2125046 - Redacted Justification for Sole Source JnA-JFOC.pdf

Justification and Approval Justification Under Simplified Procedures for Certain Commercial Items in Accordance with FAR 13.5

This acquisition is conducted in accordance with Federal Acquisition Regulation (FAR) 13.106-1(b)(1), Soliciting from a single source, under the authority of Simplified Acquisition Procedures (41 U.S.C. 1901).

1. Identification of the agency and the contracting activity.

a. Federal Agency and Contracting Activity Health and Human Services (HHS), National Institutes of Health (NIH)

b. Sponsoring Organization

National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Clinical Trials Program (CTP), Regulatory Science and Strategy Program (RSSP)

c. Project Officer

2. Nature and/or description of the action being approved.

a. Brief Summary and Program Background

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), mission is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The NIAID Intramural Research Program (IRP) is an ongoing investment in expanding understanding of the broad areas of infectious, allergic, and immunologic science. The three (3) intramural divisions are the Division of Clinical Research (DCR), the Division of Intramural Research (DIR), and the Vaccine Research Center

(VRC).

The VRC develops, manufactures, conducts clinical trials and sponsors Investigational New Drug (INDs) applications and Drug Master Files (DMFs) for investigational vaccine and monoclonal antibody products with prophylactic and therapeutic indications for a number of pathogens including filovirus, flavivirus, influenza and HIV. Clinical development of these investigational products is managed by the VRC’s Clinical Trials Program (CTP) and is conducted in the intramural clinic at the NIH Clinical Center and/or via external collaborations and partnerships, both domestic and international. INDs and DMFs preparation and submission of documentation to support clinical evaluation of VRC products are managed by the VRC RSSP.

Technical Resources International (TRI) has been providing regulatory support services to the VRC RSSP through a parent Purchase Order 75N93019P01252 awarded from September 27, 2019, for the base year, and option years extension until September 26, 2023.

b. Project Title

Regulatory Submission Support Services – Transition of eCTD to Lorenz

c. Nature of the Action

Requirement type.

Support services (non-research & development) Supplies/equipment Information technology (IT) Other (specify): ______________________

Type of action. Check the appropriate box:

New requirement Follow-on Short-term Bridge

Proposed contract/order type. Check all that apply:

Firm-fixed-price Other fixed-price

Type: (specify e.g., fixed-price award-fee, fixed-price incentive-fee) Time and materials Indefinite delivery

Type: (specify whether indefinite quantity, definite quantity, or requirements)

Acquisition Identification Number

AMBIS #

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Description of the Required Supplies/Services

I. Review of Files on NIAID Content Server

The Contractor shall review the files on the NIAID Content Server. OCICIB noted that the source of what is being used in the submission migration is the published output .xml files that are in the file share. Thus, data cleansing may be necessary to remove non .xml files.

The VRC RSSP will confirm the location of the original submission documentation. The VRC RSSP will work with OCICB to obtain a report to facilitate this task. This task will be completed before removing files.

II. Training

The Contractor shall streamline the training process and provide strong support for both contracts. Currently all TRI publishers supporting the VRC and DAIDS projects are trained on the current Liquent eCTD publishing tool.

The Contractor shall manage the training for the new tool in a similar manner. All TRI publishers will be trained by the “TRI Trainer” on the new LORENZ tool.

TRI shall provide training for other TRI users as required.

III. Updates to SOPs

The Contractor shall provide updates to procedures will be compiled during our review of the documentation provided and during the training sessions conducted by LORENZ, and they will be shared across the TRI Team.

The Contractor shall provide updates to the project SOPs and project-specific work instructions, will be allocated to each project, accordingly.

IV. Software installation, validation, and software maintenance

The Contractor shall support the Lorenz DocuBridge software installation, validation, and software maintenance, the NIAID QA testing will be in May 2022, and the NIAID production installation will be in July 2022. TRI’s client installation activities will be determined per VRC RSSP assessment. Please note that they are dependent NIAID installation completing first.

b. Total estimated dollar value and performance/delivery period

4. An identification of the statutory authority permitting other than full and open competition.

a. Acquisition authority: FAR 13.106-1(b)(1), in accordance with FAR 13.501(a)(1)(ii), as authorized by:

41 U.S.C. 1901 Simplified Acquisition Procedures

41 U.S.C. 1903 Special Emergency Procurement Authority

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Exclusive and Required Nature of the Product(s) and/or Service(s)

TRI is already providing regulatory support through the parent PO for IND Submission Support Services including the eCTD solution that is integrated with VRC RSSP program needs which meet the requirements and complexities of VRC RSSP. The current eCTD application, Liquent that was provided by NIAID Office of Cyber Infrastructure and Computational Biology (OCICB), is going to be transitioned over to a new eCTD system due to several business reasons such as the software was slow when multiple users or submissions were being rendered, dissatisfaction with the technical support and cost of moving to Liquent’s Software-as-a-Service (SAAS) offering was prohibitively expensive. NIAID conducted an open and competitive acquisition process for the new eCTD system during the summer of 2021. The award to Lorenz was made on September 30, 2021. Transition support from TRI for this new eCTD software is out of the scope of current purchase order. Liquent will stop supporting the on-premise version of their software summer of 2022 and Lorenz’s expected production deployment of DocuBridge is June 30, 2022. RSSP cannot have a stoppage of the eCTD system therefore the transition must occur as planned. TRI’s service is required to continue the IND support and they have to be trained in Lorenz DocuBridge, the new eCTD application in order to provide continued support for the IND PO.

b. Only one Source Available

Name and address of the proposed contractor(s) if applicable

Technical Resources International, Inc 6500 Rock Spring Drive, Suite 650 Bethesda, MD 20817 POC Name: David Malloy POC Email: DMalloy@tech-res.com POC Phone: Phone: 301-897-7408

Proposed contractor(s) unique qualifications

Technical Resources International (TRI) is currently providing regulatory support services to the VRC RSSP through Purchase Order 75N93019P01252 awarded from September 27, 2019 for the base year, and option years extension until September 26, 2023.

TRI provides regulatory support including the eCTD solution that is integrated with VRC RSSP program needs which meet the requirements and complexities of VRC RSSP. The current eCTD application, Liquent that was provided by NIAID Office of Cyber Infrastructure and Computational Biology (OCICB), is going to be transitioned over to a new eCTD system due to several business reasons such as the software was slow when multiple users or submissions were being rendered, dissatisfaction with the technical support and cost of moving to Liquent’s Software-as-a-Service (SAAS) offering was prohibitively expensive. NIAID conducted an open and competitive acquisition process for the new eCTD system during the summer of 2021. The award to Lorenz was made on September 30, 2021. Transition support from TRI for this new eCTD software is to ensure there is adequate knowledge of the new eCTD application such that TRI can continue to perform the IND submission for the Purchase Order 75N93019P01252.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

The Vendor is already contracted under another Purchase Order for IND Submission Support Services. This is a one-off project that follows the transition of a NIAID eCTD project to provide operational knowledge for Contractor to provide continual support to the existing parent PO.

For example, the installation of the DocuBridge client at the vendor’s site is only applicable to the Contractor TRI that is contracted through the parent PO to continue its support. Choosing another vendor would significantly hamper the VRC’s federally mandated, critical work of submitting regulatory applications such as INDs and reports to the FDA and other regulatory agencies. VRC has worked with TRI over several years to establish processes and procedures to ensure IND applications and other regulatory reports could be submitted accurately and quickly. Choosing another vendor would affect the timeline and competing priorities, making it less cost effective. Additionally, work quality would be affected due to the lack of historical information created and obtained by the current vendor.

7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

Based on the aforementioned contracts negotiated with and awarded to TRI, proposed costs are anticipated to be fair and reasonable. The costs/price proposed for this one-off project is based on the existing parent PO labor rate that was previously competed to support the expectation of a fair and reasonable offer. Furthermore, the Contract Specialist/Contracting Officer (CS/CO) will determine if cost is fair and reasonable by performing cost analysis. The CS/CO will also work with the COR to ensure proposed costs are technically reasonable based on their programmatic knowledge. Lastly, the CS/CO will ensure that the costs/price paid by the Government is in line with the cost/price paid by others in the market. A final determination by the Contracting Officer will be conducted prior to award of this task order.

8. A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

Market research was conducted on the parent PO under formal solicitations procedures under FAR Part 5. Both sources sought and pre-solicitation notices were used to satisfy FAR Part 10. Market research will not be conducted for the RTOP because the intent is to award a sole source PO to the Contractor that is a current awardee of the parent PO for IND Submission Support Services.

However, market research will be conducted following proposal submission and prior to task order award for cost analysis.

9. Any other facts supporting the use of other than full and open competition.

The Vendor is already contracted under a parent Purchase Order for IND Submission Support Services. This is a one-off project that follows the transition of a NIAID eCTD project to provide operational knowledge for Contractor to provide continual support to the existing parent PO.

Choosing another vendor would significantly hamper the VRC’s federally mandated, critical work of submitting regulatory applications such as INDs and reports to the FDA and other regulatory agencies. VRC has worked with TRI over several years to establish processes and procedures to ensure IND applications and other regulatory reports could be submitted accurately and quickly.

Choosing another vendor would affect the timeline and competing priorities, making it less cost effective. Additionally, work quality would be affected due to the lack of historical information created and obtained by the current vendor.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Not applicable because the parent PO for IND Submission Support Services was already competed.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Not applicable because the parent PO for IND Submission Support Services was already competed.

Certifications1

Program office certification. The program officials cited shall complete the information required below and sign the certification in the blocks provided.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date Program Manager

(PM)

PM’s Immediate Supervisor

Head of the Sponsoring Program Office

Contracting Officer certification. The CO shall complete the information required below and sign the certification in the block provided. [Sufficient for actions not exceeding $750,000]

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

1 In accordance with FAR 13.501(a)(2), updated 7/1/2021

Competition Advocate signature. The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided, shall complete the information required below and sign in the block provided as the approving official for any order over $750,000 but not exceeding $15 million.

Official

Competition Advocate

Head of the Contrac upon acceptance of the rationale provided, shall complete the information required below and sign in the block provided as the approving official for any order over $15 million but not exceeding $75 million.

Official Name & Title Signature Date

NIH Head of the Contracting Activity

HHS Senior Procurement Executive signature. The HHS Senior Procurement Executive (SPE), upon acceptance of the rationale provided, shall complete the information required below and sign in the block provided as the approving official for any order exceeding $75 million.

Official Name & Title Signature Date

HHS Senior Procurement Executive