New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin, 44277-44278 [2014-17912]
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44277
Federal Register / Vol. 79, No. 147 / Thursday, July 31, 2014 / Rules and Regulations
amended to remove a cross-reference to
a combination drug medicated feed that
is no longer codified.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DATES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2014–N–0002]
New Animal Drugs; Bacitracin
Methylene Disalicylate; Dinoprost
Solution; Gonadorelin Hydrochloride;
Progesterone Intravaginal Inserts;
Salinomycin; Ractopamine; Tylosin
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during June 2014. 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:
This rule is effective July 31,
2014.
21 CFR Parts 520, 522, 529, and 558
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during June 2014 as listed in
table 1. In addition, FDA is informing
the public of the availability, where
applicable, of documentation of
environmental review 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 Center for Veterinary
Medicine (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.
Also, the regulations are being
amended in 21 CFR 558.76 to remove a
cross-reference to a combination drug
medicated feed which was removed in
earlier corrections to part 558 (79 FR
10976, February 27, 2014). This
amendment is 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.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JUNE 2014
NADA/
ANADA
Sponsor
New animal drug product
name
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
LUTALYSE (dinoprost injection) Injection.
128–686 ....
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
200–473 3 ..
Huvepharma AD, 5th Floor,
3A, Nikolay Haytov Str.,
1113 Sophia, Bulgaria.
BIO–COX 60 (salinomycin
sodium) Type A medicated
article.
TYLOVET (tylosin tartrate)
Soluble.
200–560 ....
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
200–562 ....
mstockstill on DSK4VPTVN1PROD with RULES
108–901 ....
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
ACTOGAIN (ractopamine
HCl), RUMENSIN
(monensin), MGA
(melengestrol acetate), and
Type B and C medicated
feeds.
ACTOGAIN (ractopamine
HCl), RUMENSIN
(monensin), TYLAN (tylosin
phosphate), and MGA
(melengestrol acetate)
Type B and C medicated
feeds.
21 CFR
Sections
Action
Supplemental approval of
label references to approved uses with
gonadorelin hydrochloride
injection and progesterone
intravaginal inserts.
Supplemental approval of revised assay limits for Type
A medicated articles.
Supplemental approval of a
change in marketing status
from over-the-counter
(OTC) to by veterinary prescription (Rx).
Original approval as a generic copy of NADA 141–
234.
Original approval as a generic copy of NADA 141–
233.
FOIA
Summary
NEPA
Review
522.690,
522.1077,
529.1940
yes .......
CE1 2
558.4
no .........
CE1 2
520.2640
no .........
CE1 2
558.500
yes .......
CE1 2
558.500
yes .......
CE1 2
1 The Agency has determined under 21 CFR 25.33 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 individually or cumulatively have a significant effect on the human environment.
2 CE granted under 21 CFR 25.33(a)(1).
3 The application listed was identified as being affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209’’, December 2013.
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44278
Federal Register / Vol. 79, No. 147 / Thursday, July 31, 2014 / Rules and Regulations
List of Subjects
21 CFR Parts 520, 522, and 529
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 and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 520, 522, 529, and 558 are
amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
72 hours later by 100 to 200 mcg
gonadorelin by intramuscular injection.
Dinoprost injection as in § 522.690,
provided by No. 054771 in § 510.600(c)
of this chapter.
*
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
6. The authority citation for 21 CFR
part 529 continues to read as follows:
§ 520.2640
Authority: 21 U.S.C. 360b.
7. In § 529.1940, revise paragraph (d),
the second sentence in paragraph
(e)(1)(i) and the last sentence in
paragraph (e)(1)(iii) to read as follows:
■
[Amended]
2. In § 520.2640, in paragraphs (b)(1)
and (d) remove ‘‘No. 000986’’ and in its
place add ‘‘Nos. 000986 and 016592’’;
and in paragraph (b)(2) remove ‘‘Nos.
016592 and 061623’’ and in its place
add ‘‘No. 061623’’.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 522.690, revise the section
heading and paragraph (d)(2)(v) to read
as follows:
■
§ 522.690
Dinoprost.
*
*
*
*
*
(d) * * *
(2) * * *
(v) Dinoprost injection as provided by
No. 054771 in § 510.600(c) of this
chapter may also be used concurrently
with gonadorelin hydrochloride
injection as in § 522.1077 and with
progesterone intravaginal inserts as in
§ 529.1940 of this chapter.
*
*
*
*
*
■ 5. In § 522.1077, revise paragraph
(c)(1)(ii) to read as follows:
§ 522.1077
Gonadorelin hydrochloride.
mstockstill on DSK4VPTVN1PROD with RULES
*
*
*
*
*
(c) * * *
(1) * * *
(ii) 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 mcg gonadorelin by
intramuscular injection, followed 6 to 8
days later by 25 mg dinoprost by
intramuscular injection, followed 30 to
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17:37 Jul 30, 2014
§ 529.1940
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BILLING CODE 4164–01–P
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
8. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
[Amended]
9. In paragraph (d) of § 558.4, in the
‘‘Category I’’ table, in the ‘‘Assay limits
percent type A’’ column, in the entry for
‘‘Salinomycin’’, remove ‘‘95–115’’ and
in its place add ‘‘90–110’’.
■
§ 558.76
[Amended]
10. In § 558.76, remove and reserve
paragraph (d)(3)(vii).
■
§ 558.500
[Amended]
[MCC FR 14–03]
Touhy Regulations
Millennium Challenge
Corporation.
ACTION: Final rule.
Frm 00018
Fmt 4700
This rule implements the
procedures by which the Millennium
Challenge Corporation responds to
subpoenas or other official demands for
information and testimony served upon
itself or its employees.
DATES: This rule is effective July 31,
2014.
SUMMARY:
John
C. Mantini, Office of the General
Counsel, Millennium Challenge
Corporation, 202–521–3863, or foia@
mcc.gov.
FOR FURTHER INFORMATION CONTACT:
The
United States Supreme Court held in
United States ex rel. Touhy v. Ragen,
340 U.S. 462 (1951), that the head of a
federal agency may make the
determination on his/her sole authority
to produce documents and authorize
employee’s testimony in response to a
subpoena or other demand for
information. This regulation governs the
Millennium Challenge Corporation’s
procedures for authorizing or denying
such demands. MCC published a
proposed regulation on May 9, 2014 in
79 FR 26659 and invited interested
parties to submit comments. MCC
received no comments. Accordingly, the
proposed regulation is adopted as a final
regulation with only minor editorial
changes.
SUPPLEMENTARY INFORMATION:
List of Subjects in 22 CFR Part 1305:
Administrative Practice and
procedure, Courts, Disclosure,
Exemptions, Government employees,
Subpoenas, Records, Testimony.
For the reasons set forth above, the
Millennium Challenge Corporation
amends Chapter XIII of 22 CFR by
adding Part 1305, to read as follows:
■
11. In § 558.500, in the table in
paragraphs (e)(2)(viii) and (e)(2)(x), in
the ‘‘Sponsor’’ column, remove
■
PO 00000
22 CFR Part 1305
AGENCY:
*
*
*
*
(d) Special considerations. Product
labeling shall bear the following
warning: ‘‘Avoid contact with skin by
wearing protective gloves when
handling inserts. Store removed inserts
in a sealable container until they can be
disposed of in accordance with
applicable local, state, and Federal
regulations.’’
(e) * * *
(1) * * *
(i) * * * When used for indications
listed in paragraph (e)(1)(ii)(A) of this
section, administer 25 mg dinoprost as
a single intramuscular injection 1 day
prior to insert removal (Day 6). * * *
*
*
*
*
*
(iii) * * * Dinoprost injection for use
in paragraphs (e)(1)(ii)(A) and
(e)(1)(ii)(B) of this section as in
§ 522.690 of this chapter, provided by
No. 054771 in § 510.600(c) of this
chapter.
*
*
*
*
*
§ 558.4
MILLENNIUM CHALLENGE
CORPORATION
Progesterone intravaginal
*
■
Dated: July 24, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
■
■
Authority: 21 U.S.C. 360b.
‘‘000986’’ and in its place add ‘‘000986,
054771’’.
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]]>Agencies
[Federal Register Volume 79, Number 147 (Thursday, July 31, 2014)]
[Rules and Regulations]
[Pages 44277-44278]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17912]
[[Page 44277]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 529, and 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost
Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts;
Salinomycin; Ractopamine; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during June 2014. 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 remove a cross-reference to a combination drug
medicated feed that is no longer codified.
DATES: This rule is effective July 31, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during June 2014 as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review 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 Center for Veterinary Medicine (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.
Also, the regulations are being amended in 21 CFR 558.76 to remove
a cross-reference to a combination drug medicated feed which was
removed in earlier corrections to part 558 (79 FR 10976, February 27,
2014). This amendment is 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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During June 2014
----------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR FOIA NEPA
NADA/ ANADA Sponsor product name Action Sections Summary Review
----------------------------------------------------------------------------------------------------------------
108-901........ Zoetis Inc., 333 LUTALYSE Supplemental 522.690, yes......... CE\1\ \2\
Portage St., (dinoprost approval of 522.1077,
Kalamazoo, MI injection) label references 529.1940
49007. Injection. to approved uses
with gonadorelin
hydrochloride
injection and
progesterone
intravaginal
inserts.
128-686........ Zoetis Inc., 333 BIO-COX 60 Supplemental 558.4 no.......... CE\1\ \2\
Portage St., (salinomycin approval of
Kalamazoo, MI sodium) Type A revised assay
49007. medicated limits for Type
article. A medicated
articles.
200-473 \3\.... Huvepharma AD, TYLOVET (tylosin Supplemental 520.2640 no.......... CE\1\ \2\
5th Floor, 3A, tartrate) approval of a
Nikolay Haytov Soluble. change in
Str., 1113 marketing status
Sophia, Bulgaria. from over-the-
counter (OTC) to
by veterinary
prescription
(Rx).
200-560........ Zoetis Inc., 333 ACTOGAIN Original approval 558.500 yes......... CE\1\ \2\
Portage St., (ractopamine as a generic
Kalamazoo, MI HCl), RUMENSIN copy of NADA 141-
49007. (monensin), MGA 234.
(melengestrol
acetate), and
Type B and C
medicated feeds.
200-562........ Zoetis Inc., 333 ACTOGAIN Original approval 558.500 yes......... CE\1\ \2\
Portage St., (ractopamine as a generic
Kalamazoo, MI HCl), RUMENSIN copy of NADA 141-
49007. (monensin), 233.
TYLAN (tylosin
phosphate), and
MGA
(melengestrol
acetate) Type B
and C medicated
feeds.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 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 individually or cumulatively have a significant effect on the human environment.
\2\ CE granted under 21 CFR 25.33(a)(1).
\3\ The application listed was identified as being affected by guidance for industry (GFI) 213, ``New
Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water
of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions
with GFI 209'', December 2013.
[[Page 44278]]
List of Subjects
21 CFR Parts 520, 522, and 529
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 and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
522, 529, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.2640 [Amended]
0
2. In Sec. 520.2640, in paragraphs (b)(1) and (d) remove ``No.
000986'' and in its place add ``Nos. 000986 and 016592''; and in
paragraph (b)(2) remove ``Nos. 016592 and 061623'' and in its place add
``No. 061623''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 522.690, revise the section heading and paragraph (d)(2)(v)
to read as follows:
Sec. 522.690 Dinoprost.
* * * * *
(d) * * *
(2) * * *
(v) Dinoprost injection as provided by No. 054771 in Sec.
510.600(c) of this chapter may also be used concurrently with
gonadorelin hydrochloride injection as in Sec. 522.1077 and with
progesterone intravaginal inserts as in Sec. 529.1940 of this chapter.
* * * * *
0
5. In Sec. 522.1077, revise paragraph (c)(1)(ii) to read as follows:
Sec. 522.1077 Gonadorelin hydrochloride.
* * * * *
(c) * * *
(1) * * *
(ii) 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 mcg 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
mcg gonadorelin by intramuscular injection. Dinoprost injection as in
Sec. 522.690, provided by No. 054771 in Sec. 510.600(c) of this
chapter.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 529.1940, revise paragraph (d), the second sentence in
paragraph (e)(1)(i) and the last sentence in paragraph (e)(1)(iii) to
read as follows:
Sec. 529.1940 Progesterone intravaginal inserts.
* * * * *
(d) Special considerations. Product labeling shall bear the
following warning: ``Avoid contact with skin by wearing protective
gloves when handling inserts. Store removed inserts in a sealable
container until they can be disposed of in accordance with applicable
local, state, and Federal regulations.''
(e) * * *
(1) * * *
(i) * * * When used for indications listed in paragraph
(e)(1)(ii)(A) of this section, administer 25 mg dinoprost as a single
intramuscular injection 1 day prior to insert removal (Day 6). * * *
* * * * *
(iii) * * * Dinoprost injection for use in paragraphs (e)(1)(ii)(A)
and (e)(1)(ii)(B) of this section as in Sec. 522.690 of this chapter,
provided by No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
8. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.4 [Amended]
0
9. In paragraph (d) of Sec. 558.4, in the ``Category I'' table, in the
``Assay limits percent type A'' column, in the entry for
``Salinomycin'', remove ``95-115'' and in its place add ``90-110''.
Sec. 558.76 [Amended]
0
10. In Sec. 558.76, remove and reserve paragraph (d)(3)(vii).
Sec. 558.500 [Amended]
0
11. In Sec. 558.500, in the table in paragraphs (e)(2)(viii) and
(e)(2)(x), in the ``Sponsor'' column, remove ``000986'' and in its
place add ``000986, 054771''.
Dated: July 24, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-17912 Filed 7-30-14; 8:45 am]
BILLING CODE 4164-01-P
