Notice of Intent to Sole Source – Extension of Ordering Period for IDIQ Contract 75N94019D00004 (Health Decisions, Inc. )
Closed Pre-Solicitation Posted
- Solicitation number
- 75N94019D00004_P00006
- Agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Place of performance
- Bethesda, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, is seeking to extend the existing Indefinite Delivery, Indefinite Quantity (IDIQ) contract with Health Decisions, Inc. (HDI) for the Contraceptive Development Program's Statistical and Clinical Coordinating Center (SCCC). The contract extension will support critical research activities for the Contraceptive Clinical Trials Network (CCTN), specifically focusing on conducting clinical trials for novel male and female contraceptive products. Key contract requirements include providing statistical and clinical coordinating services, developing data entry protocols, conducting data quality reviews, performing data analyses, and preparing clinical study reports for submission to regulatory authorities like the FDA. The government will evaluate potential alternative contractors based on their ability to meet the agency's specific research support requirements. Interested parties must submit a capabilities statement via email to Elizabeth Bulger and Ty Main by 4:00 p.m. EST on May 21, 2025.
The pre-solicitation notice indicates no specific set-aside designations for this contract opportunity. The sole source modification is being pursued under Federal Acquisition Regulation (FAR) 6.302-1, which allows for a single source when no other supplier can meet the agency's requirements. The current contract (75N94019D00004) with Health Decisions, Inc. will be extended for 27 months to ensure continuity of research support and allow time for a new competitive contract to be solicited and awarded. The contract covers comprehensive services including site coordination, protocol development, data analysis, regulatory submissions, and ancillary services such as product formulation, packaging, distribution, insurance, and stability testing. While specific award values are not detailed in the notice, the scope suggests a significant research and development contract within the biotechnology and health research domain, aligned with the NAICS category 541714 for Research and Development in Biotechnology.
Notice text
The purpose of this announcement is for the Contraceptive Development Program (CDP), within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, to issue a modification to the existing Indefinite Delivery, Indefinite Quantity (IDIQ) contract number 75N94019D00004 on a sole source basis, under the authority of 41 U.S.C. § 3304(a)(1) as implemented by FAR6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements and FAR 6.301-1(a)(2)(ii) to extend the ordering period of the existing IDIQ contract with Health Decisions, Inc. (HDI), entitled “NICHD Contraceptive Clinical Trials Network (CCTN) Statistical and Clinical Coordinating Center (SCCC).”
A twenty-seventh (27) month extension of the ordering period of the IDIQ contract is necessary to ensure continuity of critical research support to sustain the ongoing statistical and clinical coordinating support to the CCTN and NICHD for the conduct of clinical trials of novel methods of male and female contraceptive products under Good Clinical Practices guidelines as well as for ancillary services, such as product formulation, packaging, distribution, insurance, and stability testing, until a new competitive contract can be solicited and awarded. Specifically, this action is necessary to ensure HDI continues providing the statistical and clinical coordinating services supporting ongoing CCTN Phase I-III contraceptive clinical trial activities under Good Clinical Practices guidelines. HDI will also continue providing ancillary services such as meeting coordination, product formulation, packaging, distribution, insurance, stability testing, and regulatory support services as needed. In addition, HDI would continue developing data entry protocols that allow for the review of data quality, data analyses, and the composition of clinical study reports with the intent of submitting them to the Food and Drug Administration and other relevant regulatory authorities. HDI is also tasked with data storage for past, current, and future CCTN studies.
See attached document for additional details.
Files
| File | Type | Posted |
|---|---|---|
| SAM.gov Notice JA_SCCC Extension IDIQ rev.pdf |
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