SOURCES SOUGHT
A -- Medical Countermeasures against Radiological Threats: Product Development
- Notice Date
- 2/18/2005
- Notice Type
- Sources Sought
- 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
- SS-NIH-NIAID-DAIT-05-37
- Response Due
- 3/7/2005
- Archive Date
- 3/22/2005
- Description
- The Division of Allergy, Immunology, and Transplantation (DAIT), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking capability statements from organizations with technical expertise and facilities to support NIAID in achieving its goal of providing product development of medical countermeasures against radiological threats. DAIT is seeking a contractor to provide a variety of assays to screen for and confirm compound activity, safety pharmacology, and toxicology; use animal models of 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; conduct human safety studies; and formulate and manufacture products under current Good Manufacturing Practices (cGMP). This is a new effort; there is no incumbent. There is an immediate need to move promising medical countermeasures through development and licensure, and into the Strategic National Stockpile, which, currently, includes only a limited number of medications for use following radiation exposure. Few radiation medical countermeasures have been developed to date; therefore, the requirements for investigational new drug application (IND), new drug application (NDA), and/or biologics license application (BLA) submissions and licensure are uncertain and will have to be determined for each product candidate. Of particular note is that it is unlikely that efficacy testing for these products will be done in humans. Therefore, the FDA will rely on information generated from animal efficacy studies done in accordance with Good Laboratory Practices (GLP) regulations to demonstrate efficacy, as described in 21 CFR Pars 314 and 601 ?New Drug and Biological Drug Products: Evidence Needed to Demonstrate Effectiveness of New Drugs when Human Efficacy Studies Are Not Ethical or Feasible.? The final rule is available at: http://www.fda.gov/cber/rules/humeffic.pdf . The Contractor will need to maintain awareness of the evolving regulatory requirements for animal research and with the FDA regulatory guideline for animal studies in support of licensure. 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 proposed contract will not identify or conduct basic research on new medical countermeasures. The NIAID anticipates that products selected by the government for screening, testing, and development will come from industry, academia, and government agencies. This effort will complement these programs by providing the expertise, capabilities, facilities and the full range of product development support services to obtain FDA licensure. This requirement will be awarded as a cost-reimbursement contract with the emphasis being on the contractor?s ability to provide the capabilities and facilities to perform in the below listed major areas. NIAID is aware that no single organization or institution may have the expertise and facilities required to perform all requirements set forth in the Statement of Work. The Offeror must provide information on how they plan to use subcontractors and consultants and the contribution that they will provide. The NIAID does not know the specific number or types of new drugs that will be available for development. New drug candidates could be small molecules or biologicals, therefore, the Contractor should have demonstrated expertise and experience in developing drugs for New Drug Applications (NDA) and Biological Licensure Applications (BLA). The Statement of Work is divided into five (5) major areas: A. Development and Performance of Screening and Efficacy Animals Models B. Chemistry, Manufacturing and Controls Support Services C. Nonclinical Safety Studies for IND/NDA/BLA Submissions D. Clinical Safety and GLP Animal Efficacy Studies for NDA/BLA Submissions E. Program Management and Regulatory Support Offerors will be evaluated on staff and expertise in the above stated areas. It is anticipated that the period of performance for this contract will be a total of five (5) years. Interested Small Business organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. See Numbered Note 25. No collect calls will be accepted. No facsimile transmissions will be accepted. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS SOURCES SOUGHT, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE, NAICS CODE 541710, WITH A SIZE STANDARD OF 500 EMPLOYEES.
- Place of Performance
- Address: To Be Determined
- Zip Code: TBD
- Country: TBD
- Zip Code: TBD
- Record
- SN00754779-W 20050220/050218212554 (fbodaily.com)
- Source
-
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