Amendment 2 - CRPMC RFP 75N93026R00003.pdf

Amendment 2 RFP # 75N93026R00003 Page 1 of 2

Amendment No. 2

RFP # 75N93026R00003,

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

Solicitation Number: 75N93026R00003

Amendment Number: Two (2)

Amendment Issue Date: May 15, 2026

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

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 is unchanged. Offerors must acknowledge receipt of this Amendment by identifying this amendment number (Amendment # 2) and the date of the amendment (May 15, 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 is to revise the responses provided to questions #2 and #5 in Amendment # 1 and revise Attachment 5: Additional Business Proposal Instructions & Uniform Cost Assumptions.

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

Attachment 5: Additional Business Proposal Instructions & Uniform Cost Assumptions:

Attachment 5 has been revised to include cost assumptions for international and domestic shipping. The revised version is attached, and changes are highlighted in yellow.

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

Amendment 2 RFP # 75N93026R00003 Page 2 of 2

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.

Revised Response to Question 2: Please reference ‘Attachment 5: Additional Business Proposal Instructions & Uniform Cost Assumptions’ for instructions on ‘Special Shipping, Packaging, and Storage’ cost assumptions. The cost assumptions provided in Section 3 of Attachment 5 are applicable to the Base Period plus Options 1-6. 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

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.

Revised Response to Question 5: Please reference ‘Attachment 5: Additional Business Proposal Instructions & Uniform Cost Assumptions’ for instructions on ‘Special Shipping, Packaging, and Storage’ cost assumptions. The cost assumptions provided in Section 3 of Attachment 5 are applicable to the Base Period plus Options 1-6. 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 https://rsc.niaid.nih.gov/networks-protocol-teams/useful-links https://rsc.niaid.nih.gov/networks-protocol-teams/useful-links

Attachment 5 – Additional Business Proposal Instructions & Uniform Cost Assumptions Clinical Research Products Management Center (CRPMC) Page 1 of 6 RFP No: 75N93026R00003 Revised 5.15.2026 (Amendment 2)

ATTACHMENT 5: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

AND UNIFORM COST ASSUMPTIONS

Clinical Research Products Management Center (CRPMC)

75N93026R00003

In addition to the format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented in this section of the RFP is intended to provide uniform cost assumptions and business clarifications.

Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the Technical Evaluation Criteria, and the RFP as a whole, in the development of your proposal. The information requested in these instructions should be used as a guide for the development and formatting of your Business Proposal. Offerors should consider and include the information requested here, as well as any other information which will benefit the proposal.

BUSINESS PROPOSAL – TABLE OF CONTENTS

SECTION 1 – PROPOSAL COVER SHEET (use form NIH 2043 identified in Section J of the solicitation)

SECTION 2 – COST OR PRICE SUPPORT

Section L of the RFP specifies the minimum documentation requirements for cost data and all cost-related support. All related documentation should be included in a clearly marked section of the proposal.

SECTION 3 – UNIFORM COST ASSUMPTIONS

1) Technical Cost Assumptions

a. Ongoing Activities on the effective date of the contract - assume responsibility for the following:

• Assume 65 new clinical protocols will be conducted annually

• Assume 160 ongoing clinical protocols annually

• Assume 5 audits of suppliers/manufacturers annually

b. New activities during the contract period of performance – assume the following:

1. Number of clinical research sites and locations:

• 100 clinical research sites located in varying regions, time zones and climates.

2. Study product destruction at clinical research sites o Assume quarterly visits by 1 FTE to a clinical research site for the purposes of study product destruction and study product accountability reconciliation.

- assume 3 days on site

- 2 days total travel

Clinical Research Products Management Center (CRPMC) Page 2 of 6 RFP No: 75N93026R00003 Revised 5.15.2026 (Amendment 2)

2) Travel

a. Contract Initiation Meeting: Assume one meeting in Rockville, Maryland within one month after the effective date of the contract to discuss contract initiation. Assume that this meeting will require a three-night stay in Rockville, Maryland and will be attended by the Project Director and the Business Representative.

b. Training Workshops: Assume 4 one-day NIAID-sponsored training workshops per year for clinical site staff, to be held in the Rockville, Maryland area, each requiring 4 Contractor staff presenters.

c. Clinical Site Pharmacy Visits: Assume 8 four-day-day clinical research site pharmacy visits per year.

d. Weekly Protocol Meetings: Assume a weekly 2-hour meeting requiring all Contractor staff pharmacists actively involved with protocols. These meetings may be virtual or in-person.

e. Clinical Research Trials Network Meetings: Assume the Project Director and 2 other contract pharmacists shall attend 4 clinical research trials network meetings per year within a 50-mile radius of Washington, D.C., for a duration of 3 to 4 days per meeting.

This is to support forecasting and planning for study product management.

f. Audit Visits: Assume 10 vendor/supplier/manufacturer GMP audit visits per year.

g. Destruction Visits: Assume quarterly visits by 1 FTE to clinical research sites for the purposes of study product destruction

- assume 3 days on site

- 2 days total travel

For costing purposes only, assume 150 clinical research site pharmacies located in varying regions, time zones and climates, 3000 miles from the central distribution center.

3) Special Shipping, Packaging, and Storage

A. Offerors should include a uniform cost assumption for secondary (auxiliary) labeling, packaging and repackaging study products:

Assume the following:

• Assume that 30 different study products consisting of 78,000 individual units per year will be repackaged; 40% of those will be oral dosage forms,20% frozen vials (-20 C), 20% frozen vials (-80 C)

• Assume that 8 protocols per year will require secondary repackaging to patient-specific-unit of use packaging from bulk product.

• Each protocol will consist of 7 study products each.

• Assume secondary (auxiliary) labeling of 250,000 individual units per year, 350 different study products.

B. Offerors should include a uniform assumption of 20,000 shipments per year. Assume 45% of the shipping will be international and 55% of the shipping will be domestic.

Clinical Research Products Management Center (CRPMC) Page 3 of 6 RFP No: 75N93026R00003 Revised 5.15.2026 (Amendment 2) o Assume 8 different shipping packaging configurations will be validated per year.

o 20% of study product will be shipped to clinical research sites located in varying regions, time zones and climates that are at least 3,000 miles away from the central distribution facility and must be delivered within one to five days.

o 30% of study product shipment to clinical research sites will originate from suppliers outside the U.S.

o 50% of study product shipments will be delivered within 24 hours o assume 40% of shipments will require wet and/or dry ice o assume 20% of shipments will require 5 to 8 pallets per shipment

4) Government Furnished Property

Government Furnished Property is offered for this acquisition.

No Government Furnished Property is offered for this acquisition.

The purchase of Government Furnished Property will not be authorized as a direct charge under the resultant contract.

3) Type of Contract and Estimate of Effort

It is anticipated that a cost reimbursement, term/level of effort (LOE) type contact will be awarded as a result of this solicitation. The period of performance will be for one year (Base Period) plus six (6) one-year Options to extend the term of the contract that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately March 16, 2027. The requirement will be the delivery of 27 full time equivalents (FTEs) per year for the base period (Year 1) and 27 FTEs per year for Options 1-6 (Years 2-7). PLEASE NOTE: The number of FTEs includes the effort of subcontractors and consultants. While the total LOE provided below is a requirement, the labor mix is the Government’s estimate and should not be considered restrictive for proposal purposes. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

Labor Category Years 1 - 7 Project Director 1.0 Assistant Project Director 1.0 DEPOT, Assistant Project Director 1.0 USA Pharmacist 5.48 DEPOT Pharmacist 1.19 Computer Programmer 1.17 Operations Supervisor 1.19 Scientist III, Chemistry 1.19 USA Pharmacist Other 5.34 Repository Other 1.19 Depot Pharmacist Other 3.57 Other 1.19 Total 27

Clinical Research Products Management Center (CRPMC) Page 4 of 6

SECTION 4 – OPTIONS

Options 1-6: Extend the Term of the Contract: The Government may exercise Options to extend the term of the contract beyond the base period (Year 1), and to increase the level of effort to cover unanticipated increase in demand. A breakdown of the estimate of effort for the Base Period and Options 1-6 is provided above.

Options 7-48: Increased Level of Effort: In addition, the Government may exercise options for increased level of effort that may result from unanticipated increases in demand for clinical research study product management support of NIAID related studies or to support additional trials or studies that were not anticipated at the writing of this solicitation. This may include increases in labeling, packaging, and shipments of study products, as well as increases in U.S.

and international distribution activities. This chart is included to show you the numbering of these Options:

Option Type Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Options for Additional

Effort 2 FTEs up to 4 times per year

Option 7 Option 11 Option 15 Option 19 Option 23 Option 27 Option 31

Option 8 Option 12 Option 16 Option 20 Option 24 Option 28 Option 32

Option 9 Option 13 Option 17 Option 21 Option 25 Option 29 Option 33

Option 10 Option 14 Option 18 Option 22 Option 26 Option 30 Option 34

Options for Additional

Effort

0.5 FTEs up

to 2 times per year

Option 35 Option 37 Option 39 Option 41 Option 43 Option 45 Option 47

Option 36 Option 38 Option 40 Option 42 Option 44 Option 46 Option 48

A. Options 7-34: Increased Level of Effort

Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 2 Full Time Equivalents (FTEs) for each option exercised. These options may be exercised up to 4 times each year. A separate cost proposal which includes a breakdown of costs on an annual basis should be provided for Options 7-34.

It is estimated that the labor mix is to be constituted as specified below and will be expended approximately as follows:

Labor Category Years 1 – 7 Pharmacist 1.0 Assistant Project Director 1.0 Total 2.0

NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

Clinical Research Products Management Center (CRPMC) Page 5 of 6

The following cost assumptions should be considered when preparing the cost proposal for Options 7 through 34:

a) Ongoing Activities on the effective date of the contract - assume responsibility for the following:

• Assume 15 new clinical protocols shall be conducted

• Assume a total n = 5,500 participants

b) New activities during the contract period of performance –Assume 150 clinical research site pharmacies located in varying regions, time zones and climates, 3,000 miles from the central distribution center.

1) Secondary (auxiliary) Labeling, packaging and repackaging study products o Assume that the 4 different study products consisting of 15,000 individual units per year will be repackaged; 45% frozen vials (-20 C), 40% frozen vials (-80 C)

2) Shipping and distribution of study products o Assume approximately 2,500 additional shipments of study products

B. Options 35-48: Increased Level of Effort

Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.50 FTE for each option exercised. These options may be exercised up to 2 times each year. A separate cost proposal which includes a breakdown of costs on an annual basis should be provided for Options 35-48.

It is estimated that the labor mix is to be constituted as specified below and shall be expended approximately as follows:

Labor Category Years 1 – 7 Pharmacist .25 Assistant Project Director .25 Total .5

NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

The following cost assumptions should be considered when preparing the cost proposal for Options 35 through 48:

a) Ongoing Activities on the effective date of the contract - assume responsibility for the following:

o Assume 2 new clinical protocols o Assume a total n=1,500 participants

b) New activities during the contract period of performance – assume the following:

a. 150 clinical research site pharmacies located in varying regions, time zones and climates, 3000 miles from the central distribution center.

Clinical Research Products Management Center (CRPMC) Page 6 of 6 RFP No: 75N93026R00003 Revised 5.15.2026 (Amendment 2)

b. Labeling, packaging and repackaging study products o Assume that 2 different study products consisting of 5,000 individual units per year will require repackaging and labelling o Assume study product will be all frozen vials (-80 C)

c. Shipping and distribution of study products o Assume 800 additional shipments of study product to clinical research site pharmacies located in varying regions, time zones and climates, up to 3,000 miles from the central distribution center.

C. Summary of Base Period and Options 1-48:

Provide a Summary Page that shows the total cost of the Base Period, and each of the Options separately.

SECTION 5 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER

SECTION L OF THE SOLICITATION

Refer to Section L of the solicitation for documentation requirements. All relevant documentation should be included in a clearly marked section of the proposal.