ATTACHMENT_6_-_Core_and_Study_Development_Support_Task_Order.pdf

RFP 75N94025R00008

ATTACHMENT 6 – Core and Study Development Support Task Order

RFP 75N94025R00008

Core and Study Development Support for the NIAAA Medications Development Clinical Trials Network 2.20.26

Task Order Statement of Work

Core and Study Development Support for the NIAAA Medications Development Clinical Trials Network

[Note: This task order will be awarded concurrent with the award of the base Indefinite Delivery/Indefinite Quantity contract]

I. Background

Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol problems. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone.

Thus, the search for new molecular targets and more efficacious drugs is critical. The creation of the NIAAA’s Medications Development program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct clinical trials of promising compounds to treat alcohol problems.

This task order is a cost-plus fixed fee type task order with a base performance period of 12 months with six successive 12-month option periods for a total potential performance period of 7 years. The request for services under this task order may occur at any time during the task order period of performance.

II. Scope

The Contractor shall provide core and study development support services for potential new studies under consideration for the NIAAA Medications Development Clinical Trials Network in support of the mission of the NIAAA Medications Development Branch. Support services include, but are not limited to, literature reviews, protocol development, regulatory affairs materials preparation and submittal to determine current Food and Drug Administration (FDA) perspectives on key study elements for potential new studies, and queries and meeting support related to the development of possible new studies.

RFP 75N94025R00008

Core and Study Development Support for the NIAAA Medications Development Clinical Trials Network 2.20.26

III. Objectives To assist in the review of candidate study mediations, human laboratory paradigms, protocol and literature reviews, and activities associated with obtaining FDA input on potential investigational compounds.

IV. Technical Requirements Independently, and not as an agent of the Government, the Contractor shall provide all necessary labor, materials, supplies, equipment, facilities, and services to perform the Statement of Work below.

Specifically, the Contractor shall:

A. LITERATURE REVIEW

The Contractor shall review and analyze new literature related to investigational products for alcohol use disorder and to synthesize the relevant findings in support of the development of possible new studies.

B. PROTOCOL DEVELOPMENT

The Contractor shall assist NIAAA in development of new clinical protocols for potential new studies to be conducted under the NIAAA Medications Development Clinical Trials Network in accordance with the FDA and International Conference on Harmonisation (ICH) guidelines for clinical trials.

C. REGULATORY AFFAIRS

The Contractor shall prepare and submit pre-IND meeting packages, develop FDA presentation materials, and submit all required documents to the FDA or other regulatory agencies for potential new studies or post-study FDA communications. The Contractor shall also submit regulatory requests on behalf of the NIAAA and shall prepare an Investigator’s Brochure, if required.

D. QUERIES AND MEETINGS

The Contractor shall respond to inquiries regarding potential new studies and to coordinate logistics for virtual meetings to discuss information related to the proposed investigational product.

Core and Study Development Support Task Order

Core and Study Development Support for the NIAAA Medications Development

Clinical Trials Network

Task Order Reports and Deliverables

Reports & Deliverable Due Date Electronic Copy to:

Technical Reports

Literature Review / Findings 2 weeks from date of COR request

COR

FDA Pre-IND Meeting Package for Potential New Study

1 week before submission COR

Draft Protocol for Potential New Study

2 weeks before FDA submission

COR

Meeting/Teleconference Minutes Within 2 days after call or meeting

COR

Annual Report of Task Order Activities

Last day of each annual performance period

COR, CO

Service Contract Annual Report

[ONLY IF TOTAL TASK ORDER VALUE

ABOVE SAT $350K]

Reference FAR Clause 52.204-15, “Service Contract Reporting Requirements for Indefinite Delivery Contracts” included in full text in the IDIQ base contract, Section L.

October 31st of each Task Order year

Reporting Period is the previous Government Fiscal Year (October 1 through September 30)

Submit electronically to https://www.SAM.gov

All electronic reports and deliverables submitted shall be compliant and in conformance with the Revised Section 508 Standards of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Additional information about testing all deliverables and reports including guidance and specific checklists, by application, as well as completion of VPATs for Section 508 compliance and conformance, can be found at https://www.hhs.gov/web/section-508/index.html under “Making Files Accessible” for checklists and “Contracting” for required appropriate VPAT templates using the ART tool that are to be completed. Information about the ART tool and the needed VPAT statements is located at https://www.sam.gov/ https://www.hhs.gov/web/section-508/index.html

Core and Study Development Support Task Order https://www.itic.org/policy/accessibility/vpat as Word document or using an online tool at https://www.section508.gov/buy/accessibility-requirements-tool .

https://www.itic.org/policy/accessibility/vpat https://www.section508.gov/buy/accessibility-requirements-tool