N02CP71028-70_-_Amendment_0001.pdf

Amendment 0001 RFP N02CP71028-70 Page 1 of 6

Questions and Answers

1. Is it required to submit “Study Record: PHS Human Subjects and Clinical Trials Information” form and/or the “PHS Human Subjects and Clinical Trials Information” form with the proposal for each study that may be exempt from use of a single IRB (reference, Article H.4.a., bottom of page 26 and text on pages 26-28 and pages 91-92)?

Answer: If the Offeror has determined that a study is exempt from the use of a Single Institutional Review Board (sIRB), the Offeror shall submit the Study Record: PHS Human Subjects and Clinical Trials Information form for each study. The PHS Human Subjects Clinical Trials Information form shall be submitted with the proposal if human subjects are involved. The PHS Human Subjects Clinical Trials Information form allows you to input multiple studies in the form. Please complete the forms to the best of your abilities with the known information.

2. On page 5 and page 17, the “Option to Extend Services” period of performance is stated to be 12/01/2023 to 05/31/2024, however, on page 62, the “Option to Extend Services” is stated to be 09/01/2023 to 02/28/2024. Which is the correct period of performance, and if the period is adjusted for the table listed on page 62, could you please indicate if there is any corresponding adjustment to the labor hours for each of the positions? It is noted that there is a minor difference in the dates for Option Period 5 as well (on both tables on page 5 and the table on page 17, the period is stated as 09/01/202-11/30/2023, while on page 62 it is stated as 09/01/2023-11/31/2023).

Answer: The Labor Hours table on Page 62, is incorrect. Please see the attached table for the corrected dates.

LABOR

CATEGORY

Base Period

(12/01/2018

08/31/2019)

Option Period 1

(09/01/2019

08/31/2020)

Option Period 2

(09/01/2020

08/31/2021)

Option Period 3

(09/01/2021

08/31/2022)

Option Period 4

(09/01/2022

08/31/2023)

Option Period 5

(09/01/2023

11/30/2023)

Option to Extend

Services (12/01/2023

05/31/2024)

Project Director 576 768 768 768 768 192 384 Computer Manager

432 576 576 576 576 144 288

Study Manager 1 720 960 960 960 960 240 480 Study Manager 2 576 768 768 768 768 192 384 Res. Assisstant 1 1440 1920 1920 1920 1920 480 960 Res. Assisstant 2 1440 1920 1920 1920 1920 480 960 Biospecimen Coordinator

360 480 480 480 480 120 240

Exposure experts 288 384 384 384 384 96 192 Data Manager 360 480 480 480 480 120 240 Study Support Personnel

360 480 480 480 480 120 240

Other support 360 480 480 480 480 120 240

TOTAL 6912 9216 9216 9216 9216 2304 4608

3. The table on page 62 lists “Exposure experts” as a labor category. Please indicate if this position is requested or if another position is preferred.

Answer: Exposure experts (e.g. diet, physical activity, microbiome and metabolomics sample collection) is requested.

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4. RFP section L (page 91) asks offerors to “submit a plan for the Single Institutional Review Board (sIRB) information in the technical proposal for each protocol involving more than one domestic site.” Because this is a support services contract with existing studies that are already IRB approved, and because planned studies are not described in enough detail to complete a plan, is submission of a plan not applicable to this proposal?

Answer: It is understood that Offerors may not be fully aware at this point of protocols involving more than one domestic site. For the purposes of this RFP, submit an acknowledgement of the following as your plan:

a. Participating sites will adhere to the sIRB Policy;

b. Sites and the sIRB will adhere to the communication plan described in the authorization/reliance agreement; and

c. If, in the case of restricted-award, a sIRB has not yet been identified, include a statement that the offeror will follow the sIRB Policy and communicate plans to select a registered IRB of record. This information must be provided to the Contracting Officer prior to initiating recruitment for a multi-site study.

During the performance of the Contract, the Contractor may be required to submit a specific plan per protocol involving more than one domestic site.

5. RFP section L (page 92) asks offerors to “provide the "New Human Subjects and Clinical Trial Information form" in its technical proposal.” Because this is a support services contract with existing studies that are already IRB approved, and because planned studies are not described in enough detail to complete the form, is submission of the form not applicable to this proposal?

Answer: Please fill out the form to the best of your ability. If it is not applicable, please state as such in your proposal with a justification.

6. RFP Attachment 7, section 4, Facilities and Equipment (page 5 of 5), states “Although the Government anticipates that most work will be done on personal computers, the facilities of the National Institutes of Health (NIH), Division of Computer Information Technology (CIT) may be used for computer processing. If so, programmers shall access the CIT computer via remote terminals provided by the contractor.” Please provide more details about the circumstances under which the contractor would need to use the mainframe NIH/CIT system. Would this be primarily done to retrieve data from archived studies?

Answer: The Contractor would need to access the NIH CIT system via remote terminals when scientific staff directs the Contractor to work on existing files or complete tasks that reside on or must be submitted to the NIH network. This will require establishing an NIH account and being able to work through remote terminals set up by NIH.

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7. The RFP page 124 (Attachment 3 - Background Statement, Page 2 of 18) includes brief descriptions for new studies expected over the first 2 years of the contract.

a. What is the expected complexity of the new studies? i.e. what is the estimated 'size' of the new studies? (S, M, or L - as provided for on-going studies in Tables 1a and 1b (page 134))

b. What are the associated activities for the new studies (as provided for on-going studies in Tables 1a and 1b (page 134))

Answer: Please see table below:

Studies Supported by New MEB SSC

SUPPORT ACTIVITIES*

STUDY INVESTIGATORS A B C D E F G H I J K Size of Effort

ACT24 Matthews X X X X X X X X M

AMBER Study Matthews X X X X S Barrett’s Esophagus Integrative Tissue Epidemiology Study (BITE)

Cook X X X X X X M

Coffee Feeding Study Sinha X X X X X M Case-Control Study Esophageal Squamous Cell Carcinoma, Malawi Dawsy X X X X X X M Feasibility study: oral and fecal samples in cohort studies Sinha X X X X S Fecal bacterial structure in US Population Sinha X X X X X X L

Fibrosis Progression Freedman X X X X X X X X X M

FNA/BMA/BMbx Training Project Dawsey X X S Follow-up Study of Women Evaluated and Treated for Infertility

Trabert X X X S

GCPL Study Camargo X X X X X X L Ghana Breast Cancer Study Brinton X X L

Ghana Prostate Cancer Study Cook X S

Gut Microbiome in Colorectal Neoplasia: Pilot Study in Piedmont CRC Screening Program

Sinha X X X X X X

L

Liver Cancer Case-Control Study in Guatemala McGlynn

X L

Microbiome Sample Collection in ESMaestras Study Sinha X X X X X M Support PLCO Cancer Screening Trial Freedman X S NIH-AARP Diet and Health Study Sinha X X X X X X X X VL

PanScan Stolzenberg- Solomon X X X X M

Pancreatic Cancer Survival Data Stolzenberg- Solomon X X S

Study of Cancer in Eastern Africa Dawsey X X X X X X X M Thinker and STEP Studies Abnet X X X X X X M

* Support Activities A: Multi-center Coordination and Liaison G: Record Abstraction and Coding B: Form Development H: Biologic Specimen Collection and Processing, GIS Support

RFP N02CP71028-70 Page 4 of 6

C: Study Subject selection I: Data Processing, Computerization, Access to Data D: Interviewer/Abstractor/Measurer Training J: Quality Control E: Field Supervision and/or Management K: Tracing and Follow-up F: Interviewing Size of Effort: S = small (<$150K), M = medium ($150K-<$500), L = large ($500K-<$1M), VL = very large (>$1M)

8. Can the government provide a list of the data management systems and/or databases that are utilized for each of the current and planned studies? Does the government expect continued use of those same systems into the next contract?

Answer: Under the current contract, the Contractor has implemented their own data management systems and databases for each current study. The new Offeror will have to be able to handle the transfer of data from previous systems and design/implement a similarly secure robust plan for data management.

9. What websites are utilized for each of the current studies? Will the contract require the development of a new public website or otherwise include information/documentation/support on a website? The SoW does not indicate these services are requested however the RFP page 43 states:

This acquisition requires the contractor to:

[X] Prepare, review, and/or distribute NIH Publications and Audiovisuals [X] Create and/or Manage a Public Website which includes NIH hosted social media site(s), Web application(s) and mobile Web Site(s)."

Answer: Here are some examples of websites that are currently maintained for MEB studies:

https://nihaarpstars.com/ https://act24demo.westat.com/

The contract could require similar development of public websites for new studies, and will require updating and maintaining support on current websites.

10. Can the government provide an estimate on the number of each type of biospecimen sample collected for each of the MEB (NEB/HREB) studies? What are the expectations around particular storage conditions, duration, and requirements?

Answer: The number of each type of biospecimen samples varies between studies and this number will be directly related to the size of the study described in Statement of Work (SOW). There will be a large number of samples and it could range up to 600,000 samples collected. Types of biospecimens collected are listed in the SOW. The contractor is not expected to provide any storage of samples. The contractor would work with National Cancer Institute (NCI) staff to provide recommendations for appropriate storage and transport of each type of biospecimens that would minimize degradation, and coordinate such activity.

11. Who will hold/execute the clinical site contracts for the studies in this program?

Answer: The Offeror will be required to execute subcontracts with all of the clinical sites.

https://nihaarpstars.com/

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12. Are any current or future studies to be performed in Europe and therefore subject to General Data

Protection Regulation?

Answer: Yes, there are current and/or future studies that are or will be performed in Europe and subject to General Data Protection Regulation.

13. Article G.6 indicates government property may or may not be acquired/used for the studies.

However, Attachment 05 (List of Government Furnished Property) specifically identifies GFP to be provided to the awardee. Will NCI require the contractor to receive and use the materials/equipment in Attachment 05? Are these materials/equipment located at labs or sites?

Answer: The Contractor will not be required to utilize the items listed in Attachment 05: List of Government Furnished Property (GFP). However, it will be made available to the predecessor Contractor. The equipment may be located at labs or sites. The transfer of equipment will need to be coordinated with the current Contractor during the Initial Transition Period. The Government Furnished Property may be revised at a later date.

However, for the purposes of this Solicitation and estimation for the proposal, please use the listed GFP.

14. Is the contractor responsible for developing and completing enrollment plans (e.g. Planned Enrollment Report – Attachment 8) for each of the MEB studies, or will NCI provide enrollment criteria for each study’s performance?

Answer: The Contractor will work with NCI to implement enrollment criteria defined by NCI Principal Investigators.

15. Will NCI identify IRB(s) to be used for ongoing and future studies (see Article H.5)? Articles H.4 and H.8 require completion of Attachment 11, but this cannot be done at the proposal stage without further information (IRB, IORG #, study activity review status, etc.).

Answer: Please fill out the form to the best of your ability. If it is not applicable, please state as such in your proposal with a justification.

16. Will the Principal Investigator identified in the proposal (Attachment 14) also be named the Principal Investigator to the FDA or similar regulatory authorities on Form 1571 and other required documents for clinical trials?

Answer: Yes.

17. What PII/PHI would contractor need to collect to meet NCI’s needs?

Answer: The type of PII/PHI collected varies for each study and could range from names/birth dates to residence addresses/Social Security Numbers/medical records, as examples.

Contractor must be prepared to collect all encompassing kinds of PII/PHI and be prepared to securely store all of this data.

18. What is the anticipated number of PII/PHI records contractor will need to collect for performance?

Answer: This number varies based on study size, but could range up to 600,000 records.

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19. Will contractor be responsible for receiving and/or maintaining datasets containing PII/PHI? If so, how many records are in such datasets?

Answer: Yes, the Contractor is responsible for receiving and/or maintaining datasets containing PII/PHI. The number of records in the datasets vary based on study size and can reach about 600,000.

20. Do the government's labor hour estimates (RFP page 62) include transition activities?

Answer: No, they do not include transition activities.

21. Attachment 7, page 160 requires the contractor to have the ability to hold frequent face-to-face meetings with NCI COR and NCI study investigators to monitor activities of the studies being simultaneously conducted. What is the frequency of the meetings? What is the assumed location of the meetings?

Answer: Meetings will be held once per month at NCI’s Shady Grove location.

22. For the new studies contemplated under the MEB, "Feasibility of collecting fecal and oral samples in the prospective studies" discusses sample collection in cohorts located in various global locations, including the Pars cohort in Iran, which is subject to restrictions and sanctions under BIS and OFAC.

What activities will the contractor perform as related to the study in Iran?

Answer: We conduct a number of studies in collaboration with the Tehran University of Medical Sciences (TUMS). Our collaborative work has been repeatedly reviewed by NIH Fogarty, the US Department of State, and the US National Academy of Sciences and they determined that we do not need to obtain a License from the Department of Treasury because our collaboration consists of only scientist-to-scientist contact. We give them advice and they share data that we analyze and publish. We do not anticipate asking the Support Service contractor to do anything that would require any contact with Iranian entities.

23. Given the additional information requested in order to support an accurate proposal response, would the government consider an extension to the RFP due date?

Answer: Yes, the Government will extend the Request for Proposal due date to 10:00AM Eastern Time on April 9, 2018.

24. RFP Page 80, under Technical Work Instructions, the contractor is required to, "Provide a schedule for completion of the work and delivery of items specified in the statement of work." However, the SOW (page 135) states that, "the scientific design of studies...are the responsibility of MEB scientific staff." Given that the study designs will impact the Contractor's work schedule, it seems a detailed status for each on-going study as well as the final study designs for new studies would be required to develop the requested schedule. Can the government clarify its expectations around the schedule to be submitted with the RFP?

Answer: Final study designs for new studies will not be provided as they have not yet been planned out at this time. The Contractor will participate in ongoing discussions and collaborate with NCI PIs of each study to develop a schedule suitable to meet the needs of the NCI PIs. For the purposes of the RFP, please provide a recommended schedule based on the work specified in the SOW.