Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine Sterile Suspension, 21946-21947 [05-8510]
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21946
Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Rules and Regulations
(e) Restrictions. (1) Except for the
transit provisions provided for in
paragraph (f) of this section, a vessel
issued a valid Category F permit may
only fish for, possess, and land
monkfish in or from the Offshore
Fishery Program Area while on a
monkfish DAS.
(2) A vessel enrolled in the Offshore
Fishery Program is restricted to fishing
under its monkfish DAS during the
season in paragraph (d) of this section.
(3) A vessel issued a Category F
permit that is fishing on a monkfish
DAS is subject to the minimum mesh
size requirements applicable to limited
access monkfish Category A and B
vessels, as specified under
§ 648.91(c)(1)(i) and (c)(1)(iii), as well as
the other gear requirements specified in
paragraphs (c)(2) and (c)(3).
(4) A vessel issued a Category F
permit must have installed on board an
operational VMS unit that meets the
minimum performance criteria specified
in §§ 648.9 and 648.10 during the entire
season established under paragraph (d)
of this section. Unless otherwise
required to maintain an operational
VMS unit under the VMS notification
requirements specified at § 648.10(b)(1),
a vessel issued a Category F permit may
turn off its VMS unit outside of this
season.
(f) Transiting. A vessel issued a
Category F permit and fishing under a
monkfish DAS that is transiting to or
from the Offshore Fishery Program Area,
described in paragraph (c)(1) of this
section, shall have all gear stowed and
not available for immediate use in
accordance with the gear stowage
provisions specified under § 648.23(b).
(g) Monkfish possession limits and
DAS allocations. (1) A vessel issued a
Category F permit may land up to 1,600
lb (726 kg) tail weight or 5,312 lb (2,409
kg) whole weight of monkfish per
monkfish DAS (or any prorated
combination of tail weight and whole
weight based on the conversion factor of
3.32).
(2) The monkfish DAS allocation for
vessels issued a Category F permit shall
be equal to the trip limit applicable to
the vessel’s monkfish limited access
permit category divided by the fixed
daily possession limit specified in
paragraph (g)(1) of this section, and then
multiplied by the DAS allocation for
limited access monkfish vessels not
issued Category F permits, specified
under § 648.92(b)(1). For example, if a
vessel has a limited access monkfish
Category C permit, and the applicable
trip limit is 800 lb (363 kg) for this
category, and the vessel has an annual
allocation of 40 monkfish DAS, then the
monkfish DAS allocated to that vessel
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15:55 Apr 27, 2005
Jkt 205001
when issued a Category F permit would
be 20 monkfish DAS (800 lb divided by
1,600 lb, multiplied by 40 monkfish
DAS equals 20 DAS). Any carryover
monkfish DAS will be included in the
calculation of monkfish DAS for
Category F vessels.
(3) Vessels issued a Category F permit
that are fishing under a NE multispecies
DAS in the NFMA are subject to the
incidental catch limit specified in
paragraph (c)(1)(i) of this section.
(h) DAS usage by NE multispecies or
sea scallop limited access permit
holders. A vessel issued a Category F
permit that also has been issued either
a NE multispecies or sea scallop limited
access permit, and is fishing on a
monkfish DAS, is subject to the DAS
usage requirements specified in
§ 648.92(b)(2).
I 17. In § 648.96, paragraph (c)(1)(i) is
revised to read as follows:
§ 648.96 Monkfish annual adjustment
process and framework specifications.
*
*
*
*
*
(c) * * *
(1) * * *
(i) Based on their annual review, the
MFMC may develop and recommend, in
addition to the target TACs and
management measures established
under paragraph (b) of this section,
other options necessary to achieve the
Monkfish FMP’s goals and objectives,
which may include a preferred option.
The MFMC must demonstrate through
analysis and documentation that the
options it develops are expected to meet
the Monkfish FMP goals and objectives.
The MFMC may review the performance
of different user groups or fleet sectors
in developing options. The range of
options developed by the MFMC may
include any of the management
measures in the Monkfish FMP,
including, but not limited to: Closed
seasons or closed areas; minimum size
limits; mesh size limits; net limits; liverto-monkfish landings ratios; annual
monkfish DAS allocations and
monitoring; trip or possession limits;
blocks of time out of the fishery; gear
restrictions; transferability of permits
and permit rights or administration of
vessel upgrades, vessel replacement, or
permit assignment; measures to
minimize the impact of the monkfish
fishery on protected species; gear
requirements or restrictions that
minimize bycatch or bycatch mortality;
transferable DAS programs; and other
frameworkable measures included in
§§ 648.55 and 648.90.
*
*
*
*
*
I 18. Section 648.97 is added to subpart
F to read as follows:
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Frm 00026
Fmt 4700
Sfmt 4700
§ 648.97
Closed areas.
(a) Oceanographer Canyon Closed
Area. No fishing vessel or person on a
fishing vessel may enter, fish, or be in
the area known as Oceanographer
Canyon Closed Area (copies of a chart
depicting this area are available from
the Regional Administrator upon
request), as defined by straight lines
connecting the following points in the
order stated, while on a monkfish DAS:
OCEANOGRAPHER CANYON CLOSED
AREA
Point
(1)
(2)
(3)
(4)
(5)
OC1
OC2
OC3
OC4
OC1
N. Lat.
W. Long.
40°10′
40°24′
40°24′
40°10′
40°10′
68°12′
68°09′
68°08′
67°59′
68°12′
(b) Lydonia Canyon Closed Area. No
fishing vessel or person on a fishing
vessel may enter, fish, or be in the area
known as Lydonia Canyon Closed Area
(copies of a chart depicting this area are
available from the Regional
Administrator upon request), as defined
by straight lines connecting the
following points in the order stated,
while on a monkfish DAS:
LYNDONIA CANYON CLOSED AREA
Point
(1)
(2)
(3)
(4)
(5)
(6)
LC1
LC2
LC3
LC4
LC5
LC1
N. Lat.
W. Long.
40°16′
40°16′
40°20′
40°27′
40° 27′
40°16′
67°34′
67°42′
67°43′
67°40′
67°38′
67°34′
[FR Doc. 05–8450 Filed 4–26–05; 2:21 pm]
BILLING CODE 3510–22–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Penicillin G
Benzathine and Penicillin G Procaine
Sterile 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
approval of a supplemental new animal
drug application (NADA) filed by Cross
Vetpharm Group Ltd. The supplemental
NADA provides for the addition of
E:\FR\FM\28APR1.SGM
28APR1
Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Rules and Regulations
statements to labeling of an injectable
penicillin suspension warning against
the use of this product in calves to be
processed for veal. FDA is also
amending the regulations to correctly
identify approved indications for use for
several penicillin products. This action
is being taken to improve the accuracy
of the regulations.
DATES: This rule is effective April 28,
2005.
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.gov.
SUPPLEMENTARY INFORMATION: Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed a
supplement to NADA 65–506 that
provides for the addition of statements
to labeling of COMBI–PEN–48
(penicillin G benzathine and penicillin
G procaine) injectable suspension
warning against the use of this product
in calves to be processed for veal. The
supplemental NADA is approved as of
March 23, 2005, and the regulations are
amended in § 522.1696a (21 CFR
522.1696a) to reflect the approval. FDA
is also amending § 522.1696a to correct
an error in the indications for use for
several penicillin products which was
introduced during reformatting of this
section in 2001 (66 FR 711, January 4,
2001). This is being done to improve the
accuracy of the regulations.
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.
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 522
Animal drugs.
VerDate jul<14>2003
15:55 Apr 27, 2005
Jkt 205001
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 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Section 522.1696a is amended by
revising the section heading and
paragraphs (b)(2), (b)(3), and (d)(2)(iii) to
read as follows:
I
§ 522.1696a Penicillin G benzathine and
penicillin G procaine suspension.
*
*
*
*
*
(b) * * *
(2) Nos. 010515, 059130, and 061623
for use as in paragraphs (d)(2)(i),
(d)(2)(ii)(A), and (d)(2)(iii) of this
section.
(3) Nos. 000856 and 049185 for use as
in paragraphs (d)(2)(i), (d)(2)(ii)(B), and
(d)(2)(iii) of this section.
*
*
*
*
*
(d) * * *
(2) * * *
(iii) Limitations. Limit treatment to
two doses. Not for use within 30 days
of slaughter. For Nos. 010515, 049185,
059130, and 061623: A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
Dated: April 8, 2005.
Stephen D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–8510 Filed 4–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 2002P–0520] (formerly Docket
No. 02P–0520)
Dental Devices; Reclassification of
Tricalcium Phosphate Granules and
Classification of Other Bone Grafting
Material for Dental Bone Repair
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is reclassifying
tricalcium phosphate (TCP) granules for
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Frm 00027
Fmt 4700
Sfmt 4700
21947
dental bone repair from class III to class
II (special controls), classifying into
class II (special controls) other bone
grafting material for dental indications,
and revising the classification name and
identification of the device type. Bone
grafting materials that contain a drug
that is a therapeutic biologic will remain
in class III and continue to require a
premarket approval application. The
classification identification includes
materials such as hydroxyapatite,
tricalcium phosphate, polylactic and
polyglycolic acids, or collagen. This
action is being taken to establish
sufficient regulatory controls that will
provide reasonable assurance of the
safety and effectiveness of these devices.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of the guidance document
that will serve as the special control for
the class II devices.
EFFECTIVE DATE: May 31, 2005.
FOR FURTHER INFORMATION CONTACT:
Michael E. Adjodha, Center for Devices
and Radiological Health (HFZ–480),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–827–5283, e-mail:
michael.adjodha@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 301 et seq.), as
amended by the Medical Device
Amendments of 1976 (the 1976
amendments) (Public Law 94–295), the
Safe Medical Devices Act of 1990
(Public Law 101–629), the Food and
Drug Administration Modernization Act
of 1997 (Public Law 105–115), and the
Medical Device User Fee and
Modernization Act of 2002 (Public Law
107–250) established a comprehensive
system for the regulation of medical
devices intended for human use.
Section 513 of the act (21 U.S.C. 360c)
established three categories (classes) of
devices, depending on the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513 of the act, devices
that were in commercial distribution
before May 28, 1976 (the date of
enactment of the 1976 amendments),
generally referred to as preamendments
devices, are classified after the
following requirements are met: (1) FDA
has received a recommendation from a
device classification panel (an FDA
advisory committee); (2) FDA has
published the panel’s recommendation
E:\FR\FM\28APR1.SGM
28APR1
]]>Agencies
[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Rules and Regulations]
[Pages 21946-21947]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8510]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Penicillin G Benzathine and Penicillin G Procaine Sterile 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 approval of a supplemental new animal drug
application (NADA) filed by Cross Vetpharm Group Ltd. The supplemental
NADA provides for the addition of
[[Page 21947]]
statements to labeling of an injectable penicillin suspension warning
against the use of this product in calves to be processed for veal. FDA
is also amending the regulations to correctly identify approved
indications for use for several penicillin products. This action is
being taken to improve the accuracy of the regulations.
DATES: This rule is effective April 28, 2005.
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, e-mail:
joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed a supplement to NADA 65-506 that
provides for the addition of statements to labeling of COMBI-PEN-48
(penicillin G benzathine and penicillin G procaine) injectable
suspension warning against the use of this product in calves to be
processed for veal. The supplemental NADA is approved as of March 23,
2005, and the regulations are amended in Sec. 522.1696a (21 CFR
522.1696a) to reflect the approval. FDA is also amending Sec.
522.1696a to correct an error in the indications for use for several
penicillin products which was introduced during reformatting of this
section in 2001 (66 FR 711, January 4, 2001). This is being done to
improve the accuracy of the regulations.
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.
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 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 part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Section 522.1696a is amended by revising the section heading and
paragraphs (b)(2), (b)(3), and (d)(2)(iii) to read as follows:
Sec. 522.1696a Penicillin G benzathine and penicillin G procaine
suspension.
* * * * *
(b) * * *
(2) Nos. 010515, 059130, and 061623 for use as in paragraphs
(d)(2)(i), (d)(2)(ii)(A), and (d)(2)(iii) of this section.
(3) Nos. 000856 and 049185 for use as in paragraphs (d)(2)(i),
(d)(2)(ii)(B), and (d)(2)(iii) of this section.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Limit treatment to two doses. Not for use within
30 days of slaughter. For Nos. 010515, 049185, 059130, and 061623: A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
Dated: April 8, 2005.
Stephen D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-8510 Filed 4-27-05; 8:45 am]
BILLING CODE 4160-01-S
