SOURCES SOUGHT
R -- Computational Science Capabilities Assessment, Strategic and Operational Planning and Implementation Support
- Notice Date
- 4/24/2008
- Notice Type
- Sources Sought
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- 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
- FDA-SOL-08-00608
- Point of Contact
- Karen R. Petty,, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Solicitation: FDA-SOL-08-00608 Agency/Office: Food and Drug Administration Location: Office of Acquisitions and Grants Services Title: R – Computational Science Capabilities Assessment, Strategic and Operational Planning and Implementation Support. Description(s): THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any sources with capabilities or prior experience to engage outside expert consultants to perform, as required under specific tasks, scientific computing and business informatics needs assessments, benchmarking and business plan development, environmental assessments, strategic and operational plans, implementation support, and other technical assistance needed to ensure effective, efficient, sustainable and successful establishment and operation of scientific computing resources to support the mission of the Food and Drug Administration. This is a potential Indefinite Delivery Indefinite Quantity (IDIQ), firm-fixed price contract with a base period and four option years. A previous source for a similar requirement was Booz Allen Hamilton. STATMENT OF WORK: The contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things, except as provided in the schedule, necessary for or incident to the performance of the work as described below. The contractor shall be prepared to develop a response to individual tasks as they are assigned. This will be a task order contract extending for one year with four option years. This contract could be used for one or more strategic assessment, planning and implementation tasks, and other technical assistance work as needed to support scientific computing and business informatics for CDER human drug programs. This contract could also be used for similar tasks and technical assistance for non-CDER FDA programs, but these would have to be funded with resources other than CDER funds. The contractor shall specify the methods it will employ in accomplishing the key tasks of each task order. The contractor shall demonstrate the ability to do the following: 1. Develop project designs and plans, including an evaluation study design and plan, including retrospective and prospective analyses and comparisons of performance as appropriate for each task. 2. Develop a data collection plan that includes the kinds, and availability of, data necessary to complete specified tasks. 3. Analyze program parameters as appropriate including scientific computing information management requirements, technology requirements and assessments, identification of best practices, forecasting technology and business needs, and application of other relevant analytic tools. 4. Evaluate the effectiveness of current, proposed and planned capabilities, identifying appropriate benchmarks, developing performance metrics, and other appropriate measures of merit. 5. Retrospectively evaluate or prospectively estimate the impact of changes in scientific computing and business informatics on center costs and mission performance. 6. Develop plans for and support engagement of internal and external stakeholders in planning and implementation activities, as needed, to ensure well-informed and well-designed approaches that are effective, successful and sustainable. 7. Develop strategy for sustained implementation of scientific computing and business informatics needs to support the review process. 8. Develop business plans as needed to support the implementation of strategic plans 9. Develop reports and presentations per agency-specified requirements 10.Provide routine briefings to designated FDA/CDER staff on the progress of work under specified task orders, analysis findings, and other contract deliverables. 11.Provide detailed breakdown of work and associated costs for each requested data task. Special Terms and Conditions: 1. The Contractor must possess expertise in Information Management (IM) and Health Care Systems including Food and Drug Administration. Anticipated Areas of Analyses for which Task Orders May be Issued to the Contractor The following list illustrates the kind of evaluation tasks that may be requested. Actual task orders will reflect agency priorities at the time of initiation. The contractor shall demonstrate the ability to conduct technical assistance and program evaluations over several years. 1). Provide technical analysis and strategic planning support for development of short term, intermediate and longer term strategy for CDER information management supporting regulatory decisions from a team-based perspective. This may include medical officer, statistician, safety reviewer, toxicology, chemistry and manufacturing controls/quality-by-design clinical pharmacology, genomics, epidemiology, compliance perspectives, and other perspectives. 2). Provide technical analysis/input for transformation of computational infrastructure to facilitate enhanced drug review and signal detection to support improved analyses and decision making. 3). Conduct comprehensive baseline needs assessment and target capabilities for computational science in CDER, including development of a multi-year plan including scenario analysis and contingency planning. 4). Conduct review to identify benchmarks to gauge CDER progress in achieving targeted computational and related analytic and decision support capabilities and evaluation of measurable impact on achievement of center mission objectives. 5). Develop and prioritize work streams for implementation which include project management, tracking, creation and implementation of metrics (e.g., progress, impact, cost), and communication of progress based upon key milestones identified in strategic planning activities. These work streams will be phased into scoping and implementation based on priorities and funding over the contract period. 6). Implement prioritized work streams which include a plan for cultural change related to staff training in scientific computing tools and processes. This includes a team strategy that promotes collaboration and support of the interdisciplinary teams to support regulatory decision making. 7). Propose a governance structure for oversight of CDER scientific computing needs and implementation process. 8). Develop and incorporate a plan for sustained cultural change within CDER that is consistent with a team-based approach using available scientific computing tools. 9). Provide analytic and technical support to programs in developing operating plans that are appropriately integrated across functions commonly supported by the evolving computational infrastructure. Reporting Requirements and Deliverable Items: These requirements will vary by task and are to be determined upon issuance of individual task orders. Final reports will be required for each task order. The contractor shall submit a final report within 30 days of completion of each task. The contractor shall be responsible for the following: A. TRAVEL ARRANGEMENTS, including but not limited to the following services: 1. Development of detailed travel itineraries; 2. Making complex travel arrangements, utilizing a variety of modes of transportation, as dictated by the needs of a given project and budget; 3. Purchase of economy airfare or other tickets in conformance with Federal Travel Regulations for domestic and international travel; 4. Purchase of ground transportation as required. B. PROGRAM DATABASE AND ACCOUNTING SYSTEM: The contractor shall establish and maintain a database or information system to keep the Project Officer apprised at any time of: 1. The status of arrangements for any particular delegation or visitor 2. The costs attributable to a particular delegation or visitor, both projected costs and the final actual costs. The contractor shall establish and maintain a system whereby charges are clearly segregated and billed according to the work order. C. COMMUNICATIONS AND REPORTING: 1. The contractor will be advised in writing of all work requirements, including meeting/conference requirements, delegation visits, visits by ranking officials, requirements for translation or interpretation services, or any other activity covered by this contract. However, in some instances, due to time constraints, the initial request may be by telephone, in all cases, the initial request will be followed by a written work order. 2. The contractor shall provide the Project Officer written confirmation upon receipt of each work order. Upon completion of each individual work order, the contractor shall provide the Project Officer with a comprehensive written accounting of the actual costs and charges for the work. 3. The contractor shall only take requests for services/instructions from the Project Officer, Alternate Project Officer, Contracting Officer, or other designee authorized in the contract. d. The contractor shall only accept changes in a program or services from the Project Officer, Alternate Project Officer, Contracting Officer, or other designee authorized in the contract. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the contractor when the manager is absent, shall be designated in writing (technical proposal key personnel) to the Contracting Officer. The contract manager or alternate(s) shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate(s) shall be available during normal business hours, as well as evenings and weekends. The contract manager and alternate(s) shall be able to read, write, speak, and understand English. PLACE OF PERFORMANCE: Work shall be performed at the Contractor's normal place of business, or as specified in the individual task order. Companies are encouraged to respond if they have the capability and capacity to provide the identified services with little or no disruption of services to the current users at the FDA. Interested small business potential offerors 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 numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above wile 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. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541611 with size limitation standards of $6.5M and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement shall also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE no later than 3:00pm, Eastern Time, May 12, 2008. The capabilities response shall be e-mailed to: karen.petty@fda.hhs.gov. All information received in response to this notice that is marked Proprietary will be handled accordingly. Responses to the notice will not be returned, nor will there be any ensuing discussions or debriefings of any responses. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. This notice is part of Government Market Research, a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. The FDA will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the content of any responses to this notice may be reflected in subsequent solicitation. FDA reserves the right to contact any respondent to this notice for the sole purpose of enhancing FDA's understanding of the notice submission. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited.
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