40010 Federal Register / Vol. 71, No.
135 / Friday, July 14, 2006 / Rules and Regulations
approved by the FAA in accordance
with § 21.305(d) or Technical Standard
Order C–100b, or a later version.
(D) Except as provided in
§ 125.211(b)(2)(C)(3) and
§ 125.211(b)(2)(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
(c) * * *
(1) Except as provided in
§ 125.211(b)(2)(ii)(C)(3) and
§ 125.211(b)(2)(ii)(C)(4), no certificate
holder may permit a child, in an
aircraft, to occupy a booster-type child
restraint system, a vest-type child
restraint system, a harness-type child
restraint system, or a lap held child
restraint system during take off, landing,
and movement on the surface.
* * * * *
PART 135—OPERATING
REQUIREMENTS: COMMUTER AND
ON-DEMAND OPERATIONS
■ 7. The authority citation for part 135
continues to read as follows:
Authority: 49 U.S.C. 106(g), 44113, 44701–
44702, 44705, 44709, 44711–44713, 44715–
44717, 44722.
■ 8. Amend § 135.128 by revising
paragraphs (a)(2)(ii)(C)(3), (a)(2)(ii)(D),
and (b)(1), and adding pargraph
(a)(2)(ii)(C)(4) to read as follows:
§ 135.128 Use of safety belts and child
restraint systems.
(a) * * *
(2) * * *
(ii) * * *
(C) * * *
(3) That the seat or child restraint
device furnished by the certificate
holder was approved by the FAA
through Type Certificate or
Supplemental Type Certificate.
(4) That the seat or child restraint
device furnished by the certificate
holder, or one of the persons described
in paragraph (b)(2)(i) of this section, was
approved by the FAA in accordance
with § 21.305(d) or Technical Standard
Order C–100b, or a later version.
(D) Except as provided in
§ 135.128(a)(2)(C)(3) and
§ 135.128(a)(2)(C)(4), booster-type child
restraint systems (as defined in Federal
Motor Vehicle Safety Standard No. 213
(49 CFR 571.213)), vest- and harness-
cprice-sewell on PROD1PC66 with RULES
type child restraint systems, and lap
held child restraints are not approved
for use in aircraft; and
(b) * * *
(1) Except as provided in § 135.128
(a)(2)(ii)(C)(3) and § 135.128
VerDate Aug<31>2005 15:14 Jul 13, 2006 Jkt 208001
(a)(2)(ii)(C)(4), no certificate holder may
permit a child, in an aircraft, to occupy
a booster-type child restraint system, a
vest-type child restraint system, a
harness-type child restraint system, or a
lap held child restraint system during
take off, landing, and movement on the
surface.
* * * * * Friday.
Issued in Washington, DC, on July 7, 2006.
Marion C. Blakey,
Administrator.
[FR Doc. E6–11112 Filed 7–13–06; 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;
Ivermectin Paste
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 an abbreviated new animal
drug application (ANADA) filed by
Med-Pharmex, Inc. The ANADA
provides for oral use of ivermectin paste
in horses for treatment and control of
various internal parasites or parasitic
conditions.
DATES: This rule is effective July 14,
2006.
FOR FURTHER INFORMATION CONTACT:
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, e-
mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Med-
Pharmex, Inc., 2727 Thompson Creek
Rd., Pomona, CA 91767–1861, filed
ANADA 200–390 for oral use of
Ivermectin Paste 1.87% in horses for the
treatment and control of various species
of internal parasites or parasitic
conditions. Med-Pharmex’s Ivermectin
Paste 1.87% is approved as a generic
copy of Merial Ltd.’s EQVALAN Paste,
approved under NADA 134–314.
ANADA 200–390 is approved as of June
20, 2006, and 21 CFR 520.1192 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
PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\14JYR1.SGM
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
The agency has determined under 21
CFR 25.33(a)(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.
■ 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:
Authority: 21 U.S.C. 360b.
■ 2. In § 520.1192, add paragraph (b)(4)
John
to read as follows:
§ 520.1192 Ivermectin paste.
* * * * *
(b) * * *
(4) No. 054925 for use of a 1.87
percent paste as in paragraphs (e)(1)(i),
(e)(1)(ii)(A), and (e)(1)(iii) of this
section.
* * * * *
Dated: June 30, 2006.
Catherine P. Beck,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. E6–11073 Filed 7–13–06; 8:45 am]
BILLING CODE 4160–01–S
14JYR1