Questions_and_Answers_Spreadsheet.xls
XLS spreadsheet 52 KB Posted
- Solicitation number
- FDA-SOL-1126588
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*Questions and Answers*
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Other files
| File | Type | Posted |
|---|---|---|
| Final_Q A_for_Question_22.doc | DOC document | |
| FDA-RFP-1126588.FINAL.doc | DOC document | |
| APPENDIX_K.docx | DOCX document | |
| FDA-RFP-1126588.FINAL.doc | DOC document | |
| FDA-RFP-1126588.FINAL.doc | DOC document |
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Sheet1
| QUESTIONS | |
| Questions regarding Solicitation No: FDA-SOL-1126588: | |
| 1. Can you please clarify the difference between “number of individual patients or covered lives” and “Number and percent of patients or covered lives with corresponding enrollment information”? These are requested on Page 82, Section 4.1, paragraph 1. | This is a potential multiple award contract. We are interested in the total number of unique patients within the outpatient databases, as well as the number and % of patients with corresponding enrollment information such as in a healthcare claims database (if enrollment is applicable to the proposed database) |
| 2. Can you please clarify the terminology “ambulatory health care plans”, located on Page. 82, Section 4.1, paragraph 1? | Ambulatory health care plans: managed care organizations or individual healthcare plan, such as commercial healthcare coverage plans |
| 3. Can you please clarify the terminology “prescriber new prescription versus substitutions”, located on Page 82, Section 4.1, paragraph 2? | Prescriber new prescriptions: the number of times a product was prescribed but not necessarily dispensed as written. A capture of how prescriptions were written prior to dispensing |
A new prescription is defined as a prescription dispensed to a patient filling current therapy who, during the assigned look-back period, has not filled any therapy within the clinically relevant defined market.
Subsitutions is a prescription dispensed to a patient filling current therapy who, during the assigned look-back period, has never filled the brand previously but who has filled another clinically relevant defined market drug previously.
| 4. Regarding the Past Performance Review: Is it the expectation of the FDA that we provide Appendix K to our references, or should we provide a list of contacts for FDA to send Appendix K to? | It is the Contractors responsibility to send Appendix K to the appropriate Agencies or references and then ask them to send them to the CO before the proposal deadline. |
| 5. The FBO announcement states that proposals are to be mailed or hand delivered to FDA, and on Section 13.1and 13.2 – General Proposal Instructions indicates seven (7) copies are to be provided and may be submitted electronically. Which delivery method is requested – hand delivery/mailing or electronic submission? | Proposal repsonses are to be mailed or hand delivered to FDA. |
| 6. Section 2 – 2.1, Pricing Schedules indicates the Offeror is to provide IDIQ rates for seven (7) labor categories. Can the Offeror include additional labor categories that may be utilized over the course of the contract performance, along with a labor category description and rates? | Yes |
| 7. Section 2 – 2.1, Pricing Schedules indicates the Offeror is to provide IDIQ rates for seven (7) labor categories. Attachment #3 provides labor category descriptions, but does not include the required education or experience by labor category. Please provide the minimum years of education and experience by labor category. | Minimum of 3 years of education and experience per labor category |
| 8. If the Government does not want to specify the minimum years of education and experience by labor category, may the Offeror assume the minimum years of education and experience by labor category that conforms to their internal roles and hiring requirements? | Yes- Provide the minimum years of education and experience that the offeror requires for these roles. |
| 9. Section 2 – 2.1, Pricing Schedules requests pricing for additional ad-hoc hours in increments of 100 hours, however there is no indication of the labor categories that are to be used, or a breakout of the labor categories to be used. Further, this request does not indicate what time frame it would be needed. Is the Offeror able to split the 100 hour increments by labor category, and additionally propose by each option year? | The labor categories required will vary by project to be undertaken under the ad-hoc hours. |
| 10. Section 13. 13.2 – General Technical Proposal Instructions indicates that resumes, bibliographies and the past performance questionnaire are not included in the 125 page limit/page count. | Correct |
| 11. Is Appendix C –Section 508 Standards/Voluntary Product Accessibility Template to be included in the page count, or provided as an Appendix to the Technical Volume? | No |
| 12. Is Appendix H – Trial Subscription Agreement to be included in the page count, or provided as an Appendix to the Technical Volume? | No, as an Appendix to Technical Volume |
| 13. Is Attachment 4 – Data Characteristics Table to be included in the page count, or provided as an Appendix to the Technical Volume? | No, as an Appendix to Technical Volume |
| 14. Section 13. 13.2 – General Technical Proposal Instructions does not indicate if any additional information that would be helpful in the proposal evaluation can be provided. If so, can this be provided as an Appendix to the technical volume? | Yes |
| 15. Section 13. 13.2 – General Technical Proposal Instructions indicates that the FDA is requesting a Technical proposal of not more than 125 pages, double spaced. Please confirm the page limit and spacing requirements. | Confirming that the page limit is 125 pages, doubled spaced. |
| 16. Section 13, article 13.4.3 – Small Business Subcontracting Plan. Since the Government is requesting a currently existing, commercially available HIPAA compliant product, there are very little to no opportunities to subcontract the acquisition of this type of data. Will the Government reconsider the requirement for a Small Business Subcontracting Plan given the acquisition is for a commercial product? | The FAR requires a Subcontracting Plan for any procurement over $650,000.00 for anything that is unrestricted competition. |
| 17. On Page 34 of the Solicitation Amendment 1 - Section 13.4 Contents of Business Volume, the bulleted area references Sections 12.4.1 (Pricing), 12.4.2 (Narrative) and 12.4.3 (SB Subcontracting Plan). Are the referenced Sections meant to be 13.4.1, 13.4.2 and 13.4.3? | Yes, labeled incorrectly, should be 13.4.1, 13.4.2 and 13.4.3 |
| 18. Section 4.1 requires the Offeror to provide historic prescription information at a national level for trend analyses. What is the historic period required? | A minimum of five years of historical national-level data for trend analyses |
| 19. Section 4.3 requests optional additional ad hoc hours in 200 hour increments, however Section 2 indicates 100 hour increments. Which is correct? | The CLIN is 200 ad hoc hours and the 100 hour increments are for IDIQ requirements |
| 20. Section 4.9 indicates that other DHHS agencies would be allowed to access the data provided, with thirty (30) clearances for reports generated by each agency and up to thirty (30) programming hours for reports not available through the interface tool. However, the solicitation provides: | No CLIN - under IDIQ Section of Contract |
| 21. No CLIN for this effort. | This requirement is part of the IDIQ portion of the Contract |
| 22. No identification of how many other DHHS agencies, number of users, or specific limitation on these agencies’ use of the data and services, nor any assurances that these other users would be bound by the terms of the license agreement (e.g., license grant, confidentiality, license restrictions). In the absence of this information, we would have to assume that this contract is essentially a DHHS-wide contract, and price the access to the data accordingly. But even then, how would all the license terms apply to the users outside the FDA, since the contract, by its terms, applies to the FDA, not DHHS as a whole? | Three other DHHS Agencies |
| 23. No correlation if the thirty clearances and thirty programming hours are to be for each additional agency or a total, and if so, is it by year, or for the entire contract period. | 30 clearances and 30 programming hours for each individual Agency outside the FDA, for each base or option year exercised |
| 24. Section 6.2 identifies that the FDA will purchase a site license, but that other authorized users within the FDA will need access to the data as appropriate for their work. Is this to be interpreted as individuals within the FDA, or does this apply to individuals within other DHHS agencies? | Within the FDA |
| 25. Section 7 – Deliverables is more complete and includes items that are not a part of the Pricing Schedules. Please confirm that the Pricing Schedule and Attachment 2 – Pricing should include all the deliverables that are listed in this section. | Yes, the Pricing Schedule should include all the deliverables that are listed in this section 7. |
| 26. If an Offeror cannot provide the all of the required characteristics/functionality of the data in their data asset(s) that is requested, may the Offeror indicate which and what areas they cannot do/comply with - without being deemed technically unacceptable? | Yes, please provide which data assests or characteristics are or aren't available, with explanation if possible |
| 27. We request the Government extend the due date of the proposal by one (1) week, given the number of questions and the time required to incorporate answers to the questions into the proposal response. | Proposals must be mailed, or hand delivered by 12:00 p.m. ET on Wednesday, July 16, 2014. |
| 28. The 16th line item in this attachment requests “Availability of prescription and patient-level data by setting of care [Y/N]”. We would like to clarification on the intent of setting of care since this opportunity is based on Outpatient data. | Settings of care include but are not limited to outpatient retail (chain, food, and independent) pharmacies in the U.S., outpatient clinics, mail-order and/or specialty pharmacies, home health care, etc. The Agency desires the ability to obtain counts of prescriptions, and link them to individual patients to evaluate use longitudinally and obtain counts of unique patients over time. |
| 29. Section 13.3.4.1 e (p34): The Offeror shall provide its ability as it relates to the following: a method of access for examining national Outpatient Prescription and patient Level Drug Utilization patterns; interface documentation (white paper, training manual); and the ability to receive e-mail confirmation when reports are complete, if applicable. Not exactly clear, is it in terms that the offeror creates white papers on patterns of use or a training manual? Please clarify what the E-mail confirmation is for and for whom? | It is up to the offeror, white paper or training manual. For reports which require more that a brief wait time before the results are provide, the ability for the user to receive an email alerting them that the report is complete is desired. |
| 30. Section 4.2 (p83): Technical Requirements and Capabilities: “To protect any sensitive data which may be transmitted electronically between the data vendor and the FDA” Do the deliverables include the ability of FDA to download patient level data via the online tool? | Yes, FDA can download patient level data via the online tool. Datasets for large amounts of data can be delivered via hard drives if not via the online tool |
| 31. Section 4.7 (p84): Monthly Usage Reports: The Contractor shall provide Monthly Usage Reports detailing use of the resource by individual FDA users and type of use (See Appendix I - Example of Monthly Usage Report). Does this pertain to the use of the online interface to the data resource? | Yes, this is in reference to the online interface to the data resource. |
| 32. Sec 13.3 (p32): Please note that the FDA shall only use the data for the purposes of evaluation of the data resource. FDA shall not use the data, nor any analyses derived from the data, for public disclosure or regulatory decision-making. For the technical evaluation, FDA is requesting access to the data resource (online data tool). There is no requirement to provided data as part of the proposal. Should the word ‘resource’ be inserted after the word ‘data’ in the first sentence? | The FDA requests access to the data in the database for the purposes of evaluation of the data resource only. The data will not be used or shared outside this purpose. |
| 33. Sec 13.3.4.1 f (p34): The Offeror shall provide a description of the Offeror’s business that specifically details the percentage of data committed for Outpatient Prescription and Patient Level Drug Utilization Data. In addition, the Offeror shall provide the largest percentage of any single data provider. Statement unclear. ‘Largest Percentage’ of what aspect of the data or aspect of the data provider is of interest? | Provide the percentage of the total data offered by the offeror for the largest percentage made up of any single data provider of the Offeror's database |
| 34. Appendix K (p75): The proposal due date is listed at July 2nd, 2014 at 10am ET. Please clarify that the proposal due date is actually July 11th, 2014 at 9:00am ET? | July 11th, 2014 |
| 35. Data Requirements for Outpatient Prescription and Patient Level Drug Utilization Data (p81) Per the requirements of this section, must all stated capabilities already exist in the data resource (online data tool) or can some capabilities be added in response to being awarded this RFP? | The FDA is not interested in building the data resource. However, the offeror may propose to include in their proposal work to add additional functionality to meet the capability requirements. Provide a brief description of additional work, timeline, and additional costs not include in the base price. |
| 36. 13.3.4.3 (a) (pg 34) states: Offeror’s shall provide at least two previous clients with contact information to allow FDA to follow up and obtain independent references. Does FDA intend for the offeror to distribute the Past Performance Questionnaire (Appendix K) or will FDA contact our references independently? Please clarify. | Under the section for Relevant Experience, the offere is to provide two references in which the FDA can contact. As for Appendix K, this is a separate document regarding past performance. It is the Contractors responsibility to send Appendix K to the appropriate Agencies or references and then ask them to send them to the CO before the proposal deadline. |
| 37. The RFP lists seven labor categories for the IDIQ response. Can our response include other specific senior researcher categories, such as health services researcher or senior health economist? | Yes |
| 38. What is the anticipated start date for this contract? | Sep-14 |
| 39. Are the contents of the proposed data dictionary and data users’ guide included in the 125-page limitation or may these be included as an appendix? | These may be included as an appendix |
| 40. Can the FDA provide a rough estimation or range of the number of unique users that will need access to the web-based tools? | ~10-12 heavy users, possibly an additional 20-30 occasional users |
| 41. Can the FDA provide a rough estimation or a range of the number of concurrent users that will access the web-based tools? ? | Typically, 8-10 possible concurrent users |
| 42. The FDA is requesting hourly rates to support task orders released under the IDIQ portion of this solicitation. Would the agency accept GSA labor rates for this response? | Yes |
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