This is a combined synopsis/solicitation for a commercial item prepared with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541611, is to notify contractors that the government intends to issue a contract in accordance with FAR part 12. Quotes are being requested. This is a request for pricing (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 05-26. The small business size standard is $6.5.M. Solicitation is to procure the services of a company that has proven experience, expertise, knowledge, and abilities to continue the OC-wide Strategic Planning, Executive Leadership, Coaching and Facilitation Initiatives and to expand the nature of the work being done. The objectives are to continue to assess, plan, develop, implement and evaluate the needs and culture of the CDER Office of Compliance and its key stakeholders to maximize it program and personnel's effectiveness in protecting and promoting the public health of the American public. This will be accomplished by developing and implementing individualized and prioritized Strategic Plans and leadership training for a base year plus two additional years encompassing every program area in the Office of Compliance. Independently and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials, services, facilities and otherwise do all things necessary for or incident to the performance of the work described below. The contractor shall provide all personnel, equipment, supplies, supervision necessary to provide Strategic Planning Initiation, Executive consultation and coaching and Collaboration/Facilitation Services to the FDA CDER Office of Compliance, in accordance with the Statement of Work and all terms and conditions of this contract. The period of performance shall be from 1 September 2008 - 31 August 2009 with two (2) option years. All work shall be performed in accordance with the following statement of work, all terms and conditions of this contract and each individual task order. The capabilities required under this contract include a thorough and comprehensive understanding of the organization, its structure, key stakeholders, and the cross over relationships and work process interdependencies between the Office of Compliance and other Offices within the Center and other key stakeholders within the agency. Additionally, the capability to plan, sustain - breakthrough strategies techniques for strategic planning implementation and - resilient leadership modeling for change management will be required. All prospective contractors shall propose a firm hourly rate and estimated hours required for each objective and optional tasks and an estimated total dollar amount per objective and task. SECTION B - SUPPLIES OR SERVICES AND PRICE/COST The Center for Drug Evaluation and Research (CDER) Office of Compliance initiated a 5-year Strategic Planning Initiative, along with Executive Leadership Development and Facilitation Skills development to prioritize and focus its resources and efforts to maximize its impact on public health, improve its leadership and management practices, and strengthen its collaborative interactions with other key agency stakeholders in order to maximize dedicated efforts to accomplishing these goals. This initiative will strive to meet the Agency and Center mission and vision and address many of the concerns raised by the 2006 IOM Report on Safety. To achieve this initiative, CDER Office of Compliance (OC) engaged the collaboration of a skilled and expert consultant along with key leaders and managers from the Office of Compliance and CDER managers at large. Strategic planning objectives, executive level professional coaching, Center collaboration model development, and CDER Senior Management Team (SMT) leadership development initiatives were implemented and remain ongoing. Now that a framework has been established, the scope of the program needs to expand and additional services will be needed as this broad Office-wide initiative moves forward while continuing to develop, implement and prioritize strategic planning, leadership development, and quality system management tools encompassing every program area in the Office of Compliance and its collaborations with key agency stakeholders. The total estimated hours for all tasks per year may not exceed 900 hours. 1. Strategic Planning Objectives (a) The contractor shall serve as an advisor and facilitator for the Center for Drug Evaluation and Research Office of Compliance (CDER OC) strategic planning process implementation, working in close cooperation with the OC leadership and staff, the CDER Senior Management Team (SMT) and other key stakeholders and others in performing the Strategic Planning tasks; (b) Develop and deploy an ongoing process of implementation and accountabilities as it relates to the OC Strategic Initiative program and related OC mission and vision. (c) Develop recommendations and materials to document the overall process, design, timing, key components and emphasis; (1) Develop selected documents to support the process, including outlines, discussion papers, and process recommendations; (2) Attend and participate at regular meetings with staff where key planning issues or topics are addressed. (3) Assist in the ongoing development of key strategic questions; (4) Provide on-site facilitation/moderation of key meetings, retreats, conferences and work sessions, including meetings planned for internal and external groups, and a strategic planning conference; (5) Assist in developing and fine tuning outlines for the strategic plan, as well as review of drafts prepared by the project leaders and project management officers; (6) Monitor and regularly report on the status of the overall project, and develop related recommendations for upcoming activities; (7) Establish a format and process for semi-annual Office-wide evaluation of ongoing and new initiatives based on the ever-evolving priorities of the Agency, Center and Office; (8) Provide advice and council to the CDER OC Director, Deputy Director and staff on all matters related to the development of the strategic plan. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 1.1 : (a) Develop and establish a Quality Systems Management approach to the overall business operations of the CDER Office of Compliance which would integrate various internal processes (i.e., policies, processes, and procedures) within the organization and provide and approach for project(s) execution and organizational planning. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 1.2: (a) Linking and integrating a QSM approach to the overall Strategic Planning Initiatives in CDER OC Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ 2. Executive Coaching CDER OC identified Executive Coaching as an important vehicle that facilitates organizational transformation and strategic leadership development at the individual, team, organizational, and Center level. CDER OC commenced Executive Coaching training with experiential learning, leadership training, organizational development interventions, and Office-wide cultural change initiatives to transform its leadership culture. Senior leaders are now seeking to expand those coaching opportunities for their teams and groups at the Division and Office-wide level. By continuing this service, senior leadership will have personalized confidential one-on-one coaching and team/group coaching to create shared vision, strategy and action. The goals of this Executive Coaching model includes, but is not limited to: - Integration of Executive Coaching through utilization of the adaptation of the Bowen Theory to leadership to effect comprehensive leadership, organizational development and change management strategies. - Link the Executive coaching program's vision to CDER OC's bottom-line leadership and regulatory issues and challenges, core values, leadership competencies, and desired cultural attributes and behaviors. - Shift CDER OC's leadership mindset, behaviors and ways of relating at the individual, organizational, and agency levels. The contractor shall 1. Provide support for functions and tasks as directed and prioritized by the Office of Compliance and CDER SMT. These overall functions are: (a) Strategic and Operational Program Management (b) Orienting, Building, and Sustaining the Executive Leadership (c) Building an Executive Leadership Cadre (d) Program Evaluation & Feedback 2. Create and implement an Executive Coaching culture that encourages connection, continuous learning and commitment. The contractor shall provide advice, and counsel to Office of Compliance leadership, key stakeholders to assist in setting clear goals, objectives, tactics and strategies that will move the program to its desired vision for the future. 3. Assist the Office of Compliance management team in refining the vision for Executive Coaching as is necessary. 4. Implement processes and approaches to assess current capabilities, create a picture and plan for the desired future, and deliver appropriate activities and actions to get there. The contractor shall facilitate the continued development and implementation of a corporate culture of coaching that is fully integrated and linked with the leadership strategy, organizational development and change management strategy, and FDA's vision, mission, and workforce excellence strategy. The contractor shall build and continue to implement a solid foundation for the program and provide innovative processes and procedures that will sustain the program while simultaneously increasing the program's capacity and impact. 5. Maintain and evolve an Executive Coaching Strategy document, which leverages current efforts and expands the programs vision and capabilities throughout the Office/Center. 6. Provide guided self-study materials on a regular basis (i.e., quarterly) 7. Plan and facilitate team building sessions on a quarterly basis or as needed ( i.e., two - - day and two -1 day sessions for FY 2009) 8. Design and implement a process to monitor the effectiveness of Executive Coaching services. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 2.1 - Ensure linkages between OC, the CDER Senior Management Team (SMT) and/or other key agency stakeholders through regular coaching sessions Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 2.2 - Provide executive coaching services for members of the OC-SMT and utilize the results of a customized self-assessment and OC team management team assessment to create and advance a professional development plan for identified members. This is a function of budget, client interest and programmatic needs. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 2.3 - The Contractor may provide coaching/executive development services that may include one-on-one in-person coaching, telephonic coaching, team/group coaching, coach-related assessment and coach awareness and skills training. The CDER OC cannot accurately predict how many sessions will occur in any year. This is a function of budget, client interest and programmatic needs. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ 3. Leadership Development CDER OC identified Leadership Development as an important vehicle that facilitates organizational transformation and strategic leadership development at the individual, team, organizational, and Center level and supports the organizational efforts of the Strategic Planning Initiative. In this regard, the Contractor shall 1. Enhance the professional development plan(s) to improve leadership effectiveness 2. Research, develop and continue to implement a customized leadership development program to make significant progress in: (a) effective teamwork, (2) strategic thinking and planning, (3) strategic leading, (4) change and transition management, (5) collaboration with CDER OC and key agency stakeholder groups, (6) emotional intelligence, (7) OC employee engagement. 3. Provide status reports as directed by the OC senior management (i.e., quarterly) Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 3.1 - The contractor shall build a cadre of individuals that become proficient in executive leadership as demonstrated through the key elements awareness of experiential learning, leadership competencies and training of others, desired cultural attributes and behaviors, organization development interventions, and agency-wide cultural change initiatives. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 3. 2 - The contractor shall evolve and maintain a cadre of individuals that become proficient in executive leadership as demonstrated through the key elements awareness of experiential learning, leadership competencies and training of others, desired cultural attributes and behaviors, organization development interventions, and agency-wide cultural change initiatives. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 3.3 - In addition to leadership development, the Contractor may also include other related executive services (e.g. individual; team/group coaching; coach skills training) and shall be used as directed by the Office of Compliance senior management team. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Option Task 3.4 - During the year, upon concurrence from the OC Management Team, senior leaders and mid-level managers may utilize just-in-time and highly customized Executive Leadership services to meet the needs of their individual organization (Office/Division). The OC cannot accurately predict how many sessions will occur in any year. This is a function of budget, client interest and programmatic needs. Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ 4. Collaboration/Facilitation Skills Initiative The contractor shall transfer knowledge of facilitation and communication enhancement models to senior level management positions, mid level manager positions and technical experts through a customized collaboration/facilitation model. The Contractor shall 1. Develop and implement a collaboration model in conjunction with senior level management, mid-level managers and technical experts as identified by the Office of Compliance and other key stakeholders. Communication enhancement sessions would be conducted over a one year period with one-two hour meetings/consultations as identified by the CDER Office of Compliance leadership. 2. Implement and facilitate authorized strategies for improved collaboration 3. Establish annual targets and milestones for collaboration model 4. Meet with the assigned leadership in face-to-face or by conference call settings. 5. Provide assistance to the Compliance leadership and other stakeholders in feedback (quarterly) on milestones achieved or areas of weakness identified. 6. Develop and Implement a plan for assessment and evaluation of achievements 7. Evaluate and recommend alternate assessment methods for individuals and team/group facilitation Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 4.1 - Maximize the function and relationships between the CDER OC and other key stakeholder groups to meet the mission of CDER and programmatic areas of mutual interest Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ Optional Task 4.2 - Facilitate focus groups, meetings, and other forums as directed by the OC on behalf of itself or its key stakeholder groups Hourly Rate Estimated Hrs Estimated Total $_____________ __________ $______________ The Government and Contractor will work together to make professional decisions regarding recommended processes, planning and direction. The contractor shall provide all personnel, equipment, supplies, supervision necessary to provide executive consultation and coaching services to the FDA CDER Office of Compliance, in accordance with the Statement of Work and all terms and conditions of this contract. The period of performance shall be from 1 September 2008 through 31 August 2009, plus two (2) one-year options'each renewable annually at the discretion of the Government. All work shall be performed in accordance with the statement of work, all terms and conditions of this contract and each individual task order. ISSUANCE OF TASK ORDERS. The contractor will be provided a statement of work for the individual task to be performed. The contractor shall, with in the timeframe specified, submit in writing a proposal for the work to be performed. The proposal shall identify all necessary labor classification of work, number of labor hours and (if any), associated costs needed to perform the task. The number of hours assigned to individual task orders and all associated cost will be subject to negotiation between the contractor and the Contracting Officer (CO) or his/her designated government representative. TRAVEL AND PER DIEM COST Occasional travel may be required in performance of task orders. Travel rates will be subject to the provisions of the Federal Travel Regulations in effect at the time of negotiations. Reimbursement of travel expenses shall be in accordance with current Federal Travel Regulations and upon presentation of required receipts. Expenses for subsistence and lodging are reimbursed to the contractor only to the extent where overnight stay is necessary and allowable by the current Federal Travel Regulation in effect at the time of stay for the temporary duty station. The contractor shall include travel costs in its quote as appropriate to each task/deliverable. PERIOD OF PERFORMANCE: The Government may extend the term of this task order by preliminary written notice to the Contractor of its intent to exercise an option period thirty days prior to the expiration of a task order period. This preliminary notice does not commit the Government to an extension. The total duration of this task order shall not exceed 3 years. Upon execution of an option year, an additional 12 months shall be added to the task order performance and an additional $_________________ will be added to the established task order ceiling. Performance of this task order shall begin upon award and shall not extend beyond three years. Except for emergency situations, proposals for Task Orders shall be submitted within fourteen calendar days after receipt of the Statement of Work. If additional time is needed the contractor shall request additional time within three calendar days after receipt of the statement of work. Proposals shall include a schedule of performance and a staff plan including estimated man hours by labor category. The Contractor shall warrant that the rates charged under this task order shall not exceed the rates charged by the Contractor to its most favored customers for like items or services under comparable conditions. It is anticipated that the following types of labor may be necessary to perform under this task order: Senior Project Manager Executive Coaching and Collaboration/Facilitation Improvement/Strategic Planning Initiative: The Government requires a minimum of a 40 hour full-time equivalent with experience in both executive coaching and facilitation and social systems skills to provide Executive Coaching, Facilitation and collaboration skill-building and Strategic Planning related services. The contractor shall oversee the various tasks as outlined in conjunction with the OC Senior-level management team. EQUIPMENT The Contractor shall provide all desktop hardware & software for their personnel that are requested / required to perform the work on Government sites as well as contractor sites. Hardware and software must be compatible with FDA systems and meet any / all security requirements of the FDA. Hardware shall include interface devices required to interact with Government systems / networks. Software applications shall include standard applications as used by the Government to provide for interaction between the Government and the Contractor personnel and systems. Government furnished equipment shall only be provided at the discretion of the Government. CONFIDENTIALITY: A. The contractor's personnel shall agree to comply with the Privacy Act of 1974 (the Act) and other applicable federal laws, rules, regulations and policies issued under the Act during and after the execution of this contract. Any information about an individual that is maintained by the FDA, including, but not limited to, education, financial transactions, medical history, and criminal or employment history or any record that contains the person's name, or the identifying number, symbol, or other identifying particular assigned to the individual, shall be kept CONFIDENTIAL. REPORTING REQUIREMENTS: The contractor shall report on a monthly basis the number of hours worked. Deliverables will vary, depending upon the statement of work of the individual task order. Each task order will state in details the specifications, quantity, method of submission and due date of all deliverables. Deliverables may include consulting services, project schedules, software, analysis and design documents, monthly reports, presentations, and documentation generated from work performed under the statement of work. Deliverables may be required in person, printed hard copy and electronic form. Electronic submissions shall be made via e-mail. The Contractor shall provide quarterly progress reports to the Contracting Officer throughout the contract period. Progress reports shall contain a brief summary of efforts, accomplishments, problems and action plans. The Contractor shall deliver services and products described by this contract and the individual task order. All deliverables shall be submitted to the Contracting Officer or his/her designee. The provisions of FAR Clause 52.212-1, Instructions to Offerors-Commercial Items, is applicable to this acquisition. The Offeror shall submit a fixed price labor hour cost quote. The quote shall indicate the applicable direct labor categories with loaded hourly rates, and any associated other direct costs. Other direct costs should include an explanation for the basis of the estimate. In addition to a price quote, the Offeror must submit a detailed technical plan, which will receive paramount consideration in the selection of a Contractor. The total number of pages for the technical plan is not expected to exceed ten (10) pages in length, excluding resumes. A detailed technical plan must indicate how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical plan should reflect a clear understanding of the nature of the work being undertaken. The technical plan must include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks. Plans, which merely offer to conduct a program in accordance with the requirements of the Government's scope of work, will not be eligible for further consideration. The offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. The evaluation will be based upon the demonstrated capabilities of the prospective contractor in relation to the needs of the project as set forth in the RFQ. The evaluation will be based on the demonstrated capabilities of the prospective offeror in relation to the technical plan and needs of the project as detailed in the Statement of Work and on the following technical evaluation criteria: (a) Past Performance: Offeror's experience with strategic planning, leadership development, executive coaching and facilitation skills management , in the context of the organization, its programs and organizational structure to sufficiently to guide an efficient and inclusive process. The plan must detail the work performed by the Offeror within the last three years which demonstrates relevant experience. 40 points. Offeror's knowledge and experience working with the organization and stakeholders in the context of the FDA CDER OC and its programs within the last three years 20 points. (b) Technical: Offeror's knowledge and experience with the methods and models of executive coaching and leadership development, and if applicable, experience with the breakthrough strategy techniques and resilient leadership coaching models 20 points Offeror's experience in successful implementation of strategic planning and executive leadership development and coaching 20 points Offeror's approach for managing contract work, including general on-site management background and approach, supervisory responsibility, lines of authority, organizational structure, and qualifications of staff. Describe relevant experience in performing similar activities with reference to current or previous clients 10 points COMMERCIAL CLAUSES IN ACCORDANCE WITH FAR PART 12 - INCORPORATED IN FULL TEXT: FAR 52.212-4 CONTRACT TERMS AND CONDITIONS'COMMERCIAL ITEMS (FEB 2007) (a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights (1) Within a reasonable time after the defect was discovered or should have been discovered; and (2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item. (b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Government wide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract. (c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties. (d) Disputes. This contract is subject to the Contract Disputes Act of 1978, as amended (41 U.S.C. 601-613). Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract. (e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference. (f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence. (g) Invoice. (1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include (i) Name and address of the Contractor; (ii) Invoice date and number; (iii) Contract number, contract line item number and, if applicable, the order number; (iv) Description, quantity, unit of measure, unit price and extended price of the items delivered; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading; (vi) Terms of any discount for prompt payment offered; (vii) Name and address of official to whom payment is to be sent; (viii) Name, title, and phone number of person to notify in event of defective invoice; and (ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract. (x) Electronic funds transfer (EFT) banking information. (A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract. (B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer'Central Contractor Registration, or 52.232-34, Payment by Electronic Funds Transfer'Other Than Central Contractor Registration), or applicable agency procedures. (C) EFT banking information is not required if the Government waived the requirement to pay by EFT. (2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315. (h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings. (i) Payment. (1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract. (2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315. (3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause. (4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made. (5) Overpay...