SOURCES SOUGHT
A -- NHLBI Clinical Trials Research Network for the Prevention and Treatment of Acute Lung Injury - Clinical Center
- Notice Date
- 1/25/2012
- 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-HR-14-03
- Archive Date
- 5/18/2012
- Point of Contact
- Marianne DiSomma, Phone: 3014350369, Scott A. Bredow, Phone: 301-435-0333
- E-Mail Address
-
marianne.disomma@nih.gov, bredowsa@nhlbi.nih.gov
(marianne.disomma@nih.gov, bredowsa@nhlbi.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 a Clinical Center (CC) for a new seven-year program, the NHLBI Clinical Trials Research Network for the Prevention and Treatment of Acute Lung Injury (Network). The Network will develop and conduct randomized controlled clinical trials to prevent, treat, and/or improve the outcome of patients with or at risk for acute lung injury (ALI). More than one trial will be conducted simultaneously and it is expected that multiple trials will be completed during the course of the contract. The emphasis is expected to be on prevention and early treatments. The Network will consist of approximately twelve CCs, each with at least one other site that will assist with recruiting, and a Clinical Coordinating Center (CCC). Each CC will have two co-principal investigators from one institution that represent (1) an intensive care unit and (2) another clinician-investigator, such as an emergency department clinician, with early access to patients at risk for lung injury. The CCs shall also include at least one other institution that will participate in enrollment and study conduct but not Network leadership. Each CC will be expected to enroll a total of 220 subjects over 5 ½ years of a seven-year project. The Co-Principal Investigators (Co-PI) from the 12 main CCs will contribute substantially to the trials' scientific leadership and operational management. CC Co-PIs s will participate in Steering Committee and other subcommittees meetings. The CCs will work collaboratively with the CCC to develop, prioritize, and conduct clinical trials in critically ill patients. CCs will collect data at the local level in accordance with the trial and manuals of operational procedures, transmit data to the CCC, and manage each participant's treatment. CCs will also participate in developing a plan to carry out biospecimen collection from critically ill patients that can be archived for future measurement of longitudinal molecular phenotypes. Research conducted by this network should utilize the most modern and flexible electronic data collection, transfer, decision support, and monitoring. Members of the Network will be encouraged to develop and participate in a collaborative Institutional Review Board (IRB) program to reduce the time and redundancy of protocol approvals and monitoring. The CCC will coordinate all aspects of the research, including development of protocols, management and analysis of data, and assurance of data quality. The CCC will be responsible for collecting and archiving biospecimens during the contract and depositing the specimens in the NHLBI biorepository at the end of each study. Project Requirements The CC is expected to fulfill the following: 1) Experienced and highly competent in multi-center clinical trials in critically ill patients with or at risk for ALI. 2) One Co-PI will be a pulmonary/critical care clinician investigator. The other Co-PI, from the same institution, will represent another specialty such as an emergency department physician who can identify at risk patients. 3) Capable of proposing and working collaboratively with other CCs and the CCC to select and develop at least 2 clinical treatment protocols in the first year. Protocols are expected to emphasize prevention and early treatment, but treatments for established ALI and/or very high priority observational studies may be conducted if they have high potential to improve patient outcomes. 4) Participate in developing a scheme to collect biospecimens that can be archived for future longitudinal molecular phenotyping studies of critically ill patients from being at risk until recovery from ALI. 5) Assist with the development of an efficient Network IRB review process to enhance timeliness and value of IRB reviews e. g., collaborative or central IRB. 6) Participate in subcommittees including protocol development and writing committees, publications, sub-studies, ethics, enrollment and others, as necessary. 7) Enroll a minimum of 40 patients per year; oversee or obtain informed consent, and collect and transmit screening and enrollment data to the CCC. Collect and send high quality biospecimens as described in protocols. 8) Conduct regular site-coordination meetings that review screening enrollment practices, data quality and accuracy, oversight of patient care, and adherence to protocols. If coordinators do not have clinical background, activities to supplement medical knowledge must be carried out. 9) Serve as a protocol PI, as appropriate. 10) Coordinate with the CCC to train staff in Network protocols and procedures, including 1) care and treatment of critically ill patients as described in approved protocols; 2) bedside data collection and possibly use of decision support tools; 3) collection, processing, and shipping of specimens to the network central laboratory; 4) clinical testing, extraction of clinical data from medical records, data entry, and transmission of clinical data to the CCC; and 5) adverse and unexpected event reporting. 11) Participate in regular meetings and teleconferences of the PIs and research coordinators to monitor trial and Network progress, identify problems, and develop solutions. 12) Work collaboratively with other CCs and with the CCC to develop new protocols ensuring an available new protocol at all times. 13) Participate in site visits, as needed. 14) Participate in writing final reports and data sets. 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 Marianne DiSomma, Contracting Officer, at disommam@nhlbi.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. 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 approximately twelve (12) cost-reimbursement Indefinite Quantity Indefinite Delivery (IDIQ) contracts, for a period of seven years with an approximate award date of October 3, 2013. Original Point of Contact Marianne DiSomma, Contracting Officer, NHLBI Extramural Contracts Branch, Phone (301) 435-0340, Fax (301) 480-3338, Email: disommam@nhlbi.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-HR-14-03/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, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02661284-W 20120127/120125235041-ed33b075e04124a030296cc1387acd0a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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