FDA-JA-1224405 CBER_OTAT Regenerative Medicine Therapies.pdf

Last Modified: April 5, 2017 Page 1 of 8

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Department of Health and Human Services/Food and Drug Administration.

b. Sponsoring organization.

Food and Drug Administration/Center for Biologics Evaluation and Research/Office of Tissues and Advanced Therapies

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

Name: Donna Monk Mailing address: 10903 New Hampshire Ave, Silver Spring MD 20993 E mail address: Donna.Monk@FDA. hhs.gov Telephone number: 240 402 8333

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

This request is for a sole source award to assist FDA/CBER in supporting the requirements and goals set forth in the 21st Century Cures Act as it relates to the needs for standards development in regenerativemedicine. Specifically, (1) increase the number of regenerativemedicine standards being advanced in the field, (2) accelerate the advancement and availability of regenerative medicine standards, and (3) elevate U.S. leadership in standards development.

a. Acquisition purpose and objectives.

In December 2016, Congress passed, and President Obama signed into law the 21st Century Cures Act (Cures Act). Title 3 Section 3036 of the Cures Act adds section 506G to the FD&C Act and directs FDA, in consultation with the National Institutes of Standards and Technology (NIST) and stakeholders to "facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms, through a public process, to support, through regulatory predictability, the development , evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products." In carrying out the requirements stated in the Cures Act FDA and NIST are charged with identifying ways to help advance the development of regenerative medicine therapies. This includes working in a public private arena to develop laboratory regulatory

Last Modified: April 5, 2017 Page 2 of 8 science research and documentary standards that would aid in the development, evaluation and review of regenerative medicine therapies.

Standards development is an ongoing priority in CBER's efforts to promote development of regenerative medicine therapies, which are often developed for the treatment of serious or life threatening diseases with unmet medical needs. Increased development and use of standards have the potential to transform product development, contribute to regulatory predictability, and facilitate the overaII development of regenerative medicine therapies.

b. Project background.

On September 26, 2017, FDA/CBER/OTAT awarded contract HHSF223201710592A to Nexight Group LLC. to support standards development activities outlined in Section 3036 of the Cures Act.

Nexight subcontracted with the Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell Based Drug Discovery, Inc.(SCB). In order to employ the processes developed under the initial contract, the contract was modified to extend the performance period for 6 months from September 27, 2018 through March 26, 2019. Due to the government shutdown, a modification was completed to extend the end date to April 29, 2019 to allow the Nexight Group to complete the 2 day workshop on the development and use of reference materials/physical standards and documentary standards at no additional cost to the government.

On, July 29, 2019, FDA/CBER/OTAT awarded contract 75F40119P10294 to Nexight Group LLC., to continue standard development activities outlined in Section 3036 of the Cures Act. Performance under this contract ends on 07/30/2020. The objective of this requirement is to assist FDA/CBER/OTAT in supporting the requirements and goals in the 21st Century Cures Act, as it relates to the needs for standards development in regenerative medicine. There is a continual need to (1) increase the number of regenerative medicine standards advanced in the field, (2) accelerate the advancement and availability of regenerative medicine standards, and (3) elevate U.S. leadership in standards development.

3. Description of the supplies or services required tomeet the agency’s needs (including the estimated value).

a. Project title.

Standards Development for Regenerative Medicine Therapies

b. Project Description.

An in depth discussion of the project and its tasks are outlined in the Statement of Work (SOW).

A brief description of the project’s tasks is below:

Task 1. Conduct feasibility assessments to accelerate the process for which standards are published

Task 2: Update the Landscape Report through engagement with the regenerative medicine community to ensure content remains reflective of current community needs.

Last Modified: April 5, 2017 Page 3 of 8

Task 3: Engage regenerativemedicine subject matter experts to coordinate drafting and comment adjudication of draft standards.

Task 4: Enhance current website by creating a portal which will be more interactive and allow for real time commenting on draft standards by RM stakeholders.

Task 5: Develop one pilot curriculum to assist with standards implementation and conformity assessment to standards.

Task 6: Reporting of activities via a monthly progress report to the COR.

Requirement type.

Research & Development (R&D)

R&D support services

Support services (non R&D)

Supplies/equipment

Information Technology (IT)

Construction

Architect Engineer (A&E) services

Design build

Other:

Type of action.

New requirement

Follow on

Other:

Proposed contract/order type.

Firm fixed price

Other fixed price:

Cost plus fixed fee

Other cost reimbursement:

Time and materials

Indefinite delivery:

Other:

Completion Form

Term Form

Last Modified: April 5, 2017 Page 4 of 8

Acquisition identification number.

Standards Development for Regenerative Medicine Therapies

c. Total estimated dollar value and performance/delivery period.

Total: $1,723,922.24 Base: $861,961.24 Option Year One: $861,961.24

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

6.302 1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

6.302 2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

6.302 3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302 4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302 5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

6.302 6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302 7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

NEXIGHT Group LLC, 8405 Colesville Rd,Silver Spring, MD 20910 3317

Last Modified: April 5, 2017 Page 5 of 8

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Under the current contract Nexight has developed processes to identify needed standards and evaluate the plausibility of development and implementation of such standards. This includes working in a public private arena to develop laboratory regulatory science research and documentary standards that would aid in the development, evaluation and review of regenerative medicine therapies. Since the implementation of the current contract and the publication of several reports on standards, CBER has experienced an increase in inquiries on how to get involved in the standards development processes and how to use standards to meet regulatory requirements. Nexight/SCB has most notably conducted a public workshop on March 18 19, 2019, "Realizing the Benefit of the 21st Century Cures Act through Standards Development".

These workshops have allowed the community to identify needed standards that can foster product development and shorten time to market for regenerative medicine advanced therapies.

In order to continue progress from the current contract and maximize deliverables, it would be in the best interest of the Government to continue this Congress (21st Century Cures Act, Title 3 Section 3036) with the following FDA/CBER/OTAT requirements;(1) increase the number of regenerative medicine standards being advanced in the field, (2) accelerate the advancement and availability of regenerative medicine standards, and (3) elevate U.S. leadership in standards development. The purpose of this new contract is to ensure that the regenerative medicine standards that have been proposed are monitored and fostered through the pipeline until final approval. If not, provide CBER with the feedback from the experts as to why the specific standard was not supported.

In summary, the level of effort involved with the creation of medical standards cannot be done with knowledge of just one organization. It is industry known practice, that in order to create impactful standards, it takes the entire field of medical professionals in both federal and private industry to work together to make effective standards. FDA does not currently have the broad range of medical professionals and more importantly would not want to pursue this critical initiative with just the localized knowledge in the federal sector. The FDA can be better served by leveraging mechanisms already in place such as the current contract with NEXIGHT Group LLC which has laid the foundation for CBER' s effort to coordinate and prioritize the development of standards and consensus definition of terms, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to themanufacturing processes and controls of such products. Additionally, the work that has been achieved with NEXIGHT Group LLC's subcontractor, SCB, which includes but is not limited to, cooperation between SCB and NIST and the existing SCB organizational structure to meet the requirements set out by the Cures Act and its congressional mandate. No other Vendor has the current organizational structure , historical knowledge and experience to be able to meet the Agency’s needs.

6. 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.

Last Modified: April 5, 2017 Page 6 of 8

Sources Sought Notice FDA SSN 1224405 was posted to beta.SAM.gov Contracting Opportunities website 5/18/20 with the purpose of identifying small or large businesses capable of providing the required services. One (1) response was received from Nexight Group, LLC (recommended source) by the closing date 6/1/20.

Intent to Sole Source Notice FDA INT 1224405 was posted to the beta.SAM.gov Contracting Opportunities website 7/7/20 with a response due date on 7/22/20. The contract file has been documented outlining no responses were received on or before the deadline. The Contracting Officer will subsequently publish a beta.SAM.gov notice as requirement by FAR Subpart 5.2.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

"In accordance with FAR Part 13.106 3(a) Basis for award. Prior to award, the Contracting Officer will determine the proposed price to the Government is fair and reasonable by obtaining cost or pricing information from the proposed contractor and performing and documenting price and/or cost analysis".

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market Research was performed by surveying other federal health organizations (NIST, NIH, etc.) in addition to researching the available vendors within in industry. Currently only NEXIGHT Group LLC has been identified.

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

Not Applicable

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

Not Applicable

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

There are no plans to acquire the same type of services because the type of work being conducted will be leveraged to improve the standards of regenerative medicine and thus a new type of contract mechanism would be needed for future efforts.

12. Program office certification.

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

Last Modified: April 5, 2017 Page 7 of 8 minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Donna Monk, CBER OTAT COR/Requiring Activity POC

Signature:____________________________________

Risa Schecter, CBER OTAT COR/POC Immediate Supervisor

Signature:____________________________________

Dr. Wilson Bryan, CBER OTAT Head of the Sponsoring Program Office

13. Contracting Officer Certification.

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.

Signature:____________________________________

Nick Sartain, OAGS, DAP, FOB Date Contracting Officer

Donna M. Monk -S Digitally signed by Donna M. Monk -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Donna M. Monk -S, 0.9.2342.19200300.100.1.1=2000111987 Date: 2020.09.16 13:19:25 -04'00'

Risa B. Schecter -S Digitally signed by Risa B. Schecter -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000349117, cn=Risa B. Schecter -S Date: 2020.09.16 13:26:57 -04'00'

Wilson Bryan -S Digitally signed by Wilson Bryan -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Wilson Bryan -S, 0.9.2342.19200300.100.1.1=0011265579 Date: 2020.09.16 16:18:45 -04'00'

Last Modified: April 5, 2017 Page 8 of 8

14. Competition Advocate signature.

Signature:____________________________________

Jim Sig, OC, OO Date Competition Advocate

Signature:____________________________________

Leonard D. Grant, OAGS Date Head of Contracting Agency