RFP 75N91021R00043 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

The purpose of this amendment is to: 1) provide responses to questions received, 2) update Attachment 1- Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website and, 3) update Attachment 5- Additional Technical Proposal Instructions. Updated Attachments 1 and 5 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 75N91021R00043

1 4

10/29/2021

10/15/2021

RFP 75N91021R00043

Title: Drug Development Support for Cancer Therapy Evaluation Program (CTEP)

Amendment 00001

I. Questions and Answers

A. Technical Questions:

1. Attachment 5 (page 7 of 12), Additional Technical Proposal Instructions, Information Technology Staff: Please confirm the level of effort offerors should assume (1 FTE per year, 0.5 FTE per year,

0.25 FTE per year, etc.) for one or more IT staff to support the maintenance of on-site computer hardware and software used to support CTEP tasks.

NCI Response: Offerors should propose the appropriate level of effort for the IT staff based on their technical approach in the proposal.

2. Page 74: 2.G.15 - ARTICLE H.10 HHS Security and Privacy Language for Information. The section states that "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." Please confirm that a specific section for the security plan and related information security functions is not expected.

NCI Response: The government highly recommends that the technical proposal includes a separate section for the HHS IT Security Considerations and offeror(s)’ plans to address them.

B. Business and Administrative Questions:

1. Attachment 5, Additional Technical Proposal Instructions, Mandatory Criteria 2: Please clarify/confirm the following regarding the proximity requirement for a non-water based fire suppression room:

i. For transition-in plan and budgets, please confirm the location where the incumbent offeror is currently providing the document storage.

ii. For transition-in budgets, please confirm the number of boxes and/or filing cabinets that are stored in the incumbent’s 750 cubic square foot CTEP-dedicated room.

NCI Response:

i. For the transition-in plan budget proposal, offerors can assume that the fire suppression document storage room is located in Bethesda, Maryland, Zip Code 20817.

ii. For the transition-in plan budget proposal offerors can assume that at the time of transition, the storage space will contain 6 vertical four drawer filing cabinets (approximately 52"H x 15"W x 26.5"D) and 200 storage boxes (approximately 12"H x 10"W x 15D").

2. Similar to the Uniform Cost Assumptions provided in Attachment 10 of the previous RFP for this program (RFP No. N02CM41007-27 issued on December 5, 2014), please provide a Labor

Category and Hours Per Year table breakdown for the 86,480 year labor hours in each base and term option (2014 RFP example included below).

Labor Category Hours Per Year

Project Manager 1,880

Deputy Project Manager 1,880

IDB Support Team Manager 1,880

Safety Team Manager 1,880

Safety Team – Physician 1,880

Safety Team – Nurse Specialist 3,760

Safety Team Specialist 9,400

Safety Team Associate 9,400

Clinical Research Professional 11,280

IND Regulatory Professional 7,520

Regulatory Processing Team Leader

1,880

Regulatory Associate 5,640

InSight Technical Lead 1,880

InSight Publisher 3,760

IT Support 470

TOTAL 64,390

NCI Response: As stated in the RFP, the Government’s requirement is for 86,480 Direct Labor hours for the Base Period and each 12-month option period. The offerors shall propose an appropriate labor mix based on their technical approach.

3. Due to the volume of documentation required, please confirm the required Mandatory Criteria documentation (for Mandatory Criteria 1 and 2) is exempt from the 150-page limit for the Technical Proposal (e.g., eCTD application user report, user system validation report, Google maps print-out, detailed floor plan, etc.).

Page136; Attachment 5 - ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS- Section 2.b:

Documentation Required to Support Having Met the Mandatory Qualification Criteria 1. Will the Documentation Required to Support Having Met the Mandatory Qualification Criteria 1 be excluded from the Technical Proposal page count?

Page137; Attachment 5 - ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS- Section 2.b:

Documentation Required to Support Having Met the Mandatory Qualification Criteria 2. Will the Documentation Required to Support Having Met the Mandatory Qualification Criteria 2 be excluded from the Technical Proposal page count?

NCI Response: The Documentation required to support having met the Mandatory Criteria 1 and 2 shall not be counted towards the page limit. However, the offerors are advised to be succinct in their response to Mandatory Qualification Criteria 1 and 2, and follow the directions stated in the Section 2 of Attachment 5- Additional Technical Proposal Instructions, while preparing their technical proposal. Solicitation Attachments 1 and 5 are updated.

4. Attachment 9 (Additional Business Proposal Instructions), page 3 of 5, Section F (Software

Licenses):

i. For non-incumbent offeror budgets, please confirm (1) the annual eCTD submission software (Extedo) fees and (2) eCTD viewer application annual fees for 25 users.

ii. Can offerors propose an alternative, offeror-hosted eCTD submission platform?

NCI Response:

i. The Offerors needs to perform their own due diligence regarding these costs and contact the appropriate vendor(s) for pricing. The fees need to be included in the proposed budget.

ii. Offerors may not propose an alternative offeror-hosted eCTD submission platform. The Extedo platform is noted in the Statement of Work.

5. Can you please provide us with the contract value for this opportunity?

NCI Response: The Government does not intend to provide a contract value for this opportunity.

Attachment 1

RFP: 75N91021R00043

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

Attachment 1

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 150 pages.

2. Total page count does not include:

a. Title and Back Page; NIH FORM 1688-1; Government Notice for Handling of Proposals; Table of Contents; Section Dividers that do not contain information other than title of Section; VPAT; letters of commitment from subcontractors and consultants;

b. Documentation required to support having met the Mandatory Qualification Criteria 1 and 2 (i.e., response to Section 2 in the Additional Technical Proposal Instructions); and

c. 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 3 pages.

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

Attachment 5

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

The following additional Technical Proposal instructions are meant to provide additional instructions as well as a uniform format for technical proposals. The information requested in these instructions shall be used as a guide for formatting and preparing the proposal. Offerors shall follow the instructions in Section L of the solicitation, plus include the information requested in this Attachment.

Offerors are 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.

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.

The Government encourages the Offerors to be complete but succinct in the proposal and to limit the total number of pages for the entire proposal to 150 pages.

TOTAL PAGE COUNT DOES NOT INCLUDE: (some of which may be added as appendices):Title and Back page, NIH FORM 1688-1, Government Notice for Handling of Proposals, Table of Contents; Documentation required to support having met the meeting Mandatory Qualification Criteria 1 and 2; Section Dividers that do not contain information other than title of Section; VPAT; letters of commitments from subcontractors and consultants, Principal Investigator’s (PI’s) Resume/Curriculum Vitae (CV),with highlights of any items that are directly related to the subject project, indicated by preceding them with a double asterisk (**); Resumes/CVs of other key personnel and any other proposed personnel (same information and format as used for the PI).

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:

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

A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, DUNS number, and proposal part.

B. PROJECT OBJECTIVES (NIH FORM 1688-1)

C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

D. TABLE OF CONTENTS

SECTION 2: MANDATORY QUALIFICATION CRITERIA

This section of the Technical Proposal shall not count towards the Page Limitation.

The Offerors shall include all information that documents and/or supports the mandatory qualification criteria in one clearly marked section of their technical proposal. This section related to the Mandatory Qualification Criteria must be listed in the Table of Contents with a page reference.

The Mandatory Qualification Criteria establish the conditions that must be met at the time of receipt of the Technical Proposal by the Contracting Officer for your proposal to be considered any further for award.

Failure to meet all the requirements of the mandatory qualification criteria will result in the proposal being determined non-responsive and it will not be considered further for award.

Mandatory Criteria 1 – Electronic Common Technical Document (eCTD) System (Pass/Fail) The Government shall evaluate documentation the Offeror submits that demonstrates experience related to a 21 CFR Part 11 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11) electronic common technical document (eCTD) application for electronic submissions to the Food and Drug Administration (FDA) and the completion of an eCTD system validation, specifically:

a) Publish FDA submissions in eCTD format acceptable for submission through the

FDA Electronic Submission Gateway (ESG) and the capability to act as an eCTD technical contact.

b) Validation of an eCTD application within the user environment.

Documentation Required to Support Having Met the Mandatory Qualification Criteria 1:

a. A copy of the eCTD Technical Information section of a Module 1.2 submission, noting the Offeror as an eCTD technical contact.

b. A copy of a confirmation of receipt acknowledging the Offeror’s submission to the FDA electronic document room.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

c. A copy of the Offeror’s eCTD application user report with a line listing noting a minimum of 500 published sequences within the past 12 months from the time of receipt of the Initial Proposal. The report shall be sorted by date.

d. A copy of a cover, scope and signature page from a user system validation report of an eCTD application completed by the Offeror.

Mandatory Criteria 2 – Proximity of a Non-Water Based Fire Suppression Room (Pass/Fail) The Government shall evaluate documentation the Offeror submits that demonstrates its ability to provide a non-water based fire suppression file room located within a two hour driving distance (during 8 AM to 6 PM business days, including rush hour) to the address below to deliver documents. The fire suppression file room must have a minimum of 750 cubic square feet available for CTEP files, have secure access measures and utilize a non-water based fire suppression system with a minimum of NFPA 2001 standards and pass, at minimum, an annual inspection.

The CTEP Program is located at the following address:

National Institutes of Health National Cancer Institute 9609 Medical Center Drive Rockville, Maryland 20850

Documentation Required to Support Having Met the Mandatory Qualification Criteria 2:

a. Documentation of address of Offeror’s facility and a print-out showing the distance and maximum estimated time to drive to the Program location using an internet map search such as MapQuest or Google maps. The maximum estimated time should be provided at two timepoints- to arrive at the Program location at 8:30 AM EST and 4 PM EST.

b. A copy of a detailed floor plan of the facility with dimensions drawn to scale with the location of the minimum 750 cubic square feet available for CTEP files in the non-water based fire suppression file room clearly identified. Documentation of the file room secure access measures in place.

c. A copy of an inspection certificate for the file room indicating compliance with NFPA 2001 standards dated within 12 months from the time of receipt of the Initial Proposal by the Contracting Officer.

SECTION 3: TECHNICAL DISCUSSIONS

The technical discussions included in the technical proposal shall respond to the items set forth below:

A. Personnel and Experience

General:

Key personnel shall not be consultants or subcontractors. Please note that subcontractor staff may not be proposed for the Principal Investigator position which is considered Key Personnel.

The NCI expects the team would be comprised of Senior Level Personnel to include: Principal Investigator, Deputy Principal Investigator, Safety Team Leader(s), eCTD publishing and submission lead, Clinical Research Specialist team leader and the IND regulatory support team leader.

Because of the complex and detailed nature of the information involved, employees shall require considerable instruction and orientation to function efficiently. A stable workforce is therefore necessary. Indicate the employment stability of key and senior personnel assigned to this project by evidence of CV’s or resumes noting continued service with this or another organization.

For Additional Personnel: List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity should be indicated and the anticipated sources should be specified and qualified. 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. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include: 1) The specific items or expertise they will provide, 2) Their availability to the project and the number of hours and hourly rate they can commit to, 3) Willingness to act as a consultant, and 4) How rights to publications and patents will be handled.

Key Personnel

This is the Offeror's key contact for technical aspects of the program and the individual responsible for supervision and management of staff. It is expected that the Principal Investigator (PI) would represent one individual responsible for overall project management with additional team leaders for the management of Clinical Research Specialist support, IND Support staff, Biomarker Review Committee support and Adverse Event Reporting. The Principal Investigator(s) will be named as Key Personnel in the contract and is expected to be fully available with labor hours equivalent to 1 FTE.

The Principal Investigator must possess at minimum, a Master’s Degree in regulatory sciences, biomedical, health related field, or equivalent, with relevant experience working to meet FDA Regulations in the scope of IND activities and demonstrated knowledge of FDA Regulations with expertise in oncology applications and precision medicine studies (biomarker and genomic based). The individual shall have experience directing a workforce regarding applications to FDA (CDER, CBER, CDRH) that is of similar size, scope, complexity, and duration with multiple tasks and shifting priorities. The Contract PI shall also have experience in successfully managing a project with several multi-disciplinary teams with complex flow of data and documents related to clinical research and FDA regulatory requirements. The proposal shall document this individual’s knowledge and experience in the development of a quality assurance and control program, the use of database systems, and the management of employees who use computers to work with Microsoft Office 365, SharePoint and an eCTD software application.

Senior Personnel/Team Leads

It is expected that team leads/senior personnel responsible for the management of the Clinical Research Specialist support team and IND Regulatory support staff must possess at minimum either a Master’s Degree, or equivalent, in regulatory sciences, biomedical or health related field. These personnel must have experience supervising efforts similar to those in the SOW, particularly the supervision of activities involving the support of an IND lifecycle, collection, and processing of medical research data. Also, extensive experience with technical writing, electronic databases and SharePoint utilization must be documented.

It is expected that the team lead for the Adverse Event (AE) Reporting team have a sound understanding of medical terminology, CTCAE, MedDRA, organ system terminology and medical case management. This senior personnel must demonstrate experience in leading an AE Reporting team and possess a minimum of a Master’s Degree or equivalent in a biomedical or health related field. This team must include a minimum of one physician and either one nurse or pharmacist with experience in the assessment of oncology AE reports. These staff must demonstrate experience with computerized databases, biomedical research record-keeping or clinical research abstraction and the use of SharePoint workflows.

It is expected that a senior personnel responsible for Biomarker Review Committee support staff must possess a minimum of a Master’s Degree, or equivalent, in a biomedical or health related field with experience supervising efforts in summarizing and abstraction of clinical biomarker information.

As part of the presentation of Senior Personnel/Team Leads, describe which management personnel will be responsible for:

-acting as the primary key contact for technical aspects of the contact, -staffing of the contract and monitoring hours and expenses charged to the contract, -seeking approval of purchases and travel within the scope of the contract, -overall personnel management, -supervision of Clinical Research Specialists, IND Regulatory support staff and, Biomarker Review Committee support staff

-secondary key contact for technical aspects of the contract, -supervision and management of the Safety Team for Adverse Event

Reporting -supervision of electronic eCTD software IND publishing and FDA gateway submissions -leading an on-site team to support inspections from regulatory health agencies

Other Professional Support

i) Clinical Research Specialists (or equivalent positions)

The proposal must document the personnel that will fulfill the role as a Clinical Research Specialist (CRS) who are responsible for drafting INDs, FDA Annual Reports and DSURs and support IDB medical officers in the solicitation of new clinical studies.

These staff must have experience in preparing IND modules in eCTD IND compatible format. These individuals may attend relevant NCI and pharmaceutical company meetings.

In conjunction with the IDB medical officer responsible for a clinical agent or portfolio of agents, the CRSs must be capable of developing a thorough familiarity with the agents in order to update Investigator’s Brochures, and prepare FDA Annual Reports, DSURs and other summary data reports. A least one CRS staff attends IDB and BRC meetings. These staff draft Project Team Member Application announcements and draft responses to Letters of Intents. The preparation of reports relevant to drug/biologics development is performed by CRS staff, as is the analyses of data. CRS staff summarize and abstract biomarker information from clinical protocols and update relevant databases.

These CRS personnel are expected to have a Masters or higher degree (or equivalent experience) in relevant sciences (Immunology, Chemistry, Microbiology, Toxicology, Pharmacology, etc.) and excellent writing skills. Additional experience with supporting precision medicine and biomarker studies. Familiarity with database searches and the use of SharePoint workflows is also desirable.

ii) Regulatory Affairs Specialists (or equivalent positions)

Regulatory Affairs Specialists support the functions of the Regulatory Affairs Branch. These staff draft IND amendments, Master Files and submission forms in eCTD format, format pre-IND/EOP2 meeting requests and briefing packages and draft RAB correspondence. Regulatory Affairs Specialists file documents in shared drives, track regulatory documents and enter regulatory milestones in databases. These individuals organize and assemble CDRH Pre-subs from materials supplied by RAB.

These staff must have experience in preparing IND amendments in eCTD format and have an understanding of eCTD publishing and submission software, and the use of SharePoint workflows. Additional experience includes support of precision medicine and biomarker studies.

These staff provide on-site support for inspections by the FDA inspections and other regulatory health agencies. These staff must be knowledgeable in the various types of regulatory documents and have experience retrieving these documents from an online trial master file (or equivalent) and preparing inspection meeting minutes.

These staff provide laboratory monitoring to meet CDRH, FDA Abbreviated IDE monitoring requirements. These staff must have experience in conducting laboratory monitoring visits of labs conducting genomic sequencing in support of clinical studies.

It is expected that personnel assigned to this work will possess at least a Bachelor’s Degree in relevant sciences, or equivalent experience, and excellent writing skills.

iii) Adverse Event Reporting Staff

Adverse event (AE) reporting requires staff that will be responsible for processing all adverse events transmitted to the NCI for DCTD, NCI-sponsored therapeutic clinical trials as outlined in Section 2 (A-J) of the Statement of Work. Individuals proposed for this work must demonstrate knowledge of Common Toxicity Criteria for Adverse Events (CTCAE), MedDRA terminology and usage, and electronic AE reporting systems.

The composition of the Adverse Event team must have a minimum of one physician and either one nurse or pharmacist. They must demonstrate their experience with safety reporting for oncology agents, be familiar with the conduct of cancer clinical trials and have prior work experience in AE reporting. In addition, personnel must have documented knowledge of medical terminology, the requirements of AE reporting, data entry, database access experience and utilizing SharePoint workflows. These staff providing this support must be trained in NCI Adverse Event reporting guidelines and the use of CTEP- AERS. Historically the HelpDesk has been staffed by the professional staff from the adverse event team.

iv) Information Technology Staff

Information technology staff will be responsible for maintaining on-site computer hardware and software used to support CTEP tasks. Staff must be involved in the upgrade and maintenance of on-site IT systems to ensure that they are current with evolving technology, operational requirements, and NCI security standards. Staff are also involved in the security assessment of an electronic Common Technical Document (eCTD) software application to support an NCI authorization to operate.

Staff will also develop workflows that enable the routing of review documents from the Contractor to NCI staff within the CTEP instance of SharePoint. Staff will be responsible for maintaining a document sharing portal for documents provided to Pharmaceutical Collaborators. These areas of expertise must be demonstrated by providing resumes of IT staff with examples of past experience noting staff’s extent of involvement.

These individual(s) will collaborate with IT and operational staff from the NCI or NCI contractors to troubleshoot application and identify system improvements.

v) Regulatory Affairs Associates (or equivalent positions)

Regulatory Affairs Associates are involved in the following task areas:

a) Research and Development Agreement Support (Sections 1.E. i-

vii) of the Statement of Work). Experience and familiarity with generating PDF files, database applications, and utilizing SharePoint is expected by personnel proposed for this support.

b) FDA submission processing as specified in Sections 1.A, 1.B, 1.C., of the Statement of Work Personnel proposed for this activity are expected to demonstrate familiarity with eCTD format and publishing, electronic FDA submissions, Microsoft Word, PDF files, database applications and utilizing SharePoint.

c) Data entry activities. Familiarity with regulatory and medical terminology and experience with high level data entry pertaining to Sections 1.A.ix, 1.D.i,v,vi, 1.E.ii and 4.E of the Statement of Work.

d) Administrative Support. Documentation of experience with medical terminology, RABITS, FDA electronic submissions, Microsoft Office 365 (including PowerPoint), PDF files, SharePoint, and database entry and retrieval must be provided (paragraphs 4.D-E) of the Statement of Work).

Staffing Plan

The Offeror must propose a plan for an adequate and appropriate back-up personnel and succession plan for key and senior personnel. Address the time in either days, weeks, or months for a learning curve with back filling senior/key personnel. Include a plan to provide an adequate stable trained workforce. Provide a succession plan for key personnel and a detailed description of how the contract performance will be maintained during fluctuations in the personnel needs because of high or low levels of work, etc. Explain in detail the plan for maintaining performance during periods of extended absences by personnel (defined as greater than 10 consecutive working days). For personnel proposed as "backup" personnel to a key position, Curriculum Vitae or resumes must be provided. Back-ups named must be thoroughly familiar with the position that they are supporting. Demonstrate stability of the workforce, indicating turnover rate, on a project of similar scope and task. Discuss obstacles to a stable workforce and how to minimize gaps in staffing. Describe any telework or other alternate work schedules offered to staff and under what conditions, which must address any benefits and pitfalls associated with such a program.

B) Technical Approach

The Offeror must discuss overall technical project approaches and approaches to special problems in regulatory affairs and support of clinical research. The proposal must demonstrate an understanding of the needs of the project and an understanding of the FDA and the Center for Biologics Evaluation and Research (CBER) and the Office of Oncologic Drugs, CDER and Office of In Vitro Diagnostics and Radiologic Health, CDRH.

In addition to addressing the Statement of Work requirements as stipulated under “Technical Discussions” and “SOW”. Offerors must discuss the following:

1. The Offeror must discuss its technical understanding of the requirements for investigational anti-cancer agent development as it pertains to FDA regulations, the contents of INDs and Risk Determinations, annual reports, DSURs, and adverse event reporting, and approach to clinical research information management.

2. The Offeror must discuss its understanding of the scientific needs of the project as it pertains to sponsoring clinical research with a large number of investigational anti-cancer agents.

3. The Offeror must discuss its understanding of the technical aspects of investigational anti-cancer adverse event evaluation, assessment and tracking, clinical research information management, and regulatory requirements associated with sponsoring clinical research with investigational agents.

4. The Offeror must discuss its understanding of the preparation of eCTD

IND submissions that comply with FDA gateway submission standards.

5. The Offeror must discuss its understanding of providing support for monitoring of clinical laboratories supporting clinical trials

6. The Offeror must propose an approach to provide on-site Contract staff support during regulatory health agency inspections.

7. The Offeror must propose an approach to transmit documents and review requests to pharmaceutical collaborators as outlined in the Statement of Work (SOW).

8. The Offeror must discuss its understanding of the barriers and problems that arise in a similar type of contract and the strategies to successfully resolve issues.

9. Initial Contract Transition (Phase-In)

The Contractor shall perform Phase-in transition from an incumbent Contract/Contractor. The Phase-in transition shall occur within the first 90 days of the effective date of the contract. The Contractor shall work with the incumbent Contract to implement the transition-in plan and take on the duties necessary to execute the Statement of Work and to ensure continuous support to all the activities as most of the work is time sensitive. Concerns anticipated or encountered shall be immediately communicated to the COR and an approved resolution pursued.

The Contractor shall submit a draft Contract Transition Phase-In Plan with their Technical Proposal. The draft Contract Transition Phase-In Plan shall detail the specific transition activities to be undertaken and provide a timeline for implementation of each transition activity.

The Contractor shall revise the draft Contract Transition Phase-In Plan, in accordance with COR comments, and submit the final Contract Transition Phase- In Plan within 7 business days of contract award.

The Contractor shall meet with the incumbent Contractor for briefings on execution of the final Contract Transition Phase-In Plan to ensure that work operations are fully understood, and continuity of operations are maintained throughout the transition. The final Contract Phase-In Plan shall be followed to ensure an orderly, secure, efficient, and expedient transition of all contract activities.

C) Corporate Experience

Offerors must describe in detail prior experience of the organization in furnishing services similar to each area described in the Statement of Work. The proposal must include sufficient information to demonstrate the previous effectiveness of the firm in similar or related work and the ability to smoothly coordinate all aspects of the Statement of Work. This documentation must include clear and concise description of these project(s) and must indicate the project sponsors (e.g., pharmaceutical company, Government contract or grant, etc.). For each of the described projects, references (including phone numbers and email addresses) must be provided. Please note that organizational experience is defined as accomplishment of work, either past or ongoing that is comparable or related to the effort required by this RFP. This includes overall Offeror or corporate experience, but not necessarily the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in the RFP. The relationship of the proposed working group within the Offeror's organizational structure must be described as well as how this relationship may facilitate performance on this project. Describe the hierarchal organization of the proposed staff and the approach to supervision and management. Information must be provided on how staff training needs will be met.

The Corporate experience must demonstrate ability to carry out the specific tasks and requirements of the RFP, including:

i. The organization's corporate experience with similar projects of size and scope in each of the project areas of the Statement of Work.

ii. Include a statement on the priority your organization would place on this work effort as compared to other commitments now or reasonably expected during the proposed period of performance of the contract.

iii. The corporate plan to respond to concerns regarding matters such as staffing, quality, budget, and timelines.

D) Facilities and Equipment

The Offeror must provide detailed information regarding the office facilities, and equipment available for use on this project, or clearly describe how they will be available at the start of the project.

Performance of the Statement of Work will be conducted in other than NCI facilities and the contractor will be required to provide suitable office space and equipment to permit their staff to perform file maintenance and storage, managerial and report preparation, copying and distribution, and record-keeping functions. The Offeror must provide a plan for upgrading this equipment and discuss the frequency and benchmark by which the upgrades must occur. The Offeror must demonstrate how it will assure that the stored files will be maintained in their original condition and in electronic files. The Offeror must have the ability to readily transfer paper files upon request and to transfer other information rapidly via electronic means (E-mail, SharePoint, CTEP network folders). The Offeror must have the ability to access publication databases such as PubMed. The Offeror must submit a floor plan showing the space which would be dedicated to this project. If the work is to be performed in more than one location, describe the interrelationships, organization and personnel of the respective organizations. In addition, describe and demonstrate efficient integration of the locations and provide a contingency plan for when phone and computer systems are down.

If the offeror proposes cloud computing they shall run in an NCI CBIIT authorized cloud environment.

Specifically discuss:

i. Infrastructure, facilities, and equipment to perform the tasks outline in the SOW including all computers, hardware, software, data back-up, computer equipment, FAX machine, copiers and dedicated space for staff and equipment.

ii. A plan to upgrade and replace computer hardware and software as needed to maintain compatibility with NCI operations and eCTD FDA submissions.

iii. Ability to transfer computer files (including encrypted and large size files

>15 MB) via electronic means (e.g. E-mail, SharePoint, shared network drives and/or a document portal).

iv. A plan for completing work during power outages and inclement weather conditions.

v. A plan to provide a minimum of three Contractor laptops configured to access CTEP databases and shared drives during on-site inspection support.