PIO_Pre-Sol_03_01_2023_1.pdf

PRE-SOLICITATION NOTICE

Request for Proposal (RFP) 75N91023R00002

Title: Protocol Information Office (PIO) Support Services

THIS PRE-SOLICITATION SYNOPSIS IS NOT AN AUTHORIZATION TO START WORK

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL (RFP); NO QUOTES

OR BIDS ARE BEING SOLICITED BY THE GOVERNMENT, NOR WILL ANY BE

ACCEPTED FOR REVIEW IN RESPONSE TO THIS SYNOPSIS.

Note: This synopsis follows a Small Business Sources Sought notice that was released on July 8, 2022, under HHS-NIH-NCI-SBSS-PCPSB-00009-39. This requirement is 100% set-aside for

Small Business. Only qualified Small Businesses under the size classification relative to the

North American Industry Classification System (NAICS) code 541611 – Administrative

Management and General Management Consulting Services need apply. The small business size standard is $24.5M. An organization that is not a Small Business under the applicable NAICS code will not be considered.

This is a re-competition of contract HHSN261201800045C awarded to ARServices, LTD located at 5904 Richmond Hwy Suite 550, Alexandria, VA 22303-1855, on September 14, 2018.

Pursuant to the Federal Acquisition Regulation (FAR) 5.204, “Pre-Solicitation Notice”, this is a notification to inform the public of the Government's intent to award a definitive, Cost-Plus

Fixed Fee (CPFF) contract.

The Department of Health and Human Services (HHS), National Cancer Institute (NCI), Office of Acquisitions (OA), on behalf of the Division of Cancer Prevention (DCP), intends to solicit for administrative support services for its Protocol Information Office. The mission of the

Protocol Information Office (PIO) is to facilitate the development of quality clinical trials;

minimize the administrative burden related to clinical trial development, implementation, and oversight; and maintain clinical trial information in the DCP database systems. The PIO presently supports several clinical trial contracts sponsored by the Division of Cancer Prevention at the NCI.

The PIO has a requirement for administrative support services for the processing of clinical trial protocol documents and tracking the implementation and completion of human clinical research studies. The scope of these services consists of the following Project Areas:

• Project Area 1. Abstraction of Key Elements from Protocol Related Documents

• Project Area 2. File Management

• Project Area 3. Clinical Trial Review Support

• Project Area 4. Manage People (persons such as investigators, coordinators, reviewers. etc.) and Organization’s data in DCP Clinical Trials Database

• Project Area 5. PIO Operational Support

OFFERORS MUST PROPOSE ON ALL PROJECT AREAS INCLUDED IN THE

STATEMENT OF WORK.

It is anticipated that one award will be made for all Project Areas in the Statement of Work.

Additional Information:

Request for Proposal (RFP) Number 75N91023R00002 will be available on or about March 20, 2023 with a due date for receipt of proposals on or about April 20, 2023.

The RFP is only available electronically and must be accessed through “Contract Opportunities” at the https://sam.gov/ website. All information required for submission of a proposal must be contained in the electronic RFP package. It is the Offeror's responsibility to monitor the above website for the release of this RFP and amendments, if any. All responsible sources may submit a proposal, which shall be considered by the agency. This notice does not commit the

Government to award a contract.

Offerors are required to submit their proposals directly to the Contracting Officer. Proposals submitted in hard copy (paper) will not be accepted. Facsimile transmissions will not be accepted. This notice does not commit the Government to award a contract

POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF

THE SOLICITATION AND ANY POSSIBLE AMENDMENTS. ALL INQUIRIES SHALL BE

SUBMITTED ELECTRONICALLY TO THE POINTS OF CONTACTS LISTED HEREIN.

The Government anticipates a definitive contract to be awarded in August 2023. This action will be competed and set aside for certified small businesses. The services will be a cost-plus fixed fee contract, expected to have a duration of five (5) years, consisting of a base year and four 12-month option periods.

You must be registered in System for Award Management (SAM) Database to receive a

Government contract award. You may register for SAM at: https://www.sam.gov/portal/public/SAM/.

All responsible and eligible sources meeting the standards as detailed above, may submit a proposal, which shall be considered by the agency. Additional questions may be emailed to the

Contracting Officer, noor.shakeel@nih.gov.

No attachments or links have been added to this opportunity.

Point of Contact:

Noor Shakeel, Contracting Officer; 240-276-5167; noor.shakeel@nih.gov

Alternate Point of Contact:

Sara McLaurin, Contracting Officer; 240-276-538; sara.mclaurin@nih.gov https://sam.gov/ https://www.sam.gov/portal/public/SAM/ mailto:noor.shakeel@nih.gov mailto:noor.shakeel@nih.gov mailto:sara.mclaurin@nih.gov