New Animal Drugs; Change of Sponsor's Name, 32487-32488 [05-11030]
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32487
Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Rules and Regulations
APPENDIX E TO PART 305—ROOM AIR CONDITIONERS
[Range information]
Range of energy efficiency ratios (EERs)
Manufacturer’s rated cooling capacity in Btu’s/yr
Low
Without Reverse Cycle and with Louvered Sides:
Less than 6,000 Btu .........................................................................................................................................................
6,000 to 7,999 Btu ............................................................................................................................................................
8,000 to 13,999 Btu ..........................................................................................................................................................
14,000 to 19,999 Btu. .......................................................................................................................................................
20,000 and more Btu ........................................................................................................................................................
Without Reverse Cycle and without Louvered Sides:
Less than 6,000 Btu .........................................................................................................................................................
6,000 to 7,999 Btu ............................................................................................................................................................
8,000 to 13,999 Btu ..........................................................................................................................................................
14,000 to 19,999 Btu. .......................................................................................................................................................
20,000 and more Btu ........................................................................................................................................................
With Reverse Cycle and with Louvered Sides ........................................................................................................................
With Reverse Cycle, without Louvered Sides .........................................................................................................................
*
High
8.0
8.5
9.0
8.8
8.2
10.0
10.3
12.0
10.7
10.0
(*)
8.5
8.5
(*)
(*)
8.5
8.0
(*)
9.6
9.2
(*)
(*)
11.5
9.0
No data submitted for units meeting Federal Minimum Efficiency Standards effective January 1, 1990.
Cost Information for Appendix E
Appendix H to part 305 [Amended]
When the ranges of comparability in
Appendix E are used on EnergyGuide labels
for room air conditioners, the estimated
annual operating cost disclosure appearing in
the box at the bottom of the labels must be
derived using the 1995 Representative
Average Unit Costs for electricity (8.67¢ per
kiloWatt-hour) and the text below the box
must identify the costs as such.
by adding, in its place, the figure
‘‘13.6¢’’.
I 4. In section 2 of Appendix H of Part
I 5. The formula in section 2 of
305, the text is amended by removing the Appendix H of part 305 is revised to read
figure ‘‘8.60¢’’ wherever it appears and
as follows in both places that it appears:
by adding, in its place, the figure
Appendix H to Part 305—Cooling
‘‘9.06¢’’. In addition, the text in this
Performance and Cost for Central Air
section is amended by removing the
Conditioners
figure ‘‘12.9¢’’ wherever it appears and
*
*
*
*
*
Your cooling Your electrical rate
Listed average annual load hours ** in cents per KWH
Your estimated cost = operating cost * ×
×
1,000
9.06¢
*
*
*
*
*
Appendix I to Part 305 [Amended]
I 6. In section 2 of Appendix I of part
305, the text is amended by removing the
figure ‘‘8.60¢’’ wherever it appears and
by adding, in its place, the figure
‘‘9.06¢’’. In addition, the text and
formulas are amended by removing the
figure ‘‘12.90¢’’ wherever it appears and
by adding, in its place, the figure
‘‘13.6¢’’.
Appendix I to Part 305—Heating
Performance and Cost for Central Air
Conditioners
*
*
*
*
*
7. In section 2 of Appendix I of part
305, the formula is revised to read as
follows in both places that it appears:
I
Your electrical cost
in cents per KWH
Your estimated cost = Listed annual heating cost * ×
9.06¢
*
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
BILLING CODE 6750–01–P
New Animal Drugs; Change of
Sponsor’s Name
AGENCY:
Food and Drug Administration,
HHS.
VerDate jul<14>2003
17:45 Jun 02, 2005
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ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Steris
Laboratories, Inc., to Watson
Laboratories, Inc.
DATES: This rule is effective June 3,
2005.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
E:\FR\FM\03JNR1.SGM
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ER03JN05.010</GPH>
*
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05–11026 Filed 6–2–05; 8:45 am]
ER03JN05.009</GPH>
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32488
Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Rules and Regulations
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.
Steris
Laboratories, Inc., 620 North 51st Ave.,
Phoenix, AZ 85043–4705, has informed
FDA of a change of sponsor’s name to
Watson Laboratories, Inc. Accordingly,
the agency is amending the regulations
in 21 CFR 510.600(c) to reflect the
change.
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.
Drug labeler
code
000402
Watson Laboratories, Inc.,
620 North 51st Ave.,
Phoenix, AZ 85043–4705
*
*
*
SUPPLEMENTARY INFORMATION:
Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–11030 Filed 6–2–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Drug labeler
code
Food and Drug Administration,
HHS.
ACTION:
Final rule.
Section
Trade Name
VerDate jul<14>2003
*
17:45 Jun 02, 2005
*
Jkt 205001
520.2261a
Purina Sulfa
097–258
558.485
Purina Ban Worm For Pigs
099–767
558.630
Purina Tylan 40 Plus
Sulfamethazine
113–748
520.1182
Purina Oral Pigemia
558.325
Purina Check-R-Ton LI
135–941
558.485
Check-E-Ton BM
136–116
520.905d
Purina Worm-A-Rest Litter
Pack
520.1840
Purina Bloat Block; Purina
Saf-T-Block BG
013–214
558.274
Purina Hygromix-Swine
520.100a
520.2380a
Purina Horse Wormer Medicated
558.185
Purina 6-Day Worm-Kill
Feed
042–660
558.630
Purina Pork-Plus Medicated
558.625
Purina Hog Plus II
List of Subjects
21 CFR Parts 520 and 522
Purina Liquid Amprol
040–205
Accordingly, the agency is amending
the regulations in parts 520, 522, and
558 (21 CFR parts 520, 522, and 558).
Sections 520.100a, 520.905d, 520.1182,
520.1840, 520.2261a, 520.2380a,
522.940, 558.185, 558.274, 558.325,
558.365, 558.485, 558.625, and 558.630
will reflect the transfer of ownership
and a current format. Sections 520.1182
and 522.940 are being revised to reflect
a current format.
In addition, § 520.2380a is being
revised to correct the citation for the
approved indications for Virbac AH’s
thiabendazole dewormer approved
under NADA 040–205. The citation was
corrected in the Federal Register of
March 3, 1976 (41 FR 9149), but an error
was reintroduced in the 1978 printing of
the Code of Federal Regulations. This
action is being taken to improve the
accuracy of the regulations.
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.
Purina Pigemia 100
043–387
Firm name and address
522.940
042–116
*
011–779
013–663
*
(2) * * *
*
Statyl
Food and Drug Administration
No.
*
558.365
BILLING CODE 4160–01–S
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 16 approved new
animal drug applications (NADAs) from
PART 510—NEW ANIMAL DRUGS
Purina Mills, Inc., to Virbac AH, Inc.
DATES: This rule is effective June 3,
I 1. The authority citation for 21 CFR
2005.
part 510 continues to read as follows:
FOR FURTHER INFORMATION CONTACT:
Authority: 21 U.S.C. 321, 331, 351, 352,
David R. Newkirk, Center for Veterinary
353, 360b, 371, 379e.
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
I 2. Section 510.600 is amended in the
table in paragraph (c)(1) by removing the Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.
entry for ‘‘Steris Laboratories, Inc.’’ and
SUPPLEMENTARY INFORMATION: Purina
by alphabetically adding an entry for
Mills, Inc., P.O. Box 66812, St. Louis,
‘‘Watson Laboratories, Inc.’’; and in the
MO 63166–6812, has informed FDA that
table in paragraph (c)(2) by revising the
it has transferred ownership of, and all
entry for ‘‘000402’’ to read as follows:
rights and interest in, the following 16
§ 510.600 Names, addresses, and drug
approved NADAs to Virbac AH, Inc.,
labeler codes of sponsors of approved
3200 Meacham Blvd., Ft. Worth, TX
applications.
76137:
*
*
*
*
*
TABLE 1.
(c) * * *
(1) * * *
NADA
21 CFR
Drug labeler
code
046–700
132–574
*
AGENCY:
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 510 is amended as follows:
*
Trade Name
049–729
*
New Animal Drugs; Change of Sponsor
I
*
000402
21 CFR
Section
21 CFR Parts 520, 522, and 558
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
*
*
Watson Laboratories, Inc.,
620 North 51st Ave.,
Phoenix, AZ 85043–4705
*
*
*
NADA
No.
140–869
List of Subjects in 21 CFR Part 510
Firm name and address
TABLE 1.—Continued
Firm name and address
*
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
Animal drugs.
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 520, 522, and 558 are amended as
follows:
I
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]]>Agencies
[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Rules and Regulations]
[Pages 32487-32488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11030]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Name
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's name from Steris
Laboratories, Inc., to Watson Laboratories, Inc.
DATES: This rule is effective June 3, 2005.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary
[[Page 32488]]
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6967, e-mail: david.newkirk@fda.gov.
SUPPLEMENTARY INFORMATION: Steris Laboratories, Inc., 620 North 51st
Ave., Phoenix, AZ 85043-4705, has informed FDA of a change of sponsor's
name to Watson Laboratories, Inc. Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to reflect the change.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
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. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entry for ``Steris Laboratories, Inc.'' and by
alphabetically adding an entry for ``Watson Laboratories, Inc.''; and
in the table in paragraph (c)(2) by revising the entry for ``000402''
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
------------------------------------------------------------------------
* * * * *
Watson Laboratories, Inc., 620 North 51st 000402
Ave., Phoenix, AZ 85043-4705
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
000402 Watson Laboratories, Inc., 620 North 51st
Ave., Phoenix, AZ 85043-4705
* * * * *
------------------------------------------------------------------------
Dated: May 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-11030 Filed 6-2-05; 8:45 am]
BILLING CODE 4160-01-S
