[Federal Register Volume 70, Number 139 (Thursday, July 21, 2005)]
[Rules and Regulations]
[Pages 41958-41963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14329]


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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; Roxarsone; Semduramycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is correcting the 
single-ingredient roxarsone Type A medicated article that may be used 
to formulate three-way, combination drug Type C medicated broiler 
chicken feeds containing semduramicin, virginiamycin, and roxarsone 
under a new animal drug application (NADA) recently approved for Phibro 
Animal Health. FDA is also amending the animal drug regulations to 
reflect two roxarsone Type A medicated articles

[[Page 41959]]

approved under separate new animal drug applications (NADAs) for 
different conditions of use. This action is being taken to improve the 
accuracy of the agency's regulations.

DATES: This rule is effective July 21, 2005.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA has found that the list of approved, 
single-ingredient Type A medicated articles used to formulate three-
way, combination drug Type C medicated broiler chicken feeds containing 
semduramicin, virginiamycin, and roxarsone under NADA 141-226 is in 
error. The Federal Register document that described approval of that 
application for Phibro Animal Health on February 23, 2004 (69 FR 13221, 
March 22, 2004), listed 3-NITRO (roxarsone) Type A Medicated article as 
the source of roxarsone; however, the correct source for this 
combination feed is ROXARSONE (roxarsone) Type A Medicated article, 
approved under NADA 92-953. At this time, FDA is amending the 
regulations in 21 CFR 558.555 to reflect the roxarsone Type A medicated 
article approved for this combination and a current tabular format.
    In addition, FDA has found that the April 1, 2004, edition of parts 
500 to 599 (21 CFR parts 500 to 599) of Title 21 of the Code of Federal 
Regulations (CFR) does not accurately reflect the approved conditions 
of use for roxarsone Type A medicated articles. Roxarsone is approved 
as single-ingredient Type A medicated articles under two separate 
applications, NADA 7-891 for 3-NITRO and NADA 92-953 for ROXARSONE, 
held by Alpharma, Inc. In error, portions of the regulation describing 
approvals had been consolidated in July 2000 (65 FR 45711, July 25, 
2000). At this time, FDA is amending the regulations in Sec.  558.530 
to reflect two separate approvals for roxarsone Type A medicated 
articles with different approved conditions of use and a current 
tabular format.
    Also, FDA has found that the approved conditions of use codified 
for NADA 92-953 prior to the July 2000 change were in error. A specific 
technical amendment to remove turkeys as an approved species (49 FR 
30927, August 2, 1984) was reversed in a subsequent change that 
implemented revised terminology for feed premixes (51 FR 7400, March 3, 
1986). At this time, FDA is amending the regulations in Sec.  558.530 
to reflect approval of NADA 92-953 for chickens only.
    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 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. Section 558.530 is amended by revising paragraphs (a) through 
(d)(3); removing paragraph (d)(4); and by redesignating paragraph 
(d)(5) as paragraph (d)(4) to read as follows:


Sec.  558.530  Roxarsone.

    (a) Specifications. Type A medicated articles containing 10, 20, 
50, or 80 percent roxarsone.
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 046573 for use of 10, 20, and 50 percent Type A medicated 
articles as in paragraph (d)(1)(i) of this section.
    (2) No. 046573 for use of 10, 20, 50, and 80 percent Type A 
medicated articles as in paragraphs (d)(1) through (d)(3) of this 
section.
    (c) Related tolerances. See Sec.  556.60 of this chapter.
    (d) Conditions of use--(1) Chickens. It is used in chicken feed as 
follows:

------------------------------------------------------------------------
Roxarsone in   Combinations
  grams per    in grams per    Indications     Limitations     Sponsor
     ton            ton          for use
------------------------------------------------------------------------
(i) 22.7 to   ..............  Growing        Feed                 046573
 45.4                          chickens:      continuously
                               For            throughout
                               increased      growing
                               rate of        period; do
                               weight gain,   not feed to
                               improved       chickens
                               feed           producing
                               efficiency,    eggs for
                               and improved   human
                               pigmentation   consumption;
                               .              withdraw 5
                                              days before
                                              slaughter; as
                                              sole source
                                              of organic
                                              arsenic; drug
                                              overdose or
                                              lack of water
                                              may result in
                                              leg weakness.
------------------------------------------------------------------------
(ii) 22.7 to  Chlortetracycl  Growing        As in           ...........
 45.4          ine 10 to 50    chickens: As   paragraph
                               in paragraph   (d)(1)(i) of
                               (d)(1)(i) of   this section.
                               this           Chlortetracyc
                               section.       line as
                                              provided by
                                              No. 046573 in
                                              Sec.
                                              510.600(c) of
                                              this chapter.
------------------------------------------------------------------------
(iii) 22.7    Chlortetracycl  Growing        As in           ...........
 to 45.4       ine 100 to      chickens: As   paragraph
               200             in paragraph   (d)(1)(i) of
                               (d)(1)(i) of   this section
                               this           except feed
                               section; and   continuously
                               for control    for 7 to 14
                               of             days.
                               infectious     Chlortetracyc
                               synovitis      line as
                               caused by      provided by
                               Mycoplasma     No. 046573 in
                               synoviae       Sec.
                               susceptible    510.600(c) of
                               to             this chapter.
                               chlortetracy
                               cline.
------------------------------------------------------------------------

[[Page 41960]]

 
(iv) 22.7 to  Chlortetracycl  Growing        As in           ...........
 45.4          ine 200 to      chickens: As   paragraph
               400             in paragraph   (d)(1)(i) of
                               (d)(1)(i) of   this section
                               this           except feed
                               section; and   continuously
                               for control    for 7 to 14
                               of chronic     days.
                               respiratory    Chlortetracyc
                               disease        line as
                               (CRD) and      provided by
                               air sac        No. 046573 in
                               infection      Sec.
                               caused by M.   510.600(c) of
                               gallisepticu   this chapter.
                               m and
                               Escherichia
                               coli
                               susceptible
                               to
                               chlortetracy
                               cline.
------------------------------------------------------------------------
(v) 22.7 to   Chlortetracycl  Growing        As in           ...........
 45.4          ine 500         chickens: As   paragraph
                               in paragraph   (d)(1)(i) of
                               (d)(1)(i) of   this section
                               this           except feed
                               section; and   continuously
                               for            for 5 days.
                               reduction of   Chlortetracyc
                               mortality      line as
                               due to E.      provided by
                               coli           No. 046573 in
                               infections     Sec.
                               susceptible    510.600(c) of
                               to             this chapter.
                               chlortetracy
                               cline.
------------------------------------------------------------------------

    (2) Turkeys. It is used in turkey feed as follows:

------------------------------------------------------------------------
Roxarsone in   Combinations
  grams per    in grams per    Indications     Limitations     Sponsor
     ton            ton          for use
------------------------------------------------------------------------
(i) 22.7 to   ..............  Growing        Feed                 046573
 45.4                          turkeys: For   continuously
                               increased      throughout
                               rate of        growing
                               weight gain,   period; do
                               improved       not feed to
                               feed           turkeys
                               efficiency,    producing
                               and improved   eggs for
                               pigmentation   human
                               .              consumption;
                                              withdraw 5
                                              days before
                                              slaughter; as
                                              sole source
                                              of organic
                                              arsenic; drug
                                              overdose or
                                              lack of water
                                              may result in
                                              leg weakness.
------------------------------------------------------------------------
(ii) 22.7 to  Chlortetracycl  Growing        As in           ...........
 45.4          ine 10 to 50    turkeys: As    paragraph
                               in paragraph   (d)(2)(i) of
                               (d)(2)(i) of   this section.
                               this           Chlortetracyc
                               section.       line as
                                              provided by
                                              No. 046573 in
                                              Sec.
                                              510.600(c) of
                                              this chapter.
------------------------------------------------------------------------
(iii) 22.7    Chlortetracycl  Growing        As in           ...........
 to 45.4       ine 200         turkeys: As    paragraph
                               in paragraph   (d)(2)(i) of
                               (d)(2)(i) of   this section
                               this           except feed
                               section; and   continuously
                               for control    for 7 to 14
                               of             days.
                               infectious     Chlortetracyc
                               synovitis      line as
                               caused by      provided by
                               Mycoplasma     No. 046573 in
                               synoviae       Sec.
                               susceptible    510.600(c) of
                               to             this chapter.
                               chlortetracy
                               cline.
------------------------------------------------------------------------
(iv) 22.7 to  Chlortetracycl  1. Growing     As in           ...........
 45.4          ine 400         turkeys: As    paragraph
                               in paragraph   (d)(2)(i) of
                               (d)(2)(i) of   this section
                               this           except feed
                               section; and   continuously
                               for control    for 7 to 14
                               of             days.
                               hexamitiasis   Chlortetracyc
                               caused by      line as
                               Hexamita       provided by
                               meleagrides    No. 046573 in
                               susceptible    Sec.
                               to             510.600(c) of
                               chlortetracy   this chapter.
                               cline.
                              2. Turkey
                               poults not
                               over 4 weeks
                               of age:
                               Reduction of
                               mortality
                               due to
                               paratyphoid
                               caused by
                               Salmonella
                               typhimurium
                               susceptible
                               to
                               chlortetracy
                               cline.
------------------------------------------------------------------------
(v) 22.7 to   Chlortetracycl  Growing        As in           ...........
 45.4          ine 25 mg/lb    turkeys: As    paragraph
               body weight     in paragraph   (d)(2)(i) of
               daily           (d)(2)(i) of   this section
                               this           except feed
                               section; and   continuously
                               for control    for 7 to 14
                               of             days.
                               complicating   Chlortetracyc
                               bacterial      line as
                               organisms      provided by
                               associated     No. 046573 in
                               with           Sec.
                               bluecomb       510.600(c) of
                               (transmissib   this chapter.
                               le
                               enteritis,
                               coronaviral
                               enteritis)
                               susceptible
                               to
                               chlortetracy
                               cline.
------------------------------------------------------------------------

    (3) Swine. It is used in swine feed as follows:

[[Page 41961]]



------------------------------------------------------------------------
Roxarsone in   Combinations
  grams per    in grams per    Indications     Limitations     Sponsor
     ton            ton          for use
------------------------------------------------------------------------
(i) 22.7 to   ..............  Growing and    Feed                 046573
 34.1                          finishing      continuously
                               swine: For     throughout
                               increased      growing
                               rate of        period;
                               weight gain    withdraw 5
                               and improved   days before
                               feed           slaughter; as
                               efficiency.    sole source
                                              of organic
                                              arsenic.
------------------------------------------------------------------------
(ii) 22.7 to  Chlortetracycl  Growing and    Feed for not    ...........
 34.1          ine 400 (to     finishing      more than 14
               administer 10   swine: As in   days;
               mg/lb body      paragraph      withdraw 5
               weight)         (d)(3)(i) of   days before
                               this           slaughter; as
                               section; and   sole source
                               for            of organic
                               treatment of   arsenic.
                               bacterial
                               enteritis
                               caused by E.
                               coli and S.
                               choleraesuis
                               and
                               bacterial
                               pneumonia
                               caused by
                               Pasteurella
                               multocida
                               susceptible
                               to
                               chlortetracy
                               cline.
------------------------------------------------------------------------
(iii) 181.5   ..............  Growing and    Feed for not         046573
                               finishing      more than 6
                               swine: For     consecutive
                               the            days; if
                               treatment of   improvement
                               swine          is not
                               dysentery.     observed,
                                              consult a
                                              veterinarian;
                                              withdraw 5
                                              days before
                                              slaughter; as
                                              a sole source
                                              of organic
                                              arsenic;
                                              animals must
                                              consume
                                              enough
                                              medicated
                                              feed to
                                              provide a
                                              therapeutic
                                              dose.
------------------------------------------------------------------------
(iv) 181.5    Chlortetracycl  Growing and    Feed for not    ...........
               ine 10 to 50    finishing      more than 6
                               swine: As in   consecutive
                               paragraph      days; if
                               (d)(3)(i) of   improvement
                               this           is not
                               section; and   observed,
                               for            consult a
                               treatment of   veterinarian;
                               swine          withdraw 5
                               dysentery.     days before
                                              slaughter; as
                                              a sole source
                                              of organic
                                              arsenic;
                                              animals must
                                              consume
                                              enough
                                              medicated
                                              feed to
                                              provide a
                                              therapeutic
                                              dose.
------------------------------------------------------------------------
(v) 181.5     Chlortetracycl  Growing and    Feed for not    ...........
               ine 400 (to     finishing      more than 6
               administer 10   swine: As in   consecutive
               mg/lb body      paragraph      days; if
               weight)         (d)(3)(iii)    improvement
                               of this        is not
                               section; and   observed,
                               for            consult a
                               treatment of   veterinarian;
                               bacterial      withdraw 5
                               enteritis      days before
                               caused by E.   slaughter; as
                               coli and S.    a sole source
                               choleraesuis   of organic
                               and            arsenic;
                               bacterial      animals must
                               pneumonia      consume
                               caused by P.   enough
                               multocida      medicated
                               susceptible    feed to
                               to             provide a
                               chlortetracy   therapeutic
                               cline.         dose.
------------------------------------------------------------------------

* * * * *

0
3. Section 558.555 is amended by revising paragraph (d) to read as 
follows:


Sec.  558.555  Semduramicin.

* * * * *
    (d) Conditions of use in chickens. It is used in chicken feed as 
follows:

------------------------------------------------------------------------
 Semduramicin    Combinations
 in grams per    in grams per   Indications    Limitations     Sponsor
      ton            ton          for use
------------------------------------------------------------------------
(1) 22.7 (25    .............  Broiler       Do not feed to       066104
 ppm)                           chickens:     laying hens.
                                For the
                                prevention
                                of
                                coccidiosis
                                caused by
                                Eimeria
                                acervulina,
                                E.
                                brunetti,
                                E. maxima,
                                E. mivati/
                                E. mitis,
                                E.
                                necatrix,
                                and E.
                                tenella.
------------------------------------------------------------------------
(2) 22.7        Bacitracin     Broiler       Feed                 066104
                 methylene      chickens:     continuously
                 disalicylate   As in         as sole
                 10 to 50       paragraph     ration. Do
                                (d)(1) of     not feed to
                                this          laying hens.
                                section;      Bacitracin
                                for           methylene
                                improved      disalicylate
                                feed          as provided
                                efficiency.   by No. 046573
                                              in Sec.
                                              510.600(c) of
                                              this chapter.
------------------------------------------------------------------------

[[Page 41962]]

 
(3) 22.7        Bacitracin     Broiler       Feed                 066104
                 methylene      chickens:     continuously
                 disalicylate   As in         as sole
                 10 to 50       paragraph     ration. Use
                 plus           (d)(4) of     feed within 2
                 roxarsone      this          weeks of
                 45.4           section;      production.
                                for           Do not feed
                                improved      to laying
                                feed          hens. Use as
                                efficiency.   sole source
                                              of organic
                                              arsenic.
                                              Poultry
                                              should have
                                              access to
                                              drinking
                                              water at all
                                              times. Drug
                                              overdosage or
                                              lack of water
                                              intake may
                                              result in leg
                                              weakness or
                                              paralysis.
                                              Withdraw 5
                                              days before
                                              slaughter.
                                              Bacitracin
                                              methylene
                                              disalicylate
                                              and roxarsone
                                              as provided
                                              by No. 046573
                                              in Sec.
                                              510.600(c) of
                                              this chapter.
------------------------------------------------------------------------
(4) 22.7        Roxarsone      Broiler       Feed                 066104
                 45.4           chickens:     continuously
                                For the       as sole
                                prevention    ration. For
                                of            broiler
                                coccidiosis   chickens
                                caused by     only. Do not
                                Eimeria       feed to
                                acervulina,   laying hens.
                                E.            Use as sole
                                brunetti,     source of
                                E. maxima,    organic
                                E. mivati/    arsenic.
                                E. mitis,     Withdraw 5
                                E.            days before
                                necatrix,     slaughter.
                                and E.        Roxarsone as
                                tenella,      provided by
                                including     No. 046573 in
                                some field    Sec.
                                strains of    510.600(c) of
                                E. tenella    this chapter.
                                that are
                                more
                                susceptible
                                to
                                semduramici
                                n combined
                                with
                                roxarsone
                                than
                                semduramici
                                n alone.
------------------------------------------------------------------------
(5) 22.7        Virginiamycin  Broiler       Feed                 066104
                 5              chickens:     continuously
                                As in         as sole
                                paragraph     ration. Do
                                (d)(1) of     not feed to
                                this          laying hens.
                                section;      Virginiamycin
                                for           as provided
                                increased     by No. 066104
                                rate of       in Sec.
                                weight gain   510.600(c) of
                                and           this chapter.
                                improved
                                feed
                                efficiency.
------------------------------------------------------------------------
(6) 22.7        Virginiamycin  Broiler       Feed                 066104
                 5 to 15        chickens:     continuously
                                As in         as sole
                                paragraph     ration. Do
                                (d)(1) of     not feed to
                                this          laying hens.
                                section;      Virginiamycin
                                for           as provided
                                increased     by No. 066104
                                rate of       in Sec.
                                weight        510.600(c) of
                                gain.         this chapter.
------------------------------------------------------------------------
(7) 22.7        Virginiamycin  Broiler       Feed                 066104
                 20             chickens:     continuously
                                As in         as sole
                                paragraph     ration. Do
                                (d)(1) of     not feed to
                                this          laying hens.
                                section;      Virginiamycin
                                for           as provided
                                prevention    by No. 066104
                                of necrotic   in Sec.
                                enteritis     510.600(c) of
                                caused by     this chapter.
                                Clostridium
                                perfringens
                                susceptible
                                to
                                virginiamyc
                                in.
------------------------------------------------------------------------
(8) 22.7        Virginiamycin  Broiler       Feed                 066104
                 20 plus        chickens:     continuously
                 roxarsone      As in         as sole
                 22.7 to 45.4   paragraph     ration
                                (d)(1) of     throughout
                                this          growing
                                section;      period. Do
                                for           not feed to
                                prevention    laying hens.
                                of necrotic   Use as sole
                                enteritis     source of
                                caused by     organic
                                Clostridium   arsenic.
                                perfringens   Poultry
                                susceptible   should have
                                to            access to
                                virginiamyc   drinking
                                in; for       water at all
                                increased     times. Drug
                                rate of       overdose or
                                weight gain   lack of water
                                and           may result in
                                improved      leg weakness.
                                feed          Roxarsone as
                                efficiency;   in Sec.
                                and for       558.530(b)(1)
                                improved      of this
                                pigmentatio   chapter
                                n.            provided by
                                              No. 046573 in
                                              Sec.
                                              510.600(c) of
                                              this chapter;
                                              semduramicin
                                              and
                                              virginiamycin
                                              as provided
                                              by No.
                                              066104.
------------------------------------------------------------------------



[[Page 41963]]

    Dated: April 25, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation.
[FR Doc. 05-14329 Filed 7-20-05; 8:45 am]
BILLING CODE 4160-01-S