SRCSGT | A | Research and Development Sources Sought PACES-AARA-OS

FBO DAILY ISSUE OF FEBRUARY 27, 2010 FBO #3017
SOURCES SOUGHT

A -- Research and Development Sources Sought PACES-AARA-OS

Notice Date: 2/25/2010
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, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: PACES-ARRA-OS
Archive Date: 3/23/2010
Point of Contact: Dominique H Malone, Phone: (301) 827-7227, Doreen Williams,
E-Mail Address: dominique.malone@fda.hhs.gov, doreen.williams@fda.hhs.gov
(dominique.malone@fda.hhs.gov, doreen.williams@fda.hhs.gov)
Small Business Set-Aside: N/A
Description: A. General Information: In accordance with FAR 15.201(e), this request is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in the announcement. This is a Sources Sought regarding potential sources. The Food and Drug Administration (FDA) requires. The NAICS Code is 541712 with a small business size standard of 500 employees. This announcement is a Sources Sought for planning purposes only. The intent of this Sources Sought is to conduct market research to identify sources to support informed decisions to procure for the required services, i.e., a total small business set-aside action (e.g., SBA Certified 8(a), Service-Disabled Veteran Owned, HUBZone, Small Disadvantaged, Veteran-Owned, Women-Owned,), GSA task order, etc. This notice is a Sources Sought for all interested qualified small businesses that meet the requirements for this effort. This is not an invitation for bid, request for quote or other solicitation and in no way obligates the Government to award a contract. B. Project Background: Initiatives to compare the effectiveness of different medical interventions and approaches to their delivery have attracted tremendous interest. While comparative effectiveness research (CER) has typically been associated with enhancing the efficiency in the use of health care resources are used, there is a broader vision of the potential goals and benefits of such research. CER could extend beyond the application of specific intervention methods to controlled clinical trials or within specific health care settings. For example CER could be used to better understand what interventions work best for individuals and subgroups within populations. As such, CER can be instrumental in supporting and driving the development of personalized medicine, and improving not only the efficiency of care, but also outcomes for all individuals. The science can be used to increase patient benefit, by identifying individuals who are most likely to benefit from an intervention, and to reduce risks, by identifying and protecting individuals who may be harmed. The hope of personalized medicine is that new and existing therapies and devices will be used in combination with improved diagnostic assessments to develop a tailored strategy for treating each patient. A significant step in achieving this goal is to define subtypes or subpopulations of patients with disease, such that different therapies, often with different targets and mechanisms of action, can be compared with respect to how they perform in each of these subtypes. Within the FDA, the intent is to help provide a scientific framework that can capitalize on increased CER efforts to better realize these goals of personalized medicine. The FDA houses the largest known repository of clinical study data--including data on drug biologics and devices safety, effectiveness and performance. These data are an invaluable resource for CER. Both pre- and post-approval data collected and housed at the FDA can be combined with other datasets on long term health outcomes that reside in other agencies or the private sector. As personalized medicine develops, FDA expects an increase in the need for comparisons across products (and associated delivery mechanisms) to define how these products should be used in combination for individualized health care before and after FDA approval. Development and use of sound, consistent science-based approaches to the design, conduct and analysis of such data; and the assessment for labeling and regulatory purposes, will be critical. C. Objective: The Partnership in Applied Comparative Effectiveness Science (PACES) is an initiative that seeks to advance the science for such CER studies through leveraging available data, in particular the joint ARRA FDA-CER efforts, to form an enhanced standardized database, Janus. The PACES initiative will be conducted with centers residing outside of the FDA who have state-of –the-art medical, biological, and clinically relevant computational expertise. These centers will work with FDA Center scientific and statistical experts to define questions, datasets and approaches for performing complex analyses for comparative and multi-study analyses on FDA and other large clinical datasets. As part of this effort these Centers will conduct analyses on defined datasets including datasets previously developed as part the joint Janus initiative, where Center specific questions will drive the data transformed, standardized and loaded into the Janus data warehouse. Additionally, PACES Centers will be expected to participate in FDA-hosted scientific workshops that address issues such as methods for cross-study and other comparative analyses, best practices in CER, and candidate studies and their design and analysis methods. These strategies will also encompass clinical trial designs that can help advance personalized medicine and health outcomes both within and outside of the FDA. The Government intends on using a contract or contract(s) to establish two PACES Centers, each through a separate contract(or set of task orders) awarded to two uniquely different Contractors. Each Contractor will establish a PACES Center to develop and use advanced computational strategies and tools to conduct CER. Using CER methodologies, these Centers will address potential uses of large FDA datasets as well as or in conjunction with health outcomes data from other sources. In addition, the Centers will help to develop innovative clinical trial design and data analysis strategies that can be used by the Government to facilitate prospective studies that incorporate CER and personalized medicine approaches. The PACES Centers will provide scientific training and collaboration to benefit future FDA-CER efforts and enhance academic capacity and expertise in product related data. These training efforts will promote collaborative interactions with FDA scientific staff including, support of Postdoctoral Fellows both within the FDA and the PACES Centers; exchanges of scientific personnel between the FDA and the PACES Centers; and the sharing of collaborative studies, including potential joint manuscripts for publication of findings to benefit the medical and scientific community. Furthermore, the PACES Centers will be expected to participate in FDA-hosted scientific workshops to develop their plans for CER, and to discuss computational strategies developed and the findings from their analyses. This is a new requirement. D. Statement of Work: D. 1. Scope The Contractor shall establish and operate a PACES Center to conduct CER. This work effort shall include five principle components as follows: •Component 1- The Contractor shall plan and organize the CER project with FDA stakeholders, including a planning workshop to define candidate CER questions and issues, analyses strategies and datasets to be utilized. •Component 2 – The Contractor shall establish a PACES Center capable of supporting the Contractor’s staff and providing FDA-designated researchers access to CER analysis tools and datasets. •Component 3- The Contractor shall develop and establish a training program for scientific exchange. •Component 4 - The Contractor shall develop new scientific computing strategies and hone existing computational strategies to perform CER analyses on datasets. These analyses shall include reports and manuscripts of the results suitable for publication in scientific journals. The Contractor shall participate in FDA-hosted workshops to discuss analyses of results and proposed publications. •Component 5- The Contractor shall develop innovative clinical trial design strategies for prospective CER clinical trials, including providing formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons as well as CER related work targeted towards personalized medicine. These strategies and recommendations shall be documented in reports and manuscripts suitable for publication in scientific journals. D.2 Specific Work Requirements Component 1 – Plan and organize project 1.1.1Project Plan The Contractor shall develop and deliver a PACES project plan. This plan shall include: a)Contractor’s organizational structure, responsibilities for key members of the organization, and recommendations for alignment with the Government’s PACES team. b)Schedule of all required activities (tasks) and deliverables with adequate time allotted for Government review and comment for deliverables. c)Resources required to accomplish each task, including an estimate of the funding required and expected government furnished equipment (GFE), property (GFP), and information (GFI). d)Approach to be used to protect privacy information used and generated through the conduct of research required by this contract. 1.1.2Strategic Planning The Contractor shall participate in an FDA-hosted planning workshop with the PACES team to develop and deliver a strategic planning document that encompasses all future PACES Center plans. This plan shall: a)Include significant input from FDA Center representatives for candidate CER projects. Input for this plan shall be proposed by the PACES Center Principal Investigators and contain detailed information about CER methodological issues, scientific and clinical questions to be addressed, and the datasets that will be utilized to support the work. b)Be developed in consultation with FDA PACES staff. Requirements to provide support for the definition of CER questions that are part of the Janus joint portion of the FDA-CER project and which will be provided by the FDA, should also be delineated in this strategic plan. CER questions shall fall within one of the top 100 Institute of Medicine (IOM) topic recommendations for CER or within one of the 14 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) priority areas as defined by AHRQ as not currently addressed. Lists of these priority areas will be provided in Appendix 1 of this document. c)Outline the scientific computing strategies that will be undertaken to address the FDA-CER questions posed--including timelines, interim assessments and final result timelines and deliverables as agreed upon by the FDA Center representatives and FDA PACES project directors. As a result of conducting the strategic planning workshop, the Contractor shall update the PACES Project Plan with key strategic planning activities. d)For planning purposes, the Contractor shall participate in one meeting each year at the FDA’s White Oak Facility (10903 New Hampshire Avenue, Silver Spring, MD 20993). During this meeting, the contractor shall support planning sessions to discuss the work to be accomplished during the following year under the contract and report on the results of the activities accomplished during the previous year (if applicable). Component 2 – PACES Center 2.1.1Facility Requirements The Contractor shall provide/establish a PACES Center to: a)Provide adequate office and meeting space for Center staff to plan and conduct required research and other activities required by this task order. b)Include necessary Information Technology (IT) resources to support research activities to be conducted as part of this task order. These resources shall be available to Center staff and FDA-designated individuals. c)Include adequate protection of privacy information d)Include adequate physical and cyber security measures for the protection of sensitive information. e)Support research activities by Government-designated individuals within the Center as required Collaborative Environment. The Contractor shall provide the following capabilities to enhance collaboration between researchers and other stakeholders: a)Adequate office space for FDA-designated individuals (researchers) to conduct research within the Center. Office space for up to 4 researchers at a time with support for/access granted to up to 10 researchers over the life of the contract. b)Adequate conference facility space with supporting presentation capabilities (projector(s), white-boards, flip charts, audio amplification, tele- and video-conferencing) to support collaboration activities required by this task order. c)Support for remote collaboration with FDA and their stakeholders. Any tools (software, hardware) used by the contractor to support remote collaboration shall comply with FDA security requirements. Component 3 - Develop and establish training programs for scientific exchange 3.1.1Key Personnel The Contractor shall designate primary and secondary points of contact (POCs) for the PACES Center as key personnel. For the purpose of this task order, these POCs shall be designated as the Principal Investigator (PI) and Co-Principal Investigator/s (Co PI). a)Contractor’s POCs shall work collaboratively with FDA Center scientific staff to exchange information and approaches for computational analyses, including sharing of algorithms developed, statistical approaches developed or used and analysis datasets developed as part of the CER. b)The Contractor shall include responsibilities and qualifications for the PI and Co-PI in the project plan. 3.1.2Training and Scientific Exchange The Contractor shall develop and execute a training and scientific exchange program as follows: a)Scientific and research exchanges shall include opportunities for FDA scientific staff to spend time working at the Center. Conversely, PACES PI and Co-PI shall meet with FDA scientific staff at least bi-monthly to promote a confidential exchange of ideas as necessitated by FDA data. For planning purposes, the Contractor shall attend meetings for two business days at the FDA’s White Oak Facility (10903 New Hampshire Avenue, Silver Spring, MD 20993). b)Provide support for FDA-approved Postdoctoral Fellows to conduct CER research within each PACES Center. These Fellows will be expected to meet routinely with FDA staff and to provide support to FDA computational efforts undertaken as part of the CER initiative. c)Provide opportunities for statisticians, epidemiologists, clinicians and other scientific staff involved with the Center to work at the FDA in the form of scientific exchanges at the FDA and scientific exchanges for FDA staff at the PACES Centers or other non-FDA institutions that may be part of the CER Strategic Plan. Component 4 – Develop scientific computing strategies for CER and analyze datasets 4.1.1Develop CER Issues and Questions for Studies and Analyses The contactor shall develop advanced scientific computing strategies as follows: a)Address CER issues and questions, provided as part of the FDA Janus CER Initiative (also ARRA supported). b)Address issues and questions developed by the Contractor in consultation with the FDA Center representatives. The Contractor shall be prepared to discuss these issues and questions during the FDA-hosted strategic planning conference. c)After consultation with the FDA and stakeholders, define and prioritize the list of issues and questions to be studied. Questions must fit into the IOM or AHRQ priority areas as provided in Appendix 1. d)Once CER issues and questions are defined, develop and provide a written plan to conduct the necessary studies and analyses to address the agreed-upon issues and questions. e)Additionally, in conjunction with the FDA, catalog and provide datasets to address these issues and questions to support necessary analyses. f)Work jointly with the FDA Centers to define and assess quality of datasets intended to address CER questions if they are outside of the Janus CER Initiative scope. 4.1.2Develop/Select Methodologies for Studies and Analyses For each study/analysis effort identified and agreed upon by the Contractor and Government, the Contractor shall develop new or use existing advanced scientific statistical and computational methodologies to analyze datasets and produce reports with their findings. The Contractor shall: a)Work with FDA scientific staff to collaborate on analysis approaches, particularly when using the training and scientific exchange activities described in Component 3. b)Document the study/analysis methodology to be used. c)Document all algorithms, annotate code and analysis datasets, and document data structures used to support and conduct analyses. d)Document all data/analysis rights associated with the research e)Document programming languages used to develop analysis tools. If analysis tools were developed using non-standard programming language(s) (languages other than SAS, C and other standard software languages) the Contractor shall provide the justification for the use of non-standard languages and if approved by the Government, provide language/code reference manuals. 4.1.3Studies and Analyses Results The Contractor shall: a)In conjunction with the work effort provided in support of Components 1-3 (Sections 4.1, 4.2, and 4.3), participate in Janus CER Initiative analyses. b)Conduct and produce a minimum of two CER studies/analyses as defined by the PACES Center activities in sections 4.4.1 and 4.4.2 above. c)Where feasible and appropriate, prepare scientific findings that will be useful in advancing CER related methods and analyses (and other important results) for submission to peer reviewed scientific journals. These analyses shall include reports and manuscripts of the results suitable for publication in scientific journals. d)Conduct workshops to discuss analyses of results and proposed publications. The Contractor shall be prepared to discuss analysis methodologies used, results and recommendations for further study during the FDA-hosted strategic planning conference. e)Not publish results without receiving prior approval of the Government. Component 5- Evaluate and develop comparative innovative clinical trial design strategies 5.1.1Clinical Trial Review The Contractor shall initiate a review of a sample of FDA clinical trials performed to assess drugs, biologics and devices. As part of this review, the Contractor shall: a)Initiate a review of a sample of FDA clinical trials performed to assess drugs, biologics and devices. In this review, the Contractor will evaluate comparator groups, and populations studied and study design/endpoints, including in subpopulations to determine the impacts of study design resultant data analyses from these studies with respect to informing medical practice. b)Support the review and selection of clinical trials in different areas for review jointly by the FDA Centers and the PACES Centers. Particular attention should be paid to areas of significant impact on medical care. c)Be prepared to discuss proposed reviews and results from previous reviews (as applicable) during the FDA-hosted strategic planning conference. 5.1.2Best Practices Based on the results of the Clinical Trial Review(s) the Contractor shall identify and share best practices and innovative approaches that will improve utility of information obtained from clinical studies, including enhanced prediction of the comparative effectiveness of interventions, and their evaluation among different populations, subpopulations and individuals. The Contractor shall be prepared to discuss best practices during the FDA-hosted strategic planning conference. 5.1.3Design Strategies The Contractor shall: a)Propose strategies that take into account appropriate uses of control groups, and the potential use of interim analyses to adapt studies for patients most likely to benefit. These innovative designs are intended to provide strategies for the FDA to provide scientific input into enhancing the design and analysis of clinical trials targeted both towards comparison of interventions and towards enabling personalized medicine. b)Work with FDA scientific staff to collaborate on design strategies, particularly when using the training and scientific exchange activities described in Component 3. c)Provide reports of the design strategies to the FDA and prepare manuscripts for submission to scientific journals when appropriate. d)Conduct workshops to discuss analyses of results and proposed publications. The Contractor shall be prepared to discuss results of the analysis of design strategies, and recommendations for further study during the FDA-hosted strategic planning conference. e)Not publish results without receiving prior approval of the Government. D.2 Security Requirements This contract requires the Contractor pursuant to Federal and HHS Information Security Program Policies, and any subcontractor performing under this contract to comply with the following requirements: a) Contractor-Employee Non-Disclosure Agreements Each Contractor/Subcontractor employee who may have access to non-public Department information under this contract shall complete the Commitment to Protect Non-Public Information - Contractor Agreement (http://nitaac.nih.gov/downloads/ciosp2/Contractor_Employee_Non-Disclosure.doc). A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer prior to performing any work under the contract b) Confidential Treatment of Sensitive Information The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of any contract issued under this contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive or of pre-decisional nature Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer or designee (e.g., COTR). Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer or designee (e.g., COTR) c) Contractor and Subcontractor Staff The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under task orders of this contract. The roster submitted to FDA shall be submitted to the COTR, with a copy to the Federal Contracting Officer, within 2 business weeks of the effective date of the task order E. Procurement/Contract Strategy: 1) The government is anticipating that one or more contracts may be awarded for this requirement for one or more PACES centers. 2) The government is anticipating award of a Cost Plus Fixed Fee (CPFF) contract for this effort. F. Period of Performance The contract will have a base year period of performance from July 1, 2010 to June 30, 2013 with two (2) one (1) year options. G. Capability Statement Requirements: Interested parties are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 (“Limitations on Subcontracting”). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Respondents must address their capability, experience and knowledge directly correlated to the Statement of Work. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. H. Instructions/Requirements for Submitting Sources Sought Responses to FDA: 1.Business Information -- a.DUNS: b.Company Name c.Company Address d.Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the CCR. All Offeror’s must register on the Central Contractor Registration located at http://www.ccr.gov/index.asp. Note: To receive an award under the anticipated solicitation/RFP, all Offerors must be CCR registered, referencing the NAICS code of 541712. e.Company Point of Contact, Phone and Email address f.GSA Schedule Contract Number (if applicable) g.Point of Contact, Phone and Email address of individuals who can verify the capabilities/experience identified in the responses. 2. Capability Statement and Experience - Responses must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive evaluation; and evidence that the contractor can satisfy the minimum requirements listed in section G above while in compliance with FAR 52.219-14 (“Limitations on Subcontracting”). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Respondents must address their capability, experience and knowledge directly correlated to the Statement of Work. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. 3.All transmitted information marked proprietary shall be treated as such. Therefore, businesses should identify any proprietary information in their Sources Sought response. Proprietary materials will neither be distributed, nor discussed with, any other organization. Information submitted in response to this SOURCES SOUGHT will be used at the discretion of the Government. Further, the information submitted will remain confidential insofar as permitted by law, including the Freedom of Information and Privacy Acts. FDA does reserve the right to utilize any non-proprietary technical information in the anticipated SOW or solicitation. 4.Respondents should be aware that this Sources Sought is for marketing purposes only and any responses thereto, or lack thereof, will not constitute a commitment by FDA to treat any potential offeror more or less favorably in the anticipated forthcoming solicitation and/or ultimate award. Please be advised that FDA will not respond directly to organizations submitting information in response to this Sources Sought. The information received will be used solely to make informed acquisition decisions. 5.Email your responses to the cognizant Contract Specialist, Dominique.Malone@fda.hhs.gov on or before 8:30 AM eastern standard time March 8, 2010. Disclaimer: Responses to this Sources Sought are not offers and cannot be accepted by FDA to form a binding contract. FDA does not intend to award a contract on the basis of this SOURCES SOUGHT or to otherwise pay for the information solicited. Other Information: •Proprietary Information and Disclaimers: All transmitted information marked proprietary shall be treated as such. Therefore, respondents should identify any proprietary information in its Sources Sought response. Information submitted in response to this Sources Sought will be used at the discretion of the Government. Proprietary materials will neither be distributed, nor discussed with, any other organization or business. Further, the information submitted will remain confidential insofar as permitted by law, including the Freedom of Information and Privacy Acts. Respondents should be aware that this SOURCES SOUGHT is for marketing purposes only and any responses submitted do not constitute a commitment by FDA to treat any offeror more or less favorably in any anticipated forthcoming solicitation and/or ultimate award. •Responses to the Sources Sought are not offers and cannot be accepted by FDA to form a binding contract. FDA does not intend to award a contract on the basis of this Sources Sought, or to otherwise pay for the information solicited. No reimbursement for costs will be made associated with providing information in response to this Sources Sought or follow-up information request. •Responses to the Sources Sought will not be returned and will not be accepted after the due date. All communications shall be by email. •Respondents will not be notified of the results of the review of the responses. Information received will be considered solely to make informed decisions regarding a potential procurement. On behalf of the Food and Drug Administration, thank you for your interest.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/PACES-ARRA-OS/listing.html)
Place of Performance: Address: Contractors location and, WO1 RM2312 HF-22, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN02076881-W 20100227/100226095050-66e2666b82b4adf17c6840e3a5587436 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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A -- Research and Development Sources Sought PACES-AARA-OS