RFP_-_MCM_CSN.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The Offeror acknowledges receipt of amend-ments to the SOLICITATION for Offerors and related documents numbered and dated:

(Type or Print)

PAGES

(Date) (Hour)

SEC. PAGE(S) SEC. PAGE(S)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The Offeror acknowledges receipt of amend-ments to the SOLICITATION for Offerors and related documents numbered and dated:

15A. NAME

AND

ADDRESS

OF

OFFEROR

(Type or Print)

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 156

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

RFP-13-100-SOL-00008

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED

(RFP)

5. DATE ISSUED

04/01/2013

6. REQUISITION/PURCHASE

NO.

N/A

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

HHS/OS/ASPR/AMCG

330 Independence Ave, SW, RM G-640 Washington, DC 20201

NOTE: In sealed bid solicitations “offer” and “Offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 0 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in See Block 7 until 12:00 PM local time May 16, 2013

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Matthew McCord

a. TELEPHONE (NO COLLECT CALLS)

(202) 260-0689

b. E-MAIL ADDRESS matthew.mccord@hhs.gov

11. TABLE OF CONTENTS

((x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 01 X I CONTRACT CLAUSES 41

X B SUPPLIES OR SERVICES AND PRICES/COSTS 03 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 09 X J LIST OF ATTACHMENTS 52

X D PACKAGING AND MARKING 17 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 18 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 19 X OTHER STATEMENTS OF OFFERORS 53

xx X G CONTRACT ADMINISTRATION DATA 25 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 56

X H SPECIAL CONTRACT REQUIREMENTS 30 X M EVALUATION FACTORS FOR AWARD 70

OFFER (Must be fully completed by Offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _________calendar days (60 calendar days unless a different period is inserted by the Offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

% AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

FAR (48 CFR) 53.214©

K

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/ Contract Form, accounting, appropriation and general information applicable to the contract award.

The contract schedule, set forth in Sections B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that will be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

MEDICAL COUNTERMEASURES CLINICAL STUDIES NETWORK

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This Request for Proposals (RFP) solicits proposals for an indefinite delivery, indefinite quantity

(IDIQ) contracts for the execution of clinical services. It is anticipated that fixed price or cost type task orders will be issued under this contract.

The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the

Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and

Human Services (HHS), seeks to establish a Medical Countermeasure Clinical Studies Network

(MCM CSN) to facilitate Medical Countermeasure (MCM) product development towards licensure.

BARDA has a specific need to create a clinical core service to support clinical development of the product candidates in its development pipeline. BARDA needs clinical core services because

BARDA-sponsored product developers and manufacturers may not have the appropriate or adequate clinical expertise, may not be interested in pursuing an indication relevant to the mission of BARDA, or may be cost-prohibited to pursue. Additionally, during a public health medical emergency, additional clinical services beyond present government capacities may be needed to provide supportive regulatory data for the use of these products (e.g., post-licensure field effectiveness studies). Through a set of contractual agreements, BARDA will establish a network of Clinical

Research Organizations (CROs) to provide a wide-array of clinical services to meet BARDA requirements. The activities and clinical sites of the BARDA MCM CSN will be coordinated with clinical studies performed by HHS interagency and industry partners, especially with those of the

National Institute of Allergy and Infectious Diseases (NIAID). BARDA will coordinate the activities and management of the MCM CSN.

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Biomedical

Advanced Research and Development Authority (BARDA) to support development and acquisition of medical countermeasures (MCMs) to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza (PI), and emerging infectious diseases (EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is entrusted to foster innovation of technologies that enable better manufacturing, testing, and utilization of these medical countermeasures.

This network will complement the academic and research focused network of clinical sites established by NIAID using a CRO-based clinical network for product evaluations rather than an academic institution-based model. Clinical samples from BARDA MCM CSN clinical studies will be made available to the NIAID as requested to compare and further analyze immunological and other host responses to the product(s) and to provide further knowledge on the mode of action or identification of surrogates/correlates. The provision of samples will be closely coordinated and established by BARDA and NIAID with industry partners and CROs during clinical protocol development.

As directed by Task Order(s), MCM CSN contractors shall provide clinical services in support of the execution of adequate and well controlled Food and Drug Administration (FDA) regulated trials, either Phase 1 – 4, or trials during a public health medical emergency. Clinical services will support the evaluation of Chemical, Biological, Radiological, Nuclear (CBRN), Pandemic Influenza (PI), and

Emerging Infectious Disease (EID) medical countermeasures. Studies may include healthy adults, pediatric, elderly and other populations with special medical requirements. Study timelines will be specified in the Task Order (e.g. routine or urgent). MCM CSN contractors will perform targeted clinical studies relevant to BARDA‘s vision to create a nation with the capability to respond quickly and effectively to deliberate, natural and emerging threats by providing a range of clinical study services that can be used by BARDA and development partners of BARDA.

B.2. SPECIFIC REQUIREMENTS

Objective 1: Clinical Studies: Clinical services shall support the evaluation of CBRN, PI and/or

EID MCMs.

Objective 2: Clinical Trial Response Readiness: Task Orders may require the development and implementation of a detailed plan to permit the initiation of a clinical study within a predefined timeframe.

B.3. CONTRACT TYPE

The Government intends to award one or more indefinite-delivery, indefinite-quantity (IDIQ) contract(s) for clinical study services. During the period of performance of the contract, the government may order, and the Contractor shall provide, services as identified in future Task Orders.

At the discretion of the government, Task Orders issued under this contract may be Firm-Fixed Price

(FFP) or Cost Reimbursement (CR).

B.4. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the

Offeror.

It is anticipated that any contract awarded under this solicitation shall contain a base period of two years (24 months). It is further anticipated that any resulting contract will include three consecutive one year (12 months) contract options. Contract options are exercised at the discretion of the government. Exercise of these options could increase the total period of performance to five years

(60 months).

The Government will issue Requests for Task Order Responses (RTORs) and contractors will compete for Task Orders for clinical research services based on the work described in the Statement of Objectives in SECTION C of this contract. Upon delivery and acceptance of the services described in each Task Order, the Government shall pay to the Contractor the price, costs or fee set forth in the Task Order.

Below is a possible Contract Line Item Number (CLIN); the final contract will contain CLINs agreed upon by the Government and the Offeror. Offerors are invited to propose alternate CLINs and sub-CLINs.

B.4.1. Base Period

CLIN # Description of Option Item(s) -or- Option

Service(s)

Estimated Cost or Price

0001 Base Period (24 months) – Clinical Study Services and Technical Reports on Task Orders.

TBD*

* Business proposals shall include labor rate costs, facility costs, and all other costs necessary to complete clinical study services

B.4.2. Option Periods

The final contract will contain the price/cost provisions for Options agreed upon by the

Government and the Offeror.

Below is a list of possible Optional CLINs; the final contract will contain Optional CLINs agreed upon by the Government and the Offeror:

CLIN # Description of Option Item(s) -or- Option

Service(s)

Estimated Cost or Price

0002 Option Year One – Clinical Study Services and

Technical Reports on Task Orders.

TBD*

0003 Option Year Two – Clinical Study Services and

Technical Reports on Task Orders.

TBD*

0004 Option Year Three – Clinical Study Services and

Technical Reports on Task Orders.

TBD*

* Business proposals shall include labor rate costs, facility costs, and all other costs necessary to complete clinical study services

Unless the Government exercises its option pursuant to the option clause referenced in SECTION I.3.

Additional Contract Clauses, this contract consists only of the base award.

B.4.2.1. Option Year One

The USG may exercise optional CLIN 0002 to extend the contract for clinical study services for 12 months beyond the base award term.

B.4.2.2. Option Year Two

The USG may exercise optional CLIN 0003 to extend the contract for clinical study services for 12 months beyond Option Year One.

B.4.2.3. Option Year Three

The USG may exercise optional CLIN 0004 to extend the contract for clinical study services for 12 months beyond Option Year Two.

B.5. ADVANCE UNDERSTANDINGS

The final contract may contain additional advance understandings between the Government and the Offeror.

B.5.1. Minimum Ordering Amount

The Contractor or Contractors shall each be reimbursed by the Government in an amount not less than a total of $400,000.00 for all contract Task Orders awarded during the base period under this solicitation. The Government is not obligated to order more than the stated minimum for the base contract period.

Each of the possible Optional CLINs, if exercised, would obligate the government for an additional

$200,000.00 per Contractor.

B.5.2. Maximum Ordering Amount – $600,000,000.00

The Contractor(s) shall not receive payment from the Government in an amount greater than

$600,000,000.00 for successful performance under this contract. This contract ceiling is the

Government‘s most optimistic scenario with respect to the Government‘s needs and level of funding.

B.5.3. Fulfilling Minimum Order Requirements

The minimum guarantee under this IDIQ contract is $400,000.00 per contractor. This amount can only be claimed at the end of the period of performance of the base contract if the Contractor takes advantages of fair opportunity, as described in FAR 16.505, by proposing on at least one Task Order.

If the Government fails to award Task Orders to each contractor in the amount of $200,000.00 during any option period of performance after exercising any of the possible Optional CLINs as described in

SECTION B.4, the affected Contractor(s) may invoice for the balance of this additional guaranteed minimum. This amount can only be claimed at the end of the period of performance of the corresponding option contract if the Contractor takes advantages of fair opportunity, as described in

FAR 16.505, by proposing on at least one Task Order during that period.

B.5.4. Pricing of Task Orders

Individual Task Orders will be issued as requirements occur, and will specify work to be performed.

The Contractor shall perform all services in accordance with each task order‘s work statement/specifications. The terms and conditions set forth in this contract will always apply.

See SECTION G.4. for further ordering information and procedures.

B.5.5. Funding

Funds for the services provided will be obligated, at the task order level, as they become available, or excess funds de-obligated at the task order level, by modification to the task order contracts unilaterally by the Government. The contractor will only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed.

B.5.6. Cost Unallowable Unless Authorized by the Contracting Officer

This section prohibits or restricts the use of contract funds for the following, unless otherwise approved in advance by the Contracting Officer:

a) Acquisition, by purchase or lease, of any interest in real property;

b) Rearrangement or alteration of facilities;

c) Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar value;

d) Accountable Government Property;

e) Travel to attend general scientific meetings/conferences;

f) Foreign Travel Costs;

g) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

h) Costs to be paid for the performance of a fixed-price subcontract that exceeds $150,000.00;

i) Patient Care Costs; and

j) Light Refreshment and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the

Contracting Officer‘s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to ―HHS Policy on Promoting Efficient

Spending: Use of Appropriate Funding for Conferences and Meetings, Food and Promotional

Items and Printing and Publications.‖ The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provide; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility.

B.5.7. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

For contract work performed on a cost reimbursement basis, the Contractor agrees to provide a detailed breakdown on invoices of the following cost categories (as applicable):

1. Direct Labor - Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.

2. Fringe Benefits - Cite rate and amount

3. Overhead - Cite rate and amount

4. Materials & Supplies - Include detailed breakdown when unit price is over $1,000.

5. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

6. Consultant Fees - Identify individuals and amounts.

7. Subcontracts - Attach subcontractor invoice(s).

8. Equipment - Cite authorization and amount.

9. G&A - Cite rate and amount.

10. Total Cost

11. Fixed Fee

12. Total Cost Plus Fixed Fee (Total CPFF)

For contract work performed on a cost reimbursement basis, monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the

Government. Also note the Contracting Officer may require the Contractor to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31.

SECTION C – STATEMENT OF OBJECTIVES (SOO)

C.1. INTRODUCTION/BACKROUND

This acquisition is part of a comprehensive strategy and commitment in the BARDA Strategic Plan

(2011) to establish core service assistance to MCM developers directly in the form of technical, clinical and regulatory assistance, and assist BARDA in addressing public health needs in an emergency. To date, BARDA has provided core service assistance to developers directly in the form of technical, clinical, and regulatory assistance from internal subject matter experts. BARDA has partnered with more than 12 laboratories comprising an animal studies network to provide CBRN

MCM developers with animal model development and current Good Laboratory Practice (cGLP) animal challenge studies. BARDA has utilized the animal studies network to evaluate lead product candidates to determine whether additional development and investment into these product candidates were warranted. Further BARDA core services include the Centers for Innovation in

Advanced Development and Manufacturing (CIADM) established by BARDA in 2012 with industry and government partners to assist biological product developers with development and manufacturing assistance. The CIADMs were created to manufacture rapidly vaccines and other biological products in emergencies including influenza pandemics or emerging infectious disease outbreaks.

BARDA also wishes to provide core service assistance to MCM developers in the clinical evaluation of MCMs towards product licensure such as those product developers utilizing the services of the

BARDA-supported Centers for Innovation in Advanced Development and Manufacturing.

Additionally, there is need for clinical studies by BARDA during public health emergencies, when collection of clinical information about a MCM is necessary for its utilization during that emergency or to fulfill post-licensure marketing commitments with industry partners during an event. This core service will assist in the clinical development of MCMs addressing the public health and medical consequences of CBRN accidents, incidents and attacks, PI, and EID. This core service supports the

Office of the ASPR‘s objective to lead the country in preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters.

The strategic objectives of this acquisition are to:

Provide a clinical study core service for use on a routine or emergency basis by

BARDA and by BARDA‘s product development partners

Enhance BARDA‘s preparedness and response to CBRN, PI and EID threats.

Promptly complete clinical activities supporting regulatory applications including but not limited to EUA.

Conduct urgently needed clinical trials during a public health emergency.

Improve financial management of clinical trials and potentially reduce the MCM clinical development costs to BARDA.

Reduce the risk associated with less mature or repurposed products by expanding the available clinical data.

This acquisition provides the clinical services needed for BARDA to establish a network of clinical research organizations. BARDA MCM Programs will identify their clinical service needs, and

BARDA will review and prioritize these clinical service requests. The prioritized list of clinical service requests will be presented to an HHS interagency coordination committee, which will include representatives from the Centers for Disease Control and Prevention (CDC), the Food and Drug

Administration (FDA), NIAID, and BARDA to identify clinical service resources that may be available. If the determination is made that the BARDA clinical services network best addresses the

BARDA program‘s clinical service request, then BARDA will issue a task order for competitive bid among members of the BARDA clinical services network, in accordance with FAR 16 for ―Indefinite delivery – indefinite quantity (ID-IQ) contracts.‖

Request for Task Order Response (RTOR) proposals from BARDA clinical service network members will be evaluated and awarded in accordance with FAR 16.505.

MCM safety and efficacy data in healthy adult, pediatric, elderly, immune-compromised and other special populations are critical for the use of these products in these populations. Once the regulatory path for these populations has been defined, the BARDA clinical services network is expected to address BARDA‘s clinical study needs in these groups in normal development but especially during public health emergencies. The BARDA clinical services network will allow collection of data for special populations or product uses that are not in the approved package insert or business plan of the company developing the product, when other means are not available.

The studies executed by the BARDA clinical services network are expected to provide data packages supportive of Emergency Use Authorization (EUA) for BARDA MCMs. The BARDA clinical services network will also allow the collection of efficacy data during a declared emergency and

EUA product use and assist industry partners in the planning and execution of post-licensure safety and effectiveness studies during public health emergencies using BARDA-supported MCMs (e.g., pandemic influenza vaccines).

C.2. REFERENCES

Pandemic All-Hazard Preparedness Act of 2006 (PL109-417)

Pandemic and All-Hazards Preparedness Reauthorization Act of 2012 (PL113-5)

BARDA Strategic Plan 2011-2016 (Washington DC: U.S. Department of Health and Human Services

Assistant Secretary for Preparedness and Response, October 14, 2011), http://www.phe.gov/about/barda/Documents/barda-strategic-plan.pdf

ASPR Strategic Plan 2011-2015, accessed February 29, 2012.

http://www.phe.gov/about/aspr/strategic-plan.

C.3. SCOPE AND TECHNICAL REQUIREMENTS

Independently and not as an agent of the US Government (USG), the Contractor shall furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities not otherwise provided by the USG as needed to perform the work described.

C.3.1. Objective 1: Clinical Studies

The Offeror shall provide clinical research services and study execution as a service to BARDA.

These studies will clinically evaluate CBRN, PI and/or EID MCMs. These studies may be Phase 1, 2, 3, or 4 (as defined by the FDA) or combinations of these phases.

Clinical research services may include the following components:

1. Planning and pre-study activities

a. Protocol development support services, including the development of clinical protocols and protocol-related documents

b. Assist BARDA/DCS in final study protocol and investigator brochure development

c. Regulatory and other document preparation, editing, formatting, submission and approval(s)

d. Protocol specific clinical site monitoring, identification, assessments and selection plans

e. Establishment of sub-contracts necessary to execute the study

f. Development and implementation of training programs for clinical site personnel regarding the conduct of clinical trials including Quality

Management

2. Safety monitoring

a. Provision of 24 hour medical monitoring

b. Develop, initiate, and maintain an appropriate safety review committee (SRC) or independent data safety and monitoring board (DSMB)

c. Develop and institute plans for safety assessment and monitoring activity including identification, reporting and tracking systems for AEs, SAEs, as well as an effective medical monitoring action plan which includes stopping rules and communications of adverse events to all clinical sites

3. Document creation and management

a. Receipt, assessment and maintenance of essential site regulatory documentation

b. Creation and maintenance of clinical trial master file(s)

c. Provide clinical site regulatory support including preparing, submitting and maintaining regulatory documents

d. Assistance in the preparation of study-related materials and instructions

e. Medical writing including but not limited to final clinical study reports

f. Assist BARDA in obtaining necessary regulatory documents and approvals, developing CRFs, investigational drug brochures and clinical trial master file(s)

4. Clinical trial execution

a. Performing clinical site initiation visits

b. Execution of the clinical protocol including assisting sites with the development of subject recruitment plans, subject retention strategies and monitoring enrollment

c. Planning and conducting clinical site monitoring and reporting

d. Development and implementation of clinical site quality management programs

e. Site essential document management activities

f. Enrollment, site visits, SAEs, etc

g. Training of clinical site staff and assessment of clinical site capabilities for data collection and management

5. Identification and contractual agreements with clinical research vendors to support studies as needed, including but not limited to:

a. Clinical laboratories

b. Remote data entry

c. Investigational product packaging, labeling and shipping

d. Interactive voice response systems for subject randomization and tracking

6. Data management and Biostatistics including but not limited to:

a. Case Report Form (CRF) design and database development/implementation

b. Establishment and maintenance of a centralized data reporting system to track the performance of all clinical support service activities, e.g. clinical specimen tracking system, radiological diagnostic data system

c. Design and execution of a statistical analysis plan

d. Real time data-access

e. Database off-site backup and retention post-trial completion

7. Quality metrics

a. Implementation of an effective internal Quality Assurance and Quality

Control plan for the Offeror‘s coordinating and documented preparation activities

b. Development and implementation of a Quality Assurance and Quality Control plan to ensure clinical sites comply with domestic and country-specific regulations governing research with human subjects

c. An established internal system to measure, monitor and improve the level of performance of the personnel responsible for direct management of the sites

(e.g. CRA monitoring activities, CTA essential records management)

8. Clinical site management

a. Have the in house capability, or through established subcontract relationships to conduct a broad range of activities involved in clinical studies including but not limited to: clinical site(s) selection, clinical and research laboratory support, statistical design and analyses functions, data collection including electronic data entry, data management services, product or specimen labeling, as well as storage and transport of investigational product and clinical specimens

b. Have current access to a network of sites/investigators available to perform clinical studies; including sites with access to special populations such as the elderly, immuno-compromised, neurologically impaired, children and infants

c. Plan and conduct pre-study activities related to the clinical site readiness including clinical site training for protocols and development of successful subject recruitment strategies

d. Development and implementation of clinical site quality management programs; including data quality assessments, source data validation, and data master files, and perform quality audits. The Contractor shall also have well designed and regularly instituted clinical site quality checks on study personnel performance as well as study specific regulatory and SOP documents

e. Establishment and maintenance of centralized data reporting systems to track individual site activities such as numbers of subjects screened, enrolled, withdrawn and completed, percentage of CRF reviewed and locked

f. Develop and maintain a system to monitor all clinical site items that require expiratory dates such as site personnel professional licensures, IRB initial approval and periodic IRB status reports, Federal Wide Assurance certification, equipment inspections, temperature monitoring or calibration, and laboratory license(s)

g. Risk management clinical site contingency plans for slow enrollment such as frequent meetings with the clinical sites and identification and pre-qualification of back-up clinical sites

C.3.2. Objective 2: Clinical Trial Response Readiness

Successful Offerors shall provide clinical study execution services, as described in Objective 1, for

CBRN, PI and EID MCMs. RTORs will be divided into two components – preparedness and response.

C.3.2.1. Preparedness

Offerors may be required to perform the following activities to prepare for a clinical trial during a public health emergency:

Provide a plan that is ready to execute for the trial to include but not limited to personnel, documentation, regulatory approvals, material and management plans as appropriate

Test the plan

Provide Clinical Protocol (CPs)

Provide Case Report Forms (CRFs)

Provide Informed Consent forms (ICFs)

Develop a clinical and safety database in preparation for Clinical database readiness

Pre-identify clinical research sites including study budget and contracts in place

Pre-qualify central laboratories for validated assays

Provide documented product delivery, storage and pharmaceutical product accountability procedures

Obtain Institutional Review Board (IRB) approval of the clinical protocols, annotated

CRFs and ICFs. (National IRB if available/appropriate)

Establish an identified project team. The project team may include a clinical research associate, safety monitor, data manager, regulatory specialist, medical writer, project manager and pharmacovigilance specialist.

Document data flow and sample handling processes (lab manual)

Gather clinical data

Annual review and renewal of the plan

Specific roles for BARDA and the Contractor will be established at the time of TO.

C.3.2.2. Response

Offerors shall commit upon Task Order (TO) award to start the study within defined timelines. The protocols for these studies may be established prior to the public health emergency, or created at the time of the public health emergency.

During an event, the Contractor shall provide a dedicated project team to handle the site/patient management, enrollment, data capture and pharmacovigilance responsibilities for the protocols.

Once the initial protocols are fully enrolled and the data cleaned and locked, the Contractor will provide draft clinical study reports within the defined timelines. After BARDA review of the draft documents, the Contractor will provide a completed CSR for BARDA‘s approval and issuance within the defined timeline.

C.4. DELIVERY SCHEDULE

The schedule for delivery of services is set forth below in SECTION F.

C.5. EARNED VALUE MANAGEMENT SYSTEM

C.5.1. Earned Value Management System Plan

Subject to the requirements under HHSAR Clause 352.234-3, the Contractor shall use principles of

Earned Value Management System (EVMS) in the management of any work ordered under a cost reimbursement Task Order that exceeds the cost thresholds set forth in HHSAR 334.203(c) and (d).

The Seven Principles of EVMS are:

I. Plan all work scope for the program to completion.

II. Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.

III. Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured.

Control Changes to the baseline.

IV. Use actual cost incurred and recorded in accomplishing the work performed.

V. Objectively assess accomplishments at the work performance level.

VI. Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.

VII. Use Earned Value information in the company‘s management processes.

Elements of EVMS shall be applied to all cost reimbursement work under Task Orders that exceed the cost thresholds set forth in HHSAR 334.203(c) and (d) as part of the Integrated Master Project

Plan. The Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements when proposing on a qualifying

Task Order.

C.5.2. Performance Measurement Baseline Review (PMBR)

The Contractor shall submit a plan for a PMBR to occur within 90 days of the award of a Task Order of sufficient size and cost to require EVMS. At the PMBR, the Contractor and the contracting officer shall mutually agree upon the budget, schedule and technical plan baselines (Performance

Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as follows:

1. Jointly assess areas such as the Contractor‘s planning for complete coverage of the

SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks

2. Confirm the integrity of the Performance Measurement Baseline (PMB)

3. Foster the use of EVM as a means of communication

4. Provide confidence in the validity of Contractor reporting

5. Identify risks associated with the PMB

6. Present any revised PMBs for approval

7. Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-

MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/).

8. Present the Risk Management Plan. The Contractor shall develop and maintain a risk management plan that highlights potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template, Attachment 09, in SECTION J to be completed by any prospective Contractor.

C.5.3. Integrated Master Schedule

The Contractor shall submit an updated Integrated Master Schedule in a format agreed upon by

BARDA to the COR and the CO for approval prior to the initiation of any work to be performed under a Task Order of sufficient size and cost to require EVMS. The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract. The

Contractor shall include the key milestones and Go/No Go decision gates. The Contractor will include BARDA Portfolio Management Milestones in their IMS and provide monthly updates. This

IMS shall include the following fields at a minimum; baseline start and finish, forecast start and http://www.acq.osd.mil/pm/ finish; actual start and finish, predecessor and/or successor. The Contractor shall deliver the

Integrated Master Schedule, viewed at the work package level in MS Project file format.

C.6. QUALITY CONTROL/ QUALITY ASSURANCE

The Contractor shall develop a quality control (QC)/quality assurance (QA) monitoring plan that ensures compliance with federal and local regulations, and the ethics committee approved protocol.

C.7. MEETINGS

The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer‘s Representative

(COR). Such meetings may include, but are not limited to, site visits to the Contractor‘s and/or subcontractor‘s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

C.8. REPORTING REQUIREMENTS

See SECTION F for specific reporting requirements.

Performance of the contract will be monitored by the CO/COR on a regular basis. The Contracting

Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Contractor. The first ―kick-off‖ site visit will be convened within 30 days of contract award to review HHS procedures, processes and expectations, as well as Contractor‘s data and plans. Program assessment will be performed by qualified subject matter experts.

C.9. SECURITY PLAN

The Contractor’s Security Plan will be included as an attachment to any contract awarded under this solicitation upon approval by the Contracting Officer.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, delivery of all deliverable items described in to be furnished to the government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email as described in SECTION F.3.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or a duly authorized representative. Technical inspection and acceptance will be take place at:

Biomedical Advanced Research and Development Authority

Office of the Assistant Secretary for Preparedness and Response

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)

FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

FAR 52.246-16, Responsibility for Supplies (April 1984)

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The period of performance of this contract is anticipated for TWENTY FOUR months from date of award. The period of performance may be extended with the exercise of options, structured as

CLINs, as set forth in SECTION B.

F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Objectives in SECTION C of this contract and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or their duly authorized representative.

Deliverables will be further defined upon the issuance of specific Task Orders.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents should be delivered electronically to the Contracting Officer (CO) and the Contracting

Officer‘s Representative (COR). Unless otherwise specified by the Contracting Officer all deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

Contracting Officer

HHS/ASPR/AMCG

330 Independence Avenue, S.W., Room G640

Washington, DC 20201

Email: TBD

Contracting Officer Representative

HHS/ASPR/BARDA

330 Independence Avenue, S.W., Room G640

Washington, DC 20201

Email: TBD

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this contract, the Contractor(s) shall submit to the CO and the COR technical progress reports as identified in the TO. These reports shall be subject to the technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the following format:

F.3.2.1. Safety Reports

Serious Adverse Events (SAEs) that are designated as possibly or probably associated with the administration of the drug/use of the product or Suspected Unexpected Serious Adverse Reaction

(SUSARs) shall be reported by e-mail and phone calls to the COR and CO within 24 hours of knowledge of the event. Essential information including the SAE descriptive narrative and initial/follow-up information received from the investigative site including the subject number, the onset and resolution of the event, the investigator‘s assessment of severity, if any medical intervention was used to resolve the event or its intensity and if the drug was discontinued should be included in the communication.

Protocol deviations that impact patient safety should be reported within no more than 24 hours from

Contractor knowledge of the event.

F.3.2.2 Monthly Technical Progress Reports

During periods in which work is being performed under a TO, Monthly Technical Progress Reports are due on the fifteenth (15th) calendar day of each month for the previous calendar month or within fifteen (15) days past the achievement of project milestones, the Contractor shall submit a report to the COR and the CO. The Contractor shall submit a separate Monthly Technical Progress Report for each TO under which work is being performed. Monthly Technical Progress Reports are not required for periods with no active Task Orders.

The format and type of Monthly Technical Progress Report and Executive Summary will be provided by the COR within fifteen (15) calendar days of contract award. Monthly Technical Progress

Reports will include project timelines, milestones and summaries. A Monthly Technical Progress

Report will not be required for the period when a Quarterly Technical Report or Final Technical

Report is due. The Contractor shall submit one copy of the Monthly Technical Progress Report electronically via e-mail to the COR and the CO.

The report shall be submitted in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft

Project or compatible, editable formats. Technical Progress reports shall, at a minimum, include the following information:

Title Page: The Technical Progress Report title page shall include the contract number and title, the period of performance or milestone being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission.

Distribution List: A list of persons receiving the Technical Progress report.

Introduction/ Background: An introduction covering the purpose and scope of the report.

Summary: A table organized by Task Order summarizing:

Ongoing activities including but not limited to protocol and CRF development, clinical site assessments, regulatory document preparation, enrollment, safety issues, interim analysis, CSR construction

If there are ongoing clinical studies, the study‘s number and percent of target enrollment, overall clinical site performance status, and clinical site training status.

If work is being performed under a TO with EVM requirements, Budgeted Cost of

Work Performed, Budgeted Cost of Work Scheduled, Actual Cost of Work

Performed, Schedule Performance Index and Cost Performance Index should also be reported.

Progress: The report shall detail, document and summarize, organized by Task Order, the results of work performed, test results and milestones achieved during the period covered.

Progress should be represented as % of total project plan completed, as well as % completed for the month based on forecasted for the month. Information supporting the summary shall also be provided.

A summary of work and travel planned for the next reporting period shall be included.

During active clinical studies an update on subject recruitment in terms of numbers screened, numbers enrolled and drop-outs will be provided per clinical site.

Issues: Issues resolved, new issues and outstanding issues shall be enumerated with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if project activity is delinquent, then what corrective steps are planned. Revised timelines shall be provided.

Invoices: Summary of any invoices submitted during the reporting period.

Action Items: Summary table of activities or tasks to be accomplished by a certain date and by whom.

Attachments: Each report will include an attachment with an up to date contract history including invoice submission/acceptance dates, and modifications. Results on the project are provided as attachments where appropriate.

F.3.2.3. Quarterly Technical Progress Reports

The format and type of the Quarterly Technical Progress Report and Executive Summary will be provided by the COR within fifteen (15) calendar days of contract award. Quarterly Technical

Progress Reports will include project summaries as well as performance metrics for the prime contractor. A Quarterly Technical Progress Report will not be required for the period when the Final

Technical Report is due. The Contractor shall submit one copy of the Quarterly Technical Progress

Report electronically via e-mail to the COR and the CO. The report shall be submitted in Microsoft

Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project or compatible, editable formats.

Quarterly Technical Progress Reports are required for periods with no active Task Orders.

Quarterly Technical Progress reports shall, at a minimum, include the following information:

Title Page: The Quarterly Technical Progress Report title page shall include the contract number and title, the period of performance being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission.

Distribution List: A list of persons receiving the Technical Progress report.

Introduction/ Background: An introduction covering the purpose and scope of the report.

Summary: A table organized by Task Order summarizing ongoing activities.

Progress: The report shall summarize, organized by Task Order, the results of work performed. Progress should be represented as % of total project plan completed, as well as % completed for the quarter based on forecasted for the quarter. Information supporting the summary shall also be provided. A summary of work and travel planned for the next reporting period shall also be provided.

Issues: Issues resolved, new issues and outstanding issues shall be enumerated with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if project activity is delinquent, then what corrective steps are planned. Revised timelines shall be provided.

Quality Metrics: For active clinical studies (not exclusively those funded by BARDA):

Update subject recruitment (numbers screened, numbers enrolled and drop-outs per clinical site).

Contractor staff stability (over each quarter) for CRAs, Project Manager, Regulatory and other personnel.

Clinical study Trip Report timeliness.

Queries as a measure of whether the clinical study PMs and CRAs are in control of their studies.

Invoices: Summary of any invoices submitted during the reporting period.

Action Items: Summary table of activities or tasks to be accomplished by a certain date and by whom.

Attachments: Each report will include an attachment with an up to date contract history including invoice submission/acceptance dates, and modifications. Results on the project are provided as attachments where appropriate.

F.3.2.4. Executive Summary

The Executive Summary shall accompany…