraph (a)(4) to read as follows:
Sec. 520.1660d Oxytetracycline powder.
(a) * * *
(4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets:
2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb).
* * * * *
Sec. 520.1855 [Amended]
0
10. In Sec. 520.1855, in paragraph (b), remove ``000859'' and in its
place add ``050604''.
0
11. In Sec. 520.2218, revise paragraphs (d)(1)(i)(A) and (B), and
paragraphs (d)(2)(i)(A) and (B) to read as follows:
Sec. 520.2218 Sulfamerazine, sulfamethazine, and sulfaquinoxaline
powder.
* * * * *
(d) * * *
(1) * * *
(i) * * *
(A) As an aid in the control of coccidiosis caused by Eimeria
tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine,
and sulfaquinoxaline: Provide medicated water (0.04 percent solution)
for 2 to 3 days, then plain water for 3 days, then medicated water
(0.025 percent solution) for 2 days. If bloody droppings appear, repeat
at 0.025 percent level for 2 more days. Do not change litter.
(B) As an aid in the control of acute fowl cholera caused by
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2
to 3 days. If disease recurs, repeat treatment.
* * * * *
(2) * * *
(i) * * *
(A) As an aid in the control of coccidiosis caused by Eimeria
meleagrimitis and E. adenoeides susceptible to sulfamerazine,
sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.025
percent solution) for 2 days, then plain water for 3 days, then
medicated water (0.025 percent solution) for 2 days, then plain water
for 3 days, then medicated water (0.025 percent solution) for 2 days.
Repeat if necessary. Do not change litter.
(B) As an aid in the control of acute fowl cholera caused by
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2
to 3 days. If disease recurs, repeat treatment.
* * * * *
Sec. 520.2640 [Amended]
0
12. In Sec. 520.2640, in paragraphs (e)(2)(iii) and (e)(3)(iii),
remove the first sentence.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
13. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. Sec. 522.1073 and 522.1075 [Removed]
0
14. Remove Sec. Sec. 522.1073 and 522.1075.
[[Page 34279]]
0
15. Revise Sec. 522.1077 to read as follows:
Sec. 522.1077 Gonadorelin.
(a) Specifications. Each milliliter (mL) of solution contains:
(1) 43 micrograms ([micro]g) of gonadorelin as gonadorelin acetate;
(2) 100 [micro]g of gonadorelin as gonadorelin acetate;
(3) 50 [micro]g of gonadorelin as gonadorelin diacetate
tetrahydrate; or
(4) 50 [micro]g of gonadorelin as gonadorelin hydrochloride.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 000061 for use of the 43-[micro]g/mL product described in
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of
this section.
(2) No. 068504 for use of the 100-[micro]g/mL product described in
paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of
this section.
(3) Nos. 000859 and 050604 for use of the 50-[micro]g/mL product
described in paragraph (a)(3) as in paragraphs (d)(1)(ii) and (d)(2) of
this section.
(4) No. 054771 for use of the 50-[micro]g/mL product described in
paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vi), and (d)(2)
of this section.
(c) Special considerations. Concurrent luteolytic drug use is
approved as follows:
(1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of
this section as provided by No. 000061 in Sec. 510.600(c) of this
chapter.
(2) Cloprostenol injection for use as in paragraph (d)(1)(v) of
this section as provided by No. 000061 or No. 068504 in Sec.
510.600(c) of this chapter.
(3) Dinoprost injection for use as in paragraph (d)(1)(vi) of this
section as provided by No. 054771 in Sec. 510.600(c) of this chapter.
(d) Conditions of use in cattle--(1) Indications for use and
amounts--(i) For the treatment of ovarian follicular cysts in dairy
cattle: Administer 86 [mu]g gonadorelin by intramuscular or intravenous
injection.
(ii) For the treatment of ovarian follicular cysts in dairy cattle:
Administer 100 [mu]g gonadorelin by intramuscular or intravenous
injection.
(iii) For the treatment of ovarian follicular cysts in cattle:
Administer 100 [mu]g gonadorelin by intramuscular injection.
(iv) For use with cloprostenol injection to synchronize estrous
cycles to allow for fixed-time artificial insemination (FTAI) in
lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [mu]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 86 [mu]g gonadorelin by intramuscular injection.
(v) For use with cloprostenol injection to synchronize estrous
cycles to allow for fixed-time artificial insemination (FTAI) in
lactating dairy cows and beef cows: Administer to each cow 100 [mu]g
gonadorelin by intramuscular injection, followed 6 to 8 days later by
500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72
hours later by 100 [mu]g gonadorelin by intramuscular injection.
(vi) For use with dinoprost injection to synchronize estrous cycles
to allow fixed-time artificial insemination (FTAI) in lactating dairy
cows: Administer to each cow 100 to 200 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost
by intramuscular injection, followed 30 to 72 hours later by 100 to 200
[mu]g gonadorelin by intramuscular injection.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.1145 [Amended]
0
16. In Sec. 520.1145, in paragraph (e)(2)(i), remove ``000859'' and in
its place add ``050604''.
0
17. In Sec. 522.2470, revise paragraph (b) to read as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) Sponsors. See Nos. 026637 and 054771 in Sec. 510.600(c) of
this chapter.
* * * * *
0
18. In Sec. 522.2483, revise paragraph (b) to read as follows:
Sec. 522.2483 Triamcinolone.
* * * * *
(b) Sponsors. See Nos. 000010 and 054628 in Sec. 510.600(c) of
this chapter.
* * * * *
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
20. In Sec. 526.313, revise paragraph (d)(1)(ii) to read as follows:
Sec. 526.313 Ceftiofur.
* * * * *
(d) * * *
(1) * * *
(ii) Indications for use. For use in lactating dairy cattle:
(A) For the treatment of clinical mastitis associated with
coagulase-negative staphylococci, Streptococcus dysgalactiae, and
Escherichia coli; and
(B) For the treatment of diagnosed subclinical mastitis associated
with coagulase-negative staphylococci and S. dysgalactiae.
* * * * *
PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
0
21. The authority citation for 21 CFR part 528 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 528.1070 [Amended]
0
22. In Sec. 528.1070, in paragraph (b), remove ``042976'' and in its
place add ``086047''.
Dated: June 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-14734 Filed 6-15-15; 8:45 am]
BILLING CODE 4164-01-P
