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FBO DAILY ISSUE OF JUNE 26, 2009 FBO #2769
MODIFICATION

R -- Training for Leasdership and Development for Successful Organizational Change for the FDA

Notice Date

6/24/2009
 

Notice Type

Modification/Amendment
 

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

1058150
 

Archive Date

7/14/2009
 

Point of Contact

Mary Rose A. Nicol, Phone: 3018277183
 

E-Mail Address

MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

The purpose of this Amendment 0003 is to include the following vendor questions and FDA responses for this soliciation. The subject solicitation has been posted FEDBIZ and we received the following questions. Please review and forward me your response as soon as possible. QUESTION I: Your RFP states "Deliver a 2-day training program on team development and training service to each of three OSE divisions." This is a total of six days of training. Your Pricing Table appears to be asking for a different service: It asks for multiple days of interviews for two consultants and two separate two day retreats. The pricing schedule does not match the statement of work. Is the pricing schedule provided as an example of the format that you would like us to use for pricing this RFP. Please explain. The only requirement is the three 2- day training sessions and coaching fulfilling the technical requirement. If it takes the contractor longer than the projected/estimated time we projected for the preparation of the training program it’s on the contractor’s time. QUESTION II: Do expect the training to be delivered by two consultants? Yes for the Divisions of Epidemiology, and Medication Errors Prevention and Analysis. One for the Division of Risk Management. QUESTION III: How many participants will be involved in each training event? As stated in the solicitation: Division of Epidemiology – estimated 20 participants Division of Medication Errors Prevention and Analysis – estimated 30 participants Division of Risk Management – estimated 10 participants Do you know if the above-cited solicitation will require evaluation of the training solicited? 1.Is DEPI, DMEP and DRISK the new OSE divisions? What is the difference between the three, and the difference between those who make up the new divisions? This info is public record and can be found on the internet especially on the FDA and CDER websites. 2.Is the two-day retreat the same material for each of the three divisions? The overall content of the training material should incorporate the requirements in the technical section of the solicitation, but should be modified to according to the specific organizations needs. Or will you expect the material to be modified for each division? We expect modification based on each division's requirements. 3.Are you requiring two consultants in order to speed up the interview process? No. The two consultants are for the actual training. We want a 10-15 participants to 1 consultant ratio. Are we allowed to use only one? You may use one for the preparation if you wish to propose it, but in the training we require 2 consultants for the organizations larger than 15 participants. Our reasoning is that we want the consultants to be familiar with the staff and supervisors, specifically names and roles since this training is only for two days, along with the acquired knowledge from the interview process to differentiate among the organization teams within each division its deficiencies that need addressed when performing the training so the consultants know what to emphasized from the training materials and exercises. 4.Are you requiring two consultants to team-teach the retreat? No. We require the ratio for the actual training to be 10-15 participants to 1 consultant. Are we allowed to use only one? For the Division of Risk Management "Yes", but for the other two divisions we require 2 consultants due to the size of the organizations. 5.Is this a customized training that is ‘specifically designed’ to meet your needs? Yes 6.Is the reason for the individual interviews to collect information by which to design the training? Yes 7.During the individual interviews are the interviewees to act as subject matter experts to offer content and information by which to design the training? Yes. 8.In the pricing sheet there appears to be line items for everything except the design time. The Independent Government Cost Estimate is a tool and requirement for the government organization to estimate/project cost of services. The design is incorporated in the preparation section. We do not need price to be broken down. Where would you like us to submit our estimate for time and pricing for the designing of the program / writing the curriculum? We do not need price to be broken down. 9.Who is responsible to design, hand out, collect, and analyze the feedback forms? The Contractor is responsible for the design & handout and the Gov. is responsible for approving the design, and collecting and analyzing feedback. 10.Do we understand Requirement #2 correctly that the contractor is responsible to teach concepts that develop the participants, and Requirement #3 is to teach concepts that help participants to develop others? Correct. Develop the participants requirement is for the entire staff, and participants to develop others is for supervisors & team leaders. 11.What were the previous roles of the new OSE members? We want the training to assist them in meeting their new roles. 12.Can we use personality assessments and 360 feedback methods as part of the training? Yes. 13.It is stated that the period of performance is four months. Solicitation needs to be amended to 12 months as period of performance. Are you wanting all three retreats and related services to be completed within four months? No. We want it to be completed within 12 months. 14.Requirement #2 states that coaching is to take place. Coaching is only limited to the Division Director, Deputy, and team leaders. Is this only to take place within the two-day retreat? At the end of the training. Or the four month time period? No. We want it to be completed within 12 months. 15.Will there be a separate pricing line item for coaching / consulting? No. A total cost for services sought is sufficient. 16.Is it correct that we are to submit the pricing table and a proposal? Submit a pricing proposal and a technical proposal. 17.What is the purpose of requesting labor rates? Evaluation of price Are there additional services needed that are not mentioned in the RFQ? No. 18.Since each retreat is 2 days in length, is this equivalent to 16 hours of material for each retreat? Depends on the organizations needs. We are just setting a cap as to the length based upon past training experiences and success of the training provided. Also taking into account that a longer length of time would compromise day to day operations, workload responsibilities and deadlines when a whole organization is out of the office. 19.Will the government furnish the training facility, training supplies, and participant materials? Government will furnish all but the training manual for each participant. 20.Who retains the copyright for the training material – the government or the contractor? Government 21.Will the contractor repeat this training after the four months? The performance duration is 12 months. After 6 months from completion an evaluation process by senior management will dictate if future training is needed. 22.If not, are you expecting the contractor to train someone else to deliver it? Preference is to keep same contractor/consultants that were successful, but because of sole source limitations by the FAR, this may not be feasible and future training requests will need to be solicited for full and open competition. 23.Is the ‘transformation plan’ available? Public record. On the internet (See CDER Transformation or Safety First). 24.Is the organizational chart available? Public record. On the internet See FDA website (Organization Charts). 25.Does the government anticipate that the offeror will design and deliver the feedback document or will the government provide this document? If the government will provide this document, may I have access to the document? Contractor - Design & handout. Gov. - approve design, collect and analyze. 26.Would you please clarify what is meant by ‘training service’ in reference to – “Deliver a 2-day training program on team development and training service to each of three OSE divisions.” May have been in error in the publication of our information, but the term “training service” refers to the type of services the organization is seeking. 27.What are the “newly established division component, staff, and functions and responsibilities”? Need to concentrate on the Divisions of Epidemiology, Division of Medication Errors Prevention and Analysis, and the Division of Risk Management. What are the “old functions and responsibilities”? Need to concentrate on current and approved functions and responsibilities, and the new mandates that are stipulated under the Food and Drug Administration Amendments Act of 2007 (FDAAA) especially in the areas of drug safety, risk management, pharmaco-vigilance. All this information is on the internet in the FDA and CDER web sites (i.e. search for Functions and Delegations of Authority). We are attempting to determine how big of a ‘jump’ this will be for people in the workshops. The important determinations will be acquired under the interview and preparation phases. We require you to based your proposal according to the technical requirements. 28.What are the, “customer service and delivery of training program as required for FDA employees” requirements? Customer services – i.e. respond to calls with-in a day, address customer’s issues, concerns complaints, and delivery of training program as required for FDA employee is “The suggested training will be appropriate for the FDA scientific staff”. 29.Is the ‘transformation plan’ available? On the internet. 30.Is the organizational chart available? On the Internet. 31.Does the government anticipate that the offeror will design and deliver the feedback document or will the government provide this document? If the government will provide this document, may I have access to the document? See question 25. 32.Would you please clarify what is meant by ‘training service’ in reference to – “Deliver a 2-day training program on team development and training service to each of three OSE divisions.” See question 26. 33.What are the “newly established division component, staff, and functions and responsibilities”? What are the “old functions and responsibilities”? We are attempting to determine how big of a ‘jump’ this will be for people in the workshops. See question 27 34.What are the, “customer service and delivery of training program as required for FDA employees” requirements? See question 28. 35.Is the ‘transformation plan’ available? See question 29. 36.Is the organizational chart available? See question 30. 37.Does the government anticipate that the offeror will design and deliver the feedback document or will the government provide this document? If the government will provide this document, may I have access to the document? See question 25 38.Would you please clarify what is meant by ‘training service’ in reference to – “Deliver a 2-day training program on team development and training service to each of three OSE divisions.” See question 26. 39.What are the “newly established division component, staff, and functions and responsibilities”? See question 27 What are the “old functions and responsibilities”? See question 27 We are attempting to determine how big of a ‘jump’ this will be for people in the workshops. See question 27 40.What are the, “customer service and delivery of training program as required for FDA employees” See question 28 Is the ‘transformation plan’ available? See question 29. Is the organizational chart available? See question 30. 41.Does the government anticipate that the offeror will design and deliver the feedback document or will the government provide this document? If the government will provide this document, may I have access to the document? See question 25. 42.Would you please clarify what is meant by ‘training service’ in reference to – “Deliver a 2-day training program on team development and training service to each of three OSE divisions.” See question 26. 43.What are the “newly established division component, staff, and functions and responsibilities”? What are the “old functions and responsibilities”? We are attempting to determine how big of a ‘jump’ this will be for people in the workshops. See question 44.What are the, “customer service and delivery of training program as required for FDA employees” requirements? See question 45.Is the ‘transformation plan’ available? See question 29. 46.Is the organizational chart available? See question 30. 47.Does the government anticipate that the offeror will design and deliver the feedback document or will the government provide this document? If the government will provide this document, may I have access to the document? See question 25. 48.Would you please clarify what is meant by ‘training service’ in reference to – “Deliver a 2-day training program on team development and training service to each of three OSE divisions.” See question 26. 49.What are the “newly established division component, staff, and functions and responsibilities”? What are the “old functions and responsibilities”? We are attempting to determine how big of a ‘jump’ this will be for people in the workshops. See question 27. 50.What are the, “customer service and delivery of training program as required for FDA employees” requirements? See question 28. 51.While the pricing table allows time for interviews, time for meeting with the Director of each of three OSE divisions, time to generate an agenda, and time to conduct the 2 day retreats, there does not seem to be time allowed to: 1. analyze data collected during the interviews Incorporated in the preparation process. 2. actually design the 2-day retreat so that it is responsive to the issues surfaced in interviews, Incorporated in the preparation process. 3.conduct the close-out conferences to discuss the outcomes of the meeting. Incorporated in the coaching with supervisors. 52.Can additional time be allocated for data analysis, design, and conducting close-out conferences? Yes it maybe proposed and we will consider. 53.Will the selected contractors have access to the FDA’s drug safety transformation plans, organizational structure, and transformation plans so that they can be incorporated into the retreat design? All this information is public record and on the internet, and any additional information will be provided in interview/preparation phase for the selected contractor. 54.It appears that access to consulting/coaching for managers and team leaders is to be included in the Management Plan. Is said consulting/coaching a part of the pre-retreat and retreat activities or is add-on coaching to be considered if deemed appropriate during the interviews and retreat? Yes, we will consider since new supervisors may need additional consulting/coaching time. 55.The list of tools to be provided (process management, communication, conflict resolution) and skills to be developed (teambuilding, developing employees, adapting to the transitional environment) is quite substantial. While all of these topics can be touched upon, actual meaningful skill development in all areas in 2 days is not realistic. What steps will be taken to prioritize and specify the desired outcomes? Not all three organizations will need in-depth training in all sections. We require you touch on important principles of all these, but emphasize the areas of importance for the respective organization, hence design training that is not off the shelf standard training courses. We ask for samples of all these for evaluation, and your methodology for determining which to emphasize for the specific organization during the preparation and delivery phases. The 2-day requirement is based more on not compromising day to day operations, workload, and responsibilities. We want the organizations to improve in these areas, and to acquire a base level, and have reference materials and tools by which they can apply to achieving their individual and organization’s goals and objectives. 56.We are a company with a long history of successful engagements in large Fortune 500 companies. However, our experience, to date, with government contracts is limited. Will limited government experience reduce the likelihood that a prospective contractor will be seriously considered for this work? Meeting/Exceeding the technical requirements is much more important than past government experience, and will be highly considered. 57.Statement of Work, item 2, you request a non-off the shelf training program: •Can you define what this means? An off- the-shelf training program is one that is standardized and structured based on a basic training factor/element/principle similar to a college course (i.e. Intro to Management) without any options for modification. A non-off - the - shelf training program is one that takes from various training programs to design/develop a training program that caters to the needs and requirements of the client. Are you looking for a course that already exists, that can be customized to the needs of the FDA? Contractor may use courses that exist and incorporate into organization specific training program according to the requirements in the solicitation. Or are you looking for someone to design and develop a course from scratch? Contractor may develop a course from scratch to meet requirements. 58.In Requirement 2, you must provide “coaching”. Please clarify. After consultants complete the delivery of the training, they are required to provide the supervisors with feedback, advice, and recommendations for improvement. Provide guidance, encouragement, and insight on implementing training principles in day to day operations based on their experience and observations of participants and organization. 59.In Overall Deliverables, you mention: For each training module, you would like the vendor to meet with a division director. Yes •Do you have a requirement for the number of modules in the program? Are you expecting one module for each of the requirements #2-6 (5 modules)? One training program with multiple modules that can be modified for the respective division’s needs and requirements. •What is the expectation of those meetings? To acquire knowledge, insight, and needs on the specific organization, and determine/tailor training according to these factors. Do you want the vendor to tailor their training materials for each of your 3 divisions as a result of the meeting? Yes. Or is this meeting to give the trainer additional insight on the division prior to delivering the program? Both. 60.In Overall Deliverables, you mention you want a 2-day training program. How have you determined that you need 2 days worth of training? Has a training assessment been completed that defined this need? See question 55. 61.Under Technical Evaluation Criteria, A. Technical Proposal, 2. Management Plan, you mention that the management plan shall include: •A “designed training program”. This is similar to our question regarding statement of work, item 2: Are you expecting the training course to exist already and the vendor will customize it for you? See questions 76, 78, 95, 99, 110, 111, 112, 116. Or are you expecting the course to be built from scratch? You may build a training program from scratch and submit for consideration. If you expect it to be built from scratch, can you clarify this requirement for the technical proposal since the training program won’t be designed until after award. We require the training program to cover all areas mentioned on the solicitation. Once selected during the preparation phase we expect you to fine tune and modify according to the specification and needs of the respective organization. Do you have more details about the specific learning objectives for the program other than what was provided in requirements #2-6? See questions 76, 78, 95, 99, 110, 111, 112, 116. 62.Will all training be delivered in Maryland? Yes. In the city of Silver Spring. Most likely at the Labor College depending on availability. 63.How many participants need to be trained in each division? Estimated since we do not have exact figures at this time. 20 – Division of Epidemiology, 30 – Division of Medication Errors Prevention and Analysis, and 10 – Division of Risk Management. 64.Will the FDA provide the training facilities? Yes. See question 62. If yes, how many participants can each classroom accommodate? Facilities accommodate 20 per classroom. 65,Will the FDA make arrangements for course registration and communication? Yes. 66.If the course is developed from scratch, does the FDA have subject matter experts to review content during course development? Yes. 67.If the course is developed from scratch, does the FDA have restrictions on where the instructional designer works? For the preparation no, but training must be preformed in person at facility provided by FDA. Is a remote employee acceptable? Yes, but again training must be provided in person at facility provided by FDA. 68.Will the FDA reimburse for travel costs for the course delivery? Yes. Must provide estimated cost in proposal. 69.The Pricing Table does not seem to align with the requirements of this Solicitation. We will take a look at the Independent Government Cost Estimate and make corrections if necessary. Will a new pricing table be provided? If there are any errors an amended ICGE will be provided. 70.Please provide the background or circumstances which resulted in this solicitation, why leadership training for these three organizations? This training is driven by new mandates from the Food and Drug Administration Amendments Act of 2007, Agency/Center transformation goals and objectives, and study recommendations. OSE has an organization that has only existed for less than two years. These three organizations have new responsibilities, strategic goals, reporting/working relationships with other FDA Center/Office organizational components, and new supervisors and staff. Leadership training was highlighted as an important factor in the success of these organizational components. 71.Once successful, what would you like the participating managers to have learned, what skills will they have been exposed to? See questions 76, 78, 91, 95, 99, and 114. 72.How will you define success? Each organization’s needs are addressed in their respective training module and re-enforced in the exercises and coaching/consulting for the division directors, deputies and team leaders. Delivery of the training services by the contractor in a timely manner during the duration period. Consistent Positive feedback from the trainee surveys. 73.Can you please provide a copy of the following: The transformation plan Information is public record and may be obtained via the internet. See FDA & CDER web-sites. Organizational charts for the FDA; OSE; DEpi; DMEP & DRISK Information is public record and may be obtained via the internet. See FDA & CDER web-sites. The CDER transformation process Information is public record and may be obtained via the internet. See FDA & CDER web-sites (Institute of Medicines Recommendations & CDER’s response). 74.Please explain or provide additional information for the statement in requirement 2 “multilateral relationships”? See question 91. 75.Please confirm the statement “place of performance” means that all delivery of services will be in the Rockville Maryland location? Means actual training will be performed at facility provided by FDA (See question 62 for location). 76.If we proposed additional coaching and or consulting services beyond the 2 day delivery period how should that be identified in the cost proposal? Separate line, but within the respective organization. Note, coaching is intended for Directors, Deputies, and team leaders, and may be separate than the training of both supervisors and staff. Coaching is intended to re-enforce leadership, conflict resolution, communication, and team building principles for implementation in day to day program activities for supervisors. 77. While the solicitation uses the term “2-day training”. Please clarify. Based on previous experience “2 days” is the appropriate amount of time an entire organization may be out for training without imposing on day to day operations. 78.In the same context as the question above, please clarify the term “training module”. What is the government looking for when using this term? Is this a specific aspect of one training course (i.e., module) or a “topic” related to leadership development? The training module must incorporate the specified training elements/principles (i.e. communication, team building, conflict resolution, leadership development) and group exercises to assist in the “how to implement” within the two day period. Contractor has discretion on how to develop the training module, and incorporate all these elements in a logical methodology for participants to incorporate in their day to day jobs based on their respective organization’s functions, responsibilities, goals and objectives. The use of day to day experiences as examples in exercises will ensure success of the individual, team leader, division director, team, and division. Since each division and subsequent substructure is broken down by functions and responsibilities each training module most cater to the specific organization. Although all the elements have to be present in the module, some need to be emphasized more than others depending on the organization. Leadership development principles and exercises maybe covered with the entire training class, but must be directed toward the team leaders, deputies and directors. The overall goal is for the training to improve on the overall performance and ensure the organizations success of mandated requirements. 79.Pricing – please confirm that labor cost for development of materials, preparation for meetings, travel cost, and FDA meetings/training are all to be included on the provided pricing sheet. The Independent Government Cost Estimate is a tool and requirement for the government organization to estimate/project cost of services. The design is incorporated in the preparation section. We do not need price to be broken down. 80.Requirement 1: Other than working for OSE, how might offerors demonstrate alignment with FDA’s DST plans? Is this solicitation limited only to offeror with prior OSE experience? No, but we require offerors to acquire the background knowledge and determine training needs of specific organizations. Is there an incumbent currently performing this work? No, this is a new requirement. Under “Management Plan” 2.a – are the “45 min interviews” identified in the price sheet used for “consulting/coaching for managers and team leaders” or is the purpose of the 45min interviews to gather data to inform development of a customized 2-day training program? Please clarify. To customize the 2-day training program. 81.Please provide bullet points that clearly outline the overall objectives for the FDA training program. Please see questions 2, 3, 14, 55, 58, 59, 70, 76, 78, and 95. There are various components of training and development listed throughout the solicitation (i.e., communication skills, organizational change, teambuilding, conflict resolution, process management, etc.). However, can you provide a succinct statement of the training objectives so that a proper approach can be provided? We want contractors to develop a training program with all the components mentioned in the solicitation. We are giving a wide latitude for contractors to incorporate in their proposal their experience with other client’s organizations in similar situations, and how their training was an integral part of the client success. 82.Please provide projected budget for this effort. Independent Government Cost Estimate is included in the solicitation. Is this a firm fixed price, or time and materials contract? Firm Fixed Price. 84. The price proposal it indicates that 2 consultants are requested for DEpi - Approximately 20 participants and DMEP – Approximately 30 participants. During the preparation and delivery phases; will you accept one consultant to handle the planning and delivery of all sessions? You may propose it and we will consider, but we require 2 consultants for the delivery of training with participants of more than 15. 85. QUESTION II: Do expect the training to be delivered by two consultants? Yes. For the Divisions of Epidemiology, and Medication Errors and Prevention Analysis which are estimated participants of 20 and 30. FDA wants to keep training sessions at a 10-15 per 1 consultant ratio. Any larger and the training will not be as effective. 86. QUESTION III: How many participants will be involved in each training event? Division of Epidemiology - estimated 20 Division of Medication Errors and Prevention Analysis - estimated 30 Division of Risk Management - estimated 10 87.Do you know if the above-cited solicitation will require evaluation of the training solicited? Yes 88.Is there an incumbent contractor or consultant who has performed drug safety training, leadership training or team building training or facilitation for the Office of Surveillance and Epidemiology at FDA? Who are they? Are they eligible to bid on this requirement? No this is a new requirement. 89. What are the key components and focus of the transformation process this program will integrate with? This is useful for building congruency between the language and framework of the programs and the work environment. Also for building follow up back on the job into the program. Information is public record and may be obtained via the internet. See FDA & CDER web-sites. 90.Rqmt 1: What is the OSE organization structure, including reporting relationships? What are the new mandates mentioned, roles and responsibilities and transformation plan? Information is public record and may be obtained via the internet. See FDA & CDER web-sites. 91.Rqmt 2: What are 2-3 examples of the multilateral relationships mentioned? What specific organization components do new SOE managers and supervisors need to learn to deal with? 1 – OSE works with the Office of Compliance, Office of Combination Products, Office of Regulatory Affairs, Office of Regulatory Policy in the performance of, the mandated goal under FDAAA, ensuring pharmaceutical drugs are safe and effective. Each organization has certain specified functions, responsibilities, and delegated authorities, but all are interacting with and working toward one common goal and mission. 2- OSE, Office of Compliance, and Office of Regulatory Policy report to the Center Director, and the other Offices report to the Commissioner, but all are working to achieve the Agency’s mission as mandated in all Acts, statutes, and regulatory policies. The interactions between these offices to achieve their respective and common goals and objectives are defined as multilateral relationships. 92.Rqmt 3: What is the performance management process at OSE? Useful for making sure these programs leverage their existing tools and reinforces the current processes/practices. Selected contractor will be furnished these answers during the preparation phase. 93.Rqmt 4: What types of tools are used successfully today in the line operational processes and multilateral programs? Where are the significant performance gaps? Selected contractor will be furnished these answers during the preparation phase. 94.Rqmt 5: What will employees’ responsibility changes look like as they move to equal partners from advisors? How about their authority changes? What are potential roadblocks and concerns? Selected contractor will be furnished these answers during the preparation phase. 95.What specific change leadership skills will OSE expect their managers and supervisors to obtain? (Note – most of the skills listed are good basic management skills, new manager training. Does the FDA want to add more advanced skills such as recognizing and leading through stages of change, creating change campaigns (including enlisting sponsors, champions…), analysis of stakeholders, recognizing communication and work styles and creating communication plans, etc…).Please clarify. For some it may be a needed refresher and others a new acquired tool and skill. We highly encourage you to include these advanced skills in your submission. Note: OSE is a new organization and changing at a fast rate. A large percentage of its staff is new to the organization, government, and US Workforce. Managers/Supervisors range from having extensive experience with lots of supervisory and leadership training to supervisors with a couple years, and finally new supervisors with minimal training and experience. OSE is interested in establishing a base from which, in the future, to move forward to more advanced training in these areas. Also, the advance training and coaching is highly desirable especially for the division directors and deputies. 96.The first page says that it is a firm fixed price contract, but the pricing table includes labor rates. Is it intended to be firm fixed price or time and materials? If FFP, what is the purpose of the hourly rates in the pricing table. This is a firm fixed price requirement. Hourly rates are requested for pricing information. 97.Each of the 6 requirements discuss “the training program”, but the technical proposal description requires “demonstrated capability to provide Management and Leadership development and coaching” and the description of the management plan seems to suggest the same. Can you confirm that it is your intention that the program be a combination of training and coaching? Yes. Our intent is a combination. 98.The description of the management plan requires that it include “a designed training program, which includes consulting/coaching for managers and team leaders as well as teambuilding and communication exercises for staff”. Is it your intention that the training materials are fully custom-designed and included in the proposal? No not entirely. We want the contractor to use training modules that have proven successful with other clients in similar situations as the OSE and modify/incorporate according to the respective divisions needs and specifications. The pricing table also includes 45 minutes with each team member and generation of the agenda – if the materials are fully designed, would the agenda not be fixed? The pricing table is a tool for OSE to project potential cost. This is a Fixed price solicitation. 99.The description of the management plan requires that it include “a designed training program, which includes consulting/coaching for managers and team leaders as well as teambuilding and communication exercises for staff”. Is it your intention that the two are carried out simultaneously (managers and team leaders being coached in one location while staff does teambuilding and communication elsewhere) or as blended sessions? OSE has no set methodology, because each organization is different. It’s the contractors responsibility to propose a training program to include these principles/exercises in its training modules. OSE will evaluate its merits and capabilities to meet the objectives. Would the coaching of the leadership team be as a group or as individuals? It may be. It depends on the respective organization. You may propose it in this manner and we will consider it. If blended sessions, would it be anticipated that the staff are in the room while the leadership is coached on how to deal with new employees and how to develop the potential of their staff? No. See questions 2, 3, 14, 55, 58, 59, 70, 76, and 78 for clarification. If simultaneously, how is it anticipated that one person could handle DRISK alone? No. See questions 2, 3, 14, 55, 58, 59, 70, 76, and 78 for clarification. 100.Can you explain for each of the three organizations how many “managers and team leaders” will attend and how many “staff” will attend? We can not provide exact figures at this time because the organization is in its recruitment and staffing phase and is not fully staffed. We have provided an estimated amount of participants per organization based on this Fiscal Year’s budget ceiling. Each division has a Director, Deputy, and team leaders at a (1 to 5 ratio) some may be in an acting capacity. Each organization is different in size, workload, professions, etc.. (i.e. all have science based educational degrees and a high percentage have advanced degrees) 101.Is there an incumbent, and if so could you provide the name of the incumbent? This is a new requirement. 102.How does this work relate to the work being performed by the Center for Professional Development? The work helps the office meet recommendations from the Institute of Medicine and work CPD was contracted to perform at the Center level. In addition, they are responsible for assisting substructure senior management with incorporating Center goals and objectives to address IOM recommendations. 103.When is the work anticipated to begin? A month or two after award of the contract. 104.The pricing table appears to calculate in “days”, yet has the hourly rates appended. Preparation before and follow-up meetings after each session would lengthen a “day” to more than the 8 hours delivered to the attendees of the retreat. Can you give more detail on what is expected in the pricing table in respect to days/hours/etc? Please see questions 1, 8, 18, 51, 52, 69, 79, 83, and 96 for clarification. -105.Can you explain what is meant by transition from SME roles to “equal partners under one voice”? Before FDAAA the old organization was more of an advisory organization and provided subject matter expertise to other FDA Center/Office organizations in the performance of the Agency/Center’s mission. The new organization “Office of Surveillance and Epidemiology” through FDAAA has equally delegated authorities with the organizations it once advised and consulted. These organizations and OSE now have the same goals, but different responsibilities such as ensuring pharmaceutical drugs are safe and effective ( i.e. pre-market (Office of New Drugs) and post-market (Office of Surveillance and Epidemiology) regulatory responsibilities). 106.What is the total number of managers and employees that work for FDA’s Office of Surveillance and Epidemiology (OSE)? This organization is over a year old and had 153 employees and managers at the beginning of the fiscal year. The organization has over 180 employees and managers on board now and expects to reach its budgeted ceiling of 211 by the end of the fiscal year. Since, we do not know the exact figure because the Office is in its recruitment and staffing phase we provided an estimated amount of participants based on ceiling limitations for the training by organization. 107.Our understanding is that there should be a separate module for managers and a separate module for employees -- Is this accurate? Not necessarily. Please see questions 55, 58, and 78. 108.Is it the government’s expectation that each two-day session for managers should address all of the requirements including: oLeadership development and coaching for new OSE managers and supervisors to develop potential of new employees oProvide process management tools oProvide communication conflict resolution tools and skill development to assist OSE employees transition from advisor to partners oProvide team building skills The 2-day training is for both managers and staff. Please see questions 55, 58, and 78 for more clarification. 109. What expectations does the government have regarding adapting training based upon the feedback from the project officer before launching the training and/or after the initial implementation of training? Need more clarification as to what you are asking. 110. Is it possible that the government will consider having separate modules to address each of the specific requirements outlined in the RFQ (including: leadership skills and tools, process management tools, communication conflict resolution tools, team building skills) The government expects contractors to provide a sample training program with modules the contractor intents to use for evaluation and the methodology as to how they are going to incorporate them in the design of the training module for the respective Divisions. 111.Are there existing models or standards that the organization has established and need to be incorporated into the training in the areas of leadership, process management, communication conflict resolution, and team building? No models exist at this time. OSE’s goals regarding standards is the training, upon successful completion, is to establish and set a base standard from which OSE-wide is successful in meeting its mandates and responsibilities, and continue to improve. 112.What existing training leadership, process management, communication conflict resolution, and team building tools need to be incorporated into the training? We require all these to be incorporated in the training program. OSE is a new organization and has staff/supervisors that are highly trained and experience that may just need a refresher to those that are new to government/workforce that need the basics. It is the contractor’s responsibility to determine through the preparation phase, and which to emphasize in the delivery of the training and coaching phase. 113.Are the new OSE managers: oNew under the new organization Some are. oNew to management Some are. oNew to FDA Some are. oAll of the above 114.What level of knowledge of the Office of Surveillance and Epidemiology organizational structure, reporting relationships and new mandates under the FDA’s Amendments Act is needed to successfully conduct this training? We do not expect the contractor to be subject matter experts, but we expect them to know the organizational structure, functions and responsibilities of each organizational component and the requirements as mandated under the Food and Drug Administration Amendments Act (Especially the areas of epidemiology, drug safety, risk management, and pharmaco-vigilance). The comprehension of the new mandates and the establishing of new relationships with the Office of New Drugs, Office of Compliance, etc.. from what was an advisory role to a role of partners in the performance of the new mandates with other FDA Center/Office organizations is important (i.e. teach of inter-relationship skill, diplomacy, teambuilding across organizational components to achieve common goal and objectives). All information is public information and is disseminated on the internet (i.e. FDA web-site) 115.Is it the government’s expectation that the contractor will design an evaluation tool for the training or does the government intend to use an existing evaluation tool? The contractor will design and distribute to the attendees after completion of the training to fill out. Government will approve, collect and evaluate. 116.What expectation does the government have regarding providing coaching after the design training program? Coaching is intended for team leaders, deputy and division directors to re-enforce the training by incorporating the principles, especially leadership development, in day to day operations. 117.Is there a limit to the number of pages for responses other than a total of six pages for past performance section? None was set, but prefer responses within 200 pages total for proposal. 118. Is there an incumbent for this training? No, this is a new requirement. 119.How will price enter into the assessment of the ideal partner for this project? Decide among those highly qualified within the competitive range and then pricing will be evaluated. 120.What is the possibility the government will issue an extension for responses to this RFP, assuming we will not have answers to these questions before COB Wednesday? Proposals are due June 28, 2009. at 2:00 PM.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1058150/listing.html)
 

Place of Performance

Address: Rockville, Maryland, 20857, United States

Zip Code: 20857
 

Record

SN01854941-W 20090626/090624235933-7f4f0f48b5d6ae740e2a040ebc969127 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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