Support services for PMI IRB

Background Information

Precision Medicine Initiative (PMI) will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. A critical part of PMI is the PMI Cohort Program led by the National Institutes of Health (NIH). This program seeks to extend precision medicine to all diseases by building a national research cohort of one million or more U.S. participants.

The Office of Science Policy(OSP), Office of the Director(OD), National Institutes of Health (NIH), is seeking qualified business concerns, 8(a) small businesses, Woman-owned, small disadvantaged businesses, HUB Zone small businesses and Service-disabled Veteran small business concerns fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The Government anticipates award of a fixed price, indefinite delivery type contract under solicitation number NIHOD2016764J. The resultant contract shall be for a period of one year commencing on or after September 1, 2015 and shall include four successive 12-month option periods.
 
Anticipated period of performance September 19, 2016 - September 18, 2021.

The base period of performance for the contracts will be twelve (12) month base periods with options to renew for four (4) successive twelve (12) month periods.

The intended procurement will be classified under North American Industry Classification System (NAICS) code 541611, Administrative Management and General Management Consulting Services $15.0.

Purpose and Objectives
The purpose of this requirement is to provide to NIH an organization that is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) to perform approximately 20-30 protocols per year. Current protocols will be transferred to this new requirement.

All research protocols submitted to the PMI Cohort Program will go through review by a newly convened Institutional Review Board (IRB). The PMI Cohort Program IRB will serve as the IRB of record for all protocols received. This Statement of Work sets forth the management, administrative and regulatory support needed for the PMI IRB.

The closing date for receipt of all proposals is September 9, 2016 3pm EST.

Hard copies of this solicitation will not be available. Interested firms are responsible for downloading copies of the solicitation and amendments and monitoring FedBizOpps.gov for updated information concerning solicitation number NIHOD2016764J.

Business and Technical proposals must be received at the address identified in this synopsis no later than 3PM EST, September 9, 2016 3pm to the following address:

National Institutes of Health
OA/OLAO/RFP NIHOD2016764J
Attention: John Best (301) 402-3063
BestJ@OD.NIH.GOV
6011 Executive Blvd., Room 541C (MSC 7663)
Rockville, MD 20852

Responses via facsimile (FAX) or email WILL NOT BE ACCEPTED.