New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin, 15884-15885 [E8-6063]

Download as PDF 15884 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554, 555, 556, 557. 2. In § 17.2, revise the introductory text to read as follows: I § 17.2 Maximum penalty amounts. The following table shows maximum civil monetary penalties associated with the statutory provisions authorizing civil monetary penalties under the act or the Public Health Service Act: * * * * * Dated: March 18, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–6082 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Nicarbazin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing bacitracin methylene disalicylate and nicarbazin to formulate two-way combination drug Type C medicated feeds for broiler chickens. DATES: This rule is effective March 26, 2008. FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary Medicine (HFV–128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8116, email: timothy.schell@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rt. 22, Bridgewater, NJ 08807, filed NADA 141–279 that provides for use of BMD (bacitracin methylene disalicylate) and NICARB (nicarbazin) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for broiler chickens. The NADA is approved as of February 21, 2008, and the regulations are amended in 21 CFR 558.366 to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Combination in grams per ton Nicarbazin in grams per ton 113.5 (0.0125 pct) * * * * sroberts on PROD1PC70 with RULES VerDate Aug<31>2005 * 16:40 Mar 25, 2008 PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. 2. In the table in paragraph (d) of § 558.366, alphabetically add new entries for ‘‘Bacitracin methylene disalicylate 4 to 50’’ and ‘‘Bacitracin methylene disalicylate 50’’ to read as follows: I § 558.366 * Frm 00024 Fmt 4700 Sponsor * * * 046573 * Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. * Sfmt 4700 * Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for outbreaks of coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. * * * * Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. PO 00000 Nicarbazin. * * (d) * * * * * * Jkt 214001 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 part 558 is amended as follows: Limitations Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency. Bacitracin methylene disalicylate 50. * List of Subjects in 21 CFR Part 558 Indications for use Bacitracin methylene disalicylate 4 to 50. * The agency has determined under 21 CFR 25.33(a)(2) that this action 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. 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. E:\FR\FM\26MRR1.SGM * 26MRR1 046573 * Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations Dated: March 12, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–6063 Filed 3–25–08; 8:45 am] Regulatory Analysis and Notices DEPARTMENT OF STATE [Public Notice: 6147] Amendment to the International Traffic in Arms Regulations: North Atlantic Treaty Organization (NATO) Department of State. Final rule. AGENCY: SUMMARY: The Department of State is amending the International Traffic in Arms Regulations (ITAR), to clarify United States policy to allow for reexports or retransfers of U.S.-origin components incorporated into a foreign defense article to the North Atlantic Treaty Organization (NATO), and its agencies, as well as to NATO member governments. Effective Date: This rule is effective March 26, 2008. ADDRESSES: Interested parties may submit comments at any time by any of the following methods: • E-mail: DDTCResponseTeam@state.gov with an appropriate subject line. • Mail: Department of State, Directorate of Defense Trade Controls, Office of Defense Trade Controls Policy, ATTN: Regulatory Change, ITAR Part 123, SA–1, 12th Floor, Washington, DC 20522–0112. Persons with access to the Internet may also view this notice by going to the regulations.gov Web site at http:// regulations.gov/index.cfm. FOR FURTHER INFORMATION CONTACT: Director Ann Ganzer, Office of Defense Trade Controls Policy, Department of State, Telephone (202) 663–2792 or Fax (202) 261–8199; E-mail DDTCResponseTeam@state.gov. ATTN: Regulatory Change, Part 123. SUPPLEMENTARY INFORMATION: To clarify the current regulation, it is necessary to explicitly provide that NATO and its agencies, in addition to the government of a NATO country, or the governments of Australia or Japan, are authorized without the prior written approval of the Directorate of Defense Trade Controls, upon meeting certain conditions, to reexport or retransfer U.S.-origin components incorporated into a foreign defense article. sroberts on PROD1PC70 with RULES DATES: 16:40 Mar 25, 2008 PART 123—LICENSES FOR THE EXPORT OF DEFENSE ARTICLES Regulatory Flexibility Act Since this amendment involves a foreign affairs function of the United States, it does not require analysis under the Regulatory Flexibility Act. 22 CFR Part 123 VerDate Aug<31>2005 I Administrative Procedure Act This amendment involves a foreign affairs function of the United States and, therefore, is not subject to the procedures required by 5 U.S.C. 553 and 554. BILLING CODE 4160–01–S ACTION: Jkt 214001 15885 Unfunded Mandates Reform Act of 1995 This amendment does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Small Business Regulatory Enforcement Fairness Act of 1996 This amendment has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996. Executive Orders 12372 and 13132 This amendment will not 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. Therefore, in accordance with Executive Order 13132, it is determined that this amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on federal programs and activities do not apply to this amendment. Executive Order 12866 This amendment is exempt from review under Executive Order 12866, but has been reviewed internally by the Department of State to ensure consistency with the purposes thereof. Paperwork Reduction Act This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35. List of Subjects in 22 CFR Part 123 Arms and munitions, Exports. PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 Accordingly, for the reasons set forth above, Title 22, Chapter I, Subchapter M, part 123 is amended as follows: 1. The authority citation for part 123 continues to read as follows: I Authority: Secs. 2, 38, and 71, Pub. L. 90– 629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2753; E.O. 11958, 42 FR 4311; 3 CFR, 1977 Comp., p. 79; 22 U.S.C. 2651a; 22 U.S.C. 2776; Pub. L. 105–261, 112 Stat. 1920; Sec. 1205(a), Pub. L. 107–228. 2. Section 123.9 is amended by revising paragraph (e) introductory text to read as follows: I § 123.9 Country of ultimate destination and approval of reexports or retransfers. * * * * * (e) Reexports or retransfers of U.S.origin components incorporated into a foreign defense article to NATO, NATO agencies, a government of a NATO country, or the governments of Australia or Japan, are authorized without the prior written approval of the Directorate of Defense Trade Controls, provided: * * * * * Dated: March 10, 2008. John C. Rood, Acting Under Secretary for Arms Control and International Security, Department of State. [FR Doc. E8–6019 Filed 3–25–08; 8:45 am] BILLING CODE 4710–25–P DEPARTMENT OF THE INTERIOR Minerals Management Service 30 CFR Parts 203, 206, 210, 216, 218, and 227 [Docket No. MMS–2008–MRM–0021] RIN 1010–AD20 Reporting Amendments Minerals Management Service (MMS), Interior. ACTION: Final rule. AGENCY: SUMMARY: The MMS is amending existing regulations for reporting production and royalties on oil, gas, coal and other solid minerals, and geothermal resources produced from Federal and Indian leases in order to align the regulations with current MMS business practices. These amendments reflect changes that were implemented as a result of major reengineering of MMS financial systems and other legal requirements. DATES: Effective Date: April 25, 2008. E:\FR\FM\26MRR1.SGM 26MRR1

Agencies

[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Rules and Regulations]
[Pages 15884-15885]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene 
Disalicylate and Nicarbazin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient Type A medicated articles containing bacitracin 
methylene disalicylate and nicarbazin to formulate two-way combination 
drug Type C medicated feeds for broiler chickens.

DATES: This rule is effective March 26, 2008.

FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rt. 22, Bridgewater, NJ 
08807, filed NADA 141-279 that provides for use of BMD (bacitracin 
methylene disalicylate) and NICARB (nicarbazin) Type A medicated 
articles to formulate two-way combination drug Type C medicated feeds 
for broiler chickens. The NADA is approved as of February 21, 2008, and 
the regulations are amended in 21 CFR 558.366 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(2) that this action 
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.
    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 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 part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In the table in paragraph (d) of Sec.  558.366, alphabetically add 
new entries for ``Bacitracin methylene disalicylate 4 to 50'' and 
``Bacitracin methylene disalicylate 50'' to read as follows:


Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *

------------------------------------------------------------------------
 Nicarbazin    Combination
in grams per   in grams per    Indications     Limitations     Sponsor
     ton           ton           for use
------------------------------------------------------------------------
113.5          *              * *             * *                      *
 (0.0125
 pct)
------------------------------------------------------------------------
              Bacitracin     Broiler         Feed                 046573
               methylene      chickens; aid   continuously
               disalicylate   in preventing   as sole
               4 to 50.       outbreaks of    ration from
                              cecal           time chicks
                              (Eimeria        are placed on
                              tenella) and    litter until
                              intestinal      past the time
                              (E.             when
                              acervulina,     coccidiosis
                              E. maxima, E.   is ordinarily
                              necatrix, and   a hazard; do
                              E. brunetti)    not use as a
                              coccidiosis;    treatment for
                              for increased   outbreaks of
                              rate of         coccidiosis;
                              weight gain     do not use in
                              and improved    flushing
                              feed            mashes; do
                              efficiency.     not feed to
                                              laying hens;
                                              withdraw 4
                                              days before
                                              slaughter.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
              Bacitracin     Broiler         Feed                 046573
               methylene      chickens; aid   continuously
               disalicylate   in preventing   as sole
               50.            outbreaks of    ration from
                              cecal           time chicks
                              (Eimeria        are placed on
                              tenella) and    litter until
                              intestinal      past the time
                              (E.             when
                              acervulina,     coccidiosis
                              E. maxima, E.   is ordinarily
                              necatrix, and   a hazard; do
                              E. brunetti)    not use as a
                              coccidiosis;    treatment for
                              as an aid in    outbreaks of
                              the             coccidiosis;
                              prevention of   do not use in
                              necrotic        flushing
                              enteritis       mashes; do
                              caused or       not feed to
                              complicated     laying hens;
                              by              withdraw 4
                              Clostridium     days before
                              spp. or other   slaughter.
                              organisms
                              susceptible
                              to
                              bacitracin.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------



[[Page 15885]]

    Dated: March 12, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6063 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S