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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 09, 2013 FBO #4095
SOURCES SOUGHT

A -- Biomedical Analysis of Human Biospecimens for the Division of Epidemiology, Statistics, and Prevention

Notice Date
2/7/2013
 
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-2013-12
 
Archive Date
3/6/2013
 
Point of Contact
Megan Gnall, Phone: 301-435-6924, Elizabeth D Osinski, Phone: 301-435-6947
 
E-Mail Address
megan.gnall@nih.gov, eo43m@nih.gov
(megan.gnall@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 human biospecimens collected in numerous NICHD research studies. It is anticipated that the resultant contract will be an Indefinite Delivery Indefinite Quantity (IDIQ) type contract. Potential sources must demonstrate and document experience in conducting the following assays that are anticipated: a) Reproductive hormones (including testosterone, estrone, estradiol, estriol, progesterone, quantitative human chorionic gonadotropin, inhibin A) in serum/plasma, urine, and saliva; steroid hormone binding globulin in serum/plasma; b) vitamin D 2, vitamin D 3, and metabolites thereof including 25(OH)D 2, 25(OH)D 3, total 25(OH)D and 1,25(OH) 2 D 3 ; c) total and allergen specific IgE; d) Fox3p levels from T cell subpopulations; e) asthma-specific real-time PCR; f) cytokines and inflammatory markers (including but not limited to TNF-alpha, IL1-beta, IL-6, IL-8 and high-sensitivity CRP); g) DNA extraction from whole blood, blood spots, and saliva; h) urinary leukotrienes including leukotriene E 4 ; i) DHEA and DHEA-S from saliva; j) proteomic and metabolomic analyses of samples from plasma/serum, urine, and saliva; k) DNA methylation in candidate genes and global methylation from previously frozen samples of plasma/serum and saliva; l) global gene expression including RNA extraction and array analyses; m) SNP genotyping of previously collected and prepared DNA samples; n) extraction and amplification of DNA from saliva and identification of polymorphisms in genes (to be specified) relating to obesity, diet, physical activity, substance abuse, and aggression; o) stress hormones (including cortisol, SCTH, CRH, alpha-amylase) in serum/plasma urine, and saliva; p) protein hormones (including parathyroid hormone, insulin, C-peptide, prolactin, IGF-1, IGF-2,and IGFBP-2) in serum/plasma and urine, as appropriate; q) enzymatic (glucokinase) assays for 1,5 anhydroglucitol in whole blood; r) angiogenesis-related compounds (including placental growth factor, soluble endoglin, soluble vascular endothelial growth factor receptor-1) in serum and placental growth factor in urine; s) nutritional biomarkers (including alpha- and beta-carotene, total tocepherol, lycopene, zeaxanthin plus lutein, retinol, retinol binding protein 4, beta-cryptoxanthin, ferritin, transferrin receptor) in serum/plasma; t) urinary 8-iso-prostaglandin F2 and microalbumin ; u) genome-wide association studies of children with rare syndromes from previously collected DNA including identification of polymorphisms and copy number variants. Anticipated Period of Performance: The anticipated period of performance is seven years from September 2013 - August 2020. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the criteria listed below. 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: 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 in accordance with 42 CFR 493, should such certification exist for the analytes listed in the overall statement of work. 2. Documentation of the Centers for Disease Control and Prevention (CDC) Vitamin D standardization certification program. 3. Documentation of capability and previous experience performing all the assays noted in the statement of work. 4. 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. 5. 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. 6. Documentation illustrating soundness of procedures for measurement of specific standards for quality assurance and quality control, including proficiency testing and application of Westgard rules violation. 7. Experience and expertise of a doctoral-level laboratory scientist, as evidenced by peer reviewed publications, which demonstrate active participation in research closely related to the assays performed by the Offeror, particularly those relevant to human health. 8. Demonstrated relevant qualifications and experience of key research staff in successfully conducting all analyses in the statement of work. 9. Documentation of the ability to process, handle, and track shipments of banked human biospecimens that contain bar-coded labels on vials. Respondents must list their DUNS number, organization name, address, technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers and e-mail addresses and size and type of business (e.g., 8(a), HUBZONE, etc.) pursuant to the applicable NAICS code. 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 the 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 perform this project should submit electronic copies (e-mail to megan.gnall@nih.gov ) in addition to four (4) hard copies of their capability statement addressing the areas above (hard copies to be mailed to Megan Gnall 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 February 19, 2013, 3:00 PM. Capability statements must identify the business status of the organization. No collect calls will be accepted. Inquiries should be directed to: Megan Gnall, 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 301-435-6924, FAX 301-402-3676, e-mail megan.gnall@nih.gov
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-DESPR-SBSS-2013-12/listing.html)
 
Place of Performance
Address: Contractor's site, United States
 
Record
SN02982417-W 20130209/130207235201-6d35d3ea10f73b7824da860b92c3e8da (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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