JUSTIFICATION APPROVAL FOR CIPROFLOXACIN FOR ODS 18 JAN 91

File: 970107_sep96_decls58_0003.txt
Page: 0003
Total Pages: 6

Subject: JUSTIFICATION  APPROVAL FOR CIPROFLOXACIN FOR ODS  18 JAN 91    

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: APPROVAL FOR ANTIBIOTIC CIPROFLOXACIN FOR DESERT SHIELD                                         

Document Number:       1001

Folder Seq  #:          6





                                                  Antibiotic Ciprofloxacin
                                                  DAMD17-91-C-1032




                               JUSTIFICATION AND APPROVAL
                       FOR OTHER THAN FULL AND OPEN COMPETITION



         1. Contractina Aaency - U.S. Army Medical Research and
         Development Command, Fort Detrick, Frederick, MD 21702-5012.

         2. Descri-otion of Action - The acquisition is for a new firm-
         fixed-price type contract utilizing OMA funds. A letter contract
         was awarded 06 December 1990. Definitization of the letter
         contract was completed 04 January 1991.

         3. Description of Supplies/Services - Thirty million 500 mg.
         tablets of the antibiotic ciprofloxacin will be acquired, with the
         option to purchase an additional thirty million tablets. The
         total contract value, including the option, is $90 million. The
         price per tablet is $1.50.

         4. Authority Cited - This action is authorized under 10 U.S.C.
         2304(c)(2), unusual and compelling urgency (as implemented by FAR
         6.302-2).

         5. Reason for Authority Cited -


             a. To date, diarrhea has been the most common medical problem
         encountered during Operation Desert Shield. Between 2-5 percent
         of troops in the Operation visit health care facilities every week
         for diarrhea; however, only 20 percent of persons are presenting
         themselves for treatment, thus approximately 20,000 cases per week
         are occurring. The problem will become worse as more new forces
         are deployed, and the present cool weather subsides. A common
         form of diarrhea, in the geographic area, is resistant to all
         commonly used antibiotics except ciprofloxacin. The required
         delivery schedule  of tablets for treatment is as follows:

                  5,000,000                11 Dec 90
                  5,000,000                18 Dec 90
              5,000,000                21 Dec 90
                  5,000,000                03 Jan 91
                  5,000,000                15 Jan 91
                  5,000,000                22 Jan 91

             b. The contractor is Miles,    Inc., West Haven, CT, the only
         pharmaceutical firm in the U.S. licensed by the Food and Drug
         Administration (FDA) to produce ciprofloxacin.

         6. Efforts to Obtain Competition

             a. There are no other FDA licensed producers of
         ciprofloxacin; accordingly, no effort was made to solicit offers
         from other sources. Deployment of vaccines and drugs not licensed

                                              2

Document 6 f:/Week-36/BX003201/APPROVAL FOR ANTIBIOTIC CIPROFLOXACIN FOR DESERT SHIELD/justification approval for ciprofloxacin for od:01029715474559
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = APPROVAL FOR ANTIBIOTIC CIPROFLOXACIN FOR DESERT SHIELD
Folder Seq # = 6
Subject = JUSTIFICATION APPROVAL FOR CIPROFLOXACIN FOR OD
Document Seq # = 1001
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 02-JAN-1997