A -- DEVELOPMENT OF A HEMOSTATIC DRESSING

Notice Date

October 26, 2000

Contracting Office

Director, USAMRAA, 820 Chandler St, Fort Detrick, MD 21702-5014

ZIP Code

21702-5014

Solicitation Number

DAMD17-01-R-0002

Point of Contact

Cheryl R. Miles, Tel: 310-619-7148; Fax: 301-619-3166

E-Mail Address

Click here to contact the Contracting Office (cheryl.miles@amedd.army.mil)

Description

The U.S. Army Medical Research and Materiel Command (USAMRMC) intends to award a contract for a development of a hemostatic dressing (HD) that controls potentially fatal hemorrhage. The overall objective of this RFP is to develop an FDA approved hemostatic dressing (HD) that, when applied using direct pressure, is intended to provide enhanced hemorrhage control in wounds with severe, life-threatening arterial, venous, and/or diffuse bleeding. A product to control minor or oozing hemorrhage is not being sought. The AMEDD is soliciting proposals to fund one or more manufacturers who are actively developing or marketing hemostatic dressings. Technical Objectives of this program include, but are not limited to a HD: (1) that utilizes any combination of hemostatic materials composed of biologically compatible components that can be used for internal and external casualty sites. If human blood components are utilized, they must be treated to inactivate potential blood borne pathogens including viruses; (2) that will develop a strong, durable clot at the bleeding site within two minutes or less when properly applied with appropriate pressure and provide a surface area equivalent to a 4"X4'" bandage; (3) that does not require mixing or combining of ingredients prior to use; (4) with a shelf life of three years or longer; (5) that does not require refrigerated storage; (6) that is capable of being affixed to a wound by hand; (7) that is capable of being individually packaged to retain sterility, be moisture proof and crush proof and permit survival in a field environment, will survive exposure to -30 to 150 degrees f. and function from 35 to 120 degree Fahrenheit; (8) with a support structure that is strong enough to prevent puncture or tearing by fingers after application. It is anticipated that any product selected will require non-clinical (animal) trials prior to the initiation of human safety and efficacy testing. Following the completion of any necessary animal trials, USAMRMC will provide assistance to the contractor in the preparation of protocols and other FDA required documentation necessary for initial clinical testing using prior informed consent required for elective surgery indication. This may be followed by a second series of clinical trials for trauma treatment. The Contractor shall develop a real time shelf life protocol and conduct real time shelf life testing acceptable to the FDA to validate a shelf life of at least three years for the dressing when stored at 35 -- 120 degrees Fahrenheit. The Contractor shall prepare the Chemistry, Manufacturing, and Control Data (CMC) section for the new Investigational New Drug Application for the HD and submit to the FDA the Biologics License Application (BLA) required for FDA licensure for human use for the HD. The Government anticipates the award of one or more 5-year term contracts. The RFP will be released on or about 20 November 2000 and may be accessed on the Internet at http://www-usamraa.army.mil. Interested parties may submit written requests to Director, U.S. Army Medical Research Acquisition Activity, ATTN: Ms. Cheryl Miles, Fort Detrick, MD 21702-5014 via mail, fax or email. Telephone requests will not be honored. Proposals are expected 45 days after release of the RFP.

Web Link

U.S. Army Medical Research Acquisition Activity (http://www-usamraa.army.mil)

Record

Loren Data Corp. 20001030/ASOL006.HTM (W-300 SN5052B4)