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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; technical  amendment.

# SUMMARY:

The  Food  and  Drug  Administration  (FDA)  is  updating  the  animal  drug  regulations  for  medicated  feeds  to  correctly  reflect  previously  approved  assay  limits  for  Type  A  medicated  articles  containing  monensin,  or  sulfadimethoxine  and  ormetoprim  in  combination.   This  action  is  being  taken  to  improve  the  accuracy  of  the  agency’s  regulations.

# DATES:

This  rule  is  effective May 2, 2001.

# FOR FURTHER INFORMATION CONTACT:

Mary  G.  Leadbetter,  Center  for  Veterinary  Medicine  (HFV-143),  Food  and  Drug  Administration,  7500  Standish  Pl.,  Rockville,  MD   20855,  301-827-6964.

# SUPPLEMENTARY INFORMATION:

FDA  has  found  that  the  April  1,  2000,  edition  of  Title  21,  Parts  500  to  599  of  the  Code  of  Federal  Regulations  (CFR)  does  not  reflect  revised  assay  limits  for  Type  A  medicated  articles  containing  monensin,  or  sulfadimethoxine  and  ormetoprim  in  combination,  that  were  approved  in  the  new  animal  drug  applications  for  these  drugs.   At  this  time,  FDA  is  amending  the  regulations  to  correct  these  errors  in 21  CFR   558.4.
      ( print page 21862)    
This  is  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.

§  558.4

                    2.   Section  558.4                     *Requirement  of  a  medicated  feed  mill  license*                     is  amended  in  paragraph  (d)  in  the  “Category  I”  table  in  the  entry  for  “Monensin”  in  the  “Assay  limits  percent  type  A”  column  by  removing  “90-110”  and  adding in  its  place “85-115”;  and  in  the  “Category  II”  table  in  both  paired  entries for  “Sulfadimethoxine”  and  “Ormetoprim”  in  the  “Assay  limits  percent  type  A”  column  by  removing  “95-115”  and  in  its  place  adding  “90-110”.                

Dated: April 20, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

[FR Doc. 01-10874 Filed 5-1-01; 8:45 am]

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