Support Services for the CTEP Pharmaceutical Management Branch

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.

Note: This synopsis follows a Small Business Sources Sought notice that was released on April 7, 2021 under HHS-NIH-NCI-SBSS-ETSB-00030-10.

Title: Support Services for the CTEP Pharmaceutical Management Branch

Background

The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for the management and distribution of agents used in NCI sponsored treatment trials, as well as agent distribution support for select Division of Cancer Prevention (DCP) and select non-NCI sponsored treatment trials. 

In accordance with being a regulatory sponsor of clinical trial research, the PMB is responsible for maintaining NCI registration and credentialing information for its investigators and associates, which allows them to participate in sponsored trials.  Maintenance includes, but is not limited to, annual collection and storage of FDA Form 1572, NCI Biosketch, Financial Disclosure Form and Agent Shipment Form (if applicable) for all investigators and a subset of this data for registered individuals.

The PMB manages the Treatment Referral Center (TRC) for handling special CTEP clinical agent initiatives, referrals to high priority clinical trials and the coordination, authorization, and processing of all requests for Special Exception and Treatment Referral Center protocol agent use.  The PMB is responsible for assuring that authorization and distribution of agents to only eligible NCI investigators.  In order to accomplish this, the PMB pharmacists prepare agent forecasting, agent acquisitions, and perform inventory management of all Investigational New Drug (IND) agents distributed by CTEP for open-label and blinded clinical trials.   The PMB staff coordinate distribution of NCI agents to investigators for non-human (preclinical) use.  The PMB pharmacists also provide pharmaceutical reviews of all applicable CTEP trials.

This acquisition is a re-competition of contract HHSN261201700007C awarded to EDJ Associates, LLC and was conducted as a Women-Owned Small Business (WOSB) set-aside.  Previous contracts for this initiative that was awarded to EDJ Associates include: contract N02-CM-27023 (August 1, 2002 to April 30, 2007), contract HHSN2612007022000C (March 2007 to April 2012), contract HHSN261201200009C (May 1, 2012 to April 30, 2017).

Requirements

             1.  General Requirements

The Contractor shall  provide staff for the PMB office at NCI Medical Center Dr and off-site facility and be available to conduct all aspects of the Statement of Work during regular PMB business hours (8:30 AM - 5:00 PM, Eastern Time), Monday through Friday, except for official Federal Government holidays.  The Contractor shall also provide and maintain an off-site location including all equipment necessary at that site for other personnel and file storage.

           2.  Contract Transition (Phase-In and Phase-Out):

During the first 60 days of the contract, the Contractor shall implement a seamless transition, in cooperation with the incumbent, to ensure the knowledge and activities of the contract are transitioned to the Contractor staff.  At the end of the 60-day period, the Contractor shall be able to independently initiate new and maintain ongoing work.

Sixty days prior to the expiration date of the contract, the Contractor shall ensure an orderly, secure, efficient, and expedient transition of all contract activities to a successor contractor.

          3.  Agent Distribution Support

• The Contractor staff, herein referred to as Contractor, shall perform inventory activities such as attend monthly PMB Drug status meetings, monitor agent usage, scanning and electronic file maintenance.
• Agent Order Processing: process and authorize Clinical Drug requests using the NCI Clinical Oncology Research Enterprise (CORE) systems
• Agent Transfers: transfer IND agents between sites and protocols as permitted by the NCI and work with the requestor to verify that established criteria are met.  
• Local Destruction of agents: Requests for local destruction shall be collected, reviewed, and processed based on an established list of agents approved for local destruction and PMB SOPs.
• Site Communication/Document Management:   Perform and maintain a record of electronic mailings required by the Government (PMB). 

         4.  Person Registration and Credentialing

The Contractor shall develop a method to review and quality assure/quality check the submitted profiles for newly registering and renewing persons (Investigator, Sub-Investigator, Associate, Associate Basic) in accordance with PMB standards and maintain the information in the Registration and Credential Repository (RCR) database including Identity and Access Management, (IAM), Enterprise Core Module (ECM)

         5.  Administrative Tasks

• The Contractor shall be responsible for answering the PMB phone line during normal business hours (8:30 a.m. – 4:30 p.m. Eastern Time). 
• The Contractor shall be responsible for receiving, sorting and distributing to the appropriate staff member, mail received at PMB.  The contractor shall prepare outgoing mail as needed.
• The Contractor shall be responsible for monitoring general PMB email boxes and responding or triaging to the appropriate PMB staff member.
• The Contractor shall also provide Clerical Support such as: scanning, word processing, data entry, filing, photocopying support as necessary.
• The Contractor shall provide a monthly report summary of administrative tasks and agent distribution reports as needed.

         6.  Quality Assurance (QA)/ Quality Control (QC) Plan

The Contractor shall develop and implement a written plan for QA/QC of activities as described in Sections 3 and 4 which include requirements for maintaining  current SOPs, methods for ensuring documents are accurate and free of error/s, procedures for ensuring “zero error rate” when processing orders and completeness and accuracy of electronic document files maintained in PMB.

Anticipated Period of Performance

These non-R&D severable services will be acquired through a Total Small Business Set-Aside. It is anticipated that one (1) cost reimbursement, level of effort contract will be awarded with a one (1) year base, plus four (4), one (1) year option periods beginning on or about May 1, 2022. In addition, there will be options for increased capacity, options for Phase-in and a Phase-Out of 60 days each. The NAICS Code for this requirement is 541611.

The Solicitation will be available electronically on or around August 6, 2021 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS’ RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL RESPONSIBLE SMALL BUSINESSES TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. 

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.