Inactive

The Centers for Disease Control and Prevention intends to award a Justification For Other Than Full and Open firm fixed price purchase order to Kaiser Foundation Research Institute. CDC, NCBDDD, Child... The Centers for Disease Control and Prevention intends to award a Justification For Other Than Full and Open firm fixed price purchase order to Kaiser Foundation Research Institute. CDC, NCBDDD, Child Health and Disability Branch (CBDD) has completed three phases of the Study to Explore Early Development (SEED), a case control study of young children aged 2-5 years with autism. CDC is now planning for the implementation of a follow-up study of the original participants. Kaiser Foundation Research Institute is the original entity that collected the SEED data in California during Phase 1 and 2. Therefore, they are the only entity that has access to individual contact and eligibility data for the participants from California. This information will be provided to CDC so that CDC can reach these individuals for the SEED follow-up studies. No other entity has access to individual contact and eligibility data for participants of SEED Phase 1 and 2 in California. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of 6.302-1 and 10 U.S.C. 2304(c)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals/quote. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within seven (7) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to contract specialist at tqv7@cdc.gov by COB 24, May, 2022. Statement of Work Procurement Request #: 65514 Title: Follow-up of SEED Participants in California Period of Performance: July 1, 2022 – November 30, 2023 SECTION 1 – BACKGROUND In 2016, an estimated 1 in 54 children 8 years of age living in 11 communities across the United States had autism spectrum disorder (ASD), a developmental disability that can cause significant social, communication, and behavior challenges. Total annual cost associated with ASD have been estimated between $11.5-$60.9 billion (2011 US dollars), yet major gaps in knowledge remain about risk factors for ASD, and associated challenges and needs for persons with ASD and their families. Additionally, while most research on ASD has focused on children, ASD is considered a lifelong condition – although an estimated 70,000 to 111,000 youth with ASD turn 18 years of age annually, little is known about the transition to adolescence and adulthood for persons with ASD. Despite the call to address transition and lifespan issues in the Autism CARES Acts of 2014 and 2019, only 2% of ASD funding from 2008-2018 was spent on lifespan issues. To address these gaps and assess risk factors for and characteristics of individuals with autism from childhood through early adulthood, CDC is implementing a longitudinal follow-up study of children, previously studied at ages 2-5 years during 2006-2020, through the Study to Explore Early Development, Phases 1, 2, and 3 (SEED 1-3). SEED was originally implemented in limited geographic areas within portions of eight states (California, Colorado, Georgia, Maryland, Pennsylvania, and North Carolina, during SEED 1 and 2; and in Colorado, Georgia, Maryland, Missouri, North Carolina, and Wisconsin, during SEED 3). Data for SEED Phases 1-3 were collected by the implementing sites in collaboration with CDC under a Certificate of Confidentiality in accordance with section 301(d) of the Public Health Service Act. As such SEED 1-3 participants were provided assurances that only those entities that originally collected their personal information would use this information to contact them for future studies. Kaiser Foundation Research Institute is the original entity that collaborated with CDC to collect the original SEED data on children 2-5 years of age during Phase 1 and 2. Therefore, they are the only entity that can provide the individual contact and eligibility data for CDC to follow up with participants in California. Through this funding, California will provide contact information to CDC so that CDC can follow-up with these individuals to conduct the follow-up surveys described above. SECTION 2 – PURPOSE The objective of this work is to support the inclusion of the California participants in the SEED follow-up surveys. Performance objectives include responsiveness to the proposed timelines in line with the reporting schedule outlined below. SECTION 3 – SCOPE OF WORK Kaiser Foundation Research Institute will provide contact data for SEED 1-2 participants from California to CDC. This will involve working with CDC to obtain an agreement from the Kaiser Foundation Research Institute’s IRB to rely on CDC’s IRB, and then organizing participant contact data to be sent to CDC. CDC will then use this information to invite participants from California to participate in the SEED follow-up study. CDC will enroll participants and complete the study. SECTION 4 – TASKS TO BE PERFORMED Kaiser Foundation Research Institute will provide contact data for SEED 1-2 participants in California to CDC. Specifications include the following: Review of IRB protocol – CDC is working with the funded SEED sites to develop a protocol for the SEED Follow-up Study. Establish an agreement in which the IRB for the Kaiser Foundation Research Institute agrees to rely on CDC’s IRB for study oversite. Prepare a data file with the data for contacting participants. Send data file with contact data to CDC through a Secure File Transfer Protocol (sFTP) SECTION 5 – GOVERNMENT FURNISHED MATERIALS CDC will provide the draft IRB protocol to be submitted to CDC’s IRB for the Kaiser Foundation Research Institute to review. Once the protocol is approved, CDC will provide the final version, and any subsequent amendments obtained. Additionally, CDC will provide a list and definition of key data elements to be provided for contacting participants, and the details for using their sFTP for file transfer. SECTION 6 – PERIOD OF PERFORMANCE July 1, 2022 – November 30, 2023 SECTION 7 – PLACE OF PERFORMANCE Kaiser Foundation Research Institute will provide all contact and eligibility data required for CDC to follow up with participants in California, as outlined in this contract All work will be performed in the contractor’s office. SECTION 8 – DELIVERABLES/REPORTING SCHEDULE (Note: List each deliverable, quantity or (in the case of reports) number of copies required, the date required, and who to deliver the item to. Reports, for example, are often delivered to both the COR and the CO. Add or delete rows in the table as needed. Delete this note before submitting the Statement of Work.) Items Description Delivery Date Review of draft IRB protocol Within 60 days of award Establish reliance relationship with CDC IRB This information will be sent to CDC via a SFTP site Within 60 days of award Provide data file with contact information for SEED 1-2 participants in California This information will be sent to CDC via a SFTP site Within 120 days of award SECTION 9 – TRAVEL No travel is required to complete this work. SECTION 10 – REFERENCE MATERIALS None. Special Considerations Electronic and Information Technology Accessibility (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. (b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-aboard.gov/sec508/standards.htm. (c) The Section 508 accessibility standards applicable to this contract are: 1194. 205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services? In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508. In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues. ? (d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense. (e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.