Oral Dosage Form New Animal Drugs; Omeprazole, 59374 [E6-16604]
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59374
Federal Register / Vol. 71, No. 195 / Tuesday, October 10, 2006 / Rules and Regulations
3. The authority citation for part 135
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 44113, 44701–
44702, 44705, 44709, 44711–44713, 44715–
44717, 44722.
4. In § 135.128, amend paragraph
(a)(2)(ii)(D) to read as follows:
§ 135.128 Use of safety belts and child
restraint systems
(a) * * *
(2) * * *
(ii) * * *
(D) Except as provided in
§ 135.128(a)(2)(ii)(C)(3) and
§ 135.128(a)(2)(ii)(C)(4), booster-type
child restraint systems (as defined in
Federal Motor Vehicle Safety Standard
No. 213 (49 CFR 571.213)), vest- and
harness-type child restraint systems,
and lap held child restraints are not
approved for use in aircraft; and
*
*
*
*
*
Issued in Washington, DC on September
29, 2006.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.
[FR Doc. E6–16622 Filed 10–6–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Omeprazole
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Merial
Ltd. The supplemental NADA provides
for administration of omeprazole paste
to horses for 8 or 28 days for the
prevention of gastric ulcers.
DATES: This rule is effective October 10,
2006.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@.fda.hhs.gov.
VerDate Aug<31>2005
15:57 Oct 06, 2006
Jkt 211001
Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640, filed a
supplement to NADA 141–227 for
ULCERGARD (omeprazole) Paste. The
supplemental application provides for
administration of omeprazole paste to
horses for 8 or 28 days for the
prevention of gastric ulcers. The
supplemental NADA is approved as of
September 15, 2006, and 21 CFR
520.1615 is amended to reflect the
approval. The basis of approval is
discussed in the freedom of information
summary.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
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.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
approval qualifies for 3 years of
marketing exclusivity beginning
September 15, 2006.
The agency has determined under 21
CFR 25.33(d)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
SUPPLEMENTARY INFORMATION:
PART 135—OPERATING
REQUIREMENTS: COMMUTER AND
ON-DEMAND OPERATIONS AND
RULES GOVERNING PERSONS ON
BOARD SUCH AIRCRAFT
List of Subjects in 21 CFR Part 520
Animal drugs.
I 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 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:
I
Authority: 21 U.S.C. 360b.
§ 520.1615
Omeprazole.
2. In paragraph (d)(1)(ii) of § 520.1615,
at the end of the first sentence remove
‘‘for up to 28 days’’ and add in its place
‘‘for 8 or 28 days’’.
I
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
Dated: September 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–16604 Filed 10–6–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF DEFENSE
Office of the Secretary
[DOD–2006–OS–0134; RIN 0790–AG91]
32 CFR Part 284
Waiver Procedures for Debts Resulting
from Erroneous Payments of Pay and
Allowances
Department of Defense.
Final rule.
AGENCY:
ACTION:
SUMMARY: This rule implements policy
and prescribes procedures for
considering applications for the waiver
of debts resulting from erroneous
payments of pay and allowances
(including travel and transportation
allowances) to or on behalf of members
of the Uniformed Services and civilian
Department of Defense (DoD)
employees. The Legislative Branch
Appropriations Act of 1996 transferred
to the Director of the Office of
Management and Budget (OMB) the
Comptroller General’s authority to settle
claims. The OMB Director subsequently
delegated some of these authorities to
the Department of Defense. Later, the
General Accounting Office Act of 1996
codified many of these delegations to
the Secretary of Defense and others and
transferred to the OMB Director the
authority of the Comptroller General to
waive uniformed service member and
employee debts arising out of the
erroneous payment of pay or allowances
exceeding $1,500. The OMB Director
subsequently delegated the authority to
waive such debts of uniformed service
members and DoD employees to the
Secretary of Defense. The Secretary of
Defense further delegated his claims
settlement and waiver authorities to the
General Counsel. This rule implements
the reassignment of the Comptroller
General’s former duties within the
Department of Defense with little
impact on the public.
DATES: Effective Date: October 10, 2006.
FOR FURTHER INFORMATION CONTACT:
Michael Hipple, 703–696–8510.
SUPPLEMENTARY INFORMATION: On
Thursday, November 14, 2002 (67 FR
68964), the Department of Defense
published 32 CFR part 284 along with
parts 281, 282, and 283 as proposed
rules with request for public comments.
E:\FR\FM\10OCR1.SGM
10OCR1
]]>Agencies
[Federal Register Volume 71, Number 195 (Tuesday, October 10, 2006)]
[Rules and Regulations]
[Page 59374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16604]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Omeprazole
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Merial Ltd. The supplemental NADA provides
for administration of omeprazole paste to horses for 8 or 28 days for
the prevention of gastric ulcers.
DATES: This rule is effective October 10, 2006.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@.fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-227 for
ULCERGARD (omeprazole) Paste. The supplemental application provides for
administration of omeprazole paste to horses for 8 or 28 days for the
prevention of gastric ulcers. The supplemental NADA is approved as of
September 15, 2006, and 21 CFR 520.1615 is amended to reflect the
approval. The basis of approval is discussed in the freedom of
information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application 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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies
for 3 years of marketing exclusivity beginning September 15, 2006.
The agency has determined under 21 CFR 25.33(d)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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 520
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 part 520 is
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. 520.1615 Omeprazole.
0
2. In paragraph (d)(1)(ii) of Sec. 520.1615, at the end of the first
sentence remove ``for up to 28 days'' and add in its place ``for 8 or
28 days''.
Dated: September 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-16604 Filed 10-6-06; 8:45 am]
BILLING CODE 4160-01-S
