New Animal Drugs; Change of Sponsor's Name, 4224-4225 [2012-1756]
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Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations
the Internet through the Commission’s
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Room during normal business hours
(8:30 a.m. to 5 p.m. Eastern time) at 888
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22. From the Commission’s Home
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Title 18, Code of Federal Regulations, as
follows.
E. Effective Date and Congressional
Notification
24. These regulations are effective
March 27, 2012. The Commission has
determined, with the concurrence of the
Administrator of the Office of
Information and Regulatory Affairs of
OMB, that this rule is not a ‘‘major rule’’
as defined in section 351 of the Small
Business Regulatory Enforcement
Fairness Act of 1996. The rule is being
submitted to the Senate, House,
Government Accountability Office, and
the Small Business Administration.
PART 284—CERTAIN SALES AND
TRANSPORTATION OF NATURAL GAS
UNDER THE NATURAL GAS POLICY
ACT OF 1978 AND RELATED
AUTHORITIES
List of Subjects in 18 CFR Part 284
Continental shelf, Natural gas,
Reporting and recordkeeping
requirements.
By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
1. The authority citation for part 284
continues to read as follows:
■
Authority: 15 U.S.C. 717–717w, 3301–
3432; 42 U.S.C. 7101–7352; 43 U.S.C. 1331–
1356.
§ 284.13
[Amended]
2. Section 284.13 is amended as
follows:
■ a. Paragraph (e) is removed.
■ b. Paragraph (f) is redesignated as
paragraph (e).
■
§ 284.126
[Amended]
3. Section 284.126 is amended by
removing paragraph (c).
■
In consideration of the foregoing, the
Commission amends Part 284, Chapter I,
Appendix
LIST OF COMMENTERS AND ABBREVIATIONS
Commenter
Abbreviation
American Gas Association ...............................................................................................................................................................
Cranberry Pipeline Corporation ........................................................................................................................................................
Enogex LLC ......................................................................................................................................................................................
Enstor Operating Company, LLC .....................................................................................................................................................
Interstate Natural Gas Association of America ................................................................................................................................
Jefferson Island Storage & Hub, LLC ..............................................................................................................................................
Niska Gas Storage LLC ....................................................................................................................................................................
Northern Natural Gas Company .......................................................................................................................................................
Spectra Energy Transmission, LLC & Spectra Energy Partners, LP ..............................................................................................
Texas Pipeline Association ...............................................................................................................................................................
Williston Basin Interstate Pipeline Company ....................................................................................................................................
AGA.
Cranberry.
Enogex.
Enstor.
INGAA.
Jefferson.
Niska.
Northern.
Spectra.
TPA.
Williston Basin.
[FR Doc. 2012–1612 Filed 1–26–12; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA–2011–N–0003]
pmangrum on DSK3VPTVN1PROD with RULES
New Animal Drugs; Change of
Sponsor’s Name
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from
SUMMARY:
VerDate Mar<15>2010
15:16 Jan 26, 2012
Jkt 226001
Nycomed US, Inc., to Fougera
Pharmaceuticals, Inc.
DATES: This rule is effective January 27,
2012.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, (240) 276–8300,
email: steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Nycomed
US, Inc., 60 Baylis Rd., Melville, NY
11747 has informed FDA of a change of
name to Fougera Pharmaceuticals, Inc.
Accordingly, the Agency is amending
the regulations in 21 CFR 510.600(c) to
reflect these changes.
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.
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
List of Subjects in 21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
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 Center for Veterinary Medicine, 21
CFR part 510 is amended as follows:
PART 510—NEW ANIMAL DRUGS
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
‘‘Nycomed US, Inc.’’; alphabetically add
a new entry for ‘‘Fougera
Pharmaceuticals, Inc.’’; and in the table
■
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Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations
heartworm disease, for prevention and
control of fleas, and for the treatment
and control of various internal parasites
in dogs.
DATES: This rule is effective January 27,
§ 510.600 Names, addresses, and drug
2012.
labeler codes of sponsors of approved
applications.
FOR FURTHER INFORMATION CONTACT:
Steven Fleischer, Center for Veterinary
*
*
*
*
*
Medicine (HFV–110), Food and Drug
(c) * * *
Administration, 7500 Standish Pl.,
(1) * * *
Rockville, MD 20855, 240–276–8234,
Drug labeler
email: steven.fleischer@fda.hhs.gov.
Firm name and address
code
SUPPLEMENTARY INFORMATION: Novartis
Animal Health US, Inc., 3200 Northline
Ave., Suite 300, Greensboro, NC 27408,
*
*
*
*
*
filed NADA 141–333 that provides for
Fougera Pharmaceuticals,
Inc., P.O. Box 2006, 60
the veterinary prescription use of
Baylis Rd., Melville, NY
SENTINEL SPECTRUM (milbemycin
11747 ................................
025463 oxime/lufenuron/praziquantel) Tablets
for the prevention of heartworm disease,
*
*
*
*
*
for the prevention and control of flea
populations, and for the treatment and
(2) * * *
control of adult roundworm, adult
hookworm, adult whipworm, and adult
Drug labeler
Firm name and address
tapeworm infections in dogs and
code
puppies 2 pounds of body weight or
greater and 6 weeks of age and older.
*
*
*
*
*
The NADA is approved as of December
025463 ........ Fougera Pharmaceuticals,
8, 2011, and 21 CFR part 520 is
Inc., P.O. Box 2006, 60
amended by adding new § 520.1447 to
Baylis Rd., Melville, NY
reflect the approval.
11747.
A summary of safety and effectiveness
data and information submitted to
*
*
*
*
*
support approval of this application
may be seen in the Division of Dockets
Dated: January 24, 2012.
Management (HFA–305), Food and Drug
William T. Flynn,
Administration, 5630 Fishers Lane, Rm.
Acting Director, Center for Veterinary
1061, Rockville, MD 20852, between 9
Medicine.
a.m. and 4 p.m., Monday through
[FR Doc. 2012–1756 Filed 1–26–12; 8:45 am]
Friday.
BILLING CODE 4160–01–P
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
DEPARTMENT OF HEALTH AND
approval qualifies for 3 years of
HUMAN SERVICES
marketing exclusivity beginning on the
date of approval.
Food and Drug Administration
The Agency has determined under 21
CFR 25.33 that this action is of a type
21 CFR Part 520
that does not individually or
[Docket No. FDA–2011–N–0003]
cumulatively have a significant effect on
the human environment. Therefore,
Oral Dosage Form New Animal Drugs;
neither an environmental assessment
Milbemycin Oxime, Lufenuron, and
nor an environmental impact statement
Praziquantel
is required.
This rule does not meet the definition
AGENCY: Food and Drug Administration,
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
HHS.
it is a rule of ‘‘particular applicability.’’
ACTION: Final rule.
Therefore, it is not subject to the
congressional review requirements in 5
SUMMARY: The Food and Drug
U.S.C. 801–808.
Administration (FDA) is amending the
animal drug regulations to reflect
List of Subjects in 21 CFR Part 520
approval of a new animal drug
Animal drugs.
application (NADA) filed by Novartis
Animal Health US, Inc. The NADA
Therefore, under the Federal Food,
provides for the veterinary prescription
Drug, and Cosmetic Act and under
use of milbemycin oxime, lufenuron,
authority delegated to the Commissioner
and praziquantel for the prevention of
of Food and Drugs and redelegated to
pmangrum on DSK3VPTVN1PROD with RULES
in paragraph (c)(2), revise the entry for
‘‘025463’’.
The addition and revision read as
follows:
VerDate Mar<15>2010
15:16 Jan 26, 2012
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Fmt 4700
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4225
the Center for Veterinary Medicine, 21
CFR part 520 is 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:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 520.1447 to read as follows:
§ 520.1447 Milbemycin oxime, lufenuron,
and praziquantel tablets.
(a) Specifications. Each tablet
contains:
(1) 2.3 milligrams (mg) milbemycin
oxime, 46 mg lufenuron, and 22.8 mg
praziquantel;
(2) 5.75 mg milbemycin oxime, 115
mg lufenuron, and 57 mg praziquantel;
(3) 11.5 mg milbemycin oxime, 230
mg lufenuron, and 114 mg praziquantel;
or
(4) 23 mg milbemycin oxime, 460 mg
lufenuron, and 228 mg praziquantel.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use—(1) Dogs—(i)
Amount. 0.5 mg milbemycin oxime, 10
mg lufenuron, and 5 mg of praziquantel
per kilogram of body weight, once a
month.
(ii) Indications for use. For the
prevention of heartworm disease caused
by Dirofilaria immitis; for the
prevention and control of flea
populations (Ctenocephalides felis); and
for the treatment and control of adult
roundworm (Toxocara canis, Toxascaris
leonina), adult hookworm (Ancylostoma
caninum), adult whipworm (Trichuris
vulpis), and adult tapeworm (Taenia
pisiformis, Echinococcus multilocularis,
and E. granulosus) infections in dogs
and puppies 2 pounds of body weight
or greater and 6 weeks of age and older.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) [Reserved]
Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 2012–1744 Filed 1–26–12; 8:45 am]
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]]>Agencies
[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Pages 4224-4225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1756]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Change of Sponsor's Name
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Nycomed US,
Inc., to Fougera Pharmaceuticals, Inc.
DATES: This rule is effective January 27, 2012.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, (240) 276-8300, email:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Nycomed US, Inc., 60 Baylis Rd., Melville,
NY 11747 has informed FDA of a change of name to Fougera
Pharmaceuticals, Inc. Accordingly, the Agency is amending the
regulations in 21 CFR 510.600(c) to reflect these changes.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
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 Center for Veterinary Medicine, 21 CFR part 510 is
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 ``Nycomed US, Inc.''; alphabetically add a new entry for ``Fougera
Pharmaceuticals, Inc.''; and in the table
[[Page 4225]]
in paragraph (c)(2), revise the entry for ``025463''.
The addition and revision 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
------------------------------------------------------------------------
* * * * *
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis 025463
Rd., Melville, NY 11747................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
025463.............................. Fougera Pharmaceuticals, Inc.,
P.O. Box 2006, 60 Baylis Rd.,
Melville, NY 11747.
* * * * *
------------------------------------------------------------------------
Dated: January 24, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1756 Filed 1-26-12; 8:45 am]
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