SOLICITATION NOTICE
A -- Biological Testing Facility
- Notice Date
- 10/3/2008
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-CPR-09-05
- Point of Contact
- Katharine R Minker,, Phone: 301-402-7571, Ross Kelley,, Phone: 301-435-6960
- E-Mail Address
-
km571@nih.gov, rk17a@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) intends to solicit proposals to recompete its contract for a Biological Testing Facility through full and open competitive procedures under NAICS 541712. It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 5-year period of performance beginning on or about, 4/16/2009. The contractor will perform assays on hundreds of submissions annually for classical endocrine and anti-fertility activity and establish potency ratios (in terms of standards) for those that exhibit significant effects. The contractor will also develop methods for determining the duration of biological activity following oral, subcutaneous and topical (transdermal, transvaginal, etc) administration and to evaluate the potential clinical utility of new compositions of matter and formulations. The contractor will be required to perform a wide range of screens, assays, safety tests and analytical procedures for the evaluation of new compounds, formulations and delivery systems. In addition, this project will also require the following: 1. Work conducted in a BSL2 facility. 2. An AAALAC-accredited animal facility. 3. Toxicology studies, including acute, subacute, subchronic, chronic, reproductive and genetic, may be undertaken in-house or through subcontracts. 4. Rabbit vaginal irritation testing for the evaluation of formulations of spermicides and microbicides to include both gross and histopathological examination of external genitalia and cervix. Services of a board certified pathologist are required for performance of both gross and microscopic examinations. This test is usually performed under "Good Laboratory Practices" (GLP) Guidelines so that, if necessary, the results may be submitted to the FDA in support of a Notice of Claimed Investigational Exemption for a New Drug (IND) initiation of clinical investigations. New compounds and/ or formulations must have an IND before clinical work can proceed. 5. Contraceptive efficacy tests required to predict clinical activity of potential contraceptives. Dose-response and time related efficacy curves must be provided for comparison with various standards. 6. Growth and maintenance of cell cultures for the conduct of in vitro assays required for evaluation of compounds. Theses assays include, but are not limited to, transfection of specific cell lines with estrogen and progesterone receptor expression plasmids and appropriate reporter constructs. These in vitro tests will permit a more thorough exploration of tissue-specific effects of a number of steroids, their antagonists, and other compounds exhibiting antifertility activities. The RFP will be available electronically on or about October 17, 2008 and may be accessed through the FedBizOpps. All responsible sources may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=f8687e785ee69ba97a034c62983b30ad&tab=core&_cview=1)
- Record
- SN01688202-W 20081005/081003221933-f8687e785ee69ba97a034c62983b30ad (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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