2023-08-01 Signed Justification for Other than Full and Open Competition 1263483.pdf

Last Modified: April 5, 2017 Page 1 of 6

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS)

b. Sponsoring organization.

Food and Drug Administration (FDA) Office of the Commissioner (OC) Office of the Chief Scientist (OCS) Office of Scientific Professional Development (OSPD) 10903 New Hampshire Ave Silver Spring, MD 20993

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

POC:

Rokhsareh Shahidzadeh, MSN, RN Senior Regulatory Health Education Specialist 301-796-8740 Rokhsareh.Shahidzadeh@fda.hhs.gov

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

The Food and Drug Administration (FDA) is responsible for ensuring that Human Subjects Research (HSR)complies with Federal regulations. FDA is mandated by federal regulations to give its employees the opportunity to acquire the skills and competencies necessary to carry out its mission. FDA must provide the required trainings for FDA researchers in the areas of Human Subjects Research Protection, Responsible Conduct of Research, Animal Care and Use, Good Clinical Practice, and general research ethics compliance.

These trainings are mandated by the following Federal regulations:

The regulations at Code of Federal Regulations (CFR) Title 45, Part 46, Federal Policy for the Protection of Human Subjects (with Subpart A known as the “Common Rule”), describe requirements for research involving human subjects conducted, supported or otherwise subject to regulation by the U.S. Department of Health and Human Services, and accordingly for research involving human subjects conducted or supported by FDA.

The FDA, including the FDA Institutional Review Board (IRB), will comply with 45 CFR Part 46 and FDA standard operating procedures (SOPs) regarding human subjects’ research conducted or supported by the FDA. In addition, such research and the FDA IRB must comply with FDA regulations (such as 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812), as

Last Modified: April 5, 2017 Page 2 of 6 applicable, and should generally follow applicable FDA and Office for Human Research Protections (OHRP) guidance documents.

The contractor shall provide web-based trainings in the areas of research ethics, compliance, and best practices education, in all mandated areas. The trainings should be accessible to FDA employees in various geographic sites (currently 20 in total) to meet the training needs of FDA researchers in FDA’s various geographic areas.

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

The objective of the Project, titled “Web-Based Training System for FDA Personnel in the areas of Human Subjects Research Protection, Responsible Conduct of Research, Animal Care and Use, and Good Clinical Practice,” is for the contractor to provide mandated research ethics/compliance training to FDA authorized personnel (referred to herein as “FDA learners”) as required to support FDA’s responsibilities, which include oversight and monitoring functions for research protections in FDA supported and regulated research.

a. Project title.

Web-Based Training System for FDA Personnel in the areas of Human Subjects Research Protection, Responsible Conduct of Research, Animal Care and Use, and Good Clinical Practice.

b. Project Description.

The Contractor shall develop and provide a web-based educational program in research ethics and compliance. The educational program shall be available to FDA personnel with 24/7 online access.

The web-based training program shall contain subject matter content specifically addressing Human Subjects Research (“HSR”) ethics requirements under applicable Federal regulations, as well as Responsible Conduct of Research (RCR), Animal Care and Use (ACU), and Good Clinical Practice

(GCP).

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

Last Modified: April 5, 2017 Page 3 of 6

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

Acquisition identification number.

Requisition Number: 1263483

ALP Request Number: OC-2023-116925

Center Item Number: OC-23-C-0001

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

- Base year period of performance is from September 30th, 2023- September 29, 2024= $80,925

- 1st option year is from September 30th, 2024- September 29, 2025, with 3% increase= $83,352

- 2nd option year is from September 30th, 2025- September 29, 2026, with 3% increase =$85,839

- 3rd option year is from September 30th, 2026- September 29, 2027, with 3% increase =$88,407

- 4th option year is from September 30, 2027- September 29, 2028, with 3% increase =$91,056

- Total Price (Base Year + Option Years 1, 2, 3, and 4) = $429,579

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).

Last Modified: April 5, 2017 Page 4 of 6

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).

Biomedical Research Alliance of New York LLC (“BRANY”)

1981 Marcus Ave Suite 210 Lake Success, NY 11042-1055

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

CITI program (Collaborative Institutional Training initiative) through BRANY (Biomedical Research Alliance of New York) is the only known provider that can offer all of the legally mandated training courses and certifications needed by FDA researchers. While CITI/ BRANY has been providing this training to FDA users for more than a decade ago, they have also been the sole provider for other Federal Agencies, such as the U.S. Department of Agriculture, the National Institutes for Health, Office of Naval Research, and others. The critical requirements for maintaining this service from CITI/BRANY are:

- CITI program has offered its training services to the FDA staff for more than a decade with exceptional performance records delivering high-quality trainings using over 200 subject matter expert content contributors to develop its training courses.

- FDA recently invested in adding Single Sign On (SSO) feature that allows learners to sign into the CITI Program with the same credentials they use at the FDA, increasing security and facilitating FDA staff access.

- The CITI Program offers a user-friendly online platform that allows FDA employees to access training materials 24/7 at their convenience. The platform provides a seamless learning experience, with interactive modules, quizzes, and resources that enhance understanding and retention of the content.

- The CITI Program provides comprehensive reporting tools that allow FDA Centers to monitor researchers’ compliance with training requirements.

- The CITI Program offers a customizable training solution that allows FDA to tailor the content and modules according to agency’s specific requirements. This flexibility ensures that FDA employees receive training that is directly applicable to their roles and responsibilities, enhancing the effectiveness of the program.

- As it has been selected in the past, it is more efficient to continue using CITI program training service as the procurement process can be streamlined, saving government staff time and resources to negotiate with multiple vendors.

- Maintaining the same program avoids disruption of the training service for the FDA staff, and mitigate the potential risks associated with using the less-known vendors.

- Maintaining the same training program fosters a long-term partnership with CITI that can lead to a better understanding of the FDA’s needs, and alignment with the FDA’s objectives.

Last Modified: April 5, 2017 Page 5 of 6

- Training received under CITI program will be transferable to another agency should the employee transfer to another agency that is also serviced by CITI/BRANY. This helps save the Government time and money by not needing to have their employees re-certify every time they move to a new Federal Agency-operated research facility.

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.

A pre-solicitation notice of intent to sole source this procurement was posted publicly on SAM.gov on July 6, 2023. Capable parties who wished to challenge the sole source award were asked to contact the Contracting Officer and Contract Specialist. No responses were received.

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

Since the procedures of FAR Parts 12 and 13 will be used for this requirement, the procedures of FAR Part 13.106-3(a)(2) will be used to determine that the pricing is fair and reasonable.

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 conducted using general online searches and contacting potential research ethics training service providers to determine if any other sources might be capable of providing these services. It was concluded that there is no other viable training service provider than CITI program that could meet the training needs of the entire research community at the FDA.

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

See section 5. b. above.

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

Aside from BRANY, no other sources expressed any interest in this requirement.

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.

Market research was done, and no viable competitor was available.

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 minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Rokhsareh Shahidzadeh, MSN, RN Senior Regulatory Health Education Specialist

Last Modified: April 5, 2017 Page 6 of 6

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:____________________________________

Nicholas Bisher, Contracting Officer