Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin; Correction, 65052-65053 [E6-18679]
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Federal Register / Vol. 71, No. 215 / Tuesday, November 7, 2006 / Rules and Regulations
§ 385.2011 Procedures for filing on
electronic media (Rule 2011).
(a) * * *
(9) FERC Form No. 60, Annual report
of centralized service companies.
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(c) What to file. * * *
(3) With the exception of the Form
Nos. 1, 2, 2–A, 6 and 60, the electronic
media must be accompanied by the
traditional prescribed number of paper
copies.
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[FR Doc. E6–18061 Filed 11–6–06; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Ivermectin, Pyrantel, and Praziquantel
Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Virbac AH,
Inc. The NADA provides for veterinary
prescription use of chewable tablets in
dogs containing ivermectin, pyrantel
pamoate, and praziquantel for the
treatment and control or prevention of
various internal parasites.
DATES: This rule is effective November
7, 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.
SUPPLEMENTARY INFORMATION: Virbac
AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, filed NADA 141–257
for IVERHART MAX (ivermectin,
pyrantel pamoate, praziquantel)
Chewable Tablets that provides for
veterinary prescription use of chewable
tablets in dogs containing ivermectin,
pyrantel pamoate, and praziquantel for
the treatment and control or prevention
of various internal parasites. The NADA
is approved as of October 13, 2006, and
21 CFR part 520 is amended by adding
new § 520.1199 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
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SUMMARY:
VerDate Aug<31>2005
14:06 Nov 06, 2006
Jkt 211001
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)(ii) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(ii)),
this approval qualifies for 3 years of
marketing exclusivity beginning October
13, 2006.
FDA has determined under 21 CFR
25.33 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.
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
(ii) 12.1 to 25 lb: one tablet as
described in paragraph (a)(2) of this
section.
(iii) 25.1 to 50 lb: one tablet as
described in paragraph (a)(3) of this
section.
(iv) 50.1 to 100 lb: one tablet as
described in paragraph (a)(4) of this
section.
(v) Greater than 100 lb: use the
appropriate combination of tablets.
(2) Indications for use. Prevents
canine heartworm disease by
eliminating the tissue stage of
heartworm larvae (Dirofilaria immitis)
for 1 month (30 days) after infection and
for the treatment and control of
roundworm (Toxocara canis, Toxascaris
leonina), hookworm (Ancylostoma
caninum, Uncinaria stenocephala,
Ancylostoma braziliense) and tapeworm
(Dipylidium caninum, Taenia
pisiformis) infections.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: October 23, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–18684 Filed 11–6–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Lincomycin;
Correction
AGENCY:
Authority: 21 U.S.C. 360b.
I
2. Add § 520.1199 to read as follows:
ACTION:
Food and Drug Administration,
HHS.
§ 520.1199 Ivermectin, pyrantel, and
praziquantel tablets.
(a) Specifications. Each chewable
tablet contains:
(1) 34 micrograms (mcg) ivermectin,
28.5 milligrams (mg) pyrantel pamoate,
and 28.5 mg praziquantel;
(2) 68 mcg ivermectin, 57 mg pyrantel
pamoate, and 57 mg praziquantel;
(3) 136 mcg ivermectin, 114 mg
pyrantel pamoate, and 114 mg
praziquantel; or
(4) 272 mcg ivermectin, 228 mg
pyrantel pamoate, and 228 mg
praziquantel.
(b) Sponsors. See No. 051311 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer monthly according
to body weight as follows:
(i) 6 to 12 lb: one tablet as described
in paragraph (a)(1) of this section.
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Final rule; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
document amending the animal drug
regulations to reflect approval of an
abbreviated new animal drug
application (ANADA) that appeared in
the Federal Register of September 1,
2006 (71 FR 51995). FDA is correcting
the date of approval of an ANADA for
a generic lincomycin injectable solution
which was drafted in error. This
correction is being made to improve the
accuracy of the Federal Register.
DATES: This rule is effective November
7, 2006.
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, email: george.haibel@fda.hhs.gov.
E:\FR\FM\07NOR1.SGM
07NOR1
Federal Register / Vol. 71, No. 215 / Tuesday, November 7, 2006 / Rules and Regulations
In FR Doc.
E6–14509, appearing on page 51995 in
the Federal Register of September 1,
2006, the following correction is made:
1. On page 51995, in the third
column, in the third sentence of the
SUPPLEMENTARY INFORMATION section, the
date of ANADA approval ‘‘July 27,
2006’’ is corrected to read ‘‘August 2,
2006’’.
SUPPLEMENTARY INFORMATION:
Dated: October 20, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–18679 Filed 11–6–06; 8:45 am]
BILLING CODE 4160–01–S
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Bambermycins
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ycherry on PROD1PC64 with RULES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to correct an
inadvertent error in the conditions of
use of bambermycins free-choice cattle
feeds. This action is being taken to
improve the accuracy of the animal drug
regulations.
DATES: This rule is effective November
7, 2006.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301–827–4567, email: george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending the animal drug regulations
in 21 CFR 558.95 to correct an
inadvertent error in the conditions of
use of bambermycins free-choice cattle
feeds. The error was introduced in a
final rule for liquid and free-choice
medicated feeds that published May 27,
2004 (69 FR 30194). This action is being
taken to improve the accuracy and
readability of the animal drug
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.
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14:06 Nov 06, 2006
Jkt 211001
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. In § 558.95, revise the last sentence
of paragraph (d)(4)(iii)(d) to read as
follows:
I
Bambermycins.
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Food and Drug Administration
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
§ 558.95
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
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 558 is amended as follows:
I
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(d) * * *
(4) * * *
(iii) * * *
(d) * * * Daily bambermycins intakes
in excess of 20 mg/head/day have not
been shown to be more effective than 20
mg/head/day.
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Dated: October 20, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–18680 Filed 11–6–06; 8:45 am]
BILLING CODE 4160–01–S
LEGAL SERVICES CORPORATION
45 CFR Part 1624
Prohibition Against Discrimination on
the Basis of Disability
Legal Services Corporation.
Final rule.
AGENCY:
ACTION:
SUMMARY: This Final Rule amends the
Legal Services Corporation’s regulation
on prohibitions against discrimination
on the basis of disability. These changes
are intended to improve the utility of
the regulation for LSC, its grantees and
other interested persons, by updating
the terminology used throughout the
regulation, to add a reference to
compliance with the Americans with
Disabilities Act and by adding language
to the enforcement provision setting
forth LSC policy regarding investigation
of complaints of violation of this
regulation.
This Final Rule is effective on
December 7, 2006.
FOR FURTHER INFORMATION CONTACT:
Mattie Cohan, Senior Assistant General
Counsel, Office of Legal Affairs, Legal
Services Corporation, 3333 K Street,
NW., Washington DC 20007; 202–295–
1624 (ph); 202–337–6519 (fax);
mcohan@lsc.gov.
DATES:
PO 00000
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65053
SUPPLEMENTARY INFORMATION:
Background
Section 504 of the Rehabilitation Act
of 1973 (29 U.S.C. 706), as amended,
prohibits discrimination on the basis of
handicap by recipients of Federal
assistance. As recipients of federal
assistance, Legal Services Corporation
(LSC) grant recipients are subject to the
non-discrimination requirements of
Section 504. At the same time, while the
Corporation is not obligated to enforce
Section 504 of the Rehabilitation Act
(since it is not an agency, department or
instrumentality of the Federal
government), it does have the authority
to ensure that LSC grant recipients
comply with its provisions. LSC chose
to exercise this authority and adopted
the Part 1624 regulation implementing
the non-discrimination requirements in
Section 504 in 1979. The regulation has
not been amended since that time.
On October 29, 2005, the LSC Board
of Directors directed that LSC initiate a
rulemaking to consider revisions to
LSC’s regulation at 45 CFR part 1624. At
the Board’s further direction, prior to
the development of this Notice of
Proposed Rulemaking (‘‘NPRM’’), LSC
convened a Rulemaking Workshop 1 to
consider revisions to this Part. The
intention of the rulemaking proceeding
was intended to provide the opportunity
for an unlimited and thorough review of
the regulation with the intent of
updating and improving the rule as
appropriate.
LSC convened a Rulemaking
Workshop on December 13, 2005 to
discuss Part 1624. The following
persons participated in the Workshop:
John ‘‘Chip’’ Gray, South Brooklyn Legal
Services; John Herrion, United Spinal
Association; Linda Perle, Center for Law
and Social Policy; Don Saunders,
National Legal Aid and Defender
Association; Helaine Barnett, LSC
President (welcoming remarks only);
Karen Sarjeant, LSC Vice President for
Programs and Compliance; Charles
Jeffress, LSC Chief Administrative
Officer; Mattie Condray, LSC Office of
Legal Affairs; Curtis Goffe, LSC Office of
Compliance and Enforcement; Tillie
Lacayo, LSC Office of Program
Performance; Mark Freedman, LSC
1 Under LSC’s Rulemaking Protocol, a
Rulemaking Workshop is a meeting at which the
participants (which may include LSC Board
members, staff, grantees and other interested
parties) ‘‘hold open discussions designed to elicit
information about problems or concerns with the
regulation (or certain aspects thereof) and provide
an opportunity for sharing ideas regarding how to
address those issues. * * * [A] Workshop is not
intended to develop detailed alternatives or to
obtain consensus on regulatory proposals.’’ 67 FR
69762, 69763 (November 19, 2002).
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]]>Agencies
[Federal Register Volume 71, Number 215 (Tuesday, November 7, 2006)]
[Rules and Regulations]
[Pages 65052-65053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18679]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Lincomycin; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
document amending the animal drug regulations to reflect approval of an
abbreviated new animal drug application (ANADA) that appeared in the
Federal Register of September 1, 2006 (71 FR 51995). FDA is correcting
the date of approval of an ANADA for a generic lincomycin injectable
solution which was drafted in error. This correction is being made to
improve the accuracy of the Federal Register.
DATES: This rule is effective November 7, 2006.
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, e-mail:
george.haibel@fda.hhs.gov.
[[Page 65053]]
SUPPLEMENTARY INFORMATION:
In FR Doc. E6-14509, appearing on page 51995 in the Federal
Register of September 1, 2006, the following correction is made:
1. On page 51995, in the third column, in the third sentence of the
SUPPLEMENTARY INFORMATION section, the date of ANADA approval ``July
27, 2006'' is corrected to read ``August 2, 2006''.
Dated: October 20, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-18679 Filed 11-6-06; 8:45 am]
BILLING CODE 4160-01-S
