SOLICITATION NOTICE
A -- Assessing Safety of Cell Substrates and Vaccine Components
- Notice Date
- 10/14/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700 B Rockledge Room 2230 MSC7612, Bethesda, MD, 20892-7605
- ZIP Code
- 20892-7605
- Solicitation Number
- NIH-NIAID-DMID-04-22
- Response Due
- 1/22/2004
- Archive Date
- 2/6/2004
- Point of Contact
- Paul McFarlane, Senior Contracting Officer, Phone 301-496-0349, Fax 301-402-0972, - Paul McFarlane, Senior Contracting Officer, Phone 301-496-0349, Fax 301-402-0972,
- E-Mail Address
-
pm24v@nih.gov, pm24v@nih.gov
- Description
- The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) has a requirement to solicits proposals for the development, characterization and validation of in vitro assays and in vivo animal models to assess the safety of cell substrates and vaccine components that are being considered for use in vaccine manufacturing. The need for contemporary in vitro assays and in vivo animal models has arisen from 1) the development of vaccine candidates that can only be grown in cell substrates and/or require use of excipients or adjuvants that have not previously been used to manufacture licensed vaccines, and 2) previously unrecognized theoretical safety questions. For example, few tests are available to specifically assess certain safety issues that are unique to new cell substrates. These issues include tumorgenicity of the whole cell substrate, oncogenicity of the cellular DNA, and the detection of latent/occult adventitious agents in the cell substrate. Experimental data are needed regarding these issues in order for manufacturers and regulatory agencies to meaningfully assess and analyze the safety of vaccines manufactured in these new cell substrates. The focus of this RFP is to develop both in vitro assays and in vivo animal models to assess current and future safety concerns that arise regarding vaccines and vaccine manufacturing and/or formulation, including 1) assessing the tumorgenic potential of cell substrates; 2) assessing the oncogenic potential of cell substrate DNA; and 3) screening for latent/occult adventitious agents in cell substrates. This acquisition comprises five separate parts, each focusing on a specific area of in vitro assay development or in vivo animal model development: Part A: Develop, characterize and validate in vivo animal model(s) to assess tumorgenic potential of cell substrates. Animal models will be developed to assess the tumorgenic potential of live cells themselves. Part B: Develop, characterize and validate in vitro assays to assess and characterize tumorgenic potential of cell substrates. In vitro assays will be developed to assess the tumorgenic potential of live cells themselves. In vitro assays will also be developed to identify markers of cellular immortalization/transformation. Part C: Develop, characterize and validate in vivo animal models to analyze the oncogenic potential of cellular DNA. Animal models will be developed to assess the risk of cell substrate DNA itself having oncogenic potential. Part D: Develop, characterize and validate in vitro assays to analyze the oncogenic potential of cellular DNA. In vitro assays will be developed to assess the risk of cell substrate DNA itself having oncogenic potential. Part E: Develop, characterize and validate assays for detection of novel or latent/occult adventitious agents in cell substrates. Assays will be developed to screen for infectious agents that are not detected by currently used adventitious agent tests. This will include development of assays to assess the potential for cell substrates to harbor and transmit TSEs. Additionally, Offerors may propose a single in vivo animal model, multiple in vivo animal models, a single in vitro assay or multiple in vitro assays for each Part of this solicitation. However, each proposed animal model and/or assay must be tested using two cell substrates. The development process for both in vitro assays and in vivo animal models will consist of two stages. The first stage will be to determine the general feasibility, utility and sensitivity of the in vitro assay and in vivo animal model. Upon completion of the first stage, the results will be analyzed, and those in vitro assays and in vivo animal models deemed promising by the government will be selected for validation ? the second stage of development. Validation will be conducted in accordance with the most current U.S. Food and Drug Administration (FDA) and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines. Links to the most current information concerning validation can be found on the FDA website http://www.fda.gov/, and the ICH website http://www.ich.org/ich5.html. To the extent possible, efforts should focus on applying existing technologies, reagents, techniques, and animal strains to animal model development. For example, proposals to develop assays for in vitro analysis of the oncogenic potential of live cells could include a more thorough development and validation effort of the currently used growth in soft agar assay. The use of currently available animal strains, rather than the development of new animal strains (i.e., new knockout mice) is strongly encouraged. Furthermore, it is expected that the animals used in model development will be rodent models, such as mouse, rat or hamster. However, proposals to use other types of animals, either rodent of non-rodent, will be acceptable and considered. Offerors may respond to any or all of Parts A, B, C, D, and E; however, a separate technical and business proposal must be submitted for each Part. Tasks encompassed under Parts B and D, including validation, must be completed within thirty-six (36) months from the date of award. Tasks encompassed under Parts A, C, and E, including validation, must be completed within sixty (60) months from the date of award. This acquisition has total available funding in the amount $3,000,000 per year for all contracts awarded under this solicitation. It is anticipated that two to five (2-5) cost-reimbursement, completion type contracts will be awarded for a three to five (3-5) year period, beginning on or about September 30, 2004. RFP NIH-NIAID-DMID-04-22 will be available electronically on or about October 20, 2003, and may be accessed through the NIAID Contract Management Branch (CMB) Home page by using the following electronic address and instructions: NIAID/CMB Home Page (via www): Use http://www.niaid.nih.gov/contract to access the NIAID/CMB Home Page. Once at the NIAID/CMB Home Page, click on the "RFPs" link and then click on "RFP NIH-NIAID-DMID-04-22." Please note that the RFP for this acquisition only includes the work statement, deliverable and reporting requirements, special requirements, the technical evaluation criteria, and the proposal preparation instructions and provisions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due approximately January 22, 2004. Any responsible offeror may submit a proposal which will be considered by the Government. This advertisement does not commit the Government to award a contract. See Government wide Numbered Note 26. No collect calls will be accepted. Point of Contact: Yvette R. Brown, Contract Specialist, Phone (301) 451-3686, FAX (301) 480-5253, Email: ybrown@niaid.nih.gov - Paul McFarlane, Senior Contracting Officer, Phone (301) 496-0349, FAX (301) 402-0972, email: pm24@nih.gov.
- Record
- SN00451955-W 20031016/031014213125 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |