SOURCES SOUGHT
A -- NIDDK Genetics and Biosample Repositories
- Notice Date
- 1/29/2016
- 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 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-NIDDK-KUH-ASB-2016-19
- Point of Contact
- Richard Bailey, Phone: 301-402-1139, Dana Harris, Phone: 301-443-7798
- E-Mail Address
-
BaileyRichard@mail.nih.gov, harrisd@mail.nih.gov
(BaileyRichard@mail.nih.gov, harrisd@mail.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 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. The National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking an organization or an institution to continue supporting both the NIDDK Genetics and Biosample Repositories. NIDDK GENETICS REPOSITORY. The Genetics repository will allow the continued storage, maintenance, and quality control, and equitable, ethical distribution of DNA and other resources important to the study of diseases under the mandate of the NIDDK. It facilitates sharing of resources, thus encouraging work by a broad group of investigators and perhaps, increasing the sample size and the resulting power of a study to identify the genetic determinants of a disease. It helps to ensure that research participants will be making a maximal contribution, and decreases duplicative sampling efforts. The current contractor is the Rutgers State University. The cell immortalization and other tasks outlined in this notice are highly technical, and require extensive experience and expertise. The success rate for cell immortalization is extremely variable. It depends on how well the established methods are implemented, as well as on the quality and volume of the initial blood sample. As the value of many genetics studies rests on the ability to analyze the DNA of relatives, inability to recover DNA from any particular sample may negate the value of multiple samples. In addition, samples collected from pediatric patients may be very small, but valuable and irreplaceable. Therefore, it is essential that the success rate for establishing cell lines be as close to 100% as possible. Furthermore, the ability to track thousands of genetic samples, preventing sample mix-ups and cross-contamination while maintaining a high-throughput processing system, is crucial to the integrity of the studies being supported. The Contractor's project director must have extensive experience in successfully providing these genetics and sample processing services, including blood cell immortalization and DNA extraction and distribution, to a large group of investigators. The Contractor's staff must be highly trained to carry out exacting technical tasks accurately and reproducibly. As all the work is with samples from human subjects, all staff must be familiar with human subjects protections and be sensitive to the bioethical and safety issues involved in handling human biosamples. Finally, the Contractor must have a demonstrable long-term interest in providing these services, to ensure that there is continuity throughout the period of the contract. PURPOSE AND OBJECTIVES. The objective of this requirement will be to continue the NIDDK Genetics Repository, in order to accomplish the following in a highly efficient, rapid, and cost-effective manner: •Receive blood samples from NIDDK funded grants •Process these data and materials to create cell lines and DNA samples •Receive externally produced immortalized lymphocyte cell lines; and •Widely distribute all materials to qualified investigators in the scientific community in variety of customized formats PROJECT REQUIREMENTS. All qualified small businesses, veteran-owned small businesses, service-disabled veteran-owned small businesses and/or HUBZone small businesses interested in submitting a corporate capability must demonstrate experience and knowledge for performing the following tasks: •Establish biospecimen preparation, shipping, receipt, and tracking systems for numerous individual multi-center clinical studies; •Maintain the confidentiality of subjects by removing all traditional personal identifiers from samples; •Establish one or more subcontracts for timely and cost-effective shipping of biosamples between multiple sites and the repository; •Create and store viable cell lines via Epstein-Barr virus transformation of lymphocytes from blood samples, with a success rate of 98% or greater and expanding the lymphoblastoid cell lines; •Receive and store lymphoblastoid cell lines prepared at other facilities and carry out quality control assessments; •Extract and store DNA from cell lines, whole blood and, with designated samples, separate the white blood cells (buffy coat) from the plasma of received blood samples; •Extract and store RNA from cell lines or from isolated blood cells; •Carry out limited genotyping for verifying sample identity and quality; •Distribute cell lines and biosamples to investigators granted access by the Project Officer, including arraying in a variety of formats, packaging, handling, and coordinating sample shipments to domestic and international sites; •Withdraw and destroy samples from the repository as directed in writing by the Project Officer; •Establish and maintain Quality Assurance (QA) and Quality Control (QC) programs; •Provide security and back-up systems and a plan for disaster recovery; •Maintain high quality, secure information systems to allow detailed tracking and reporting of sample receipt, processing, storage and distribution, rapid retrieval of samples, storage of QA/QC information associated with the sample, seamless interaction with the Database Repository, and listing of investigators using the repository; •Work in a cooperative fashion with the Project Officer, customers, and the Steering Committee. NIDDK BIOSAMPLE REPOSITORY. The NIDDK conducts and supports much of the clinical research on the diseases of internal medicine and related subspecialty fields. Many of the large clinical studies funded by the NIDDK collect biospecimens from subjects for analysis and future study. The collection of these patient and control samples from many different studies in a single repository is a valuable resource with which researchers can rapidly validate clinical hypotheses and algorithms for clinical decision. The collection is also advancing the development of prognostics, markers, and therapeutics for diseases related to the mission of the NIDDK. This project, which will be referred to herein as "the Biosample Repository", continues an important collection begun in 2003 and is conceptually related to repositories in existence at other institutes at the NIH. The current contractor is Fisher Bioservices. The repository stores and maintains biosamples under high quality conditions, and distributes them in an equitable and ethical manner. This facilitates sharing of NIDDK-supported resources, thus encouraging work by junior investigators, investigators with novel approaches, and others not included in current collaborations, without excluding those who are established in their fields. It helps to ensure that research participants make a maximal contribution, and decreases duplicative sampling efforts. The specimen archiving tasks outlined in this notice are highly technical, and require extensive experience, expertise, and long-term commitment. The samples were collected over many years from carefully chosen subjects and are present in a finite quantity. Each sample is unique and cannot be replaced if lost, damaged, or contaminated. Therefore, it is essential that the samples be stored under optimal conditions, which vary from sample type to sample type. The Contractor's project director must have extensive experience in successful management of an archival storage facility that stores various types of biosamples, including blood, stool, urine, DNA, and tissue, and distributes aliquots to many different investigators. The Contractor's staff must be highly trained to carry out technical tasks accurately and reproducibly. As all the work is with samples from human subjects, all staff must be familiar with human subjects protections and be sensitive to the bioethical and safety issues involved in handling human biosamples. Finally, the Contractor must have a demonstrable long-term interest in providing these services, to ensure that there is continuity throughout the period of the contract, and to prevent repeated shipment of samples from storage site to storage site, as shipment can sometimes damage these unique materials. PURPOSE AND OBJECTIVES. The objective of this requirement will be to continue the NIDDK Biosample Repository, in order to accomplish the following in a highly efficient, rapid, and cost-effective manner: •Receive and store biosamples collected in many different studies; •Carry out specified sample processing and analyses, and •Widely distribute biosamples to qualified investigators PROJECT REQUIREMENTS. All qualified small businesses, veteran-owned small businesses, service-disabled veteran-owned small businesses and/or HUBZone small businesses interested in submitting a corporate capability statement must demonstrate experience and knowledge for performing the following tasks: •Establish biospecimen preparation, shipping, receipt, and tracking systems for numerous individual multi-center clinical studies; •Maintain the confidentiality of subjects by removing all traditional personal identifiers from samples; •Establish one or more subcontracts for timely and cost-effective shipping of biosamples between multiple sites and the repository and for timely and cost-effective laboratory processing and/or testing of biosamples; •Store biosamples under optimal conditions to minimize loss, damage or contamination; •Distribute biosamples to qualified investigators granted access by the Project Officer, including packaging, handling, and coordinating sample shipments to domestic and international sites; •Withdraw and destroy samples from the repository as directed in writing by the Project Officer; •Establish and maintain Quality Control (QC) and Quality Assurance (QA) programs; •Provide security and back-up systems and a plan for disaster recovery; •Maintain robust, flexible, high quality, secure information systems to allow detailed tracking of sample receipt, processing, storage and distribution, rapid retrieval of samples, storage of QA/QC information associated with the sample, and listing of investigators using the repository; •Work in a cooperative fashion with the Project Officer, the External Advisory Committee and the Steering Committee. CAPABILITY STATEMENT/INFORMATION SOUGHT. A fixed price Indefinite Delivery, Indefinite Quantity (IDIQ) type contract for the NIDDK Genetics Repository using NAICS code 54172 Professional, Scientific, and Technical Services - Research and Development in Physical, Engineering, and Life Sciences (except) is contemplated. A base year plus four one year option periods is anticipated to start on or about 9/1/2016. A cost-reimbursement type contract for the NIDDK Biosample Repository services using NAICS code 493120 Warehousing and Storage - Refrigerated Warehousing and Storage is contemplated. A base year plus four one year option periods is anticipated to start on or about 9/1/2016. The intention of this announcement is to survey the market for potential offerors. No large businesses should respond to this announcement. All interested small businesses including veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns must provide 5 copies of their capability statement in writing to the address identified in this synopsis no later than Monday, February 8, 2016 at 12:00pm EDT. Responses must be in writing and will not be accepted via email or fax, and sent to the following address: Richard E. Bailey, Contracting Officer Office of Acquisitions, NICHD 6100 Executive Blvd, Room 5C01 Rockville, MD, 20852 If hand-delivered or delivery service, use Bethesda, Maryland 20817 Capability Statements should clearly convey information regarding the respondents capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Each response should include the following Business Information: • DUNS. • Company Name. • Company Address. • Company Point of Contact, Phone, and Email address • Current GSA Schedules appropriate to this Sources Sought. • Whether the organization has a Government approved accounting system, and if so, the agency that approved the system. • Company size and type (i.e., small business, 8(a), woman owned, veteran owned, etc.) pursuant to the applicable NAICS code, as validated via the System for Award Management (SAM). All offerors must register on the SAM located at https://www.sam.gov/ The content of the capability statements shall be limited to fifteen pages, excluding resumes, describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) the capability to provide the required level of effort on a continuing and emerging needs basis; (4) resumes for proposed key personnel, which reflect education, and previous work relevant to the proposed requirement; (5) a general description of the facilities and other resources needed to perform the work; and (6) demonstrated ability to carry out the work. 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/NICHD/NIH-NIDDK-KUH-ASB-2016-19/listing.html)
- Place of Performance
- Address: To be determined., United States
- Record
- SN04004637-W 20160131/160129234053-3df92008af596f2d934f622401ba3684 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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