SOURCES SOUGHT
Q -- Molecular Epidemiology Sample Processing and Assay Support (MESPA)
- Notice Date
- 6/12/2015
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-ETSB-51005-56
- Archive Date
- 7/7/2015
- Point of Contact
- Juana A Diaz, Phone: 240-276-5414, Jill Johnson, Phone: 240-276-5395
- E-Mail Address
-
diazj@mail.nih.gov, jill.johnson2@nih.gov
(diazj@mail.nih.gov, jill.johnson2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- HHS-NIH-NCI-ETSB-51005-56 NOTICE INFORMATION Agency/Office: National Institutes of Health Location: National Cancer Institute, Office of Acquisitions Title: Molecular Epidemiology Sample Processing and Assay Support (MESPA) 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; HUBZone small businesses; service-disabled, veteran-owned 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 NAICS code of 541380 and the small business size standard for such requirements is $12 Million per annum. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business concern's name, point of contact, address, and DUNS number. The Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. THERE IS NO SOLICITATION AVAILABLE. THIS IS STRICTLY FOR MARKET RESEARCH. Background: The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. Many of the studies undertaken by the Division include analyses performed using human biological specimens obtained through family and population-based collection efforts. For approximately thirty (30) years DCEG investigators have been relying on contract services to provide technical assistance in the areas of specimen collection, receipt, processing and in identifying laboratories to perform state-of-the-art testing using high quality biological specimens collected from clinical and field sites. Contract services have also been used to establish contractual relationships to implement and oversee this testing. Two previous contracts awarded competitively and entitled, "Molecular Epidemiology Assay Support," and "Procurement of DNA, RNA, Transformed Lymphocytes and Lymphoblastoid Lines for Genetic Studies," respectively have provided support. These include contract numbers HHSN261100105C awarded to PPD Vaccines and Biologics, LLC, Wayne, PA, and HHSN261201200035C awarded to the American Type Culture Collection, Manassas, VA. Purpose and Objectives: Definitions DNADeoxyribonucleic acid RNARibonucleic acid PBMCPeripheral blood mononuclear cell EBVEpstein Barr Virus The purpose of this project is to provide support services for studies on the genetic and other cellular events which influence the onset of different types of cancer. Specifically, the contractor will receive whole blood, lymphocytes, granulocytes, skin fibroblasts, PBMCs, process the cells for DNA and RNA extraction as well as to cryopreserve cells as needed. The contractor will also immortalize cell lines as needed by EBV transformation. Each of these tasks supports studies that will be able to determine the genetic and other molecular changes that accompany the onset of various cancer types. Project Requirements: The Contractor shall furnish services, qualified personnel, material, equipment, including secure computers, and facilities, to provide support services to DCEG studies in the areas of field support for human and environmental specimen collection, receipt and processing of biospecimens in the field, temporary storage of biospecimens until they are ready to be included in research activities, and transfer to laboratory for testing. Offerors may to respond to a single Task Area or to multiple Task Areas. Major tasks required of the Contractor for each Task Area include the following: NOTE 1 TO OFFERORS FOR ALL TASK AREAS: 1. Samples will be delivered to the Contractor by the Government. The Contractor will return any residual samples after testing to long-term storage in Frederick, Maryland. 2. The Contractor shall prepare technical reports for submission to the Contracting Officer's Representative (COR) with one copy to the Contracting Officer. The reports shall be submitted electronically as a 508 compliant PDF. 3. All biological materials delivered will need to be packaged in appropriate containers and delivered according to Department of Transportation regulations. NOTE 2 TO OFFERORS FOR TASK AREAS 2 AND 3: 1. The Contractor must submit a response to Task Area 1 when submitting responses to Task Areas 2 and/or Task Area 3. 2. The Contractor shall be available for frequent teleconferences to discuss strategies and review tasks, as appropriate. 3. The Contractor shall upload processing and specimen characterization as needed into the NCI Biospecimen Inventory System (www.bsisystem.com). Task Area 1 - Phase-in 1. Delineate transition activities to be undertaken. 2. Timelines for the completion of each transition activity. 3. Staff to be assigned. Task Area 2 - Processing of fresh biospecimens 1. Receive and process whole blood, buccal, bone marrow, lymphocytes/leukocytes (fresh and frozen) and fibroblast specimens each weekday from Monday through Friday and proces them on the same day on which they are received. As little as three to four hours' notice may be given in rare circumstances, although routine submission of samples will usually be scheduled several days in advance. Samples requiring immediate processing will generally number 3 or fewer on a typical workday, however, staffing and facilities must be adequate to handle up to 10 samples per week. In rare circumstances, when sample number exceeds more than 10 per week, submission of samples will be scheduled at least several days in advance. Approximately 4,000 specimens are expected to be processed each year. 2. Extract DNA and RNA from fresh, whole blood specimens, transformed lymphoblastoid lines, cultured fibroblasts, granulocytes and lymphocytes. 3. Isolate PBMCs from whole blood. 4. Immortalize cell lines by EBV transformation. 5. Arrange for specimen transfer to other NCI laboratories and repositories, as needed. Transfers are expected to take place approximately every two weeks. Task Area 3 - Support of field studies, identification of laboratories for molecular testing using frozen biospecimens, preparation of samples for current and future testing, and oversight of testing activities 1. Provide support services for field studies and other specimen collection efforts. Field collection efforts may be international or located within the United States. The Contractor shall provide, prepare and transport supplies, lab equipment and procedures for collecting, processing, and aliquotting biospecimens to designated field centers and transport and provide supplies for the shipment of specimens back to the Contractor or other domestic or designated international facility. Supplies may need to be stored by the Contractor for extended periods of time (approximately 100 square feet for periods less than 12 months) before shipments are made and afterwards to allow for the additional supplies to be used for subsequent field efforts. 2. Maintain a laboratory that can process and store a wide range of biospecimens, such as serum, plasma, red blood cells, white blood cells, urine, feces, saliva/buccal cells, and tumor tissue. 3. Maintain a short-term repository for the storage of biospecimens and environmental samples (e.g., air, water and soil samples) managed under this effort. Biospecimens stored should be only those that are either being prepared to be distributed to laboratories for testing or from which laboratories they have been recently returned. The total number of specimens is expected to be less than 20,000 stored in -80°C mechanical freezers. Some +4 °C (less than one upright refrigerator at most) and ambient storage (less than one 20 cubic foot area) may also be needed. 4. Laboratory testing on any biological specimens shall be performed either by the Contractor through a subcontract or by support provided outside of the contract. The latter case would exist when the cost for performing the testing is covered outside of the contract, but where specimens are prepared and shipped to the testing laboratory by the Contractor. The costs for shipping will be reimbursed by the Government. Task Area 4 - Metabolomic analyses of specimens from DCEG studies 1. Perform metabolomics profiling to measure relative concentrations of at least 800 metabolites in serum, EDTA plasma, Heparin plasma, and feces using liquid chromatography-mass spectrometry and gas chromatography-mass-spectrometry (LC-MS, GC-MS) with at least 300 metabolites having known identity in all of the above types of specimens. Measured metabolites must include metabolites from each of the following chemical classes: lipids, amino acids, peptides, xenobiotics, carbohydrates, cofactors and vitamins, nucleotides and energy metabolites. Sensitivity must be sufficient to detect metabolites within the nanomolar range. 2. The Contractor must be able to analyze 30 samples or more per day, and, for any given sample set, curate data / perform metabolite identification within three or fewer months Task Area 5 - LC-MS/MS measurements of estrogen and estrogen metabolites in biomaterials Measure estrogens and estrogen metabolites, in both unconjugated and total (sulfated + glucuronidated + unconjugated) forms, in human serum, heparin-plasma, or EDTA-plasma and urine using a stable isotope dilution liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay that exhibits high sensitivity, validity and reproducibility according to the methods described by Xu X et al, Anal Chem.2007; 79: 7813-21 and Xu X et al, Anal Chem 2005; 77:6646-54. The specific estrogens and estrogen metabolites to be measured include the parent estrogens (estrone and estradiol); metabolites in the 2-hydroxylation pathway (2-hydroxyestrone, 2-methoxyestrone, 2-hydroxyestradiol, 2-methoxyestradiol, and 2-hydroxyestrone-3-methyl ether); metabolites in the 4-hydroxylation pathway (4-hydroxyestrone, 4-methoxyestrone, and 4-methoxyestradiol); and metabolites in the 16-hydroxylation pathway (16a-hydroxyestrone, estriol, 17-epiestriol, 16-ketoestradiol, and 16-epiestriol). Task Area 6 - Detection of human papilloma virus (HPV) subtypes in cervical, oral and anal samples The Contractor shall extract DNA from cervical, oral and anal samples and use the short PCR Fragment (SPF-PCR) method described by Kleter et. al Am J Pathol. 1998 153:1731-1739 and Kleter et al., J Clin Microbiol. 1999 37-2508-2512 to detect constituent HPV subtypes in samples from the National Cancer Institute Costa Rica Vaccine Trial Long-term follow-up (CVT LTFU) effort. The SPF/DEIA LiPA25 HPV testing system (Version 1) makes use of a SPF10 primer set to amplify a broad spectrum of approximately 54 HPV genotypes. In addition, genotype-specific PCR primer sets are also used to optimize the detection of HPV 16 and 18, the two HPV genotypes contained in the bivalent HPV vaccine that is being evaluated in the CVT. The complete HPV testing system has two components, the DEIA component which is conducted on all specimens and then subsequently the LiPA is conducted only on DEIA-positive specimens. Specimens that test positive by SPF10 but are negative for HPV16 or HPV18 by the LiPA25 are selectively amplified for HPV16 and 18 using type-specific primers. Task Area 7 - Microdissection of tumor and adjacent normal tissue and extraction of nucleic acids from frozen and formalin-fixed paraffin-embedded (FFPE) tissue blocks and slides The Contractor will provide pathology laboratory staff and services to review diagnosis, microdissect tumor and adjacent normal tissue and extract DNA and RNA from fresh frozen or formalin-fixed paraffin-embedded (FFPE) tissue blocks or slides. The breadth of activity of the pathology lab should also encompass additional techniques including immunohistochemistry, in situ hybridization (ISH), fluorescence in situ hybridization (FISH) and molecular analyses. The lab should have experience handling of tissues with known complicating issues, such as melanin pigment in melanoma or melanocytic tissues or loss of surface epithelium in ovarian tissue. Anticipated Period of Performance: It is anticipated the services will be acquired through full and open competitive procedures. It is anticipated that four to six (4-6) Indefinite Delivery Indefinite Quantity (IDIQ) contracts will be awarded with a five (5) year period of performance beginning on or about February 1, 2016. Information Sought: To be deemed capable of providing services that meet the DCEG requirements, please submit a written capability statement demonstrating your ability and experience. Submission Information: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Organizations may respond to a single Task Order or multiple Task Orders. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concerns name, point of contact, address and DUNS number. Information submission instructions: All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Juana A. Diaz, Contracting Officer, at diazj@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF) by June 22, 2015 4:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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.
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