Amendment 1-RFP_75N93021R00003wAttachments.pdf

AMENDMENT #1 RFP No. 75N93021R00003 1

Amendment No. 1 RFP No. 75N93021R00003

“Clinical Pharmacology Quality Assurance (CPQA) Program”

Solicitation Number: 75N93021R00003

Amendment Number: One (1)

Amendment Issue Date: March 2, 2021

Proposal Due Date/Time: Monday, March 29, 2021 at 3:00 PM, Local Time (Unchanged)

Issued By: Shane Sarchiapone

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY shane.sarchiapone@nih.gov Shane Sarchiapone, Contracting Officer Phone: 301.761.7504

SECONDARY

manouelj@mail.nih.gov John Manouelian, Contracting Officer Phone: 240.669.5152

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. 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:

(1) provide responses to questions from potential offerors, regarding the solicitation; (2) amend ARTICLE C.2. REPORTING REQUIREMENTS to address concerns raised by potential offerors; (3) amend PART I – THE SCHEDULE, SECTION D – PACKAGING, MARKING AND SHIPPING, to address concerns raised by potential offerors; (4) amend Attachment 1 – Packaging and Delivery of Proposal, to address concerns raised by potential offerors; (5) amend Attachment 3 – Statement of Work, to address concerns raised by potential offerors; and (6) amend Attachment 5 – Additional Business Proposal mailto:shane.sarchiapone@nih.gov mailto:manouelj@mail.nih.gov

AMENDMENT #1 RFP No. 75N93021R00003 2

Instructions and Uniform Cost Assumptions, to address concerns raised by potential offerors.

RESPONSES TO QUESTIONS FROM POTENTIAL OFFERORS:

Question 1:

Please clarify Section D of the solicitation, regarding the shipment of reagents. For Pharmacology lab methods, reagents are AGRS/reference drug powders, which cannot be re-shipped (re-distributed) in their original form due to restrictions in Material Transfer Agreements (MTAs) and purchasing agreements. For example, the proposed program could not purchase dolutegravir from a vendor and then re-distribute it to another laboratory.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

Under PART I – THE SCHEDULE, SECTION D – PACKAGING, MARKING AND SHIPPING, of the solicitation (on page 16 of the solicitation), it states the following: “The Contractor will be expected to ship AGRS/reference drug powder, PT and QC samples (i.e., QCMs), and reagents to specified U.S. and non-U.S. Labs, under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with IATA/ICAO (http://www.iata.org) and International Civil Aviation Organization (ICAO) (http://www.icao.int/Pages/default.aspx) dangerous goods shipping regulations and other relevant shipping regulations. The specific shipping/packaging requirements are provided in the Statement of Work.”

NIAID Response to Question 1:

Shipping the AGRS to other Labs may be problematic and we have removed this requirement by virtue of this amendment (see related revision, at the end of this Amendment, following the Questions & Response section). However, the offeror should have the ability to obtain and ship drug powder to Labs, if necessary.

Question 2:

Please clarify what is meant by “QCMs”, which are roughly defined in Attachment 1 - Statement SOW, Section B., item 1.b) (“Provide Labs with quality control materials (QCMs), similar to those described in section A.2., above, for drug stability studies.”), and appear to also relate to Proficiency Testing (PT) samples for stability studies (e.g., “Confirm quality (e.g., impurities) of all PT samples prior to distribution.”).

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Under PART I – THE SCHEDULE, SECTION D – PACKAGING, MARKING AND SHIPPING, of the solicitation (on page 16 of the solicitation), it states the following:

“The Contractor will be expected to ship AGRS/reference drug powder, PT and QC samples (i.e., QCMs), and reagents to specified U.S. and non-U.S. Labs, under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with IATA/ICAO (http://www.iata.org) and International Civil Aviation Organization (ICAO) (http://www.icao.int/Pages/default.aspx) dangerous goods shipping regulations and other http://www.icao.int/Pages/default.aspx

AMENDMENT #1 RFP No. 75N93021R00003 3 relevant shipping regulations. The specific shipping/packaging requirements are provided in the Statement of Work.”

• Under Attachment 3 – Statement of Work, Section C. ACQUIRE, CHARACTERIZE, STORE, DOCUMENT, AND DISTRIBUTE QUALITY CONTROL MATERIALS

(QCMs), paragraph 4. Shipment of AGRS/Reference Drug Powder, PT and QC Samples, and Reagents, states the following: “As required, the Contractor shall ship AGRS/reference drug powder, PT and QC samples (i.e., QCMs), and reagents to specified U.S. and non-U.S. Labs, under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with IATA/ICAO (http://www.iata.org) and International Civil Aviation Organization (ICAO) (http://www.icao.int/Pages/default.aspx) dangerous goods shipping regulations and other relevant shipping regulations.”

NIAID Response to Question 2:

“Quality control materials” (QCMs) are the materials and reagents described in Section C.

ACQUIRE, CHARACTERIZE, STORE, DOCUMENT, AND DISTRIBUTE QUALITY

CONTROL MATERIALS (QCMs), paragraph 4. Shipment of AGRS/Reference Drug Powder, PT and QC Samples, and Reagents. Calibrated standards and controls will also be shipped to labs, and used by the offeror to create proficiency testing samples and panels for shipping to labs.

There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 3:

Please clarify the number of AGRS/reference drug powders to be purchased each year, as the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 1)a.1., instructs offerors to assume up to 25 drugs per year, whereas the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 1)c.1., instructs offerors to assume the purchase of only 3 AGRS/reference drug powders per year.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph a., item 1., instructs offerors to assume the following: “Two rounds of PT will be executed at eight U.S. Laboratories and three non-US Laboratories located in Africa and Asia. This will include the design, preparation, characterization, and distribution of PT panels, capture and analysis of test results, assessment of lab’s performance, generation of Lab-specific performance report, and provision of remediation samples and assistance labs.

Specifically, assume the preparation and shipment on dry-ice of six sets of 275 PT samples (5 sets with varying drug concentrations of up to 25 drugs, and one panel of blank samples; a total of 1650 samples).”

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph c., item 1., instructs offerors to assume the following: “Assume that three (3) AGRS/reference drug

AMENDMENT #1 RFP No. 75N93021R00003 4 powders and appropriate known QC standards/reagents will be purchased with COAs per year.”

NIAID Response to Question 3:

Proficiency testing panels may contain up to 25 drugs per year. Those panels would be produced by the offeror using their own standards and controls that are characterized for the intended use.

For costing purposes, assume that, on average in any given year, the offeror will purchase up to 3 AGRS. Actual numbers may vary during the course of the contract. There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 4:

Please clarify how many compounds initially, and then annually, must be checked for identity and purity. The specification in Attachment 3 – Statement of Work, under Section C.2., is different than the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 1)c.2., which asks for two identity and purity checks per year.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 3 – Statement of Work, Section C. ACQUIRE, CHARACTERIZE, STORE, DOCUMENT, AND DISTRIBUTE QUALITY CONTROL MATERIALS (QCMs), item

2. Characterization of AGRS/Reference Drug Powder and Preparation of PT and QC Samples, states the following: “Conduct initial and periodic purity checks on each lot of AGRS/reference drug powder.”

Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph c., item 2., instructs offerors to assume the following: “Assume that two (2) identity and purity specific studies will be conducted and 100 representative samples of AGRS/reference drug powders will be analyzed per year.”

NIAID Response to Question 4:

Please assume two identity and purity studies per year, in order to keep reference standards up to date. Each study will require multiple samples to be tested. There are no revisions to the solicitation as a result of NIAID’s response to this question. However, please also see NIAID’s response to Question 9, below, which does result in a revision to Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph c., item 2.

Question 5:

Attachment 5 – Additional Business Proposal Instructions, Section 3.1)a.3., instructs offerors to assume the following: “...pre-testing to determine accuracy of 25 representative PT samples, using HPLC-UV and UPLC-MS methods.” However, the term, “accuracy” is not mentioned in Attachment 3 – Statement of Work. Attachment 3 – Statement of Work, Section A. PROVIDE

AN ISO-CERTIFIED PHARMACOLOGY PROFICIENCY TESTING (PT)

PROGRAM, paragraph 2. Proficiency Testing (PT) Samples, item b), states the following:

“Confirm quality (e.g., impurities) of all PT samples prior to distribution.” Please clarify if pre-

AMENDMENT #1 RFP No. 75N93021R00003 5 testing should determine accuracy or if it should confirm quality (e.g., impurities) of all PT samples prior to distribution.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph a., item 3., instructs offerors to assume the following: “Prior to each PT round, pre-testing to determine accuracy of 25 representative PT samples, using HPLC-UV and UPLC-MS methods.”

• Attachment 3 – Statement of Work, Section A. PROVIDE AN ISO-CERTIFIED PHARMACOLOGY PROFICIENCY TESTING (PT) PROGRAM, paragraph 2.

Proficiency Testing (PT) Samples, item b), states the following: “Confirm quality (e.g., impurities) of all PT samples prior to distribution.”

NIAID Response to Question 5:

Pre-testing should determine the concentration of the analyte in the PT samples. As a result of our response to Question 5, we have revised the language of the instruction at Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph a., item 3., to replace the phrase, “accuracy of” with “the concentration of drug or metabolite using”, by virtue of this amendment (see related revision, at the end of this Amendment, following the Questions & Response section).

Question 6:

Please clarify if the cost assumption Attachment 5 – Additional Business Proposal Instructions, Section 3, item 1)b.2., should include the development of a guidance document, or if it should include a laboratory method that NIH wants developed and validated.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 2., instructs offerors to assume the following: “Assume that development of one bioanalytical procedure/method each year at the Contractor’s facilities, which refines sample processing suitable for cellular extract of peripheral blood mononuclear cells, or of other biological matrices (e.g., hair, urine, granuloma tissues, and whole blood), for drug analysis using HPLC-MS or immunoassays.”

• Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 1. Bioanalytical Assay Development, item c), states the following: “Develop methods or procedures that refine and improve sampling processes, sample processing, and storage of non-plasma biological samples. If necessary, consult with experts, in order to determine the optimal procedures for the processing of non-traditional matrices (e.g., hair). Assemble and

AMENDMENT #1 RFP No. 75N93021R00003 6 statistically analyze data from the above-mentioned studies and provide assay development and validation reports to the COR and others as directed by the COR within 60 calendar days following the completion of data analysis.”

NIAID Response to Question 6:

The cost assumption should include the laboratory “method” [as described in Section B.1.c) of Attachment 3 – Statement of Work]. There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 7:

Please clarify how the cost assumption in Attachment 5 – Additional Business Proposal Instructions, Section 3, item 1)b.4., relates to Attachment 3 – Statement of Work.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 4., instructs offerors to assume the following: “Assume that 400 QC samples and 1,100 tested samples will be prepared and analyzed for one (1) new assay development study, each year.”

• Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 1. Bioanalytical Assay Development, item c), states the following: “Develop methods or procedures that refine and improve sampling processes, sample processing, and storage of non-plasma biological samples. If necessary, consult with experts, in order to determine the optimal procedures for the processing of non-traditional matrices (e.g., hair). Assemble and statistically analyze data from the above-mentioned studies and provide assay development and validation reports to the COR and others as directed by the COR within 60 calendar days following the completion of data analysis.”

NIAID Response to Question 7:

The cost assumption in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 4., relates to Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 1. Bioanalytical Assay Development, item c), which describes the work on the development of new assays and the testing of samples. There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 8:

Please clarify how the cost assumption in Attachment 5 – Additional Business Proposal Instructions, Section 3, item 1)b.5., relates to Attachment 3 – Statement of Work.

AMENDMENT #1 RFP No. 75N93021R00003 7

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 5., instructs offerors to assume the following: “Assume that one (1) validated assay study will be conducted and one validated assay will be transferred from the offeror’s facility to one (1) Laboratory each year.”

NIAID Response to Question 8:

3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 5., relates to the following: (1) Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 1.

Bioanalytical Assay Development, which describes assay development and validation; (2) Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 2. Bioanalytical Assay Validation, which describes validation work; and (3) Attachment 3 – Statement of Work, Section B.

SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph

3. Assay Implementation, item d., which describes the transfer of validated assays to Labs.

There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 9:

Please clarify what would be considered “100 representative samples of AGRS/reference drug powders”, since the assumption in Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 1)c.2., is asking for 2 studies.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph c., item 2., instructs offerors to assume the following: “Assume that two (2) identity and purity specific studies will be conducted and 100 representative samples of AGRS/reference drug powders will be analyzed per year.”

NIAID Response to Question 9:

Each study will require several samples to be tested. For costing purposes, offerors shall assume that 100 samples per year will be tested for identity and purity. As a result of our response to Question 9, we have revised the language of the instruction at Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph c., item 2., by virtue of this amendment (see related revision, at the end of this Amendment, following the Questions & Response section).

Question 10:

Regarding Attachment 5 – Additional Business Proposal Instructions, Section 3, item 1)d.1., please clarify what standards need to be developed, what SOPs need to be written, and how these relate to Attachment 3 – Statement of Work.

AMENDMENT #1 RFP No. 75N93021R00003 8

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph d., item 1., instructs offerors to assume the following: “Assume that CPQA standards will be developed for assays for sampling procedures, sample processing, and analysis; and ten

(10) SOPs will be written and finalized each year.”

NIAID Response to Question 10:

3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph d., item 1., relates to the following: (1) Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 2.

Bioanalytical Assay Validation, item d), which describes maintaining and revising guidance documents on assay validation, and providing labs with guidance documents for assay validation; (2) Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 3. Assay Implementation, items a) and b), which cover the development of SOPs, QA documents, and guidance documents for assay implementation, and the development of procedures to help Labs improve the quality of pharmacology outcome measures; and (3) Attachment 3 – Statement of Work, Section D. PROVIDE GUIDANCE AND ASSISTANCE, item 1., which relates to providing Labs with up to 10 procedures/SOPs for performing pharmacological assays and for conducting assay validation studies. These documents should help ensure validation of the methods according to GLP. There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 11:

Please clarify the information requested in the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 2)a., as it does not match the number of Labs (domestic and international) in Attachment 3 – Statement of Work, and it does not match the number of shipments per year in Attachment 3 – Statement of Work (twice per year).

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 2) Special Shipping and Packaging Cost Assumptions, subparagraph a., instructs offerors to assume the following:

“a. Offerors shall assume making:

1. Eighteen (18) domestic shipments and two (2) international shipments for PT per year, in one-cubic foot boxes/shipment on dry ice.

AMENDMENT #1 RFP No. 75N93021R00003 9

2. Twelve (12) domestic shipments for assay development and validation per year, in one-cubic foot boxes/shipment with dry ice.”

NIAID Response to Question 11:

Shipments of PT panels may be combined into one shipment per year containing two PT panels.

The panels would be stored at the Lab until tested. Additional shipments may be required to account for shipment problems, shipments to Labs that might need new panels after failing the initial panel, and shipments of standards and controls that are not part of the proficiency testing panels. We estimated these numbers based on past shipping needs, but they may vary based on actual needs. There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 12:

Regarding the cost assumption in Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 2)a.2., please clarify what would be included in these shipments. In addition, please clarify the number of Labs in the cost assumption in Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 2)a.2., as it does not match the number of Labs in the SOW.

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 2) Special Shipping and Packaging Cost Assumptions, subparagraph a., item 2., instructs offerors to assume the following: “Twelve (12) domestic shipments for assay development and validation per year, in one-cubic foot boxes/shipment with dry ice.”

NIAID Response to Question 12:

These shipments would include standards and controls for use by the Lab, in assay development or validation. Not all Labs will require every shipment, as not all Labs will be validating or developing the same assays. We estimated these numbers based on past shipping needs, but they may vary based on actual needs. There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 13:

Attachment 3 – Statement of Work, Section D.5., specifies “…visits to labs to provide further guidance and assistance.” However, no number of days, personnel, location, or frequency of visits are specified, and this activity does not appear in the cost assumptions. Can the NIAID suggest the number of days, potential locations (domestic or international), frequency of visits, and number of personnel for the offeror to include in the preparation of their budget/cost proposal?

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 3 – Statement of Work, Section D. PROVIDE GUIDANCE AND ASSISTANCE, item 5., states the following: “Recommend to the COR, the planning and

AMENDMENT #1 RFP No. 75N93021R00003 10 conduct of visits to Labs to provide further guidance and assistance, based on Lab-specific needs/performance. Not less than 30 business days prior to each visit, the Contractor shall submit to the COR a written plan providing relevant information, including visit purpose/goals, duration, existing materials to be provided and/or new materials requiring preparation, names of visiting contract staff/experts, and a budget estimate. Within 10 business days following visit completion, prepare a report delineating observations, activities conducted, resolution of needs/problems, and any recommended future plans for additional site-specific guidance/assistance. Distribute the report to the visited Lab, User Groups, and the COR.”

NIAID Response to Question 13:

For this activity, please assume conducting up to two visits per year to three Labs in the U.S.

over the course of the 7-year contract. Assume two-day visits, each requiring 2 Contractor staff.

Question 14:

Attachment 3 – Statement of Work, Section D.6., specifies costs for labs to train at CPQA.

However, no number of days, personnel, or frequency of visits are specified. This activity does appear as a cost assumption (Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 1)d.2.), specifies 2 days for each of the 7 years, for up to 5 Lab investigators).

Should this cost assumption information be used by offerors for the preparation of their budget/cost proposal?

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 3 – Statement of Work, Section D. PROVIDE GUIDANCE AND ASSISTANCE, item 6., states the following: “At the request of the COR, make arrangements for Lab staff visits to the Contractor’s site, or other suitable locations for state-of-art pharmacological methodologies, for the purpose of providing guidance and assistance to the Lab staff. The Contractor shall provide the Lab staff with materials required for training/demonstrations. The Contractor shall not be responsible for the travel costs of participants. Where necessary and feasible, make arrangements for virtual visits by Lab staff, providing guidance and assistance through webinars, videoconferencing, or other appropriate remote platforms, that are accessible by all parties. Following each training session, the Contractor shall prepare a Training Report and provide the report to the COR and others (as specified by the COR) within one month of completion of each training session.”

NIAID Response to Question 14:

Yes, please use the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph d., item 2. However, we have revised the language of the instruction at Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph d., item 2., to provide additional specificity (to include the phrase “per year”), by virtue of this amendment (see related revision, at the end of this Amendment, following the Questions & Response section).

AMENDMENT #1 RFP No. 75N93021R00003 11

Question 15:

Attachment 3 – Statement of Work, Section D.9. specifies the provision of training at NIAID-funded meetings. However, no number of days or personnel are specified. This activity does appear as a cost assumption (Attachment 5 – Additional Business Proposal Instructions, under Section 3, item 1)i., specifies 3 CPQA staff at 2 meetings per year in Washington, DC, for each of the 7 years). Should this cost assumption information be used for the preparation of the budget?

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 3 – Statement of Work, Section D. PROVIDE GUIDANCE AND ASSISTANCE, item 9., states the following: “Provide assistance and guidance to clinical investigators and technicians at NIAID-funded investigator meetings, in order to improve testing proficiency, optimize assay development, and achieve appropriate patient sample handling.”

Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph i., instructs offerors to assume the following: “For the purposes of preparing a cost estimate related to dissemination of clinical pharmacology quality assessment technical and scientific data, assume the costs of attending 2 two-day User Group meetings in Washington DC, each requiring the attendance of 3 Contractor staff per year [refer to the Statement of Work: Section 3) Technical Requirements, paragraph G. Dissemination of Clinical Pharmacology Quality Assessment Technical and Scientific Data].”

NIAID Response to Question 15:

Yes, for the activity associated with Attachment 3 – Statement of Work, Section D. PROVIDE GUIDANCE AND ASSISTANCE, item 9., please use the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph i. As a result of NIAID’s response to Question 15, we have revised Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph i., in order to include the reference to Attachment 3 – Statement of Work, Section D. PROVIDE GUIDANCE AND ASSISTANCE, item 9. (see related revision, at the end of this Amendment, following the Questions & Response section).

Question 16:

Attachment 3 – Statement of Work, Section E. PREPARE LABS FOR FDA LABORATORY INSPECTIONS AND STUDY AUDITS, specifies both “on-site” or “remote” assessments.

However, no number of days, personnel, location, or frequency of visits are specified. These activities do appear in two related cost assumptions for on-site visits (Attachment 5 – Additional Business Proposal Instructions, Section 3, item 1)e.1. – international; Attachment 5 – Additional Business Proposal Instructions, Section 3, item 1)e.2. - domestic), which specify “…two 10-day visits to two non-US Labs, one in Africa, one in Asia, each requiring 2 Contractor staff each year over the course of the 7-year contract period” and “…two 2-day visits to three Labs in the U.S., each requiring 2 Contractor staff each year over the course of the 7-year contract”, respectively.

AMENDMENT #1 RFP No. 75N93021R00003 12

Can the NIAID provide some clarification on whether the budget should be prepared for either “on-site assessments” OR “remote assessments”, as the costs will differ significantly due to travel expenses?

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 3 – Statement of Work, Section E. PREPARE LABS FOR FDA LABORATORY INSPECTIONS AND STUDY AUDITS, item 2., states the following:

“Assess Lab compliance with clinical pharmacology study-specific requirements. The Contractor shall maintain the capability to perform both on-site and remote assessments (where necessary and feasible), including…”

Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph e., item 1., instructs offerors to assume the following: “Assume conducting two ten-day visits to two non-US Labs, one in Africa, one in Asia, each requiring 2 Contractor staff each year over the course of the 7-year contract period.”

Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph e., item 2., instructs offerors to assume the following: “Assume conducting two, two-day visits to three Labs in the U.S., each requiring 2 Contractor staff each year over the course of the 7-year contract.”

NIAID Response to Question 16:

For costing purposes, when preparing your budget, please assume “on-site” assessments.

However, “remote” assessments may be necessary when “on-site” assessments are not possible.

Question 17:

Attachment 3 – Statement of Work, Section B.2.b. specifies review and evaluation of AVRs, but does not specify the number of AVRs per year. However, the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 1., specifies 20 AVR reviews per year for each of the 7 years. Should this cost assumption information be used for the preparation of the budget?

Solicitation Reference(s): Please also refer to the solicitation, to view the below reference(s) in their context.

• Attachment 3 – Statement of Work, Section B. SUPPORT ASSAY DEVELOPMENT, VALIDATION, AND IMPLEMENTATION, paragraph 2. Bioanalytical Assay Validation, item b), states the following: “Review and evaluate AVRs submitted by the Labs, to ensure the accuracy, sensitivity, specificity, and precision or reproducibility of the methods. For trials where the pharmacology data is expected to be submitted to a regulatory agency for approval, review the AVR for conformance to specific agency guidelines for submission.”

AMENDMENT #1 RFP No. 75N93021R00003 13

Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 1., instructs offerors to assume the following: “Assume review of twenty assay validation reports (AVR) and AVR SOPs developed and submitted to the program by the Labs per year.”

NIAID Response to Question 17:

Yes, please use the cost assumption provided in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph b., item 1., for this activity. There are no revisions to the solicitation as a result of NIAID’s response to this question.

Question 18:

Attachment 1 of the RFP specifies, “The total page count of the Technical proposal for each task Area shall not exceed 150 pages.” Can NIH clarify what is included in a task area? Or is the intent of the NIH to limit the entire Technical Proposal to 150 pages?

NIAID Response to Question 18:

The use of the phrase “task area” was in error (there are no task areas, as this is not an IDIQ requirement). Yes, the intent of the guidance is to limit the entire Technical Proposal to 150 pages (the page count for the entire Technical Proposal shall not exceed 150 pages). As a result of NIAID’s response to this question, Attachment 1 is revised to remove the phrase “for each Task Area”, by virtue of this amendment.

The RFP is hereby revised as follows (Please note: All the insertion revisions in these documents are in yellow highlight):

As a result of NIAID’s response to Question 1, PART I – THE SCHEDULE, SECTION D – PACKAGING, MARKING AND SHIPPING, of the solicitation (on page 16 of the solicitation), is hereby revised to remove the phrase “AGRS/reference”, and shall read as follows: “The Contractor will be expected to ship drug powder, PT and QC samples (i.e., QCMs), and reagents to specified U.S. and non-U.S. Labs, under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with IATA/ICAO (http://www.iata.org) and International Civil Aviation Organization (ICAO) (http://www.icao.int/Pages/default.aspx) dangerous goods shipping regulations and other relevant shipping regulations. The specific shipping/packaging requirements are provided in the Statement of Work.” All other terms and conditions of the solicitation remain unchanged.

Similarly, as a result of NIAID’s response to Question 1, ARTICLE C.2. REPORTING REQUIREMENTS, paragraph a. Technical Progress Reports, subparagraph 2. Semi-Annual Progress Report, item (a), sub-item 4. (on page 7 of the solicitation), is hereby revised to remove the phrase “AGRS/reference”, and shall read as follows: “Summary and highlights of activities related to acquisition, characterization, and distribution of drug powder and quality control (QC) materials; results related to stability studies of PT and QC samples;”

AMENDMENT #1 RFP No. 75N93021R00003 14

Similarly, as a result of NIAID’s response to Question 1, Attachment 3 – Statement of Work, Section C. ACQUIRE, CHARACTERIZE, STORE, DOCUMENT, AND DISTRIBUTE QUALITY CONTROL MATERIALS (QCMs), paragraph 4. is hereby revised to remove the phrase “AGRS/reference”, and shall read as follows:

“4. Shipment of Drug Powder, PT and QC Samples, and Reagents

As required, the Contractor shall ship drug powder, PT and QC samples (i.e., QCMs), and reagents to specified U.S. and non-U.S. Labs, under appropriate shipping conditions (e.g., temperature monitoring) and in accordance with IATA/ICAO (http://www.iata.org) and International Civil Aviation Organization (ICAO) (http://www.icao.int/Pages/default.aspx) dangerous goods shipping regulations and other relevant shipping regulations. Additionally, the Contractor shall:

a) Execute agreements with Labs regarding relevant standards for the safe handling, authorized use, and discard of drug powder, PT and QC samples, and reagents.

b) Arrange overnight (or within 3 days, if being sent to a non-U.S. destination) delivery of shipments to the Labs.

c) Obtain the appropriate interstate and foreign shipping licenses and permits for transporting biohazardous materials.

d) Coordinate the shipments of drug powder, PT and QC samples, and reagents, to the Labs, including notices of incoming shipments.”

Similarly, as a result of NIAID’s response to Question 1, Attachment 3 – Statement of Work, Section J. EXECUTE INITIAL AND FINAL TRANSITION, paragraph 1. Initial Transition, subparagraph b), item 1), is hereby revised to replace the acronym “AGRS” with “drug powder”, and shall read as follows: “Stored drug powder, PT samples, QC samples, and reagents;”

Similarly, as a result of NIAID’s response to Question 1, Attachment 3 – Statement of Work, Section J. EXECUTE INITIAL AND FINAL TRANSITION, paragraph 2. Final Transition, subparagraph c), item 1), is hereby revised to remove the acronym “AGRS/”, and shall read as follows: “Stored drug powder, PT samples, QC samples, and reagents. The Contractor shall perform calibration and lot-to-lot comparisons between drug powder, PT and QC samples (QCMs), and reagents prior to them being transferred to the successor Contractor;”

As a result of NIAID’s response to Question 5, the instruction in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph a., item 3., is hereby revised to replace the phrase, “accuracy of” with “the concentration of drug or metabolite using”, and shall read as follows:

“Prior to each PT round, pre-testing to determine the concentration of drug or metabolite using 25 representative PT samples, using HPLC-UV and UPLC-MS methods.”

AMENDMENT #1 RFP No. 75N93021R00003 15

As a result of NIAID’s response to Question 9, the instruction in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph c., item 2., is hereby revised to read as follows:

“Assume that two (2) identity and purity specific studies will be conducted per year using a total of 100 representative samples of AGRS/reference drug powders.”

As a result of NIAID’s response to Question 14, the instruction in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph d., item 2., is hereby revised to include the phrase “per year”, and shall read as follows: “Conducting one 2 two-day hands-on clinical pharmacology Lab-specific training sessions per year at the Contractor site over the 7-year course of the contract, each hosting up to 5 Lab investigators. Travel and lodging costs of visiting investigators will not be borne by the Contractor.”

As a result of NIAID’s response to Question 15, the instruction in Attachment 5 – Additional Business Proposal Instructions, under Section 3 – Uniform Cost Assumptions, paragraph 1) Technical Cost Assumptions, subparagraph i., is hereby revised to include the reference to Attachment 3 – Statement of Work, Section D. PROVIDE GUIDANCE AND ASSISTANCE, item 9., and shall read as follows: “For the purposes of preparing a cost estimate related to dissemination of clinical pharmacology quality assessment technical and scientific data, assume the costs of attending 2 two-day User Group meetings in Washington DC, each requiring the attendance of 3 Contractor staff per year [refer to the Statement of Work: Section 3) Technical Requirements, paragraph G. Dissemination of Clinical Pharmacology Quality Assessment Technical and Scientific Data, and paragraph D. Provide Guidance and Assitance, item 9.].”

As a result of NIAID’s response to Question 18, Attachment 1 – Packaging and Delivery of Proposal, paragraph II. FORMATTING AND PAGE LIMITATIONS, subparagraph B. Page limitations, item 1., is hereby revised to remove the phrase “for each Task Area”, and shall read as follows: “The total page count of the Technical proposal shall not exceed 150 pages.”

The following revised attachments, reflecting the above changes, are also included with this amendment: Attachment 1 – Packaging and Delivery of Proposal, Attachment 3 – Statement of Work, and Attachment 5 – Additional Business Proposal Instructions (see attached).

END OF AMENDMENT NO. 1, RFP No. 75N93021R00003

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

RFP No. 75N93021R00003 Page 1 of 2

Attachment 1 RFP No. 75N93021R00003

Clinical Pharmacology Quality Assurance (CPQA) Program

Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

RFP No. 75N93021R00003 Page 2 of 2

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 150 pages.

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not exceed 3 pages.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

STATEMENT OF WORK

December 15, 2020

ATTACHMENT 3

ATTACHMENT 1: STATEMENT OF WORK

CLINICAL PHARMACOLOGY QUALITY ASSURANCE (CPQA) PROGRAM

RFP NO. 75N93021R00003

1) BACKGROUND AND INTRODUCTION

The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related co-infections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions.

The purpose of NIAID Clinical Pharmacology Quality Assurance (CPQA) Program is to provide a comprehensive quality assessment program for clinical pharmacologic laboratories testing samples from subjects enrolled in NIAID-supported clinical studies. The CPQA Program ensures the validity and inter- and intra-laboratory comparability of pharmacological study data by providing laboratories with materials for pharmacology proficiency testing and assay controls, and monitoring proficiency and assay data from each laboratory. The program also develops and implements standards of performance for new pharmacology assays, develops and tests methods relating to the assays, and acquires, tests, stores, and dispenses quality control materials and reagents. Thus, the CPQA Program is critical to the scientific integrity of on-going and future studies concerning the assessment of therapeutic and prevention measures for HIV and other infectious diseases.

The current contract provides services to 11 U.S. and non-U.S. clinical pharmacology laboratories (Labs) affiliated with NIAID-supported clinical trial networks and collaborating study groups (User Groups). Labs are chosen by User Groups to participate in a clinical trial. It is critical to evaluate, both initially and on an on-going basis, the ability of Labs to perform protocol-specified pharmacology assays correctly and reliably.

The current contract is held by the Research Foundation of State University of New York, under Contract No. HHSN272201500006C. The period of performance of the current contract is May 30, 2015 through May 29, 2022.

2) SCOPE

The Contractor shall provide comprehensive quality assessment programs to clinical pharmacology laboratories (Labs) that test samples from subjects enrolled in NIAID-supported clinical studies. Options to provide increased level of effort to support additional labs (domestic and international) and to support unanticipated increases in demand for the activities supported by the base requirements of the contract, are also within the scope of the contract work.

3) TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise

ATTACHMENT 3

provided by the Government, as needed, to perform the Statement of Work below.

Specifically, the Contractor shall:

A. PROVIDE AN ISO-CERTIFIED PHARMACOLOGY PROFICIENCY TESTING (PT)

PROGRAM

1. Quality Assurance (QA) Standards for Executing Proficiency Testing

Develop and maintain Standard Operating Procedures (SOPs) and manuals for executing…