Notice Number: NOT-PM-16-002

Key Dates
Release Date: December 9, 2015
Response Date: January 15, 2016

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Request for Information (RFI) is to solicit input on identifying or establishing a system(s) for conducting a physical evaluation and collecting biospecimens from Direct Volunteers for the Precision Medicine Initiative (PMI) Cohort Program.

Background Information
On November 17, 2015, NIH released the first set of funding opportunity announcements for the PMI Cohort Program: https://www.nih.gov/precision-medicine-initiative-cohort-program/funding-opportunities.

Initially, a pilot program will enroll a limited number of Direct Volunteers to determine the most effective strategies for engaging participants and maintaining that engagement over time (see OT-PM-16-001). Subsequently, in summer 2016, the NIH anticipates awarding cooperative agreements for the full implementation phase that is intended to recruit 300,000 or more Direct Volunteers through a PMI Cohort Program Coordinating Center (see RFA-PM-16-001). The Coordinating Center (alone or with subcontractors) is expected to implement the Direct Volunteer component of the program, scheduling, tracking, and funding the physical evaluation and biospecimen acquisition. The Coordinating Center will also work closely with the PMI Cohort Program Biobank for long-term archiving of biosamples (see RFA-PM-16-004). It is anticipated that the baseline physical evaluation for Direct Volunteers will include measuring vital signs, height and weight and potentially simple physical measurements such as waist and hip circumference. It is anticipated that the biospecimen collection will include blood and urine, and the blood specimens will require prompt separation into plasma and serum and appropriate temperature controlled storage until and during shipment. Biospecimen collection kits, to be provided by the PMI Cohort Program Biobank, will contain EDTA, plasma separator, serum separator, and ACD tubes, as well as a urine collection cup. The collected biospecimens will need to be shipped to the PMI Cohort Program Biobank where they will undergo further processing and storage.

Information Requested
The NIH seeks information regarding strategies that would allow for baseline physical evaluation and biospecimen acquisition from a large cohort of Direct Volunteers, potentially 300,000 or more, who will be located throughout the United States.

The NIH seeks comment on any or all of the following topics:

• Strategies for creating an infrastructure to cost effectively administer a brief, standardized baseline physical evaluation and collect blood and urine biospecimens from Direct Volunteers located anywhere in the United States. Approaches to ensure diversity and participation of all volunteers and their convenience.
• Strategies for distributing standardized biospecimen collection kits to healthcare workers performing the baseline health examinations or to Direct Volunteers.
• Strategies for meeting pre-analytic requirements of Clinical Laboratory Improvement Amendments (CLIA) and assuring biospecimen quality and integrity after collection, including consideration of processing site(s), with strategies and justification for distributed versus centralized biospecimen processing, followed by shipment to the PMI Cohort Program Biobank.
• Information on issues of protocol standardization, and quality control of specimen handling and chain of custody.
• Cost estimates for providing these services.

Responses
All responses must be submitted online via the following website: https://grants.nih.gov/grants/rfi/rfi.cfm?ID=53 by January 15, 2016. Response to this RFI is voluntary. Responders are free to address any or all of the items listed above; respondents should not feel compelled to address all items. Please note that the text box for each topic has a maximum limit of 250 words.

This RFI is for planning purposes only and should not be construed as a solicitation for applications or as an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the United States Government will not pay for the preparation of any information submitted or for its use of that information.

Responses will be compiled and may be shared publically. We look forward to your input and hope that you will share this RFI document with your colleagues. Updates to this document, if any, will be noted. Please check before submission.

Inquiries

Please direct all inquiries to the PMI Cohort Program Team via email to precisionmedicine@nih.gov.