SOURCES SOUGHT
A -- Services for Pre-Clinical Development of Therapeutic Agents
- Notice Date
- 7/5/2005
- 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
- RFP-NIH-NIAID-DMID-06-09
- Response Due
- 7/18/2005
- Archive Date
- 8/2/2005
- Description
- 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 RESPONSES 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. The Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), NIH, DHHS, is conducting a market survey to determine the availability and capability of firms able to establish an NIAID resource to provide services for activities commonly associated with preclinical development of therapeutic agents, including those activities required for the submission of Investigational New Drug (IND) applications. While the overall suite of services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of product candidates, rather than carry a single product candidate through an entire preclinical development pathway. One award is expected to be made in response to this solicitation. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the preclinical development services set forth in the Statement of Work and, consequently, that the Contractor may need to utilize the expertise and resources of subcontractors to perform the tasks required. Therefore, the services to be provided under the contract shall be performed either directly by the Contractor or indirectly through subcontractors. At a minimum, the Contractor will be required to:1) provide an infrastructure for the overall technical and administrative management; 2) provide the personnel, equipment, technical expertise, and infrastructure either at their own facilities or identify qualified subcontractors; 3) solicit for and evaluate subcontract proposals, and execute, manage and assess subcontractor performance; 4) retain all records, samples, histopathological slides, etc., as indicated by GLP and cGMP guidelines; 5) maintain awareness of evolving regulatory requirements for preclinical evaluations of therapeutic agents; 6) arrange for site visits and independent audits, as needed or as requested by the NIAID Project Officer; 7) develop and/or submit to NIAID, Standard Operating Procedures (SOPs) for any of the assays, processes, procedures, etc. performed by the Contractor or a subcontractor in the execution of this contract; 8) participate as necessary in discussion with the FDA during pre-IND, IND, pre-new drug application (NDA), and pre-biologic license application (BLA) meetings; and 9) provide an orderly transition to a successor contractor or to the United States Government at the end of the contract. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractor(s). Mandatory qualification criteria. Mandatory Criterion #1: The Offeror must document access to BSL2 and 3 facilities. Mandatory Criterion #2: The Offeror must document access to an AAALAC-accredited (or equivalent) animal facility and the capacity (appropriate cage space, etc.) for In Vitro and In Vivo Preclinical Safety, Toxicology, and Biokinetics Services. To assess capacity, assume the following studies involving animals will be done each year: (a) toxicology and pharmacokinetic studies for one compound per year under GLP: acute and oral intravenous (iv) toxicity and pharmacokinetics (PK) studies in rats; acute oral toxicity and PK studies in dogs; 14 day oral toxicity study in rats with toxicokinetics; 14 day oral toxicity study in dogs with toxicokinetics; and (b) reproductive toxicity testing of two compounds per year. Mandatory Criterion # 3: The Offeror must document prior successful completion and submission to the FDA of preclinical studies performed under GLP by the Offeror or proposed subcontractors as required to fulfill the services included in the Statement of Work that require studies/assays to be performed according to GLP guidelines. Include an indication of FDA acceptance of studies. Potential Sources must also demonstrate and document the following abilities: (1) Experience in providing preclinical development services and resources for therapeutic agents in the following five (5) categories: (a) lead identification and development services; (b) chemistry and manufacturing services; (c) in vitro microbiological services; (d) in vitro and in vivo preclinical safety, toxicology, and biokinetics services; and (e) preclinical development planning and evaluation services. (2) Demonstrated understanding of and experience with regulatory requirements for preclinical activities leading to submission of INDs; appropriate quality assurance/quality control methods; ability to define milestones and approaches to tracking progress toward milestone achievement; and knowledge of problems/obstacles likely to occur at various stages of preclinical therapeutic development and proposed approaches for addressing such problems/obstacles. (3) Demonstrated experience with: a. receiving, formatting, storing and shipping compounds and biological agents: b. technology transfer processes: c. shipping, handling and storing pathogens or toxins that require select agent registration; and d. providing and evaluating preclinical product development plans for therapeutic agents for which the Animal Efficacy Rule (21CFR Parts 314 and 601) may impact the licensure path. (4) Experience working with potential biohazards, toxic chemicals, and radioisotopes; and adequacy of the plan for training, implementation, and monitoring of safety procedures. (5) Demonstrated experience to oversee, coordinate, integrate and manage work performed including activities carried out under subcontracts. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit two (2) copies of their capability statement addressing the areas above, to be received no later than 3:30 PM local time on July 18, 2005, to the attention of Erin Goldstein at the address listed above. See Government-wide Numbered Note 22. NO COLLECT CALLS WILL BE ACCEPTED. FACSIMILE AND E-MAIL TRANSMISSIONS WILL BE ACCEPTED. Point of Contact Erin Goldstein, Contracting Officer, Phone 301-496-6423, Fax 301-480-0972, Email eg108r@nih.gov; Lawrence Butler, Acting Branch Chief, Phone 301-496-0195, Fax 301-402-0972, Email LButler@niaid.nih.gov
- Record
- SN00841244-W 20050707/050705211716 (fbodaily.com)
- Source
-
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