MODIFICATION
A -- Medical Countermeasures against Radiological Threats: Product Development Support Services
- Notice Date
- 4/27/2005
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-NIAID-DAIT-05-37
- Response Due
- 6/10/2005
- Archive Date
- 6/25/2005
- Point of Contact
- Carl Newman, Contract Specialist, Phone 301-496-8371, Fax 301-480-5253, - Paul McFarlane, Senior Contracting Officer, Phone 301-496-0349, Fax 301-402-0972,
- E-Mail Address
-
CNewman@niaid.nih.gov, pm24v@nih.gov
- Description
- The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) has a requirement for technical expertise and facilities to support NIAID in achieving its goal of providing product development of medical countermeasures against radiological threats. A variety of assays will be necessary to screen for and confirm compound activity, safety pharmacology, and toxicology. In addition, the use of animal models will be necessary in radiation injury, protection, therapy, or recovery to provide mechanistic, safety, and animal efficacy data to support FDA approval for human use when it is not ethical to perform human efficacy studies. Further human safety studies will be conducted. In addition another requirement will be to formulate and manufacture products under current Good Manufacturing Practices (cGMP). Products and compounds submitted for evaluation will include prophylactic agents or radioprotectors that must be given before radiation exposure, radiation mitigators that reduce the potential severity of the injury, and radiation therapeutics that are given after overt symptoms develop. The Statement of Work is divided into Six (6) major areas: A. Project Management, Data Management and Statistical Analysis and Administrative Support B. Development and Performance of Animal Models for Screening and Efficacy Testing Including GLP Animal Efficacy Under The FDA Animal Rule C. Chemistry, Manufacturing and Controls (CMC) Support Services D. Nonclinical Safety Studies for Investigational New Drug Application (IND)/New Drug Application (NDA/Biologics License Application (BLA) Submissions E. Phase I Clinical Safety and Pharmacology Testing F. Transition Plan It is anticipated that one (1) cost-reimbursement, completion type contract with work assignments will be awarded for a period of five (5) years beginning September 30, 2005. This is a new effort; there is no incumbent. RFP-NIH-NIAID-DAIT-05-37 will be available electronically on or about April 12, 2005 and may be accessed through the NIAID Contract Management Program (CMP) Home Page by using the following electronic address and instructions: NIAID/CMP Home Page (via the WWW): Use http://www.niaid.nih.gov/contract to access the NIAID/CMP Home Page. Once at the NIAID/CMP Home Page, click on the ?RFPs? link and then click on ?RFP NIH-NIAID-DAIT-05-37.? Please note that the RFP has been revised to include only the Work Statement, Notes, to Offerors, Deliverable and Reporting Requirements, Technical Evaluation Criteria, and the specific RFP instructions and provisions. All information required for the submission of an offer will be contained in the electronic RFP package. Responses to this RFP will be due on or about June 13, 2005. Any responsible Offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. See Government-wide numbered note 26. No facsimile transmissions will be accepted.
- Place of Performance
- Address: To Be Determined
- Zip Code: TBD
- Country: TBD
- Zip Code: TBD
- Record
- SN00796529-W 20050429/050427211727 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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