SAM.gov Notice JA_SCCC Extension IDIQ rev.pdf

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

Reference Number: 75N94019D00004

Description

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT MODIFICATION. THIS IS NOT

A SOLICITATION OR A REQUEST FOR COMPETITIVE PROPOSALS.

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.

Although a request to increase the ceiling of the IDIQ contract was approved previously via a sole source modification on August 5, 2024, the ordering period remained unchanged 9/20/2019–

9/19/2026. It was initially anticipated that all required work could be initiated by September 19, 2026; however, due to delays and changes in resource allocations, the projected workload and clinical trials will take longer to finalize. An extension of the ordering period is required to complete these critical activities, ensuring continuity without disruption or loss of investment.

Health Decisions, Inc. (HDI) is the incumbent contractor and possesses unique qualifications and experience essential to maintain continuity of operations without unacceptable delays or risk to the data integrity, patient safety, and regulatory submissions. HDI's responsibilities include the following activities along with ancillary functions related to the coordination and monitoring of clinical trials of investigational products:

• Site initiation, coordination and monitoring of CCTN clinical sites in conducting phase 1, 2 and 3 clinical trials

• Acquisition of IRB approval and assistance in obtaining reliance agreements for participating sites

• Protocol development, regulatory review, compliance monitoring, and notification to clinicaltrials.gov

• Product distribution to participating sites and product accountability throughout the trial

• Advisory and data monitoring committee organization

• Creation of data entry protocols and maintenance of databases

• Data quality review and analysis

• Composition of clinical study reports for submission to the Food and Drug Administration

(FDA)

• Secure storage of clinical data for past, ongoing, and future studies

• Statistical analysis of trial data and assistance in manuscript preparation for describing study results.

Transitioning to a new contractor during such critical junctures as data and safety monitoring, tracking study progress, preparing reports and submitting study data to the Food and Drug

Administration (FDA) requires a high level of coordination, effort and time; therefore, any delays pose considerable harm to the multiple clinical studies, data collection and data reporting process that would be to the detriment of CDP's mission. Specifically, interruption in these activities would result in unacceptable and costly delays as well as unrecoverable losses in vital areas such as subject recruitment, data analyses, data quality review, and the submission of finalized data to the

FDA for clinical development of novel contraceptive products. In view of that, it is critical that the

SCCC services not be interrupted, as this operation is essential to the success of the CCTN and

CDP.

The loss of acquired experience and knowledge from ongoing activities would cause considerable detriment to government investment if the expertise of HDI is not utilized to complete the ongoing projects.

There will not be a solicitation or Request for Proposals (RFP) issued as a result of this announcement. Any responses or inquiries to this notice must demonstrate clear and convincing evidence that competition will be advantageous to the Government. All information received from this notice shall be used for planning and market research purposes only.

The statutory authority for this sole source action is implemented by FAR 6.302-1. Only one responsible source and no other supplies or services will satisfy the agency's requirements. The award is subject to approval of the Justification and Approval for Sole Source (J&A).

Once the J&A is approved, this action will serve to change the IDIQ contract’s ordering period via a modification to the contract. Notwithstanding the stated intent, if other organizations believe they can fully meet the Government's requirement, they may submit a written capabilities statement.

The capabilities statement must contain sufficient documentation to establish a bona fide capability to fulfill the requirement and must be received by the response date listed in this posting. A determination not to compete with this requirement, based upon responses to this notice, is solely within the discretion of the Government.

NICHD will not be responsible for any costs incurred by interested parties in responding to this notice. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the evaluation of the information received. Interested parties may respond and provide a capability statement no later than 4:00 p.m. Eastern Standard Time (EST), May 21, 2025, via email to Elizabeth Bulger, Contracting Officer, at elizabeth.bulger@nih.gov and Ty Main at ty.main@nih.gov. Emails must reference the announcement number in the subject line. This is not an RFP, and this announcement does not commit the Government to award a contract. The reference number to be used is 75N94019D00004.