New Animal Drugs; Change of Sponsor's Drug Labeler Code, 35340-35341 [E8-14149]

Download as PDF 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]


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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
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