ENRICHED_Modified_Pre-Sol_FINAL_5_5_23_2.pdf

Rhode Island Children’s Health Equity and Development Study “ENRICHED” Solicitation Number: 75N94023R00009 Agency: Department of Health and Human Services Office: National Institutes of Health Location: National Institute of Child Health and Human Development

Notice Type: Posted Date:

Presolicitation May 5, 2023

Response Date: Archiving Policy:

May 22, 2023 Automatic, 15 days after response date

Archive Date: Original Set Aside:

May 22, 2023 N/A

Classification Code:

A – Research & Development

NAICS Code:

541- Professional, Scientific and Technical Service/541715 – Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

MODIFICATION to Pre-Sol Announcement dated March 31, 2023

In addition to the assessments at the 6- and 12-months postpartum, and the additional recruitment requested in the Pre-Solicitation announcement issued by NICHD on March 31, NICHD intends to add long term longitudinal follow-up studies into its proposed noncompetitive contract with Brown University on a sole source basis. The changes to the announcement are included below in bold.

The Social and Behavioral Sciences Branch in the Division of Population Health Research of the Division of Intramural Research at the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), intends to negotiate a new contract entitled “Rhode Island Children’s Health Equity and Development Study” (ENRICHED), on a sole source basis with Brown University under the authority of FAR 6 302-1 (a)(2) (ii), 41 U.S.C 3304(a)(1), and HHSAR 306.302-1.

The proposed initiative is to collect data on 282 participants already recruited to the ENRICHED study and to recruit participants necessary to meet the next phases’ diverse sample requirements. The aims are 1) to investigate socioeconomic and racial/ethnic disparities in parental psychopathology and maternal neuroendocrine, immune, and metabolic responses; and 2) to investigate factors that contribute to socioeconomic and racial/ethnic disparities in children’s health and development from birth through the first year of life. Women and their co-parents are recruited early in their pregnancy and complete assessments during the prenatal period. Subsequent postnatal assessments are scheduled, as well as family follow-ups at 6- and 12-months postpartum. Brown University (Brown) in affiliation with Women and Infants Hospital, Providence RI (WIH) served as the clinical site via subcontracts with NICHD’s primary contractor to complete the collection of Cohort 1 as part of the first phase of the study. The primary contractor has voluntarily elected not to continue its management of the subsequent phases of the study. Since Brown and WIH furnished the qualified personnel, materials, equipment, and services to implement, maintain, coordinate, and manage recruitment and assessment of the participants from early pregnancy through 12 months postpartum, the Government must contract with Brown serving as the prime contractor, and WIH serving as the subcontractor in order to follow-up the existing cohort. Among those already recruited to the study, the majority have completed assessments in their first and second trimester but have not yet completed their third trimester assessments or provided a biospecimen at delivery, and none have completed the postpartum follow-ups. A contract with Brown/WIH is needed to collect the additional assessments on the recruited participants. As this cohort was recruited and consented by Brown/WIH, it is policy that data collection on participants recruited at WIH can only be conducted by staff employed by Brown University or WIH.

Additional recruitment in Rhode Island is needed to meet the requisite number of participants from this study site with sufficient racial/ethnic diversity to meet the study’s specific aims. The targeted racial and ethnic composition of the sample is 33% Hispanic, 33% African American, and 33% White or other race/ethnicity. African Americans make up approximately 10% of those currently enrolled, and thus will need to be over-sampled amongst newly recruited participants. Targeted recruitment will be implemented at participating clinics serving African American women in the next phase of the study.

Because this effort is part of a larger research project, it is imperative that there is sufficient representation from each race/ethnicity recruited from each geographic region. To have substantial imbalance in the race/ethnic composition in samples obtained at individual sites creates analytic issues and makes findings regarding race and ethnicity difficult to interpret, even if the sample as a whole is sufficiently diverse. Without within-site sample diversity, it would be unclear if differences found are attributable to race/ethnicity or to place. Thus, additional recruitment over-sampling African American women is necessary to meet the study aims.

In addition, long-term longitudinal follow-up studies would be conducted. These long-term longitudinal follow-up studies are important to understand the effects of inequalities at the individual, family, and neighborhood levels beginning during fetal development and across the lifespan. The in-depth data obtained on this cohort from early pregnancy through the first year of life would provide a unique opportunity to examine later consequences of early disparities, such as effects on early childhood development and school readiness. A study of early child development would be conducted following these families up to their infants being three years of age and would target neurodevelopmental milestones as well as continuing to examine parental mental health, and the social and environmental factors targeted in the first two phases of the study. The study would involve multiple assessments utilizing methods demonstrated as feasible in this cohort in the first two phases, including telephone interviews, online self-assessments, home visits, and collection of biospecimens (e.g., infant hair samples). A second follow-on study would also be done examining school readiness, assessing the study children up to five years of age. This will provide for children to be assessed regarding their social, cognitive, physical, and emotional readiness for the pre-K and kindergarten environments and utilize assessment modes similar to those used in the previous phase.

Extensive resources have been used to create an infrastructure to support this study, including training staff on recruitment, enrollment, and assessment procedures, and implementation of the assessment schedule, electronic data collection systems, and biospecimen collections. Both located in downtown Providence, RI, Brown University and WIH have a long history of partnering on research. Study staff from Brown University have dual appointments with WIH and can access WIH patients as part of research protocols. The WIH IRB is not likely to allow access to their patient population without the participation of WIH faculty in the research. This study has an established collaboration between Brown and WIH faculty. Thus, this effort can only be provided by Brown University because of their relationship with WIH, existing study infrastructure, access to participants, and data required to perform the proposed work. Almost all the work previously conducted would need to be duplicated if the follow-up assessments were to be conducted elsewhere and would result in unacceptable delays and increase the costs to the government. Timeliness of the resumption of data collection is of particular importance, as missing data is created by any delay.

This is not a Request for Proposals (RFP). However, if any responsible source believes it can perform the above requirement, it may submit a capability statement electronically for consideration by the NICHD to Gannon White, Contract Specialist, at Gannon.White@nih.gov and Elizabeth Osinski, Contracting Officer at eo43m@nih.gov. Information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work, including ability to access currently enrolled participants at WIH; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information should be provided if you submit a capability statement. Your capability statement should be no more than 15 pages in length, excluding resumes. All responses must be received by email no later than May 22, 2023, 4:00 pm Eastern Standard Time, and must contain material in sufficient detail to allow the NICHD to determine if the organization can perform this requirement. Emails must reference the announcement number in the subject line. The capability statement will be considered solely for the purposes of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. This is not an RFP, and this announcement does not commit the Government to a contract.

The reference number to be used is 75N94023R00009.

Contracting Office Address:

Contracts Management Branch 6710B Rockledge Dr., Suite 1124, MSC7000 Bethesda, Maryland 20892-7510 United States

Place of Performance:

Brown University 121 South Main Street Providence RI 09203

Primary Point of Contact:

Gannon White Contract Specialist gannon.white@nih.gov Phone: 301-402-9178

Secondary Point of Contact:

Elizabeth Osinski Contracting Officer Eo43m@nih.gov mailto:Eo43m@nih.gov

Phone: 1-240-550-5028