New Animal Drugs; Change of Sponsor's Drug Labeler Code, 35340-35341 [E8-14149]
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35340
Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Rules and Regulations
PART 122—AIR COMMERCE
REGULATIONS
1. The authority citation for part 122
continues to read as follows:
I
Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66,
1431, 1433, 1436, 1448, 1459, 1590, 1594,
1623, 1624, 1644, 1644a, 2071 note.
§ 122.15
[Amended]
2. The listing of user fee airports in
§ 122.15(b) is amended as follows: by
adding, in alphabetical order, in the
‘‘Location’’ column ‘‘Lansing,
Michigan’’ and by adding on the same
line, in the ‘‘Name’’ column, ‘‘Capital
City Airport’’; by adding, in alphabetical
order, in the ‘‘Location’’ column ‘‘San
Antonio, Texas’’ and by adding on the
same line, in the ‘‘Name’’ column
‘‘Kelly Field Annex.’’
I
Dated: June 18, 2008.
Jayson P. Ahern,
Acting Commissioner, U.S. Customs and
Border Protection.
[FR Doc. E8–14125 Filed 6–20–08; 8:45 am]
558.274, 558.311, 558.355, 558.485,
558.625, and 558.630 are amended to
reflect this new DLC. 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.
Drug labeler
code
012286
*
*
Firm name and address
ADM Alliance Nutrition,
Inc., 1000 North 30th St.,
Quincy, IL 62305–3115
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
I
List of Subjects
21 CFR Part 510
Authority: 21 U.S.C. 360b.
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
§ 520.445b
[Amended]
4. In paragraph (b)(4) of § 520.445b,
remove ‘‘021930’’ and in its place add
‘‘012286’’.
I
21 CFR Part 520
Animal drugs.
§ 520.2380a
[Amended]
21 CFR Part 558
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Animal drugs, Animal feeds.
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 parts 510, 520, and 558 are
amended as follows:
Food and Drug Administration
PART 510—NEW ANIMAL DRUGS
21 CFR Parts 510, 520, and 558
I
New Animal Drugs; Change of
Sponsor’s Drug Labeler Code
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
BILLING CODE 9111–14–P
5. In paragraph (c)(3) of § 520.2380a,
remove ‘‘021930’’ and in its place add
‘‘012286’’.
6. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.95
AGENCY:
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s drug labeler code
for ADM Alliance Nutrition, Inc. This
action is being taken to improve the
accuracy of the regulations.
DATES: This rule is effective June 23,
2008.
yshivers on PROD1PC62 with RULES
FOR FURTHER INFORMATION CONTACT:
Charise Kasser, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9069,
e-mail: charise.kasser@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: ADM
Alliance Nutrition, Inc., 1000 North
30th St., Quincy, IL 62305–3115, has
informed FDA that it has obtained a
new drug labeler code (DLC) in 2007,
which has not been reflected in the
animal drug regulations. Accordingly,
the regulations in 21 CFR 510.600,
520.445b, 520.2380a, 558.95, 558.128,
14:49 Jun 20, 2008
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘ADM Alliance Nutrition, Inc.’’; and in
the table in paragraph (c)(2), remove the
entry for ‘‘021930’’ and in numerical
sequence add an entry for ‘‘012286’’ to
read as follows:
I
ACTION:
VerDate Aug<31>2005
§ 510.600
Jkt 214001
[Amended]
7. In paragraph (a)(4) of § 558.95,
remove ‘‘016968, 017790, and 021930’’
and in its place add ‘‘012286, 016968,
and 017790’’.
I
§ 558.128
[Amended]
8. In § 558.128, in paragraph (b)(2),
remove ‘‘021930’’ and in its place add
‘‘012286’’; and in the tables in
paragraphs (e)(1) through (e)(4), in the
‘‘Sponsor’’ column, remove ‘‘021930’’
wherever it occurs and in its place add
‘‘012286’’.
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
§ 558.274
*
I
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
ADM Alliance Nutrition,
Inc., 1000 North 30th St.,
Quincy, IL 62305–3115
*
*
*
Drug labeler
code
*
012286
*
*
*
PO 00000
*
9. In § 558.274, in paragraph (a)(7),
remove ‘‘021930’’ and in its place add
‘‘No. 012286’’; and in the table in
paragraphs (c)(1)(i) and (c)(1)(ii) in the
‘‘Sponsor’’ column, remove ‘‘021930’’
and in numerical sequence add
‘‘012286’’.
§ 558.311
[Amended]
10. In paragraph (b)(5) of § 558.311,
remove ‘‘017800 and 021930’’ and in its
place add ‘‘012286 and 017800’’.
I
(2) * * *
Drug labeler
code
[Amended]
§ 558.355
Firm name and address
*
*
*
Frm 00004
Fmt 4700
Sfmt 4700
*
[Amended]
11. In paragraph (b)(13) of § 558.355,
remove ‘‘021930’’ and in its place add
‘‘No. 012286’’.
I
E:\FR\FM\23JNR1.SGM
23JNR1
Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Rules and Regulations
§ 558.485
[Amended]
12. In paragraph (b)(3) of § 558.485,
remove ‘‘021930’’ and in numerical
sequence add ‘‘012286’’.
I
§ 558.625
[Amended]
13. In paragraphs (b)(10) and (b)(12) of
§ 558.625, remove ‘‘021930’’ and in its
place add ‘‘No. 012286’’.
I
§ 558.630
[Amended]
14. In § 558.630, in paragraph (b)(2),
remove ‘‘021930’’ and in its place add
‘‘012286; and in paragraph (b)(5),
remove ‘‘021930’’ and in numerical
sequence add ‘‘012286’’.
I
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–14149 Filed 6–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 860, 862, 864, 866, 868,
872, 874, 876, 878, 880, 882, 886, 888,
890, and 892
[Docket No. FDA–2008–N–0331]
Medical Devices; Change of Name;
Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to implement a
nomenclature change and to ensure
accuracy and clarity in the agency’s
regulations.
DATES:
This rule is effective June 23,
2008.
Paul
S. Gadiock, Center for Devices and
Radiological Health (HFZ–215), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 240–276–
2343.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
yshivers on PROD1PC62 with RULES
I. Background
This document amends FDA’s
regulations to reflect a nomenclature
change. It replaces the phrase ‘‘good
manufacturing practice regulations’’
with the phrase ‘‘good manufacturing
practice requirements of the quality
system regulation’’ in 21 CFR parts 860,
862, 864, 866, 868, 872, 874, 876, 878,
880, 882, 886, 888, 890, and 892.
VerDate Aug<31>2005
16:45 Jun 20, 2008
Jkt 214001
35341
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
notice and public comment are
unnecessary because these changes are
nonsubstantive.
IV. Paperwork Reduction Act of 1995
FDA has determined that this final
rule contains no collections of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
II. Environmental Impact
V. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 860,
862, 864, 866, 868, 872, 874, 876, 878,
880, 882, 886, 888, 890, and 892 are
amended as follows:
The agency has determined under 21
CFR 25.30(i) that this final rule 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.
III. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is not a
significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because this rule makes only
typographical and nonsubstantive
changes in existing regulations and does
not change in any way how devices are
regulated, the agency certifies that the
final rule will not have a significant
economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $127
million, using the most current (2006)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
PARTS 860, 862, 864, 866, 868, 872,
874, 876, 878, 880, 882, 886, 888, 890,
and 892—[AMENDED]
1. Parts 860, 862, 864, 866, 868, 872,
874, 876, 878, 880, 882, 886, 888, 890,
and 892 are amended by removing the
phrase ‘‘good manufacturing practice
regulations’’ wherever it appears and by
adding in its place the phrase ‘‘good
manufacturing practice requirements of
the quality system regulation’’.
I
Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14153 Filed 6–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2008–0321]
Special Local Regulation; Thunderboat
Regatta; Mission Bay, San Diego, CA
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
E:\FR\FM\23JNR1.SGM
23JNR1
]]>Agencies
[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Rules and Regulations]
[Pages 35340-35341]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14149]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
New Animal Drugs; Change of Sponsor's Drug Labeler Code
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's drug labeler code for
ADM Alliance Nutrition, Inc. This action is being taken to improve the
accuracy of the regulations.
DATES: This rule is effective June 23, 2008.
FOR FURTHER INFORMATION CONTACT: Charise Kasser, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9069, e-mail: charise.kasser@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: ADM Alliance Nutrition, Inc., 1000 North
30th St., Quincy, IL 62305-3115, has informed FDA that it has obtained
a new drug labeler code (DLC) in 2007, which has not been reflected in
the animal drug regulations. Accordingly, the regulations in 21 CFR
510.600, 520.445b, 520.2380a, 558.95, 558.128, 558.274, 558.311,
558.355, 558.485, 558.625, and 558.630 are amended to reflect this new
DLC. 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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
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), revise the entry
for ``ADM Alliance Nutrition, Inc.''; and in the table in paragraph
(c)(2), remove the entry for ``021930'' and in numerical sequence add
an entry for ``012286'' 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
------------------------------------------------------------------------
* * * * *
ADM Alliance Nutrition, Inc., 1000 North 012286
30th St., Quincy, IL 62305-3115
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
012286 ADM Alliance Nutrition, Inc., 1000 North
30th St., Quincy, IL 62305-3115
* * * * *
------------------------------------------------------------------------
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.
Sec. 520.445b [Amended]
0
4. In paragraph (b)(4) of Sec. 520.445b, remove ``021930'' and in its
place add ``012286''.
Sec. 520.2380a [Amended]
0
5. In paragraph (c)(3) of Sec. 520.2380a, remove ``021930'' and in its
place add ``012286''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
6. 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
7. In paragraph (a)(4) of Sec. 558.95, remove ``016968, 017790, and
021930'' and in its place add ``012286, 016968, and 017790''.
Sec. 558.128 [Amended]
0
8. In Sec. 558.128, in paragraph (b)(2), remove ``021930'' and in its
place add ``012286''; and in the tables in paragraphs (e)(1) through
(e)(4), in the ``Sponsor'' column, remove ``021930'' wherever it occurs
and in its place add ``012286''.
Sec. 558.274 [Amended]
0
9. In Sec. 558.274, in paragraph (a)(7), remove ``021930'' and in its
place add ``No. 012286''; and in the table in paragraphs (c)(1)(i) and
(c)(1)(ii) in the ``Sponsor'' column, remove ``021930'' and in
numerical sequence add ``012286''.
Sec. 558.311 [Amended]
0
10. In paragraph (b)(5) of Sec. 558.311, remove ``017800 and 021930''
and in its place add ``012286 and 017800''.
Sec. 558.355 [Amended]
0
11. In paragraph (b)(13) of Sec. 558.355, remove ``021930'' and in its
place add ``No. 012286''.
[[Page 35341]]
Sec. 558.485 [Amended]
0
12. In paragraph (b)(3) of Sec. 558.485, remove ``021930'' and in
numerical sequence add ``012286''.
Sec. 558.625 [Amended]
0
13. In paragraphs (b)(10) and (b)(12) of Sec. 558.625, remove
``021930'' and in its place add ``No. 012286''.
Sec. 558.630 [Amended]
0
14. In Sec. 558.630, in paragraph (b)(2), remove ``021930'' and in its
place add ``012286; and in paragraph (b)(5), remove ``021930'' and in
numerical sequence add ``012286''.
Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-14149 Filed 6-20-08; 8:45 am]
BILLING CODE 4160-01-S
