New Animal Drugs; Meloxicam; Nicarbazin, 22-25 [2012-31234]

Download as PDF 22 Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations subpart F of part 23, the earliest that an SD or MSP would be required to comply with such requirements is December 31, 2012. The changes to compliance dates for § 23.201 will extend the compliance date for certain provisions of this rule until May 1, 2013. The changes to compliance dates being adopted do not change the substance of the rules; rather, they merely provide additional time by which parties can comply. As such, the costs and benefits of the Commission’s action relate only to the additional time provided. Commission expects that reduced market liquidity would increase the costs of hedging, which would then be passed on the public in the form of higher costs. 4. Section 15(a) Section 15(a) of the CEA requires the Commission to consider the effects of its actions in light of the following five factors: such a decrease in swaps activity will adversely impact the price discovery process of the swaps markets. d. Sound Risk Management If counterparties refrain from transacting in swaps, the ability of other market participants to hedge their risks using these instruments may suffer. By mitigating the concerns of market participants regarding compliance with Commission rules, the changes to compliance dates being adopted herein help ensure that, while firms diligently complete the compliance requirements, they can continue entering into swap transactions to hedge their business and investment risks. tkelley on DSK3SPTVN1PROD with 2. Costs The Commission does not anticipate there being any new, quantifiable costs attributable to these changes to compliance dates being adopted because it is only extending the compliance dates for certain requirements in part 23 of the Commission’s regulations. At the same time, however, the Commission is mindful that a delay in the protections afforded by the regulations could result in costs to the public, even if the same is not amenable to quantification. The Commission believes, however, that these costs are mitigated by the maintenance of various other provisions relating to (i) prohibitions on fraud, manipulation and abusive practices, (ii) fair dealings in communications, and (iii) reasonable diligence regarding recommended swaps. These provisions are unaffected by delayed compliance from this extension. The Commission invites comments from the public on any costs, quantitative and qualitative, arising from the delay granted by the changes to compliance dates being adopted. 3. Benefits The additional time for compliance provided for in this release will yield substantial benefit for market participants and the public alike. Absent this extension, market participants would be required to implement temporary solutions while the more permanent, industry wide solutions described earlier are finalized. The Commission believes that this duplication of efforts to achieve compliance would impose extensive burdens and costs on parties without any concomitant benefit to the public. Moreover, the Commission is concerned that based on the representations made by market participants, absent the changes to compliance dates being adopted, market participants might exit the market or curtail their swaps activity due to a lack of legal certainty and protection afforded by Commission relief. If that were to occur, the a. Protection of Market Participants and the Public The Commission believes that by extending the compliance date for certain regulations in part 23, market participants will be able to continue to participate in the swaps market without concerns about potential consequences of failure to comply with the specified regulations. This will, in turn, protect the public by ensuring that the economy does not suffer as a result of any unintended consequences that may have arisen if market participants exited the swaps market. The Commission recognizes that any delay in compliance with the aforementioned business conduct and documentation requirements continues to leave the public without the protections and attendant benefits of those requirements. However, the Commission believes that delaying compliance for only certain business conduct and documentation requirements, while retaining the original compliance dates for fundamental counterparty protections relating to (i) prohibitions on fraud, manipulation and abusive practices, (ii) fair dealings in communications, and (iii) reasonable diligence regarding recommended swaps, will mitigate those effects while avoiding this risk that market participants will exit the market due to legal uncertainty. b. Efficiency, Competitiveness, and Financial Integrity of Markets The Commission believes that extending the compliance dates for the aforementioned rules will help protect the efficiency and competitiveness of the markets by obviating the need to stop transacting in swaps due to delay in complying with specific Commission regulations. It will also strengthen the financial integrity of markets by ensuring that market participants do not transact in the swaps markets while not being in full compliance with these regulations. BILLING CODE 6351–01–P c. Price Discovery If concerns regarding non-compliance results in a reduction in participation by a large number of market participants, ACTION: VerDate Mar<15>2010 16:06 Dec 31, 2012 Jkt 229001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 e. Other Public Interest Considerations The Commission has not identified an impact on other public interest considerations, other than those mentioned above, as a result of the changes to compliance dates being adopted herein, but seeks comment as to any potential impact on this and other 15(a) factors. Issued in Washington, DC on December 18, 2012, by the Commission. Sauntia S. Warfield, Assistant Secretary of the Commission. Appendix to Business Conduct and Documentation Requirements for Swap Dealers and Major Swap Participants— Commission Voting Summary Note: The following appendices will not appear in the Code of Federal Regulations. Appendix 1—Commission Voting Summary On this matter, Chairman Gensler and Commissioners Sommers, Chilton, O’Malia and Wetjen voted in the affirmative; no Commissioner voted in the negative. [FR Doc. 2012–30885 Filed 12–31–12; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 558 [Docket No. FDA–2012–N–0002] New Animal Drugs; Meloxicam; Nicarbazin AGENCY: Food and Drug Administration, HHS. Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect SUMMARY: E:\FR\FM\02JAR1.SGM 02JAR1 23 Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. DATES: This rule is effective January 2, 2013. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect original and supplemental approval actions during October 2012, as listed in table 1 of this document. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents 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. Persons with access to the Internet may obtain these documents at the Center for Veterinary Medicine FOIA Electronic Reading Room: http:// www.fda.gov/AboutFDA/CentersOffices/ OfficeofFoods/CVM/ CVMFOIAElectronicReadingRoom/ default.htm. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER 2012 New animal drug product name NADA/ANADA Sponsor 009–476 .......................................... Phibro Animal Health Corp., GlenPointe Centre East, Third floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666. Phibro Animal Health Corp., GlenPointe Centre East, Third floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666. Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. 098–378 .......................................... 200–496 .......................................... 21 CFR section Action FOIA summary NEPA review NICARB 25% (nicarbazin) Type A medicated article. Supplement revising nicarbazin dosage to a range consistent with dosage approved for use in combination feeds. 558.366 No ...... CE 1 NICARB 25% (nicarbazin) and bacitracin methylene disalicylate Type A medicated articles. Supplement revising nicarbazin dosage to a range consistent with dosage approved for use in combination feeds. 558.366 No ...... CE 1 AMPROMED P for Poultry (amprolium) 9.6% Oral Solution. Original approval as a generic copy of NADA 13–149. 520.100 Yes .... CE 1 1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment. 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. PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. List of Subjects 2. In § 520.100, revise paragraph (b)(4) and the introductory text in paragraph (d)(1) to read as follows: ■ 21 CFR Part 520 Animal drugs. 21 CFR Part 558 § 520.100 * tkelley on DSK3SPTVN1PROD with 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 and 558 are amended as follows: VerDate Mar<15>2010 16:06 Dec 31, 2012 Jkt 229001 Amprolium. * * * * (b) * * * (4) No. 061623 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (d) of this section. * * * * * PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 (d) * * * (1) Growing chickens, turkeys, and laying hens. It is used in drinking water as follows: * * * * * PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 3. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. 4. In § 558.366, in paragraph (d), amend the table as follows: ■ a. Revise the entries for ‘‘90.8 to 181.6 (0.01 to 0.02 pct)’’. ■ b. In the entry for ‘‘113.5 (0.0125 pct)’’, in the entry for ‘‘Chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) ■ E:\FR\FM\02JAR1.SGM 02JAR1 24 Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations coccidiosis’’, remove ‘‘066104’’ from the ‘‘Sponsor’’ column. ■ c. In the entry for ‘‘113.5 (0.0125 pct)’’, in the entry for ‘‘Bacitracin Nicarbazin in grams per ton methylene disalicylate 30’’, remove ‘‘066104’’ from the ‘‘Sponsor’’ column. The revisions read as follows: Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; and for increased rate of weight gain and improved feed efficiency. Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; and for increased rate of weight gain and improved feed efficiency. Penicillin 2.4 to 50 .. tkelley on DSK3SPTVN1PROD with * * Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis. Bacitracin methylene disalicylate 30. VerDate Mar<15>2010 * ................................. Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency. * 16:06 Dec 31, 2012 Jkt 229001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 Nicarbazin. * * (d) * * * Indications for use Bacitracin methylene disalicylate 4 to 50 and roxarsone 22.7 to 45.4. * 90.8 to 181.6 (0.01 to 0.02 pct). Combination in grams per ton § 558.366 Limitations * * Sponsor * * * Feed continuously as sole ration from 066104 time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ ton. Feed continuously as sole ration from 066104 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. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by No. 066104; bacitracin methylene disalicylate and roxarsone by No. 046573 in § 510.600(c) of this chapter. Feed continuously as sole ration from 066104 time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ ton. Feed continuously as sole ration from 066104 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 chickens producing eggs for human consumption. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Penicillin as procaine penicillin G. Nicarbazin and penicillin as provided by No. 066104 in § 510.600(c) of this chapter. E:\FR\FM\02JAR1.SGM 02JAR1 25 Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Rules and Regulations Nicarbazin in grams per ton Combination in grams per ton Indications for use Broiler chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency, and improved pigmentation. Penicillin 2.4 to 50 and roxarsone 22.7 to 45.4. * * Limitations 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. Feed as the sole source of organic arsenic; drug overdose or lack of water may result in leg weakness; do not use in flushing mashes. Discontinue medication 5 days before marketing the birds for human consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Penicillin as procaine penicillin G. Nicarbazin and penicillin as provided by No. 066104; roxarsone by No. 046573 in § 510.600(c) of this chapter. * Dated: December 21, 2012 Bernadette Dunham, Director, Center for Veterinary Medicine. * * CDC barges in the RNA from their dangerous cargo or vessel arrival and movement reporting obligations currently in effect under other regulations or placed into effect under appropriate Coast Guard authority. [FR Doc. 2012–31234 Filed 12–31–12; 8:45 am] BILLING CODE 4160–01–P Effective midnight January 15, 2013, 33 CFR 165.830(d), (e), (f), (g), and (h) are stayed until midnight September 30, 2013. DATES: DEPARTMENT OF HOMELAND SECURITY Coast Guard Documents indicated in this preamble as being available in the docket are part of docket USCG–2012– 1074. To view documents mentioned in this preamble as being available in the docket, go to http:// www.regulations.gov, type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH’’. Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12–140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. ADDRESSES: 33 CFR Part 165 [USCG–2012–1074] RIN 1625–AA11 Regulated Navigation Area; Reporting Requirements for Barges Loaded With Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District; Extension of Stay (Suspension) Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: The Commander, Eighth Coast Guard District is extending the previously published stay (suspension) of reporting requirements under the Regulated Navigation Area (RNA) established by 33 CFR 165.830 for barges loaded with certain dangerous cargoes (CDC barges) in the inland rivers of the Eighth Coast Guard District. A two year stay was previously published at 76 Federal Register (FR) 1360 (January 10, 2011), which expires January 15, 2013. This extension is necessary because the Coast Guard continues to analyze future reporting needs and evaluate possible changes in CDC reporting requirements. This extension of the suspension of the CDC reporting requirements in no way relieves towing vessel operators and fleeting area managers responsible for tkelley on DSK3SPTVN1PROD with SUMMARY: VerDate Mar<15>2010 16:06 Dec 31, 2012 Jkt 229001 If you have questions about this temporary rule, call or email LT Jason Doherty, Coast Guard; telephone 504–671–2266, email: Jason.C.Doherty@uscg.mil. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366– 9826. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Acronyms CDC Certain Dangerous Cargo DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 * Sponsor 066104 * A. Regulatory History and Information The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it would be impracticable, unnecessary, and contrary to the public interest. The contract for the CDC barge reporting system at the Inland River Vessel Movement Center (IRVMC) expired in January 2011. Due to the expiration of this contract, the Coast Guard would not be able to receive and process reports, therefore, in late December 2010, the Coast Guard decided to suspend the IRVMC reporting requirements for a two-year period. This suspension was published in the Federal Register at 76 FR 1360 (January 10, 2011), and expires on January 15, 2013. At this time, the contract for the CDC barge reporting system has not been renewed, and the Coast Guard is still considering whether to enter into a new contract and lift the suspension, modify the reporting requirements in the RNA, or repeal the RNA completely. An extension of the stay is necessary while the Coast Guard continues to consider these options. We believe prior notice and comment is unnecessary because we expect the affected public will have no objection to E:\FR\FM\02JAR1.SGM 02JAR1

Agencies

[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Rules and Regulations]
[Pages 22-25]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31234]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

[Docket No. FDA-2012-N-0002]


New Animal Drugs; Meloxicam; 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

[[Page 23]]

approval actions for new animal drug applications (NADAs) and 
abbreviated new animal drug applications (ANADAs) during October 2012. 
FDA is also informing the public of the availability of summaries of 
the basis of approval and of environmental review documents, where 
applicable.

DATES: This rule is effective January 2, 2013.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
to reflect original and supplemental approval actions during October 
2012, as listed in table 1 of this document. In addition, FDA is 
informing the public of the availability, where applicable, of 
documentation of environmental review required under the National 
Environmental Policy Act (NEPA) and, for actions requiring review of 
safety or effectiveness data, summaries of the basis of approval (FOI 
Summaries) under the Freedom of Information Act (FOIA). These public 
documents 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. Persons 
with access to the Internet may obtain these documents at the Center 
for Veterinary Medicine FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

                                    Table 1--Original and Supplemental NADAs and ANADAs Approved During October 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            New animal drug                            21 CFR
            NADA/ANADA                    Sponsor            product name             Action          section       FOIA summary         NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
009-476..........................  Phibro Animal Health  NICARB 25%            Supplement revising     558.366  No.................  CE \1\
                                    Corp., GlenPointe     (nicarbazin) Type A   nicarbazin dosage
                                    Centre East, Third    medicated article.    to a range
                                    floor, 300 Frank W.                         consistent with
                                    Burr Blvd., suite                           dosage approved for
                                    21, Teaneck, NJ                             use in combination
                                    07666.                                      feeds.
098-378..........................  Phibro Animal Health  NICARB 25%            Supplement revising     558.366  No.................  CE \1\
                                    Corp., GlenPointe     (nicarbazin) and      nicarbazin dosage
                                    Centre East, Third    bacitracin            to a range
                                    floor, 300 Frank W.   methylene             consistent with
                                    Burr Blvd., suite     disalicylate Type A   dosage approved for
                                    21, Teaneck, NJ       medicated articles.   use in combination
                                    07666.                                      feeds.
200-496..........................  Cross Vetpharm Group  AMPROMED P for        Original approval as    520.100  Yes................  CE \1\
                                    Ltd., Broomhill       Poultry (amprolium)   a generic copy of
                                    Rd., Tallaght,        9.6% Oral Solution.   NADA 13-149.
                                    Dublin 24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
  human environment.

    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 520

    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 and 
558 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


0
2. In Sec.  520.100, revise paragraph (b)(4) and the introductory text 
in paragraph (d)(1) to read as follows:


Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (4) No. 061623 for use of products described in paragraphs (a)(1) 
and (a)(2) of this section as in paragraph (d) of this section.
* * * * *
    (d) * * * (1) Growing chickens, turkeys, and laying hens. It is 
used in drinking water as follows:
* * * * *

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

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

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


0
4. In Sec.  558.366, in paragraph (d), amend the table as follows:
0
a. Revise the entries for ``90.8 to 181.6 (0.01 to 0.02 pct)''.
0
b. In the entry for ``113.5 (0.0125 pct)'', in the entry for 
``Chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and 
intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti)

[[Page 24]]

coccidiosis'', remove ``066104'' from the ``Sponsor'' column.
0
c. In the entry for ``113.5 (0.0125 pct)'', in the entry for 
``Bacitracin methylene disalicylate 30'', remove ``066104'' from the 
``Sponsor'' column.
    The revisions read as follows:


Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Combination in  grams
    Nicarbazin in  grams per ton             per ton                   Indications for use                          Limitations                 Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
90.8 to 181.6 (0.01 to 0.02 pct)...  ......................  Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                                              preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard. Do not use as a
                                                              and E. brunetti) coccidiosis.            treatment for coccidiosis. Do not feed
                                                                                                       to laying hens. Withdraw 4 days before
                                                                                                       slaughter for use levels at or below
                                                                                                       113.5 g/ton. Withdraw 5 days before
                                                                                                       slaughter for use levels above 113.5 g/
                                                                                                       ton.
                                     Bacitracin methylene    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      disalicylate 4 to 50    preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                      and roxarsone 22.7 to   tenella) and intestinal (E.              past the time when coccidiosis is
                                      45.4.                   acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis; and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Discontinue medication 5
                                                              improved feed efficiency.                days before marketing the birds for
                                                                                                       human consumption to allow for
                                                                                                       elimination of the drug from edible
                                                                                                       tissue. Do not feed to laying hens in
                                                                                                       production. Nicarbazin as provided by
                                                                                                       No. 066104; bacitracin methylene
                                                                                                       disalicylate and roxarsone by No.
                                                                                                       046573 in Sec.   510.600(c) of this
                                                                                                       chapter.
                                     Bacitracin methylene    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      disalicylate 30.        preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard. Do not use as a
                                                              and E. brunetti) coccidiosis; and for    treatment for coccidiosis. Do not feed
                                                              increased rate of weight gain and        to laying hens. Withdraw 4 days before
                                                              improved feed efficiency.                slaughter for use levels at or below
                                                                                                       113.5 g/ton. Withdraw 5 days before
                                                                                                       slaughter for use levels above 113.5 g/
                                                                                                       ton.
                                     Penicillin 2.4 to 50..  Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                                              preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                                              tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis, and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Do not use in flushing
                                                              improved feed efficiency.                mashes. Do not feed to chickens
                                                                                                       producing eggs for human consumption.
                                                                                                       Discontinue medication 5 days before
                                                                                                       marketing the birds for human
                                                                                                       consumption to allow for elimination
                                                                                                       of the drug from edible tissue.
                                                                                                       Penicillin as procaine penicillin G.
                                                                                                       Nicarbazin and penicillin as provided
                                                                                                       by No. 066104 in Sec.   510.600(c) of
                                                                                                       this chapter.

[[Page 25]]

 
                                     Penicillin 2.4 to 50    Broiler chickens: As an aid in           Feed continuously as sole ration from       066104
                                      and roxarsone 22.7 to   preventing outbreaks of cecal (Eimeria   time chicks are placed on litter until
                                      45.4.                   tenella) and intestinal (E.              past the time when coccidiosis is
                                                              acervulina, E. maxima, E. necatrix,      ordinarily a hazard; do not use as a
                                                              and E. brunetti) coccidiosis, and for    treatment for outbreaks of
                                                              increased rate of weight gain and        coccidiosis. Feed as the sole source
                                                              improved feed efficiency, and improved   of organic arsenic; drug overdose or
                                                              pigmentation.                            lack of water may result in leg
                                                                                                       weakness; do not use in flushing
                                                                                                       mashes. Discontinue medication 5 days
                                                                                                       before marketing the birds for human
                                                                                                       consumption to allow for elimination
                                                                                                       of the drug from edible tissue. Do not
                                                                                                       feed to laying hens in production.
                                                                                                       Penicillin as procaine penicillin G.
                                                                                                       Nicarbazin and penicillin as provided
                                                                                                       by No. 066104; roxarsone by No. 046573
                                                                                                       in Sec.   510.600(c) of this chapter.
 
                                                                      * * * * * * *
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    Dated: December 21, 2012
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-31234 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P