Certain Other Dosage Form New Animal Drugs; Formalin, 45157-45158 [E7-15763]
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Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Rules and Regulations
EFFECTIVE DATE:
0901 UTC, October 25,
2007.
Paul
Gallant, Airspace and Rules Group,
Office of System Operations Airspace
and AIM, Federal Aviation
Administration, 800 Independence
Avenue, SW., Washington, DC 20591;
telephone: (202) 267–8783.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
History
On April 26, 2007, the FAA published
in the Federal Register a notice of
proposed rulemaking to amend R–
3702A and R–3702B at Fort Campbell,
KY (72 FR 20787). Interested parties
were invited to participate in this
rulemaking effort by submitting written
comments on the proposal to the FAA.
No comments objecting to the proposal
were received. With the exception of
editorial changes, this amendment is the
same as that proposed in the notice of
proposed rulemaking.
Section 73.37 of 14 CFR part 73 was
published in the FAA Order 7400.8N,
Special Use Airspace, dated February
16, 2007. The restricted area listed in
this document will be published
subsequently in the Order.
jlentini on PROD1PC65 with RULES
The Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) part 73 to
realign the designated altitudes
separating restricted areas R–3702A and
R–3702B at Fort Campbell, KY. This
rule changes the designated altitudes for
R–3702A from ‘‘surface to 6,000 feet
MSL,’’ to ‘‘surface to 10,000 feet MSL.’’
In addition, the designated altitudes for
R–3702B are changed from ‘‘6,000 feet
MSL to FL 220,’’ to ‘‘10,000 feet MSL to
FL 220.’’ This change will allow Fort
Campbell to conduct hazardous
activities that do not exceed 10,000 feet
MSL without unnecessarily restricting
the airspace up to FL 220. This change
also allows air traffic control to provide
better service to nonparticipating
aircraft in the area.
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under Department of
Transportation (DOT) Regulatory
Policies and Procedures (44 FR 11034;
February 26, 1979); and (3) does not
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that will only affect air traffic
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16:17 Aug 10, 2007
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procedures and air navigation, it is
certified that this rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
45157
Issued in Washington, DC, on August 6,
2007.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. E7–15747 Filed 8–10–07; 8:45 am]
BILLING CODE 4910–13–P
Environmental Review
The FAA has reviewed the above
referenced action according to
Department of Transportation Order
5610.1C, ‘‘Procedures for Considering
Environmental Impacts’’ and FAA Order
1050.1E, ‘‘Environmental Impacts:
Policies and Procedures.’’ In accordance
with FAA Order 1050.1E paragraphs
311d and 401p(5) it is determined that
the action qualifies for categorical
exclusion from further environmental
review. Additionally, the
implementation of this action will not
result in any extraordinary
circumstances in accordance with Order
1050.1E paragraph 304. Therefore, on
July 27, 2007 the FAA issued a
categorical exclusion declaration for the
change in the internal boundaries for R–
3702A and R–3702B.
List of Subjects in 14 CFR Part 73
Airspace, Prohibited areas, Restricted
areas.
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 73 as follows:
I
PART 73—SPECIAL USE AIRSPACE
1. The authority citation for part 73
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 73.37
[Amended]
2. Section 73.37 is amended as
follows:
*
*
*
*
*
I
R–3702A Fort Campbell, KY
[Amended]
Under Designated altitudes, by
removing the words ‘‘Surface to 6,000
feet MSL,’’ and inserting the words
‘‘Surface to 10,000 feet MSL.’’
*
*
*
*
*
R–3702B Fort Campbell, KY
[Amended]
Under Designated altitudes, by
removing the words ‘‘6,000 feet MSL to
FL 220,’’ and inserting the words
‘‘10,000 feet MSL to FL 220.’’
*
*
*
*
*
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
Certain Other Dosage Form New
Animal Drugs; Formalin
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 B.L.
Mitchell, Inc. The ANADA provides for
the use of formalin in a water bath for
the control of certain external parasites
on finfish and shrimp and for the
control of certain fungi on finfish eggs.
DATES: This rule is effective August 13,
2007.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: B.L.
Mitchell, Inc., 103 Hwy. 82 E., Leland,
MS 38756, filed ANADA 200–414 that
provides for use of Formacide-B
(formalin) in a water bath for the control
of certain external parasites on finfish
and shrimp and for the control of
certain fungi on finfish eggs. B.L.
Mitchell, Inc.’s Formacide-B is
approved as a generic copy of ParasiteS, sponsored by Western Chemical, Inc.,
under NADA 140–989. The ANADA is
approved as of July 17, 2007, and the
regulations are amended in § 529.1030
to reflect the approval.
In addition, B.L. Mitchell, Inc., has
not been previously listed in the animal
drug regulations as a sponsor of an
approved application. Accordingly, 21
CFR 510.600(c) is being amended to add
entries for this firm.
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
E:\FR\FM\13AUR1.SGM
13AUR1
45158
Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Rules and Regulations
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
21 CFR Part 510
Drug labeler
code
*
067188
*
*
*
Firm name and address
*
*
*
B.L. Mitchell, Inc., 103
Hwy. 82 E., Leland, MS
38756
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 529 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 529.1030
[Amended]
4. In paragraph (b)(1) of § 529.1030,
remove ‘‘Nos. 049968 and 050378’’ and
add in its place ‘‘Nos. 049968, 050378,
and 067188’’.
I
Dated: August 1, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–15763 Filed 8–10–07; 8:45 am]
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
BILLING CODE 4160–01–S
21 CFR Part 529
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 parts 510 and 529 are amended as
follows:
I
PART 510—NEW ANIMAL DRUGS
ACTION:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add a
new entry for ‘‘B.L. Mitchell, Inc.’’; and
in the table in paragraph (c)(2)
numerically add a new entry for
‘‘067188’’ to read as follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
jlentini on PROD1PC65 with RULES
Firm name and address
*
*
*
B.L. Mitchell, Inc., 103
Hwy. 82 E., Leland, MS
38756.
*
*
*
Implantation or Injectable Dosage
Form New Animal Drugs; Ampicillin
Sodium
Drug labeler
code
*
067188
*
*
*
Food and Drug Administration,
HHS.
1. The authority citation for 21 CFR
part 510 continues to read as follows:
*
*
(c) * * *
(1) * * *
21 CFR Part 522
AGENCY:
I
*
Food and Drug Administration
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 G. C.
Hanford Manufacturing Co. The
ANADA provides for the use of
ampicillin sodium powder in aqueous
solution by injection in horses for the
treatment of various bacterial infections.
DATES: This rule is effective August 13,
2007.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: G. C.
Hanford Manufacturing Co., P.O. Box
1017, Syracuse, NY 13201, filed
ANADA 200–335 that provides for use
of ampicillin sodium as a constituted
solution by injection in horses for the
treatment of various bacterial infections.
(2) * * *
VerDate Aug<31>2005
16:17 Aug 10, 2007
Jkt 211001
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Frm 00012
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G. C. Hanford Manufacturing Co.’s
Ampicillin Sodium is approved as a
generic copy of Pfizer, Inc.’s, AMPEQUINE, approved under NADA 55–
084. The ANADA is approved as of July
12, 2007, and the regulations are
amended in 21 CFR 522.90c to reflect
the approval and a current format. 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
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.
FDA 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.
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 522 is amended as follows:
PART 522—IMPLANTATION AND
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.
I
2. Revise § 522.90c to read as follows:
§ 522.90c
Ampicillin sodium.
(a) Specifications. Each milliliter of
aqueous solution constituted from
ampicillin sodium powder contains 300
milligrams (mg) ampicillin equivalents.
(b) Sponsors. See Nos. 000069 and
010515 in § 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount: 3 mg per pound of body
weight twice daily by intravenous or
intramuscular injection.
(2) Indications for use. For the
treatment of respiratory tract infections
(pneumonia and strangles) due to
E:\FR\FM\13AUR1.SGM
13AUR1
]]>Agencies
[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Rules and Regulations]
[Pages 45157-45158]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15763]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
Certain Other Dosage Form New Animal Drugs; Formalin
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 B.L. Mitchell, Inc. The ANADA provides for
the use of formalin in a water bath for the control of certain external
parasites on finfish and shrimp and for the control of certain fungi on
finfish eggs.
DATES: This rule is effective August 13, 2007.
FOR FURTHER INFORMATION CONTACT: John 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: B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland,
MS 38756, filed ANADA 200-414 that provides for use of Formacide-B
(formalin) in a water bath for the control of certain external
parasites on finfish and shrimp and for the control of certain fungi on
finfish eggs. B.L. Mitchell, Inc.'s Formacide-B is approved as a
generic copy of Parasite-S, sponsored by Western Chemical, Inc., under
NADA 140-989. The ANADA is approved as of July 17, 2007, and the
regulations are amended in Sec. 529.1030 to reflect the approval.
In addition, B.L. Mitchell, Inc., has not been previously listed in
the animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
firm.
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
[[Page 45158]]
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 529
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 parts 510 and
529 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1) alphabetically
add a new entry for ``B.L. Mitchell, Inc.''; and in the table in
paragraph (c)(2) numerically add a new entry for ``067188'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, 067188
MS 38756.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
067188 B.L. Mitchell, Inc., 103 Hwy. 82 E.,
Leland, MS 38756
* * * * *
------------------------------------------------------------------------
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1030 [Amended]
0
4. In paragraph (b)(1) of Sec. 529.1030, remove ``Nos. 049968 and
050378'' and add in its place ``Nos. 049968, 050378, and 067188''.
Dated: August 1, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-15763 Filed 8-10-07; 8:45 am]
BILLING CODE 4160-01-S
