Notice Number: NOT-AI-06-020

Key Dates
Release Date: February 21, 2006
Receipt Date: July 14, 2006 at 3:30 P.M. EST

Update: The following update relating to this announcement has been issued:

• March 21, 2006 (NOT-AI-06-027) - Notice to announce modifications of the proposal due date and ARTICLE H.1 HUMAN SUBJECTS for RFP-NIH-NIAID-DMID-07-13.

Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

The Bacteriology and Mycology Branch (BMB), Division of Microbiology and Infectious Diseases (DMID), National Institutes of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) is seeking contractors interested in advancing the field of contemporary clinical laboratory diagnostics for Invasive Aspergillosis (IA).

It is anticipated that up to one (1) cost-reimbursement, incrementally-funded, completion type contract will be awarded for a period of seven (7) of years, beginning approximately May 4, 2007 . RFP NIH-NIAID- DMID-07-13 will be available electronically on or about February 15, 2006, and may be accessed at http://www.niaid.nih.gov/contract/rfps.htm or http://www.fedbizopps.gov/. Only electronic copies of the solicitation will be available. All information required for the submission of an offer will be contained in the solicitation. Responses to this RFP will be due approximately July 15, 2006 (Update: new proposal due date and time will be July 14, 2006 at 3:30 P.M. EST).

DMID intends to solicit this project under full and open competitive procedures under NAICS 541710. It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 7-year period of performance beginning on or about May 4, 2007, with an anticipated total effort of approximately 6.75 total FTEs. Diagnosis and treatment of serious fungal infections are high priorities of the NIAID. Systemic fungal infections are a significant health problem in immunocompetent hosts (the endemic mycoses) and immunocompromised hosts (the opportunistic mycoses in addition to the endemic mycoses). The burden of invasive fungal disease in the U.S. has shifted from the community to the hospital base. These are recognized as important emerging infectious diseases, especially in nosocomial settings involving the management of bone marrow and solid organ transplant recipients, neutropenic cancer patients, and surgical, trauma and critical care patients. Fungi cause approximately ten percent of nosocomial bloodstream infections. This contract will link the appropriate clinical specimens (e.g., blood, urine) from subjects at risk for IA and potentially interfering medical conditions to currently available and experimental laboratory tests for the purposes of diagnostic proof of principle, test comparison, and evaluation of the effect of potentially interfering medical conditions (pathologies/interventions), unrelated to IA, on the performance of the diagnostic test. It is expected that these goals be achieved through the establishment and maintenance of a repository of clinical samples from patients at risk for IA and by performing evaluation and comparison studies between FDA-cleared tests for IA and experimental IA diagnostic tests. Offerors are required to demonstrate relevant experience in establishing and operating a clinical sample repository in accordance with the Office for Human Research Protections (OHRP) guidelines, access to human subjects at high risk for developing Invasive Aspergillosis that must include subjects receiving hematopoietic stem cell transplantation therapy and subjects at high risk for IA with potentially interfering medical conditions that must also include subjects receiving hematopoietic stem cell transplantation therapy, personnel with experience in Good Clinical Practices (GCP) and collection of samples from human subjects, personnel with experience in Good Laboratory Practices and diagnostic test development, and adequate facilities. It is expected that these goals be achieved through the establishment and maintenance of a repository of clinical samples from patients at risk for IA and by performing evaluation and comparison studies between FDA-licensed tests for IA and experimental IA diagnostic tests. Offerors will be evaluated against the adequacy of their training, experience, expertise and availability of the proposed PI, including technical and management skills, knowledge of applicable regulations to manage a GCP and GLP compliant clinical sample repository and ability to direct GLP compliant test studies along with personnel that have appropriate GCP and GLP training. Offerors should have access to patient populations at risk for Invasive Aspergillosis (IA) such that it is highly probable that serial clinical samples will be collected from a minimum of forty-five (45) subjects diagnosed with proven IA and a minimum of forty-five (45) subjects diagnosed with proven IA with potenitially interfering medical conditions during the first three years of the contract. Offerors will be asked to provide a cost-effective plan for obtaining and storing samples from subjects at risk for developing IA and provide documented evidence of all collaborations/consortiums that will be formed to collect and/or store specimens. Patient populations must include subjects receiving hematopoietic stem cell transplantation therapy and may also include neutropenic cancer patients, and solid organ transplant recipients.

Your proposal should address staff expertise in the collection of clinical research samples and medical information in a GCP compliant manner along with an understanding of the OHRP guidelines for the operation of a repository. It is expected that offerors have experience in the storage, retrieval and distribution of samples and would be expected to provide personnel, facilities (e.g., clean rooms, laboratories, storage area), and equipment (e.g., freezers, refrigerators) available for preparing the samples and the repository, along with a system that will be used to track samples in the repository. Offerors should have an understanding of Federal, State and international shipping regulations, validation testing for cold chain shipping containers, preparation of SOPs based on the results of validation testing, preparation of all shipping documents, preparation of SOPs for the receipt and proper storage of clinical samples, experience in the techniques used in published laboratory tests available to detect Aspergillus fumigatus, including PCR and other technologies that could potentially be used to develop IA diagnostic tests, expertise in performing and interpreting the results from the Bio-Rad PlateliaTM Aspergillus EIA test, and access to samples required for replication studies (IA animal model or samples from previous IA clinical studies).

Any responsible Offeror may submit a proposal that will be considered by the Government, however, this notice does not commit the Government to the award of a contract. No collect calls will be accepted. No facsimile or e-mail transmissions will be accepted. See Government-wide Numbered Note 26.

Inquiries

For questions or further information, contact:

Brenda Lee
Contract Specialist
A Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive , Rm. 3214, MSC 7612
Bethesda , MD 20892-7612 (Express Mail: Use Zip Code 20817-7612)
Phone: 301-402-2443
Fax: 301-480-2622
E-mail BLee@niaid.nih.gov

Ross Kelley
Contracting Officer
A Office of Acquisitions, DEA, NIAID, NIH, DHHS
6700-B Rockledge Drive , Rm. 3214, MSC 7612
Bethesda , MD 20892-7612 (Express Mail: Use Zip Code 20817-7612)
Phone: 301-402-2234
Fax: 301-480-5253
E-mail: rk17a@nih.gov