Notice of Intent to Sole Source – Extension of Ordering Period for IDIQ Contract 75N94019D00004 (Health Decisions, Inc.)

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.