SOURCES SOUGHT
A -- The National Myelodysplastic Syndromes Natural History Study (The National MDS Study) – Central Laboratory and Biorepository (CL/B)
- Notice Date
- 11/27/2012
- Notice Type
- Sources Sought
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-SBSS-2014-06
- Point of Contact
- Allison M Cristman, Phone: 301-435-0359, Sarah Bank, Phone: 3014352158
- E-Mail Address
-
allison.cristman@nih.gov, Sarah.bank@nih.gov
(allison.cristman@nih.gov, Sarah.bank@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 those sources 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) the 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. Background The National Heart, Lung, and Blood Institute (NHLBI) is seeking to better understand the progression of myelodysplastic syndromes (MDS) through the initiation of an observational study of adults newly diagnosed with MDS (The National MDS Study). For additional information, please refer to Request for Information Notice Number HHS-NIH-NHLBI-RFI-12-147 (https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RFI-12-147/listing.html), titled "Building a National Resource to Study Myelodysplastic Syndromes (MDS) -The MDS Cohort Natural History Study." An estimated 20,000 or more new cases of MDS are diagnosed in the United States each year. The incidence of MDS dramatically increases with age. MDS is a heterogeneous collection of clonal blood disorders characterized by ineffective hematopoiesis leading to anemia, neutropenia, and thrombocytopenia. While most cases occur in older adults, chemotherapy and other toxin-induced MDS and MDS due to inherited disorders occur in younger persons as well. Those suffering with this syndrome are predisposed to iron overload from repeated transfusions, lethal infections, and life-threatening bleeding. Some patients with MDS can develop chemotherapy-resistant acute myeloid leukemia. Mortality resulting from hemorrhage or infection from failure of normal hematopoiesis is high. Most therapies for MDS are suboptimal and not curative. MDS is frequently asymptomatic, but clinically suspected in older patients with abnormal routine blood tests, recurrent infections, or excessive bleeding. Diagnosis requires evaluation of bone marrow for evidence of cells that are maturing abnormally and malignant cells. These findings, combined with peripheral cytopenia(s), abnormal bone marrow cytogenetics, and the degree of transfusion dependence, classify patients with MDS into risk groups and provide a general assessment of disease severity and possible prognosis. Biomarkers clinically useful for accurate diagnosis, prognosis, and prediction of a patient's response to therapy are not available. Currently the etiologies of MDS are not well defined. Distinct mutations and genetic modifications are thought to underlie the molecular basis of MDS, some of which may be independent predictors of poor survival. A comprehensive standardized longitudinal clinical dataset and a consistently-processed, well-annotated biospecimen collection will provide national resources that potentially can be used to: (1) identify genetic, epigenetic and biological factors associated with initiation and progression of MDS; (2) uncover fundamental information on the changes that occur in hematopoietic stem cells and bone marrow stroma during normal aging; (3) reveal clinically useful biomarkers; (4) identify potential targets for new interventions; and (5) facilitate understanding of how MDS are managed in practice. These resources will facilitate the conduct of basic and translational research on the evolution of MDS over time, and improve the diagnosis and clinical management of affected individuals. Purpose and Objectives The NHLBI is seeking a small business with the ability to serve as the Central Laboratory and Biorepository (CL/B) for a new program, The National Myelodysplastic Syndromes (MDS) Natural History Study (The National MDS Study). During the seven year contract period, this new program will establish a cohort of up to 3000 adults recently diagnosed with MDS and create a comprehensive standardized longitudinal clinical dataset linked to a prospective collection of high-quality, well-characterized biospecimens to advance the understanding of disease progression. A small number of age-matched adults who are not diagnosed with MDS, but clinically suspected of having this syndrome, will be enrolled on the study. The National MDS Study protocol will define the clinical data and biospecimens to be collected, and research studies that will be performed on biospecimens to provide additional data (genetic, molecular, and biological) to enrich the value of the clinical data set and the biospecimen collection. The biospecimen collection, clinical data set, and datasets generated by the protocol-defined research studies will support current and future research in MDS, and be made available to the scientific community as national resources to encourage research to advance the understanding of the biology and genetics of these syndromes. Overall coordination of The National MDS Study will be performed by a Data Coordinating Center (DCC; see Sources Sought Notice #HHS-NHLBI-SBSS-2014-05). The CL/B will collaborate with the DCC and experts appointed by NHLBI to develop a protocol for The National MDS Study, conduct the study, and build a resource that will be comprised of well-annotated, quality biospecimens linked to comprehensive clinical, genetic, and molecular datasets. The CL/B will provide the scientific and technical expertise and the facilities to design, build, and store a quality biospecimen collection that will be linked to phenotypic, molecular and genotypic data. The biospecimens will be collected from participants enrolled at multiple clinical sites. The CL/B will also perform research assays defined in the study protocol and transfer the biospecimen collection to a new facility at the end of the contract. During the contract period, biospecimens will be made available to the wider scientific community for approved scientific research protocols following procedures established by the NHLBI and The National MDS Study. At the end of the contract, the resource will be made available through the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) program (www.biolincc.nhlbi.nih.gov). Project Requirements The CL/B is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 1. Experienced and highly competent in managing a central laboratory, performing and interpreting research assays, and designing and building hematological biospecimen collections for multi-center clinical studies. 2. Key personnel with demonstrated knowledge and leadership, as attested by his/her publication record, in: designing hematological biospecimen collections for multi-center clinical studies; serving as a central laboratory for multi-center clinical studies storing hematological biospecimens (e.g., bone marrow, plasma, serum, whole blood); and performing research using fresh and frozen samples. 3. Key personnel with demonstrated knowledge in developing and implementing procedures to establish a central laboratory and build a biospecimen collection for multi-center clinical studies, and managing multi-center clinical study central laboratories and biospecimen collections. 4. Receive, process, inventory, aliquot, store, retrieve, distribute, and track hematological biospecimens, including histopathology slides, collected on multi-center clinical studies using validated procedures. 5. Perform research in MDS using fresh and frozen samples and interpret and apply the results, including performing and interpreting immunophenotyping assays, and isolating cell populations. 6. Provide a validated electronic biospecimen and laboratory management system and customize the system to enable study-specific functions to be performed. 7. Develop and distribute study-specific barcode label sets, collection kits, forms, and shipping materials to collection sites. 8. Develop, implement, and manage a program to train site personnel to perform study specific procedures and monitor collection site performance. 9. Transfer a biospecimen collection and all associated electronic documents and data files in a secure and safe manner to a new facility. Other Important Considerations The solicitation release date is pending. The Government intends to negotiate one (1) cost-reimbursement Indefinite Delivery/Indefinite Quantity contract for a period of seven years with an approximate award date of June 30, 2014. Capability Statement - How to Submit a Response Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees of the small business; 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 3) a description of general and specific facilities and equipment available, including a description of the software used to manage a biospecimen inventory; 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; and 5) any other information considered relevant to this program. The capability statement must not exceed 16 single sided or 8 double sided pages in length using an 11-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Allison Cristman, Contracting Officer, at allison.cristman@nih.gov, and Sarah Bank, Contract Specialist, at sarah.bank@nih.gov, in either MS Word or Adobe Portable Document Format (PDF All responses must be received by the specified due date and time in order to be considered. 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(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-2014-06/listing.html)
- Place of Performance
- Address: National Heart, Lung, and Blood Institute, Office of Acquisitions, 6701 Rockledge Drive, Rockledge II, Room 6126A, MSC 7902, Bethesda, Maryland, 21092, United States
- Zip Code: 21092
- Zip Code: 21092
- Record
- SN02937843-W 20121129/121127234606-ac50995ca2947d2ea37a704c2f024267 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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