New Animal Drugs For Use in Animal Feeds; Ivermectin, 37437-37439 [E7-13369]

Download as PDF Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subjects in 21 CFR Part 520 Animal drugs. 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 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I [Amended] 2. In paragraph (a) of § 520.538, remove ‘‘25 or 100 milligrams’’ and in its place add ‘‘25, 75, or 100 milligrams’’. I Dated: June 24, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–13372 Filed 7–9–07; 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; Ivermectin AGENCY: Food and Drug Administration, HHS. Ivermectin in g/ton of feed rmajette on PROD1PC64 with RULES VerDate Aug<31>2005 SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine for the treatment and control of various internal and external parasites. DATES: This rule is effective July 10, 2007. Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640, filed a supplement to NADA 140–974 that provides for use of IVOMEC (ivermectin) Premix for Swine, a Type A medicated article, for the treatment and control of various internal and external parasites. The supplement revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine. The supplemental NADA is approved as of June 15, 2007, and the regulations in 21 CFR 558.300 are amended to reflect the approval and a current format. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. Combination in g/ton of feed FDA has determined under 21 CFR 25.33(a)(1) 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. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 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: I 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. I 2. Revise § 558.300 to read as follows: § 558.300 Ivermectin. (a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb). (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.344 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use in swine. It is used in feed as follows: Bacitracin methylene disalicylate, 10 to 30 15:13 Jul 09, 2007 Jkt 211001 Indications for use Limitations Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). (1) 1.8 (to provide 0.1 milligram per kilogram (mg/kg) of body weight per day) (2) 1.8 (to provide 0.1 mg/kg of body weight per day) Final rule. FOR FURTHER INFORMATION CONTACT: Authority: 21 U.S.C. 360b. § 520.538 ACTION: 37437 Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. 050604 Weaned, growing-finishing swine: As in paragraph (e)(1) of this section; and for increased rate of weight gain and improved feed efficiency. For use in swine feed only. Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. 050604 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\10JYR1.SGM 10JYR1 Sponsor 37438 Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations Ivermectin in g/ton of feed Combination in g/ton of feed (3) 1.8 (to provide 0.1 mg/kg of body weight per day) Indications for use Limitations Bacitracin methylene disalicylate, 250 Weaned, growing-finishing swine: As in paragraph (e)(1) of this section; and for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where symptoms have not yet occurred, or following an approved treatment of disease condition. For use in swine feed only. Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. 050604 (4) 1.8 (to provide 0.1 mg/kg of body weight per day) Lincomycin, 20 Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for increased rate of weight gain. Feed as the only feed for 7 consecutive days. Not to be fed to swine that weigh more than 250 lbs. Withdraw 5 days before slaughter. Also see paragraphs (c)(1) and (c)(2) in § 558.325 of this chapter. 050604 (5) 1.8 (to provide 0.1 mg/kg of body weight per day) Lincomycin, 40 Weaned, growing-finishing swine: As in paragraph (e)(4) of this section; and for control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred. Feed as the only feed for 7 consecutive days. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in § 558.325 of this chapter. Withdraw 5 days before slaughter. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment. 050604 (6) 1.8 (to provide 0.1 mg/kg of body weight per day) Lincomycin, 100 Weaned, growing-finishing swine: As in paragraph (e)(4) of this section; and for treatment of swine dysentery. Feed as the only feed for 7 consecutive days followed by a separate feed containing 100 g/ ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in § 558.325 of this chapter. 050604 (7) 1.8 (to provide 0.1 mg/kg of body weight per day) Lincomycin, 200 Weaned, growing-finishing swine: As in paragraph (e)(4) of this section; and for reduction in severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae. Feed as the only feed for 7 consecutive days followed by a separate feed containing 200 g/ ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 lbs. Also see paragraphs (c)(1) and (c)(2) in § 558.325 of this chapter. 050604 Adult and breeding swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. 050604 rmajette on PROD1PC64 with RULES (8) 1.8 to 11.8 (to provide 0.1 mg/kg of body weight per day) VerDate Aug<31>2005 15:13 Jul 09, 2007 Jkt 211001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\10JYR1.SGM 10JYR1 Sponsor Federal Register / Vol. 72, No. 131 / Tuesday, July 10, 2007 / Rules and Regulations Ivermectin in g/ton of feed Combination in g/ton of feed (9) 1.8 to 11.8 (to provide 0.1 mg/kg of body weight per day) Bacitracin methylene disalicylate, 250 Indications for use Pregnant sows: As in paragraph (e)(8) of this section; and for control of clostridial enteritis caused by Clostridium perfringens in suckling piglets. Feed as the only feed for 7 consecutive days. Withdraw 5 days before slaughter. Feed bacitracin methylene disalicylate Type C medicated feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. 050604 Top dress on daily ration for individual treatment for 7 consecutive days. Withdraw 5 days before slaughter. 050604 Dated: June 27, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–13369 Filed 7–9–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1300 and 1315 [Docket No. DEA–293I] RIN 1117–AB08 Import and Production Quotas for Certain List I Chemicals Drug Enforcement Administration (DEA), Justice. ACTION: Interim final rule with request for comment. AGENCY: SUMMARY: In March 2006, Congress enacted the Combat Methamphetamine Epidemic Act of 2005, which mandates that DEA establish total annual requirements, import quotas, individual manufacturing quotas, and procurement quotas for three List I chemicals— ephedrine, pseudoephedrine, and phenylpropanolamine. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements. Effective Date: July 10, 2007. Comment Date: Written comments must be postmarked on or before September 10, 2007. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–293’’ on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, rmajette on PROD1PC64 with RULES DATES: 15:13 Jul 09, 2007 Sponsor Adult and breeding swine: As in paragraph (e)(8) of this section. (10) 18.2 to 120 (to provide 0.1 mg/kg of body weight per day) VerDate Aug<31>2005 Limitations 37439 Jkt 211001 Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through https:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the https:// www.regulations.gov Web site. DEA will accept attachments to electronic comments in Microsoft word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here. Posting of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection online at https://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment but do not want it to be posted online, you must include the phrase ‘‘CONFIDENTIAL BUSINESS PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on https:// www.regulations.gov. Personal identifying information and confidential business information identified and located as set forth above will be redacted and placed in the agency’s public docket file, and, where possible, posted online. If you wish to inspect the agency’s public docket file in person by appointment, please see the ‘‘For Additional Information’’ paragraph. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537 at (202) 307– 7183. SUPPLEMENTARY INFORMATION: DEA’s Legal Authority DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801–971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, for lawful exports, and for maintenance of reserve stocks while deterring the diversion of controlled substances to illegal purposes. The CSA mandates that DEA E:\FR\FM\10JYR1.SGM 10JYR1

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[Federal Register Volume 72, Number 131 (Tuesday, July 10, 2007)]
[Rules and Regulations]
[Pages 37437-37439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13369]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Ivermectin

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 supplemental new animal drug 
application (NADA) filed by Merial Ltd. The supplemental NADA revises 
the approved concentration of ivermectin in Type C medicated feed 
administered as a top dress to adult and breeding swine for the 
treatment and control of various internal and external parasites.

DATES: This rule is effective July 10, 2007.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 140-974 that 
provides for use of IVOMEC (ivermectin) Premix for Swine, a Type A 
medicated article, for the treatment and control of various internal 
and external parasites. The supplement revises the approved 
concentration of ivermectin in Type C medicated feed administered as a 
top dress to adult and breeding swine. The supplemental NADA is 
approved as of June 15, 2007, and the regulations in 21 CFR 558.300 are 
amended to reflect the approval and a current format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    FDA has determined under 21 CFR 25.33(a)(1) 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 the 
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. Revise Sec.  558.300 to read as follows:


Sec.  558.300  Ivermectin.

    (a) Specifications. Type A medicated article containing 2.72 grams 
ivermectin per pound (g/lb).
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.344 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use in swine. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
Ivermectin in g/ton  Combination in g/ton
      of feed               of feed               Indications for use               Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 1.8 (to provide  ....................  Weaned, growing-finishing swine:  Feed as the only feed        050604
 0.1 milligram per                          For treatment and control of      for 7 consecutive days.
 kilogram (mg/kg)                           gastrointestinal roundworms       Withdraw 5 days before
 of body weight per                         (Ascaris suum, adults and         slaughter.
 day)                                       fourth-stage larvae; Ascarops
                                            strongylina, adults;
                                            Hyostrongylus rubidus, adults
                                            and fourth-stage larvae;
                                            Oesophagostomum spp., adults
                                            and fourth-stage larvae);
                                            kidneyworms (Stephanurus
                                            dentatus, adults and fourth-
                                            stage larvae); lungworms
                                            (Metastrongylus spp., adults);
                                            threadworms (Strongyloides
                                            ransomi, adults and somatic
                                            larvae); lice (Haematopinus
                                            suis); and mange mites
                                            (Sarcoptes scabiei var. suis).
----------------------------------------------------------------------------------------------------------------
(2) 1.8 (to provide  Bacitracin methylene  Weaned, growing-finishing swine:  For use in swine feed        050604
 0.1 mg/kg of body    disalicylate, 10 to   As in paragraph (e)(1) of this    only. Feed as the only
 weight per day)      30                    section; and for increased rate   feed for 7 consecutive
                                            of weight gain and improved       days. Withdraw 5 days
                                            feed efficiency.                  before slaughter.
----------------------------------------------------------------------------------------------------------------

[[Page 37438]]

 
(3) 1.8 (to provide  Bacitracin methylene  Weaned, growing-finishing swine:  For use in swine feed        050604
 0.1 mg/kg of body    disalicylate, 250     As in paragraph (e)(1) of this    only. Feed as the only
 weight per day)                            section; and for control of       feed for 7 consecutive
                                            swine dysentery associated with   days. Withdraw 5 days
                                            Treponema hyodysenteriae on       before slaughter.
                                            premises with a history of
                                            swine dysentery, but where
                                            symptoms have not yet occurred,
                                            or following an approved
                                            treatment of disease condition.
----------------------------------------------------------------------------------------------------------------
(4) 1.8 (to provide  Lincomycin, 20        Weaned, growing-finishing swine:  Feed as the only feed        050604
 0.1 mg/kg of body                          For treatment and control of      for 7 consecutive days.
 weight per day)                            gastrointestinal roundworms       Not to be fed to swine
                                            (Ascaris suum, adults and         that weigh more than
                                            fourth-stage larvae; Ascarops     250 lbs. Withdraw 5
                                            strongylina, adults;              days before slaughter.
                                            Hyostrongylus rubidus, adults     Also see paragraphs
                                            and fourth-stage larvae;          (c)(1) and (c)(2) in
                                            Oesophagostomum spp., adults      Sec.   558.325 of this
                                            and fourth-stage larvae);         chapter.
                                            kidneyworms (Stephanurus
                                            dentatus, adults and fourth-
                                            stage larvae); lungworms
                                            (Metastrongylus spp., adults);
                                            lice (Haematopinus suis); and
                                            mange mites (Sarcoptes scabiei
                                            var. suis); and for increased
                                            rate of weight gain.
----------------------------------------------------------------------------------------------------------------
(5) 1.8 (to provide  Lincomycin, 40        Weaned, growing-finishing swine:  Feed as the only feed        050604
 0.1 mg/kg of body                          As in paragraph (e)(4) of this    for 7 consecutive days.
 weight per day)                            section; and for control of       Not to be fed to swine
                                            swine dysentery on premises       that weigh more than
                                            with a history of swine           250 lbs. Also see
                                            dysentery, but where symptoms     paragraphs (c)(1) and
                                            have not yet occurred.            (c)(2) in Sec.
                                                                              558.325 of this
                                                                              chapter. Withdraw 5
                                                                              days before slaughter.
                                                                              A separate feed
                                                                              containing 40 g/ton
                                                                              lincomycin may be
                                                                              continued to complete
                                                                              the lincomycin
                                                                              treatment.
----------------------------------------------------------------------------------------------------------------
(6) 1.8 (to provide  Lincomycin, 100       Weaned, growing-finishing swine:  Feed as the only feed        050604
 0.1 mg/kg of body                          As in paragraph (e)(4) of this    for 7 consecutive days
 weight per day)                            section; and for treatment of     followed by a separate
                                            swine dysentery.                  feed containing 100 g/
                                                                              ton lincomycin for an
                                                                              additional 14 days to
                                                                              complete the lincomycin
                                                                              treatment. Withdraw 6
                                                                              days before slaughter.
                                                                              Not to be fed to swine
                                                                              that weigh more than
                                                                              250 lbs. Also see
                                                                              paragraphs (c)(1) and
                                                                              (c)(2) in Sec.
                                                                              558.325 of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------
(7) 1.8 (to provide  Lincomycin, 200       Weaned, growing-finishing swine:  Feed as the only feed        050604
 0.1 mg/kg of body                          As in paragraph (e)(4) of this    for 7 consecutive days
 weight per day)                            section; and for reduction in     followed by a separate
                                            severity of swine mycoplasmal     feed containing 200 g/
                                            pneumonia caused by Mycoplasma    ton lincomycin for an
                                            hyopneumoniae.                    additional 14 days to
                                                                              complete the lincomycin
                                                                              treatment. Withdraw 6
                                                                              days before slaughter.
                                                                              Not to be fed to swine
                                                                              that weigh more than
                                                                              250 lbs. Also see
                                                                              paragraphs (c)(1) and
                                                                              (c)(2) in Sec.
                                                                              558.325 of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------
(8) 1.8 to 11.8 (to  ....................  Adult and breeding swine: For     Feed as the only feed        050604
 provide 0.1 mg/kg                          treatment and control of          for 7 consecutive days.
 of body weight per                         gastrointestinal roundworms       Withdraw 5 days before
 day)                                       (Ascaris suum, adults and         slaughter.
                                            fourth-stage larvae; Ascarops
                                            strongylina, adults;
                                            Hyostrongylus rubidus, adults
                                            and fourth-stage larvae;
                                            Oesophagostomum spp., adults
                                            and fourth-stage larvae);
                                            kidneyworms (Stephanurus
                                            dentatus, adults and fourth-
                                            stage larvae); lungworms
                                            (Metastrongylus spp., adults);
                                            threadworms (Strongyloides
                                            ransomi, adults and somatic
                                            larvae, and prevention of
                                            transmission of infective
                                            larvae to piglets, via the
                                            colostrum or milk, when fed
                                            during gestation); lice
                                            (Haematopinus suis); and mange
                                            mites (Sarcoptes scabiei var.
                                            suis).
----------------------------------------------------------------------------------------------------------------

[[Page 37439]]

 
(9) 1.8 to 11.8 (to  Bacitracin methylene  Pregnant sows: As in paragraph    Feed as the only feed        050604
 provide 0.1 mg/kg    disalicylate, 250     (e)(8) of this section; and for   for 7 consecutive days.
 of body weight per                         control of clostridial            Withdraw 5 days before
 day)                                       enteritis caused by Clostridium   slaughter. Feed
                                            perfringens in suckling           bacitracin methylene
                                            piglets.                          disalicylate Type C
                                                                              medicated feed to sows
                                                                              from 14 days before
                                                                              through 21 days after
                                                                              farrowing on premises
                                                                              with a history of
                                                                              clostridial scours.
----------------------------------------------------------------------------------------------------------------
(10) 18.2 to 120     ....................  Adult and breeding swine: As in   Top dress on daily           050604
 (to provide 0.1 mg/                        paragraph (e)(8) of this          ration for individual
 kg of body weight                          section.                          treatment for 7
 per day)                                                                     consecutive days.
                                                                              Withdraw 5 days before
                                                                              slaughter.
----------------------------------------------------------------------------------------------------------------


    Dated: June 27, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-13369 Filed 7-9-07; 8:45 am]
BILLING CODE 4160-01-S
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