RFP 75N91021R00021 Amendment 00001.pdf

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

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

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

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

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

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

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

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

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

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

NUMBER IN ITEM 10A.

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

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

D. OTHER (Specify type of modification and authority)

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 (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

00001

The purpose of this amendment is to: 1) provide responses to questions received, 2) update Attachments 1 - Packaging and Delivery, 3) update Attachment 4 - Task Order 1A, 4) update Attachment 8 - Task Order 5A, 5) update Attachment 9 - Task Order 6A, 6) update Attachment 14 - Additional Technical Proposal Instructions, 7) update Attachment 21 - Additional Business Proposal Instructions, and 8) Update/revise RFP Articles.

Updated attachments 1, 4, 8, 9, 14 and 21 are included in this Amendment.

National Cancer Institute Office of Acquisitions NCI Shady Grove 9606 Medical Center Drive, MSC 9705 Rockville, MD 20850-9705

To All Potential Offerors 75N91021R00021

1 23

10/21/2021

10/21/2021

RFP 75N91021R00021

Amendment 00001

I. QUESTIONS AND ANSWERS:

The table below provides answers to the questions submitted in response to RFP 75N91021R00021.

# RFP Section and Page

RFP Reference Question Answer

1 RFP - Article F.2 (Deliveries) Table, Item 13 (Page 16 of RFP);

Article C.2.c.13 (Information and/or Physical Security Deliverables) (Page 8 of the

RFP)

Within the Article F.2.

Deliveries table, on Page 16 of the RFP, item 13 indicates that the Valid Authority to Operate (ATO) is due within 120 days after contract award.

However, on Page 8 of the RFP (C.2.c.13), it specifies the ATO is due within 3 months (90 days) of contract award.

Please confirm the ATO is due within 120 days after contract

The ATO is due within 120 days of the contract award. Section C.2.c.13 on Page 8 of the RFP and Section H.12.3.A.2. are modified. Please see Updates to Solicitation Section of this document.

2 RFP Section H, Article H.18, D

Significant Financial Interest disclosures

Please confirm that the Significant Financial Interest disclosures can be included as an appendix and not count towards the technical proposal page limits.

Yes, if applicable significant financial interest disclosures can be included as an appendix. They will not count towards the page limitation. Attachment 1 is updated.

3 RFP Section L, 2.

Instructions to Offerors

Technical Proposal Cost Summary

Technical Proposal Cost Summary (Attachment 11) can be included as an appendix and not count towards the technical proposal page limits.

Technical Proposal Cost Summary (Attachment

11) will count towards the page limitation and shall not be included as an attachment.

4 RFP -

Instructions to Offerors #14 page 83 and #11

Past Performance Page 83 of the RFP states as past performance 3 contracts completed during the past 3 years and 3 current contracts, but under qualification of

Yes. The lists that address the requirements on Page 83 and Pages 101-102 of the RFP may overlap.

offeror it states to list each related contract completed within the last 3 years or currently in process. Confirm while these two lists may overlap, they are separate listings.

5 RFP page 46, Article H.15

Requirements to include a copy of the "Facility Standard for Records Storage Facilities Inspection Checklist," self-certifying that the facility being used to store federal records meets established NARA standards:

Is the checklist excluded from the page count?

The checklist mentioned in Article H.15. of the RFP can be provided as an attachment and will be excluded for the page count. Attachment 1 to the RFP is updated.

6 RFP SECTION

M -

EVALUATION

FACTORS FOR

AWARD: Task Area 5, page or Attachment 8 SOW Task Order 5A page

Terminology, should the protocol writing service be referred to as PSWS, Protocol and Scientific Writing Support (page 110) or CPWS, Centralized Protocol Writing Support (page 242)?

Please confirm whether the term used in this proposal should be for PSWS or CPWS?

Offerors are advised that PSWS should be used throughout the proposal response for Task Area 5. CPWS should be used for response for Task Order 5A. Attachment 8 is updated. The title of Task Order 5A is also updated in Attachments 14 and 21. Please see Updates to Solicitation

7 RFP Page 89, Technical Proposal Instructions on

Technical Proposal Instructions on Page 89, "the offeror must submit a plan in its technical proposal for data

Is the Research Data Sharing Plan excluded from the page limitation?

This contract is not expected to generate research data and does not need a data sharing plan. The RFP is modified. Please see sharing or state why data sharing is not possible."

Updates to Solicitation

8 Task Area 5 Task Area 5 General Contract Question

Will multiple contractors be authoring protocols under Task 5 simultaneously?

The NCI’s intent is to have a single contractor authoring protocols during any contract period; however, it is possible that multiple contractors may be needed if the volume of protocols to be authored increases significantly and the current contactor cannot handle the volume within the expected time frames.

9 RFP Article F.3.a, page 17

Level of Effort Please clarify – we respectfully submit that the statement should say “exclude” rather than “include.” Typically, LOE is direct labor hours only (direct work year, whereas vacation, holiday, sick leave are indirect labor hours). The term “direct labor hours” is contained in F.3.a., and also in specific task order LOE references in Attachment 21, where LOE is stated as direct labor hours only

Yes- it should state “exclude.” Article F.3.a.

of the RFP is updated.

Please see Updates to Solicitation Section of this document.

10 Regarding Phase-Out Period of Performance.

Regarding Phase-Out Period of Performance.

Is Phase-Out Period of performance part of the Option 4 period?

Phase-out Transition is part of the last Option Period for Task Orders 2A-6A

11 RFP, Article C.2.

Reporting Requirements, Information and/or Physical Security Deliverables

13. Security Requirements

On Page 8 of the RFP, Section 13 lists security requirements with specific timeframes related to “contract award” (e.g., 60, 90, 120 days). Since Task Order 6a

The IT Security Reporting Requirements shall apply starting with Phase II of Task Order 6A. Attachment 9 is is broken down into multiple phases starting with Phase 1:

Requirements and Recommendation’s for 1 full year then Phase 2: System Configuration and Implementation, could the government clarify if the security timeframes noted around page 8 not applicable to Task Order 6a until Phase 2?

updated. Please see Updates to Solicitation

12 RFP, Article C.2.

Reporting Requirements, Information and/or Physical Security Deliverables

16. Security Plan

Can the Security Plan be excluded from the page limit?

The IT Security Plan is a part of the Technical Proposal and shall count towards the page limitations.

13 RFP Section J List of Attachments, Task Area 3 Can NCI confirm there are no specific Attachments associated with Area 3 (because other Areas 1 - 6 have attachments except Area 3).

NCI confirms that there are no specific attachments associated with Task Area 3 and Task Order 3A.

14 RFP - Section A

Due Date Will NCI consider extending the RFP deadline inconsideration of the magnitude of the proposal response required for offerors.

The deadline for proposal submission is November 15, 2021. NCI is not extending the due date for the proposals.

15 Attachment 1, Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, electronic Contract Proposal Submission (eCPS)

Is there a size limit for each file that can be uploaded to the electronic Contract Proposal Submission (eCPS)? If so, what is the limit?

The maximum file upload size for the entire proposal submission including technical and business proposal cannot exceed

387.19 MB in eCPS.

16 Attachment 1

Delivery of

Regarding the page limitations listed on Page 115 in

Are the General Requirements and Task Area 1 response

Offerors are not required to submit a technical response for

Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, page 2, Section

II. B.

Attachment 1, Section II. B.

excluded from the page limitation?

Task Area 1, so the page limit does not apply.

Offerors only need to respond to Task Order 1A.

General Requirements of the base IDIQ SOW do not apply to Task Order 1A. (Attachment 4 is updated).

17 Attachment 1 -

Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, page 2, Section

II. B.

Page Limitations - SOPs

Is the list of SOPs excluded from the page count?

Yes. The list of SOPs will be excluded from the page count and can be provided as an attachment/appendix.

18 Attachment 1

Delivery of Proposals page 2

II. Formatting and Page Limitations – B.2 Total page count does not include:

2. Total page count does not include:

a. Title and Back Page; Table of Contents;

Section Dividers that do not contain information other than title of Section, VPAT, letters of commitment from

Will the government consider excluding other documents from the total page count including CVs, Technical Proposal Cost Summary and Summary of Related Activities?

Page 3 of Attachment 1:

Packaging and Delivery of Proposals states that CVs shall not count towards page limitation and each CV shall not exceed three pages. The Government has modified the instructions further.

Please see updated Attachment 1 included in this amendment.

subcontractors and consultants; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

19 Attachment 3:

Base IDIQ SOW;

C. General Task Order Requirements (page 3 of 13) or Attachment 14:

Additional Technical Proposal Instructions (page 2 of 13)

Attachment 3:

“C. GENERAL TASK

ORDER

REQUIREMENTS

The following general requirements shall apply to all Task Orders:” Attachment 14:

“Offerors will be evaluated on their ability to address the General Requirements in the Base IDIQ Statement of Work (SOW) for the individual Task Areas for which the Offeror will submit proposals in response to a Task Order, as well as, for each Task Order response.”

Section C General Task Order Requirements of the RFP state that the general requirements apply to all Task Orders while Attachment 14 Additional Technical Proposal Instructions state that the general requirements are to be addressed for each Task Area and Task Order.

1. Please clarify whether

Offerors are expected to include a response to the General Task Order Requirements for Task Areas AND Task Orders they are responding to – for example, if an Offeror is responding to Task Area 1/Task Order 1A and Task Area 6/Task Order 6A, the government expects Offerors to include a response to the general requirements for both Task Areas 1 and 6 as well as Task Orders 1A and 6A?

2. Based on the limited SOW for Task Area 1 and Task Order 1A, please clarify whether Offerors are expected to include a response to the General Task Order Requirements for Task Area 1 and Task Order 1A?

The General Requirements of the Base IDIQ SOW do not have to be addressed for Task Area 1 and Task Order 1A; however, they should be addressed for all other Task Areas and Task Orders as stated in Attachment 14.

20 Attachment 3 - Base SOW, Page

"Task Area 1:

Project Kick-Off Meeting/Transiti on

Activities"

Are we required to answer Task Area 1 considering transition in is to be addressed as part of the Task Order response?

The offerors only need to address the requirements of Task Order 1A. There is no requirement to provide a proposal to address Task Area 1. Task Orders 2A-5A include transition in and the transition in needs to be addressed as part of the proposals for those task orders.

21 Attachment 3 -

3.

General Task Order

Are we required to respond to the General Requirements as part of each Task Order proposal?

Yes, except for Task Order 1A.

22 Attachment 3 -

General Task Order

Can the General Requirements discussions be weaved into the technical approach response of each Task Order proposal rather than in a separate section?

Please provide a separate section with discussion about the General Requirements of the Base IDIQ SOW as part of Technical Proposal for each Task Area except Task Area 1 and Task Order 1A.

23 Attachment 3

– Base SOW, Regarding the scope of the PSWS, provide standardized, centralized protocol, Informed Consent Document (ICD) and other scientific writing support for select studies and NCI initiatives.

How will studies be selected for inclusion in the protocol writing service? What proportion of writing will be dedicated to non-protocol scientific writing activities?

The Additional Business Proposal Instructions address the expected protocol volumes.

Other scientific writing is not part of the initial Task Order – Task Order 5A. Additional details for non-protocol scientific writing will be included if/when a need arises, and a Task Order Request for Proposal is issued.

24 Attachment 3 - Base SOW, page

Base SOW - Task Area 6: Electronic Patient- Reported Outcomes (PROs)

On page 128 of the RFP, Requirement 6(l) under Task Area 6, the statement is made, “Provide study participants the option to complete PROs either on paper, online..” could the government clarify whether the intent is for ePRO trials, or general PRO trials (i.e. run out of Medidata Rave).

The option of completing PROs electronically or on paper pertains to both newly developed studies and older studies that transition to the new electronic PRO system.

25 Attachment 3 – Base SOW -B.

Scope for Each Task, page 2

Task Area 1 Transition Transition is listed in both Task Area 1 and each of the other Task Area SOWs. Should transition be priced in Task Area 1 only?

Transition should be priced in each of the Task Orders 2A-6A.

Offerors only need to respond to Task Order 1A, there is no requirement to respond to Task Area 1.

26 Attachment 5 – SOW Task Order 2A, page 1

Draft transition plan Please confirm that the draft transition plan can be included as an appendix and not count

The transition-in plan will be evaluated as part of the Technical Approach and Understanding of the Project (see Section M of the RFP). So, it cannot be included as an appendix.

27 Attachment 6 – SOW Task Order 3A, page 8 and attachment 8 – SOW Task Order 5A, page 11

"draft phase-in plan due with proposal."

Deliverables for Task Orders 3 and 5 "draft phase-in plan due with proposal."

Are draft phase-in plan excluded from the page count?

Draft phase-in plan is not excluded from the page count.

28 Attachment 8

– Task Order 5A – Page 2

Section 4.4.b.v Prepare Additional Drafts of the Study Documents in the

Does this section pertain to post-first-draft document exchange with the study team leading up to original

Yes. This section pertains to post first draft document exchange with the study

Standardized Format Utilizing Boilerplate Language Based on Comments from Review Bodies and

Study Stakeholders

(ex. study PI.)

submission? The next two sections (vi and vii) deal specifically with addressing comments from the review committees (scientific review, CIRB, FDA).

team leading up to original submission.

29 Attachment 8 – Task Order 5A, Section 4.4.b.vi Ensure Comments and Stipulations from Approving Bodies Are Addressed Appropriately Within 7 Business Days After Initial Receipt.

Will the accelerated timeline for responding to reviewing body changes occur on a 7-business day timeline (Section 4.4.b.vi) or a 7-calendar day timeline (Section 4.4.b.xii.i.ii)?

It will occur on 7-business day timeline.

30 Attachment 9:

Statement of Work and Deliverables for Task Order 6a, Phase I, section 3.f.

“Accommodate various device types (smartphone, tablet, PC) for patient data entry”

Should the offeror provide and/or manage the devices or should we assume that the study participants will bring their own devices?

The offeror is not expected to provide and/or manage devices used by the participants.

31 Attachment 12 - Summary of Related Activities

Summary of Related Activities

Summary of Related Activities (Attachment 12) can be included as an appendix and not count

Summary of Related Activities can be included as appendix.

Attachment 1 is updated.

32 Attachment 14 Additional Technical Proposal

IDIQ Awardees Please clarify if resultant contracts will be one contract at the IDIQ-level per awardee or one contract at the Task Area-level per awardee. If an Offeror is selected for award for multiple Task Areas, would there be one IDIQ contract or a contract for each Task Area?

One IDIQ contract for all Task Areas the offeror qualifies for. The Government does not plan to award separate IDIQ contracts by task area.

33 Attachment 14

Task Order 1A Please confirm the required sections to be included in the 5-

The page limit for Technical Proposal for

Technical pages limit for the Task Order 1A technical proposal.

task Order 1A is 5 pages and the proposal for Task Order 1A should include sufficient detail to demonstrate a clear understanding of the requirements of Task Order 1A.

34 Attachment 14

Technical Proposal

“It is strongly recommended that offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.”

Attachment 14 page 2:

“The Government encourages the Offerors to be complete, but succinct, in writing their technical proposal(s) and to limit the total number of pages for the entire proposal to:

• Task Order 1A: 5 pages

• Task Area 2 and Task

Order 2A- CTSU Core Support Services:

100 pages

• Task Area 3 and Task Order 3A- Awareness

Can the government confirm whether the page limits provided in Attachment 14 are the total page counts for the entire technical proposal (i.e., Sections 1-9 and all applicable attachments) OR if they are the total page counts for just for Section 4: Technical Approach and Understanding of the Project that would include responses to each Task Area and Task Order?

1. If only for Section 4, please confirm page limit for the other sections beyond those listed in the RFP.

The page limits in Attachment 14 are for the entire technical proposal for a particular Task Area and corresponding Task order, except for Task Order 1A. The offerors are not required to submit a technical proposal for Task Area 1.

The page limit for Technical Proposal for Task Order 1A is 5 pages and the proposal for Task Order 1A should include sufficient detail to demonstrate a clear understanding of the requirements of Task Order 1A.

The Sections 1.-9. in Attachment 14 are applicable only to proposals for Task Area 2-6 and corresponding Task Orders. Please note that Section 2- Mandatory Qualification Criteria is only applicable to Task Area 2.

Education and Training: 50 pages

• Task Area 4 and Task Order 4A- Site Study Setup: 50 pages

• Task Area 5 and Task Order 5A- Protocol and Scientific Writing Support (PSWS): 50 pages

• Task Area 6 and Task Order 6A- Electronic Patient-Reported Outcomes (PROs):

75 pages”

35 Attachment 14

Technical Proposal

(page 4 of 13)

“The offeror shall provide documentation using specific examples that they can:

a. Demonstrate administrative and scientific support for large-scale cancer clinical trials across the protocol life-cycle

b. Operate a customer service support help desk

c. Organize working groups to support cancer clinical trials

d. Develop reports using accepted metrics for clinical trial effectiveness

e. Support large organizations that participate in cancer clinical trials

Please confirm the following regarding the list of items "a."

through "t." in the Additional Instructions for Task Area 2:

1. Please confirm that the list should be responded to in the Task Area 2 response (since it appears in the Additional Instructions for Task Area 2) and not in the Task Order 2A response which was also mentioned in the same paragraph.

2. Please confirm that Offerors should respond to the list with examples of relevant contractor experience and that the list is not meant as an additional set of requirements that bidders should document their approaches to.

1. The list should be responded to as part of Task Area 2A.

2. Offerors should respond to the list with relevant examples.

f. Develop best practices for clinical trial implementation

g. Comply with national and international cancer clinical trial regulations

h. Analyze, write, report, and present on issues in clinical research

i. Demonstrate experience with NCI standard lists including, but not limited to:

i. Data integrity and security ii.

Change/Configuration Management

iii. Cancer Data Standards Registry and Repository (caDSR).

j. For any area where direct experience can’t be demonstrated (e.g.

building CDISC-compliant forms) describe how these services will be provided via subcontract as described in “Other Considerations” in the

RFP.

k. Use best practices consistent with Capability Maturity

Model Integration (CMMI) maturity level

l. Provide evidence that they have experience following all Department of Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) practices to enhance Information Technology (IT) governance

m. Maintain compliance with all regulatory requirements concerning patient records

n. Secure an Authorization to Operate (ATO)

o. Provide system/Data back-up and disaster recovery in accordance with federal government regulations

p. Follow best practices for configuration management

q. Follow best practices for project management

r. Maintain, update, enhance, and provide training for the NCI CORE applications

(Appendix 1).

s. Submit a list of existing SOPs

t. Submit SOPs for

i. Data integrity and security ii.

Change/Configuration Management”

36 Attachment 14 -

Proposal Instructions, Technical Approach and Understanding of The Project

On page 313 of the RFP, Requirement 8 under Task Area 6: Electronic Patient Reported Outcomes states “Submit a list of SOPs?” Can the government provide clarification on types of SOPs?

The offeror should submit a list of all SOPs related to workflows of an ePRO system.

37 Attachment 14-

Proposal

On page 314 of the RFP, Requirements 4 under Task Area 6 the statement is made, “Demonstrate experience in implementing a new software system, specifically” followed by the sentence “Describe in detail how the proposed informatics solution integrates with common clinical trial databases including Medidata Rave.” Since this is at the Task Area level, is the government’s intention that we describe our experience working with Medidata Rave or is it to discuss our Task Order level solution?

Please discuss your Task order level solution.

38 Attachment 14 –

Proposal

On page 314, requirement 3 “Demonstrate an understanding of the electronic Patient Reported Outcomes task by identifying 3 potential software solutions, listing the pros and cons for each proposed solution,” could the government please clarify if respondents are

The pros and cons should be listed for the solution (s) that the offeror proposes whether a COTs product or custom application.

expected to provide existing on the market vendor ePRO tools or the type of solutions we recommend for implementation, e.g., acquire a COTS product vs develop a custom solution?

39 Attachment 14 –

Proposal

Section 8: Information Security Submission

Please confirm that Section 8:

Information Security Submission can be included as an appendix and not count towards the technical proposal page limits.

The Information Security Submission is a part of the Technical Proposal and shall count towards the page limitations.

40 Attachment 14

Technical Proposal instructions -page 11. Page 318 in the, and Attachment 1, Section II. B, page 2.

Information Security Submission and Section 508 requirements – page limitations

Are Section 8, the Section 508 Voluntary Product Assessment Templates, and Section 9 excluded from the page limit?

Section 8- for Information Security Submission is not excluded from the page limitation. Section 9- Section 508- VPAT is excluded from the Page limitation.

41 Attachment 14

Technical Proposal

“Offerors responding to Multiple Task Areas must provide separate Technical and Business Proposals for each Task Area. To be considered for award of a Base IDIQ contract, the Offeror must respond, at a minimum, to Task Order 1A, the General Requirements in the Base IDIQ Statement of Work, and one other Task Area and corresponding Task Order.”

Please clarify that if an Offeror is responding to Task Area 1 and another Task Area/Task Order (i.e., Task Area 6/Task Order 6A) that two separate, standalone technical and business proposals will be developed and submitted – one for Task Area 1/Task Order 1A and one for Task Area 6/Task Order 6A?

The Offerors only need to submit a proposal for Task Order 1A. No proposal is required for Task Area 1. All offerors must submit a proposal for Task Order 1A and another Task Area and the corresponding Task Order at a minimum. If an Offeror is responding to Task Order 1A and another Task Area/Task Order (i.e., Task Area 6/Task Order 6A) than two separate, standalone technical and business proposals will be developed and submitted – one for Task Order 1A and one for Task Area 6/Task Order 6A.

42 Attachment 1

Delivery of Proposals page 2 and Attachment Additional Technical Proposal Instructions pages 1 and 2

Attachment 1 page 2 – B.1: Page Limitations “1. The total page count of the Technical proposal for each Task Area shall not exceed the following number of pages:

a. Task Order 1A: 5 pages

b. Task Area 2 and Task Order 2A- CTSU Core Support Services:

100 pages

c. Task Area 3 and Task Order 3AAwareness Education and Training: 50 pages

d. Task Area 4 and Task Order 4A- Site Study Setup: 50 pages

e. Task Area 5 and Task Order 5AProtocol and Scientific Writing Support (PSWS): 50 pages

f. Task Area 6 and Task Order 6AElectronic Patient-Reported Outcomes (PROs): 75 pages” Attachment 14 page 1:

“It is strongly recommended that

Based on the requirements identified in the RFP, each technical proposal is required to follow the Table of Contents included in this Attachment (i.e. Section 1 through Section 9).

1. There is only a page limit included on page 2 of Attachment 14 for Task Order 1A of 5 pages. If Offerors are required to respond to each Task Area and Task Order as stated in the RFP, the 5 page limit will not be sufficient to address the required Table of Contents outline for Task Area 1, Task Order 1A, requirements of the Base IDIQ SOW, Task Area requirements, Task Order, and the required Appendices identified in the RFP (Section J).

2. Can the government confirm expectations for Task Area 1/Task Order 1A and consider increasing the page limit for this response?

3. If there is a 75-page limit for the Technical Proposal response for Task Area 6 and Task Order 6A, does that page limit also include the offeror’s response to the Base IDIQ SOW or is there a separate page limit for that section?

The offerors only need to submit a proposal for Task Order 1A. The offerors do no need to respond to the General Requirements of the Base IDIQ SOW as part of their response to Task Order 1A. Please see updated Attachment 4.

The page limit for Task Order 1A is not revised.

The Table of Contents format (Sections 1.-9.) in Attachment 14 are applicable only to proposals for Task Area 2-6 and corresponding Task Orders. Please note that Section 2- Mandatory Qualification Criteria is only applicable to Task Area 2.

The page limit for response to Task Area 6 and Task Order 6A is 75 pages. This page limit is inclusive of the offeror’s response to the General Requirements of the Base IDIQ SOW.

offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.”

Attachment 14 page 2:

“The Government encourages the Offerors to be complete, but succinct, in writing their technical proposal(s) and to limit the total number of pages for the entire proposal to:

Task Order 1A: 5 pages Task Area 2 and Task Order 2A- CTSU Core Support Services:

100 pages Task Area 3 and Task Order 3AAwareness Education and Training: 50 pages Task Area 4 and Task Order 4A- Site Study Setup: 50 pages Task Area 5 and Task Order 5AProtocol and Scientific Writing Support (PSWS): 50 pages Task Area 6 and Task Order 6AElectronic

Patient-Reported Outcomes (PROs): 75 pages”

43 Attachment 21, Page 5 - Additional Business

Task Area 3 Can NCI clarify where the Task Order to Area 3 is located on the RFP. Is it the Order 3 on Attachment 21, Page 5 - Additional Business Proposal Instructions ?.

Please see Attachment 6 to the RFP (pp 199-207 of the PDF) for the Task Order 3A SOW and requirements.

Attachment 21 provides uniform cost assumptions and business clarifications for each Task Order.

44 Attachment 21 - Additional Business Proposal Instructions.

Regarding the Uniformed Cost Assumptions for Task Order 6A

What is the number of studies per year for which ePRO will be needed? (RFP states in the Task Order the # of subjects and forms, but not number of studies)

The Government anticipates 15 trials/year at this time.

45 Attachment 21 -

Business Proposal

On page 416 for Task Area 6A: Electronic Patient Reported Outcomes (PROs), the current language states: “The Task Order award will be a cost-reimbursement, completion type contract with a Base of 12-months for Phase I and one 12-month Option for Phase II.” Could the government please confirm this Task Order is intended to be a cost-reimbursement contract under FAR 16.302 with no fee? Or would this be a cost-plus-fixed-fee under FAR 16.306?

anticipates that Task Order 6A will be a cost plus fixed fee, completion type Task Order.

46 Attachment 21 -

Business Proposal

Regarding the contract type of “completion” if this is as defined under FAR 16.306, is it the government’s intent to not provide cost reimbursement until the completion of the 12-anticipates that the cost will be reimbursed on a monthly basis upon submission of a proper invoice by the month period of Phase 1? Would the government consider other milestones/deliverables during Phase 1 for cost reimbursement?

contractor. Additionally, please note that, the fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer, and subject to the withholding provisions of the clauses

ALLOWABLE COST AND

PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of the RFP.

END OF QUESTIONS AND ANSWERS

II. UPDATES TO THE SOLICITATION

1. SECTION C, Article C.2.c.13 on Page 8 of the RFP is deleted and replaced with the following:

13. Valid Authority to Operate

A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within 120 days after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

2. SECTION F, Article F.3.a. is deleted and replaced with the following:

a. During the period of performance of this contract, the Contractor shall provide TBD at the Task Order level direct labor hours. The labor hours exclude vacation, holiday, and sick leave. These labor hours exclude/include (TBD at the Task Order level) subcontractor labor hours.

3. SECTION H, Article H.12.3. A.2. paragraph titled Security Assessment and Authorization

(SA&A) is deleted and replaced with the following:

2. Security Assessment and Authorization (SA&A)

A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within 120 days after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

4. ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT: subparagraph

6. is added to paragraph a. titled: FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES, as follows:

6. FAR Clause 52.223-99, ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR

FEDERAL CONTRACTORS (DEVIATION) (OCT 2021)

(a) Definition. As used in this clause –

United States or its outlying areas means—

(1) The fifty States;

(2) The District of Columbia;

(3) The commonwealths of Puerto Rico and the Northern Mariana Islands;

(4) The territories of American Samoa, Guam, and the United States Virgin Islands; and

(5) The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll.

(b) Authority. This clause implements Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors, dated September 9, 2021 (published in the Federal Register on September 14, 2021, 86 FR 50985).

(c) Compliance. The Contractor shall comply with all guidance, including guidance conveyed through Frequently Asked Questions, as amended during the performance of this contract, for Contractor or subcontractor workplace locations published by the Safer Federal Workforce Task Force (Task Force Guidance) at https:/www.saferfederalworkforce.gov/contractors/ .

(d) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (d), in subcontracts at any tier that exceed the simplified acquisition threshold, as defined in Federal Acquisition Regulation

2.101 on the date of subcontract award, and are for services, including construction, performed in whole or in part within the United States or its outlying areas.

(End of clause)

5. SECTION L. 2.a.15. HHS SECURITY AND PRIVACY LANGUAGE FOR INFOMAITON AND IT

PROCUREMENTS is deleted and replaced with the following:

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

15. ARTICLE H.12. HHS Security and Privacy Language for Information and Information Technology Procurements is applicable to this solicitation and resulting award.

The Homeland Security Presidential Directive (HSPD)-12 and the Federal Information Security Management Act of 2002 (P.L. 107-347) (FISMA) requires each agency to develop, document, and implement an agency-wide information security program to safeguard information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor (including subcontractor), or other source.

IMPORTANT NOTE TO OFFERORS:

The offeror should demonstrate a strong understanding and capability for information technology security requirements. The sufficiency of the proposed approach to information security will be evaluated as it applies throughout the proposal. Offerors should refer to Article H.12. of this solicitation to ensure that all applicable requirements are addressed in their proposal.

6. SECTION L.2.b.4. Obtaining and Disseminating Biomedical Resources is removed in its entirety and replaced with:

4. Reserved

LIST OF UPDATED RFP ATTACHMENTS

The following RFP attachments are updated with this amendment:

Attachment 1: Packaging and Delivery of Proposal (R&D)

Attachment 4: Statement of Work & Deliverables for Task Order 1A

Attachment 8: Statement of Work & Deliverables for Task Order 5A

Attachment 9: Statement of Work & Deliverables for Task Order 6A

Attachment 14: Additional Technical Proposal Instructions

Attachment 21: Additional Business Proposal Instructions

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

75N91021R00021 Page 1 of 3

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with HHSAR 352.215-70, Late Proposals and Revisions (December 18, 2015).

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

75N91021R00021 Page 2 of 3

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal for each Task Area shall not exceed the following number of pages:

a. Task Order 1A: 5 pages

b. Task Area 2 and Task Order 2A- CTSU Core Support Services: 100 pages

c. Task Area 3 and Task Order 3A- Awareness Education and Training: 50 pages

d. Task Area 4 and Task Order 4A- Site Study Setup: 50 pages

e. Task Area 5 and Task Order 5A- Protocol and Scientific Writing Support

(PSWS): 50 pages

f. Task Area 6 and Task Order 6A- Electronic Patient-Reported Outcomes (PROs):

75 pages

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section, VPAT, letters of commitment from subcontractors and consultants,

b. Significant Financial Interest Disclosures Form(s) in accordance with Article H.18. of the RFP, Facility Standard for Records Storage Facilities Inspection Checklist required in Article H.15., and List of SOPs.

75N91021R00021 Page 3 of 3

c. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not count towards page limitation. Each CV shall not exceed 3 pages.

4. Summary of Related Activities shall not count towards page limitation and shall be included as an appendix in the Technical Proposal.

5. Pages exceeding limitations will be removed from the proposal and will not be considered.

Attachment 14

Additional Technical Proposal Instructions

It is strongly recommended that offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These ‘Additional Technical Proposal’ instructions reflect the requirements of the solicitation and provide specific instructions and formatting for the Technical Proposal.

While Section L of the solicitation provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of the Request for Proposal (RFP). The information requested in these instructions should be used to format and prepare the Technical Proposal and should be used as a Table of Contents for your Technical Proposal. Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the IDIQ Statement of Work (SOW), Task Order SOWs, all reference materials, and attachments/appendices, the technical evaluation criteria, and the RFP, in the development of their Technical Proposals.

Offerors who propose subcontracts to perform portions of the Statement of Work shall clearly identify the specific sections for which they plan to utilize subcontractors, as well as the method and level of integration between the prime and subcontractor(s), and the expected advantages of such an approach.

The outline/order of these instructions may be inconsistent with Technical Discussion Section of the RFP, but the outline/order of the proposal shall be in accordance with these instructions rather than the section entitled “Technical Discussions" in the RFP.

Offerors must refer to the solicitation Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet website addresses (URLs) to direct readers to alternate sources of information.

The offerors are advised that the proposals submitted in response to this R&D solicitation will be evaluated in accordance with NIH Policy Manual 6315-1 for Initiation, Review, Evaluation, and Award of Research & Development (R&D) Contracts found here:

https://policymanual.nih.gov/6315-1.

TECHNICAL PROPOSAL - TABLE OF CONTENTS

It is anticipated that NCI will award Base IDIQ Contract to one contractor for Task Area 2 and multiple contractors for Task Areas 1,3,4,5, and 6.

https://policymanual.nih.gov/6315-1

NOTE: Task Areas 3 and 5 are set aside for small business concerns only (see Section L of the solicitation for more information).

Offerors may submit proposals in response to Task Areas of their choosing and are not expected to respond to all Task Areas. Offerors responding to Multiple Task Areas must provide separate Technical and Business Proposals for each Task Area. Proposals for each Task Area will be reviewed independently. To be considered for award of a Base IDIQ contract, the Offeror must respond, at a minimum, to Task Order 1A, the General Requirements in the Base IDIQ Statement of Work, and one other Task Area and corresponding Task Order. The Government encourages the Offerors to be complete, but succinct, in writing their technical proposal(s) and to limit the total number of pages for the entire proposal to:

Task Order 1A: 5 pages Task Area 2 and Task Order 2A- CTSU Core Support Services: 100 pages Task Area 3 and Task Order 3A- Awareness Education and Training: 50 pages Task Area 4 and Task Order 4A- Site Study Setup: 50 pages Task Area 5 and Task Order 5A- Protocol and Scientific Writing Support (PSWS): 50 pages Task Area 6 and Task Order 6A- Electronic Patient-Reported Outcomes (PROs): 75 pages

(Please see solicitation Attachment #1, Packaging and Delivery of Proposals, for more information).

Offerors will be evaluated on their ability to address the General Requirements in the Base IDIQ Statement of Work (SOW) for the individual Task Areas for which the Offeror will submit proposals in response to a Task Order, as well as, for each Task Order response.

Task Order 1A will only be evaluated on cost and will not be technically evaluated. All awardees who are successful in being considered for award of one of the Task Areas will receive Task Order 1A upon award of the Base IDIQ contracts. Base IDIQs will include Task Area 1 and any other Task Area(s) for which the Offeror was selected for award.

Offerors lacking the expertise to address all of the technical requirements are encouraged to identify collaborations and partnerships that, through combined expertise, can address all of these technical requirements.

NCI reserves the right to convene one panel or multiple panels to review the proposals submitted in response to the RFP.

SECTION 1

Documents submitted using Adobe .pdf shall be submitted using a pdf searchable format

1.