Coordinating Center for Continuation of Follow‐Up of DES‐exposed Cohorts

I.  Background

The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) research focuses on discovering genetic and environmental determinants of cancer and identifying new approaches to cancer prevention. DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies. The Division develops research resources and strategic partnerships in cancer epidemiology and genetics across NCI, NIH, and the global research community.

II. Purpose and Objectives

The purpose of the Diethylstilbestrol (DES) Exposed Cohorts Follow-up Study, as required by congressional mandate under the DES Research and Education Amendments of 1992, is to continue to monitor individuals participating in studies of DES for cancer risk, non-reproductive conditions, and mortality; to coordinate and support collection of blood samples from the cohort members; and to continue to survey the reproductive experience of granddaughters and possibly grandsons.

III.  Tasks

The contractor shall supply all labor, materials, facilities, equipment, and supplies to perform the following tasks:

• Monitor the cancer incidence among the DES exposed daughters, sons, granddaughters and grandsons, with focus on cancers of the breast, uterus, ovary, prostate, pancreas, and colon and rectum.
• Monitor the mortality of mothers, daughters and sons.
• Coordinate the collection of blood samples from cohort members performed by the sites.
• Continue to evaluate differences in reproductive experience among the granddaughters.
• Support and assist with sub-studies as appropriate.

1) Liaison Tasks

a) The contractor shall establish contact with field centers to obtain personal identifiers from sites and establish contact and coordinate activities with NCI’s biorepository and NCI’s computer programming support services contractor.

b) The contractor shall assist in arranging communications and meetings between the NCI Contracting Officer Representative (COR) and field center staff and report on such meetings.

c) The contractor shall respond to queries from NCI COR and meet with NCI COR at least quarterly.

2) Development of Study Materials and Manuals

a) The contractor shall establish and update procedure manuals for the study and work with field centers and NCI COR to establish standardized procedures for sub-studies.

b) The contractor shall assist field centers in developing a newsletter to be sent to cohort members.

c) The contractor shall maintain and update the study web site.

3) Data Preparation and Processing

a) The contractor shall coordinate and conduct National Death Index searches to determine vital status and coordinate and conduct state cancer registry searches to ascertain cancer status.

b) The contractor shall coordinate the study sites’ effort to collect blood from participants.

c) The contractor shall edit and transmit computer files as needed, maintain a master study file, and assist study centers in ad hoc investigations that arise from the standard data collection.

4) Monitoring, Information Management, Reporting and Documentation 

a) The contractor shall utilize a computerized information system to monitor the progress of data collection and address problems arising during data collection phases.

b) The contractor shall create reports to monitor the overall progress of the study and maintain orderly files documenting study steps and decisions made pertaining to study design, conduct, and analysis.

5) Coordination of Data Collection

The contractor shall coordinate with NCI’s research laboratory and study sites to arrange data collection. Data collection will be accomplished through phlebotomy and questionnaires. The contractor will coordinate with the individual field centers in their performance of tasks, pool and analyze data, and disseminate the data.

6) Phase In and Phase Out Periods

The selected contractor shall be given a Phase-In period of ninety (90) days to put into place the appropriate oversights and tasks and a Phase-Out period of ninety (90) days for transitioning the work to a successor contractor prior to the end of this contract.

IV.  Additional Information
 

This potential acquisition will be competed through Full and Open Competition procedures.  It is anticipated that a single award will be made and the resultant contract award will be cost reimbursement with a level of effort component (hours) with a twelve-month (12) base period and four (4), twelve-month (12) option periods.
 

The RFP will be available electronically on or around November 23, 2020 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS’ RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. 

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.
 

V.  Contracting Office

Primary Point of Contact:

Nikki Arena
Contracting Officer
nikki.arena@nih.gov

Secondary Point of Contact:
Rukshani Levy
Contracting Officer
rukshani.levy@nih.gov