SOURCES SOUGHT
A -- Lung Tissue Research Consortium – Clinical 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-16-07
- Archive Date
- 1/30/2015
- Point of Contact
- Sarah Bank, Phone: (301) 435-2158, Scott A Bredow, Phone: (301) 435-0333
- E-Mail Address
-
Sarah.bank@nih.gov, bredows@mail.nih.gov
(Sarah.bank@nih.gov, bredows@mail.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 small businesses with the ability to serve as Clinical Centers (CC) during the first three years of the 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. CCs will operate in cooperation with a Data Coordinating Center which provides overall management, oversight, and administrative support for the LTRC; a Radiology Center that analyses and archives x-ray CT images; and a Tissue Repository that processes, stores, and distributes biospecimens. It is expected that CCs will be institutions that routinely perform lung surgical procedures such as lobectomy for suspected cancer. CCs must also have experience and expertise in the enrollment and characterization of human research participants for clinical studies of pulmonary disease. Each CC will enroll donor subjects, perform laboratory and clinical testing according to the LTRC protocol, and harvest surgical waste lung tissues for processing and shipping to the LTRC Tissue Repository. In addition, the Principal Investigator will participate in designing a strategy for creation of an omics data resource based on LTRC data and high throughput analyses of selected biospecimens. Each CC is expected to fulfill the following: 1. Obtain and maintain Institutional Review Board (IRB) approval for CC activities described in the LTRC Protocol Manual, and any amendments thereto. 2. The Principal Investigator shall have expertise in pulmonary diseases and 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. Obtain and maintain training of appropriate staff in LTRC protocols and procedures, including: 1) administration of questionnaires, performance of clinical testing, extraction of clinical data from medical records, data entry, and transmission of clinical data to the Data Coordinating Center; 2) imaging procedures and transmission of CT scans to the LTRC Radiology Center; and 3) collection, processing, and shipping of specimens to the LTRC Tissue Repository. In accordance with the LTRC Protocol, the CC contractor shall: 4. Identify potential donor subjects, obtain their informed consent, and collect screening data necessary to determine eligibility for participation. Enroll donor subjects and perform clinical testing and collect donor subject data as specified in the LTRC Manual of Operations and transmit the data to the responsible LTRC center. Retain hard copy originals of data collection forms in a secure archive. 5. Procure biological specimens from enrolled donor subjects. Perform initial specimen processing and transmit processed biological specimens to the LTRC Tissue Repository. 6. Acquire CT images according to the LTRC Manual of Operations, de-identify the images, and transmit to the LTRC Radiology Center. 7. Perform quality control and quality assurance activities. 8. Report adverse events and unanticipated problems (consistent with NHLBI/NIH policies). 9. Provide reports of any radiographic or pathological abnormalities noted by the LTRC Radiology Center and/or LTRC Tissue Repository to the donor subjects' primary care physicians. Inform the LTRC Data Coordinating Center when notification is accomplished. 10. Identify any problems with existing LTRC procedures and any difficulties that may interfere with LTRC objectives. Devise strategies to improve procedures and overcome difficulties. In collaboration with other LTRC investigators, the CC contractor shall: 11. 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. Anticipated Period of Performance December 15, 2015 - December 14, 2018 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 three (3) - four (4) cost-reimbursement Indefinite Quantity Indefinite Delivery (IDIQ) contracts, for a period of three 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-16-07/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
- SN03524685-W 20140925/140924000025-f88a4f1612f131466d5a66872db1d026 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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