NEWS
04/06/1993

<TITLE>MUHAMMAD Z. MANNAN; DEBARMENT ORDER</TITLE>
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[DOCKET NO.  92N-0466]

                      MUHAMMAD Z. MANNAN; DEBARMENT ORDER


ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is issuing an order under      
section 306(a)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21     
U.S.C. 335a(a)(2)) permanently debarring Mr. Muhammad Z. Mannan, 111 Port       
Ave., Ronkonkoma, NY 11779, fromm providing services in any capacity to a       
person that has an approved or pending drug product application.  FDA bases     
this order on a finding that Mr. Mannan was convicted of a felony under         
Federal law for conduct (1) relating to the development and approval,           
including the process for development and approval, of a drug product; and (2)  
relating to the regulation of a drug product under the act.  Mr. Mannan has     
failed to request a hearing and, therefore, has waived his opportunity for a    
hearing concerning this action.

EFFECTIVE DATE:  April 6, 1993.

ADDRESSES:  Application for termination of debarment to the Dockets Management  
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,   
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
Jean M. Olson,
Center for Drug Evaluation and Research (HFD-366),
Food and Drug Administration,
7500 Standish Pl.,
Rockville, MD 20855,
301-295-8041.


[DOCKET NO.  93N-0129]

  DRUG EXPORT; ORTHO BLOOD GROUPING REAGENTS ANTI-C, ANTI-E, ANTI-c. ANTI-e,
              ANTI-K: (MONOCLONAL); CONTROL, ORTHO BIOVUE SYSTEM


ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing that Ortho       
Diagnostics Systems, Inc., has filed an application requesting approval for     
the export of the biological product Blood Grouping Reagents Anti-C, Anti-E,    
Anti-c, Anti-e, Anti-K: (Monoclonal); Control, Ortho BioVue System to           
Australia, Austria, Belgium, Canada, Denmark, Federal Republic of Germany,      
Finland, France, Iceland, Ireland, Italy, Luxembourg, The Netherlands, New      
Zealand, Norway, Portugal, Spain, Sweden, Switzerland, and The United Kingdom.

ADDRESSES:  Relevant information on this application may be directed to the     
Dockets Management Branch (HFA-305), Food and Drug Administration, Rm. 1-23,    
12420 Parklawn Dr., Rockville, MD 20857, and to the contact person identified   
below.  Any future inquiries concerning the export of human biological          
products under the Drug Export Amendments Act of 1986 should also be directed   
to the contact person.

FOR FURTHER INFORMATION CONTACT:
Frederick W. Blumenschein,
Center for Biologics Evaluation and Research (HFM-660),
Food and Drug Administration,
5600 Fishers Lane,
Rockville, MD  20857,
301-295-9070.


[DOCKET NO.  93N-0092]

              ANIMAL DRUG EXPORT; BACITRACIN ZINC TYPE A ARTICLE


ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing that Archer      
Daniels Midland Co. has filed an application requesting approval for export to  
21 countries of bacitracin zinc Type A medicated article for use in chicken,    
turkey, and swine feeds.

ADDRESSES:  Relevant information on this application may be directed to the     
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,    
12420 Parklawn Dr., Rockville, MD 20857, and to the contact person identified   
below.

FOR FURTHER INFORMATION CONTACT:
Charles J. Andres,
Center for Veterinary Medicine (HFV-128),
Food and Drug Administration,
7500 Standish Pl.,
Rockville, MD 20855,
301-295-8602.

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