New Animal Drugs; Change of Sponsor; Ketamine, 8191-8192 [E8-2607]
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Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations
Publication of Project Cost Limits
Under Blanket Certificates
TABLE I—Continued
February 5, 2008
Section 157.208(d) of the
Commission’s Regulations provides for
project cost limits applicable to
construction, acquisition, operation and
miscellaneous rearrangement of
facilities (Table I) authorized under the
blanket certificate procedure (Order No.
234, 19 FERC ¶ 61,216). Section
157.215(a) specifies the calendar year
dollar limit which may be expended on
underground storage testing and
development (Table II) authorized under
the blanket certificate. Section
157.208(d) requires that the ‘‘limits
specified in Tables I and II shall be
adjusted each calendar year to reflect
the ‘GDP implicit price deflator’
published by the Department of
Commerce for the previous calendar
year.’’
Pursuant to § 375.308(x)(1) of the
Commission’s Regulations, the authority
for the publication of such cost limits,
as adjusted for inflation, is delegated to
the Director of the Office of Energy
Projects. The cost limits for calendar
year 2008, as published in Table I of
§ 157.208(d) and Table II of § 157.215(a),
are hereby issued.
Year
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
Accordingly, 18 CFR part 157 is
amended as follows:
PART 157—[AMENDED]
1. The authority citation for part 157
continues to read as follows:
I
Authority: 15 U.S.C. 717–717w.
2. Table I in § 157.208(d) is revised to
read as follows:
I
§ 157.208 Construction, acquisition,
operation, replacement, and miscellaneous
rearrangement of facilities.
*
TABLE I
Limit
pwalker on PROD1PC71 with RULES
1982
1983
1984
1985
..........
..........
..........
..........
VerDate Aug<31>2005
Auto. proj.
cost
$4,200,000
4,500,000
4,700,000
4,900,000
16:56 Feb 12, 2008
Prior notice
$12,000,000
12,800,000
13,300,000
13,800,000
Jkt 214001
5,100,000
5,200,000
5,400,000
5,600,000
5,800,000
6,000,000
6,200,000
6,400,000
6,600,000
6,700,000
6,900,000
7,000,000
7,100,000
7,200,000
7,300,000
7,400,000
7,500,000
7,600,000
7,800,000
8,000,000
9,600,000
9,900,000
10,200,000
21 CFR Parts 510 and 522
14,300,000
14,700,000
15,100,000
15,600,000
16,000,000
16,700,000
17,300,000
17,700,000
18,100,000
18,400,000
18,800,000
19,200,000
19,600,000
19,800,000
20,200,000
20,600,000
21,000,000
21,200,000
21,600,000
22,000,000
27,400,000
28,200,000
29,000,000
*
*
*
*
3. Table II in § 157.215(a) is revised to
read as follows:
I
§ 157.215 Underground storage testing
and development.
(a) * * *
(5) * * *
Year
I
Year
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
Food and Drug Administration
Prior notice
TABLE II
J. Mark Robinson,
Director, Office of Energy Projects.
*
Auto. proj.
cost
*
List of Subjects in 18 CFR Part 157
Administrative practice and
procedure, Natural gas, Reporting and
recordkeeping requirements.
*
*
(d) * * *
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Limit
Order of the Director, OEP
*
8191
Limit
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
*
*
*
*
$2,700,000
2,900,000
3,000,000
3,100,000
3,200,000
3,300,000
3,400,000
3,500,000
3,600,000
3,800,000
3,900,000
4,000,000
4,100,000
4,200,000
4,300,000
4,400,000
4,500,000
4,550,000
4,650,000
4,750,000
4,850,000
4,900,000
5,000,000
5,100,000
5,250,000
5,400,000
5,550,000
*
[FR Doc. E8–2531 Filed 2–12–08; 8:45 am]
BILLING CODE 6717–01–P
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New Animal Drugs; Change of
Sponsor; Ketamine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for an abbreviated
new animal drug application (ANADA)
for ketamine hydrochloride injectable
solution from Veterinary Research
Associates, Inc., to Putney, Inc.
DATES: This rule is effective February
13, 2008.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Veterinary
Research Associates, Inc., 2817 West
Country Rd., 54G, Fort Collins, CO
80524, has informed FDA that it has
transferred ownership of, and all rights
and interest in, ANADA 200–073 for
Ketamine Hydrochloride Injection, USP,
to Putney, Inc., 400 Congress St., suite
200, Portland, ME 04101. Accordingly,
the regulations are amended in 21 CFR
522.1222a to reflect this change of
sponsorship.
Following these changes of
sponsorship, Veterinary Research
Associates, Inc., is no longer the sponsor
of an approved application. In addition,
Putney, Inc., is not currently listed in
the animal drug regulations as a sponsor
of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove the entries for
Veterinary Research Associates, Inc.,
and to add entries for Putney, Inc.
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 522
Animal drugs.
E:\FR\FM\13FER1.SGM
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8192
Federal Register / Vol. 73, No. 30 / Wednesday, February 13, 2008 / Rules and Regulations
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 522 are amended as
follows:
I
PART 510—NEW ANIMAL DRUGS
2. In § 510.600, in the table in
paragraph (c)(1) remove the entry for
‘‘Veterinary Research Associates, Inc.’’
and alphabetically add a new entry for
‘‘Putney, Inc.’’; and in the table in
paragraph (c)(2) remove the entry for
‘‘064408’’ and numerically add an entry
for ‘‘026637’’ to read as follows:
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
Drug
labeler
code
Firm name and address
*
*
*
*
Putney, Inc., 400 Congress St.,
suite 200, Portland, ME 04101
*
*
*
*
026637
*
*
(2) * * *
Drug
labeler
code
Firm name and address
*
026637
*
*
*
*
Putney, Inc., 400 Congress St.,
suite 200, Portland, ME 04101
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 522.1222a
[Amended]
4. In § 522.1222a, revise paragraph (b)
by removing ‘‘064408’’ and numerically
adding ‘‘026637’’.
pwalker on PROD1PC71 with RULES
I
Dated: January 31, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–2607 Filed 2–12–08; 8:45 am]
BILLING CODE 4160–01–S
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16:56 Feb 12, 2008
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PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Phenylbutazone Tablets
ACTION:
I
*
Food and Drug Administration
Food and Drug Administration,
HHS.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
*
*
(c) * * *
(1) * * *
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
AGENCY:
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Final rule.
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Revise § 520.1720a to read as
follows:
I
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of two supplemental new
animal drug applications (NADAs) filed
by IVX Animal Health, Inc. The
supplemental NADAs provide revised
labeling for phenylbutazone tablets used
in horses and dogs.
DATES: This rule is effective February
13, 2008.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
supplements to NADA 91–818 and
NADA 94–170 for Phenylbutazone
Tablets. The supplemental applications
provide for revisions to warning
statements on product labeling. The
supplemental NADAs are approved as
of January 17, 2008, and 21 CFR
520.1720a is amended to reflect the
approval.
Approval of these supplemental
NADAs did not require review of
additional safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(a)(1) that these actions are of
a type that do 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.
§ 520.1720a
boluses.
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
Dated: January 31, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–2608 Filed 2–12–08; 8:45 am]
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
Phenylbutazone tablets and
(a) Specifications. Each tablet
contains 100, 200, or 400 milligrams
(mg), or 1 gram (g) phenylbutazone.
Each bolus contains 2 or 4 g
phenylbutazone.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter, as follows:
(1) No. 000061 for use of 100- or 400mg or 1-g tablets, or 2- or 4-g boluses,
in dogs and horses.
(2) Nos. 000010 and 059130 for use of
100- or 200-mg or 1-g tablets in dogs and
horses.
(3) Nos. 000856, 058829, and 061623
for use of 100-mg or 1-g tablets in dogs
and horses.
(4) No. 055246 for use of 100-mg
tablets in dogs.
(5) No. 000143 for use of 1-g tablets
in horses.
(c) Conditions of use—(1) Dogs—(i)
Amount. 20 mg per pound of body
weight daily.
(ii) Indications for use. For the relief
of inflammatory conditions associated
with the musculoskeletal system.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Horses—(i) Amount. 1 to 2 g per
500 pounds of body weight daily.
(ii) Indications for use. For the relief
of inflammatory conditions associated
with the musculoskeletal system.
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law prohibits the use of this
drug in female dairy cattle 20 months of
age or older. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 73, Number 30 (Wednesday, February 13, 2008)]
[Rules and Regulations]
[Pages 8191-8192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2607]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
New Animal Drugs; Change of Sponsor; Ketamine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for an abbreviated new
animal drug application (ANADA) for ketamine hydrochloride injectable
solution from Veterinary Research Associates, Inc., to Putney, Inc.
DATES: This rule is effective February 13, 2008.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Veterinary Research Associates, Inc., 2817
West Country Rd., 54G, Fort Collins, CO 80524, has informed FDA that it
has transferred ownership of, and all rights and interest in, ANADA
200-073 for Ketamine Hydrochloride Injection, USP, to Putney, Inc., 400
Congress St., suite 200, Portland, ME 04101. Accordingly, the
regulations are amended in 21 CFR 522.1222a to reflect this change of
sponsorship.
Following these changes of sponsorship, Veterinary Research
Associates, Inc., is no longer the sponsor of an approved application.
In addition, Putney, Inc., is not currently listed in the animal drug
regulations as a sponsor of an approved application. Accordingly, 21
CFR 510.600(c) is being amended to remove the entries for Veterinary
Research Associates, Inc., and to add entries for Putney, Inc.
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 522
Animal drugs.
[[Page 8192]]
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
522 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) remove the entry
for ``Veterinary Research Associates, Inc.'' and alphabetically add a
new entry for ``Putney, Inc.''; and in the table in paragraph (c)(2)
remove the entry for ``064408'' and numerically add an entry for
``026637'' 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
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Putney, Inc., 400 Congress St., suite 200, 026637
Portland, ME 04101
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
026637 Putney, Inc., 400 Congress St., suite 200,
Portland, ME 04101
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1222a [Amended]
0
4. In Sec. 522.1222a, revise paragraph (b) by removing ``064408'' and
numerically adding ``026637''.
Dated: January 31, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-2607 Filed 2-12-08; 8:45 am]
BILLING CODE 4160-01-S
