SOURCES SOUGHT
A -- IMMUNOLOGY QUALITY ASSESSMENT PROGRAM
- Notice Date
- 1/25/2013
- 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 Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-12-150
- Archive Date
- 2/23/2013
- Point of Contact
- Robert J. Corno, Phone: 3014513683, John Manouelian, Phone: 301-451-3694
- E-Mail Address
-
robert.corno@nih.gov, manouelj@mail.nih.gov
(robert.corno@nih.gov, manouelj@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; women-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. Background The mission of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) is to help ensure an end to the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the development of therapies for HIV infection and its complications and co-infections, and supporting the development of vaccines and other prevention strategies. Reliable laboratory data are important for the meaningful interpretation of therapeutic and prevention clinical trials/studies and for the appropriate management of subjects enrolled in these studies. Immunological tests, as well as frozen peripheral mono-nuclear cells (PBMC) for future or off-site testing, are included in many DAIDS-supported trials. It is, therefore, important to evaluate objectively the ability of laboratories to process PBMC and perform tests reliably, and to enhance laboratory performance by providing assistance and training when deficiencies are identified. Purpose and Objectives The purpose of the proposed contract will be to continue to provide a Immunology Quality Assessment Program (IQA) resource to: (1) evaluate the abilities of U.S. and non-U.S. laboratories to accurately and reliably perform study-specified immunological tests (with focus on CD4 and CD8 T cell lymphocyte counts and percentages) and viable PBMC freezing; (2) advise and train when deficiencies are identified; (3) evaluate immunology-based novel technologies (with focus on novel, simple tests for diagnosis and disease monitoring) for implementation in multi-site NIAID trials; and (4) maintain a computerized data management system and document library that includes lab performance data and guidance documents. The current Immunology Quality Assessment (IQA) Program contract was awarded to Duke University Medical Center, Durham, NC, on September 30, 2007 for a total period of seven years. Currently, the IQA supports approximately 70 CD4 laboratories in the U.S. and approximately 45 non-U.S. CD4 laboratories in 17 countries. The IQA also supports approximately 65 U.S. PBMC processing laboratories as well as approximately 30 such laboratories in 12 countries. The IQA will continue to support laboratories that are part of current and future NIAID-sponsored clinical trial networks (http://www.niaid.nih.gov/about/organization/daids/networks/pages/daidsnetworks.aspx). The Government anticipates a potential need to: (1) expand the number of non-U.S. CD4 laboratories serviced by the IQA during the course of the contract; and (2) expand the number of U.S. and non-U.S. PBMC processing laboratories serviced by the IQA during the course of the contract. Increases in effort for these services would be implemented through the exercise of contract options, at the discretion of the Government. Project Requirements The Contractor shall provide support to: (1) evaluate the abilities of U.S. and non-U.S. laboratories to accurately and reliably perform study-specified immunological tests and viable PBMC freezing; (2) advise and train when deficiencies are identified; (3) evaluate immunology-based novel technologies for implementation in multi-site NIAID trials; and (4) maintain a computerized data management system and document library that includes lab performance data and guidance documents. Specifically, the Contractor shall be responsible for the following: 1. Monitoring laboratories ability to perform accurately and reliably study-specified immunological tests (e.g. flow cytometric determination of CD4 and CD8 T cell lymphocytes and their subsets, serum/plasma levels of various cytokines and chemokines). This shall include preparation of proficiency testing panels and distribution to participating laboratories, capture and statistical analysis of test results, determination of performance acceptability and generation of lab-specific performance reports. 2. Monitoring laboratories' ability to viably freeze PBMC. This shall include receipt of frozen samples from participating laboratories, determination of cell viability and yields, determination of acceptable performance and generation of lab-specific performance reports. 3. Providing assistance, guidance and training in corrective action when Lab's testing performance is unacceptable, including assistance with procedures and Standard Operating Procedures related immunological tests and PBMC freezing, laboratory qualify management and instrument/test validation. The contractor must have experience with creating and utilizing training tools and must have staff able to travel to various laboratories in and outside the U.S. to provide training. 4. Evaluating new immunological instruments/assays (e.g. point-of-case CD4 methodologies) by conducing in-house preliminary studies as well as facilitating multi-lab studies to determine the suitability of implementing these instruments/assays in vaccine, prevention and therapeutic studies. 5. Obtaining materials and reagents needed for the preparation of quality control materials (QCMs) used to prepare proficiency testing panels and for method evaluation studies. Examples of QCMs include cells and plasma from a well characterized pool of HIV-infected (e.g. CD4 and viral load levels, HLA type) and non-infected donors, labeled monoclonal antibodies, mitogens, pathogen-specific antigens and commercial reference standards and reagents. 6. Hosting and maintaining an existing IQA computerized data management system and document library to track and make available documents in support of activities performed under the contract. The contractor must have the ability to maintain the computerized system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA). The Contractor will be expected to have experience and expertise to carry out a project of this size and complexity, must understand cultural sensitivity issues relevant to resource-constrained countries, and must have the flexibility to address emerging needs and expansion. Anticipated Period of Performance It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about June 30, 2014. The requirement will be for the delivery of 6.50 full time equivalents (FTEs) per year for the Base Period (Year 1) and each option period (Years 2 through 7). In addition, the Government may unilaterally exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include: Increased Level of Effort for Additional non-U.S. CD4 laboratories: During the course of the contract it may be necessary to incorporate additional laboratories to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each Option of this type will implement work commensurate with the addition of 10 Laboratories. If the Government elects to exercise this Option, the Contractor shall provide an additional.30 FTEs per option. The period of performance of an Option for Increased Services will not exceed the term of the Base year or Option year in which the Option is exercised. Increased Level of Effort for Additional US and non-U.S. PBMC processing laboratories: During the course of the contract it may be necessary to incorporate additional laboratories to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each Option of this type will implement work commensurate with the addition of 10 Laboratories. If the Government elects to exercise this Option, the Contractor shall provide an additional.35 FTEs per option. The period of performance of an Option for Increased Services will not exceed the term of the Base year or Option year in which the Option is exercised. Capability Statement/Information Sought Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey information regarding the respondent's 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; Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought. f. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must be registered in CCR which is located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract, including any work performed by any subcontractors and consultants. The Contractor shall ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than 3:00 PM (E.S.T.), February 8, 2013. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Robert Corno, Contract Specialist. He can be emailed at the address provided below. Electronic submissions should be submitted in PDF format; however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID(AI)-SBSS-12-150. A paper copy can be sent via regular mail at the address provided below. If sending a paper copy, please send an original and one copy. Robert Corno Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700 B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 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 Presolicitation synopsis and solicitation may be published in the 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. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Robert Corno Email Address: cornorj@niaid.nih.gov Contracting Officer: John R. Manouelian Email Address: manouelj@niaid.nih.gov
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