New Animal Drugs; Change of Sponsor; Sometribove Zinc Suspension, 53164 [E9-24881]
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53164
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the U.S. Code. Subtitle 1,
Section 106, describes the authority of
the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more
detail the scope of the agency’s
authority. This rulemaking is
promulgated under the authority
described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it adds
additional controlled airspace at MidWay Regional Airport, MidlothianWaxahachie, TX.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR Part 71 as follows:
■
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
Issued in Fort Worth, Texas, on October 1,
2009.
Walter L. Tweedy,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. E9–24647 Filed 10–15–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA–2009–N–0665]
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 for sometribove zinc
suspension from Monsanto Co. to
Elanco Animal Health, A Division of Eli
Lilly & Co.
DATES:
This rule is effective October 16,
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
SUPPLEMENTARY INFORMATION:
[Amended]
2. The incorporation by reference in
14 CFR Part 71.1 of the Federal Aviation
Administration Order 7400.9T, Airspace
Designations and Reporting Points,
signed August 27, 2009, and effective
September 15, 2009, is amended as
follows:
■
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface.
CPrice-Sewell on DSKDVH8Z91PROD with RULES
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ASW TX E5 Midlothian-Waxahachie, TX
[Amended]
Mid-Way Regional Airport, TX
(Lat. 32°27′22″ N., long. 96°54′46″ W.)
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of Mid-Way Regional Airport and
within 1.8 miles each side of the 184° bearing
from the airport extending from the 6.5-mile
radius to 9.8 miles south of the airport.
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VerDate Nov<24>2008
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15:49 Oct 15, 2009
Jkt 220001
21 CFR Part 522
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 and 522 are amended as
follows:
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
‘‘Monsanto Co.’’; and in the table in
paragraph (c)(2) remove the entry for
‘‘000911’’.
■
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.
2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
1. The authority citation for 14 CFR
Part 71 continues to read as follows:
■
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
PART 510—NEW ANIMAL DRUGS
New Animal Drugs; Change of
Sponsor; Sometribove Zinc
Suspension
AGENCY:
List of Subjects
Monsanto
Co., 800 North Lindbergh Blvd., St.
Louis, MO 63167, has informed FDA
that it has transferred ownership of, and
all rights and interest in, NADA 140–
872 for POSILAC (sometribove zinc
suspension) to Elanco Animal Health, A
Division of Eli Lilly & Co., Lilly
Corporate Center, Indianapolis, IN
46285. Accordingly, the regulations are
amended in 21 CFR 522.2112 to reflect
this change of sponsorship.
Following this change of sponsorship,
Monsanto Co. is no longer the sponsor
of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove the entries for
Monsanto Co.
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 00014
Fmt 4700
Sfmt 4700
§ 522.2112
[Amended]
4. In paragraph (b) of § 522.2112,
remove ‘‘000911’’ and add in its place
‘‘000986’’.
■
Dated: October 9, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–24881 Filed 10–15–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs;
Tulathromycin
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
E:\FR\FM\16OCR1.SGM
16OCR1
]]>Agencies
[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Rules and Regulations]
[Page 53164]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24881]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Change of Sponsor; Sometribove Zinc Suspension
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 for sometribove zinc
suspension from Monsanto Co. to Elanco Animal Health, A Division of Eli
Lilly & Co.
DATES: This rule is effective October 16, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Monsanto Co., 800 North Lindbergh Blvd., St.
Louis, MO 63167, has informed FDA that it has transferred ownership of,
and all rights and interest in, NADA 140-872 for POSILAC (sometribove
zinc suspension) to Elanco Animal Health, A Division of Eli Lilly &
Co., Lilly Corporate Center, Indianapolis, IN 46285. Accordingly, the
regulations are amended in 21 CFR 522.2112 to reflect this change of
sponsorship.
Following this change of sponsorship, Monsanto Co. is no longer the
sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is
being amended to remove the entries for Monsanto Co.
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 Part 522
Animal drugs.
0
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 and
522 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 ``Monsanto Co.''; and in the table in paragraph (c)(2) remove the
entry for ``000911''.
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.
Sec. 522.2112 [Amended]
0
4. In paragraph (b) of Sec. 522.2112, remove ``000911'' and add in its
place ``000986''.
Dated: October 9, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-24881 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S
