New Animal Drugs For Use in Animal Feed; Semduramicin, 811-813 [E7-25605]
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811
Rules and Regulations
Federal Register
Vol. 73, No. 3
Friday, January 4, 2008
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 526
Intramammary Dosage Form New
Animal Drugs; Pirlimycin
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PROD1PC69 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
Pharmacia and Upjohn Co., a Division
of Pfizer, Inc. The supplemental NADA
extends the dosage regimen for
pirlimycin hydrochloride
intramammary infusion in lactating
dairy cattle to daily treatment for up to
8 days.
DATES: This rule is effective January 4,
2008.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmacia
& Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017,
filed a supplement to NADA 141–036
that provides for veterinary prescription
use of PIRSUE (pirlimycin
hydrochloride) Sterile Solution in
lactating dairy cattle for the treatment of
mastitis. The supplement extends the
dosage regimen to daily treatment for up
to 8 days. The supplemental NADA is
approved as of December 12, 2007, and
the regulations are amended in 21 CFR
526.1810 to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
VerDate Aug<31>2005
14:27 Jan 03, 2008
Jkt 214001
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
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval.
FDA has determined under 21 CFR
25.33(d)(5) 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 526
Animal drugs.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 526 is amended as follows:
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 526 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
hour intervals for up to 8 consecutive
days.
(2) Indications for use. For the
treatment of clinical and subclinical
mastitis in lactating dairy cattle
associated with Staphylococcus species
such as Staphylococcus aureus and
Streptococcus species such as
Streptococcus agalactiae, Streptococcus
dysgalactiae, and Streptococcus uberis.
(3) Limitations. Milk taken from
animals during treatment and for 36
hours following the last treatment must
not be used for food regardless of
treatment duration. Following infusion
twice at a 24-hour interval, treated
animals must not be slaughtered for 9
days. Following any extended duration
of therapy (infusion longer than twice at
a 24-hour interval, up to 8 consecutive
days), animals must not be slaughtered
for 21 days. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
Dated: December 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–25606 Filed 1–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feed; Semduramicin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
2. In § 526.1810, revise the section
heading and paragraphs (a), (b), and (d)
to read as follows:
I
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
§ 526.1810 Pirlimycin.
application (NADA) filed by Phibro
(a) Specifications. Each 10-milliliter
Animal Health. The NADA provides for
syringe contains 50 milligrams (mg)
use of a Type A medicated article
pirlimycin (as pirlimycin
containing semduramicin (as
hydrochloride).
semduramicin sodium biomass) to
manufacture Type C medicated broiler
(b) Sponsor. See No. 000009 in
chicken feed for the prevention of
§ 510.600(c) of this chapter.
coccidiosis.
*
*
*
*
*
DATES: This rule is effective January 4,
(d) Conditions of use in cattle—(1)
Amount. Infuse 50 mg into each infected 2008.
quarter. Repeat treatment after 24 hours. FOR FURTHER INFORMATION CONTACT: Joan
Daily treatment may be repeated at 24C. Gotthardt, Center for Veterinary
PO 00000
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04JAR1
812
Federal Register / Vol. 73, No. 3 / Friday, January 4, 2008 / Rules and Regulations
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Phibro
Animal Health, 65 Challenger Rd., 3d
floor, Ridgefield Park, NJ 07660, filed
NADA 141–281 that provides for the use
of AVIAX II (semduramicin) Type A
medicated article containing
semduramicin (as semduramicin
sodium biomass) to manufacture Type C
medicated broiler chicken feed for the
prevention of coccidiosis caused by
Eimeria tenella, E. acervulina, E.
maxima, E. brunetti, E. necatrix, and E.
mitis. The NADA is approved as of
December 3, 2007, and the regulations
are amended in 21 CFR 558.4 and 21
CFR 558.555 to reflect the approval.
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)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
FDA has determined under 21 CFR
25.33(a)(3) 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 558
Animal drugs, Animal feeds.
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
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. In paragraph (d) of § 558.4, in the
‘‘Category I’’ table, revise the entry for
‘‘Semduramicin’’ and alphabetically add
an entry for ‘‘Semduramicin (as
semduramicin sodium biomass)’’ to read
as follows:
I
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
(d) * * *
*
*
CATEGORY I
Assay limits percent1 Type A
Drug
*
*
*
Semduramicin (as semduramicin sodium)
Semduramicin (as semduramicin sodium biomass)
*
*
*
*
90–110
90–110
Assay limits percent1 Type
B/C2
Type B maximum (200x)
*
2.27 g/lb (0.50%)
2.27 g/lb (0.50%)
*
*
*
80–110
80–120
*
*
*
1Percent
of labeled amount.
2Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a
Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for
the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.
*
*
*
*
*
3. In § 558.555, revise paragraphs (a)
and (b); and add paragraph (e) to read
as follows:
I
§ 558.555
Semduramicin.
(a) Specifications. Type A medicated
article containing:
Semduramicin in grams per ton
(1) 22.7 grams (g) per pound (lb) (50
g/kilogram (kg)) semduramicin (as
semduramicin sodium).
(2) 22.7 g/lb (50 g/kg) semduramicin
(as semduramicin sodium biomass).
(b) Approvals. See No. 066104 in
§ 510.600(c) of this chapter for use of
product described in paragraph (a)(1) as
Combination in
grams per ton
(1) 22.7 (25 ppm)
in paragraph (d) of this section; for use
of product described in paragraph (a)(2)
as in paragraph (e) of this section.
*
*
*
*
*
(e) Conditions of use in chickens. It is
used in chicken feed as follows:
Indications for use
Limitations
Broiler chickens: For the prevention of coccidiosis caused by
Eimeria tenella, E. acervulina,
E. maxima, E. brunetti, E.
necatrix, and E. mitis.
Do not feed to laying hens.
ebenthall on PROD1PC69 with RULES
(2) [Reserved]
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Sponsor
066104
813
Federal Register / Vol. 73, No. 3 / Friday, January 4, 2008 / Rules and Regulations
Dated: December 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–25605 Filed 1–3–08; 8:45 am]
BILLING CODE 4160–01–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 0
[DA 07–4354]
List of Office of Management and
Budget Approved Information
Collection Requirements
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: This document revises the
Commission’s list of Office of
Management and Budget (OMB)
approved public information collection
requirements with their associated OMB
expiration dates. This list will provide
the public with a current list of public
information collection requirements
approved by OMB and their associated
control numbers and expiration dates as
of September 28, 2007.
DATES: Effective January 4, 2008.
FOR FURTHER INFORMATION CONTACT:
Judith B. Herman, Office of the
Managing Director, (202) 418–0214 or
by e-mail to Judith-B.Herman@fcc.gov.
SUPPLEMENTARY INFORMATION: This
document adopted on December 10,
2007 and released on December 10,
2007 by the Managing Director in DA
07–4354 revised 47 CFR 0.408 in its
entirety.
1. Section 3507(a)(3) of the Paperwork
Reduction Act of 1995, 44 U.S.C.
ebenthall on PROD1PC69 with RULES
OMB Control
No.
3060–0004
3060–0009
3060–0010
3060–0016
3060–0017
3060–0027
3060–0029
3060–0031
3060–0053
3060–0055
3060–0056
3060–0057
3060–0059
3060–0061
3060–0065
3060–0068
3060–0075
3060–0076
3060–0084
3060–0093
List of Subjects in 47 CFR Part 0
Reporting, recordkeeping and third
party disclosure requirements.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
For the reasons discussed in the
preamble, the Federal Communications
Commission amends 47 CFR part 0 as
follows:
I
PART 0—COMMISSION
ORGANIZATION
1. The authority citation for part 0
continues to read:
I
Authority: Secs. 5, 48 Stat. 1068, as
amended; 47 U.S.C. 155, 225, unless
otherwise noted.
2. Section 0.408 is revised to read as
follows:
I
§ 0.408 OMB control numbers and
expiration dates assigned pursuant to the
Paperwork Reduction Act of 1995.
(a) Purpose. This section displays the
control numbers and expiration dates
for the Commission information
collection requirements assigned by the
Office of Management and Budget
(‘‘OMB’’) pursuant to the Paperwork
Reduction Act of 1995, Public Law 104–
13. The Commission intends that this
section comply with the requirement
that agencies ‘‘display’’ current control
numbers and expiration dates assigned
by the Director, OMB, for each approved
information collection requirement. Not
withstanding any other provisions of
law, no person shall be subject to any
penalty for failing to comply with a
collection of information subject to the
Paperwork Reduction Act (PRA) that
does not display a currently valid OMB
control number. Questions concerning
the OMB control numbers and
expiration dates should be directed to
the Associate Managing Director—
Performance Evaluation and Records
Management, (‘‘AMD–PERM’’), Office of
Managing Director, Federal
Communications Commission,
Washington, DC 20554 by sending an email to Judith-B.Herman@fcc.gov.
(b) Display
FCC form number or 47 CFR section or part, docket number or title identifying the collection
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
VerDate Aug<31>2005
3507(a)(3), requires agencies to display
a current control number assigned by
the Director, Office of Management and
Budget (‘‘OMB’’) for each agency
information collection requirement.
2. Section 0.408 of the Commission’s
rules displays the OMB control numbers
assigned to the Commission’s public
information collection requirements that
have been reviewed and approved by
OMB.
3. Authority for this action is
contained in section 4(i) of the
Communications Act of 1934 (47 U.S.C.
154(i)), as amended, and § 0.231(b) of
the Commission’s rules. Since this
amendment is a matter of agency
organization procedure or practice, the
notice and comment and effective date
provisions of the Administrative
Procedure Act do not apply. See 5
U.S.C. 553(b)(A)(d). For this reason, this
rulemaking is not subject to the
Congressional Review Act and will not
be reported to Congress and the
Government Accountability Office. See
5 U.S.C. 801.
4. Accordingly, it is ordered, that
section 0.408 of the rules is revised as
set forth in the revised text effective on
January 4, 2008.
5. Persons having questions on this
matter should contact Judith B.Herman
at (202) 418–0214 or e-mail to JudithB.Herman@fcc.gov.
Guidelines for Evaluating the Environmental Effects of Radiofrequency Radiation, ET Docket No. 93–62 ...........
FCC 316 ...................................................................................................................................................................
FCC 323 ...................................................................................................................................................................
FCC 346 ...................................................................................................................................................................
FCC 347 ...................................................................................................................................................................
FCC 301 ...................................................................................................................................................................
FCC 340 ...................................................................................................................................................................
FCC 314, FCC 315 ...................................................................................................................................................
FCC 703 ...................................................................................................................................................................
FCC 327 ...................................................................................................................................................................
Part 68 ......................................................................................................................................................................
FCC 731 ...................................................................................................................................................................
FCC 740 ...................................................................................................................................................................
FCC 325 ...................................................................................................................................................................
FCC 442 ...................................................................................................................................................................
FCC 702 ...................................................................................................................................................................
FCC 345 ...................................................................................................................................................................
FCC 395 ...................................................................................................................................................................
FCC 323–E ...............................................................................................................................................................
FCC 405 ...................................................................................................................................................................
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OMB
expiration
date
03/31/08
08/31/08
01/31/09
05/31/08
05/31/09
09/30/08
02/28/10
08/31/08
08/31/08
10/31/09
04/30/08
12/31/08
02/28/10
12/31/08
06/30/08
08/31/08
09/30/08
12/31/07
06/30/08
01/31/09
]]>Agencies
[Federal Register Volume 73, Number 3 (Friday, January 4, 2008)]
[Rules and Regulations]
[Pages 811-813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25605]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feed; Semduramicin
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 new animal drug application
(NADA) filed by Phibro Animal Health. The NADA provides for use of a
Type A medicated article containing semduramicin (as semduramicin
sodium biomass) to manufacture Type C medicated broiler chicken feed
for the prevention of coccidiosis.
DATES: This rule is effective January 4, 2008.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary
[[Page 812]]
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-7571, e-mail: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d
floor, Ridgefield Park, NJ 07660, filed NADA 141-281 that provides for
the use of AVIAX II (semduramicin) Type A medicated article containing
semduramicin (as semduramicin sodium biomass) to manufacture Type C
medicated broiler chicken feed for the prevention of coccidiosis caused
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix,
and E. mitis. The NADA is approved as of December 3, 2007, and the
regulations are amended in 21 CFR 558.4 and 21 CFR 558.555 to reflect
the approval.
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)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
FDA has determined under 21 CFR 25.33(a)(3) 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 558
Animal drugs, Animal feeds.
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 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. In paragraph (d) of Sec. 558.4, in the ``Category I'' table, revise
the entry for ``Semduramicin'' and alphabetically add an entry for
``Semduramicin (as semduramicin sodium biomass)'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category I
------------------------------------------------------------------------
Assay limits Assay limits
Drug percent\1\ Type Type B maximum percent\1\ Type
A (200x) B/C\2\
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Semduramicin (as 90-110 2.27 g/lb 80-110
semduramicin sodium) (0.50%)
Semduramicin (as 90-110 2.27 g/lb 80-120
semduramicin sodium (0.50%)
biomass)
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
\1\Percent of labeled amount.
\2\Values given represent ranges for either Type B or Type C medicated
feeds. For those drugs that have two range limits, the first set is
for a Type B medicated feed and the second set is for a Type C
medicated feed. These values (ranges) have been assigned in order to
provide for the possibility of dilution of a Type B medicated feed
with lower assay limits to make a Type C medicated feed.
* * * * *
0
3. In Sec. 558.555, revise paragraphs (a) and (b); and add paragraph
(e) to read as follows:
Sec. 558.555 Semduramicin.
(a) Specifications. Type A medicated article containing:
(1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin
(as semduramicin sodium).
(2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium
biomass).
(b) Approvals. See No. 066104 in Sec. 510.600(c) of this chapter
for use of product described in paragraph (a)(1) as in paragraph (d) of
this section; for use of product described in paragraph (a)(2) as in
paragraph (e) of this section.
* * * * *
(e) Conditions of use in chickens. It is used in chicken feed as
follows:
------------------------------------------------------------------------
Semduramicin Combination
in grams per in grams per Indications Limitations Sponsor
ton ton for use
------------------------------------------------------------------------
(1) 22.7 (25 ............. Broiler Do not feed to 066104
ppm) chickens: laying hens.
For the
prevention
of
coccidiosis
caused by
Eimeria
tenella, E.
acervulina,
E. maxima,
E.
brunetti,
E.
necatrix,
and E.
mitis.
------------------------------------------------------------------------
(2) [Reserved] ............. ............ .............. ...........
------------------------------------------------------------------------
[[Page 813]]
Dated: December 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-25605 Filed 1-3-08; 8:45 am]
BILLING CODE 4160-01-S
