JA Brown University fully signed 6-28print.pdf

HHS Template and Instructions for a Justification for Other than Full and Open Competition

Completion Instructions: HHS has established a standard template for preparation of a Justification for Other than Full and Open Competition (JOFOC) for non-Federal Supply Schedule acquisitions exceeding the simplified acquisition threshold. Operating Divisions (OPDIVs) shall prepare the template in accordance with these completion instructions.

(NOTE: The Project Officer (PO) has responsibility for completing all of the information items included in the template, with any necessary assistance from the cognizant Contracting Officer (CO) and Contract Specialist (CS) -- especially for items 3.(b), 4., 6., 7., 8. and 10.

listed below.

The instructions for preparing a JOFOC are specified in “red” and should be deleted prior to processing the document for review and approval. Also, do not include the completion instructions in the completed document.

A completed JOFOC must contain all of the applicable bolded headings in the order specified. Place the required information directly next to, or under, the applicable heading. If a heading does not apply to a specific JOFOC, indicate “not applicable” (N/A) next to it.

Reference and attach any additional information necessary to support the JOFOC.

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Department of Health and Human Services (DHHS), National Institutes of Health (NIH)

b. Sponsoring organization.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Division of Intramural Research (DIR), Division of Population Health Research (DiPHR), Social and Behavioral Sciences Branch

(SBSB)

c. Project Officer information.

Project Officer name. Denise L. Haynie, PhD, MPH

Mailing address. 6710 Rockledge Dr.

Room 3139D MSC 7004 Bethesda MD 20817

E-mail address. Denise.Haynie@nih.gov

Telephone number. 301-435-6933

Nature and/or description of the action being approved.

Acquisition purpose and objectives.

The Social and Behavioral Sciences Branch (SBSB), an intramural research group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) conducts research on the social and behavioral determinants of health and health-related behaviors over the life course. An area of emphasis for the SBSB is understanding the developmental mechanisms underlying health disparities over the life course. To that end, investigators in the SBSB initiated The Rhode Island Children’s Health Equity and Development Study (”ENRICHED”). The aims of ENIRICHED 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. To address these aims, women and their co-parents (the infants’ fathers or other persons who will be sharing parenting responsibilities) will be recruited early in their pregnancy and complete in-depth assessments during the prenatal period. Subsequent postnatal assessments will be scheduled, including family follow-ups at 6- and 12-months postpartum. In addition, long-term longitudinal follow-up studies of subjects will also be conducted up to approximately five years of age, the aim of which will be to examine later consequences of early disparities, such as effects on early childhood development and school readiness opportunity to examine later consequences of early disparities, such as effects on early childhood development and school readiness assessing variables including but not limited to social, cognitive, physical, and emotional development and school readiness.

Proj ect background.

Name of Contractor: Research Triangle Institute (RTI);

Subcontractors: Brown University and Women and Infants Hospital Contract Number: HHSN275201800011I / Task Order umber:75N94019F00125

Period of Performance of Task Order: September , 201 – February 28, Total Dollar Amount Obligated to date: $2,593,519

Award: Full and open competition procedures were used for the award of the Population Health Centers Indefinite Delivery, Quantity (IDIQ) network of contractors; the task order for this study was competed within the multiple-award network of IDIQ contractors.

In the , a cohort of 282 women were enrolled at less than 13 gestational weeks ( , by 12 weeks plus 6 days, as determined by ultrasound dating of the pregnancy or by best clinical estimate if ultrasound dating was not available). The assessments completed capture participants’ experiences and health in early restrictions at the clinical site. These data have been useful to determine that it is feasible to recruit participants very early in pregnancy and conduct in-depth interviews remotely; as well as to have good retention rates in the absence of in-person contact. Having established the cohort, this acquisition will enable NICHD to obtain more detailed assessments of maternal health and social history, and familial risk and protective factors for fetal development. This information will be used to characterize differences during pregnancy according to socioeconomic status and race/ethnicity, as well as socioeconomic and racial/ethnic differences in birth outcomes and infant development. Additionally, participants will be asked to identify the person with whom they anticipate sharing parenting responsibilities for the child (e.g., child’s biological father or participant’s spouse/partner); if available, this person will be asked to complete an interview covering their mental health and social history. Infant development will be assessed by parental questionnaires at 1-2 months and 6 months of age, and by during an in-person neurological assessment as part of a home visit at 12-months. Abstraction of maternal prenatal, neonatal, and infant pediatric medical records will provide information on health and preventive care. This data, will provide a more in-depth measurement of a diverse sample of families to assess early mechanisms of health disparities, thereby allowing the opportunity to continue examining later consequences of early disparities, such as effects on early childhood development and school readiness (e.g., approximately 5 years of age), enhancing the utility of the data and meeting the overarching aim of the study.

The proposed initiative will also provide essential additional recruitment, including oversampling of African American women. The race/ethnic composition of the initial cohort highlighted the need for more targeted recruitment efforts to achieve the sample diversity required to meet the study aims. To have substantial imbalance in the race/ethnic sample composition precludes doing robust analyses of race and ethnicity in relation to study outcomes. Under this acquisition, targeted sampling efforts at participating clinics serving African American women will be conducted to obtain a more racially and ethnically balanced combined sample from the site. The site would conduct prenatal visits through at least 12-month follow-up assessments with the newly recruited participants.

Having served as the clinical site for the first phase of the study, Brown/WIH is uniquely positioned to undertake the continuation of the study. The investigators and staff at Brown/WIH are knowledgeable about the study procedures and have established collaborations with NICHD and the Data Coordinating Center. More importantly, they have access to the enrolled participants as the existing cohort was recruited and consented by WIH and have already identified clinics affiliated with WIH appropriate for targeted recruitment.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Rhode Island Children’s Health Equity and Development Study

“ENRICHED”

b. Project description. The contractor will conduct study assessments with women already recruited as indicated in the Statement of Work (SOW) including prenatal and postnatal maternal interviews, interviews with co-parents and collection of cord blood. Prenatal, postnatal, and pediatric medical records will be abstracted. The contractor will also recruit additional women, including oversampling African American women and conduct study assessments with the additional participants.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials

Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): IDIQ with cost reimbursement type task orders Other (specify): ___________

Completion Form Term form

Acquisition identification number. 75N94023R00009

c. Total estimated dollar value and performance/delivery period.

Estimated dollar value: IDIQ ceiling: $9,000,000.00.

Period of performance: 09/01/2023-08/31/2028 (IDIQ ordering period)

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of FAR 6.302-1 (a)(2)(ii), 41 U.S.C 3304(a)(1), and HHSAR 306.302-1.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Brown University Office of Sponsored Projects Box 1929 164 Angell Street (Brown Office Bldg.), 3rd Floor Providence, Rhode Island 02912 United States

Subcontractor: (Partnership with Brown University) Women and Infants Hospital of Rhode Island 101 Dudley Street Providence, RI 02905

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Brown, in affiliation with WIH, served as the clinical site via subcontracts with NICHD’s prime contractor to conduct recruitment and data collection in the first phase of the study. Specifically, Brown and WIH furnished the qualified personnel, materials, equipment, and services to implement, maintain, coordinate, and manage recruitment and assessment of the participants.

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. The cohort consists of patients recruited and consented from WIH and their affiliated clinics, therefore data collection on participants recruited at WIH can only be conducted by WIH staff. Study staff from Brown who have participant contact have dual appointments with WIH and therefore, can access WIH patients as part of research protocols. Brown and WIH have a long history of partnering on research and an established collaboration on this study. In fact, the Hassenfeld Child Health Innovation Institute at Brown University is located at

WIH; Dr. Michael Silverstein, the ENRICHED Brown PI, is also the Institute’s director. ENRICHED was initiated as part of the Hassenfeld research portfolio.

Moreover, Dr. E. Christine Brousseau, the ENRICHED WIH PI is an associate professor in the Warren Alpert Medical School of Brown University.

Institutional overlap at the PI-level as well as past experience on the project indicates that Brown and WIH will work together seamlessly. Therefore, a contract with Brown in partnership with WIH will ensure retention of the cohort and continuation of the study avoiding significant delays and loss of access to the participants already recruited. Additionally, it will allow the attainment of the balance in the race/ethnic composition of the population required from the site’s particular geographic area. Without the site sample diversity, it would be unclear if differences found are attributable to race/ethnicity or to place.

Extensive government resources have been used to create an infrastructure to support this study, including training staff at Brown and WIH on recruitment, enrollment, and assessment procedures, and implementation of the assessment schedule, electronic data collection systems, and biospecimen collections. Accordingly, Brown/WIH has the existing study infrastructure, access to participants, and data required to perform the proposed work. There are staff in place at Brown and WIH who are already trained on the study procedures, including conducting complex clinical interviews to obtain information on participants’ mental health. Participants have an established relationship with WIH, which is essential to promote participant retention in a long-term study such as ENRICHED. Conducting the follow-up assessments elsewhere would result in duplication of almost all the previous work and unacceptable delays that would increase costs to the Government.

Because the assessments are assigned specific timepoints in pregnancy and child development, the timeliness of obtaining the additional data is of particular importance as any delay will cause missing data. Once an assessment window has passed, data included in that assessment can no longer be obtained. Therefore, the Government must contract with Brown serving as the prime contractor, in partnership with WIH to complete follow-up of the existing cohort.

Regarding the necessary additional recruitment in Rhode Island, this recruitment will target clinics serving African American women. WIH affiliated clinics have already participated in the study and have been deemed as capable to fill this need due to their patient census. WIH has established successful recruitment and retention procedures that have been implemented in the clinics located in the hospital, therefore, they are able to implement the targeted recruitment quickly and efficiently.

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. 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 in Rhode Island which over-samples African American women is necessary to meet the study aims.

Establishing a different clinical site in the same geographic area would require the previously conducted work be duplicated at increased cost to the Government.

Based on the abovementioned, having served as the clinical site for the first phase of the study, Brown University is uniquely qualified to perform the required work. It is anticipated that the use of any other source for this requirement would result in substantial duplication of costs as well as additional time to recruit a new cohort and develop the necessary capability within another contractor’s staff that is not expected to be recovered through competition.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A presolicitation notice indicating the Government’s intent to negotiate a sole source contract to 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 was posted in SAM.gov on March 31, 2023. This notice also invited potential offerors to submit capability statements if they felt that they could adequately perform this requirement. Capability statements were due April 17, 2023, by 4:00pm Eastern Standard Time. There were no responses to this announcement. No other sources have expressed interest. In addition, an amendment to the original presolicitation notice was posted on SAM.gov on May 5, 2023. The amendment included language signaling the Government’s intent to conduct long-term longitudinal follow-up studies not included within the initial posting.

Responses to the amended notice were due May 22, 2023, by 4:00pm Eastern Standard Time. No original language from the initial notice was removed or modified, and no responses to the amended notice were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

(a) In accordance with FAR 15.403-4, the Contracting Officer will require submission of certified cost or pricing data, as defined in 2.101, from the contractor to the extent necessary to determine fairness and reasonableness of the costs.

{b) The COR and Contractor Officer will evaluate all proposed costs and then complete and sign the Project Officer Technical Questionnaire form. A cost analysis of the contractor's business proposal will be conducted by the Contracting Officer in accordance with FAR Subpart 15.404-1(c) and the principles established in the 0MB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The cost analysis will include a review and analysis of separate cost elements to determine fairness and reasonableness. In addition, an evaluation of the separate cost estimates of the Brown and WIH proposals will be compared against the Independent Government Cost Estimate.

The Contracting Officer will also consider historical costs. Furthermore, a cost realism analysis will be conducted in accordance with FAR 15.404-1(d) and documented in the file which will reflect the process of independently reviewing and evaluating specific elements of the contractor's proposed cost estimate to determine whether the estimated proposed cost elements are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the unique methods of performance and materials described in the contractor's technical proposal.

(c) An audit will not be necessary.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

As stated above, a pre-solicitation notice announcing the Government’s intent to award a noncompetitive contract to Brown University was published on Sam.gov on March 31, 2023. The response due date was April 17, 2023. There were no responses to this announcement, and no other sources have expressed interest. In addition, an amendment to the original presolicitation notice was posted on SAM.gov on May 5, 2023. The amendment included the Government’s intent to conduct long-term longitudinal follow-up studies that was not included within the initial posting.

Responses to the amended notice were due May 22, 2023, by 4:00pm Eastern Standard Time. No responses were received to this amended notice either. Given that Brown/WIH is the only source with access to the currently enrolled participant on whom additional data is needed to achieve the study aims, no further marketing research was conducted.

9. Any other facts supporting the use of other than full and open competition.

No additional facts to what was stated earlier in Section 5, Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Due to the unique circumstances previously mentioned, this non-competitive IDIQ sole-source award proposed to be made to Brown University is the only action that can secure essential access to and preserve this specific and existing cohort imperative to the larger research effort.

Currently, there are no approved future subsequent acquisitions anticipated. Should, in the future, similar opportunities become available, every effort will be made to establish competition. However, long term longitudinal studies are important to understand the effects inequalities have at the individual, family, and neighborhood levels beginning during fetal development and across the lifespan. If the Government determines that additional assessments would be beneficial, the Government may need to access this existing cohort in the future.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Denise Haynie, Ph.D, MPH

Project Officer’s

Immediate Supervisor

Stephen Gilman, Sc.D.

Head of the Sponsoring

Program Office

Una Grewal, Ph.D, Director, DiPHR

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/ or

Denise L.

Haynie -S

Digitally signed by Denise L.

Haynie -S Date: 2023.05.25 17:30:12 -04'00'

Stephen E. Gilman -S

Digitally signed by Stephen E.

Gilman -S Date: 2023.05.29 10:26:03 -04'00'

Grewal, Jagteshwar

(NIH/NICHD) [E]

Digitally signed by Grewal, Jagteshwar

(NIH/NICHD) [E]

Date: 2023.05.30 16:08:39 -04'00'

Official Name & Title Signature Date

Contracting Officer

Elizabeth Osinski

Section Chief and Acting

Chief, Contracts

Management Branch

Alice Pagán Pereira

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting Office, Director, NICHD Office of Acquisitions

Marlene Mireles

Head of the Contracting Activity and Director, OALM

Diane J. Frasier

Elizabeth J.

Osinski -S

Digitally signed by Elizabeth J. Osinski -S Date: 2023.05.30 16:18:30 -04'00'

Alice M. Pagan Pereira -S

Digitally signed by Alice M. Pagan Pereira -S Date: 2023.05.31 15:52:45 -04'00'

Marlene T.

Mireles -S

Digitally signed by Marlene T.

Mireles -S Date: 2023.06.01 16:59:22 -04'00'

Phillip D.

Osborne -S

Digitally signed by Phillip D.

Osborne -S Date:

2023.06.23 16:51:18 -04'00'

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

Dr. Liza Q. Bundesen, Deputy Director

OER, NIH

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive N/A

06-27-2023Liza Q.

Bundes en -S

Digitally signed by Liza Q.

Bundesen -S Date:

2023.06.27 10:05:11 -04'00'