Biomedical Assay Laboratory for the Division of Intramural Population Health Research

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 541715 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1000 employees or less. Background and Project Requirements: The Division of Intramural Population Health Research (the Division) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to obtain the services of a biomedical laboratory to provide validated, clinical analyses of biospecimens as well as to modify and/or develop new analysis as needed to measure biological specimens collected as part of the Division's intramural and collaborative research activities. 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 both the oversight of receiving and maintaining a large number of specimens (typically on average about 1,000) and conducting the following anticipated assays: a) LC/MS to measure caffeine, theobromine, and paraxanthine from serum specimens; b) isolation of RNA from PAXgene tubes and use of resulting RNA in expression analysis to characterize the products of genes related to asthma, allergy, and inflammation, with particular attention to the expression of Foxp3; c) to ascertain the feasibility of a high-throughput technique to assess DNA denaturation and fragmentation in sperm; d) measurement of reproductive hormones (including testosterone, estrone, estradiol, estriol, progesterone, human chorionic gonadotropin, inhibin A) in serum/plasma, urine, and saliva; e) measurement of vitamin D2, vitamin D3, and metabolites thereof including 25(OH)D2, 25(OH)D3, total 25(OH)D and 1,25(OH)2D3; f) measurement of cytokines and inflammatory markers (including but not limited to TNF-alpha, IL1-beta, IL-6, IL-8 and high-sensitivity CRP) from serum; g) DNA extraction from whole blood, blood spots, saliva, and buffy coat and whole exome and whole genome analyses of such DNA; h) proteomic and metabolomic analyses of samples from plasma/serum, urine, and saliva; i) DNA methylation of candidate genes and global methylation from previously frozen samples of plasma/serum and saliva; j) SNP genotyping of previously collected and prepared DNA samples; k) measurement of stress hormones (including cortisol, SCTH, CRH, alpha-amylase) in serum/plasma, urine, and saliva; l) measurement of angiogenesis-related compounds (including placental growth factor, soluble endoglin, soluble vascular endothelial growth factor receptor-1) in serum and placental growth factor in urine; m) measurement of 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. Anticipated Period of Performance: The anticipated period of performance is ten years from September 2018 - August 2028. 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: 1. Documentation of CLIA (Clinical Laboratory Improvement Amendments 1988) certification and a CLIA-approved proficiency testing program in accordance with 42 CFR part 493 as amended, should such certification exist for the above listed analytes; 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 above; 4. 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; 5. Documentation illustrating soundness of procedures for measurement of specific standards for quality assurance and quality control, including proficiency testing and application of Westgard rules violations; 6. 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; 7. Demonstrated relevant qualifications and experience of key research staff in successfully conducting all analyses; 8. Documentation of the ability to process, handle, and track shipments of banked human biospecimens that contain bar-coded labels on vials. 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 to Megan Gnall, Contracting Officer (E-mail to megan.gnall@nih.gov) Please limit responses to 20 pages or less. These pages exclude resumes. Electronic capability statements should be received by the Contracting Officer by November 2, 2017, 4:00 pm EST. Capability statements must identify the business status of the organization, NAICS code along with DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc.). Inquiries should be directed to: Megan Gnall, Contracting Officer, DHHS/NIH/NICHD/CMB, megan.gnall@nih.gov telephone 301-435-6924, OR, Secondary point of contact Lola St.John, Contracting Officer, DHHS/NIH/NICHD/CMB, Email: kelluml@mail.nih.gov