NCI_Response_to_Questions_-_AMEND_1.pdf

Ramp-on: Response to Solicitation Questions From Industry NCI Response

Question Number Solicitation Reference Background Question NCI Response 1 Attachment 14 Breakdown of

Proposed Estimated Costs The salary costs for all the periods in rows 7 and 8 (employee 1 & 2) are not calculating based on the number of months and percent of effort for each period. Option Period 1 salary cost and Base Period cost are the same even though Base Period is for 6 months and Option period 1 is for 12 months for rows 7 and 8.

Attachment 14 has been corrected with this Amendment 1. Please use "Attachment 14 - Breakdown of Proposed Estimated Costs - AMEND 1".

2 Attachment 14 Breakdown of Proposed Estimated Costs

The annual increase factor in row 50 isn't calculating into the periods after the base period for rows 7 and 8

Attachment 14 has been corrected with this Amendment 1. Please use "Attachment 14 - Breakdown of Proposed Estimated Costs - AMEND 1".

3 Attachment 05. Organization of Technical Proposal. Section 3 – Core Infrastructure (85 pages) and Section 4 – Research support (10 pages)

References/bibliography Can we include in-text references, and if so, would the bibliography be part of the page limitation?

Bibliographies may be included as Appendices, but as stated in Attachment 5 - Additional Technical Proposal Instructions "pages that exceed the specified limitations will be removed prior to evaluation."

4 Attachment 03. III A. 1. Proposals shall not include links to internet web site addresses (URL) or otherwise direct readers to alternate sources of information

References/bibliography and links in the application

Can we include hyperlinks in the bibliography (i.e. laws, reports, publications)?

Hyperlinked information will not be considered as part of proposal evaluation.

However, the bibliography may include hyperlinks to laws, reports, or publications where the content within these hyperlinks is not required for a complete proposal but is provided for reference only.

5 Attachment 05. 3.2. 7.II.b. Illustrate data flows

Flow charts and diagrams Should we include illustrations and data flows/graphics within Section 3. Item 3.2 or in the Appendices?

Offerors are responsible for determining where illustrations and data flows/graphics should be used to best convey information considering page limitations and any other factors.

6 Attachment 05. 3.1.c. The Offeror shall use a table to indicate the start and end year for the collections of each data item listed as required for collection by SEER

Table of required SEER data item (list)

Should we include the table of required SEER data items within Section 3 Item 3.1 or in the Appendices?

The table of SEER data items may be included in Section 3 or the Appendices, however Section 3.1 must clearly indicate where the table can be found.

7 Solicitation. Section M. 4. Mandatory Qualification Criteria. 2.b.

Cancer registry reporting laws Should the reporting laws be included as an attachment in the attesting letter?

Yes. Technical Proposal Section 2 "Mandatory Qualification Criteria Response" requires that the Offeror include all information which documents and/or supports the Mandatory Qualification Criteria. As such, the attesting letter shall clearly identify relevant sections of the applicable reporting laws while the full-text of the applicable law/section is attached thereto. There is no page limitation for this section.

8 Solicitation Article B.3. Provisions Applicable to Direct Costs

We often use services of consultants and rarely have subcontractors.

The B.3 Provisions #9 and #10 states that consultant and subcontractor costs are "unallowable," yet the RFP states that we should subcontract with IMS. Are subcontractors and consultants allowable if Offerors need them to carry out the SOW?

Solicitation Article B.3 does not state that consultants and subcontractor costs are unallowable. The Article states: "...unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:". Therefore, Offerors may propose the use of consultants and subcontractors for review and authorization by the Contracting Officer. Reference Attachment 10 - Additional Business Proposal Instructions for more information.

9 Solicitation Attachment 32 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment

Offeror must represent that it will or will not provide covered telecommunications equipment or services to the Government in the performance of the contract.

What kind of telecommunications equipment or services would be applied here? Does this representation refer to usual telecommunications equipment such as phones, internet, and other network connections that we plan to use in performance of the

SOW?

Yes. See FAR Clause 52.204-25 "Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment" for the specific definition of "covered telecommunications equipment or services".

See Solicitation Section I.4.

10 RFP page 13 and Attachment 5 page

Is the document referenced in the RFP page 13, #32 'SEER Bibliography Entries' the same document referenced in Attachment 5 page 14 'Relevant Publications'? If no, what is the difference between the documents?

"Relevant Publications" is the title of a Technical Proposal section used to support you Organizational Experience and Capabilities during the pre-award proposal evaluation phase. "SEER Bibliography Entries" is a potential Task Order Deliverable that may be required under future Task Orders. The specific content of the "SEER Bibliography Entries" would be determined under the future Task Order.

11 Attachment 01: Base Statement of Work page 4 and Attachment 02:

Task Order 1, page 3, Case finding Activities, Item 3

These sections state that Contractors shall establish agreements for electronic data transfer with all major case reporting facilities. However, the State law requires electronic submission of cancer data.

Is the Government requiring that formal agreements be established?

If so, what form should agreements for electronic data transfer take?

Formal agreements are not required if electronic cancer reporting is mandated by State Law and/or regulated by State Department of Health or other relevant state agency. In the absence of statutory requirements for electronic cancer reporting, contractors are expected to establish agreements for electronic data transfer with all major case reporting facilities.

Attachment 02 - Task Order 1 - Core Infrastructure - Statement of Work, page 3, case finding activities item 3, is amended to read:

" In the absence of statutory requirements for electronic cancer reporting, contractors shall establish agreements for electronic data transfer with all major case reporting facilities."

12 Attachment 02: Task Order 1, Page 5, Item 1(c)-1 Follow-Up Activities

This section states that contractor shall obtain information on vital status for ALL active cases.

However, data quality standards require follow-up rates at less than 100% (p. 6).

Should this be revised to read "should attempt" to obtain vital status for all cases, or shall obtain vital status for the percentage of patients necessary to meet the data quality goals?

Contractors shall plan to obtain and report information on vital status of all patients alive at the at the last follow-up. This is to clarify that the Contractor is expected to conduct follow-up operations on registry patients believed to be alive at the start of this contract, as opposed to conducting follow-up just on the subset of patients diagnosed after the start date of this contract.

No changes to the original text of the SOW.

13 Attachment 02: Task Order 1, Page 5, Item 1(c)-3 Follow-Up Activities

This section states that contractor shall obtain the COD from death certificates. However, death certificates are not available for all deceased patients and linkage with NDI may be used.

Should it read "from the death certificate, or from another source if no death certificate is available or if the death certificate does not document a cause of death."?

Contractors are expected to follow NAACCR standards and the SEER Program Coding Manual to code the Cause of Death (COD). The standard requires that the cause of death is coded from the death certificate. NDI linkage will provide information on the cause of death listed in the death certificate, when direct access to the death certificate is not available.

No changes to the original text of the SOW.

14 Attachment 02: Task Order 1, Page 6, Item 3 Data Quality Requirements

Quality goals do not match goals on prior years' SEER Data Quality Profiles: Pediatric follow-up goal is listed as 85%, but is 90% on DQP. Non-specific histology is listed as <2.5% but on the DQP is <1.5%. Urban Geocoding accuracy is listed as >95% but is >90% on the DQP.

Are the goals as specified in the RFP new benchmarks set by SEER?

Please confirm.

Attachment 02 - Task Order 1 - Core Infrastructure - Statement of Work, Page 6, Item 3 "Data Quality Requirements" has been revised.

15 Attachment 02: Task Order 1, Page 6, Item 4(6)

This section states that contractors shall ensure that abstracting vendors comply with State requirements.

Please define "abstracting vendors." Are these vendors who develop abstracting software or vendors who provide abstracting services?

The state has no legal authority over vendors - only over reporting facilities.

Abstracting vendors are vendors who provide abstracting services.

No changes to the original text of the SOW

16 Attachment 02: Task Order 1, Page 5, Item 2(a)

This section states that data submission will occur "prior to the end of November." However, current SEER data submission is due November 1st of each year.

Is the primary submission date "prior to the end of November" correct, as previously the due date was November 1st?

The current NCI SEER submission date is November 1st. The Government retains the right to modify the current date up to and including the last day of November. The decision regarding the data submission deadline will take into account the possibility of a future coordinated call for data with other cancer surveillance organizations.

No changes to the original text of the SOW

17 Attachment 10: Additional Business Proposal Instructions, p. 8, section

3.12 Non-Disclosure Agreements

Section 3.12 specifies that the form provided in Attachment 29 be signed by contractors and subcontractors who may have access to non-public information.

Attachment 29 is an "Employee Separation Checklist" not a Non- Disclosure Agreement (NDA). Rather the NDA is Attachment 27.

Should all staff at the registry sign the NDA or just staff who are named in the proposal as necessary to carry out the SOW?

The Additional Business Proposal Instructions are revised to reference Attachment 27 for the Non-Disclosure Agreement form. As stated in the instructions, submit this form signed for each named contractor and subcontractor personnel who may have access to non-public information.

18 RFP page 98, Section L.2.c.8 "Total Compensation Plan"

Section L.2.c.8 specifies that offerors should submit a Total Compensation Plan for professional employees as part of the Business Proposal for evaluation purposes.

Instructions state "Total Compensation Plan (salaries and benefits)" should be submitted but how is this different from what we are required to submit in the budget workbook and budget narrative? If it is a different from the cost proposal, then is there a template or structure for writing the Plan?

Section L.2.c.8 and FAR 52.222-46 outline the requirements of the Total Compensation Plan. These references include additional requirements not discussed elsewhere in the Solicitation. As described in Attachment 10 "Additional Business Proposal Instructions" the Total Compensation Plan should be included as item viii. of your Direct Labor Budget Narrative.

19 Attachment 10: Additional Business Proposal Instructions, p. 12, section 2.d.i.b.4 SEER Advanced Topics Workshop held at NCRA

Allowable travel to programmatic meetings includes SEER Advanced Topics Workshop held at NCRA, but there are no details for budget preparation.

How many staff are we allowed to send and how many days? Should we use GSA per-diem and travel rates for known conference locations and use Washington, D.C. Metro area for years when the conference location is unknown?

Attachment 10 - Additional Business Proposal Instructions, Section 2.d (Page

12) has been amended. Note: Program specific meetings have been moved under item ii "Contractor-share" of the budget.

20 Attachment 10: Additional Business Proposal Instructions, p. 15, section 2.h.vi. SEER*DMS Subcontract

SEER*DMS costs have been historically allowed under "Other Direct Costs" as a "IMS Hosting Fee" without a formal subcontract with IMS.

Are registries required to enter into a formal subcontracting agreement with IMS? For registries already on SEER*DMS, should costs include the $15,000 Annual Recurring Independent Assessment Fee in addition to the $25,000 Annual Recurring Costs?

What is the Annual Recurring Independent Assessment Fee?

Registries are required to enter a formal subcontract agreement with IMS.

Only a draft agreement is required with the Proposal. Registries currently on SEER*DMS should not include the "Initial Infrastructure Fee” but must include the "Annual Recurring Cost" and "Annual Recurring Independent Assessment Fee". Attachment 10, Section 2.h.vi. SEER*DMS Subcontract has been revised for clarity.

21 Attachment 10: Additional Business Proposal Instructions, p. 13, section 2.g.iii. "Computer Hardware"

Instructions state that if "Computer Hardware" is included in the Cost Proposal under Govt Share funding, then this "equipment will become Government Property" and Offerors should complete the Government Property Schedule (Attachment 17) and must be tracked.

On page 6 of the RFP, Section B.3.a. #12 defines "Accountable Government Property" as "non-expendable personal property with an acquisition cost of $1,000 or more" and government property is usually defined as equipment with an acquisition cost of $5,000 or more, for this RFP, does the reporting and tracking requirements for "Computer Equipment" follow either of these definitions? Or, does it apply to all "computer hardware," regardless of acquisition cost?

Attachment 10 is revised to state:

“If Computer Hardware that meets the definition of “Government Property” (See Solicitation Article G.6) is included in the Offeror’s Cost Proposal under Government-share funding, this hardware will become Government Property.”

See Article G.6 for the definitions of Government Property that apply to this contract.

22 Attachment 10: Additional Business Proposal Instructions, p. 16, section 3.b. Unallowable Costs

Section 3.b. states that "No contract funds should be used in support of the design, development, enhancement, or maintenance of a non-SEER*DMS legacy data management system…or any parts of a legacy

Does this restriction apply to any and all data collection applications including systems used to track, for example, data requests, patient contact for research studies, or other administrative tracking systems? Or is this specific to cancer surveillance data collection systems?

This restriction applies to all non-SEER*DMS systems.

data management system or data collection application.

23 PART I - THE SCHEDULE

SECTION H - SPECIAL CONTRACT

REQUIREMENTS

ARTICLE H.18. ELECTRONIC AND

INFORMATION TECHNOLOGY

ACCESSIBILITY NOTICE HHSAR

352.239-73 (December 2015)

Do the electronic proposal documents that we will be submitting via eCPS need to be compliant with Section 508 of the Rehabilitation Act of 1973 and do we need to submit completed Section 508 Accessibility Checklists for each document?

Documents submitted as part of the proposal are not required to be in compliance with Section 508 and will not be evaluated for conformance.

Section 508 standards will apply only to electronic deliverables/reports submitted under any resultant contract.

24 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors - 2. Instructions to Offerors - a. General Instructions - 17.

Solicitation Provisions Incorporated by Reference, page 73.

Page 73 of the Solicitation (end of item 17 Electronic and Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)) states The "HHS Section 508 Product Assessment Template" is included in SECTION J - List of Attachments, of this solicitation. Yet this item is not included in section J. Where can we find the template?

Since the only Information and Communication Technology (ICT) deliverables required under this contract are various reports, the "HHS Section 508 Product Assessment Template" is not required. Page 73 of the solicitation is modified accordingly. Page 35, Article H.18, Item 3, is modified to further clarify that Section 508 accessibility standards apply to Electronic Deliverables/Reports only. Electronic reports require completion of the "Accessibility checklist" (https://www.hhs.gov/web/section-508/making-files-accessible/index.html) for the appropriate file types.

25 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors - 2. Instructions to Offerors - a. General Instructions - 17.

Electronic and Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015), page 72.

Do we need to complete and submit with the proposal an HHS Section 508 Product Assessment Template? Where can we find this template? [See page 72 item 17]

No. Please reference response to questions 23 and 24.

26 Attachment 09 - Planned Enrollment Report.pdf

What are the dates of inclusion for the Planned Enrollment Table. See Solicitation Section L.2.b.3.e (page 85). For the purposes of responding to this RFP, the dates of inclusion for the Planned Enrollment Report should include January 1st to December 31st of the most recent completed year.

27 Solicitation Article - Part IV, Section M - Evaluation Factors for Award - 11.

Basis for Award - b. Source Selection Decision - Desired geographic dispersion and population characteristics, page 112.

Please provide the correct link or a pdf of this information referenced in the RFP, to replace the link that the Government provided that is not working:

https://www2.census.gov/geo/pdfs/maps-data/maps/reference/us_regdiv.pdf.

The link has been corrected in the Solicitation Amended document.

28 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors - 2. Instructions to Offerors - a. General Instructions - 15.

Past Performance Information, page

71. Solicitation Article - Part IV, Section L - Instructions, Conditions, and Notices to Offerors - 2.

Instructions to Offerors - c. Business Proposal Instructions - 10.

The time frame for the listing of like contracts is the past 5 years on page 71 and the past 3 years on page 102. Which is correct?

3 years. Solicitation Page 71 has been revised accordingly.

Qualifications of the Offeror - d.

Pertinent Contracts, page 102.

29 Attachment 05 - Additional Technical Proposal Instructions.pdf, Section 3 - Attachments and Appendices, pages 9-10.

What if you need more than 100 pages (page limit for the Appendices to accommodate resumes?

As stated in Attachment 5 - Additional Technical Proposal Instructions "pages that exceed the specified limitations will be removed prior to evaluation."

Offerors must determine the appropriate level of detail for each Attachment or Appendix to remain within the stated page limitation.

30 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors - 2. Instructions to Offerors - b. Technical Proposal Instructions - 1. Technical Proposal, page 74.

Task area 5 is referenced in both the Core Infrastructure and Research Support Sections (page 74). Should this be addressed in both sections?

Yes.

31 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors - 2. Instructions to Offerors - b. Technical Proposal Instructions - 3. Human Subjects - d.

Inclusion of Women and Minorities in Research Involving Human Subjects - Note 2, page 84.

The Note 2 on page 84 states that the bullets in the Human Subjects section should be addressed for each task order. Is it necessary to repeat the same information by Task Order or will one overall description suffice?

Offerors should describe in general terms how they will comply with bulleted items for each applicable Task Area of Attachment 01 - Base Statement of Work. In the future, when the NCI issues a Task Order Request for Proposal, each of the bulleted information items must be fully and specifically addressed in that Task Order proposal. Note that Human Subjects may not be applicable to every Task Area of the Base Statement of Work. If the approach is the same for various Task Areas this information need not be repeated so long as the proposal clearly identifies and addresses each applicable Task Area.

32 Solicitation Article - Part IV, Section M - Evaluation Factors for Award - 11.

Basis for Award - b. Source Selection Decision - Desired geographic dispersion and population characteristics, pages 111-112.

Is it required that you meet population sizes outlines under “Desired geographic dispersion and population characteristics (page 111- 112)?

The "Desired geographic dispersion and population characteristics" are not a requirement. However, when considering combinations of Offerors given the limitations of funds available, the Government may consider achieving a combination of Offerors which provide geographic dispersion and overall coverage of various population characteristics, special registry features, data quality, and past data availability.

33 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors, 2. Instructions to Offerors, c. Business Proposal Instructions, 3. requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20.

(b)(1) There offeror shall prepare and submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in accordance with the

The paragraph further states that the instructions in Table 15-2 are incorporated as a mandatory format to be used in this contract, unless the Contracting Officer and the Contractor agree to a different format and change this clause to use Alternate 1. Is the mandatory format being used and where is it?

Solicitation L.2.c.3 FAR Clause 52.215-20 Alternate I (b)(1) has been revised to read:

“(b)(1) The offeror shall submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in the following format:

The format is specified in Solicitation Section L.2.c “Business Proposal Instructions”, Attachment 14 “Breakdown of Proposed Estimated Costs - AMEND 1”, and Attachment 10 “Additional Business Proposal Instructions - AMEND 1”. Offerors are not required to follow the format in Table 15-2 of FAR 15.408, however Offerors must complete Attachment 13 “Certificate of Current Cost or Pricing Data”.”

instructions contained in Table 15-2 of FAR 15.408. p.94

34 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors, 2. Instructions to Offerors, c. Business Proposal Instructions, 5. Small Business Subcontracting Plan. P.95

The first paragraph states: "If the proposed contract exceeds a total estimated cost of $700,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan", FAR Clause No. 52.219--9." Does this mean that we will need to subcontract for work that exceeds a budget of $700K?

No. Unless your organization is considered a small business entity, see FAR 52.219(a), should your proposed budget submission exceed $700,000 it must include a plan to subcontract a percentage of the work to small business entities as described in FAR 52.219-9 (d)(2). See Solicitation L.2.c.5 "Small Business Subcontracting Plan" and Attachment 10 "Additional Business Proposal Instructions".

35 Solicitation Section J – Attachment 14 Instructions state do not overwrite formulas. For staff that are above Executive Level II salary are we allowed to change the formula for the out years?

Attachment 14, Tab “INSTRUCTIONS” states “Do not overwrite the formulas with hardcoded numbers. However, you may edit the formulas as necessary to fit your circumstances. You are responsible for ensuring all numbers are accurate and complete prior to proposal submission.” Thus, you may edit the formula in out years to ensure that no staff are above the Executive Level II Salary Limitation, however you may not simply replace the formula with hardcoded salary amounts.

36 Solicitation Section J – Attachment 14 Travel costs are not inflated in the out years, are we allowed to increase travel estimates by 2% each year?

Yes. If you choose to escalate Travel estimates, please update the "Attachment 14 - Breakdown of Proposed Estimated Costs - AMEND 1" with the appropriate formulas and clearly indicate the escalation percentage used.

36 Solicitation Section J – Attachment 14 As part of our institutions Cost Share commitment we intend to use Contractor-Share funding to reduce the Government-Share indirect costs.

As part of our institutions Cost Share commitment we intend to use Contractor-Share funding to reduce the Government-Share indirect costs. How should we show that in the Excel file?

Attachment 14, Tab “INSTRUCTIONS” states that “you may edit the formulas as necessary to fit your circumstances. You are responsible for ensuring all numbers are accurate and complete prior to proposal submission.” The NCI recommends adding a separate line on the "Gov-Share Summary" Tab showing the reduction in Government-Share Indirect Costs for each period (insert between rows 26 and 27) and adding the corresponding amount under the Contractor-Share Other Direct Costs for the appropriate source of funding.

This is merely a recommendation (not a requirement) based on our limited understanding of the question.

37 Solicitation Section J – Attachment 14 Our institution uses a salary and fringe expenses above the Executive Level II as part of our cost share commitment.

For salary and fringe expenses above the Executive Level II. How should we show that on the excel file?

Salaries above the Executive Level II Salary Rate Limitation are prohibited in both the Government-Share and Contractor-Share portions of the Budget.

38 Solicitation Section J – Attachment 14 Our institution uses Purchased Service for salaries and fringes of affiliated institutions.

Are we allowed to add worksheet pages to attachment 14 for other cost elements if needed?

Purchased Services fit under the 'Other' Other Direct Cost (ODC) category of "Attachment 14 - Breakdown of Proposed Estimated Costs - AMEND 1"

39 Attachment 10 – SEER*DMS Subcontract

Should the subcontract with IMS only include hosting fees or other cost elements such a personnel, materials and supplies, equipment?

The costs associated with the IMS Subcontract are outlined in Attachment 10, Section 2.h.vi. SEER*DMS Subcontract.

40 Additional Business Proposal instructions, Attachment 10, page 7

For budgetary purposes, please define Section 3-Core Infrastructure and Task Order 1-Core Infrastructure. Are we only to include a budget for this with everything in Section 3 and not address Section 4 at all?

"Section 3 – Core Infrastructure” of Attachment 10 is defined by Attachment 02 “Task Order 1 - Core Infrastructure - Statement of Work”. Section 3 of your Cost Proposal must address all requirements within this Statement of Work.

“Section 4 – Programmatic Meeting" refers to Attachment 01 "Base Statement of Work", Task Area 1 – Programmatic Meetings, paragraph b. Please read page 18 of Attachment 10 for instructions on responding to Section 4 of the Business Proposal. Do not include Section 4 costs in your Section 3 - Core Infrastructure - Cost Proposal.

If you are responding to Section 4 “Research Support” only, please include a Labor Rate Table for the full period of performance for the potential labor categories available to complete the “Research Support” Task Areas. A full cost estimate is not required.

41 Business Proposal, Excel file In the Excel file, the base period 1 time period begins 05/01/2020. Is that correct or should it be 11/01/2020?

Attachment 14 has been corrected with this Amendment 1. Please use "Attachment 14 - Breakdown of Proposed Estimated Costs - AMEND 1".

42 HHS Subcontracting Plan The template uses 05/01/2020 as the start of base period 1. Should this be 11/01/2020?

Yes. This has been revised in Attachment 16 "Small Business Subcontracting Plan - AMEND 1"

43 SEER*DMS Mandatory Subcontract with IMS

Must the Technical Proposal include a subcontract Technical Proposal, Letters of Commitment and Attachment 37 for this mandatory subcontract?

"Attachment 37" is an unknown reference. A subcontract Technical Proposal and Letters of Commitment are required for the SEER*DMS Subcontract, reference Attachment 10 "Additional Business Proposal Instructions" section 2.h.vi for more information. The commitment to use SEER*DMS is a mandatory criteria, therefore it is prudent for the NCI to evaluate the technical risks identified and mitigation strategies proposed associated with the migration/implementation.

44 Attachment 2 Task Order 1 Core Infrastructure SOW, Task Order Area 2 - Administrative Activities, #8, page 2.

Implement the Standard for Encryption Language requirements in HHS Contracts at: http://www.hhs.gov/ocio/policy/2009- 0002.001s.html in accordance with Section H. Article of the Base Contract. Link is not available and no reference with Section H.

Article of the Base Contract to be able to find it. Please provide a useable link.

Attachment 02 - Task Order 1 - Core Infrastructure - Statement of Work, Page 2, Item 8 has been revised.

45 Attachment 2 Task Order 1 Core Infrastructure SOW, Task Order Area 2 - Administrative Activities, #6, page 2.

Implement the System Review Analysis and Performance Metric Standards in accordance with Section H. Article of the Base Contract.

There is no information in Section H regarding System Review Analysis and Performance Metric Standards. Please provide.

Attachment 02 - Task Order 1 - Core Infrastructure - Statement of Work, Page 2, Item 6 has been revised.

46 Solicitation\Section H Special Contract Requirements\Article H.2.

(Page 29) Required Education in the Protection Research Participants:

Attachment 5 Additional Technical Proposal Instructions Surveillance, Epidemiology, and End Results (SEER) Program\Specific Instructions\

SECTION 5 - ADDITIONAL

ATTACHMENTS AND APPENDICES\5.3

Human Subjects (Page 13 and 14).

Do all personnel listed in the Core Infrastructure Proposal need to complete Human Subjects Training? (i.e. CITI) Or does this only apply to key personnel listed in the Research Support proposal?

When applicable Article H.2 "Education in the Protection of Human Research Participants" applies to all named personnel working under the contract, including subcontractors or consultants, who are responsible for the design and/or conduct of research. Reference Attachment 10 item 5.3 "Human Subjects" which requires Offerors to address this section "as appropriate for each Task Area". It is important to note that the Task Area for Core Infrastructure is an exempt public health surveillance activity. It is also important to note that the Government does not anticipate making any Task Order awards for Research Support Task Areas as a result of this Solicitation. If NCI issues a future Task Order Request for Proposal for a Research Support Task Area involving Human Subjects, Offerors would be required to satisfy these requirements.

47 Solicitation\Section H Special Contract Requirements\Article H.3.

Certificate of Confidentiality (Page 30):

Do we need to apply for a Certificate of Confidentiality? If so, when would we apply? (i.e. before or after funding is received?)

Institutions and their investigators are responsible for determining whether research they conduct is subject to this Policy and therefore issued a Certificate.

48 Solicitation\Section H Special Contract Requirements\Article H.6.

(Page 31) NIH Policy on Enhancing Reproducibility Through Rigor and Transparency

Solicitation\Section L Instructions, Conditions and Notices to Offerors 2.

Instructions to Offerors b. Technical Proposal Instructions 4. Enhancing Reproducibility Through Rigor and Transparency (Page 89):

Which technical proposal section(s) does this apply? (i.e. Core Infrastructure Technical Proposal Section 3 or Research Support Technical Proposal Section 4 or both?)

Section 4 - Research Support Only

49 Attachment 5 Additional Technical Proposal Instructions Surveillance, Epidemiology, and End Results (SEER) Program\Specific Instructions\

SECTION 5 - ADDITIONAL

ATTACHMENTS AND APPENDICES\5.6

Relevant Publications (Page 14)

This section states: “The Offeror should provide a list of research activities and publications for which your organization played an integral role (e.g. an investigator used the registry). Include studies that were active during the period 2011 to 2016.”

Please clarify if this should only include publications grouped by year and for what years?

Please group publications by year published during the period 2014-2018. The Attachment is revised accordingly.

50 Solicitation Article - Part IV, Section M - Evaluation Factors for Award - 11.

Basis for Award - b. Source Selection Decision - Desired geographic dispersion and population characteristics, page 112-113.

Are items #1-12 all required to be calculated using the "latest figures from the Bureau of the Census's American Community Survey"?

Yes.

51 PART I - THE SCHEDULE

SECTION C -

DESCRIPTION/SPECIFICATIONS/WORK

STATEMENT -

ARTICLE C.2. REPORTING

REQUIREMENTS - a.

Reports/Deliverables - 31. Data Files of Abstracts, page 13.

This section states: “The Contractor shall submit Data Files of Abstracts for each cancer site." In our field, an abstract is the comprehensive and coded cancer case, including identifiers from an individual hospital. As a central cancer registry, we take all of the abstracts from all of the hospitals where the patient was seen, consolidate the data and strip the identifiers off of the consolidated record submitted to SEER. Please confirm that "Files of Abstracts" in the context of this Request for Proposal means the consolidated and de-identified record.

Yes, confirmed.

52 PART I - THE SCHEDULE

SECTION G. - CONTRACT

ADMINISTRATION DATA - ARTICLE

G.3. TASK ORDER PROCEDURE - c.

Competitive Ordering Process - 1, page 24.

This section states: "All contractors within a technical area will receive email notification advising of the availability of each task order requirement." Please advise when offerors should expect this email (i.e. what is the scheduling of this email) in conjunction with the timeframe of this Request for Funding Proposal Solicitation (Following award? If so, how long after award?).

Please review FAR Subpart 16.5 for discussion on "Indefinite-Quantity Indefinite-Delivery" Type Contracts. In this context, the sentence in question should be read as "When the NCI has a known requirement, all contractors within a technical area will receive email notification...". Review Solicitation Section L.1.c "type of contract and number of awards", item 3 for potential Task Orders under this Solicitation. Future Task Order Requests for Proposals not currently described in Section L.1.c.3. will be issued as NCI needs arise.

There is no predetermined schedule.

53 PART I - THE SCHEDULE

SECTION H - SPECIAL CONTRACT

REQUIREMENTS

ARTICLE H.1. PROTECTION OF

HUMAN SUBJECTS, HHSAR-352.270-

4(b) (December 15) - 4, page 29.

This section states: "If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance." Where are the sections (a) and (b) reference in this sentence? Does the Government mean items 1-2 of this article?

Yes. The solicitation has been revised accordingly. Please see "75N91019R00029 Amendment 1"

54 PART I - THE SCHEDULE

SECTION H - SPECIAL CONTRACT

REQUIREMENTS

ARTICLE H.21. PUBLICATION AND

PUBLICITY, page 38.

This section states that Contractor must include the following acknowledgment when publishing: "This project has been funded in whole or in part with Federal Funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. To Be Determined." Is it possible for Offerors to use a shorter acknowledgment when working on VPR-CLS projects or national/international projects with >10 institutions, such as: "This project was funded in part by the U.S. National Cancer Institute SEER Program under Contract # To Be Determined"?

No.

55 Solicitation Article - Part IV, Section L

- Instructions, Conditions, and Notices to Offerors - 1. General Information - c. Submission, modification, and withdrawal of proposals - 1, page 58. And Attachment 03 - Delivery of Proposal Using eCPS

This section states that proposals and modifications must be submitted in paper media. Attachment 03 - Delivery of Proposal Using eCPS states that proposals must be submitted online through the electronic Contract Proposal Submission (eCPS) system and that submissions via mail carrier are no longer acceptable. Please confirm that the Government no longer requires a paper copy of the Proposal, as part of the submission process.

This section does not require proposals in paper media. The NCI no longer accepts paper copy proposals via mail carrier as part of the submission process. Please use the eCPS proposal system as referenced in the solicitation.

56 Solicitation Article - Part IV, Section M - Evaluation Factors for Award - 4.

Mandatory Qualification Criteria - 2a., page 107.

Offeror is a regional central cancer registry, not a state cancer registry.

Offeror has legal authority to operate, which is given via designation from the State health department, which gets its authority to collect cancer information in the state from a State statute. The letter of designation to our regional registry does not restrict our operations to our region, in case we accidentally receive data on cases that are in adjoining counties. However, the authority delegated is from a state law and the name of our registry includes our catchment area designation.

This section states: "Offerors shall provide documentation supporting their representation for a coverage area that is wholly within the United States of America (U.S.)" While Offeror will submit both the State law, the State letter designating us as a public health authority and the University Letter of Attestation that we operate solely in the U.S., what other "documentation" is required by the Government to meet the terms of this sentence? Does the Government intent that we submit a map, showing our catchment area?

A map is not required. Offerors in this situation need to provide the attestation delegation letter from their public health dept.

57 Request for Funding Proposal Solicitation, pages: 11, 84, 89.

Each link was tested using both Google Chrome and Internet Explorer.

The following links in the Solicitation do not work. Please provide correct links: 1.

http://www.hhs.gov/web/508/contracting/technology/vendors.html , 3. http://www.whitehouse.gov/omb/fedreg_notice_15 , 4.

http://stemcells.nih.gov/policy/pages/2009guidelines.aspx .

The Section 508 Report Template link on page 11 works without error. The Planned Enrollment Report is provided as Attachment 09 to the solicitation.

The Stem Cell Policy link on page 89 is revised in the Solicitation Amendment.

58 Solicitation Doc, Section M, 4.

Mandatory Qualification Criteria, Page 107, point 1.

We are considering an application with University as the prime and with a subcontract to the Central Registry. Currently, the Central Registry is authorized through legislation to collect cancer data.

Would we meet the Mandatory Qualification Criteria with regard to this criterion with University as the Offeror (contract prime) and the Central Registry as a subcontractor, without having a delegation of authority to University to collect cancer data?

In this situation, the prime contractor is required to provide the attestation letter that they have been delegated authority to collect the data from their public health agency.

59 Solicitation, Page 75 Single PI v Multi PI Would a 2-state proposal submitted by one state (with a sub-award PI in the second state) be considered responsive to this RFP?

In this scenario, both organizations would need to meet the mandatory criteria. The Technical Proposal must address delegation of authority and provide all required Subcontractor and Multiple PI Information.

60 Attachment 1, pg. 10 Ancillary studies may require patient interviews and other additional effort of uncertain amount.

Would this kind of study come with additional funding provided separately, or are registries expected to keep staff on hand to conduct additional studies like this right away? (If the latter, what is the likely sample size, likely number of interviews, likely number of studies, etc.?)

There is no funding associated with any resultant Base Contract or Attachment 1 - Base Statement of Work. All funding is provided as specific Task Orders (i.e.

studies) are awarded. Please review FAR Subpart 16.5 for discussion on "Indefinite-Quantity Indefinite-Delivery" Type Contracts. Review Solicitation Section L.1.c "type of contract and number of awards", item 3 for potential Task Orders that may be funded under this Solicitation. Please also review Solicitation ARTICLE G.3. TASK ORDER PROCEDURE - c. Competitive Ordering Process.

61 Attachment 10, page 9. General Instructions 1c.

“The budget narrative shall discuss the Offeror’s approach to controlling costs. This shall include an approach to ensuring that the only costs necessary to meet the requirements of the task order – Core Infrastructure – statement of work, are allocated to this contract.”

Many registries are only funded now through the CDC. Does the RFP intend us to assume that the entire registry infrastructure will be funded through SEER i.e. assuming that no CDC funding will be received?

No.

Attachment 10 “Additional Business Proposal Instructions”, 3.14 “Breakdown of Proposed Estimated Costs”, Section 1 “General Instructions / Assumptions”, items d. and e. clearly indicate that Task Order 1 – Core Infrastructure shall be “cost-sharing” and that “each registry cost-share at least 20 percent per year”.

Registries must meet the 20 percent cost-share requirement through other non-Federal funding sources, such as from their State or University.

Attachment 10 “Additional Business Proposal Instructions”, 3.14 “Breakdown of Proposed Estimated Costs”, Section 1 “General Instructions / Assumptions”, item c. is stating that registries shall only include costs (in both the Government-Share and Contractor-Share) necessary to meet the NCI’s requirements as detailed in the Statement of Work. Other costs the registry may incur for operations or projects outside of the NCI Statement of Work and that are not a direct benefit to the NCI shall not be included as Direct Costs within the Budget Proposal. Reference FAR Part 31 “Contract Cost Principles and Procedures” for more detailed information on cost allocation.

62 Task Area 8, Virtual Tissue repository This seems to be a requirement, yet only 3 of 21 registries currently do this. The logistics are likely to be very complicated and require negotiations at multiple institutions.

Is the virtual tissue repository required of all registries? Or can the application propose efforts to explore the logistics of doing this?

At time of the IDIQ Base Contract award, the Government does not anticipate making any Task Order awards for Research Support Task Areas as a result of this Solicitation. Therefore, Technical Proposal Section 4 shall provide a general overview of the Offeror’s Technical Approach, Organizational Experience, Capabilities, Resources, and Facilities, and Personnel in meeting these requirements at a high-level.

63 Solicitation document (75N91019R00029.pdf), subsection c:

The RFP states, “Task Orders under this IDIQ may be solicited as Cost- Reimbursement, Cost

Based on previous awards of the SEER IDIQ, which contract type is most commonly used for task orders? (Cost- Reimbursement, Cost Plus Fixed Fee, Cost- Sharing, or Fixed Price)

Contract Type is determined on a Task Order by Task Order basis.

Type of Contract and Number of Awards, pg. 62

Plus Fixed Fee, Cost- Sharing, or Fixed Price.”

64 Solicitation document (75N91019R00029.pdf), subsection c:

Type of Contract and Number of Awards, pg. 62

FAR 15.403-1 (b) Exceptions to certified cost or pricing data requirements. The contracting officer shall not require certified cost or pricing data...

(3) When a commercial item is being acquired (see standards in paragraph (c)(3) of this subsection);

Will NCI consider an award to a commercial item offeror who is therefore exempt from the indirect rate and cost disclosure requirements stipulated in the solicitation?

The determination of commerciality is not based on a potential offeror’s organizational classification as a “commercial item contractor”. As stated in FAR paragraph 15.403-1(c)(3), the Contracting Officer makes this determination based on several factors including the definition of “commercial item” at FAR Subsection 2.101 and the existence of adequate price competition. The Contracting Officer has determined that the SEER Program is a non-commercial Research and Development contract. Therefore, the exception at FAR paragraph 15.403-1(b)(3) is not applicable.

This does not preclude “commercial item contractors” that meet the mandatory criteria from responding to the solicitation, however because the requirement is non-commercial such organizations would be required to submit certified cost or pricing data or receive an exception as outlined under the "Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20".