SOURCES SOUGHT
R -- Agricultural Health Study Phase V
- Notice Date
- 11/16/2017
- Notice Type
- Sources Sought
- 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
- HHS-NIH-NCI-SBSS-ETSB-71026-72
- Archive Date
- 11/28/2017
- Point of Contact
- Jame Chang, Phone: 240-276-5424, Rosa M. Lopez, Phone: 2402765426
- E-Mail Address
-
jame.chang@nih.gov, rosa.lopez@nih.gov
(jame.chang@nih.gov, rosa.lopez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Type of Notice: This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small business; HUBZone small businesses; service-disabled, veteran-owned small businesses, 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a NAICS code of 541990 and the small business size standard for such requirements is $15 Million per annum. The Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. THERE IS NO SOLICITATION AVAILABLE. THIS IS STRICTLY FOR MARKET RESEARCH. Background: The Agricultural Health Study (AHS) cohort consists of approximately 52,000 private pesticide applicators (primarily farmers) and 32,000 spouses of private applicators from Iowa and North Carolina, as well as approximately 5,000 commercial pesticide applicators from Iowa. The pesticide applicators were recruited between 1993-1997 (during Phase I of the AHS) when they obtained or renewed their license to apply restricted use pesticides; spouses were recruited largely by questionnaires brought home by the pesticide applicator (81%). In addition to the extensive information on lifetime use of pesticides, demographic and other lifestyle factors were collected from all participants at enrollment using self-administered questionnaires (during Phase I of the AHS). Two follow-up telephone interviews have been conducted since enrollment. The first follow-up interview was conducted from 1999 to 2003 (during Phase II of AHS), and the second follow-up interview was conducted from 2005-2009 (during Phase III of the AHS). The most recent survey (Phase IV) was completed in 2013-2015 under the direction of the National Institute of Environmental Health Sciences (NIEHS), including a multi-modal health follow-up questionnaire by self-administered mailed forms, phone interviews, and a small web-based pilot study. Cancer incidence has been ascertained by annual linkage to the cancer registries in each state and mortality through linkage to the National Death Index since the inception of the study field work in 1993. The AHS began field work for Phase I of the study with three contracts in 1993. One contract was for a coordinating center (awarded to SRA Technology) which was primarily responsible for overall coordination of the study, developing questionnaires, and providing a secure computer system to store the vast amount of questionnaire and other data coming from the field stations in Iowa and North Carolina. The other two contracts were for a field station in Iowa (awarded to University of Iowa) and a second field station in North Carolina (awarded to Battelle Memorial Institute). Field Stations were primarily responsible for managing the distribution and retrieval of self-administered questionnaires to eligible study subjects. The coordinating center contract was awarded, via a full and open competition, to SRA Technologies for Phase II of the study and to Westat Inc. for Phase III of the study; Westat assumed the coordinating center contract during Phase II when SRA Technologies went out of business. The field station contracts were awarded again, via a full and open competition, to the University of Iowa in Iowa and Battelle Memorial Institute in North Carolina for Phases II and III of the study. In the Phase IV contract, Westat was responsible for overall coordination and day-to-day management of the study, maintaining and updating a secure database containing all study and administrative records, conducting linkages to the state cancer registries, mortality files, and IRS address databases. Westat was also the coordinating center for sub and add-on studies, including the Biomarkers of Exposure and Effect in Agriculture Study (BEEA). Purpose and Objectives: In the Phase V contract, the Contractor will serve as the coordinating center for all Agricultural Health Study (AHS) activities. They will be responsible for handling the daily operations of the study, scheduling regular and ad hoc meetings, maintaining secure data records, conducting data linkages to state cancer registries, mortality files, and other sources as needed, as well as updating cohort member contact information. They will conduct communication activities to the cohort participants and stakeholders, maintain and update the study's website, and develop the layout of an annual newsletter. They will also facilitate preparation of compliance documents and manage the study's financial budgets. Project Requirements: Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to support this study. The Contractor shall perform some or all the following support activities, as may be specified by the NCI COR, in support of the study. The scientific design of studies, supervision of ongoing data collection, data analysis and publication-related activities are the responsibility of NIH/NCI scientific staff. Tasks include: 1. Update and maintain the personally identifying information (e.g., name, address, e-mail, phone number, social security number, geographical location) for the 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. 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. 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 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) as frequently as every 36 months 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 datasets. 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. 7. Provide computer 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 add-on studies. The Contractor shall ensure that all computer databases are in full compliance with the National Institutes of Health's computer security policy. 8. 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 document their projects' progress, as well as their final manuscript and associated data set. Also, the AHS Executive Committee will use this database as a tracking system of proposed, ongoing and completed projects. 9. Update and maintain a database of biological samples for the AHS. This database shall document the collection of new samples and use of stored samples for projects. This database shall ensure that the quantity and quality of samples from each AHS participant is known. This database shall provide a link to merge all current biological sample inventory data with all laboratory data on stored AHS samples (e.g. quantity, quality, freezer location of samples), in accordance with the currently used Biological Specimen Inventory (BSI) System. 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. 10. 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. 11. Develop a database that tracks contact and participation in main study activities over time as well as in approved sub-studies/add-on 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). 12. Develop crosswalk of participants enrolled and biological samples collected during the main AHS study and each sub-study. 13. Perform data cleaning as necessary to update the main datasets. The Contractor shall update and maintain documentation of changes made to databases, and will inform the COR and AHS Executive Committee of changes. 14. Create data sets for AHS Executive Committee approved projects (approximately 2 per month). 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. 15. Develop a standard pricing matrix for data set preparation and delivery for non-AHS investigators. The Contractor shall track and manage the costs and payments for the preparation and delivery of data sets to non-AHS investigators. 16. 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 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. 17. 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. 18. Assist and facilitate the preparation of regulatory compliance documents for the entire cohort and approved add-on studies performed by non-AHS investigators. 19. 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 add-on studies (approximately 12 per year). 20. 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 datasets. 21. 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. 22. 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 add-on studies, and providing a toll-free number for AHS participants to contact study investigators through the Contractor. 23. 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. 24. Schedule, coordinate, and organize all arrangements for meetings of the AHS National Advisory Group. These meetings shall be held via in-person once every 5 years. The Contractor shall prepare all meeting materials, secure a location to hold the meeting, arrange for travel and honoria for up to 12 presenters/speakers from across the United States. These meetings include approximately 40 people and are 1.5 days long and often include a half day pre-meeting. 25. 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. 26. 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, with additional meetings if needed. Coordinate as needed, ad hoc working group meetings, e.g., on exposure assessment. 27. Coordinate and manage various administrative activities of the AHS not otherwise specified above. 28. Provide support for various tasks not otherwise specified (e.g. develop written summaries of published AHS findings). 29. 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, specimens, and documentation are prepared and packaged for delivery to the government or successful 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. 30. Update and maintain a database of all Biomarkers of Exposure and Effect in Agriculture Study (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 specimens and assist with specimen selection as requested, clean data and update the BEEA dataset, document changes to the BEEA datasets, 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. 31. Obtain discarded formalin fixed paraffin embedded prostatectomy blocks from the University of Iowa Residual Tumor Repository from participants in Iowa. Tasks include documenting and assessing 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. 32. Obtain tumor tissue samples from participants in North Carolina. Tasks include documenting and assessing 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. Anticipated Period of Performance: The anticipated period of performance for this requirement is a one-year base period and four 12-month options. Capability Statement/Information Sought: We encourage small businesses to submit a capability statement which will be considered by the agency. Small businesses possessing experience and demonstrated capability to accomplish the requirements and level of effort are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information furnished must not exceed 5 pages (12-point font minimum), including all attachments, résumés, and charts; and should include an outline of previous or similar projects performed. All responses must include an indication of current certified small business status, clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and DUNS number. Information Submission Instructions: All capability statements sent in response to this Small Businesses Sources Sought notice must be sent electronically (via email) to Jame Chang, Contracting Officer at jame.chang@nih.gov and Rosa Lopez, Contracting Officer at rosa.lopez@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by November 27, 10:00 AM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to this Sources Sought notice. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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