ATTACHMENT_5_Business_Proposal_Instructions_CPQA_15_Amendment__1_FINAL.pdf

ATTACHMENT 5: ADDITIONAL BUSINESS PROPOSAL

INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS

CLINICAL PHARMACOLOGY QUALITY ASSURANCE PROGRAM (CPQA)

RFP No. NIAID-DAIDS-NIHAI2014002

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)

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 the proposal in a clearly marked section.

SECTION 3 – UNIFORM COST ASSUMPTIONS

It is anticipated that a level of effort type contact will be awarded as a result of this solicitation. The period of performance will be for one year beginning on or about March 1, 2015 through February 29, 2016. The requirement will be the delivery of

8.85 full time equivalents (FTEs) per year for the base period (Year 1) and 8.85 FTEs per year for Options 1-6 (Years 2-7).

1) Technical Cost Assumptions

a. For costing activities related to monitoring the ability of Labs to perform pharmacology assays, assume that PT programs provided by the CPQA will

Attachment 5: Additional Business Proposal Instructions Page 1 be continued throughout the duration of the new contract. Assume that the following activities will occur on an annual basis:

1. 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 each 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).

2. Preparation of six sets of quality control standards, each consisting of 30 quality control samples of 5 antiretroviral and antimicrobial drugs, with varying drug concentrations in the cellular extracts of peripheral blood mononuclear cells or other appropriate non-plasma biomatrices;

total of 180 samples will be prepared for stability studies (or assay validation studies) at participating Labs.

3. Prior to each PT round, pre-testing to determine accuracy of 25 representative PT samples, using HPLC-UV and UPLC-MS methods.

4. Maintenance services (but not the purchase) of HPLC-UV and UPLC-MS at the offeror’s site.

b. For costing activities related to providing support to Labs conducting studies for the development, validation and implementation of pharmacology assays, assume the following activities performed by the offeror on an annual basis:

1. Review of eight assay validation reports (AVR) and AVR SOPs developed by the Labs.

2. Development of one bioanalytical procedure/method each year at the

Contractor’s facilities, which refines sample processing of cellular extract of peripheral blood mononuclear cells for drug analysis using

HPLC-MS.

3. Shipment on dry-ice of 6 packages, each containing 10 QC samples, to six US Labs, three times a year, for stability studies (or assay validation studies).

4. Shipment on dry-ice of 22 packages, each containing 8 PT samples, to

8 US Labs and 3 non-US Labs (in South Africa, Zimbabwe, and Thailand) for stability studies.

Attachment 5: Additional Business Proposal Instructions Page 2

c. For costing activities related to acquiring, characterizing, storing, documenting, and disbursing QC materials, assume the following costs annually:

1. Procurement of two AGRS/reference drug powders and appropriate known QC materials.

2. Two analytical assessments on each lot of AGRS/reference drug powder for the purity in which up to 100 representative samples will be analyzed. These will be the samples of initial and periodic purity checks on each lot of AGRS or reference drug powders in appropriate solutions for analytical assessment.

3. Conduct of three studies for PT/QC storage and shipment conditions.

4. One shipment of 1 mg AGRS/reference drug powder to one U.S. Lab and one non-U.S. Lab. The Contractor must abide by the policies contained within any agreement granted by the Provider of the AGRS/reference drug powders. For the purposes of estimated costs, the Offeror should assume only shipment costs. Any administrative (i.e., labor) costs associated with obtaining any material transfer agreements, if required, shall be accounted for within the Government’s stated level of effort requirement for this solicitation (see Section L:

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS,

paragraph 1, General Information, subparagraph d., Level of Effort).

5. Storage at -80oC of 3500 new samples.

d. For costing activities related to providing Labs and clinical site staff with assistance, and guidance for performing pharmacology assays, conducting assay validation studies, and for implementing quality practice in clinical pharmacology study conduct, assume the following activities annually:

1. Two three-day, hands-on, training sessions in basic chromatographic techniques, instrument validation and use of LDMS for PT and for protocol-specified pharmacology assays. This will take place at the Contractor’s facilities with up to 11 visiting Lab participants per session.

Travel and lodging costs of the visiting Lab participants shall not be borne by the Contractor.

2. Administration of an existing on-line tutorial for the clinical site staff on pharmacokinetics and pharmacodynamics, and on sample collection, processing and storage for clinical pharmacology study protocols.

3. Hosting 24 one-hour conference calls for eight U.S. and three non-U.S.

participants.

Attachment 5: Additional Business Proposal Instructions Page 3

e. For costing activity related to the conduct of on-site Lab assessments and study-specific audits, assume the following activities annually:

1. One three-day visit to one U.S. Lab in California, requiring two contractor staff.

2. One seven-day visit to one non-U.S. Lab in Thailand, Zimbabwe, or

South Africa, requiring two contractor staff.

2) Other Meetings – cost assumptions

a. Assume the cost of travel by three Contractor staff to provide instruction and guidance to investigators and technicians attending two NIH-funded program/network meetings a year, one in Atlanta and one in Washington DC, each lasting three days.

b. Assume the administrative costs of one contract initiation meeting of one-day duration at the Contractor site as well as one annual site visit of one-day duration by the COR and other NIAID personnel designated by the COR.

The Contractor shall not be responsible for travel support for the COR nor NIAID personnel.

SECTION 4 – OPTIONS

Options for Increased Services (Options 7-18):

The Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include the following:

Increased Level of Effort for Additional Pharmacology Laboratories (Options 7-18): During the course of the contract, it may be necessary to incorporate additional Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of one domestic or international Lab. Up to two Options per year may be exercised during years 2 through 7 of contract performance. If the Government elects to exercise these Options, the Contractor shall provide an additional 0.90 FTEs per Option. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. Below is a table that shows a breakdown of Options per year and the anticipated level of effort by labor category for each.

Attachment 5: Additional Business Proposal Instructions Page 4

FULL TIME EQUIVALENTS

Base Year Year 1

Option 1 Year 2

Option 2 Year 3

Option 3 Year 4

Option 4 Year 5

Option 5 Year 6

Option 6 Year 7

3/1/15 - 2/29/16

3/1/16 - 2/28/17

3/1/17 - 2/28/18

3/2/18 - 2/28/19

3/1/19 - 2/29/20

3/1/20 – 2/28/21

3/1/21 – 2/28/22

Option 7 Option 8 Option 9 Option 10 Option 11 Option 12

0.90 0.90 0.90 0.90 0.90 0.90 Option 13 Option 14 Option 15 Option 16 Option 17 Option 18

0.90 0.90 0.90 0.90 0.90 0.90

FULL TIME EQUIVALENTS

Labor Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7 Project Management

0.05 0.05 0.05 0.05 0.05 0.05

Research Technician

0.80 0.80 0.80 0.80 0.80 0.80

Administrator 0.05 0.05 0.05 0.05 0.05 0.05

Total 0.90 0.90 0.90 0.90 0.90 0.90 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 performance of the work.

For costing Options 7-18 for additional pharmacology Labs, offerors should assume that 2 Options per year during years 2 through 7 will be exercised as follows: 1 option for the addition of 1 domestic Lab and 1 option for an international Lab. In addition, assume for each Option, the participation of one Lab in the CPQA proficiency testing program, and shipment of PT panels every six months on dry-ice to that Lab; assume one 7-day inspection visit to a Lab in South Africa/Thailand/Zimbabwe; assume one 3-day inspection visit to a Lab in California;

assume one 3-day hands-on training session at the CPQA for 3 technicians.

SECTION 5: OTHER CONSIDERATIONS

Section L of the RFP provides minimum documentation requirements for the following items. The required information described in Section L should be assembled together, in the following clearly marked sections of the Business Proposal. Refer to Section L of the RFP for specific requirements. Read each section below carefully. In some cases, offerors may be asked to provide

Attachment 5: Additional Business Proposal Instructions Page 5 documentation which is in addition to the minimum requirements identified in Section L.

1) Small Business Subcontracting Plan

Section L of the RFP specifies the minimum documentation requirements for completing a subcontracting plan. This plan should be turned in with the original proposal. All related documentation should be included in the proposal in a clearly marked section.

2) Extent of Small Disadvantaged Business Participation

Section L of the RFP specifies the minimum documentation requirements for small disadvantaged business utilization. This information should be turned in with the original proposal. All related documentation should be included in the proposal in a clearly marked section.

3) Past Performance Data, including references

Section L of the RFP specifies the minimum documentation requirements for providing past performance information. This information should be turned in with the original proposal. All related documentation should be included in the proposal in a clearly marked section.

4) IT Systems Security

The Business Proposal should include a plan for IT Systems security.

The contract is subject to Federal Information Security Management Act (FISMA) compliance.

The NIAID Cyber Security Program will collect FISMA deliverables from the contractor, perform FISMA security audits of contractor IT environment(s) where contractual data exists, and validate the systems/data security controls.

Validation criteria are based on NIST-recommended security controls for the Health Care Research and Practitioner Education Information type.

Validation recommendations are found in NIST Special Publication 800-60, Volume II, Revision 1, § D.14.5. Failure to comply with FISMA can void the contract.

5) Section 508 Compliance

Section L of the RFP specifies the minimum documentation requirements for 508 Compliance. All related documentation should be included in the Business Proposal in this clearly marked section.

Attachment 5: Additional Business Proposal Instructions Page 6