SOURCES SOUGHT
A -- Lung Tissue Research Consortium – Data Coordinating Center
- Notice Date
- 9/23/2014
- 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-HR-16-04
- Archive Date
- 1/30/2015
- Point of Contact
- Scott C Bredow, Phone: (301) 435-0333, Sarah Bank, Phone: (301) 435-2158
- E-Mail Address
-
bredowsa@nhlbi.nih.gov, Sarah.bank@nih.gov
(bredowsa@nhlbi.nih.gov, Sarah.bank@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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 NAICS code 541712 should not submit a response to this notice. Background The NHLBI is seeking a small business with the ability to serve as the Data Coordinating Center (DCC) for a four-year renewal of the NHLBI Lung Tissue Research Consortium (LTRC). The LTRC is a network of centers cooperating to harvest and process lung tissue specimens for use in scientific studies of the etiology and pathogenesis of lung diseases, especially chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis. The LTRC prepares collections of specimens, linked to clinical data describing the donor subjects, for widespread distribution to investigators for use in their research. The DCC will operate a repository for LTRC data; provide overall management, oversight, and administrative support for the LTRC; and arrange for centralized analyses of selected biospecimens by high throughput methods such as RNAseq. The DCC will operate in cooperation with a Radiology Center that analyses and archives x-ray CT images, with a Tissue Repository that processes, stores, and distributes biospecimens, and with 3-4 Clinical Centers that recruit and characterize human subjects and harvest surgical waste lung tissues. The DCC will train LTRC Clinical Center personnel regarding data forms completion and data entry and will have primary responsibility for data quality control and assessment. The DCC will conduct site visits as needed to assure that LTRC protocol procedures are followed. The DCC will arrange for meetings of LTRC committees and boards and will prepare reports for the committees and boards and the NHLBI summarizing study progress and status. The DCC will implement procedures whereby investigators apply for LTRC resources; the applications are reviewed by the Protocol Review Committee (PRC) and the NHLBI; and tissues and data are granted to applicants whose requests are approved. In addition, the DCC will arrange for performance of high throughput analyses of selected biospecimens in accordance with scientific priorities established by the Steering Committee and approved by the PRC and the NHLBI. The DCC is expected to fulfill the following: 1. Obtain and maintain Institutional Review Board (IRB) approval for DCC activities described in the LTRC Protocol Manual, and any amendments thereto. 2. The Principal Investigator shall participate fully in the activities of the Steering Committee (SC). The SC will monitor operations of the LTRC, consider modifications and updates of the LTRC Protocol as needed to accomplish the general aims of the LTRC, and submit recommended modifications to the Protocol Review Committee (PRC) for review. 3. Provide training for LTRC Clinical Center personnel involved in data collection, forms completion, and data entry. Certify Clinical Center personnel who demonstrate proficiency in the approved data collection techniques. 4. Update as needed LTRC data collection forms and informed consent documents for use by the LTRC Clinical Centers and the DCC. Update the LTRC Protocol and Manual of Operations to describe proposed and approved modifications to the LTRC protocol and procedures. 5. Develop and maintain a public web site that includes: 1) a description of LTRC objectives, organization, and procedures, 2) the LTRC Protocol, 3) data collection forms, 4) a description of specimens and specimen collections available for distribution to researchers, 5) descriptions of research projects for which LTRC specimens or data have been provided, including the project title, the name of the Principal Investigator, and the project description provided by the applicant, 6) references to publications from research studies that have utilized LTRC resources, 7) procedures and forms for requesting LTRC specimens, specimen collections, clinical data, and data analyses, 8) a link to the NHLBI public web site, and 9) LTRC contact information. The public website designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards In accordance with the LTRC Protocol, the DCC contractor shall: 6. Develop and/or maintain computer systems and software needed for transfer of clinical data from the LTRC Clinical Centers and External Contributors to the DCC and for the storage, retrieval, and statistical analysis of these data. The computer systems and software shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http ://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards 7. Assist the LTRC Clinical Centers and External Contributors in transferring clinical and phenotypic data to the DCC. Perform quality control/quality assurance tests and report results to the NHLBI and Observational and Study Monitoring Board (OSMB). 8. Develop and maintain a database of LTRC clinical and phenotypic data, implementing procedures for backup that will minimize possibilities of data loss. The electronic database designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards 9. Serve as the representative of the Steering Committee to convey recommendations for modification of the LTRC Protocol to the PRC and OSMB for review and comment. 10. Coordinate the submission of applications for LTRC resources, review of these applications by the PRC and NHLBI, and delivery of tissues and data to applicants whose requests are approved. 11. Prepare data sets in electronic form for distribution to investigators for approved studies as authorized by the NHLBI, ensuring that study subjects cannot be re-identified using the data provided. 12. Plan, make arrangements for, and provide ongoing support for the meetings and teleconferences of the SC, PRC, and OSMB. Prepare and distribute minutes of the SC meetings. 13. Identify any problems with existing LTRC procedures and any difficulties that may interfere with LTRC objectives. Devise strategies to improve procedures and overcome difficulties. 14. Prepare final limited access data sets. The data sets shall include data with full documentation, prepared in accordance with NHLBI policies available at: http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.htm. 15. Transfer all LTRC data to a repository identified by the NHLBI at the end of the contract period, together with the coded information linking the data to tissues and CT images. In collaboration with other LTRC investigators, the DCC contractor shall: 16. Develop detailed plans for the creation of an omics data set based on LTRC biospecimens and phenotypic data. These plans will include selections of specific donor subjects, biospecimen types, and analysis platforms. Obtain approval of these plans from the PRC and NHLBI. Perform the required analyses, making use, as needed, of subcontractors to provide reliable analyses. Incorporate the omics data obtained through these analyses into the LTRC dataset for distribution to investigators. Biospecimen analyses shall not proceed until written approval has been provided by the Contracting Officer. Anticipated Period of Performance December 15, 2015 - December 14, 2019 Capability Statement 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, 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 computer equipment and software, 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 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. 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 solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Scott Bredow, Contracting Officer, at bredowsa @nhlbi.nih.gov and Sarah Bank, Contract Specialist, at sarah.bank@nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. 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 the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate one (1) cost-reimbursement Indefinite Quantity Indefinite Delivery (IDIQ) contract, for a period of four years with an approximate award date of December 15, 2015.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-HR-16-04/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions 6701 Rockledge Dr. RKL2/6016 MSC 7902, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN03524786-W 20140925/140924000133-fd5ba2c1be8db77df3dd02d2c14f90d9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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