SOURCES SOUGHT
R -- Sjögren’s International Collaborative Clinical Alliance (SICCA) Biorepository
- Notice Date
- 11/15/2012
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- NHLBI-CSB-(DE)-2013-22-DEL
- Archive Date
- 12/11/2012
- Point of Contact
- Deirdre Lyons, Phone: 3014359068, Evanthia Bouzis, Phone: 3014350367
- E-Mail Address
-
deirdre.lyons@nih.gov, Evanthia.Bouzis@nih.gov
(deirdre.lyons@nih.gov, Evanthia.Bouzis@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This Small Business Sources Sought Notice (SBSSN) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI) on behalf of the National Institute of Dental and Craniofacial Research (NIDCR). 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 NAICS code applicable to these services is 541990 - All Other Professional, Scientific, and Technical Services with a business size standard of $14.0 million. Based on the responses received from this SOURCES SOUGHT announcement, the proposed acquisition may be solicited as a Total Small Business Set-Aside. All eligible small business concerns responding to this Sources Sought Notice must have the capabilities to provide the below services at time of award. Background: In 2003, the National Institute of Dental and Craniofacial Research (NIDCR) awarded a contract to establish the Sjögren's Syndrome International Collaborative Clinical Alliance (SICCA), which comprises a group of clinical and laboratory investigators from around the world who focus on the development of the International Sjögren's Syndrome Registry. The goals of the SICCA contract were to: a) Establish an International Research Registry Network for Sjögren's syndrome; b) Establish a set of standardized classification criteria for Sjögren's syndrome that might be used by all countries for the purpose of research, prevention, diagnosis, and treatment of Sjögren's syndrome; c) Collect, process, store, ship and analyze clinical and biological specimens from participants with Sjögren's syndrome and their families; and d) Disseminate to qualified researchers clinical information and biological specimens from participants with Sjögren's syndrome and their families in order to answer approved research questions. The SICCA consortium has enrolled over 3,200 subjects in the registry and has collected tens of thousands of clinical samples and data from the participants. Objectives: NIDCR has a continuing need to store the specimens and data collected under the SICCA contract and provide for the dissemination of these materials to qualified scientific researchers conducting basic and clinical research on Sjögren's Syndrome in an ongoing effort to advance basic and translational research in this field and ultimately improve public health. The purpose of this acquisition is to support infrastructure and capacity to store and maintain biospecimens and clinical data collected from participants enrolled in the Sjögren's International Collaborative Clinical Alliance (SICCA) study, to work with qualified requesting investigators on study design and optimization of specimens, and to distribute these specimens and the accompanying clinical data to these qualified investigators. Interested qualified small business organizations should submit a tailored capability statement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described below. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Capability Statements will be reviewed based on the following criteria: 1. Evidence of the firm's status as a small business under NAICS code 541990 with a size standard of $14.0 million; 2. Adequacy of proposed plan demonstrating ability to properly handle, process, store, and disburse biospecimens/data to domestic and foreign sites; establish clear and well documented policies and procedures for access and distribution to specimens/data; develop and implement a validated Quality Assurance/Quality Control program covering all activities related to the successful operation of the biorepository; provide technical, scientific and statistical advice to approved biospecimen recipients in regards to study design to optimize use of biospecimens/ data; provide expert assessment of proposed data analysis plans to ensure that they are consistent with the intent of the initial specimen and data collection effort, and consistent with the American College of Rheumatology (ACR) provisional classification criteria for Sjögren's Syndrome; develop and maintain a comprehensive, computerized, and secure database system that provides and tracks detailed information throughout the life cycle of the biospecimens/data; design and maintain a web-based electronic interface that enables access to available information on biospecimens/data by a diverse user community; and approach various organizational activities related to the biorepository operation; 3. Documented experience, expertise and knowledge with the American College of Rheumatology (ACR) provisional classification criteria for Sjögren's Syndrome, as well as other alternative Sjögren's Syndrome classification systems and familiarity with the types of clinical specimens and data needed to support these classifications. Documented experience and expertise in Sjögren's Syndrome research with particular emphasis on clinical study design and statistical analysis. Demonstrated experience interacting with the scientific community involved in Sjögren's Syndrome research; 4. Adequacy of Project Management and Organizational Plan documenting availability of a lead Principal Investigator with solid research program management experience. Adequacy of plan for organizational and administrative structure indicating clear lines of authority and responsibility including adequacy and feasibility of the proposed staffing for the conduct of the project; and 5. Adequacy, availability, and accessibility of existing resources such as freezers, computer equipment, computer software, web systems, data security, and space (i.e. if freezers are transferred from existing contract) necessary to effectively carry out all phases of the proposed project, including back-up in case of equipment malfunctioning. All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Deirdre Lyons, Contract Specialist, at lyonsde@mail.nih.gov in either MS Word, or Adobe Portable Document Format (PDF), by Monday, November 26, 2012, 1:00 PM, EST. 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 responses. 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/NHLBI-CSB-(DE)-2013-22-DEL/listing.html)
- Record
- SN02931247-W 20121117/121115234518-147ee2b6b582f95bc69e447645d214c8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |