Notice of Intent to Sole Source - Extension of Ordering Period for IDIQ Contract... Tender

Procurement Summary

Country : USA

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

Deadline : 21 May 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 118767342

Document Ref. No. : 75N94019D00004_P00006

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

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...
Active Contract Opportunity
Notice ID : 75N94019D00004_P00006
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH NICHD
General Information
Contract Opportunity Type: Presolicitation (Original)
Original Published Date: May 06, 2025 01:29 pm EDT
Original Response Date: May 21, 2025 04:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Jun 05, 2025
Initiative: None

Classification
Original Set Aside:
Product Service Code: AN12 - HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH
NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance: Bethesda, MD USA

Documents

 Tender Notice

SAM.pdf