N02CP71009-58_Amendment_1_Final.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) provide responses to questions received; and (2) update Attachment 12

Additional Business Instructions.

Proposal Due Date: October 11, 2017; 2:00PM Eastern (Unchanged)

Questions and Answers, and Attachment 12 follow.

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

To All Potential Offerors

N02CP71009-58

1 13

09/20/2017

08/11/2017

RFP N02CP71009-58

Amendment 1 Page 2 of 13

A New Prospective U.S. Cohort Set Within Health Care System Institutions to study Cancer

N02CP71009-58

AMENDMENT #1

QUESTIONS AND ANSWERS

The following are answers to questions received from potential offerors.

Question 1:

Is the maximum of $150,000,000 Total Costs or Direct Costs?

Answer 1:

Per Article B.3 of the solicitation, the maximum of $150,000,000 includes total costs and is the combined total ceiling amount on all possible awards issued under all IDIQ contracts resulting from the RFP.

Question 2:

Is there a minimum # of subjects to be included per application?

Answer 2:

There is no required minimum, but recruitment capability is critical and therefore the Government has an expectation of at least approximately 4000 total recruited participants at each site as stated in the Additional Business Instructions.

Question 3:

What is the difference between the Statement of Work (SOW) and the technical proposal?

Answer 3:

The SOW is the work required and defined by the Government. The Technical Proposal is created by the Offeror and describes how they propose to accomplish the requirements defined in the

SOW.

Offerors are encouraged to reference the following site to determine the difference between contracts and grants:

https://grants.nih.gov/funding/contracts.htm https://grants.nih.gov/funding/contracts.htm

Amendment 1 Page 3 of 13

Question 4:

We need some clarification on Articles B.4. on page 4 and Articles H23 and H24 on page 31.

a) Article B.4. Page 4 : Prohibits or restricts, unless otherwise approved by the Contracting Officer:

1) Conferences & Meetings, 2)Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

b) Does Article B.4. Page 4 mean the items cannot be built into the response to the solicitation as expected costs or does it mean the requests have to be clearly built into and justified during our response to the solicitation?

c) Does Article H.23 and Article H.24. Page 31 mean the items cannot be built into the response to the solicitation as expected costs or does it mean the requests have to be clearly built into and justified during our response to the solicitation?

Answer 4:

Except for food for meals, light refreshments, beverages and promotional items, the items listed in Article B.4 may be built into the offeror’s response, however, such costs must be clearly broken out and justified in the offeror’s proposal. Food for meals, light refreshments beverages and promotional items cannot be reimbursed using contract funds and therefore are unallowable costs.

Question 5:

Will this be a fixed price contract or cost reimbursement contract or a combination of both?

Answer 5:

As stated on page 53 of the solicitation, the Government anticipates awarding multiple award IDIQ type contracts. Cost reimbursement and/or fixed price task orders may be awarded under the resultant IDIQ contracts.

Amendment 1 Page 4 of 13

Question 6:

Is documentation to be included for all expense requests at the time of submission, invoice submission only, or both? Does this documentation include verification of salaries?

Answer 6:

Offeror’s shall justify all proposed costs in their business proposal in accordance with Section L of the solicitation. This includes supporting documentation to verify proposed salaries and all other direct and indirect costs.

The level of detail required for invoice submission will be detailed in any resultant task orders.

Question 7:

The time periods listed on the Statement of Work in Attachment 3 do not coincide with the dates of the contract as listed on Page 4 in article B.3 nor do they match what is written in Attachment 11, the Protocol Draft Version for the SOW.

In the SOW in Attachment 3 I am getting a total of 9.5 years ending 9/4/27 while the contract dates on Page 4 say that the project period ends on 3/4/28. Can you please clarify?

Answer 7:

The protocol is in draft format and will be updated after award. The SOW includes a set of Sample Task Orders with various periods of performance. Note that the 10-year period listed in Article B.3 of the solicitation is the IDIQ ordering period. The Sample Task Orders in the SOW may be issued during this 10-year ordering period. Sample Task Orders are provided to assess the offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under the contracts awarded in response to this solicitation.

The project end date of 3/4/28 is correct and should be used for estimation purposes.

Amendment 1 Page 5 of 13

Question 8:

Can you please clarify the intervals for specimen collection as the SOW says “regular intervals” and we want to be clear for budgeting purposes.

Answer 8:

As stated in the Additional Business Instructions offerors shall assume the following:

Collect 45 ml of blood (one to two 10 ml anticoagulant free tubes, 10 ml EDTA tubes, 10 ml Heparin tubes, and a 5-15 ml whole blood sample for DNA/RNA extraction from both cells and serum/plasma), 20 ml urine, and mouthwash samples will be collected from each participant at baseline (within the first year of enrollment) and then on average every 3 years from the date of their enrollment for the duration of the study. The collection could be during a routine blood draw (with exclusion for certain conditions) or at a time convenient to the participant as described in the final study protocol.

Question 9:

Please provide detail on “mouthwash collection”. Is this for the purpose of collecting buccal cells? Do we need to budget for the collection kits, shipping, any special storage conditions?

Answer 9:

The “mouthwash collection” is for the purposes of collecting buccal cells. Offerors shall not budget for the collection kits, shipping, or special storage.

Question 10:

For collection of hair samples: do we need to budget for purchasing collection kits and for shipping of kits to participants and to NCI?

Answer 10:

Offerors shall not budget for the collection kits or shipping.

Amendment 1 Page 6 of 13

Question 11:

Can we propose collection of additional samples, such as stool samples? If so, do we budget for purchasing kits and for shipping?

Answer 11:

Offerors shall not propose collection of additional samples. Ancillary studies will be developed separately.

Question 12:

Would you be able to tell me if there is an incumbent contractor for this requirement? If so, could you please provide the contractor name and the contract number that was awarded?

Answer 12:

This is a new requirement and thus no incumbent contractor exists.

Question 13:

Do you have a definition of an IHCS?

Answer 13:

For the purposes of this study, the Government defines an integrated health care system as an institution or system that provides integrated individual healthcare including, but not limited to, out-patient care, in-patient care, pharmacy, specialist care and emergency care and all related health records are captured in patient’s electronic medical records in a single, accessible location.

Amendment 1 Page 7 of 13

Question 14:

Section 3 of the Statement of Work (Attachment 11) calls out that IHCS providers should be submitting EMR orders for their biospecimen collections when they will be collecting the biospecimens in-house. It also points out that various IHCS may have different protocols for specimen collection based on their infrastructure (e.g., some may be able to do patient self-collection, while others may require an appointment visit). In an effort to consistently implement the protocol across the various IHCS, does NCI want the order of biospecimen collection to be triggered by the study IT platform based on time, patient information, or eQuestionnaire submission? What alternatives has NCI considered to implement a consistent protocol across the IHCS?

Answer 14:

The specific collection protocols will be finalized after the IHCS sites have been identified since logistical considerations and input from the sites are required. At that point, detailed standardized procedures will be developed and finalized.

Question 15:

The Technical Evaluation Factor under Criterion 1.B.a states that the offeror must demonstrate a clear understanding of the SOW and sample task orders. This includes an understanding of EMR data abstraction. Since there will be more than one IHCS award, it may be challenging, inefficient, and costly for each IHCS contractor to harmonize and standardize the EMR data. Can we assume as part of the proposal and pricing that EMR data harmonization and standardization, including the development of harmonization standards, will be done by the study IT platform contractor?

Answer 15:

The sites will be responsible for creating a map of their data to facilitate standardization. The specific protocol for data standardization will be finalized after the IHCS sites have been identified since logistical considerations and input from the sites are required. At that point, detailed standardized procedures will be developed and finalized.

Amendment 1 Page 8 of 13

Question 16:

There are several mentions of data linkage requirements. This includes:

• As described in the protocol, the contractor shall deliver the abstracted electronic medical record data and linkage data from local cancer registries and vital statistics in accordance with a format and frequency specified in the final study protocol to the NCI via the study IT platform. All data will be accompanied by data dictionaries and any other relevant documentation (e.g. explanations of how variables were derived, a description of the version/date of abstraction, and how the variables may differ from what was expected) (page 8)

• Passive linkage with cancer registries (page 6 of Attachment 11)

• Outcomes via passive linkage to cancer and vital status registries (page 8 of Attachment

11)

• Linkage of SSN to population-based databases such as local cancer registries (page 9 of

Attachment 11)

• Record linkages of data sources to define vital status, cancer status, environmental exposure history, and census tract residence (page 14 of Attachment 11)

• Perform linkages to local (and other relevant) cancer registries and vital statistics and submit this data electronically to the study IT platform (page 3 of Attachment 12)

• Perform annual linkages to local (and other relevant) cancer registries and vital statistics and submit this data electronically to the study IT platform (page 5 of attachment 12)

• Perform annual linkages to local (and other relevant) cancer registries and vital statistics and submit this data electronically to the study IT platform (page 7 of Attachment 12)

It appears to be prudent for the IHCS to make the linkages with internal/local cancer registries and then submit these data to the study IT platform. However, there may be other linkages -- such as those with population-based databases or environmental data sources, or those requiring geographical specificity -- that might be better implemented by the study IT platform contractor. This implementation would ensure that these linkages are created in a consistent and uniform manner and that analytic data on the backend are as efficacious as possible. Please clarify what the expectations are of the IHCSs regarding linking data within their enterprise.

Answer 16:

The sites will be expected to link with local tumor registries. Linkages such as vital statistics and environmental exposures will be tasked to the Support Services Contractor for this study under a separate acquisition. The Support Services acquisition was posted to FBO under Solicitation No.

N02CP71007-58.

Amendment 1 Page 9 of 13

Question 17:

Are sites that have a general Precision Medicine Initiative (All of Us Cohort) grant eligible to apply for the NCI US Cohort Contract? Infrastructure and resources already set in place by these systems for PMI may be leveraged for efficiency.

Answer 17:

Sites that have received a general Precision Medicine Initiative (All of Us Cohort) grant are eligible to propose under this solicitation. Synergistic use of such efforts are highly encouraged.

Question 18:

Should scientific aims of interest to the site be specified in the objectives and background of the technical report?

Answer 18:

No, this is not required.

Question 19:

Are CVs counted in the page limit? We see the length is 3-pages but we were not clear if they are counted or not counted in 100 page limit of technical report?

Answer 19:

CVs are excluded from the 100-page limitation.

Question 20:

Can NIH 398 Biosketch format be used for CV? If not, is there a format available for CVs?

Answer 20:

The NIH 398 Biosketch format may be used for CVs. Please note that CVs shall not exceed a total of three (3) pages each.

Amendment 1 Page 10 of 13

Question 21:

Attachment 3 -Tasks – Is the task list a document that needs to be submitted separately from the business proposal, budget spreadsheet and technical proposals? We see file names ( attachment 1 page 2 of 2) for these three items but none for SOW tasks listed in Attachment 3. Are the tasks to be embedded in the technical proposal or are they separate documents? Clarification is greatly appreciated.

Answer 21:

The Offeror’s approach to meeting the Task requirements should be included in their Technical proposal as stated in the Additional Technical Proposal Instructions:

“All offerors should provide specific documentation in their proposal with regards to these items.

Your proposal shall be organized in accordance with the order of the Statement of Work and the technical evaluation criteria provided in Section M. The order of items should be presented in a manner that will provide the most meaningful presentation.”

Please refer to “SECTION 3: TECHNICAL DISCUSSIONS FOR EACH TASK AREA” in the Additional Technical Instructions for more details.

Question 22:

Can the budget be front loaded with costs to cover recruitment with fewer dollars spent in later years?

Answer 22:

The Offeror should provide their cost estimates with the rationale described in their proposed approach to justify front loading.

Question 23:

Is the total budget for the ten years for all sites $150,000,000?

Answer 23:

The maximum of $150,000,000 includes total costs and is the combined total ceiling amount on all possible awards issued under all IDIQ contracts resulting from the RFP.

Per the Additional Business Proposal Instructions, offerors shall provide separate budgets for the sample task orders only. NCI is not requesting budgets for the overall IDIQ.

Amendment 1 Page 11 of 13

Question 24:

May sites budget for biostatistical support beyond sampling of the population?

Answer 24:

If the biostatistical support is necessary to meet the requirements of the SOW, the Offeror should propose this labor category with justification (e.g. their role) and include it in their cost estimate.

Question 25:

If multiple health systems are joining together for a single proposal – what documents do or do not need to be provided to NCI from the subcontract sites? One budget/separate budgets etc.? Forms in business proposal (all sites or just prime site?)

Answer 25:

In accordance with page 84 of the solicitation, if subcontractors are proposed, the offeror shall include a commitment letter from the subcontractor detailing:

a. Willingness to perform as a subcontractor for specific duties (list duties)

b. What priority the work will be given and how it will relate to other work

c. The amount of time and facilities available to this project

d. Information on their cognizant field audit offices

e. How rights to publications and patents are to be handled

f. A complete cost proposal in the same format as the offeror’s cost proposal

The prime contractor’s budget shall include a budget line for the total of each subcontract.

Question 26:

Sample Task Order 1: Is the budget to be prepared two ways?- one 5 month and one 13 month budget- Or are we to budget 18 months and it may be cut to 5 months?

Answer 26:

For Sample Task Order 1, offerors shall use the Breakdown of Proposed Cost (Plus Fee) and Labor Hour Excel Spreadsheet to prepare their budgets. The 5-month base period and 13-month option must be broken out into two separate periods. Attachment 12, Additional Business Instructions has been revised to clarify this.

Amendment 1 Page 12 of 13

Question 27:

Sample Task Order 3: Is the budget to be prepared two ways?- one 12 month and three additional 12 month budgets- Or are we to budget four 12 month budgets and it may be cut to one 12 month budget?

Answer 27:

For Sample Task Order 3, offerors shall use the Breakdown of Proposed Cost (Plus Fee) and Labor Hour Excel Spreadsheet to prepare their budgets. The 12-month base period and three 12 month options must be broken out into separate periods. Attachment 12, Additional Business Instructions has been revised to clarify this.

Question 28:

Is the Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hours in addition to the Excel Spreadsheet?

Answer 28:

The Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hour includes instructions for completing the offeror’s budget and an Excel template. Offerors shall use the Excel Spreadsheet template to propose costs.

Question 29:

Is there an electronic version of the Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hours or is this to be self-created?

Answer 29:

A link to the Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hour spreadsheet is provided in Section J of the solicitation. Offerors may access the spreadsheet by clinking on the following link:

https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-014_508.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-014_508.xlsx

Amendment 1 Page 13 of 13

Question 30:

Is there an electronic version of the Technical Proposal Cost Information Summary of Labor & Direct Costs or is this to be self-created?

Answer 30:

A link to an electronic version of the Technical Proposal Cost Information and Summary of Labor and Direct Labor is provided in Section J of the solicitation. Offerors may access the electronic version by clicking on the following link:

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-relatedactivities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-relatedactivities.pdf

Attachment 12

N02CP71009-58

Additional Business Proposal Instructions

The below is hereby added to the instructions:

The Offeror shall use the assumptions below for their cost volume.

General:

The Government has provided Sample Task Orders to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. Offerors are to include separate budget spreadsheets for each sample task order. Costs for each Sample Task Order shall be broken out by contract period. The Government is not requesting a budget for the overall IDIQ.