New Animal Drugs; Change of Sponsor, 1173-1174 [E7-118]
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Federal Register / Vol. 72, No. 6 / Wednesday, January 10, 2007 / Rules and Regulations
(d) Incentive-based rate treatments for
transmission infrastructure investment.
* * * The applicant must demonstrate
that the facilities for which it seeks
incentives either ensure reliability or
reduce the cost of delivered power by
reducing transmission congestion
consistent with the requirements of
section 219, that the total package of
incentives is tailored to address the
demonstrable risks or challenges faced
by the applicant in undertaking the
project, and that resulting rates are just
and reasonable. * * *
(1) For purposes of this paragraph (d),
incentive-based rate treatment means
any of the following:
*
*
*
*
*
(i) Rebuttable presumption. (1) The
Commission will apply a rebuttable
presumption that an applicant has
demonstrated that its project is needed
to ensure reliability or reduces the cost
of delivered power by reducing
congestion for:
(i) A transmission project that results
from a fair and open regional planning
process that considers and evaluates
projects for reliability and/or congestion
and is found to be acceptable to the
Commission; or
(ii) A project that has received
construction approval from an
appropriate state commission or state
siting authority.
(2) To the extent these approval
processes do not require that a project
ensures reliability or reduce the cost of
delivered power by reducing
congestion, the applicant bears the
burden of demonstrating that its project
satisfies these criteria.
(j) Commission authorization to site
electric transmission facilities in
interstate commerce. If the Commission
pursuant to its authority under section
216 of the Federal Power Act and its
regulations thereunder has issued one or
more permits for the construction or
modification of transmission facilities in
a national interest electric transmission
corridor designated by the Secretary,
such facilities shall be deemed to either
ensure reliability or reduce the cost of
delivered power by reducing congestion
for purposes of section 219(a).
Note: The following appendix will not
appear in the Code of Federal Regulations.
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Appendix A
Requests for Rehearing
American Public Power Association and
National Rural Electric Cooperative
Association (together, APPA/NRECA)
Coalition of Midwest Transmission
Customers, PJM Industrial Customer
Coalition, NEPOOL Industrial Customer
Coalition, Southeast Electricity Consumers
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14:45 Jan 09, 2007
Jkt 211001
Association, and Southwest Industrial
Customer Coalition (collectively, Industrial
Consumers).
Connecticut Department of Public Utility
Control, the Massachusetts Municipal
Wholesale Electric Company, the
Connecticut Municipal Electric Energy
Cooperative, the New Hampshire Electric
Cooperative, the Maine Public Utility
Commission, and the New England
Conference of Public Utility
Commissioners (collectively, New England
Commissions).
Edison Electric Institute (EEI).
Energy Financing, Inc. (Energy Financing).
Midwest ISO Transmission Owners (MISO
TOs).
National Association of Regulatory Utility
Commissioners (NARUC).
New England Consumer-Owned Entities
(NECOE).
Public Utilities Commission of the State of
California (California Commission).
Sacramento Municipal Utility District
(SMUD).
Southern California Edison Company (SoCal
Edison).
Southern Company Services, Inc., on behalf
of Alabama Power Company, Georgia
Power Company, Gulf Power Company,
and Mississippi Power Company
(collectively, Southern Companies).
Transmission Access Policy Study Group
(TAPS).
Transmission Dependent Utility Systems
(TDU Systems).
Xcel Energy Services, Inc. (Xcel).
1173
ADM
Animal Health & Nutrition Division,
1000 North 30th St., Box 1C, Quincy, IL
62305–3115 has informed FDA that it
has transferred ownership of, and all
rights and interest in, the following 14
approved NADAs to ADM Alliance
Nutrition, Inc., 1000 North 30th St.,
Quincy, IL 62305–3115:
SUPPLEMENTARY INFORMATION:
Application
No.
Trade name(s)
048–480
Chloratet 50
065–256
Chlortet-Soluble-O
091–582
Gilt Edge TYLAN Mix
107–957
TYLAN 20 Sulfa-G, TYLAN 40
Sulfa-G
108–484
HFA Tylosin–10 Plus Sulfa
110–045
Good-Life TYLAN 10 Premix
110–439
HFA Hygromix 2.4 Medicated
Premix
118–877
Ban-A-Worm Pyrantel Tartrate
Ton Pack
128–411
TYLAN 5 Sulfa Premix
131–956
TYLAN Sulfa-G
131–957
TYLAN 10, TYLAN 20, TYLAN
40, TYLAN 5
132–448
FLAVOMYCIN
133–490
Ban-D-Wormer II BANMINTH
140–842
Hygromix 2.4 Premix
[FR Doc. E6–22693 Filed 1–9–07; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
New Animal Drugs; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 14 approved new
animal drug applications (NADAs) from
ADM Animal Health & Nutrition
Division to ADM Alliance Nutrition,
Inc.
DATES:
This rule is effective January 10,
2007.
Accordingly, the agency is amending
the regulations in 21 CFR 520.445b,
558.95, 558.128, 558.274, 558.485,
558.625, and 558.630 to reflect the
transfer of ownership and a current
format.
In addition, ADM Animal Health &
Nutrition Division is no longer a
sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove entries for the firm.
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
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 520
PO 00000
Frm 00039
Fmt 4700
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Animal drugs.
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1174
Federal Register / Vol. 72, No. 6 / Wednesday, January 10, 2007 / Rules and Regulations
Authority: 21 U.S.C. 360b, 371.
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 510, 520, and 558 are
amended as follows:
I
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘ADM Animal Health & Nutrition
Division’’; and in the table in paragraph
(c)(2), remove the entry for ‘‘017519’’.
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 558.128
[Amended]
7. In § 558.128, in paragraph (b)(2),
remove ‘‘017519’’ and in its place add
‘‘021930’’; and in the tables in
paragraphs (e)(1) through (e)(4), in the
‘‘Sponsor’’ column remove ‘‘017519’’
wherever it occurs and in its place add
‘‘021930’’.
I
[Amended]
8. In § 558.274, in paragraph (a)(7),
remove ‘‘017519’’ and in its place add
‘‘021930’’; and in the table in
paragraphs (c)(1)(i) and (c)(1)(ii), in the
‘‘Sponsor’’ column remove ‘‘017519’’
and in numerical sequence add
‘‘021930’’.
I
§ 558.485
[Amended]
9. In paragraph (b)(3) of § 558.485,
remove ‘‘017519’’ and in numerical
sequence add ‘‘021930’’.
I
3. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 558.625
4. In § 520.445b, revise the section
heading, and paragraphs (b) and
(d)(4)(iii)(C) to read as follows:
I
[Amended]
10. In paragraph (b)(10) of § 558.625,
remove ‘‘017519’’ and in its place add
‘‘021930’’.
I
Chlortetracycline powder.
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 048164 for use as in paragraph
(d) of this section.
(2) No. 053501 for use as in paragraph
(d)(4) of this section.
(3) No. 000010 for use as in
paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and
(d)(4)(ii) through (iv) of this section.
(4) Nos. 021930 and 059130 for use as
in paragraphs (d)(4)(i)(A), (d)(4)(i)(B),
(d)(4)(ii), and (d)(4)(iii) of this section.
*
*
*
*
*
(d) * * *
(4) * * *
(iii) * * *
(C) Limitations. Prepare fresh solution
daily; as sole source of
chlortetracycline; do not use for more
than 5 days. For Nos. 000010 and
021930, do not slaughter animals for
food within 5 days of treatment; for No.
053501, do not slaughter animals for
food within 24 hours of treatment.
*
*
*
*
*
§ 558.630
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
SUMMARY: The Food and Drug
Administration (FDA) is classifying
quality control material for cystic
fibrosis nucleic acid assays into class II
(special controls). The special control
*
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[Amended]
6. In paragraph (a)(4) of § 558.95,
remove ‘‘016968, 017519, and 017790’’
and in its place add ‘‘Nos. 016968,
017790, and 021930’’.
I
§ 558.274
[Amended]
§ 520.445b
§ 558.95
5. The authority citation for 21 CFR
part 558 continues to read as follows:
I
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14:45 Jan 09, 2007
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[Amended]
11. In § 558.630, remove and reserve
paragraphs (b)(3) and (b)(8); and in
paragraph (b)(10) remove ‘‘017519’’.
I
Dated: December 29, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–118 Filed 1–9–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2006N–0517]
Medical Devices; Immunology and
Microbiology Devices; Classification of
Quality Control Material for Cystic
Fibrosis Nucleic Acid Assays
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Final rule.
Frm 00040
Fmt 4700
Sfmt 4700
that will apply to the device is the
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Quality Control Material for Cystic
Fibrosis Nucleic Acid Assays.’’ The
agency is classifying the device into
class II (special controls) in order to
provide a reasonable assurance of safety
and effectiveness of the device.
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
this device.
DATES: This final rule is effective
February 9, 2007. The classification was
effective October 12, 2006.
FOR FURTHER INFORMATION CONTACT:
Zivana Tezak, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0496, ext. 117.
SUPPLEMENTARY INFORMATION:
I. What is the Background of this
Rulemaking?
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360c(f)(1)),
devices that were not in commercial
distribution before May 28, 1976, the
date of enactment of the Medical Device
Amendments of 1976 (the amendments),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the act, to a predicate device
that does not require premarket
approval. The agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the act
(21 U.S.C. 360(k)) and 21 CFR part 807
of FDA’s regulations.
Section 513(f)(2) of the act provides
that any person who submits a
premarket notification under section
510(k) of the act for a device that has not
previously been classified may, within
30 days after receiving an order
classifying the device in class III under
section 513(f)(1) of the act, request FDA
to classify the device under the criteria
set forth in section 513(a)(1) of the act.
FDA shall, within 60 days of receiving
such a request, classify the device by
written order. This classification shall
be the initial classification of the device.
Within 30 days after the issuance of an
E:\FR\FM\10JAR1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 6 (Wednesday, January 10, 2007)]
[Rules and Regulations]
[Pages 1173-1174]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-118]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
New Animal Drugs; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 14 approved new
animal drug applications (NADAs) from ADM Animal Health & Nutrition
Division to ADM Alliance Nutrition, Inc.
DATES: This rule is effective January 10, 2007.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: ADM Animal Health & Nutrition Division, 1000
North 30th St., Box 1C, Quincy, IL 62305-3115 has informed FDA that it
has transferred ownership of, and all rights and interest in, the
following 14 approved NADAs to ADM Alliance Nutrition, Inc., 1000 North
30th St., Quincy, IL 62305-3115:
------------------------------------------------------------------------
Application No. Trade name(s)
------------------------------------------------------------------------
048-480 Chloratet 50
------------------------------------------------------------------------
065-256 Chlortet-Soluble-O
------------------------------------------------------------------------
091-582 Gilt Edge TYLAN Mix
------------------------------------------------------------------------
107-957 TYLAN 20 Sulfa-G, TYLAN 40 Sulfa-G
------------------------------------------------------------------------
108-484 HFA Tylosin-10 Plus Sulfa
------------------------------------------------------------------------
110-045 Good-Life TYLAN 10 Premix
------------------------------------------------------------------------
110-439 HFA Hygromix 2.4 Medicated Premix
------------------------------------------------------------------------
118-877 Ban-A-Worm Pyrantel Tartrate Ton Pack
------------------------------------------------------------------------
128-411 TYLAN 5 Sulfa Premix
------------------------------------------------------------------------
131-956 TYLAN Sulfa-G
------------------------------------------------------------------------
131-957 TYLAN 10, TYLAN 20, TYLAN 40, TYLAN 5
------------------------------------------------------------------------
132-448 FLAVOMYCIN
------------------------------------------------------------------------
133-490 Ban-D-Wormer II BANMINTH
------------------------------------------------------------------------
140-842 Hygromix 2.4 Premix
------------------------------------------------------------------------
Accordingly, the agency is amending the regulations in 21 CFR
520.445b, 558.95, 558.128, 558.274, 558.485, 558.625, and 558.630 to
reflect the transfer of ownership and a current format.
In addition, ADM Animal Health & Nutrition Division is no longer a
sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is
being amended to remove entries for the firm.
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 520
Animal drugs.
[[Page 1174]]
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 510,
520, and 558 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.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``ADM Animal Health & Nutrition Division''; and in the table in
paragraph (c)(2), remove the entry for ``017519''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.445b, revise the section heading, and paragraphs (b)
and (d)(4)(iii)(C) to read as follows:
Sec. 520.445b Chlortetracycline powder.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 048164 for use as in paragraph (d) of this section.
(2) No. 053501 for use as in paragraph (d)(4) of this section.
(3) No. 000010 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B),
and (d)(4)(ii) through (iv) of this section.
(4) Nos. 021930 and 059130 for use as in paragraphs (d)(4)(i)(A),
(d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.
* * * * *
(d) * * *
(4) * * *
(iii) * * *
(C) Limitations. Prepare fresh solution daily; as sole source of
chlortetracycline; do not use for more than 5 days. For Nos. 000010 and
021930, do not slaughter animals for food within 5 days of treatment;
for No. 053501, do not slaughter animals for food within 24 hours of
treatment.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.95 [Amended]
0
6. In paragraph (a)(4) of Sec. 558.95, remove ``016968, 017519, and
017790'' and in its place add ``Nos. 016968, 017790, and 021930''.
Sec. 558.128 [Amended]
0
7. In Sec. 558.128, in paragraph (b)(2), remove ``017519'' and in its
place add ``021930''; and in the tables in paragraphs (e)(1) through
(e)(4), in the ``Sponsor'' column remove ``017519'' wherever it occurs
and in its place add ``021930''.
Sec. 558.274 [Amended]
0
8. In Sec. 558.274, in paragraph (a)(7), remove ``017519'' and in its
place add ``021930''; and in the table in paragraphs (c)(1)(i) and
(c)(1)(ii), in the ``Sponsor'' column remove ``017519'' and in
numerical sequence add ``021930''.
Sec. 558.485 [Amended]
0
9. In paragraph (b)(3) of Sec. 558.485, remove ``017519'' and in
numerical sequence add ``021930''.
Sec. 558.625 [Amended]
0
10. In paragraph (b)(10) of Sec. 558.625, remove ``017519'' and in its
place add ``021930''.
Sec. 558.630 [Amended]
0
11. In Sec. 558.630, remove and reserve paragraphs (b)(3) and (b)(8);
and in paragraph (b)(10) remove ``017519''.
Dated: December 29, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-118 Filed 1-9-07; 8:45 am]
BILLING CODE 4160-01-S
