NICHD Contraceptive Clinical Trials Network Statistical and Clinical Coordinating Center

The purpose of this announcement is to post the approved J&A for the presolicitation ntoice below.

THIS IS A NOTICE OF INTENT TO AWARD WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION. THIS IS NOT A SOLICITATION OR A REQUEST FORCOMPETITIVE 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 negotiate on a sole source basis, under the authority of 41 U.S.C. 253 ( c )(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 increase the ceiling of the existingIDIQ contract with Health Decisions, Inc. (HDI), entitled “NICHD Contraceptive Clinical Trials Network (CCTN) Statistical and Clinical Coordinating Center”.

The objective is to raise the ceiling to ensure continuation of mission critical research while the NICHD procurement team continues to pursue the re-competition of these services under a new full and open cost reimbursement contract.

The ordering period of the HDI contract does not change. The request to increase the ceiling is within the IDIQ ordering period of 9/20/2019-9/19/2026. The additional funds and increase in ceiling will sustain the ongoing statistical and clinical coordinating support to the CCTN and NICHD for the conduct of clinical trialsof 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. Additional services supporting clinicalevaluation and regulatory approval of candidate entities must be provided as needed for individual products to support the ongoing clinical trials.

As the incumbent contractor, HDI provides statistical and clinical coordinating services in support of ongoing CCTN Phase I-III contraceptive clinical trial activities. HDI is responsible for the conduct and implementation of ongoing CCTN Phase I-III clinical trials via the coordination and monitoring of CCTN sites and for ensuring protocol compliance. Moreover, it develops data entry protocols that allow for review of data quality, data analyses, and composition of clinical study reports with the intent for submission to the FDA and other relevant regulatory authorities. HDI is also tasked with data storage for past, current, and future CCTN studies.

Transitioning to a new contractor during such critical junctures as data and safety monitoring, tracking study progress, and submitting study data to the Food and Drug Administration (FDA) requires a high level of coordination, eff ort and time; therefore, any delays pose considerable harm to the multiple clinical studies, data,and subjects that would be to the detriment of CDP's mission. Specifically, interruption in these activities would result in unacceptable and costly delays as well asunrecoverable losses in vital areas such as subject recruitment, data analyses, data quality review, and the submission of finalized data to the FDA for label modification of 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.

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 andmarket 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 agencyrequirements. The award is subject to approval of the Justification and Approval for Sole Source (J&A).

Once the Justification and Approval for Sole Source (J&A) is approved, this action will serve to change the IDIQ contract’s overall price ceiling via a modification to the contract. Notwithstanding the stated intent, if firms believe they can fully meet the Government's requirement they may submit a written capabilities statement (NOT TO EXCEED 3 PAGES). The capabilities statement must contain sufficient documentation to establish a bona fide capability to fulfill the requirement and mustbe received by the response date listed in this posting. A determination not to compete 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 4:00pm., Eastern Standard Time (EST), April 23, 2024, via Email to Theresa Ranjit, Contracting Off icer, at tk12w@nih.gov. Emails must reference the announcementnumber 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 is75N94019D00004.

Awarded contract 75N94019D00004 to unknown vendor for unknown amount on 2024-12-17.