SOURCES SOUGHT
B -- RECOVERY--Assays of Biological specimens for Division of Epidemiology, Statistical and Prevention Research (DESPR)
- Notice Date
- 1/13/2010
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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-DESPR-SBSS-2010-05
- Archive Date
- 2/10/2010
- Point of Contact
- Lynn L Salo, Phone: 301-435-6962, Elizabeth D Osinski, Phone: 301-435-6947
- E-Mail Address
-
ls59u@nih.gov, eo43m@nih.gov
(ls59u@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Purpose of this Announcement: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; 8(a) small businesses, veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541380 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is $12M in annual receipts per year. Background and Project Requirements: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to obtain laboratory analysis of biospecimens collected in numerous NICHD research studies. It is anticipated that any resultant contract(s) will be Indefinite Delivery Indefinite Quantity (IDIQ) type contract and will include at least one Task Order in support of the National Standard for Normal Fetal Growth study that will be applicable to RECOVERY ACT funding. Potential sources must demonstrate and document experience in conducting the following assays that are anticipated: a) Reproductive hormones (including testosterone, estrone, estradiol, estriol, quantitative hCG, inhibin-A) in serum/plasma, urine and saliva; sex hormone binding globulin in serum/ plasma; b) Phytoestrogens, including Genistein, Daidzein, o-Desmethylangolensin, Enterodiol, and Enterolactone, in urine; c) Stress hormones (including cortisol, ACTH, CRH, alpha-amylase) in serum/plasma, urine and/or saliva; d) Protein hormones (including parathyroid hormone, insulin, C-peptide, prolactin, IGF1, IGF-2, IGFBP-2) in serum/plasma and urine, as appropriate; e) Targeted and global metabolomics in serum or plasma; f) Proteomic analysis of semen, serum and urine; g) Enzymatic (glucokinase) assay for 1,5-anhydroglucitol (1,5-AG) in whole blood; h) Angiogenesis-related compounds (including placental growth factor, soluble endoglin, soluble vascular endothelial growth factor receptior-1 (sFlt-1)) in serum; placental growth factor in urine; i) Nutritional biomarkers (including alpha- and beta-carotene, lycopene, zeaxanthin plus lutein, retinol, retinol binding protein 4, beta-cryptoxanthin, 25 hydroxy-vitamin D, ferritin, transferrin receptor) in serum/plasma; j) Urinary 8-iso-prostaglandin F2 and microalbumin; k) Cytokines and inflammatory markers (including, but not limited to TNF-alpha, IL1-beta, IL-6, IL-8 and high-sensitivity CRP) in serum, urine and cervical or vaginal fluid as appropriate; l) Adipokines and related substances (including soluble leptin receptor, leptin, resistin, adiponectin, HMW-adiponectin, visfatin, incretin, GLP-1, ghrelin) in serum/plasma; m) Cotinine in plasma/serum, urine, hair or other matrices as specified; n) Amplification, high-throughput sequencing, genus/species identification and phylogenetic analysis of DNA for bacterial 16 S ribosomes and/or chaperonin-60 in vaginal wash specimens, and in gingival crevicular fluid preserved in filter paper and frozen; o) SNP genotyping of previously collected and prepared DNA samples; p) Extraction and amplification of DNA from salivary samples; identification of polymorphisms in genes (to be specified) relating to obesity, diet, physical activity, substance use, and aggression; q) Conduct of small (n=20) genome-wide association studies of children with rare syndromes. Analysis to include polymorphisms of copy number variants. DNA will have been previously extracted and amplified; r) DNA methylation in 20 candidate genes and global methylation, including DNA extraction from buffy coat; s) Global gene expression including RNA extraction; t) Bisphenol-A and metabolites; phthalates and metabolites, in urine; u) Polychlorinated biphenyl congeners in serum; v) Organochlorine pesticides (including hexachlorobenzene, gamma-HCH, beta-HCH, oxychlordane, trans-nonachlor, trans-chlordane, cis-chlordane, cis-nonachlor, para, para-prime-DDT, para, para-prime-DDE, para, para-prime-DDD, ortho, para prme-DDT, mirex) in serum; w) PBDE congeners (including numbers 18, 47, 99, 100, 153, 154, and 209) in serum; x) Perfluorinated compounds (including PFOS, PFOA, PFOSA, PFHxS, PFHpA, PFNA, PFDA, PFUnDA, and PFDoDA) in serum; y) Complete urine panel of metals (arsenic (As), barium (Ba), beryllium e), cadmium (Cd), cobalt (Co), chromium (Cr), cesium (Cs), copper (Cu), manganese (Mn), lybdenum (Mo), nickel (Ni), lead (Pb), platinum (Pt), antimony (Sb), tin (Sn), tellurium (Te), llium (TI), uranium (U), vanadium (V),tungsten (W), and zinc (Zn). Anticipated Period of Performance: The anticipated period of performance of the base contract is five years, from September 2010 to September 2015. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the following criteria. Small Business organizations must submit Capability Statements in response to this notice and these will be evaluated against the following technical areas of experience and expertise: 1. Documentation of CLIA (Clinical laboratory Improvement Amendments 1988) certification and a CLIA-approved proficiency testing program. 2. Documentation of capability and previous experience performing all the assays noted above. 3. For all of the above analytes for which certification exists, documentation of certification to perform the requested assays under 42 CFR Part 493 as amended. 4. Documentation of participation, with satisfactory results, in Federally-sponsored or approved, or officially sanctioned laboratory proficiency program (e.g. Round robin testing, etc), such as those sponsored by the Centers for Disease Control and Prevention or the Environmental Protection Agency. 5. Documentation of experience and capability to conduct standard clinical assays including hematology (CBC, platelet counts, hemoglobin A1C), clinical chemistry (serum electrolytes; glucose; urea nitrogen; creatinine; liver enzymes; uric acid; full lipid profile including total and fractionated cholesterol, triglycerides, apolipoproteins; etc), and urine electrolytes. 6. An understanding of adherence to Federal regulations pertaining to human research, and requirements for security and confidentiality of research records, as documented by reporting to a responsible IRB. 7. Expertise and experience in laboratory research, as documented by personnel including at least one individual with an earned doctoral degree in toxicology, chemistry, biochemistry, clinical chemistry, pharmacology or related field, with a record of publication in laboratory-based research. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves to right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies (e-mail to ls59u@nih.gov) in addition to four (4) hard copies of their capability statement addressing the areas above (hard copies to be mail to Lynn Salo at the address listed below). Please limit responses to 15 pages or less. These pages exclude resumes. Written capability statements should be received by the Contracting Officer by 3:00PM ten days after publication of this notice. Capability statements must identify the business status of the organization. No collect calls will be accepted. Inquiries should be directed to: Ms. Lynn Salo, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6962, FAX 301-402-3676, e-mail ls59u@nih.gov. OR, Ms. Elizabeth Osinski, Contracting Officer, DHHS/NIH/NICHD/CMB, 6100 Executive Blvd., Suite 7A07, MSC 7510, Bethesda, MD 20892-7510, (or Rockville, MD 20852 for express/courier service), telephone 301-435-6947, FAX 301-402-3676, e-mail eo43m@nih.gov.
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