Amendment 1 - CRPMC RFP 75N93026R00003.pdf

Amendment 1 RFP # 75N93026R00003 Page 1 of 4

Amendment No. 1

RFP # 75N93026R00003,

entitled, "Clinical Research Products Management Center (CRPMC)"

Solicitation Number: 75N93026R00003

Amendment Number: One (1)

Amendment Issue Date: May 7, 2026

Proposal Due Date/Time: Friday, June 5, 2026 at 3:00 P.M. EST (CHANGED)

Issued By: Shawnice Williams

Contracting Officer

Points of Contact: PRIMARY Shawnice Williams, Contracting Officer Shawnice.Williams@nih.gov Phone: 301-761-5431

SECONDARY

Ashley Kinderdine, Contracting Officer Ashley.Kinderdine@nih.gov Phone: 240.669.5154

Please note that the proposal due date has been changed to Friday, June 5, 2026.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number (Amendment # 1) and the date of the amendment (May 7, 2026) on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of this Amendment 1 is to provide responses to questions from potential offerors, regarding the solicitation and change the proposal due date to Friday, June 5, 2026.

The solicitation is amended to provide the following responses to questions received from potential offerors:

Question 1: The RFP includes three references to ICRPMC-South Africa. Please explain what ICRPMC-South Africa is and clarify whether the government has a continuing requirement for ICRPMC-South Africa.

mailto:Shawnice.Williams@nih.gov mailto:Ashley.Kinderdine@nih.gov

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Response to Question 1: The ICRPMC (International Clinical Research Products Management Center) is the current international depot for study product management under the umbrella of the CRPMC. The references in Attachment 10 describe the capabilities of the current ordering and inventory system. The Government does not have a requirement for a specific international depot location (e.g., South Africa).

However, the contractor shall be capable of supporting shipments to clinical research site pharmacies across varying regions, time zones, and climates, within 3,000 miles, consistent with the requirements of the Statement of Work, including delivery within one (1) to five (5) days.

Question 2: To ensure a common basis for technical and cost proposal development, please define the anticipated international scope of work under this requirement. Specifically, please identify (or provide assumptions for) the expected geographic regions\zones countries of performance, the approximate distribution of effort across those regions/zones (e.g., percentage of studies or activities), and any known regulatory or operational constraints unique to those regions/zones. If specific locations cannot be disclosed, please provide standardized planning assumptions (e.g., number of countries by region/zone, study volume per region/zone, and associated logistical considerations) that all offerors should use in developing their proposals.

Response to Question 2: The anticipated international scope of work under this requirement is directly correlated to the clinical research sites of the clinical trial networks. The current clinical trial networks can be found at Useful Links | DAIDS Regulatory Support Center (RSC).

Study product should reach sites within 1 to 5 days.

Of the sites that are currently actively participating in protocols:

• ACTG has a total of 70 actively participating sites, 38 of which are international

• HPTN has a total of 39 actively participating sites, 23 of which are international

• IMPAACT has a total of 27 actively participating sites, 20 of which are international

• HVTN has a total of 25 actively participating sites, 13 of which are international

International sites are in the following countries: South Africa, Malawi, Zimbabwe, Vietnam, Kenya, Tanzania, Uganda, Botswana, Swaziland, India, Thailand, Philippines, Peru, Brazil, Mexico, Haiti

Assume 400 individual orders per month as follows:

• 2000 shipments annually

• 50% with special shipping conditions

• 45% shipping international

• 55% shipping domestic

Question 3: Section L (Technical Proposal Instructions – Personnel) requires submission of resumes for key personnel (page 72). Please confirm whether resumes/CVs are included in the Technical Proposal page limitation, or if they are excluded from the page count.

Response to Question 3: Resumes/CVs are included in the Technical Proposal page limitation. Offerors are reminded that each Curriculum Vitae (CV) shall not exceed three (3) pages, and all such pages count toward the overall 200-page limit, except for those items explicitly excluded in the solicitation.

Question 4: Please clarify whether the page limit is or is not inclusive of attachments.

https://rsc.niaid.nih.gov/networks-protocol-teams/useful-links

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Response to Question 4: The 200-page limitation applies to the entire Technical Proposal, including any attachments, unless the material is specifically identified in the solicitation as excluded from the page count (i.e., Title and Back Page, Table of Contents, and Section Dividers that do not contain substantive information).

Question 5: To ensure a common basis for technical and cost proposal development, please define the anticipated domestic scope of work under this requirement. Specifically, please identify (or provide assumptions for) the expected states of performance, the approximate distribution of effort across those states (e.g., percentage of studies or activities). If specific locations cannot be disclosed, please provide standardized planning assumptions (e.g., number of clinical sites by state, study volume per state, and associated logistical considerations) that all offerors should use in developing their proposals.

Response to Question 5: The anticipated domestic scope of work under this requirement is directly correlated to the clinical research sites of the clinical trial networks. The current clinical trial networks can be found at Useful Links | DAIDS Regulatory Support Center (RSC).

Of the sites that are currently actively participating in protocols:

• ACTG has a total of 70 actively participating sites, 32 of which are domestic

• HPTN has a total of 39 actively participating sites, 16 of which are domestic

• IMPAACT has a total of 27 actively participating sites, 7 of which are domestic

• HVTN has a total of 25 actively participating sites, 12 of which are domestic

Assume 400 individual orders per month as follows:

• 2000 shipments annually

• 50% with special shipping conditions

• 45% shipping international

• 55% shipping domestic

Question 6: The RFP gives averages (e.g., 65 new protocols/year, 20,000 shipments/year), but not variability. Are the stated assumptions ceilings, targets, or planning averages?

Response to Question 6: The assumptions are planning averages.

Question 7: For cost proposal purposes, please clarify whether supplier/manufacturer audit locations are expected to be Government-directed or may be influenced by contractor-supported sourcing activities. Additionally, please provide a representative geographic assumption (e.g., domestic vs.

international mix) for the annual supplier/manufacturer audits to support consistent travel cost assumptions.

Response to Question 7: Supplier audits have been government directed. Supplier location is variable based on various studies. Currently, there are suppliers from the US, Europe and India.

Question 8: The RFP states that COSMOS is transferable and available for use under the proposed contract, and that transition will include transfer of databases, software systems, other software, source code, and training time for transfer of operations. Please clarify whether existing COSMOS-related SOPs, work instructions, user manuals, training materials, validation/maintenance documentation, and system-administration/database-maintenance procedures will be made available to the awardee during transition for use or adaptation under the awardee’s document-control system. Please also clarify https://rsc.niaid.nih.gov/networks-protocol-teams/useful-links

Amendment 1 RFP # 75N93026R00003 Page 4 of 4 whether NIH and/or the incumbent will provide COSMOS user and system-administrator training, or whether offerors should assume they must develop and deliver their own training materials and SOPs.

Response to Question 8: COSMOS-related materials, including relevant documentation and system information necessary for contract performance, will be provided to the awardee during the 90-day Transition Period. Training necessary to support transition and continuity of operations will also be provided during this period.

Question 9: Are there specific minimum space, facility, or storage-capacity requirements the Government expects offerors to meet for CRPMC operations?

Response to Question 9: Offerors shall refer to the Technical Requirements in the Statement of Work.

No additional minimum space or facility requirements are specified beyond those described.

Question 10: Given the scope and complexity of the RFP requirements, will NIH consider extending the proposal due date from June 1, 2026, to June 22, 2026? This additional time would support preparation of a more complete, compliant, and responsive proposal.

Response to Question 10: The Proposal Due Date is changed to Friday, June 5, 2026 at 3:00 P.M. EST.