SOLICITATION NOTICE
R -- Agricultural Health Study Phase V
- Notice Date
- 1/31/2018
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP71026-72
- Archive Date
- 2/16/2018
- Point of Contact
- Charles P. Park, Phone: 240-276-5896, Jame Chang, Phone: 240-276-5424
- E-Mail Address
-
charles.park@nih.gov, jame.chang@nih.gov
(charles.park@nih.gov, jame.chang@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. The Occupational and Environmental Epidemiology Branch (OEEB), Division of Cancer Epidemiology and Genetics (DCEG), of the National Cancer Institute (NCI) is competing a contract which shall provide support services for the fifth phase of the Agricultural Health Study. In the Phase V contract, the Contractor shall serve as the coordinating center for all study activities of cohort maintenance and follow-up. They will be responsible for handling the daily operations of the study, scheduling regular and ad hoc meetings, maintaining secure data records, and updating cohort member contact information. The Contractor shall conduct data linkages to state cancer registries, mortality files, other types of records as needed (e.g. Medicare, United States Renal Data System, Internal Revenue Service, Drivers' Licenses, LexisNexis). The Contractor shall conduct communication activities to the cohort and stakeholders, maintain and update the study's website, and develop the layout of an annual newsletter. They shall also facilitate preparation of compliance documents and manage the study's financial budgets. It is anticipated that the Contractor shall be required to: Main Study Study Management 1. Update and maintain an electronic list of AHS stakeholders and their contact information. The Contractor shall provide a monthly electronic update of recent publications from the AHS to the stakeholders. 2. Provide support and facilitate the preparation of regulatory compliance documents for the entire cohort and approved ancillary studies. 3. Work with the COR to complete and submit all necessary reports and forms to the pertinent Institutional Review Boards (IRBs) for the entire cohort and approved ancillary studies (approximately 12 per year). 4. Assist in the preparation of materials to respond to Freedom of Information Act requests as necessary. This shall include removing personally identifiable information from requested materials and data sets. 5. Develop new communication strategies to keep the AHS cohort, state and local stakeholders, and other interested parties informed about the activities of the study. These activities would be in addition to the annual study update, and could include mailings and e-mails should this become available in the future. 6. Facilitate contact with the cohort, taking advantage of multiple potential contact approaches. Such contacts may include mailing information to participants about the study, collecting and updating e-mail addresses, cell phone numbers, and other address changes, determining participant willingness/ability to receive text messages about the study, updating farming status, contacting participants about approved ancillary studies, and providing a toll-free number for AHS participants to contact study investigators through the Contractor. 7. Work with the AHS Executive Committee to create an annual Study Update (i.e., newsletter). The newsletter shall translate current findings from the AHS into an attractive lay language publication of about 2 pages. The format shall comply with all federal regulations concerning accessibility for persons with disabilities. A current list of addresses for every household shall be provided to the government printing office for distribution. The newsletter shall also be posted on the AHS website. 8. Update and maintain the AHS website on a monthly basis. The website shall be a user-friendly source of information about the study for the general public and a useful resource for the scientific community. Information shall include: a description of the study and sub-studies, copies of study updates and other lay documents, demographic summaries of the AHS cohort, an up-to-date reference list of publications, links to relevant websites, instructions on how to propose collaborative studies with the AHS, contact information of AHS Executive Committee and other federal investigators, and other information about the AHS deemed of interest as provided by the COR. Study Coordination 1. Schedule, coordinate, and organize all arrangements for meetings of the AHS National Advisory Group. These meetings shall be held in-person once every 5 years (anticipated February 2023). The Contractor shall prepare all meeting materials, secure a location to hold the meeting, arrange for travel and honorarium for up to 12 presenters/speakers from across the United States. These meetings include approximately 40 people and are 1.5 days long and shall include a half day pre-meeting. 2. Schedule, coordinate and organize all arrangements for a workshop. The Contractor shall prepare and distribute meeting materials, secure a location to hold the meeting, arrange for travel and honorarium for up to 10 outside experts from across the United States. In addition to the invited experts, attendance will include AHS executive committee members and other federal investigators, up to 30 people in total. 3. Arrange, schedule and hold meetings with the COR, AHS Executive Committee and other AHS investigators. This may include in-person meetings at the Contractor facility, NCI or NIEHS, as well as teleconference and video/web conferences. There shall be approximately 2 regular meetings per month and approximately 4 ad hoc working group meetings per year). 4. Coordinate and manage various administrative activities of the AHS not otherwise specified above. 5. Provide support for various tasks not otherwise specified (e.g. develop written summaries of published AHS findings). Data Linkages & Cohort Maintenance 1. Update and maintain the personally identifying information (e.g., name, address, e-mail, phone number, social security number, geographical location) for the Agricultural Health Study (AHS) cohort using relevant sources of information. This may include tracing individuals whose contact information has changed or identifying next of kin. Identifying information shall be stored in a secure electronic database independent of other participant data to protect participant confidentiality. 2. Obtain data (e.g., cancer incidence, vital status, restricted use pesticide registration) from state cancer registries, vital statistics registries, and other important sources of data every 24 months (anticipated in years 1, 3, 5). The Contractor shall prepare and submit all necessary reports, forms and applications to appropriate state agencies to acquire these data and link them to the AHS cohort within 30 days of availability, verify the accuracy of these linked data and resolve all discrepancies. 3. Obtain mortality data from the National Death Index for participants not known to be alive and not found in the state mortality registries every 24 months (anticipated in years 1, 3, 5). The Contractor shall prepare and submit all necessary reports, forms and applications to appropriate federal offices to acquire these data and link to the AHS cohort within 30 days of availability each year, verify the accuracy of these linked data and resolve all discrepancies. 4. Obtain available data from the Internal Revenue Service every 24 months (anticipated in years 1, 3, 5) to obtain marital status data and state of residence. The Contractor shall prepare and submit all necessary reports, forms and applications to appropriate federal offices to acquire these data and link to the AHS cohort within 30 days of availability each year, verify the accuracy of these linked data and resolve all discrepancies. 5. Obtain Medicare Utilization data from the Centers for Medicare & Medicaid Services (CMS) once during the contract (anticipated in year 4) for the cohort participants who are Medicare eligible. The Contractor shall prepare and submit all necessary reports, forms and applications to the appropriate federal offices to acquire these data and perform internal controls assuring the quality of the linkage and resulting data sets. Currently, approximately 46,000 members of the cohort are Medicare eligible and this number will increase as the cohort ages. 6. Obtain data from the United States Renal Data System to identify cases of end stage renal disease. This will be done once during the period of the contract (anticipated in year 4). Data Management 1. Provide personnel and computer hardware and software to securely update and maintain comprehensive computer databases of all questionnaire and laboratory data generated from the AHS, by the federal investigators as well as outside investigators as part of ancillary studies. The Contractor shall ensure that all computer databases are in full compliance with the National Institutes of Health's computer security policy. 2. Update and maintain a web-based database of projects conducted on the AHS cohort. The Contractor shall ensure that this system will allow investigators to submit project proposals, document their projects' progress, as well as their final manuscript and associated materials. Also, the AHS Executive Committee will use this database as a tracking system of proposed, ongoing and completed projects. 3. Update and maintain a database documenting the collection of new samples and the use of stored samples for approved projects. This database shall ensure that the quantity, quality and inventory information for all samples is documented and updated for every AHS participant in accordance with the currently used Biological Specimen Inventory (BSI) System. This database shall provide a link between biological sample data and other AHS information such as questionnaire, outcome, and sub-study data. This database shall be available to all AHS Executive Committee members and others with approved access by the COR for the purposes of querying inventory. 4. Develop and maintain a searchable database that tracks published findings on pesticides from the AHS. The database should include dates of publication, links to manuscripts, and main findings between individual pesticides and cancer and non-cancer outcomes. 5. Track contact and participation in main study activities over time as well as in approved sub-studies/ancillary studies. The Contractor shall update and maintain this database, documenting all contact with AHS participants to ensure that participants are not contacted for multiple studies at one time and that contact is in compliance with AHS policies (see guidelines: http://aghealth.nci.nih.gov/guidelines.html). 6. Develop a crosswalk of participants enrolled and biological samples collected during the main AHS study and each sub-study. 7. Perform data cleaning as necessary to update the main data sets. The Contractor shall update and maintain documentation of changes made to databases, and will inform the COR and AHS Executive Committee of changes. 8. Create data sets for AHS Executive Committee approved projects (approximately 2 per month) for main and ancillary studies. Data sets shall be created within 30 days of a request. The Contractor shall collect, inventory, and maintain an archive of the final data sets used for every project produced from the AHS. Final Transition Nine months prior to the completion of this contract, provide the AHS Executive Committee and CORs with a transition plan to ensure that all data, samples, and documentation are prepared and packaged for delivery to the Government or successor Contractor. These activities shall include a complete inventory of all records and materials accumulated by the Contractor. At the completion of the contract, the Contractor shall deliver all materials to the NCI or to an agent of the NCI. Biomarkers of Exposure and Effect in Agriculture Study (BEEA) Update and maintain a database of all BEEA participants, and questionnaire and biological sample data that is separate from the main AHS database. This database shall document the use of stored samples for projects and the quantity and quality of samples. Also, this database shall provide a link to merge all current biological sample inventory data (e.g. quantity, quality, freezer location of samples) with all laboratory data on stored BEEA samples, in accordance with the currently used BSI System, and with questionnaire data. The Contractor shall provide reports on available samples and assist with sample selection as requested. The Contractor shall clean, update and document changes to the BEEA data set, and maintain an archive of interview and other data. The Contractor shall also schedule and organize regular meetings related to database management and sample tracking with the Principal Investigator. Specimen Processing, Processing and Shipping Obtain discarded formalin fixed paraffin embedded prostatectomy blocks from the University of Iowa Residual Tumor Repository from participants in Iowa. Document and assess the feasibility of obtaining samples, obtaining pathology reports, preparing and shipping samples to designated location, coding samples for linkage to the AHS cohort and laboratory storage and use. Obtain tumor tissue samples from participants in North Carolina. Document and assess the feasibility of obtaining samples, obtaining pathology reports, preparing and shipping samples to designated location, coding samples for linkage to the AHS cohort and laboratory storage and use. The NCI seeks a continuation of services to be acquired through full and open competitive procedures under RFP N02CP71026-72. It is anticipated that a cost-reimbursement, level of effort type contract with a base period of 12 months; four (4) option periods of one (1) year each; options for increased quantities, and an option to extend services of 6 months may be awarded beginning on or about September 23, 2018. The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL THAT 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. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE-MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.
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- Record
- SN04805488-W 20180202/180131231254-f8f1f8e0f633bfbd00c903fb65facb14 (fbodaily.com)
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