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 Department of Health and Human Services Food  and  Drug  Administration 21  CFR  Part  558
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Final  rule.
 SUMMARY: The  Food  and  Drug  Administration  (FDA)  is  amending  the  animal  drug  regulations  to  reflect  approval  of  a  new  animal  drug  application  (NADA)  filed  by  Elanco  Animal  Health.   The  NADA  provides  for  use  of  ractopamine  and  tylosin  single-ingredient  Type  A  medicated  articles  to  make  combination  drug  Type C  medicated  feeds  used  for  increased  rate  of  weight  gain,  improved  feed  efficiency,  increased  carcass  leanness,  and  prevention  and/or  control  of  porcine  proliferative  enteropathies  (ileitis)  in  swine.
 DATES: This  rule  is  effective April 30, 2001.
 FOR FURTHER INFORMATION CONTACT: Charles  J.  Andres,  Center  for  Veterinary  Medicine  (HFV-128),  Food  and  Drug  Administration,  7500  Standish  Pl.,  Rockville,  MD    20855,  301-827-1600.


SUPPLEMENTARY INFORMATION: Elanco  Animal  Health,  A  Division  of  Eli  Lilly  &  Co.,  Lilly  Corporate  Center,  Indianapolis,  IN  46285,  filed  NADA 141-172  that  provides  for  use  of  Paylean® (9 grams per pound (g/lb) ractopamine  hydrochloride)  and  Tylan®  (10, 40,  or  100 g/lb  tylosin  phosphate)  Type  A  medicated  article  to  make  combination  drug  Type C  medicated  feeds  used  for  increased  rate  of  weight  gain,  improved  feed  efficiency,  and  increased  carcass  leanness,  and  for  prevention  and/or  control  of  porcine  proliferative  enteropathies  (ileitis)  associated  with 
                    *Lawsonia  intracellularis*
                     in  swine.   The NADA is  approved  as  of  February 20, 2001,  and the regulations are amended in 21 CFR 558.500  and  558.625 to  reflect  the  approval.   The  basis  of  approval  is  discussed  in  the  freedom  of  information  summary. In  accordance  with  the  freedom  of  information  provisions  of  21  CFR  part 20  and  514.11(e)(2)(ii),  a  summary  of  safety  and  effectiveness  data  and  information  submitted  to  support  approval  of  this  application  may  be  seen  in  the  Dockets  Management  Branch  (HFA-305),  Food  and  Drug  Administration,  5630  Fishers  Lane,  rm.  1061,  Rockville,  MD  20852,  between  9  a.m.  and  4  p.m.,  Monday  through  Friday. The  agency  has  determined  under  21  CFR  25.33(a)(2)  that  this  action  is  of  a  type  that  does  not  individually  or  cumulatively  have  a  significant  effect  on  the  human  environment.   Therefore,  neither  an  environmental  assessment  nor  an  environmental  impact  statement  is  required. This  rule  does  not  meet  the  definition  of  “rule”  in  5  U.S.C. 804(3)(A)  because  it  is  a  rule  of  “particular  applicability.”   Therefore,  it  is  not  subject  to  the  congressional  review  requirements  in  5  U.S.C.  801-808. List  of  Subjects  in  21  CFR  Part  558 Animal  drugs
Animal  feeds
 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
 1.  The  authority  citation  for 21  CFR  part  558  continues  to  read  as  follows: Authority:
                    21  U.S.C.  360b,  371. 2.  Section  558.500  is  amended  by  revising  paragraph (d)(1) to  read  as  follows: § 558.500
 
 (d) 
                    *Conditions of use*. (1) 
                    *Swine*. Ractopamine in grams per ton
Combination in grams per ton
Indications  for use
Limitations
Sponsor(i) 4.5

For increased rate of weight gain, improved feed ­efficiency­, and increased carcass leanness
Feed continuously as sole ration.  Feed in a complete ration containing at least 16 percent crude protein to finishing  swine from 150 to 240 pounds body weight.  Not for use in  breeding swine
000986(ii) 4.5 to 18

For improved feed efficiency and increased carcass leanness
Feed continuously as sole ration.  Feed in a complete ration containing at least 16 percent crude protein to finishing swine from 150 to 240 pounds body weight.  Not for use in breeding swine
000986(iii)   4.5
Tylosin 100
For increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and  for prevention and/or control of porcine proliferative  enteropathies (ileitis) associated with 
                            *Lawsonia  intracellularis*
Feed continuously as sole ration for  21 days.  Feed in a complete ration containing at least 16 percent crude protein to finishing swine from 150 to 240 pounds  body weight.  Not for use in breeding swine
000986(iv)   4.5   to   18
Tylosin 100
For improved feed efficiency and  increased carcass leanness; and for prevention and/or control of  porcine proliferative enteropathies (ileitis) associated with 
                            *Lawsonia intracellularis*
Feed continuously as sole ration for  21 days. Feed in a complete ration containing at least 16  percent crude protein to finishing swine from 150 to 240 pounds  body weight. Not for use in breeding swine
000986
 
 3.   Section   558.625   is   amended   by   adding   paragraph   (f)(2)(vii)   to   read   as   follows: § 558.625
 
 (f) * * * (2) * * * (vii)   Ractopamine   hydrochloride   as   in   § 558.500. Dated: April 16, 2001. Stephen F. Sundlof, Director, Center for Veterinary Medicine.


[FR Doc. 01-10622 Filed 4-27-01; 8:45 am] BILLING CODE 4160-01-S