SOURCES SOUGHT
A -- Clinical Pharmacology Quality Assurance Program (CPQA)
- Notice Date
- 12/12/2013
- 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-2014002
- Archive Date
- 1/14/2014
- Point of Contact
- Dena Nannetti, Phone: 301-496-6424, John Manouelian, Phone: 301-496-0612
- E-Mail Address
-
dena.nannetti@nih.gov, manouelj@mail.nih.gov
(dena.nannetti@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), National Institutes of Health (NIH) is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the discovery and development of therapies for HIV infection and its complications, and supporting the discovery and development of vaccines and other prevention strategies. The current NIAID Clinical Pharmacology Quality Assurance (CPQA) program provides a comprehensive quality assessment program for clinical pharmacologic laboratories testing samples from subjects enrolled in NIAID-supported clinical studies to ensures the validity and inter- and intra-laboratory comparability of pharmacological study data by providing laboratories with materials for pharmacology proficiency testing and assay controls, and monitoring proficiency and assay data from each laboratory. This program serves a critical need in ensuring that the individual laboratories (1) adequately validate their methods such that they are specific, accurate, reproducible, and sufficiently sensitive to measure drug concentrations in clinical specimens, (2) accurately analyze and report drug concentrations from patient specimens, and (3) are organized, directed, and managed in accordance with the quality requirements of NIAID and/or regulatory agencies. Therefore, it is critical to continue the CPQA program that assures the scientific integrity of NIAID supported on-going and future clinical studies concerning assessment of anti-HIV treatments and preventive measures. Purpose and Objectives The purpose of the proposed contract will be to continue to provide a comprehensive quality assurance program (CPQA) resources to: (1) evaluate the ability of Labs to accurately and reliably perform study-specified pharmacology assays; (2) provide for the planning and execution of single and multi-Lab studies for the development, validation and implementation of bioanalytical methods for measuring drug concentrations in study specimens; (3) acquire, characterize, store, and distribute to Labs quality control materials and reagents; (4) provide guidance and assistance to Lab and clinical site staff in proficiency testing, assay validation and in the conduct of clinical pharmacology studies; and (5) prepare Labs for FDA inspections and study audits. The current CPQA program contract was awarded to the University at Buffalo, Research Foundation of State University of New York, on May 29, 2008 for a total period of seven years (Contract No, HHSN272200800019C). The current contract provides services to 11 U.S. and non-U.S. clinical pharmacology laboratories (Labs) affiliated with NIAID-supported clinical trial networks and collaborating study groups (User Groups). It is critical to evaluate, both initially and on an on-going basis, the ability of Labs to perform protocol-specified pharmacology assays correctly and reliably. The CPQA 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 expand the number of clinical pharmacology laboratories serviced by the CPQA 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 programs to assure the quality of the development of clinical pharmacology resources, the conduct of pharmacology activities at DAIDS-funded clinical trial research laboratories and pharmacology laboratories, the reporting of pharmacology-specific data from these DAIDS-funded entities, and disseminate assessment of trial outcomes, guidance, and strategies for quality improvement. The Contractor shall provide support to: (1) evaluate the ability of Labs to accurately and reliably perform study-specified pharmacology assays; (2) plan and conduct of single and multi-Lab studies for the development, validation and implementation of bioanalytical methods for measuring drug concentrations in study specimens; (3) acquire, characterize, store, and distribute to Labs quality control materials and reagents; (4) guide and assist Lab and clinical site staff in proficiency testing, assay validation and in the conduct of clinical pharmacology studies; and (5) prepare Labs for FDA inspections and study audits. Specifically, the Contractor shall be responsible for the following: 1. Monitoring performance of laboratories ability to accurately and reliably perform pharmacology assays (e.g., HPLC-MS, UPLC-MS, HPLC-UV). This shall include design of proficiency testing (PT) programs, preparation of PT panels, capture and statistical analysis of test results, assessment of lab's testing performance, generation of Lab-specific performance report, and provision of remediation samples for re-testing. 2. Supporting and facilitating pharmacology assay development, validation, and implementation conducted by the Labs. This shall include development assays for novel biomatrices, new drugs and drug metabolites; review and evaluation of assay validation reports (AVR) and AVR SOPs, and development of procedures that refine sampling process, sample processing and storage. 3. Acquiring, characterizing, storing, documenting, and disbursing analytical grade reference standards (AGRS)/reference drug powder and other reagents needed for the preparation of quality control samples for method development and validation studies and for proficiency testing panels; disbursing AGRS/reference drug powder and QC samples to laboratories. 4. Assisting and guiding laboratories staff in corrective action when testing proficiency is not acceptable. Assisting and guiding laboratories in procedures and SOPs in performing pharmacology assays and conducting clinical pharmacology studies; providing guidance, via on-line tutorial, to clinical site staff, for PK/PD studies, and for sample collection, processing and storage. 5. Preparing laboratories for FDA laboratory inspections and study audits via conducting on-site lab inspection and study-specific audit that assess lab's overall quality of operations, quality planning and quality improvement (pre-analytical, analytical, and post-analytical); reporting the findings and deviations, and interacting closely with the Lab to take corrective actions for errors that matters. 6. Obtaining quality control materials (QCMs) needed for the preparation of quality control samples for assay development and validation and drug panels for pharmacology proficiency testing. Examples of QCMs include antiretroviral (e.g., nucleoside and nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and CCR5 inhibitors) and anti-tuberculosis, and anti-HCV drugs. 7. Hosting and maintaining an existing CPQA computerized data management system to track and make available documents in support of activities performed under the Statement of Work of 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). 8. Disseminating CPQA technical and scientific data. The Contractor will be expected to plan for and implement the Initial, at the beginning of the contract, and Final Transitions at the end of the contract. The Contractor will be expected to have experience and expertise to carry out a project of this size and complexity, must understand technical and regulatory 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 March 1, 2015. The requirement will be for the delivery of 8.85 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-US pharmacology 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 one domestic or international Laboratory. If the Government elects to exercise this Option, the Contractor shall provide additional 0.9 FTEs per option. Up to two options per year may be exercised during years 2 through 7 of contract performance. 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. Personnel/Management: Interested parties must demonstrate adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify other projects of similar size and complexity. 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 December 30, 2013 at 4:00 PM (E.S.T.). Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail to Dena Nannetti, Contract Specialist, at dena.nannetti@nih.gov. 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-2014002. 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: Dena Nannetti Email Address: dena.nannetti@nih.gov Contracting Officer: John R. Manouelian Email Address: manouelj@niaid.nih.gov
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