CHILDRENS NATIONAL MEDICAL CTR.NOTICE OF INTENT.75N94025Q00117.pdf

75N94025Q00117

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to CHILDREN’S HOSPITAL NATIONAL MEDICAL CENTER for the Acquisition of Services for the Young At Heart Type 2 Diabetes Research Longitudinal Protocol.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541690 Other Scientific and Technical Consulting Services with a Size Standard of $19.0.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 2025-04 Effective June 11, 2025.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

PERIOD OF PERFORMANCE

9/1/2025 to 8/31/2026

PURCHASE ORDER TYPE & PAYMENT TERMS

This purchase order will be a Firm-Fixed Price. Payment shall be made Monthly in Arrears.

Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda, MD 20892

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

DESCRIPTION OF REQUIREMENT

Youth-onset type 2 diabetes (T2D) is a rapidly progressive, debilitating disease that is associated with early-onset micro- and macrovascular complications. The rate of disease progression and the natural history of subclinical atherosclerosis in T2D youth remains to be elucidated. The joint Children’s National Hospital (CNH)/ National Institute of Diabetes Digestive and Kidney Diseases (NIDDK) Y-T2DM program investigates metabolic mechanisms of diabetes risk and management in youth, and young adults. NIDDK is conducting a multi-site study with Children’s National Hospital as a site to evaluate risk for heart disease and in youth. The protocol is registered on clinicaltrials.gov (NCT06730113) and has received regulatory approval. A research collaboration agreement is being processed to support research activities and coordination between CNH and the National Institutes of Health Clinical Center (NIH CC).

PURPOSE AND OBJECTIVES

The purpose of this order is to support protocol implementation, research, and participant recruitment for the Young At Heart Type 2 Diabetes Research Longitudinal Protocol at CNH.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The goal of this project is to investigate the causes and factors for heart disease and type 2 diabetes in youth.

This project brings together the skills and expertise of investigators within the NIDDK and CNH to meet the research mission of understanding diabetes and heart disease in young populations.

Children’s National shall provide research coordination and services to support participant recruitment and outreach for youth and young-adult diabetes protocols (ClinicalTrials.gov NCT06730113). The Contractor shall support:

• Posting of study description using IRB-approved fliers and advertising materials.

• Participant outreach and communication to support study advertising and recruitment.

• Scheduling participants including outreach in clinics, via telephone, or approved IRB communications.

• Plan to screen up to 100 persons and complete screening and annual visit for up to 36 participants and

66 parents

• Complete case report forms in NIDDK Redcap including questionnaires

• Prepare research samples per protocol for transfer to NIDDK

• Ensure that data and samples are collected as outlined in protocol and experimental plan below.

• Complete regulatory forms, as required to conduct study.

TASKS AREAS

Independently, and not as an agent of the Government, the contractor shall perform all of the detailed Task Areas listed below:

Task Area 1 –

The Contractor will allow for:

• Site initiation visit. NIDDK staff will travel to Children’s National to educate and train personnel on protocol procedures prior to study start-up.

• Annual site visits. NIDDK staff will travel to Children’s National at least once per year for site visit to facilitate continued training and inspection to ensure quality assurance and consistency of protocol procedures between 2 sites. n/a

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME)

DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined CHILDREN’S NATIONAL MEDICAL CENTER to be the only reasonable available source to provide Services for the Young At Heart Type 2 Diabetes Research Longitudinal Protocol.

This acquisition was pursued on a sole source basis centered on the following: Children’s National Hospital (CNH) is the only exclusive provider of pediatric care in the metropolitan Washington, D.C. area and is the only freestanding children’s hospital between Philadelphia, Pittsburgh, Norfolk, and Atlanta. Serving the nation’s children for 150 years, the internationally recognized pediatric healthcare professionals at CNH care for more than 360,000 patients each year who come from throughout the region, nation, and world. The Type 2 diabetes program at CNH, is housed at the main campus with clinics at Regional Outpatient Centers, including the underprivileged areas of southeast side of DC and Prince George County, MD. The program serves a highly diverse population; 62% of our youth with T2D identify as non-Hispanic Black, 15% identify as Latinx, and 65% have public healthcare insurance. The center is the main referring center for children with T2D in the region and treated >200 children with newly diagnosed T2D in 2021 (during pandemic) and >80/year pre-pandemic 2018-2019. The joint CNH/ NIDDK program has recruited >100 participants since its inception and ongoing protocols require additional services. CNH services are needed because of their unique capability in serving a large group of youth with metabolic disease and diabetes. Finding alternative services elsewhere would result in prolonged protocol delays at an additional research cost. In addition, this program was established to leverage the resources at CNH and NIDDK as these two institutions are proven leaders in the development and application of innovative treatments for childhood diabetes.

Not awarding this contract would jeopardize the completion of the study due to difficulty recruiting the subject population at the NIH, jeopardizing mission-critical research aimed at combating the obesity and type 2 diabetes crisis in youth under (42 U.S.C. § 285C-1 ).

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Any submitted capability statements must demonstrate relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this http://www.sam.gov/ notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

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.

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Thursday, September 12, 2024 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov.

INVOICING PROCESSING PLATFORM (IPP)

Vendor/Contractor Must be able to accept payments via IPP (Invoice Processing Platform) The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause.

INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum "Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing" directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests" IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is:

https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at

(866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the contracting officer.

HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions. As used in this clause, Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE)

Assessment of Capability Lowest Price Technically Acceptable mailto:amber.harris@nih.gov https://www.ipp.gov/ mailto:IPPCustomerSupport@fiscal.treasury.gov