Clinical Research Products Management Center (CRPMC)

Amendment / Modification

This amendment (No. 2) revises the responses to questions #2 and #5 from Amendment #1 and updates Attachment 5: Additional Business Proposal Instructions & Uniform Cost Assumptions.

• Attachment 5: Additional Business Proposal Instructions & Uniform Cost Assumptions has been revised to include cost assumptions for international and domestic shipping. The revised version is attached, and changes are highlighted in yellow.

• Responses to Question 2 (anticipated international scope of work) and Question 5 (anticipated domestic scope of work) have been revised.

• The proposal due date remains unchanged: Friday, June 5, 2026, at 3:00 P.M. EST.

• Offerors must acknowledge receipt of this amendment by identifying Amendment #2 and the date of the amendment (May 15, 2026) on each copy of the proposal submitted. Failure to do so may result in proposal rejection.

Amendment / Modification

• The proposal due date has been changed to Friday, June 5, 2026, at 3:00 P.M. EST.

• This amendment provides responses to questions received from potential offerors regarding the solicitation.

• Proposal Due Date: Changed to Friday, June 5, 2026.

• International Scope of Work: Clarified that there is no specific international depot requirement, but the contractor must support shipments across various regions, time zones, and climates within 3,000 miles, with delivery within 1-5 days. Specific international sites and estimated order volumes were provided.

• Domestic Scope of Work: Clarified that the scope is correlated to clinical research sites, with specific numbers of domestic sites for ACTG, HPTN, IMPACT, and HVTN provided. Estimated order volumes were also detailed.

• Personnel Resumes: Confirmed that resumes/CVs are included in the Technical Proposal page limitation, with each CV not exceeding three pages.

• Page Limitation: The 200-page limitation applies to the entire Technical Proposal, including attachments, unless specifically excluded in the solicitation.

• Supplier/Manufacturer Audits: Confirmed that audits have been government-directed, with supplier locations variable (currently US, Europe, and India).

• COSMOS Transfer: COSMOS-related materials, documentation, and system information will be provided during the 90-day Transition Period. Training for transition and continuity of operations will also be provided.

• Space/Facility Requirements: Offerors should refer to the Statement of Work; no additional minimum requirements are specified.

• Offerors must acknowledge receipt of this Amendment by identifying Amendment #1 and the date of the amendment (May 7, 2026) on their proposal submission.

• The proposal due date has been extended to June 5, 2026.

Solicitation / RFP / RFQ

This solicitation is for the management and operation of the Clinical Research Products Management Center (CRPMC) to support NIAID sponsored clinical research trials, with a core focus on HIV/AIDS and its co-morbidities. The contractor shall provide cGMP-compliant facilities for the receipt, storage, handling, shipping, and disposition of study products. All functions must be conducted in accordance with federal, local, and other applicable regulations governing study product, including but not limited to, the CFR, ICH GCP, cGMP, Good Distribution Practices (GDP), and Good Documentation Practices.

• Management and operation of the CRPMC.

• Provision of cGMP-compliant facilities for receipt, storage, handling, shipping, and disposition of study products.

• Adherence to all applicable regulations (CFR, ICH GCP, cGMP, GDP, Good Documentation Practices).

• Submission of various reports, including Technical Progress Reports, Monthly Progress Reports, Annual Progress Reports, and Final Reports.

• Management and sharing of research data.

• Compliance with Information and Communication Technology (ICT) accessibility standards (Section 508).

• Contract Type: Cost-Reimbursement, level of effort/term.

• Period of Performance: Base Period from March 16, 2027, through March 15, 2028. Includes 6 one-year option periods, potentially extending the total performance period to 7 years.

• Estimated Value: Not explicitly stated, but options for increased level of effort are detailed.

• Proposals must be submitted electronically via the eCPS website by 3:00 PM Eastern Time on June 1, 2026.

• Offers will be valid for 120 days.

• Key deadlines: Questions due by April 30, 2026.

• Evaluation Factors: Technical (45%), Scientific and Technical Personnel (25%), Project Management (20%), Facilities, Equipment, and Other Resources (10%). Past performance will also be evaluated.

• This requirement is NOT set-aside for Small Business.

• NAICS Code: 541715

• Small Business Size Standard: 1,000

• Offerors must be registered in the System for Award Management (SAM) prior to award.

• The contract will incorporate numerous FAR and HHSAR clauses.

• Specific cost assumptions for options are provided in Attachment 5.