New Animal Drugs; Florfenicol, 19797-19798 [E7-7475]
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19797
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations
of Food and Drugs, 21 CFR part 522 is
amended as follows:
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. In § 522.558, paragraph (a) is
revised to read as follows:
I
§ 522.558
Dexmedetomidine.
(a) Specifications. Each milliliter of
solution contains 0.5 milligram (mg) of
dexmedetomidine hydrochloride.
*
*
*
*
*
Dated: April 13, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–7594 Filed 4–19–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
New Animal Drugs; Florfenicol
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
approval of a supplemental new animal
drug application (NADA) filed by
Schering-Plough Animal Health Corp.
The supplemental NADA provides for
the use of florfenicol by veterinary feed
directive (VFD) for the control of
mortality in freshwater-reared
salmonids due to coldwater disease
associated with Flavobacterium
psychrophilum.
DATES:
This rule is effective April 20,
2007.
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: ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit, NJ 07901, filed a
supplement to NADA 141–246 that
provides for use of AQUAFLOR
(florfenicol), a type A medicated article,
by VFD to formulate type C medicated
feed for the control of mortality in
freshwater-reared salmonids due to
coldwater disease associated with F.
psychrophilum. The supplemental
application is approved as of March 19,
2007, and the regulations are amended
in 21 CFR 556.283, 558.4, and 558.261
to reflect the approval.
The single VFD order form for
florfenicol includes both catfish and
freshwater-reared salmonid indications
because each comprises multiple
species and is approved in each for use
under similar directions and conditions
of use.
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 573(c) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360ccc-2), this supplemental
approval qualifies for 7 years of
exclusive marketing rights beginning
March 19, 2007, because the new animal
drug has been declared a designated
new animal drug by FDA under section
573(a) of the act.
The agency has carefully considered
the potential environmental impact of
this action and has concluded that the
action will not have a significant impact
on the human environment and that an
environmental impact statement is not
required. FDA’s finding of no significant
impact and the evidence supporting that
finding, contained in an environmental
assessment, may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
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
21 CFR Part 556
Animal drugs, Foods.
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 parts 556 and 558 are amended as
follows:
I
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
1. The authority citation for 21 CFR
part 556 continues to read as follows:
I
Authority: 21 U.S.C. 342, 360b, 371.
2. In § 556.283, add paragraph (b)(4) to
read as follows:
I
§ 556.283
Florfenicol.
*
*
*
*
*
(b) * * *
(4) Salmonids. The tolerance for
florfenicol amine (the marker residue) in
muscle/skin (the target tissues) is 1
ppm.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
4. In paragraph (d) of § 558.4, in the
‘‘Category II’’ table, revise the entry in
alphabetical order for ‘‘Florfenicol’’ to
read as follows:
I
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
(d) * * *
*
*
CATEGORY II
Assay limits percent 1
Type A
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Drug
*
*
*
*
Florfenicol
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*
90–110
15:15 Apr 19, 2007
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Assay limits percent1
Type B/C2
Type B maximum (100x)
*
Swine feed: n/a
Catfish feed: n/a
Salmonid feed: n/a
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*
Swine feed: 85–115
Catfish feed: 80–110
Salmonid feed: 80–110
20APR1
19798
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations
CATEGORY II—Continued
Assay limits percent 1
Type A
Drug
*
*
*
Assay limits percent1
Type B/C2
Type B maximum (100x)
*
*
*
*
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.
*
*
*
*
*
5. In § 558.261, revise paragraph
(a)(2), paragraph (c)(2)(i), and the first
two sentences of paragraph (e)(2)(iii);
and add new paragraph (e)(3) to read as
follows:
I
§ 558.261
Florfenicol.
cprice-sewell on PRODPC61 with RULES
(a) * * *
(2) 500 grams per kilogram for use as
in paragraphs (e)(2) and (e)(3) of this
section.
*
*
*
*
*
(c) * * *
(2) * * *
(i) For catfish and freshwater-reared
salmonids, must not exceed 15 days
from the date of issuance;
*
*
*
*
*
(e) * * *
(2) * * *
(iii) * * * Feed containing florfenicol
shall not be fed for more than 10 days.
Following administration, fish should
be reevaluated by a licensed
veterinarian before initiating a further
course of therapy. * * *
(3) Freshwater-reared salmonids—(i)
Amount. 10 milligrams florfenicol per
kilogram of fish daily for 10 consecutive
days.
(ii) Indications for use. For the control
of mortality due to coldwater disease
associated with Flavobacterium
psychrophilum.
(iii) Limitations. Feed containing
florfenicol shall not be fed for more than
10 days. Following administration, fish
should be reevaluated by a licensed
veterinarian before initiating a further
course of therapy. The effects of
florfenicol on reproductive performance
have not been determined. Feeds
containing florfenicol must be
withdrawn 15 days prior to slaughter.
Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–7475 Filed 4–19–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:15 Apr 19, 2007
Jkt 211001
BROADCASTING BOARD OF
GOVERNORS
22 CFR Part 504
Testimony by BBG Employees,
Production of Official Records, and
Disclosure of Official Information In
Legal Proceedings
Broadcasting Board of
Governors.
ACTION: Final rule.
AGENCY:
SUMMARY: The Broadcasting Board of
Governors (BBG) is publishing as a final
rule a regulation governing access to
BBG information and records in
connection with legal proceedings in
which neither the United States nor the
BBG is a party. The proposed rule was
published for comment in 72 FR 10954
dated March 12, 2007. The BBG
received no responses to the proposed
rule. The final rule and corresponding
regulation establishes guidelines for use
in determining whether BBG employees
are permitted to testify or to provide
records relating to their official duties
and procedures that requesters must
follow when making demands on, or
requests to, a BBG employee for official
documents or to provide testimony.
DATES: The effective date of the
regulation is April 23, 2007.
FOR FURTHER INFORMATION CONTACT:
Christopher Veith, Assistant General
Counsel, Broadcasting Board of
Governors, 330 Independence Ave.,
SW., Washington, DC 20237, phone:
(202) 203–4550 or fax at (202) 203–4585.
SUPPLEMENTARY INFORMATION: Briefly,
the final rule prohibits disclosure of
nonpublic official records or testimony
by the BBG’s employees, as defined in
Part 504.4, unless there is compliance
with the rule. The final rule sets out the
information that requesters must
provide and the factors that the BBG
will consider in making determinations
in response to requests for testimony or
the production of documents.
The final rule applies to a range of
matters in any legal proceeding in
which the BBG is not a named party and
applies to current and former BBG
employees. The final rule will ensure a
more efficient use of the BBG’s
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Frm 00016
Fmt 4700
Sfmt 4700
resources, minimize the possibility of
involving the BBG in issues unrelated to
its responsibilities, promote uniformity
in responding to subpoenas and like
requests, and maintain the impartiality
of the BBG in matters that are in dispute
between other parties. It will also serve
the BBG’s interest in protecting
sensitive, confidential, and privileged
information and records that are
generated in fulfillment of the BBG’s
statutory responsibilities.
The final rule is internal and
procedural rather than substantive. It
does not create a right to obtain official
records or the official testimony of a
BBG employee nor does it create any
additional right or privilege not already
available to the BBG to deny any
demand or request for testimony or
documents. Failure to comply with the
procedures set out in these regulations
would be a basis for denying a demand
or request submitted to the BBG.
List of Subjects in 22 CFR Part 504
Administrative practice and
procedure.
For the reasons stated in the preamble,
the Broadcasting Board of Governors
amends 22 CFR, Chapter V, by adding
part 504, as follows:
I
PART 504—TESTIMONY BY BBG
EMPLOYEES, PRODUCTION OF
OFFICIAL RECORDS, AND
DISCLOSURE OF OFFICIAL
INFORMATION IN LEGAL
PROCEEDINGS
Subpart A—General Provisions
Sec.
504.1 Scope and purpose.
504.2 Applicability.
504.3 Definitions.
Subpart B—Demands or Requests for
Testimony and Production of Documents
504.4 General prohibition.
504.5 Factors the BBG will consider.
504.6 Filing requirements for litigants
seeking documents or testimony.
504.7 Service of requests or demands.
504.8 Processing requests or demands.
504.9 Final determinations.
504.10 Restrictions that apply to testimony.
504.11 Restrictions that apply to released
records.
E:\FR\FM\20APR1.SGM
20APR1
]]>Agencies
[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Rules and Regulations]
[Pages 19797-19798]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7475]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
New Animal Drugs; Florfenicol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the approval of a supplemental new animal
drug application (NADA) filed by Schering-Plough Animal Health Corp.
The supplemental NADA provides for the use of florfenicol by veterinary
feed directive (VFD) for the control of mortality in freshwater-reared
salmonids due to coldwater disease associated with Flavobacterium
psychrophilum.
DATES: This rule is effective April 20, 2007.
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: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, filed a supplement to NADA 141-246 that
provides for use of AQUAFLOR (florfenicol), a type A medicated article,
by VFD to formulate type C medicated feed for the control of mortality
in freshwater-reared salmonids due to coldwater disease associated with
F. psychrophilum. The supplemental application is approved as of March
19, 2007, and the regulations are amended in 21 CFR 556.283, 558.4, and
558.261 to reflect the approval.
The single VFD order form for florfenicol includes both catfish and
freshwater-reared salmonid indications because each comprises multiple
species and is approved in each for use under similar directions and
conditions of use.
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 573(c) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360ccc-2), this supplemental approval qualifies
for 7 years of exclusive marketing rights beginning March 19, 2007,
because the new animal drug has been declared a designated new animal
drug by FDA under section 573(a) of the act.
The agency has carefully considered the potential environmental
impact of this action and has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
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
21 CFR Part 556
Animal drugs, Foods.
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 parts 556 and
558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
2. In Sec. 556.283, add paragraph (b)(4) to read as follows:
Sec. 556.283 Florfenicol.
* * * * *
(b) * * *
(4) Salmonids. The tolerance for florfenicol amine (the marker
residue) in muscle/skin (the target tissues) is 1 ppm.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In paragraph (d) of Sec. 558.4, in the ``Category II'' table,
revise the entry in alphabetical order for ``Florfenicol'' to read as
follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
------------------------------------------------------------------------
Type B Assay limits
Drug Assay limits percent maximum percent\1\
\1\ Type A (100x) Type B/C\2\
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Florfenicol 90-110 Swine feed: Swine feed:
n/a 85-115
....................... Catfish Catfish
feed: n/a feed: 80-
110
....................... Salmonid Salmonid
feed: n/a feed: 80-
110
------------------------------------------------------------------------
[[Page 19798]]
* * * * * * *
------------------------------------------------------------------------
\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
5. In Sec. 558.261, revise paragraph (a)(2), paragraph (c)(2)(i), and
the first two sentences of paragraph (e)(2)(iii); and add new paragraph
(e)(3) to read as follows:
Sec. 558.261 Florfenicol.
(a) * * *
(2) 500 grams per kilogram for use as in paragraphs (e)(2) and
(e)(3) of this section.
* * * * *
(c) * * *
(2) * * *
(i) For catfish and freshwater-reared salmonids, must not exceed 15
days from the date of issuance;
* * * * *
(e) * * *
(2) * * *
(iii) * * * Feed containing florfenicol shall not be fed for more
than 10 days. Following administration, fish should be reevaluated by a
licensed veterinarian before initiating a further course of therapy. *
* *
(3) Freshwater-reared salmonids--(i) Amount. 10 milligrams
florfenicol per kilogram of fish daily for 10 consecutive days.
(ii) Indications for use. For the control of mortality due to
coldwater disease associated with Flavobacterium psychrophilum.
(iii) Limitations. Feed containing florfenicol shall not be fed for
more than 10 days. Following administration, fish should be reevaluated
by a licensed veterinarian before initiating a further course of
therapy. The effects of florfenicol on reproductive performance have
not been determined. Feeds containing florfenicol must be withdrawn 15
days prior to slaughter.
Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7475 Filed 4-19-07; 8:45 am]
BILLING CODE 4160-01-S
