75N91022R00022 Amendment 00001.pdf

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

(a) By completing items 8 and 15, and returning or (c) By separate letter or 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

Pooja Rathore, Contracting Officer

The purpose of this amendment is to: (a) provide responses to questions received, (b) update RFP attachments 1, 6, & 15 and

(c) update Section L of the RFP.

Office of Acquisitions National Cancer Institute National Institute of Health 9609 Medical Center Rockville, MD 20850

To All Potential Offerors 75N91022R00022

1 9

09/12/2022

08/25/2022

RFP: 75N91022R00022

AMENDMENT 00001

I. QUESTIONS AND ANSWERS:

The table below provides answers to the questions submitted in response to RFP 75N91022R00022

# RFP

Document

Section Number

Question/Clarification Government Response

1. RFP Section 2, c.

Business Proposal Instructions,

7. Other Administrativ e Data, a.

Property, 3.

Government Furnished Property, The government states, “No Government Furnished Property is offered for this acquisition,” however, the government references Government Furnished Property in Attachment 4. Will the government confirm the difference between Government Furnished Property and Government Furnished Equipment? It is our understanding this contract has no Government Furnished Property but does have Government Furnished Equipment.

#7.a.3. Government-Furnished Property on page 74, is updated with this amendment to:

3. Government-Furnished Property – A Listing of Government Furnished Property is provided as Attachment 4 in Section J of this solicitation.

2. RFP Section L, Instructions to Offerors (pg.

61-62)

Please confirm FAR 52.209-12 as listed in the Instructions to Offerors should be included with the Section K Representations and Certifications.

Please include the representation required by FAR 52.209-12 in a clearly marked section of your Business Proposal. Attachment 15- Additional Business Proposal Instructions updated.

3. Attachment 14 Disclosure of Lobbying Form

Please confirm this form only needs to be submitted if there are lobbying activities to be disclosed.

The form needs to be submitted by all offerors submitting a proposal, whether there are lobbying activities to disclose or not. Fill in all the fields and mark NA, if not applicable.

4. RFP Part IV- Representatio ns and Instructions, Section L- Instructions, Conditions and Notices to Offerors, 2.

Instructions to Offerors, C.

Business Proposal

There seems to be a duplication between Part IV, Section L, 2.

a. 12. Past Performance Information and Part IV, Section L, 2. c. 8.

Qualifications of the Offeror.

Can the government confirm 2.

c. 8. Qualifications of the Offeror is the information that will be evaluated under the Past Performance Factor on page 82?

There is a distinction between Past Performance Information and Qualifications of the Offeror. Please see page 62 of the RFP for the Past Performance Information that needs to be included in your business proposal. Please see page 77 of the RFP for Qualifications of the Offerors information requested and to be provided in business proposal. Past Performance information will be evaluated as a separate standalone factor subsequent to the technical evaluation (See Pg. 82 of the RFP).

Section Number

Question/Clarification Government Response

Instructions, 8.

Qualifications of the Offeror, Page

5. RFP Part IV- Representatio ns and Instructions, Section L- Instructions, Conditions and Notices to Offerors, 2.

Instructions to Offerors, C.

Business Proposal Instructions, 8.

Qualifications of the Offeror, Page

There seems to be a duplication between Part IV, Section L, 2.

a. 12. Past Performance Information and Part IV, Section L, 2. c. 8.

Qualifications of the Offeror.

Can the government please rename 8. Qualifications of the Offeror to Past Performance so verbiage in instructions aligns with evaluation?

See response above.

6. RFP Section 2.

Instructions to Offerors, Section a.

General Instructions,

12. Past Performance Information, The government states that “Offerors shall submit the following information as part of their Business proposal.”

However, in the Business Proposal Instructions, there is no defined section where past performance should be included. Where does the government want Past Performance information included in the Business Proposal?

Please include Past Performance Information in a separate standalone clearly marked section in your business proposal.

7. Attachment 6 In Attachment 6, the government references Section C. Organizational/Corporate Experience, however, in the evaluation criteria of the Technical Proposal the government States, Factor 3:

Corporate Capabilities. Can the government confirm these sections are one and the same?

Yes, these sections are the same. Attachment 6- Additional Technical Proposal Instructions are updated.

Section Number

Question/Clarification Government Response

8. RFP Section 2.

Instructions to Offerors, a.

General Instructions, The government states, “A list of the last 3 contracts completed during the past Three years and ALL

CONTRACTS AWARDED

currently being performed that are similar in nature to the solicitation work scope.” Our company has hundreds of active contracts that could apply to these stipulations. For ease of evaluation and minimizing the past performance section, would the government please consider a maximum of 5 past performance references that are either completed in the past three years OR are currently being performed?

12.Past Performance Information first subparagraph of paragraph a. on Page 62 is updated to remove All CONTRACTS Awarded to three contracts awarded as follows:

“A list of the last 3 contracts completed during the past Three years and Three CONTRACTS AWARDED currently being performed that are similar in nature to the solicitation work scope.”………

9. RFP Attachment 6, B. Personnel Capability and Experience

The government states the responsibilities of the Program and Project Manager on page 80 and in Attachment 6.

However, page 3 of Attachment 6 has another set of qualifications for the same positions. Can the government please confirm which section has the correct list of responsibilities?

Please refer to Attachment 6: Additional Technical Proposal Instructions for the list of responsibilities.

10. RFP Attachment 6, B. Personnel Capability and Experience

The government states the Program Manager shall have at least 10 years of documented experience in Attachment 6.

However, page 3 of Attachment 6 has another set of qualifications for the same positions. Can the government please confirm that the Program Manager must have at least 10 years documented experience as part of the qualifications for the key position?

The government confirms that the Program Manager must have at least 10 years documented experience as stated on page 3 of Attachment 6: Additional Technical Proposal Instructions.

11. RFP Business Assuming the Government In accordance with the RFP, if there is

Section Number

Question/Clarification Government Response

Proposal Instructions, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data, pg. 71-receives adequate price competition, please confirm the Certificate of Current Cost or Pricing is not required. If the Government does not receive adequate competition, please confirm the Certificate of Current Cost or Pricing can be submitted after any negotiations prior to award.

adequate price competition, Certificate of Current Cost or Pricing Data (CCPD) will not be required, however, the Government reserves the right to request the CCPD if the CO determines that there is a need for it.

12. General Please confirm the Offeror may provide a cover letter behind the cover page of the Technical Volume and it will not be counted towards page count.

The Cover Letter will not be included in the page count. Attachment 1 and Attachment 6 are updated.

13. Attachment 10 For the NIH-2043 form, please confirm if the Offeror is to enter the total proposed price in the field labeled “ESTIMATED

DIRECT COSTS IN

PROPOSED YEAR (From Budget)”.

NIH 2043 form is only requesting Estimated Direct Costs.

14. Attachment 10 For the NIH-2043 form, please confirm we do not need to provide the Social Security Number for the Principal Investigator.

Please do not include SSN in NIH 2043.

15. Attachment 10 For the NIH-2043 form, please confirm the information related to the Subcontract and Subcontractor can be provided on the second page of the form.

Yes, an extra page can be appended to the form if the information will not fit in the provided space.

16. Attachment 10 For the NIH-2043 form, please confirm what the Government would like in the field for “Employer Identification Number”

Insert your organization’s Unique Entity Identifier (UEI) number from SAM in lieu of

EIN.

17. Attachment 1 Packaging and Delivery or Proposals;

Page 1of 2 of Attachment 1;

Section B.2

Section B.2 Create one PDF file of your Business Proposal, including all attachments suggests that the government would like to have one PDF file which constitutes the entire business proposal, including the required excel file “Breakdown of Proposed Estimated Costs

Please submit the PDF of the business proposal with the excel budget included in the PDF, and also submit the excel version of the budget as a separate file. Please see paragraphs B.2. and B.3. on Page 1 of Attachment 1.

Section Number

Question/Clarification Government Response

(Plus Fee) with Excel spreadsheet.”

Will the government confirm the contents of the referenced excel file may be submitted as a separate excel file and are not required to be imbedded in the business volume PDF file?

18. Additional Business Proposal Instructions Attachment 15

Section 2 – Cost or Price Support

RFP States “The offeror shall also provide supporting cost/price documentation for all proposed subcontractors, to include the proposed type of subcontract, how fee will be determined and paid, and if the contract with the subcontractor is Time and Materials, provide the rationale and/or justification for selection of this subcontract type and the commerciality of the proposed T&M rates. In addition to the supporting cost back-up documentation, DCAA contact information and relevant cost/pricing data shall be provided for all cost type subcontractors. Subcontractors may submit proprietary data directly to the Contracting Officer via email.”

That is correct.

19. General Does NCI use Redcap for their clinical trials?

NCI does not use Redcap. NCI uses Oracle Clinical software product which is named C3D (Cancer Central Clinical database). This product is being phased out. The new system that has been implemented is an off the shelf product Medidata’s RAVE EDC (Electronic Data Capture).

20. Attachment 6 ATPI-5th paragraph

Could the Government provide the language that should be included in response to “Government Notice for Handling Proposals”?

The offerors need to reference the RFP.

Please see Pg. 55 of the RFP, Section L, paragraph 1.a., subparagraph (e).

21. Incumbent vendors name, Contract Number, Award and end dates, total contract value?

ASRC Federal Data Networx, LLC, Contract#75N91020C00003. Expires January 14, 2023, $16.5M (inclusive of all options)

22. Estimated value greater than $250,000?

Yes

Section Number

Question/Clarification Government Response

23. Only done Fixed-price contracts. Are we eligible?

Please read the RFP requirements and determine whether you are interested in submitting a proposal in response to the RFP.

24. Is the incumbent eligible to submit a proposal?

This information is not relevant for the purposes of other offerors submitting a proposal in response to the RFP.

25. Can we partner up with another company (not an 8a certified or SB) where we retain majority of the contract allocation (51%) to submit a proposal?

The offerors will need to comply with applicable subcontracting limitation requirements. It is the offerors’ responsibility to ensure that the Ostensible Subcontractor Rule is not violated.

26. Can you disclose the allocated budget amount (first and subsequent years)?

No

27. RFP pg. 4 Is Cognizant the incumbent or involved with SBA somehow in this RFP?

The word cognizant is an adjective used for the SBA’s Business Opportunity Specialist named on page 4.

28. RFP starting on pg. 64

Section 1 – Technical Discussions

It appears NIH is requesting an approach to delivering against a Grant program in lieu of providing a technical approach to performing a services SOW.

An example: “State the overall objectives and the specific accomplishments you hope to achieve.” This does not seem appropriate for an approach to perform the technical services.

See Attachment 6 Additional Technical Proposal Instructions (ATPI) on how to organize and respond to the Technical Approach section. Please refer to Attachment 6 ATPI, page 1, paragraph 4.

29. RFP In aligning the evaluation criteria to the instructions, we are having challenges regarding mapping of which key personnel are required. The Instructions require a Single Principal Investigator/Project Director, Other Investigators, and Additional Personnel, the evaluation criteria require a Program Manager, Project Manager and Other Project Personnel.

As stated on Pag 1 of Attachment 6:ATPI, if there are any inconsistencies between Section L on page 66 and Attachment 6, the outline/order of the proposal shall be in accordance with ATPI. Please refer to Attachment 6 ATPI, page 1, paragraph 4.

30. RFP Within which Volume is the Past Performance to be provided? The requirement for “Qualification of the Offeror” is included in the Business Proposal instructions, yet the Evaluation Criteria for Past

See response to 6 above. Past Performance Information (Pg 62 of the RFP clearly states that this information should be included in the Business Proposal). Qualification of the Offeror should be included in the Business Proposal (pg. 77 of the RFP). The offerors also need to respond to Corporate Capabilities

Section Number

Question/Clarification Government Response

Performance is included in the Technical Proposal.

in their Technical Proposal. Please see Attachment 6 and Section M of the RFP. Past Performance is a standalone evaluation criterion (see Section M of the RFP).

END OF QUESTIONS AND ANSWERS

II. REVISIONS TO SECTIONS OF THE RFP

a. SECTION J – LIST OF ATTACHMENTS: The following RFP attachments are updated with this Amendment;

1. Attachment 1: Package and Delivery of Proposal (Non R&D)

2. Attachment 6: Additional Technical Proposal Instructions

3. Attachment 15: Additional Business Proposal Instructions. Please note that the paragraph titled Options for Increased Quantity on Page 2 of this attachment has been updated along with the updates required by the responses above.

b. SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. Paragraph 2.a.12. Past Performance Information, subparagraph a. on Pg. 62 - is deleted in its entirety and replaced with :

Deleted:

a. Offerors shall submit the following information as part of their Business proposal.

A list of the last 3 contracts completed during the past Three years and ALL CONTRACTS AWARDED currently being performed that are similar in nature to the solicitation workscope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a "major subcontract" is defined as greater than $500,000.

Include the following information for each contract or subcontract listed:

1. Name of Contracting Organization

2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)

3. Contract Type

4. Total Contract Value

5. Description of Requirement

6. Contracting Officer's Name and Telephone Number

7. Program Manager's Name and Telephone Number

8. North American Industry Classification System (NAICS) Code

The offeror may provide information on problems encountered on the identified contracts and the offeror's corrective actions.

Replaced with:

12. Past Performance Information

a. Offerors shall submit the following information as part of their Business proposal.

A list of the last 3 contracts completed during the past Three years and three CONTRACTS AWARDED currently being performed that are similar in nature to the solicitation workscope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a "major subcontract" is defined as greater than $500,000.

Include the following information for each contract or subcontract listed:

1. Name of Contracting Organization

2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)

3. Contract Type

4. Total Contract Value

5. Description of Requirement

6. Contracting Officer's Name and Telephone Number

7. Program Manager's Name and Telephone Number

8. North American Industry Classification System (NAICS) Code

The offeror may provide information on problems encountered on the identified contracts and the offeror's corrective actions.

2. Paragraph 2.c.7.a.3. on Page 74 of the RFP titled Government-Furnished Property, is deleted and replaced as follows:

Deleted:

3. Government-Furnished Property

No Government Furnished Property is offered for this acquisition.

Replaced With:

3. Government-Furnished Property

A listing of Government-Furnished Property is provided as Attachment 4: Government Furnished Property. Please see Section J and Attachment 4 of this solicitation.

Attachment 1

Amendment 00001

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.

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.

Attachment 1

Amendment 00001

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 shall not exceed 35 pages.

2. Total page count does not include:

a. Title and Back Page; Government Notice for Handling of Proposals; Cover Letter, Table of Contents; Section Dividers that do not contain information other than title of Section; VPAT; letters of commitment from subcontractors and consultants;

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

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

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

RFP 75N91022R00022 Amendment 00001 Attachment 6

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

The following Additional Technical Proposal Instructions reflect the requirements of the Request for Proposal (RFP) and are meant to provide additional instructions as well as a uniform format for the technical proposal. The information requested in these instructions should be used as a guide for formatting and preparing the proposal. The Offeror is advised to give careful consideration to the Statement of Work (SOW), all reference material, and attachments, the technical evaluation criteria, and the RFP as a whole, in the development of their Technical Proposal.

If the Offeror proposes subcontracts to perform portions of the Statement of Work it should 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 Government encourages the offerors to be complete but succinct in the presentation and to limit the total number of pages for the entire proposal to 35 pages.

The outline/order of these instructions may be inconsistent with the 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.

TOTAL PAGE COUNT DOES NOT INCLUDE (some of which may be added as appendices): Title and Back Page; Government Notice for Handling Proposals; Cover Letter, Table of Contents; Section Dividers that do not contain information other than title of Section; Resumes/CVs of Key personnel (same information and format as used for the PI); certificates and licensures, Standard Operating Procedures (SOP), letters of commitment from proposed consultants and subcontractor, VPAT.

FORMATTING AND LAYOUT:

Use your usual word processing and spreadsheet programs to prepare and format the technical and business proposals. For excel file, please ensure everything is formula based and that there are no references to outside files. 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 web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

General Instructions

SECTION 1

A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, UEI number, proposal part, and authorized personnel. The authorized personnel shall include the name, title, address, e-mail and phone number of the Project Manager and the company representative(s) who is authorized to negotiate on behalf of the Offeror and who can obligate the Offeror contractually.

B. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

C. TABLE OF CONTENTS

SECTION 2: TECHNICAL DISCUSSIONS

Offerors shall provide a technical proposal that includes the following general areas:

A. Technical Approach

The Offeror shall describe how it plans to accomplish the requirements of the Statement of Work in sufficient detail to demonstrate an understanding of the project and to allow National Cancer Institute, Center for Cancer Research (NCI CCR) to evaluate the offeror’s technical approach. The Offeror shall identify potential problems that could be encountered in implementing its approach as well as possible solutions.

The Offeror shall identify its internal procedures for monitoring the progress of the assigned tasks. As part of this description, explanation shall be provided on the organization of both the administrative and technical team and the degree of responsibility that key team members are expected to be able to exercise.

In the event that the Offeror utilizes subcontractors, the Offeror shall describe in detail how it plans coordination with subcontractor management. Lines of responsibility between offeror and any subcontractor must be clearly delineated.

Please assume the following when preparing the section for the Technical Approach:

For estimation purposes, the Government assumes that there will be 25 audits per year, which will be conducted at NIH, Building 10 (Medical Records Department). The Offeror shall describe its technical approach to conducting these audits.

Number of protocols: ~400 Number of protocols to be migrated to Medidata RAVE EDC: 12 Accrual per year: ~5000 Number of monitoring visits to outside Multi Institute protocol sites: 12 Protocols monitored are non-IND/IDE

Although Patient Registration and Enrollment System (PRES) has replaced Clinical Data Registry (CDR) as the CCR’s patient registration system, contractor will be expected to maintain and support CDR as a legacy system. The CCR is in the process of migrating data from its legacy clinical database, Oracle Clinical (C3D), to a new database, Medidata RAVE, the CCR’s Centralized electronic data capture (EDC) system. While maintenance of the EDC system will be handled outside of this contract, the

Contractor will be required to utilize the software to create Case Report Forms, develop reports, and provide data submissions as required. The Contractor will be expected to maintain and support Oracle Clinical (C3D) EDC as a legacy system.

Quality Assurance/Quality Control Plan (QA/QC): The Offeror shall provide a draft or a summary QA/QC Plan that shows how the Contractor will meet Good Clinical Data Management Practices with the technical proposal. The draft or summary plan should not exceed 3 pages. (This plan shall be included in the 35-page limit).

Transition- In Plan: The offeror shall develop and submit a draft Transition-In plan at the time of proposal submission, that would support your technical transition plan for a smooth transfer of responsibilities from the incumbent contractor. Offerors are required to provide detailed plans and timetable for a phase-in. The plan must include the Contractor’s approach to organizing a seamless transition and maintaining ongoing work, including capture of the incumbent and hiring new qualified staff, compiling a strong management team, transition of authority, duties, activities. and equipment. The Transition-In plan shall outline potential transition-in related risks and corresponding mitigation measures. Should a transition be required, the transition period shall be up to one month from start of the award date.

B. Personnel Capability and Experience

Evidence shall be provided demonstrating personnel capability and experience with Centralized Site QA/QC, including monitoring, auditing and trial compliance, and IT systems and programming support, including maintenance and enhancement of the research databases and maintenance of legacy systems functions, and professional development training. Describe the experience and qualifications of Key personnel and the classes of personnel who will be assigned for direct work on this project. Provide a plan that delineates the disposition of personnel to address the requirements of the statement of work and the organizational/management structure that will ensure these requirements are met.

All professional personnel who will be considered Key Personnel on the project, in particular, the Contractor Program Manager should be listed. The resumes of Key Personnel shall be included and their (his/her) qualifications, experience, and accomplishments, as well as proposed duties on the project discussed. The level of time commitment of Key Personnel to this project shall be described in the proposal. For all proposed personnel who are not currently members of the Offeror’s staff, a letter of commitment or other evidence of availability is required.

It is estimated that the following roles and responsibilities would be required to perform the contract:

(1) Program Manager

The Program Manager shall have at least 10 years of documented, successful experience of leading large, multi-disciplinary programs that performing a broad range of clinical research support functions, including development and maintenance of Quality Assurance/Quality Control programs;

Multi-Institute Study Support, in the areas of QA/QC and database support, IT systems and programming support of Electronic Data Capture (EDC) and other IT systems utilized in clinical research, development and implementation of new IT systems and maintenance of legacy IT systems, and patient registration support.

It is preferable that this experience encompasses clinical research in oncology and early phases (Phase I and Phase II) clinical trials. It is also preferable the Program Manager has a scientific and clinical education/experience background. The Program Manager shall have primary responsibility, on behalf of the Contractor, for the execution of tasks delineated in the Statement of Work, all administrative and supervisory activities, and be able to analyze and produce documents regarding the quality of each function and effective resource allocation and management.

(2) Project Manager

The Project Manager shall have documented experience of managing large projects in the areas of development and maintenance of Quality Assurance/Quality Control programs; general policies, procedures, regulations, and basic legislation mandates pertaining to the conduct of research, data and safety monitoring, and research compliance; multi-Institute study support, in the areas of QA/QC and database support maintenance and programming support of EDC and other IT systems utilized in clinical research, development and implementation of new IT systems, maintenance of legacy systems, and patient registration support.

The Project Manager’s primary responsibility shall include oversight of daily operations of all staff of Centralized Support to NCI CCR Site’s portfolio of clinical studies, including first-line Team Leads and managers. The Project Manager shall serve as a point of contact with CCR personnel, clinical research teams, and protocol coordinators and may serve as the primary interface with the NCI Bioinformatics for the maintenance of the Oracle Clinical, Medidata Rave, and PRES databases and all future information systems adopted.

The Project Manager shall perform effective resource management, monitor research and patient registration data quality and quality of IT/programing support, perform analysis of and document error trends, identify and implement measures for quality improvement. The Project Manager is expected to proactively research and provide recommendations regarding software systems solutions in order to support NCI CCR’s staying current with information technology advances.

(3) Other Project Personnel Other Project Personnel shall have the knowledge of and ability to use HTML, JavaScript, Cascading Style Sheet web-based technologies, Java, Microsoft .NET development platforms, Oracle, Medidata RAVE, Microsoft SQL Server Database systems, Spring, Struts, and LINQ programming frameworks. Capabilities and training of staff to conduct a quality assurance/quality control program to ensure all aspects of the clinical studies conduct is in compliance with protocol, sponsors, and FDA requirements and in accordance with good clinical practice standards, including the experience of personnel in good clinical practice standards and standard operating procedures.

C. Corporate Capabilities

Organizational experience is defined as accomplishment of work, either past or ongoing which is comparable or related to the effort required by this solicitation. This includes overall Offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work.

1. The offeror should describe in detail prior experience of the organization in furnishing services similar to each area described in the Statement of Work. The proposal should include sufficient information to demonstrate the previous effectiveness of the firm in similar or related work. Include documentation with specific reference(s) to applicable contract number(s), date(s) of agreement(s) and dollar volume. This documentation should include clear and concise description of these project(s) and should indicate the project sponsor (e.g., pharmaceutical company, government contract or grant, etc.). For each of the described projects, references (including contact information) should be provided. The Offeror should also reference any relevant corporate experience that demonstrates the ability to work collaboratively with other stakeholders to meet a project’s mission and goals.

2. Describe the relationship of the proposed working group within the offeror’s organizational structure as well as how this relationship may facilitate collaboration within the organization in performance of this project. Information should be provided on how the organization will support the Principal Investigator and/or Project Manager in resolving problems or special situations.

3. Describe fully the proposing organization’s recruitment and retention processes and practices. Provide employee retention rates for the past three (3) years.

D. Section 508 Accessibility Requirements: Instructions

Instructions: The following instructions are provided to help the offerors properly document how their proposed solution addresses the Section 508 requirements outlined in the Statement of Work. Vendors should include this documentation with their proposal. these instructions are not 508 requirements,

1. Provide an Accessibility Conformance Report (ACR) for each commercially available Information and Communication Technology (ICT) item offered through this contract. Create the ACR using the Voluntary Product Accessibility Template Version 2.1 or later, located at https://www.itic.org/policy/accessibility/vpat. Complete each ACR in accordance with the instructions provided in the VPAT template. Each ACR must address the applicable Section 508 requirements referenced in the Work Statement. Each ACR shall state exactly how the ICT meets the applicable standards in the remarks/explanations column, or through additional narrative. All "Not Applicable" (N/A) responses must be explained in the remarks/explanations column or through additional narrative. Address each standard individually and with specificity and clarify whether conformance is achieved throughout the entire ICT Item (for example - user functionality, administrator functionality, and reporting), or only in limited areas of the ICT Item.

Provide a description of the evaluation methods used to support Section 508 conformance claims.

The agency reserves the right, prior to making an award decision, to perform testing on some or all of the Offeror’s proposed ICT items to validate Section 508 conformance claims made in the

ACR.

2. Describe your approach to incorporating universal design principles to ensure ICT products or services are designed to support disabled users.

3. Describe plans for features that do not fully conform to the Section 508 Standards.

4. Describe "typical" user scenarios and tasks, including individuals with disabilities, to ensure fair and accurate accessibility testing of the ICT product or service being offered.

ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the technical evaluation criteria, and the RFP as a whole, in the development of your proposal. The information requested here should be used as further guidance for the development of your Business Proposal.

SECTION 1 – PROPOSAL COVERSHEET – Form NIH-2043 – PROPOSAL SUMMARY AND

DATA RECORD

SECTION 2 – COST OR PRICE SUPPORT

All related documentation should be included in the proposal in a clearly marked section. Cost and Pricing support should be provided for all proposed subcontractors.

Letters of commitment for staff that are not currently hired, but for who the Offeror plans to hire and wants to note as direct labor in the business proposal shall be provided.

Salary documentation for current staff and justification for salaries for to be hired staff shall be provided.

The offeror shall also provide supporting cost/price documentation for all proposed subcontractors, to include the proposed type of subcontract, how fee will be determined and paid, and if the contract with the subcontractor is Time and Materials, provide the rationale and/or justification for selection of this subcontract type and the commerciality of the proposed T&M rates. In addition to the supporting cost back-up documentation, DCAA contact information and relevant cost/pricing data shall be provided for all cost type subcontractors. Subcontractors may submit proprietary data directly to the Contracting Officer via email.

For proposal purposes, the offeror shall propose based on the following budget assumptions:

Uniform Cost Assumptions:

Government shall furnish the contract place of performance and all supplies and computer equipment.

Number of protocols: ~400 Number of protocols to be migrated to Medidata RAVE EDC: 12 Accrual per year: ~5000 There will be 25 audits per year and audits will be conducted in person at NIH, Building 10 and/or remotely as needed.

Protocols monitored are non-IND/IDE There will be travel costs for the staff conducting monitoring visits. Please assume the following assumptions.

o Monitoring:

Site Monitoring Visit (SMV)-related travel for performing outside sites monitoring at various locations within the United States. Assume there will be 12 outside site monitoring visits requiring 2 days of travel and 1 night of lodging for each outside site annually. While not necessarily reflective of where the visits will occur, for estimation purposes, assume travel 6 trips to the west coast, such as the University of Washington Medical Center in Seattle, WA and 6 trips to the east coast, such as the Dana Farber Cancer Institute in Boston, MA, all of which will require airfare.

Assume travel, lodging, and per diem will follow the Government’s GSA rates.

Assume the following for trainings:

Training Staff Medidata Study Build Training Part 1: Medidata Rave Study Design and Build Essentials (SDBE) - Data Managers

Protocol Analysts - new hires (2/yr)

Clinical Programmers - new hires (2/yr)

Medidata Study Build Training Part 2: Medidata Rave Study Design and Build Essentials (SDBE) - Data Validation

Protocol Analysts - new hires (2/yr)

Clinical Programmers - new hires (2/yr)

RAVE Custom Function Programming Workshop

Clinical Programmers (10/yr)

RAVE Certified Study Builder Exam Prep Course

Clinical Programmers (7/yr)

RAVE amendment Manager Clinical programmers (10/yr) CIBMTR Annual meetings CRAs/QA (3/yr) OpenJS Node.js Services Developer course and the OpenJS Node.js Application Developer course.

Programmers (2/yr)

Options for Increased Capacity:

Options for increased quantity shall be 10% of the level of effort of the base work per year (i.e., 10% of 77,436 hours = 7,744 hours). Please include one increased capacity option costs for each year as part of the proposed budget.

Estimated Level of Effort (LOE) for Base and Term Options

The Government provides the following estimated LOE for the base and all term option periods. This estimate is provided for proposal preparation purposes only. This is only an estimate. The proposed labor categories and LOE may be different based on the unique technical approach of the Offeror. You are expected to provide your best solution citing the labor mix by LCAT and labor hours required to accomplish the tasks. The options for increased quantity should be proposed at 10% of the LOE of the Offeror’s base and term options.

For the purposes of fixed fee, the Contractor shall have satisfied the requirement herein if not less than 85% nor more than 110% of the total direct labor Hours estimated by the Offeror are furnished.

Labor Category # of FTEs Per Year for Base Work Total Hours Annually in Base Program Manager 0.5 956 Project Manager 1 1,912

CRA 5 9,560

Sr. CRA 3 5,736 Master CRA 1 1,912

Monitoring Team Lead 1 1,912 Protocol Analyst 4 7,648 Protocol Analyst Team Lead 1 1,912 QA Specialist (Sr. CRA) 4 7,648 QC Specialist 6 11,472 QC Team Lead 1 1,912 Clinical Programmer 7 13,384 Sr. Clinical Programmer 4 7,648 IT Team Lead 2 3,824 Total 40.5 77,436

The Cost section of the Business Proposal shall be presented in a format similar to the following:

https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours

Phase-In Transition

For the purposes of Base Year pricing, Offerors are to assume full staffing for the entire period of performance quoted. The incoming contractor will be required to begin work on Day 1 and have sufficient experienced personnel to ensure that the services called for by this contract are maintained at the required level of proficiency. There is no need to price the Phase-In separately. The Phase-In coincides with the start of the contract (base period) and is not a separate option.

Phase-Out Transition

For the purposes of Option Year 4 pricing, there is no need to price the Phase-Out separately. The contractor shall provide transition support as required by the government in accordance with the SOW.

The incumbent would not be expected to continue to perform any duties, except for transfer of responsibilities (and associated information/training) for up to one month, if needed.

Certification Regarding Tax Matters, FAR 52.209-12 (Oct 2020)

Please include the representation required by FAR 52.209-12 in a clearly marked section of your business proposal.