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FBO DAILY ISSUE OF APRIL 11, 2004 FBO #0867
SOLICITATION NOTICE

A -- RADIOPROTECTION BY 5-ANDROSTENEDIOL (5-AED) IN NON-HUMAN PRIMATES (NHP)

Notice Date

4/9/2004
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

Contracting Office

Other Defense Agencies, Uniformed Services University of the Health Sciences, Directorate of Contracting, 4301 Jones Bridge Road, Bethesda, MD, 20814-4799
 

ZIP Code

20814-4799
 

Solicitation Number

Reference-Number-SDD40001001
 

Response Due

4/26/2004
 

Archive Date

5/11/2004
 

Point of Contact

Beverly Roberts, Contracting Officer, Phone 301-295-3868, Fax 301-295-1716, - Beverly Roberts, Contracting Officer, Phone 301-295-3868, Fax 301-295-1716,
 

E-Mail Address

broberts@usuhs.mil, broberts@usuhs.mil
 

Description

The Uniformed Services University of the Health Sciences (USUHS) and the Armed Forces Radiobiology Research Institute (AFRRI), Bethesda, MD intends to award on a sole source, cost/no-fee contract to Hollis-Eden Pharmaceuticals, Inc., San Diego, CA., to determine whether the new drug product 5-Androstenediol (5-AED) has protective effects against the hematopoietic damage caused by ionizing radiation in Non-Human Primates (NHP). This contract will be awarded in accordance with the authority permitting other than full and open competition in accordance with FAR 6.302-1(b)(2) and 6.302-3(a)(2)(b)(ii) and the Cooperative Research and Development Agreement (CRADA) between AFRRI and Hollis-Eden Pharmaceuticals, Inc. This project is being conducted in support of research into the radioprotective properties of androst-5-ene-3β, 17β-diol (5-AED) and related steroids, which is an integral mission of the Radiation Casualty Management (RCM) Team at the Armed Forces Radiobiology Research Institute (AFRRI). For ethical reasons, this drug cannot undergo efficacy trials in humans since the proposed indication for use is the prevention of mortality from lethal ionizing radiation. The FDA-accepted alternative is described in the new Animal Efficacy Rule (21 CFR Parts 314 and 601; FDA 31May2002). In compliance with this Rule, the contractor will demonstrate the efficacy of this drug product in preventing and/or ameliorating radiation induced morbidity in and enhancing survival of rhesus macaques (non-human primates, NHP). The contractor will select an appropriate NHP experimental model of radiation protection to be used to support FDA submissions for a radioprotectant using 5-AED. This model system will be used for all 3 studies listed below. In addition, the product formulation used in these studies will be the formulation that will be used in subsequent Phase I clinical safety and dosing trials. 1) The contractor will identify the optimal dosing schedule for the product that provides effective radiation protection; 2) The contractor will determine whether amelioration of febrile neutropenia can be used as a surrogate marker for enhancement of survival; 3) The contractor will demonstrate radioprotective efficacy of 5-AED as appropriate to support the FDA requirements under the Animal Efficacy Rule. The Contractor shall submit formal written interim progress reports every three (3) months during the award period of performance to the Contracting Officer?s Representative (COR) that sets forth the technical progress made and that identifies any problems that may have been encountered. These reports should also identify any goals and objectives requiring further effort. In addition, the Contractor shall exchange informal interim updates from time to time as reasonably requested by the COR. The Contractor shall submit a final report to the COR of the results of the activities conducted by the Contractor during the period of performance within one (1) month after completing the projects described above. The format of the final report shall be standard research report format. The report will be prepared and edited under the guidance of the (COR) and the Contractors Regulatory Affairs staff. A copy of the report will be provided to the Contracting Officer?s Representative (COR) and the Contracting Officer. As appropriate, the reports submitted and the data generated from the studies will be used to support FDA submissions for an IND application for 5-AED. The contractor shall provide administrative support as required to ensure successful completion of contract requirements. The contractor shall initiate and administer the appropriate subcontracts with a laboratory equipped to perform good laboratory practice (GLP) studies on NHP to carry out the objectives. 2) Shall coordinate between the subcontractor and AFRRI to carry out the necessary irradiations of NHP in the AFRRI Cobalt Facility. 3) Shall obtain all data from the subcontractor, perform the appropriate statistical analyses, and provide periodic scientific reports to the COR. The Government will provide whole-body gamma-irradiation of NHP brought to AFRRI by the contractor for that purpose, and will also provide the required radiation dosimetry. The Government will provide oversight by the AFRRI Institutional Animal Care and Use Committee (IACUC). The COR or Government personnel associated with the project will also provide weekly or daily guidance to the contractor personnel as needed. The place of performance will be at the contractor?s headquarters (administration and analysis), the subcontractor?s GLP facility (all aspects of experimentation except for irradiations), and AFRRI (irradiations). The period of performance will be one year from the date of award with the option to extend services for four additional one-year periods. The contractor is not authorized travel and per diem expenses under the terms and conditions of this contract. The following provisions apply to this acquisition: FAR CLAUSES and PROVISIONS: 52.216-7, Allowable Cost and Payment (FEB 2002), 52.216-11, Cost Contract - No Fee (APR 1984), 52.217-9, Option to Extend the Term of the Contract (MAR 2000), 52.222-21, Prohibition of Segregated Facilities (FEB 1999); 52.222-26, Equal Opportunity (APR 1984); 52.222-35, Affirmative Action for Disabled Veterans and Vietnam Era Veterans (APR 1998); 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998); 52.222-37, Employment Reports on Disabled Veterans and Veterans of the Vietnam Era (JAN 1999); 52.225-3, Buy American Act Supplies (JAN 1994); 52.225-13 Restrictions on certain Foreign Purchases (FEB 2000); 52.225-21, Buy American Act North American Free Trade Agreement Implementation Act Balance of Payments Program (JAN 1997); 52.232-33, Payment by Electronic Funds Transfer Central Contractor Registration (May 1999); 52.239-1, Privacy or Security Safeguards (AUG 1996). The clauses listed are not all inclusive for cost/no-fee contracts and additional clauses applicable to cost/no-fee contracts may be added at time of contract award or any other clauses the Contracting office deems applicable to the effort. Interested parties may request a copy of the solicitation in writing and/or fax. Requests shall be faxed to 301-295-1716 or mailed to USUHS, Directorate of Contracting, A1040C, Attn: Beverly Roberts, 4301 Jones Bridge Road, Bethesda, MD 20814-4799. RESPONSES FOR THE SOLICITATION PACKAGE ARE DUE BY APRIL 26, 2004.
 

Place of Performance

Address: 4301 Jones Bridge Raod, Bethesda, MD

Zip Code: 20814-4799

Country: United States
 

Record

SN00563514-W 20040411/040409212557 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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