Responses to Questions posted 07302024 .xlsx
XLSX spreadsheet 18 KB Posted
- Attached to
- Mindfulness Coaching Services Amended 07/30/24
- Solicitation number
- 75F40124Q00402
About this file
This document is a set of responses to questions posted regarding a Request for Quote (RFQ) issued by the Food and Drug Administration (FDA) for Mindfulness Coaching Services, Solicitation #75F40124Q00402. The RFQ is seeking evidence-based mindfulness training and coaching services to enhance personal psychological health and performance for FDA employees. Key details include:
The contract is for a 12-month period and will involve four consecutive 12-week coaching cohorts of 25 staff members each. The RFQ requires key personnel to have a Mindfulness-Based Stress Reduction (MBSR) training certificate, but no longer requires a doctoral degree in Psychology. Pricing must be submitted on the provided Attachment 6 - Pricing Spreadsheet. The Government will evaluate offers based on technical approach, relevant experience, past performance, and price, with technical factors being more important than price. This is a small business set-aside with a North American Industry Classification System (NAICS) code of 611430.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Attachment One - StatementofWork 073024.docx | DOCX document | |
| Attachmnent 4 - Instructions to Offerors Amended 073024.docx | DOCX document | |
| Attachment 6 - Pricing Spreadsheet.xlsx | XLSX spreadsheet | |
| Attachment 5 - Questions Template.xlsx | XLSX spreadsheet | |
| Attachmnent 4 - Instructions to Offerors Amended 071624.docx | DOCX document | |
| Attachmnent 4 - Instructions to Offerors.docx | DOCX document | |
| Attachment Two 52-212-3-Offeror-Representations-and-Certifications.pdf | ||
| Attachment Four - Instructions to Offerors.docx | DOCX document | |
| Attachment Three - 52-212-5-Contract-Terms-and-Conditions-Required-To-Implement-Statutes-or-Executive-Orders.docx | DOCX document | |
| Attachment One - Statement of Work.docx | DOCX document |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
FDA Responses
| Responses to Contractors Questions to the Mindfulness Coaching Services RFQ |
| Solicitation/Notice ID: 75F40124Q00402 |
| Date: 7/30/24 |
| FDA's Response | |
| Do you have a preference on the structure of the pricing quote? Per session, per task, etc? Format preference? | Yes, Please submit your pricing on Attachment 6 - Pricing Spreadsheet |
| Is there an incumbent or previous vendor for this or similar service by FDA or CDRH? | This is a new requirement. There is no incumbent or previous vendor for this requirement. |
| Are there any historical performance reports regarding this service that you can share? | There is no historical performance reports for this requirement. |
| What is the timeframe for completion of services? Ie 1, 2, 3 years? | The contract is for twelve months from the date of award |
| Can we contract with a company that has an MBSR & doctoral degree in psychology? | The requirement states in Attachment 4 - Instructions to Offerors that the "The Contractor/Company shall provide a copy of a Mindfulness Based Stress Reduction (MBSR) training certificate and resume(s) of all the key personnel. The requirement that the key personnel shall have obtained a doctoral degree in Psychology and a copy of the degree must be included in Volume II submission has been removed from the requirement . Subcontractors are acceptable and must adhere to the key personnel requirement as the prime contractor. |
| What is the bid allowance per awardee? | FDA does not have a bid allowance per awardee. This is a request for quote from contractors to provide pricing to the FDA to perform Mindfulness Coaching services. |
| Do we need to have a key person on staff with the MBSR certification? We do have our Chief Visionary Officer, Oliver North who is a Master Trainer for the Center for Relationship Education | Attachment 4 - Instructions to Offerors that the "The Contractor/Company shall provide a copy of a Mindfulness Based Stress Reduction (MBSR) training certificate and resume(s) of all the key personnel. The key personnel requirement of a doctoral degree in Psychology has been removed from the requirement. |
| Should the 21-day Meditation Challenge be calculated from the 1st day of the challenge (example 7/1-7/21); or, another way? If another way, please explain & provide an example. | The 21-day challenge must be calculated from the 1st day of the challenge. (30-minute sessions on Tuesdays and Thursdays for 21 days; Example July 1st through the 21st) |
| Is a MSBR certificate required or would you consider relevant mindfulness work experience & references? I have a trainer who is currently providing this training for the largest hospital system in our region; has been contracted with & doing this work for years, but does not have a MSBR certificate. Would his work experience & reference credentials fulfill the certificate requirement? | A MSBR certificate is required. |
| Can the key personnel requirement be split between 2 trainers; one with the Ph.D. & the other with the MSBR certificate, but neither have both. As I review & calculate quotes for the SOW tasks (4.1-4.4) most require at least 2 trainers per task. Can a task have a trainer with a Ph.D. & a trainer with a MSBR certificate? | The key personnel requirement that requires a PHD has been removed from the requirement. All key personnel must provide training and possess a training certification in MBSR. |
| Which "clauses" should be included with the Quote? I saw "by reference", but also saw some with an 'X'. Should we complete & attach those with an 'X'; should we complete none; or, which ones? | The clauses are listed in Attachment Three 52.212-5 Contract terms and conditions required to implement statues or executive orders are for your reference and all the clauses that have "X" are applicable to this requirement. You are required to complete Attachment Two " The Offeror shall complete only paragraph (b). The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision." |
| It's my understanding that we would connect locally to the FDA Zoom platform. Is this correct? | Yes, that is correct…through a FDA employee who will be hosting the platform for you. |
| Is it okay to include staff travel funds for in-person pre & post meetings? Or, are all meetings to be conducted via FDA Zoom? | All meetings will be virtual and travel is not required or acceptable. |
| Scope Clarification: Could you please clarify any specific expectations regarding the integration of mindfulness principles tailored to CDRH’s unique needs? | CDRH has an important mission to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. |
| Performance Metrics: What key performance indicators (KPIs) or metrics will be used to evaluate the success of the Mindfulness Coaching Cohorts and related tasks? | We are asking the contractor to identify KPIs that they have utilized to ensure success |
| Demographics: Is there any specific demographic information about the participants that would help tailor the mindfulness programs more effectively? | The CDRH community is diverse in terms of age, years of government service, race, highest level of degree, and sexuality. |
| Behavioral Change Assessment: Are there existing tools or methodologies preferred by CDRH for assessing behavioral change, or is there flexibility in the methods used? | There are no existing tools for assessing behavioral change. |
| Feedback and Adjustments: Can you elaborate on the process and timeline for incorporating feedback from participants and making necessary adjustments to the program? | Post-event evaluations is one tool that could be utilized at the completion of all activities in order to best understand participant's experiences and identify what worked/what to change. . Adjustments are welcomed and may be suggested to make the upcoming repeat sessions more successful. |
| Marketing Materials: Are there any branding guidelines or templates that we should adhere to when creating marketing materials for the mindfulness workshops and seminars? | A collaboration with the contractor and FDA will determine the marketing materials after contract award. |
| Security and Privacy: What are the specific data security and privacy requirements for handling participant information, especially given the online nature of the sessions? | The names of the participants is the only specific data that will be provided to the contractor. |
| Deliverable Formats: Are there preferred formats or templates for the deliverables, including session summaries, handouts, and recorded materials? | There are no preferred format or templates for the deliverables however a collaboration with FDA will be expected to ensure that the content being offered fits the needs of the CDRH Community. |
| Engagement with CDRH Wellness Team: Could you describe the expected level of engagement and collaboration with the CDRH Wellness Team during the program development and delivery? | Engagement with the Wellness Team will be important in order to ensure that the content being offered fits the needs of the CDRH Community and marketing of materials is encouraging maximum participation. |
| Budget and Cost Breakdown: Are there specific budget constraints or guidelines we should be aware of when planning the cost breakdown for each task? | Please provide your best and final quote |
| Previous Program Insights: Can you share any insights or lessons learned from previous similar programs conducted by CDRH that might help in refining our approach? | This is a new requirement. There is no incumbent or previous vendor for this requirement. |
| Will you accept a different mindfulness based certification program for key personnel in place of the MBSR requirement? | The requirement states a MSBR and different mindfulness based certifications will not be accepted. |
| How many 21-Day Meditation Challenges (Task 4.4) are planned? Will there be one challenge after each cohort's completion, or will there be a total of two challenges? | They will not be offered simultaneously, but will instead be offered as cohorts over the 12 months (SOW: Four (4) Consecutive Cohorts of 25 staff members; each cohort entails a 12-week experience) |
| What is the expected overall timeline for completing all tasks outlined in the SOW, including the four cohorts, workshops, seminars, and meditation challenges? | 12 months |
| What specific metrics or assessment methods does CDRH prefer for measuring behavioral change in participants during the cohort tasks? | We are asking the contractor to identify metrics that they have utilized to ensure success |
| What are the CDRH's expectations regarding the scope and format of the marketing materials that are to be delivered for various tasks? | The exact look and content of marketing materials will be finalized with the contractor upon award |
| In addition to the MBSR certification and a doctoral degree in Psychology, would other relevant doctoral degrees, such as a Ph.D. in Neuroscience, be considered acceptable for key personnel qualifications? | The key personnel requirement that requires a PHD has been removed from the requirement. All key personnel must provide training and possess a training certification in MBSR. |
| Can presenters without a doctoral degree assist with conduct training sessions for seminars and workshops, provided that a Ph.D.-level key personnel is present or serves as the lead? | The key personnel requirement that requires a PHD has been removed from the requirement. All key personnel must provide training and possess a training certification in MBSR. |
| Are the cohorts intended to be scheduled consecutively, or can they be spaced out with intervals between them? | The cohorts can be spaced with intervals between them |
| What specific documentation or evidence is CDRH expecting in the technical approach to demonstrate 508 compliance for the virtual training sessions? Would enabling Zoom's built-in accessibility features be considered sufficient, or are additional measures required? | Training material must be section 508 complaint. |
| For the past performance references in Volume IV, should these be specifically related to mindfulness training, or can they include other types of professional development or coaching services? | The Past Performance references should be relevant and similar to this requirement. Other types of professional development or coaching services that are similar and relevant is acceptable. |
| Is there a preferred format or template for submitting the pricing information in Volume V? | Yes, Attachment 6 must be used to submit pricing in Volume V |
| Is there a preferred scheduling approach for the various tasks (cohorts, workshops, seminars, and challenges) throughout the 12-month period of performance? | The schedule will be spread out over the 12-month period. Final determination of timing will be conducted with the contractor upon award |
| Regarding the technical approach evaluation (Phase 1 in Attachment 4), how should contractors demonstrate their ability to incorporate evidence-based mindfulness principles and provide measures to assess behavioral change? | We are asking the contractor to identify metrics that they have utilized to ensure success |
| Will the services be provided virtually/remotely (online) or in person? | All services will be virtual |
| What is the required role regarding the PhD? Mostly oversight of the program or is the PhD required for each coaching session with Q&A? | The key personnel must posses a PHD and MSBR certificate. The key personnel must be the lead for all activities |
| What are the main criteria regarding assessment measurements? Scales for resoluteness or depression etc.? | We are asking the contractor to identify metrics that they have utilized to ensure success |
| In the SOW document on page 4, section 2 and 3 show a "no min and no max for participants" Can you give an estimate min and max for those sessions? | Group sizes may vary from 20 - 300 |
File details come from the government source that posted it. Updated .