Nichd Contraceptive Clinical Trials Network Statistical and Clinical Coordinating... Tender

Procurement Summary

Country : USA

Summary : Nichd Contraceptive Clinical Trials Network Statistical and Clinical Coordinating Center

Deadline : 23 Apr 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 99855148

Document Ref. No. : 75N94019D00004

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

Purchaser : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Contracting Office Address : BETHESDA, MD 20817
Primary Point of Contact : Theresa Ranjit
Theresa.Ranjit@nih.gov

USA
Email :theresa.ranjit@nih.gov

Tender Details

Description

THIS IS A NOTICE OF INTENT TO AWARD WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION. 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 negotiate on a sole source basis, under the authority of 41 U.S.C. 253 ( c )(1) as implemented by FAR 6.302-1, 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 existing IDIQ 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 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. Additional services supporting clinical evaluation 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 CC...
Active Contract Opportunity Notice ID 75N94019D00004 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 (Updated)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Updated Published Date: Apr 08, 2024 06:21 pm EDT
Original Published Date: Apr 08, 2024 05:45 pm EDT
Updated Response Date: Apr 23, 2024 04:00 pm EDT
Original Response Date: Apr 23, 2024 04:00 pm EDT
Inactive Policy: 15 days after response date
Updated Inactive Date: May 08, 2024
Original Inactive Date: May 08, 2024
Initiative: None

Classification
Original Set Aside:

Product Service Code: AN12 - Health R&D Services; Health care services; Applied Research
NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance: USA

Documents

 Tender Notice