Limited Source Justification.pdf

General Services Administration Federal Supply Schedule Limited Source Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

FDA/CDER/OC

b. Sponsoring organization.

CDER/OC

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

i. Name: Mark Agnello

ii. Mailing address: 10903 New Hampshire Avenue, Silver Spring, MD 20903

iii. E-mail address: mark.agnello@fda.hhs.gov

iv. Telephone number: 301-348-1833

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

a. Acquisition purpose and objectives.

CDER OC is requesting a contract to support online training for the external stakeholders in the drug compounding industry. The FDA will administer online training leveraging the TRAIN Learning Network to host and manage the FDA’s online training modules. The FDA seeks to procure an annual subscription of the TRAIN Learning Network to train external stakeholders.

The purpose of this acquisition is to procure a subscription to the Public Health Foundation’s (PHF) “TRAIN Premium Affiliate – Federal Government” that will host training for compounding outsourcing facilities that will be developed under the existing Reducing Risks of Compounded Drugs: Engagement with Outsourcing Facilities, (HHSP233201500117I) which was awarded on September 30, 2019.

b. Project background.

CDER OC has an existing contract (Reducing Risks of Compounded Drugs: Engagement with Outsourcing Facilities, HHSP233201500117I) that will be utilized to, among other work products, develop online training to support the OC mission to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use and that they meet established quality standards and available to patients. This work is focused on the outsourcing facility sector of the drug compounding industry.

The Drug Quality and Security Act of 2013 created “outsourcing facilities” – a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. It is particularly important that this sector be able to meet provider needs for compounded drugs distributed without patient-specific prescriptions. Providers often hold such products in the office in anticipation of patients who present at the office with a medical need for them (aka “office stock drugs”). Under the law, outsourcing facilities have the unique ability to provide such products. Five years since its creation, this domestic industry is still relatively small (approximately 70 entities), is experiencing growth challenges, and is not yet fulfilling its potential. Businesses have encountered market challenges, and FDA continues to find concerning quality and safety problems during inspections.

To help this industry meet its intended function, FDA intends to engage in several initiatives to address challenges and support advancement, including the development and provision of online training. In order to administer the online training, CDER OC needs to procure an existing online training platform capable of hosting and supporting the online training modules. The online training needs to be available to members of the public that engage in compounding outsourcing facility work, a specialized public health-related area, in a user-friendly and easily accessible manner. Procurement of the “TRAIN Premium Affiliate – Federal Government” will fulfill the requirements to host the unique and tailored training that is being developed for the compounding outsourcing facility community.

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

a. Project title.

Reducing Risks of Compounded Drugs: Online Training Support

b. Project Description.

This acquisition will procure the TRAIN Premium Affiliate – Federal Government subscription from The Public Health Foundation, Inc. Procurement will be via GSA Schedule 70, SIN 132-52, Part Number TA-500. This subscription has an annual cost of $124,999.50. PHF’s GSA contract is valid until September 27, 2023.

CDER OC will become a TRAIN Premium Affiliate. This will enable CDER OC to post courses (online and onsite) related to compounding outsourcing facility practices and be included as part of TRAIN’s large public health-related training portfolio. Training modules will be visible to all TRAIN learners or a specific group, and it is easy for interested parties to directly obtain access to the TRAIN platform, allowing a broad external audience to view the training. CDER OC will also be able to utilize TRAIN to track learner progress and attendance for a designated group of learners (e.g., outsourcing facility staff, state regulators, or other interested parties) across courses on the network. CDER OC will be able to track individual learner progress and attendance on as well as create, assign, and manage pre- and post-assessments and evaluations.

CDER OC will be able to communicate with TRAIN learners through targeted announcements, host a branded TRAIN affiliate site, manage TRAIN learners through designated subgroups, create and assign training plans. CDER OC will also have membership to the TRAIN Affiliate Consortium (TAC), a forum to share training resources, collaborate on workforce development efforts and learn TRAIN best practices. Ongoing technical support is included. In addition, CDER OC will have access to reporting capabilities that will allow CDER OC to obtain various metrics regarding use of the individual courses.

Requirement type.

☒ Support services (non-R&D)

☐ Supplies/equipment

☐ Information Technology (IT)

☐ Other:

Type of action.

☒ New requirement

☐ Follow-on

☐ Other: Modification to increase the ceiling of the BPA

Proposed contract/order type.

☒ Firm-fixed-price

☐ Time and materials

☐ Indefinite delivery:

☐ Other: BPA Task Order

☐ Completion Form

☐ Term Form

Acquisition identification number.

CDER-20-C-0080; Requisition number 1221198A.

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

The total estimated dollar value is $124,999.50.

4. The authority and supporting rationale (see FAR 8.405-6(a)(1)(i); (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

☐ This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with Federal Acquisition Regulation (FAR) 8.405-6(a), consideration of schedule contractors will be restricted to fewer than the number required at FAR 8.405-1, FAR 8.405-2, FAR 8.405-3 (i.e., fewer than three FSS contractors). FAR 8.405-6 (a)(1)(i), for a proposed order or BPA with an estimated value exceeding the micro-purchase threshold not placed or established in accordance with the procedures in FAR 8.405-1, FAR 8.405-2, or FAR 8.405-3, the only circumstances that may justify the actions are-

☐ (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

☒ (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

☐ (C) In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

☐ This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with FAR 8.405-6(b), consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

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

Public Health Foundation, Inc.

1300 L Street, NW Suite 800 Washington, DC 20005

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

Online training courses will be developed under the Reducing Risks of Compounded Drugs:

Engagement with Outsourcing Facilities contract (HHSP233201500117I) which was awarded on September 30, 2019. This contract will allow CDER to post online courses to train external stakeholders to reducing the risk of compounding drugs. These external stakeholders include the https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 compounding facility staff, state regulators, and other public stakeholders. Procuring an annual subscription to TRAIN will allow the FDA to reach thousands of stakeholders through online access. The FDA can avoid development, as well as operations/maintenance costs of creating a new training system. If the FDA developed a new external training platform, development costs would exceed $1.5M plus operations and maintenance at $500K per year. The FDA can reduce its risks by procuring an existing training infrastructure, specifically TRAIN.

The access to these courses must be readily available to non-Government users thus making any FDA- or HHS-hosted options such as FDA University, Learning Management System or Pathlore unacceptable. All online government-developed training options require federal credentials.

(e.g. PIV or CAC cards).

The Public Health Foundation (PHF) developed a shared infrastructure and subscription-based training platform called the TRAIN Learning Network. Thus far, TRAIN reaches over 2 million people within various public health audiences, as well as state/federal regulators. We identified the Public Health Foundation’s TRAIN platform as an option after market research discussions with the Centers for Disease Control (CDC) who are extensive users of the TRAIN platform for similar training. TRAIN is the only training platform we are aware of that is specifically designed for use among the public health community and regulators to conduct publicly-focused online trainings. TRAIN’s platform also allows for the flexibility of utilizing their existing structure to upload training material and host online training sessions to non-federal audiences.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

This prospective award against an existing GSA Federal Supply Schedule contract and the resultant pricing of the award to the cited vendor has already been deemed fair and reasonable. FDA will evaluate the level of effort and skill mix required to support the work in scope of individual orders and will determine the price of the orders to be fair and reasonable prior to issuance. No change to labor rates or categories are being pursued and these rates have already been determined to be fair and reasonable at the original BPA award. Since the Contracting Officer has previously concluded that the BPA represents the best value and results in the lowest overall cost alternative during the previous competition, additional information is not required.

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.

The Public Health Foundation (PHF) developed a shared infrastructure and subscription-based training platform called the TRAIN Learning Network. Thus far, TRAIN reaches over 2 million people within various public health audiences, as well as state/federal regulators. CDER OC identified the Public Health Foundation’s TRAIN platform as an option after market research discussions with the Centers for Disease Control (CDC) who are extensive users of the TRAIN platform for similar training.

TRAIN is the only training platform we are aware of that is specifically designed for use among the public health community and regulators to conduct publicly-focused online trainings. TRAIN’s https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html platform also allows for the flexibility of utilizing their existing structure to upload training material and host online training sessions to non-federal audiences.

We contacted FDA DLOD who oversees training efforts here at the FDA and determined that they would not be efficiently or effectively leverageable to provide externally-focused, publicly accessible training. These training software modalities are typically housed within an Agency’s firewall, greatly limiting access to trainings. Any training modules developed in TRAIN would be publicly available so that any interested parties can readily obtain access to the trainings without having to be subject to Agency IT security protocols that can limit access. After discussions with DLOD we ruled out use of any FDA-hosted sites.

We then researched many other vendors on GSA Schedule 70 (SIN 132-52, Electronic Commerce and Subscription Services) and were unable to find any other vendors that met all the following requirements:

• Focus on public health and health science-related training.

• Access to an existing network of users in health-related fields.

• Capability for open public access to training.

• Does not require hosting behind the Agency’s firewall, completely external.

• Direct coding or programming is not required to add training modules to the platform.

• Allows the creation and management of course evaluations completed by individual learners.

• Ability to track course attendance and course completions of learners.

• Allows the Government to easily create and manage communications with our target audience in the compounding facilities.

• Provides continuing education credits.

• Captures a broad range of analytics describing the use of trainings on the site.

• Allows for the creation of custom reporting capabilities.

• Contains an existing range of public health related courses that are already available to users.

Other vendors evaluated had some but not all the features we determined to be necessary to successfully host the drug compounding training to be developed, for example vendors were not able to meet all our system requirements or does not focus on public health entities and topics.

Therefore, after conducting extensive market research, it was determined that the TRAIN platform was the only product that met all the above requirements.

7. Any other facts supporting the justification.

Without an award to the above vendor, FDA will not be able to make the training developed under the Reducing Risks of Compounded Drugs: Engagement with Outsourcing Facilities contract (HHSP233201500117I), awarded on September 30, 2019. This new web-based content is scheduled to be created and made available to the drug compounding community early in 2020. This training is one of the prime deliverables to the above-referenced contract. CDER OC chose a vendor with GSA schedule availability to allow for a rapid procurement.

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

Removal of barriers to competition.

None.

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

No other sources have expressed an interest, in writing, of the proposed acquisition.

Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for limited sources) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature:____________________________________

CDR Mark Agnello COR/Requiring Activity POC

Collin Figueroa COR/POC Immediate Supervisor

Kathy Anderson Head of the Sponsoring Program Office

9. Contracting Officer Certification.

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Anthony Wimbush Contracting Officer

10. Division Director and Head of the Contracting Activity signature(s).

XXXXX

Division Director

[Enter date here.]

XXXXXX

Head of the Contracting Activity

11. Competition Advocate signature.

XXXXX

Competition Advocate