RFQ 75N95021Q00147 Amendment 1.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

SCR

Joshua T. Lazarus

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Purpose: To respond to formal questions submitted in response to the solicitation and to extend the solicitation period to June 3, 2021. All other terms and conditions of the Request for Quote (RFQ) remain unchanged.

Quote Due Date: 3:00 p.m. (Eastern) on June 3, 2021 (CHANGED) Note: The Offeror should acknowledge on the cover page or first pages on its Business or Technical Quotes receipt of this RFQ and its amendment.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

NIDA Section, Contracts Management Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

75N95021Q00147

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See Block 16C

05/21/2021

X

Request for Quote Amendment No. 01 75N95021Q00147 Page 2 of 9

RESPONSE TO QUESTIONS

1. We understand the SAP FAR12/13 threshold is $7.5M and it is not limited to $250K.

Please confirm.

Response: In accordance with the Federal Acquisition Regulations (FAR) Subpart

2.101 the simplified acquisition threshold means $250,000. Pursuant to FAR 13.500(a), This subpart authorizes the use of simplified procedures for the acquisition of supplies and services in amounts greater than the simplified acquisition threshold but not exceeding $7.5 million ($15 million for acquisitions as described in 13.500(c)), including options, if the contracting officer reasonably expects, based on the nature of the supplies or services sought, and on market research, that offers will include only commercial items.

2. Please clarify if only one web interface for all devices mobile, tablet, and computer would suffice, or the contractor needs to provide iOS and Android apps separately.

Response: In accordance with the Technical Requirements section on page 2 of Attachment 1 – Statement of Work, the survey administration platform must have mobile, tablet, computer online, web link, social media capabilities and interface with the FedRamp Qualtrics software system. One web interface will suffice if it is compatible with various devices.

3. Please clarify if the contractor needs to include hosting cost for the FedRamp certified cloud hosting in its FFP price proposal.

Response: As stated in Section 9 subpart a.iv., on page 4 of the Combined Synopsis /Solicitation FedRamp certified software and recruitment and facilitation of participant sample services is a mandatory criterion.

4. Please clarify if the cost of FedRamp certification should be included in the FFP quote.

Response: Please refer to the response to Question 3.

5. Please specify the average number of questions the responder would respond to in a survey.

Response: Due to the nature of the requirement the Government needs to have flexibility with the number and type of questions it is able to ask in each survey.

6. Please confirm geographic area and citizenship restriction of the responders.

Response: As stated in the Combined Synopsis /Solicitation these participants may not be collocated in the same geographic area.

7. Please confirm if the gender of responders must be even (50% of each) or a range of

+ 15% is acceptable.

Response: Equitable accrual is planned and preferable, but the protocol does not specify a statistical margin of error.

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8. We assume about 50 question and about 15 minutes survey with no open-ended questions. Please specify if our understand is not correct.

Response: Please refer to the response for Question 5. NIDA anticipates the survey lengths to be less than 45 minutes at any one touchpoint.

9. How many would be piped or dynamic (tailored) based on preceding response(s).

Response: Please refer to the response for Question 5.

10. What would approximate duration of questions?

Response: Please refer to the response for Question 8.

11. Please clarify if the NIH Investigator needs the flexibility to change the survey content after it is officially approved when the response of the survey does not meet the NIH goals or in the event survey score is poor if so, how often the NIH would change the content and once the revised content is provided within what timeframe they should be implemented.

Response: Yes, the Government will need flexibility to change survey content at any moment.

12. Please specify if the context-sensitive help, list of options, and validation alert messages should be provided with the platform by the contractor Response: Screening and study instrument completion will be offered in one survey experience, created by the Contractor, there will be no human to human interaction. The Contractor shall provide for validation of all data integrity aspects of survey completions.

13. Should the NIH novice Investigator be able to revise pipes, context-sensitive help, list of options, and validation alert messages per their needs in real-time with an intuitive interface by their own, or if it should be responsibility of the contractor's help desk?

Response: The Contractor shall be responsible for the validation of all data integrity aspects of survey completions including real-time needs. The NIH Investigator should be able to revise all aspects of the survey.

14. Should the platform support any other language Spanish etc. for receiving the survey?

Response: The questionnaires are not validated in any other language than English.

15. Should the contractor solution provide flexibility to change remuneration mode/amount post go live in the event of poor response?

Response: Due to the nature of the requirement the Government needs to have flexibility with the survey mechanism and approach to remuneration.

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16. What is the average remuneration range, and will it change based on the survey score?

Response: Compensation will be determined by several factors including but not limited to, the length of the survey, their specific panelist profile, target acquisition difficulty, which is to be determined and provided by the Contractor.

17. Please clarify if any penalty if the contractor cannot get the required minimum required 1,000 surveys of the responder who had the Bariatric surgery in the last 10 years and 200 who had in the last 2 years within 12 weeks of the approval of the first article. Also, if any incentives when the contractor achieve the goal before 12 weeks.

Response: As stated in the Requirements Section on page 1 of Attachment 1 – Statement of Work, NIDA requires data from a minimum of 1,000 survey respondents who had bariatric surgery within 10 years of receiving the survey link. Additionally, 20% of those respondents must have had the surgery within the past 2 years. The contract will be enforced with clear expectations on participant enrollment parameters. As stated in Section 5 of the Combined Synopsis/Solicitation, NIDA anticipates the use of a Firm-Fixed-Price type contract as a result of this solicitation. However, offerors may propose incentives as part of its response to the business quote.

18. We assume that the ramp-up period, the requirement analysis phase, platform implementation and FedRAMP certification may take about 3 months. After the platform implementation the approval of the First Article per FAR 9.3 would be provided the govt the survey would be completed in 12 weeks. The contract period is for one year so for the remaining period of about 6 months, would the contractor be required to submit the survey even after meeting the target? If so, would the govt pay an extra fee of about 0.1% amount of FFP (assuming FFP cost is divided into 1000 surveys to find the cost of a survey) for an extra survey result?

Response: Please refer to the response for Question 5 regarding the FedRAMP certification. Please refer to the Deliverable Section on page 4 of Attachment 1 – Statement of Work; the final contract deliverables consist of the Final Deliverable of Respondent Data, and the Final Report. The Contractor shall have met its obligation to the Government upon the Government’s acceptance of the final deliverables. NIDA estimates a 12-month period of performance to accommodate any unforeseen changes in protocol and delays due to IRB approval. Please refer to the response for Question 17 regarding the delivery requirement and contract type. However, offerors may propose a cost type structure as part of its response to the business quote.

19. Does the contractor need to provide the capabilities to save an incomplete survey to the participants who may not complete the survey in one session with secured login credentials?

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Response: Please refer to the requirements starting on page 1 of Attachment 1 – Statement of Work. If available, please describe your capability to save an incomplete survey and provide access at a later point in time using a secured login credentials.

20. Should the contractor require to weed out fake participants completing a survey to get remuneration? If so, would the govt assist the contractor with required validations during the requirement study phase or the contractor must implement its own strategy?

Response: Please refer to the requirements starting on page 1 of Attachment 1, Statement of Work. If available, please describe your capability to effectively filter out fake participants.

21. We understand the remunerating participants would require paying them electronically and the contractor needs to provide a web application to get their account detail to make the payment upon the completion of the survey. If our understanding is correct, please clarify if the platform needs to be PCI compliant.

Response: The specific rewards vary and may include cash, airline miles, gift cards, redeemable points, charitable donations, sweepstakes entrance, and vouchers. Payment transactions are required to be secured to protect PII.

22. Please clarify if all surveys extract without PII should be provided together in one

.csv file or parts, if so, please specify the number of surveys in a file or cadence at which survey should be delivered.

Response: Please refer to the requirements starting on page 1 of Attachment 1, Statement of Work.

23. We believe the contractor does not need to transmit the .csv file via secured FTP and password protected email attachment would suffice. Please confirm.

Response: Please refer to the Technical Requirements Section on page 2 of Attachment 1- Statement of Work. The Contractor shall deliver the de-identified data from respondents to NIH Investigators via a .csv file. Once receipt is confirmed by NIH Investigators, the Contractor shall delete the data and therefore, no longer have access to the data. The Contractor shall also delete IP addresses of any respondents upon confirmation of receipt of data by NIH Investigators. The Contractor shall protect all sensitive protected health information (PHI) or personally identifiable information (PII) collected while performing the required services. Sensitive PHI/PII shall not be transferred to, nor shared with NIH Investigators. Any data collected must be deidentified or coded so that the code cannot be linked to participants by NIH Investigators.

24. Should a separate .csv file should be delivered to each NIH Investigators on demand?

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Response: Contract deliverables shall be submitted to the Contracting Officer and the Contracting Officer’s Representative.

25. Should the content of the file and metadata should change and customized per an NIH Investigator’s request?

Response: The content of the file and metadata will be determined prior to the start of questionnaire distribution.

26. Please specify the need for PII data fields with the surveys. How and when PII data of a responder should be deleted by the contractor before completion of the contract or after handing over to NIH/NIDA upon completion of the contract.

Response: Please refer to the response for Question 23. All study activities shall be performed via on-line using an anonymous ID to keep track of participants.

This anonymous ID links to a respondent profile.

27. We believe the govt will reimburse all costs incurred by the contractor while remunerating participants and so can be excluded from the FFP quote. Please confirm.

Response: Please refer to the response for Questions 17 & 18 regarding the anticipated contract type and submit the business quote accordingly.

28. We believe the govt. will reimburse all cost incurred by the contractor for

Millisecond software for psychological testing (Inquisit Web, Lab, Plugin, and Test Library) license fee. Please confirm.

29. Please elaborate on how the contractor needs to integrate with Millisecond Test

Library or Inquisit Web/Lab software platform for conducting psychological testing.

Is the scope of is only needs to integrate with Inquisit Web/Lab software platform and pull the survey data from Millisecond or the contractor need to build a survey using their Test Library?

Response: Please refer to the requirements starting on page 1 of Attachment 1 - Statement of Work. The platform to disseminate and collect questionnaire responses must be compatible with Millisecond software used for psychological testing and those created via the Government’s Qualtrics software. More information on Millisecond can be found at the following location:

https://www.millisecond.com/support/docs/v6/html/howto/interopsurveys.htm

30. Please confirm third party (Qualtrics, Millisecond software etc.) compliance of section 508 is not the responsibility of the contractor.

Response: Please refer to Section 6.f. of the Combined Synopsis/Solicitation.

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31. Apart from the required duration of 2/10 years of Bariatric surgery for adults (age) what other factor would contribute to the survey scoring? Would diversity of data age, gender, race, geographic location, ethnicity, other health conditions, etc. also contribute to the scores?

Response: Yes, diversity of data age, gender, race, geographic location, ethnicity, other health conditions, etc. also contribute to the scores.

32. Any page limitation and formatting requirement for the tech proposal, price proposal and past performances?

Response: There are no page limits or restrictions, Offerors are encouraged to provide a complete description addressing all requirements and criteria as stated in the Combined Synopsis/Solicitation. The description must be cohesive and include sufficient information to allow evaluation by reviewers and NIH staff.

However, Offerors are also encouraged to be economical when preparing a response and can reference duplicative information addressed in various sections of Technical Quote when practicable.

33. Does a minimum survey score qualify the survey to be counted against the required

1,000 surveys? If so, please elaborate to allow the offerors to estimate the effort and provide a FFP price within the range of the Independent Government Cost Estimate.

Response: Full survey completion counts as one respondent. Only completed data points shall be provided to the NIDA Investigators and retained as part of the study data.

34. Should a privacy notice be displayed to the user along with a warning to the survey responders for potential consequences for unauthorized access to the survey platform and submitting false information deliberately?

Response: Participants will receive written information via on-line e-platform to review and agree or decline to proceed with participation prior to receiving any research questionnaires. An email response will be required that will clearly indicate if the individual accepts or declines to enroll in the research study.

35. Please specify the name of social media platforms that the contractor’s platform should have the ability to connect along with desired data fields required to be pulled from them.

Response: Please refer to the requirements starting on page 1 of Attachment 1 - Statement of Work. Offerors should describe its capability to provide social media platform information as part of its Technical Quote.

36. Please specify how the contractor should interface and the data it should pull from various sources of social media.

Response: Please refer to the response for Question 35.

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37. We believe the govt will reimburse all costs paid to social media by the contractor.

38. After integrating the responses into the Qualtrics Core XM survey software and deliver the de-identified data from respondents to NIH Investigators via a .csv file.

The Contractor would block PII including the IP address data field from all intermediate data fields delivered to NIH. From where should the Contractor delete IP addresses data field upon receipt confirmation by NIH?

Response: Please refer to the requirements starting on page 1 of Attachment 1, Statement of Work.

39. We believe the contractor is required to demonstrate the ability to obtain the

FedRAMP certification on the platform but does not need to hold FedRAMP certified platform before award. Please confirm.

Response: Refer to the response to Question 3.

40. Please specify the required data impact level of FedRAMP. We believe it would be a moderate base as the PII would be filtered out before sending to NIH investigator.

Response: Refer to the response to Question 3.

41. Please elaborate on the scope of recruitment and facilitation tasks that the contractor is required to perform.

Response: As stated in the Technical Requirements Section on page 1 of Attachment 1 - Statement of Work, the Contractor shall provide conduction of the recruitment and facilitation of the participant sample (consent, distribution, data collection, remuneration, and communicating as a liaison between the NIH and the panelists).

42. Can the govt provide a metadata file (header data fields) of the .csv file or it will be determined during the requirement study phase?

Response: The final file will be agreed upon between the Government and Contractor prior to dissemination of the surveys.

43. Please clarify if any professional services and help desk support required under this contract. If so, please elaborate allow the offerors to estimate the effort, required FTEs, labor categories etc. We believe that would be advantageous to the government to get competitive FFP quotes as the offeror would not require to cover the risk of the unknown costs with their quote.

Response: Please refer to the response to Question 41. Offerors should describe the proposed approach to meet the Government’s requirements in the Technical Quote.

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44. Does the contractor need to provide any minimum number of survey for Adjustable Gastric Band (AGB), Vertical Sleeve Gastrectomy (VSG), Roux-en-Y Gastric Bypass (RYGB), Biliopancreatic Diversion with a Duodenal Switch (BPD-DS) or others?

Response: As stated in the Requirements Section on page 1 of Attachment 1 – Statement of Work, NIDA requires data from a minimum of 1,000 survey respondents who had bariatric surgery within 10 years of receiving the survey link.

45. To obtain the past patient list from facilities, does government have any pre-selected patients who must be included in the survey, or pre-selected facilities which have higher valuable data than others? Can the contractor recruit any patients who had the bariatric surgery in the past 10 years?

Response: Please refer to the response to Question 41.

46. Since the patient records are sensitive information, all facilities require the government authorization documents before providing it. Would government authorize the contractor after the contract is awarded, and provide the documents?

If yes, how long would it take?

Response: Please refer to the response to Question 41. Furthermore, obtaining patient records is not part of the Scope of Work.

47. We believe this survey will recruit the patients inside of USA. Does government have any geographic requirement? How many states should be included?

Response: The survey can be distributed within the United States.

48. Is any physical exam or checkup required to meet the protocol of survey or as an attachment?

Response: Physical exams and/or check-ups are not part of the Scope of Work.

49. Can we get an extension of a couple of days from the date of response to prepare our quote?

Response: Yes. The Solicitation period has been extended to June 3rd, 2021.