N02CP71007-58_Amendment_2_Package.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 telegram 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 your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter 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 NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

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

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

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 ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. 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 NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, 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)

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.

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)

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., 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)

NSN 7540-01-152-8070

Previous edition unusable

Jill M. Johnson

The purpose of this amendment is to: (1) update the date of the Statement of Work in Article C.1.; (2) modify M.4. Technical Evaluation Factors; (3) provide responses to questions received; (4) revise Attachment 3, SOW; (5) revise Attachment 6 Additional Technical Proposal Instructions; and (6) revise Attachment 13 Additional Business Instructions.

Proposal Due Date: September 22, 2017; 2:00PM Eastern (Unchanged)

Questions and Answers, and Attachments 3, 6 and 13 follow.

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Bethesda, MD 20892-9705

To All Potential Offerors

N02CP71007-58

1 31

09/08/2017

08/11/2017

RFP N02CP71007-58

Amendment 2 Page 1 of 31

Support Services for a Prospective U.S. Cohort Set within Health Care Systems to Study Cancer

N02CP71007-58

AMENDMENT #2

SOLICITATION UPDATES:

1. Article C.1. Statement of Work is deleted in its entirety and revised as follows:

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated September 8, 2017, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

2. Section M.4 – Technical Evaluation Factors (pages 97-99) is deleted in its entirety and revised as follows:

The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed in the order of relative importance with weights assigned for evaluation purposes. Subfactors are listed in order of relative importance.

Technical Evaluation Factors Maximum Score Criterion 1: Technical Approach 50 Points Criterion 2: Experience and capabilities of personnel

25 Points

Criterion 3: Organizational Experience 10 Points Criterion 4: Management Approach 10 Points Criterion 5: Resources and Facility 5 Points TOTAL 100 Points

CRITERION 1: TECHNICAL APPROACH (50 Points)

1. Demonstrates adequacy of overall plan for meeting all the objectives as outlined in the SOW and Technical Proposal instructions.

2. Demonstrates relevant knowledge of and ability to apply key epidemiologic features of a large-scale cohort study with serial biological specimen collection and collection of data from a variety of sources and demonstrate clear understanding of activities necessary for successful implementation.

3. Documents ability to develop study procedures and materials (e.g. Standard Operating

Procedures (SOPs), Manual of Operating Procedures (MOOPs), e-questionnaires), and implement standard procedures (e.g. training). Documents ability to incorporate innovative

Amendment 2 Page 2 of 31 approaches to study implementation as needed (e.g. novel approaches to online questionnaire administration, study participant follow-up). In addition, document ability to adapt and integrate any modifications to study protocol and facilitate ancillary studies.

4. Demonstrates adequate plan for ensuring standardization of procedures among the recruitment sites. In conjunction, demonstrate capability to accommodate site-specific requirements as needed to minimize imposition on health care system's routine operations.

5. Documents capability to work with collaborators on a multi-center research project with large number of study participants. This includes the ability to serve as liaison between major stakeholders of the projects such as integrated health care system (IHCS) sites, study IT platform contractor, processing labs, and NCI central repository, study participants, researchers for data and specimen access, and other entities. In addition, this includes the ability to work with existing infrastructure systems or newly developed information technology systems infrastructure for the project.

6. Demonstrates adequate approach to quality control, quality assurance, and the process for review of task performance in order to optimize delivery of the task within schedule and budget and minimize performance risk factors.

7. Documents ability to establish necessary infrastructure to serve as the primary point of contact for participants who have left a IHCS site's health plan as per study protocol. For example, establish, host, and triage a toll-free study telephone line and/or provide a study email address;

monitor reminders to study participants to complete their online questionnaire and/or donate research biospecimens.

8. Documents ability to perform linkages to a variety of data sources such as to define vital status, cancer status, environmental exposure history and census tract residence.

9. Documents relevant technical problems experienced and how they were addressed with timely and effective solutions. Demonstrate understanding of potential problem areas with consideration of alternative approaches.

CRITERION 2: EXPERIENCE AND CAPABILITIES OF PERSONNEL (25 Points)

1. Demonstrates adequate and appropriate education, training, qualifications, and relevant on-the-job experience of key personnel. Key Personnel includes:

a. Project Director/Project Investigator: Experience with oversight of large, complex contracts.

Experience and training in overall project management and communications.

b. Program Manager: Experience with epidemiologic studies, some of which have involved participant enrollment and follow-up and biological specimen collection. Experience with human subjects. Experience and training in tracking, monitoring and reporting on project status and progress, recommending modifications to project requirements, timelines, and procedures, and directing and ensuring the quality of functions carried out by in-house staff

Amendment 2 Page 3 of 31 as well as subcontractors, consultants, implementing corrective/remedial actions to/resolve problems and deficiencies.

2. Other Personnel: This includes but is not limited to data manager, programmer, website manager, analyst and support staff. Demonstrates that other personnel have adequate and appropriate training, experience, qualifications, and availability to perform the functions required of their area of expertise.

3. Demonstrates adequate mix of disciplines at the optimal staffing levels needed for efficient, timely delivery of high-quality service for core and ancillary activities.

CRITERION 3: ORGANIZATIONAL EXPERIENCE (10 Points)

1. Documents and demonstrates the quality of the organization's experience in the management of large cohort studies.

2. Demonstrates organizational structure and experience to perform the requirements of the

SOW.

3. Demonstrates approach to providing corporate support to Project Management.

4. Demonstrates stability of the workforce and ability to recruit and retain staff.

CRITERION 4: MANAGEMENT APPROACH (10 Points)

1. Documents effectiveness of the overall design of management approach and its relevance to the SOW. Specifically, the management approach shall address the Offeror's adequacy, appropriates and adaptability in terms of plans for staffing, organization, responsibilities, leadership, and lines of authority, as well as management of subcontracts and consultants.

2. Documents ability to provide organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of large-scale epidemiological study.

3. Documents adequate communication plan, which involves effective communication and rapid interventions when issues arise.

4. Demonstrates capability of providing budget estimates for specific tasks, monitors spending, and provides clear reporting of expenditures.

CRITERION 5: RESOURCES AND FACILITIES (5 Points)

1. Documents capacity, adequacy, suitability and availability of the secure facilities, equipment, and other resources necessary to carry out the requirements.

2. Document availability and adequacy of the security of data storage.

Amendment 2 Page 4 of 31

QUESTIONS AND ANSWERS:

The following are answers to questions received from potential offerors.

Question 1:

Does the 75-page limit for the technical proposal include CV’s (CVs limited each to 3 pages)?

Answer 1:

The 75-page technical proposal limitation does not include CVs.

Question 2:

Can you clarify what role the Contractor for the “Support Service” opportunity will have with regards to recruitment of participants at the IHCS sites? Will the Contractor be required to strategize and bring recruitment subject matter expertise to the sites as part of the “development of cohort materials/tools”?

Answer 2:

There will be no direct role for the Support Service contractor in recruiting participants. However, recruitment subject matter expertise would be beneficial to the collaborative development of recruitment materials and approaches to help ensure effective recruitment and attaining the recruitment goals.

Question 3:

Can you clarify what is meant by study website management? Is it limited to updating study website content where general study information will be provided for the general public, study participants, and researchers? (Statement of Work. Page 2. Item 5.)

Answer 3:

Website management will be limited to website content. The IT contractor shall develop the website. The website content will be developed and managed by the Support Services contractor and NCI. Attachment 13 has been updated accordingly.

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Question 4:

Can you confirm that a total of 5 past performance qualifications are to be submitted – 3 past, and 2 current in the business proposal?

Answer 4:

Offerors shall include a total of five past performance qualifications as part of their business proposal. This includes three contracts completed during the past three years AND the last two contracts currently being performed that are similar in nature to the solicitation work-scope.

Question 5:

Can you confirm if all tracking, monitoring, and reporting tools and techniques will be developed and/or delivered by the “IT Study Platform” Contractor, or does the government expect activities associated with the “Support Services” contract to require IT systems to be developed, secured, and managed by the “Support Services” Contractor?

Answer 5:

All tracking, monitoring, and reporting tools and techniques will be developed and/or delivered by the “IT Study Platform” contractor. However, until the Platform is developed, the “Support Service” contractor may need to provide tracking, monitoring, and reporting using traditional approaches (i.e. via email).

Question 6:

Can the government provide an estimate of when the IT Study Platform provided by the “IT Study Platform” Contractor will be operational and available for use by the “Support Services” Contractor?

Answer 6:

The Government currently does not have an exact date but anticipates the IT Study Platform being available for use within 12-18 months of the “IT Study Platform” contract award date (approximately within 14-20 months of award of the Support Services contract). Attachment 13 has been updated accordingly.

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Question 7:

Will the Contractor awarded this “DCEG Support Service” opportunity have any restrictions regarding bidding or performance on future Solicitation HHS-NIH-NCI-SS-ETSB-1008-58 “DCEG IT Study Platform”?

Answer 7:

The successful contractor for this requirement will not be restricted from bidding or performing on the IT Study Platform opportunity.

Question 8:

Task 1.5 states that the Support Services contractor will be updating study website content for the general public, participants and researchers. Attachment 13, General Item 3 states that the Support Services contractor will oversee study website management starting in option period 3. Is the Support Services contractor responsible for hosting the website, or only developing website content?

Answer 8:

The Support Services contractor will be responsible for management of the website content but not hosting the website. The IT Study Platform contractor and NCI will be responsible for hosting the website. Attachment 13 has been updated accordingly.

Question 9:

Does overseeing website management as stated in Attachment 13, General Item 3, include providing access to restricted areas of the website for participants and researchers?

Answer 9:

The Support Service contractor will help identify the role of each user (e.g. participant, researcher).

Based on the role identified, the IT platform will provide the appropriate access. Attachment 13 has been updated accordingly.

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Question 10:

Task 2.1 states that the Support Services contractor will be responsible for developing specifications and cognitive testing for all e-questionnaires. Attachment 3, Data/Specimen Collection Item 1 defines a baseline questionnaire and a diet questionnaire, as well as additional questionnaires approximately every 3 years. How many additional questionnaires should we assume the Support Services contractor will develop?

Answer 10:

The exact number of questionnaires cannot be predicted at this time. However, for cost estimation purposes, offerors shall assume that approximately 6-7 questionnaires will be administered that vary in scope and length, including the baseline questionnaire (during year 2), a diet questionnaire (during years 3-4), 2 follow-up questionnaires (during years 5-6 and years 8-9), and 2-3 biological specimen associated questionnaires (during year 2 and year 5). Attachment 13 has been updated accordingly.

Question 11:

Task 3.4 states that the Support Services contractor will prepare and provide study operations training programs and materials for all key study research staff at the IHCS sites. Will the Support Services contractor only be supplying training materials, or will there be any in-person training, such as train-the-trainer sessions?

Answer 11:

In-person training may be required. Offerors shall assume a $25,000 plug number for travel, per contract year which includes travel for in-person training. Attachment 13 has been updated accordingly.

Question 12:

Task 3.5 states that the Support Services contractor will serve as the primary point of contact for participants who leave IHCSs. For budgeting purposes, how many participants are anticipated to leave IHCSs each year?

Answer 12:

The participating IHCSs are currently unknown and therefore anticipated attrition rates are unknown. Because follow-up will be primarily automated, the number of participants followed by the IHCS sites is not expected to drive the cost. However, for cost estimation purposes, offerors shall assume 8% annual attrition for the first 5 years. Thereafter, offerors shall assume that attrition may stabilize to 2% annually. Attachment 13 has been updated accordingly.

Amendment 2 Page 8 of 31

Question 13:

For participants who leave IHCSs, will the Support Services contractor be responsible for arranging a location for blood draws and other specimen collections?

Answer 13:

The Government anticipates that participants who leave their IHCS will be contacted by the Support Service contractor to complete online questionnaires and linkages will be performed to obtain their cancer and vital status. However, it is possible that, at some point in the future, the Government may want to reach out to some or all of these participants for additional biospecimen collections. In such case, additional biospecimen collections will likely be self-collected. Therefore, the Government does not anticipate that the contractor shall be responsible for arranging for blood draws. Attachments 3 and 13 have been updated accordingly.

Question 14:

If the Support Services contractor will arrange for blood draws for those participants who leave IHCSs, is the contractor responsible for the expenses associated with the collection, processing, and shipping?

Answer 14:

In the unlikely event that the Government decides to collect biospecimens from these participants, the contractor would be responsible for the coordination of biospecimens collections (most likely self-collected by study participants) but not for processing and shipping. Attachments 3 and 13 have been updated accordingly.

Question 15:

Task 3.7 states that the Support Services contractor will be supporting ancillary studies. How many studies should we assume the contractor is supporting?

Answer 15:

Ancillary studies will be largely supported by the existing infrastructure for the main cohort.

Ancillary studies are expected to result in relatively small tasks for the contractor.

The Government has provided the estimated effort for this requirement, which includes ancillary studies. As previously stated, the Government expects levels of effort in various task areas to ebb and flow during the period of performance. For example, as initial efforts in rolling out recruitment eventually decline, there may be an increased effort in an ancillary study.

Amendment 2 Page 9 of 31

Question 16:

In the technical proposal instructions, under Section 7 it states that “In addition, the offeror should provide a flow chart presenting the exchange of data between the involved institutions.” Does this mean the data exchanged between the prime contractor and any subcontractors, or does it include exchanges with the IHCS, IT contractor, and NCI?

Answer 16:

This refers to the data exchange between the prime contractor and any subcontractors.

Attachment 6 has been updated accordingly.

Question 17:

Attachment 13, Data/Specimen Collection, item 3 states that the contractor is responsible for linking NDI records for participants who leave IHCSs. For costing purposes, how many cases/participants should bidders assume will need to be submitted to NDI, what number of years should be searched, and what type of linkages are anticipated?

Answer 17:

Attachments 3 and 13 has been revised to reflect the need to submit annual linkages to the National Death Index (NDI) for ALL participants, not only those who leave their IHCS. Tumor registry linkages will be performed annually for only those participants who leave their enrollment IHCS. However, we anticipate that in the future the Virtual Tumor Registry will be operational and available for use.

Question 18:

Attachment 13, Item 4 under Data/Specimen Collection indicates that the Support Services contractor will coordinate materials/devices to be sent to an estimated 50,000 participants. Should the cost for procuring the devices be included in the Support Services budget, and if so, in which year and how much money should offerors allot for this procurement?

Answer 18:

The coordination of sending devices to participants is no longer required. Attachment 13 has been revised to reflect this.

Amendment 2 Page 10 of 31

Question 19:

Is the contractor responsible for shipping devices for ancillary studies? If so, in which year and how much money should offerors allot for shipping?

Answer 19:

Question 20:

Attachment 13, Meetings, Item d states that site visits are conducted via online/video conferencing.

Will site visits be conducted in person? If yes, what assumptions should we make about number of staff and duration of visit? Should we assume 10 locations?

Answer 20:

Site visits of the IHCS sites will be conducted by NCI in person. The support service contractor may be required to join the site visits remotely by online/video conference. Offerors shall assume that 5 site awards will be made.

Question 21:

Article H.15. Information and Physical Access Security, Item A, subpart d discusses background checks and fingerprinting requirements. Will contractors be required to cover the cost for these activities?

Answer 21:

Article H.15. Information and Physical Access Security, Item A, subpart f states that typically “the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer’s discretion, justify reduction(s) in the contract price of no more than the cost of the additional investigation(s).

Amendment 2 Page 11 of 31

Question 22:

Attachment 7: Technical Cost Proposal Summary contains columns for seven years of cost information. Should we insert extra columns to accommodate all ten years of required costs or will NCI provide a revised summary that includes columns for ten years?

Answer 22:

The “Technical Proposal Cost Information/Summary of Labor and Direct Costs” form indicates that additional pages may be used as necessary. Offerors shall use the additional pages to account for the additional three years of performance. The “Technical Proposal Cost Information/Summary of Labor and Direct Costs” form is excluded from the 75-page technical proposal limitation.

Question 23:

Attachment 14: Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet – The Excel file provided contains columns for seven budget years. Will NCI provide a new shell to cover all 10 years?

Answer 23:

Section J, List of Attachments, includes a link to an Excel Spreadsheet under Attachment 14. Please use the following link to access the Excel Spreadsheet and add additional columns to cover the 10-year period of performance.

https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx

Question 24:

Small Business Subcontracting Plan – the SBSP supports five years of cost information. Should bidders complete two SBSPs where one covers the base period and option periods one through four and the second covers option periods five through nine?

Answer 24:

The following link includes a Word version of the Small Business Subcontracting Plan. This may be modified to include the base period and option periods one through nine.

HHS SubK Plan Template

Amendment 2 Page 12 of 31

Question 25:

Page 56, Item 13 Past Performance Information indicates that offerors should submit “a list of the last 3 contracts completed during the past three years and the last 2 contracts awarded currently being performed that are similar in nature to the solicitation workscope.” Should offerors interpret this to mean that the past performance information is limited to contracts held with the federal government, or are contracts, cooperative agreements, and/or grants awarded from federal, state, and local agencies or foundations also acceptable?

Answer 25:

As stated on page 56 of the solicitation, contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns.

Question 26:

Under Article C2, Reporting requirements, it states that all reports shall be compliant with Section

508. Which specific deliverables are required to be 508 compliant?

Answer 26:

All deliverables submitted in an electronic format shall be compliant with Section 508 of the Rehabilitation Act of 1973.

Question 27:

Attachment 1: Under the packaging and delivery instructions, the RFP provides requirements for the font size and spacing to be used in the proposal. Can NCI suggest fonts that meet these requirements (such as Arial, Garamond, or Times New Roman)?

Answer 27:

Offerors are encouraged to utilize fonts complaint with Section 508 of the Rehabilitation Act of 1973. These fonts include Times New Roman, Verdana, Arial, Tahoma, Helvetica and Calibri.

Amendment 2 Page 13 of 31

Question 28:

Can a font smaller than 10 to 12 points be used in tables and exhibits?

Answer 28:

A smaller font size may be utilized for tables and exhibits. The font size shall be no less than 8 points.

Question 29:

Will appendices to the technical proposal count against the 75 page limit?

Answer 29:

All technical proposal information required under Section L will count against the 75-page limitation. This includes the offeror’s technical discussion, the Information Security section and the Human Subjects section. Other appendices or attachments will not count against the 75-page limitation.

Question 30:

Given the complexity of this solicitation, would NCI extend the deadline of the proposal for two weeks until September 29th?

Answer 30:

In Amendment 1, the Government extended the proposal due date to September 22, 2017, 2PM Eastern. This amendment does not extend the due date further.

Question 31:

If a subcontractor would prefer to submit proprietary information (e.g., documentation of NICRA) to NCI via a sealed bid, how do they do that given the requirement to submit three proposal files (Technical, Business, and Excel Workbook) to NCI via eCPS?

Answer 31:

A subcontractor may submit proprietary information via a sealed bid directly to the Contracting Officer. The information may be submitted to Ms. Rosa Lopez at rosa.lopez@nih.gov and Ms. Jill Johnson at jill.johnson2@nih.gov.

mailto:rosa.lopez@nih.gov mailto:jill.johnson2@nih.gov

Amendment 2 Page 14 of 31

Question 32:

For budgeting purposes, what assumptions should be made about the NIH salary cap over the 10 years of the contract?

Answer 32:

For budgeting purposes, Offerors shall assume that the NIH salary cap may be increased by an amount commensurate with the Consumer Price Index. However, please note that the amount of salary that can be charged to the contract will be limited to the actual salary cap established for each year. Attachment 13 has been updated accordingly.

Question 33:

Are offerors expected to leverage technology, data, and resources from other cohorts, studies, initiatives? What is the expectation as to how this will aid in the recruitment totals?

Answer 33:

Offerors will not be expected to leverage technology, data, or resources from other cohorts but are expected to apply their knowledge and understanding from their experiences with other cohorts, studies and initiatives. For example, expertise in recruitment and understanding targeted approaches would assist NCI in attaining their recruitment goal.

Question 34:

Is there a content management system currently used by DCEG that is available to the Support Services contractor to use? If not, will this be provided by the IT Infrastructure contractor?

Answer 34:

The content management system will be provided by the IT Study Platform Contractor.

Attachment 13 has been updated accordingly.

Question 35:

Is the government customer expecting scientific support includes questionnaire subject matter expertise as part of support services or will this be provided external to this solicitation?

Answer 35:

Questionnaire subject matter expertise will primarily be obtained from the NCI and extramural scientific communities. The support services contractor will be expected to provide expertise in questionnaire development such as evaluation and cognitive testing of the questionnaire.

Attachment 3 has been updated accordingly.

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Question 36:

For the NCI central repository, is NCI using their central repository in Frederick, MD and managed by the BBRB or will there be a new 3rd party contractor at a different bio storage facility?

Answer 36:

The facility for storing biological specimens for this cohort has yet to be identified.

Question 37:

What does NCI use for the estimated annual FTE hours, i.e., 1920, 1880?

Answer 37:

NCI estimated annual FTE hours of 2080 to populate the estimated effort table on page 51 of the solicitation. Offerors shall propose in accordance with their established company work year.

Question 38:

Can NCI provide a breakdown of the estimates that resulted in the estimated labors? Can this be broken out per task?

Answer 38:

The Government has indicated that support is necessary as outlined in the SOW. Based on the information provided, the Offeror should propose the expected level of effort required to successfully accomplish the requirements.

Question 39:

Formatting instructions state "Font size must be 10 to 12 points." We request that offerors be able to use a smaller font size for tables and graphics.

Answer 39:

A smaller font size may be utilized for tables and exhibits. The font size shall be no less than 8 points.

Amendment 2 Page 16 of 31

Question 40:

Are offerors permitted to use fold-out pages to assist in demonstrating their technical approach?

Answer 40:

Offerors are not permitted to use fold-out pages. Please note that the Government is only accepting electronic proposals submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

Question 41:

Are key personnel and non-key personnel resumes included in the 75-page limit for the technical proposal?

Answer 41:

CVs are excluded from the 75-page technical proposal limitation.

Question 42:

Given the undefined travel requirements, will the government be providing a plug-number for travel and ODCs?

Answer 42:

For estimation purposes, the government will provide a plug-number for travel. The total travel per year shall be $25,000. Attachment 13 has been updated accordingly.

A breakdown of Other Direct costs should be proposed by the Offeror.

Question 43:

Can the offeror submit the required Section 508 Product Assessment Template exclusive of page count?

Answer 43:

The Section 508 Product Assessment Template is excluded from the 75-page technical proposal limitation.

https://ecps.nih.gov/

Amendment 2 Page 17 of 31

Question 44:

What is the current status of the study protocol, will the study protocol be finalized and ready for submission, by contract award?

Answer 44:

The protocol is in draft format. The Government intends to work with the IHCSs and other contractors to finalize the protocol after award of the respective contracts.

Question 45:

Regarding the programmer indicated in Other Personnel, is this a statistical programmer or a website programmer?

Answer 45:

The programmer should be a data/statistical programmer.

Question 46:

On page 128, the table “Technical proposal cost information/summary of labor and direct costs” only goes to Year 7 but on page 51, the estimate of effort has 10 years. Please clarify the correct time frame for this contract.

Answer 46:

As stated in Article F.1 of the solicitation, it is anticipated that the contract will include a 1-year base period with nine 1-year options, for a total of 10 years.

The “Technical Proposal Cost Information/Summary of Labor and Direct Costs” form indicates that additional pages may be used as necessary. Offerors shall use the additional pages to account for the additional three years of performance. The “Technical Proposal Cost Information/Summary of Labor and Direct Costs” form is excluded from the 75-page technical proposal limitation.

Question 47:

Budget assumptions are provided for site visits and Steering Committee meetings; however, the Additional Business Proposal Instructions (Att. 13) do not provide any assumptions regarding the contractor supporting External Advisory Panel meetings.

Please provide budget assumptions for the contractor to support External Advisory Panel meetings.

Answer 47:

The External Advisory Panel meetings have been removed from the SOW and Data/Specimen Access Committee, Expert Review Panel, and ad hoc group meetings have been added.

Attachments 3 and 13 have been updated accordingly.

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Question 48:

a. Please confirm that offerors are to budget for one online/video conference per year with each of the IHCS sites.

b. Should offerors assume any in-person site visits to the IHCS sites?

c. For budgetary purposes, should offerors assume that 10 IHCS site awards will be made?

Answer 48:

Offerors are to budget for one online/video conference per year with each of the IHCS sites.

A plug-number of $25,000 has been provided for travel. Offerors shall assume that 5 site awards will be made. Attachment 13 has been updated accordingly.

Question 49:

Please confirm that the following are exempt from the 75-page limit on the Technical Proposal:

a. CVs--In order for the Technical Proposal to include more details, we recommend that CVs be exempted from the page limit

b. Technical Proposal Cost Summary (Att. 7)

c. Summary of Related Activities (Att. 8)

d. Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Att. 9)

e. HHS Section 508 Product Assessment Templates (Att. 10)

f. Technical Appendix documents, (e.g., consultant, vendor, or subcontractor supporting documentation; CVs; Letters of Support/Commitment; Section 508 assessments)

Answer 49:

CVs, Technical Proposal Cost Summary, Summary of Related Activities, OMB Form No. 0990-0263, and the HHS Section 508 Product Assessment template are excluded from the 75-page Technical Proposal limitation. Letters of Support and Commitment from consultants and subcontractors are also excluded.

The solicitation requires offerors to include a description of any proposed subcontractor and consultant arrangements explaining how the statement of work will be accomplished. This description is included as part of the 75-page limitation.

Amendment 2 Page 19 of 31

Question 50:

Will the Offeror also be responsible for collecting biospecimen from study participants who have left an IHCS site’s health plan?

Answer 50:

It is possible that, at some point in the future, the Government may want to reach out to some or all of these participants for additional biospecimen collections. In such case, additional biospecimen collections will likely be self-collected. Therefore, the Government does not anticipate that the contractor shall be responsible for arranging for blood draws. Attachment 13 has been updated accordingly.

Question 51:

Please clarify any specific services, materials, supplies, and/or equipment that that the Offeror should or should not include in the proposed cost estimate. For example, should we cost all the supplies for biospecimen collection?

Answer 51:

The cost for biospecimen collection supplies should not be included in the Offeror’s cost estimate.

Only the supplies and/or materials that will be required to meet the requirements of the SOW should be included.

Question 52:

We respectfully request that the Government extend the proposal due date to allow adequate time

(1) for the Government to respond to Offeror questions that are due by August 25, 2018, and (2) for Offerors to revise their planned approach based on any RFP amendments issued by the Government in response to Offeror questions.

Answer 52:

In Amendment 1, the Government extended the proposal due date to September 22, 2017, 2PM Eastern. This amendment does not extend the due date further.

Amendment 2 Page 20 of 31

Question 53:

Please confirm that the Project Director/Project Investigator and the Project Manager are considered the only key roles for this response. Instructions in Att. 6 and Section M seem to be in conflict.

The number of personnel classified as Key Personnel will affect the cost estimates (e.g., attending required meetings and site visits).

Answer 53:

There was a formatting error in the Evaluation Criteria. This has been corrected to read:

Key Personnel includes:

• Project Director/Project Investigator […]

• Program Manager […]

Other Personnel: This may include, but is not limited, to data manager, programmer, website manager, analyst and support staff.

Question 54:

a. Please confirm that the Support Services Contractor (SSC) will perform data linkages to National Death Index, State Vital Statistics Office and cancer registries only once a year and only for participants who left the IHCS and are being followed by the SSC.

b. Should the Offeror include the estimated costs of data linkage in their proposed budget?

Answer 54:

a. Attachment 13 has been revised to reflect the need to submit annual linkages to the National

Death Index for ALL participants, not only those who leave their IHCS. Cancer Registry linkages are anticipated to be performed annually only for those who leave their IHCS and are followed by the SSC.

b. Yes, estimated costs for all linkages should be included in the offerors proposed budget.

Amendment 2 Page 21 of 31

Question 55:

a. Please clarify what materials/devices will be sent to participants.

b. Please clarify when the materials/devices will be sent to participants (e.g., during Baseline or follow-up).

c. Is it the responsibility of the Support Services Contractor (SSC) to procure the materials/devices and send them to the participants? If yes, should the Offeror include the cost estimates in the proposed budget?

Answer 55:

Question 56:

Will the government please exclude the Technical Proposal Cost Information, Summary of Related Activities, Section 508 Evaluation Template, Data Sharing Plan, Protection of Human Subjects, CVs, and Information Security sections from page count?

Answer 56:

The Technical Proposal Cost Information, Summary of Related Activities, Section 508 Evaluation Template, Data Sharing Plan and CVs are excluded from the technical proposal page count.

Protection of Human Subjects and the Information Security sections are included as part of the 75-page technical proposal page count.

Question 57:

The Institution shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to NIH consistent with this part.

Is FCOI training required for staff on this project?

Answer 57:

The language the offeror is referring to relates to Attachment 4, Representations, Certifications, and other Statements of Offerors. Page 11 of 13 of Attachment 4 states the following: “This certification is applicable to all Research and Development (R&D) Contracts except Phase I SBIR/STTRA and Contracts with Federal Agencies.” Please note that this is not an R&D acquisition and therefore this particular certification is not applicable.

Amendment 2 Page 22 of 31

Question 58:

RFP Section B.4 instructs the bidder to include the cost for conferences, meals, light refreshments and beverages. Section H. 22 states that contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited.

Are the cost for meals, light refreshments and beverages at conferences prohibited?

Answer 58:

The use of contract funds will be restricted for conferences unless approved, in writing, by the Contracting Officer. The use of contract funds to purchase meals, light refreshments or beverages for meetings or conferences is expressly prohibited.

Question 59:

HHS expects each procuring activity to establish minimum subcontracting goals for all procurements.

The anticipated minimum goals for this RFP are as follows: 33% for Small Business; 5% for Small Disadvantaged Business; 5% for Women-Owned Small Business; 3% for HUBZone Small Business; and 3% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business.

Are offerors required to subcontract with a small business for this procurement in order to meet the minimum expected goals?

Answer 59:

Unless the offeror is a Small Business concern, offerors are expected to include an acceptable Subcontracting Plan in accordance with FAR 52.219-9. The plan must provide for the maximum practicable opportunity for Small Businesses, Small Disadvantaged Businesses, Women-Owned Small businesses, HUBZone Small Businesses, Veteran-Owned Small Businesses, and Service Disabled Veteran-Owned Small Businesses to participate in the performance of the contract.

As stated on page 86 of the RFP, the term “subcontract” means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements/purchase orders for supplies and services such as equipment purchase, copying services, and travel services.

Amendment 2 Page 23 of 31

Question 60:

Is it correct to assume that the request for plans in the evaluation criteria under section 3. HUMAN SUBJECT EVALUATION; b. Women and Minorities is not a Phase III clinical trial and NOT applicable to this project and therefore will NOT be part of the evaluation of this section?

Answer 60:

This is not a Phase III clinical trial. Therefore, this criterion is not applicable to the evaluation of the proposals.

Question 61:

Will all deliverables and reports listed in the RFP be subject to 508-compliance? If not, can NCI specify which reports will be required to be 508 compliance.

Answer 61:

All deliverables submitted in an electronic format shall be compliant with Section 508 of the Rehabilitation Act of 1973.

Question 62:

Can NCI provide an estimate of the expected attrition rates for (a) participating sites, and (b) individual participants within sites?

Answer 62:

The participating IHCSs are currently unknown and therefore anticipated attrition rates are unknown. Because follow-up will be primarily automated, the number of participants followed by the IHCS sites is not expected to drive the cost. However, for cost estimation purposes, offerors shall assume 8% annual attrition for the first 5 years. Thereafter, offerors shall assume that attrition may stabilize to 2% annually. Attachment 13 has been updated accordingly.

Question 63:

Some participants may leave an IHCS and then receive care at another IHCS participating in the study.

What will be the support services contractor’s role for these participants? What type of follow up will the support services contractor be required to conduct for these participants?

Answer 63:

The Government anticipates that any participant who leaves their enrollment IHCS will be followed by the Support Services contractor. Attachment 13 has been updated accordingly.

Amendment 2 Page 24 of 31

Question 64:

For those participants who leave the IHCS site’s health plan and do not enroll in another participating IHCS site health plan, will the support services contractor be required to administer questionnaires and collect biospecimens? If not, how will these individuals continue to have data collected and entered into the data management system?

Answer 64:

The Government anticipates that participants who leave their IHCS will be contacted to complete online questionnaires and linkages will be performed to obtain their cancer and vital status.

However, it is possible that, at some point in the future, the Government may want to reach out to some or all of these participants for additional biospecimen collections. In such case, additional biospecimen collections will likely be self-collected. Therefore, the Government does not anticipate that the contractor shall be responsible for arranging for blood draws. Attachment 13 has been updated accordingly.

Question 65:

Should bidders assume long-term follow-up with study participants will be done in English only or should bidders assume other languages need to be accommodated?

Answer 65:

Offerors should assume follow-up of those who leave their IHCSs will be in English only.

Question 66:

Please clarify if the study website will be developed and maintained by the IT contractor and the Support contractor will just revise content as needed; or will the Support contractor assume all management beginning in Option Period 3 (Year 4)?

Answer 66:

Website management will be limited to website content. The IT contractor shall develop the website and content will be managed by the Support Services contractor and NCI beginning in Option Period 3. Attachments 3 and 13 have been updated accordingly.

Amendment 2 Page 25 of 31

Question 67:

Will the contractor be expected to pay for travel and honoraria for nonfederal experts. If so, is there an estimate of how many nonfederal external experts may participate in in person annual meetings?

Answer 67:

The contractor will not be expected to pay for travel and honoraria for non-Federal experts.

Question 68:

Does the evaluation of different methods for questionnaire administration include different modes of administration other than web (e.g., phone, mail)?

Answer 68:

The Government anticipates that most questionnaires will be completed by participants using the web (computer, mobile apps). If necessary, in the future the Government may require additional modes to be included.

Question 69:

Can NCI clarify who will develop the recruitment materials? In addition to cognitive testing, what will be the role of the support services contractor in finalizing the materials?

Answer 69:

NCI will develop the recruitment materials in collaboration with the IHCS sites. The support services contractor may be responsible for making final edits and developing the final version based on input from all collaborators. Attachment 13 has been updated accordingly.

Question 70:

Should bidders assume that in order to collect participant data (cognitive testing/focus groups and/or long-term follow-up), at least some PII will need to reside on the support services contractor’s systems (and therefore outside of the IT contractor’s systems)? Will that PII include social security numbers?

Answer 70:

All cohort related data will reside within the IT platform. The only data that might reside outside of the IT platform may be data related to cognitive testing/focus groups of non-cohort participants.

The Support Services contractor will have permission to access the restricted data including PII for the purposes of linkages etc.

Amendment 2 Page 26 of 31

Question 71:

Can NCI clarify if the support services contractor will have a role in conducting quality control of the data and data management system? If so, please describe the support required.

Answer 71:

The Government will be responsible for conducting quality control of the data.

Question 72:

Would this task include the support services contractor subcontracting to labs? (re: collection of biospecimens from patients who leave the IHCS site via self-collection)

Answer 72:

The Government does not anticipate the support services contractor needing to subcontract with labs.

Question 73:

Will the central repository be an NCI lab or another subcontracted entity?

Answer 73:

The facility for storing biological specimens for this cohort has yet to be identified.

Question 74:

Will MTAs and DUAs be executed between each IHCS and NCI, allowing NCI to directly share data and materials with researchers requesting access? Will the support services contractor also be required to enter into DUAs/MTAs with each IHCS?

Answer 74:

The Government does not expect to execute Material Transfer Agreements (MTAs) and Data Use Agreements (DUAs) between each IHCS and NCI, or between IHCSs and the support services contractor.

Amendment 2 Page 27 of 31

Question 75:

What is the anticipated volume of FOIA requests?

Answer 75:

Offerors shall assume 1 request per year.

Question 76:

Offeror’s are required to coordinate materials/devices to be sent to participants in a subset of participants upon having recruited 50,000 participants to the study. What are the devices?

Answer 76:

Attachment 13 has been revised to reflect that the coordination of sending devices to participants is no longer required. Attachment 13 has been updated accordingly.

Question 77:

Commitment to Protect Non-Public Information Technical Proposal Cost Information/Summary of Labor and Direct Costs Summary of Related Activities Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption

(OMB Form No. 0990-0263; and HHS Section 508 Product Assessment Template

Is it correct to assume that the completed attachments bulleted above are NOT included in the 75-page limit and should be provided in separate appendices?

Answer 77:

The attachments identified above…