Mod 4 ATTACHMENT 7 UPDATED 10 27 2023.pdf

FDA-23-RFTOP-SAMPLE

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Date: October 27, 2023 Request for Task Order Proposal: FDA-23-RFTOP-SAMPLE IDIQ Contract Number: xxxxx Proposal Due Date: 11/02/2023 Requirement

1. Background

2. This requirement to provide scientific support and leadership for new and ongoing research projects involving clinical data and research projects. These projects require 8 personnel.

The selected professionals must be able to work towards and accomplish tasks outlines below:

The award is a Labor Hour Task Order under the IDIQ: Operational, Technical, and Analytical Support contract vehicle xxxx. The terms and conditions of the offeror’s IDIQ contract will be applicable to this requirement.

3. Pricing Schedule (see Attachment 8)

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4. Objective

The objective of this task order is to obtain the services of one (1) Research Assistant III, Two (2) Research Analyst I, Three (3) Research Analyst III, and two (2) Bioinformatics Analyst I.

5. Tasks

The contractor shall furnish necessary services and qualified personnel needed to perform the Statement of Work as stated herein.

Tasks include:

• Oversee the design, planning and execution of phase-1 type clinical trials and provide input in areas where needed related to the execution and reporting of these clinical trials

• Provide oversight for data collection from ongoing clinical trials, including data collection from the clinical site and from sample analysis

• Lead/oversee/perform development of statistical and modeling analysis plans for clinical trials in collaboration with other clinical study team members

• Lead/oversee/perform data analysis as outlined in the analysis plan, including generation of tables and figures for presentations and manuscripts

• Provide clinical and/or other (research) input and oversight for projects and serve as a first author, co-author or senior author on research output, where needed and required

• Interact/coordinate with external consortia on research topics of mutual interest to FDA and the consortia to advance regulatory science as identified by FDA Project Officer.

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Basic Requirement:

Possess related experience and a team spirit demonstrating EACH of the following competencies;

• Demonstrated leadership overseeing clinical trials/clinical research activities spanning from project conception, project execution, data/statistical analysis, interpretation of results and communication of findings in presentations and peer-reviewed publications

• Excellent written and verbal communication and interpersonal skills are required as these candidates will be expected to work productively in a collaborative, cross-functional team environment

• Strong attention to detail with the ability to analyze, interpret and present study data coupled with an aptitude for learning.

• Familiarity with at least one programming language used for data analysis, such as SAS, R, or MATLAB

• Experience with quantitative analysis, particularly non-compartmental analysis and pharmacokinetic/pharmacodynamic modeling

• Experience with data visualization and graphical presentation of research results

• Scientific degree(s) with preference to those with clinical training in combination with an advanced degree (e.g. PhD or Master’s) that included training in quantitative sciences that can be applied to clinical trials and clinical data sets

• Experience with clinical care/clinical research for cardiac safety of drugs or cardiovascular medicine/therapies

6. Deliverables

Weekly reports regarding the progress of each activity. The weekly progress reports need to be submitted via email and are due on the first business day of each week.

7. Place of Performance

• The place of performance shall be the Division of Applied Regulatory Science, Buildings 64, 10903 New Hampshire Ave, Silver Spring, MD 20993. The position can be 100% remote (telework) until FDA and the Division of Applied Regulatory Science begin returning staff to campus other than those who work in laboratories. At that time, the position shall include on-site work up to 5 days per week, however regularly scheduled or ad hoc remote work is allowed as authorized by the Project Officer.

• Overtime is not authorized under this Task Order, (i.e., in excess of 40 hours/week) and no work shall be performed on Federal Holidays. Payments will be made only for hours worked on-site and shall not exceed those hours set forth in this Task Order.

While the Project Officer may authorize absences for sickness, vacation, etc. No payment will be made for those absences.

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Contractor Conformance with Applicable Laws, Regulations, Policies and Standards – The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/.

HHS documents are found at: http://www.hhs.gov/oirm/.

8. Period of Performance

Base Period: December 01, 2023 to November 30, 2024.

Option Year 1: December 01, 2024 to November 30, 2025 Option Year 2: December 01, 2025 to November 30, 2026

9. Payment Terms

The vendor will submit all invoices as required by the Task Order. The failure to properly submit invoices may result in a delay in payment

10. Points of Contract:

The Contract Specialist for this task order is:

Howard S. Yablon

FDA/OFBA/OAGS/DAP

4041 Powder Mill Road Beltsville, MD 20705 howard.yablon@fda.hhs.gov

The Contracting Officer for this order is:

To be determined U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705

The Contracting Officer’s Representative (COR) for this order is:

Project Manager U.S. Food and Drug Administration 10903 New Hampshire Ave http://www.cio.gov/ http://www.hhs.gov/oirm/ mailto:howard.yablon@fda.hhs.gov

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Silver Spring, MD 20993

The Contractor for this task order is:

11. Instructions to Offeror

The Technical Proposal shall be no more than five (5) pages. The Offeror shall also complete Attachment 11: Sample Task Order Resource Matrix.

For the Sample Task Order Business/Price Proposal, the Offeror shall complete the pricing table provided in Attachment 8. The offeror should provide the labor categories utilized and the number of hours, so the Government may evaluate how the pricing of each deliverable is derived.

Proposals shall be sent to the Contract Specialist, Howard S. Yablon via e-mail at howard.yablon@fda.hhs.gov, by November 02, 2023 2:00 PM Eastern Time or sooner with the Request for Task Order Proposal Number in the subject line.

The Government intends to make an award based on the initial proposal. If further questions are required, the contracting officer may contact the offeror.

Technical Evaluation Criteria Technical proposals shall be evaluated individually for compliance and conformance with the solicitation requirements and the evaluation factor.

Technical Approach The proposal shall be evaluated to determine if the offeror provides a sound, compliant approach to establish that the offeror possesses a thorough knowledge and understanding of the technical requirements outlined in the Description of Work as well as providing key personnel meeting the experience criteria set forth in Section 5 above.

12. Price Evaluation Criteria

Evaluation of Price Reasonableness

Price reasonableness shall be evaluated to ensure that the proposed prices reflect a clear understanding of the work and skills required for contract performance and are priced consistent with Base IDIQ rates for the applicable labor categories.

mailto:howard.yablon@fda.hhs.gov