Request for Information - Development of WTC Health Program Youth Research Cohort

**UPDATE (8/11/2023): The due date for response submissions to this RFI has been extended for an additional eight (8) weeks, to now October 31, 2023 at 3:00pm EST. The page limit for responses has also been extended to now twenty-five (25) pages. An amended RFI document reflecting these updates has been included in the attachments. No other changes or additions were made to the RFI. Please continue to direct any outstanding or immediate questions to Liz Cole-Greenblatt at QST7@cdc.gov. **UPDATE (7/31/2023): A copy of the Round II questions submitted by interested participating parties and all CDC answers has been posted to the Attachments/Links section of this notice. Please see the Excel Sheet titled "RFI 75D301-23-R-72680 Round II Questions and Answers" below, as well as the corresponding document "Appendix G _ Power Calculations...," which is referenced in CDC's answer to question #3. Formal Responses for this RFI continue to be due on Tuesday, September 5, 2023, at 12:00pm EST. (All vendors, whether they submitted questions or not are welcome to participate). Please submit responses via email to Liz Cole-Greenblatt at QST7@cdc.gov. **UPDATE (7/14/2023): A copy of the Round I questions submitted by interested participating parties and all CDC responses has been posted to the Attachments/Links section of this notice; please see the Excel Sheet titled "RFI 75D301-23-R-72680 Round I Questions and Answers" below. Round II of Q&A for any remaining questions or requests for clarifications regarding the RFI continues to be due on Friday, July 28, 2023, at 12:00pm EST. (All vendors, whether they submitted questions in Round I of Q&A or not, are welcome to participate in Round II). Please continue to use the Questions & Answer Template also provided below in Attachments/Links and submit via email to Liz Cole-Greenblatt at QST7@cdc.gov. This is a Request for Information (RFI). It is not a solicitation for proposals, proposal abstracts, or quotations. Release of this information should not be construed as a commitment to procure items discussed or to incur costs for which reimbursement would be required or sought. As permitted by Federal Acquisition Regulation (FAR) Part 10, this is a market research tool being utilized for informational and planning purposes only. Responses will assist the Government in the overall development of its acquisition strategy, definition of any future requirements, and assessment of available, relevant capabilities, methods, processes, and practices in the marketplace. I. PURPOSE The World Trade Center (WTC) Health Program requests information on methods for establishing a research cohort of sufficient size to conduct future studies on the health and educational impacts of 9/11 exposures on persons aged 21 years or younger at the time of exposure to the terrorist attacks and aftermath, including such individuals who are screening-eligible WTC survivors or certified-eligible WTC survivors. The cohort and its members are hereafter referred to as the - Youth Cohort and - WTC Youth, respectively. The Youth Cohort must: Be of sufficient size to conduct future research studies on the health and educational impacts of 9/11 exposures; Include sufficient representation of individuals who were 21 years of age or younger at the time of exposure; and Include individuals who are screening-eligible WTC survivors or certified-eligible WTC survivors. The cohort can also include individuals 21 or younger on September 11, 2001, who were located outside the New York City Disaster Area (NYCDA) and in Manhattan up to 14th Street; or anywhere within the borough of Brooklyn. Additionally, the cohort can include age-appropriate control populations as needed for research purposes II. BACKGROUND In Jan. of 2011, the President signed the James Zadroga 9/11 Health and Compensation Act (Zadroga Act) into law, with Title I amending the Public Health Service Act to establish the WTC Health Prgoram. The WTC Health Program is a limited federal health program administered by NIOSH, part of CDC, that provides no-cost medical monitoring and treatment for certified WTC-related health conditions to those directly affected by the 9/11 attacks in New York, the Pentagon, and Shanksville, PA. The Program also funds medical research into physical and mental health conditions related to 9/11 exposures. In Dec. of 2022, the Consolidated Appropriation Act, 2023, further amended the Public Health Service Act by directing NIOSH to establish a research cohort of sufficient size to conduct future research studies on the health and educational impacts of 9/11 exposures on persons aged 21 years or younger at the time of exposure, including such individuals who are screening-eligible WTC survivors or certified-eligible WTC survivors. - Survivors are considered to be those individuals in the dust or dust cloud in the NYCDA on September 11, 2001; or worked, lived, or attended school, childcare, or adult daycare in the NYCDA for certain timeframes on and or shortly after 9/11. III. SUPPLEMENTAL INFORMATION In 2020, the WTC Health Registry within the New York City (NYC) Dept. of Health and Mental Hygiene (DOHMH), in collaboration with the NYC Dept. of Education (DOE), published findings from a youth research cohort feasibility study that examined WTC Youth recruitment methods using public school directory information. The directory information contains key elements on children who were enrolled in NYC public schools K'12 that are needed for tracing. The concept included persons who were too young to be in school on 9/11 and were first enrolled through the 2006'2007 school year. These data may be available for future tracing; however, additional strategies will be necessary to recruit persons attending private schools or home schooled, and those not otherwise traceable using the directory information. These strategies may include media campaigns and interaction with community groups to encourage enrollment. Power calculations in support of the DOHMH feasibility study found that approximately 7,000 persons (equal exposed and unexposed groups) were needed to achieve 80% statistical power for a longitudinal study of coronary heart disease associated with dichotomous exposure, accounting for age stratification. This sample size is used in this RFI. This RFI assumes that the cohort will be restricted to persons who were 21 years of age or younger on September 11, 2001, and who fall within one of 3 categories of exposure: The - high exposed group, comprised of persons inside the NYCDA who are either screening-eligible WTC survivors or certified-eligible WTC survivors; The - low exposed group, comprising of persons outside the NYCDA and in Manhattan not further north than 14th Street; or Brooklyn; and An - unexposed group that comprise an appropriate control group for statistical comparisons. IV. INFORMATION REQUESTED This RFI requests comments and relevant, evidence-based information addressing the following areas: 1. Best-practices and preferred approaches for assembling a cohort of at least 7,000 individuals with sufficient representation of individuals who were 21 years of age or younger at the time of World Trade Center exposure. Strategies should be designed to achieve the following: An efficient cohort design that addresses the preferred characteristics for each of the 3 exposure groups listed. Identification of the best methods to utilize the DOE student directory data for assembly of the youth cohort. The DOE student directory data is a core source of information on children enrolled in NYC public schools K'12 at the time of 9/11. Recruitment strategies that are implemented without the use of the DOE student directory, such as methods necessary for persons enrolled in private schools, home schooled or not attending school (e.g., graduates less than age 21 years on 9/11). Identification of health conditions and potentially adverse educational impacts that are priorities for future WTC Youth research. Best practices required for data collection, storage, dissemination, and quality assurance. Best practices for the creation and delivery of clear, timely, accurate, detailed, and thorough progress reports 2. Methods to develop, coordinate, and manage outreach and education strategies and activities designed to identify and engage young adult survivors. Strategies should be designed to achieve the following: Establishment of a group of young adult survivors to advise and assist with the planning and implementation of outreach and education activities and initiatives required for cohort development. Identification of the best methods to communicate the positive reason(s) for young adult survivors to participate in the WTC Health Program's research component to help advance knowledge about 9/11-related environmental exposures. Identification of the most effective methods of ongoing communication. 3. Description of any relevant organizational experience and expertise. V. INSTRUCTIONS FOR SUBMISSION Questions Due There will be 2 rounds of open Q&A regarding this RFI. The first round of questions should be submitted by Friday, June 16, 2023, at 12:00pm EST. The second round of questions should be submitted by Friday, July 28, 2023, at 12:00pm EST. All questions for both rounds should be submitted in the Questions & Answer Template provided below (see attached Excel) via email to Liz Cole-Greenblatt at QST7@cdc.gov. Responses Due Responses to this RFI should be submitted in white paper format answering the 3 questions and sub-questions above. White papers should follow the flow of Section IV of this RFI and be limited to 15 pages in length. Further information regarding format and text can be found in full version of the RFI (attached below). Responses must be sent via email to Liz Cole-Greenblatt at QST7@cdc.gov by Tuesday, Oct. 31, 2023, at 3:00pm EST. Only emailed responses will be accepted. Late responses will not be accepted.