RFP_75A50119R00027_SDCC_(9.6.2019).pdf

75A50119R00027

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

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

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 99

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

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.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

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

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

OFFER (Must be fully completed by offeror)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

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

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

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

09/06/2019 X

ASPR-BARDA

ASPR-BARDA

O'Neill House Office Building Room 24F15 Washington DC 20515

1200 ET 10/07/2019

JEFFREY E BROWN

Jeffrey.Brown@hhs.gov

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PAGE(S)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

5-8 9-13 16-23 24-29 30-51

52-69

71-75

76-91 92-99

3 hardcopies and 1 electronic

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____120________ calendar days (60 calendar days unless a different period is inserted see Section L.3. of the RFP

202 730-8662

TABLE OF CONTENTS

B. SUPPLIES / SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES / SERVICES

B.2. SPECIFIC REQUIREMENTS

B.3. CONTRACT TYPE

B.4. BASE PERIOD CONTRACT LINE ITEM NUMBER (CLIN)

B.5. OPTION PERIOD CONTRACT LINE ITEM NUMBERS (CLINs)

B.6. ADVANCED UNDERSTANDINGS

C. STATEMENT OF OBJECTIVES

C.1. INTRODUCTION / BACKGROUND

C.2. STATEMENT OF OBJECTIVES

C.3. TECHNICAL REQUIREMENTS

C.4. MEETINGS

C.5. REPORTING REQUIREMENTS

C.6. CONTINUITY PLANNING REQUIREMENTS

C.7. SECURITY PLAN

D. PACKAGING AND MARKING

D.1. METHOD OF DELIVERY

E. INSPECTION AND ACCEPTANCE

E.1. FEDERAL ACQUISITION REGULATIONS INCORPORATED BY REFERENCE

E.2. GOVERNMENT RESPONSIBILITIES FOR INSPECTION AND ACCEPTANCE

E.3. PERSON-IN-PLANT

E.4. AUDITS

F. DELIVERIES / PERFORMANCE

F.1. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

F.2. PERIOD OF PERFORMANCE

F.3. DELIVERIES

F.4. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.5. DELIVERABLE SCHEDULE

G. CONTRACT ADMINISTRATION

G.1. CONTRACTING OFFICER

G.2. CONTRACTING OFFICER’S REPRESENTATIVE

G.3. DELIVERIES

G.4. CONTRACTOR’S POINT OF CONTACT

RFP 75A50119R00027

G.5. ORDERING PROCEDURES

G.6. INVOICE SUBMISSION

G.7. CONTRACT COMMUNICATIONS / CORRESPONDENCE

G.8. POST-AWARD EVALUATION OF CONTRACT PERFORMANCE

G.9. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)

G.10. Negotiated Indirect Rates and Ceiling

G.11. Government Property

H. SPECIAL CONTRACT REQUIREMENTS

H.1. ACCESS AND DISPOSITION OF DATA

H.2. KEY PERSONNEL

H.3. SUBSTITUTION OF KEY PERSONNEL

H.4. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

H.5. CLINICAL RESEARCH

H.6. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

H.7. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION SUBMISSION PLAN

H.8. NEEDLE DISTRIBUTION

H.9. ACKNOWLEDGEMENT OF FEDERAL FUNDING – PUBLICATION AND PUBLICITY

H.10. RESTRICTION ON ABORTIONS

H.11. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

H.12. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

H.13. OPTION PROVISION

H.14. DESIGNATION OF OMBUDSMAN

H.15. SUBCONTRACTING PROVISIONS

H.16. CONFIDENTIALITY OF INFORMATION

H.17. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

H.18. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

H.19. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

H.20. ACCESS TO DOCUMENTATION / DATA

H.21. IN-PROCESS REVIEW

H.22. IDENTIFICATION AND DISPOSITION OF DATA

H.23. DISSEMINATION OF INFORMATION

H.24. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE HHSAR 352.239-73 (December 2015)

H.25. INFORMATION SECURITY

I. SECTION I – CONTRACT CLAUSES

I.1. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR Chapter 1) CLAUSES

I.2. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48

CFR Chapter 3) CLAUSES

I.1. ADDITIONAL CONTRACT CLAUSES

J. – LIST OF ATTACHMENTS

K. – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

L. INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

L.1. SOLICITATION PROVISIONS INCORPORATED BY REFERENCE INCORPORATED BY REFERENCE

L.2. CONTRACT TYPE

L.3. DELIVERY AND PACKAGING OF PROPOSALS

L.4. TECHNICAL PROPOSAL

L.5. BUSINESS PROPOSAL

L.6. OTHER ADMINISTRATIVE DATA

L.7. INQUIRIES

L.8. INCURRING COSTS

L.9. NAICS CODE AND SIZE STANDARD

L.10. THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS

L.11. USE OF THE METRIC SYSTEM OF MEASUREMENT

L.12. POTENTIAL AWARD WITHOUT DISCUSSIONS

L.13. COMMITMENT OF PERSONNEL

M. EVALUATION FACTORS FOR AWARD

M.1. BASIS OF AWARD

M.2. COST / PRICE EVALUATION

M.3. PRE-AWARD SITE VISIT / SITE AUDIT

M.4. TECHNICAL EVALUATION

M.5. TECHNICAL, PERSONNEL AND MANAGEMENT MERIT RATINGS

M.6. PAST PERFORMANCE

M.7. SMALL BUSINESS SUBCONTRACTING PLAN

M.8. EVALUATION OF OPTIONS

M.9. BUSINESS PROPOSAL EVALUATION

B. SUPPLIES / SERVICE AND PRICE / COST

Medical Countermeasures Clinical Studies Network

B.1. BRIEF DESCRIPTION OF SUPPLIES / SERVICES

This Request for Proposal (RFP) solicits proposals for a single-award Indefinite Delivery, Indefinite Quantity (IDIQ) contract for a Statistical and Data Coordinating Center (SDCC) within the Clinical Studies Network (CSN) of Biomedical Advanced Research and Development Authority (BARDA). With this solicitation, the BARDA CSN seeks proposals from qualified vendors for establishing, maintaining and operating a SDCC as well as providing archives for clinical study data and documents. The SDCC will enhance data harmonization across studies, provide a central record archive, facilitate Investigational New Drug (IND) applications, IND amendment publishing, and other Food and Drug Administration (FDA) submissions. The overall goal is to improve management of clinical studies’ lifecycles more effectively and improve medical countermeasures (MCM) development efficiencies by standardizing clinical study procedures, processes, templates, etc. The SDCC will be responsible for providing necessary and sufficient statistical and data management capacities and resources consisting of systems, procedures and expertise in statistical support, data management and information flow to support multiple medical countermeasure clinical trials. The systems that will be used to support clinical study data capture, management and analysis must be commercial off-the-shelf (COTS) platforms in order to facilitate integration within the CSN and with BARDA researchers in support of the BARDA mission.

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the BARDA to support development and acquisition of 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. BARDA established the CSN as a core service in 2012 and awarded IDIQ contracts to five (5) full service clinical Contract Research Organizations (CROs) in 2014 to form the CSN infrastructure. During the five (5) years of the CSN’s existence, several important gaps in capabilities were identified. In addition to this RFP, two (2) other separate and distinct solicitations will seek to address these gaps as follows:

1. RFP No. 75A50119R00026 – Seeks offers to address the requirements for the Clinical Trial Planning & Execution (CTPE) services on a routine basis without urgent timelines, as well as services during emergencies when rapid timelines are crucial; and

2. RFP No. 75A50119R00028 – Seeks offers to address the requirements for a Biological Specimen and Investigational Product storage facility (BSIP).

This solicitation addresses requirements for the SDCC only. Offerors are encouraged to respond to one or all RFPs for which they are qualified. Any resultant contract awarded from this requirement will require close coordination with those contract(s) awarded for the BSIP and CTPE services. Collectively, awardees from all three (3) solicitations will form the revised infrastructure for the BARDA CSN.

B.2. SPECIFIC REQUIREMENTS

Clinical Studies Network Statistical and Data Coordinating Center (SDCC)

With this solicitation, BARDA seeks to:

1. Establish the SDCC infrastructure to provide the following services:

a. study designs and data analyses;

b. a web portal for CSN-wide communication and document sharing/reviews;

c. 21 CFR Part 11 validated computer systems, standards/templates, standard operating procedures (SOPs), and project management;

d. archive for study data and Trial Master Files (TMF) of completed studies;

e. data governance, transfer, integration and reporting system

f. BARDA CSN Operations Support

2. Provide the full scope of statistical and data management services for clinical studies in both routine and emergency response settings.

B.3. CONTRACT TYPE

The United States Government (USG) intends to award a single Indefinite Delivery/Indefinite Quantity (IDIQ) contract for the services identified in the Specific Requirements above. 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) and/or Cost Reimbursement.

Each Request for Task Order Response (RTOR) under the IDIQ will specify its own period of performance, task order type, and scope of work.

B.4. BASE PERIOD CONTRACT LINE ITEM NUMBER (CLIN)

The Base Period of Performance (PoP) shall be two (2) years from date of award, and shall be composed of a “Not to Exceed” CLIN to be used for potential task order awards.

BASE PERIOD

CLIN # Description Task Order Budget*

0001 Clinical Studies Network Task Orders TBD

*TBD: Task Order business proposals shall include labor rate costs, facility costs, and all other cost components necessary to complete clinical study services. Each Request for Task Order Response (RTOR) will clearly delineate proposal requirements, to include contract type.

B.5. OPTION PERIOD CONTRACT LINE ITEM NUMBERS (CLINs)

The final contract will contain Option Period CLINs agreed upon by the Government and Offeror. If exercised, each Option Period shall be one (1) year.

OPTION PERIODS

CLIN # Description Task Order Budget*

0002 Option Year 1: Clinical Studies Network Task Orders TBD

0003 Option Year 2: Clinical Studies Network Task Orders TBD

0004 Option Year 3: Clinical Studies Network Task Orders TBD

*TBD: Task Order business proposals shall include labor rate costs, facility costs, and all other cost components necessary to complete clinical study services. Each Request for Task Order Response (RTOR) will clearly delineate proposal requirements, to include contract type.

B.6. ADVANCED UNDERSTANDINGS

B.6.1. Minimum Order Amount - $1,000 The minimum order amount for any single task order issued, shall not be under $1,000.

B.6.2. Maximum Ordering Amount - $250,000,000 The maximum ordering limitation for a single task order or combination of task orders, within the entire period of performance, inclusive of any exercised option periods, is $250,000,000.

The Contractor shall not receive payment from the Government in any amount greater than said maximum, for successful performance under this contract.

B.6.3. Minimum Guarantee - $200,000 The minimum guarantee under the IDIQ is $200,000. In the event that a Contractor does not receive a task order award, or is awarded a task order(s) below the $200,000 guarantee, said minimum, minus the amount of any task order(s) performed by the Contractor within the overall period of performance, becomes payable to the Contractor when the base period or last exercised option period expires. This amount can only be claimed at the end of the period of performance, if the Contractor proposes on all issued RTORs.

In the case where the Government decides to not exercise one or more option periods, the minimum guarantee shall be prorated by the number of years that the Contractor remained under contract.

B.6.4. Task Order Funding Funds for Government requirements will be obligated at the task order level, as task order awards are issued. Excess funds will be de-obligated at the task order level, by the Government, via unilateral modification. The Contractor shall 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.6.5. Provisions Applicable to Costs This section prohibits or restricts the use of contract funds for the following, unless otherwise approved in advance by the Contracting Officer:

1. Acquisition, by purchase or lease, of any interest in real property;

2. Rearrangement or alteration of facilities;

3. Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar value;

4. Accountable Government Property;

5. Overtime;

6. General scientific meetings/conference;

7. Travel costs, including foreign travel;

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

9. Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000;

10. Refreshments 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 provided; (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.6.6. Invoicing Instructions

Invoices for payment shall be submitted to the Contracting Officer and Contracting Officer’s Representative, as one (1) hard copy and one (1) electronic copy addressed in the format indicated in G.3, shall follow the detailed invoicing instructions listed in Section J, and include an SF-1034.

The electronic version of the invoice can be submitted via e-mail or uploaded through HHS’ eRoom (shared access may be provided to the Contractor after award).

The Government may request additional information (timecards, receipts, etc.) to support costs claimed in the Contractor’s invoices. Incomplete invoices may be suspended by the Contracting Officer if the Contractor’s claimed costs cannot be substantiated.

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C. STATEMENT OF OBJECTIVES

Clinical Studies Network Statistical and Data Coordinating Center (SDCC)

C.1. INTRODUCTION / BACKGROUND

The purpose of this Request for Proposal is to solicit applications for the Statistical and Data Coordinating Center (SDCC) of the BARDA Clinical Studies Network (CSN). The CSN will provide a robust and readily accessible infrastructure for rapid implementation and quality performance of clinical trials in a breadth of indications related to development of medical countermeasures (MCMs). The CSN will consist of one CRO for SDCC, several CROs for clinical trial planning and evaluation (CTPE) of routine and/or response clinical trials relating to emergencies, and one CRO for Biological Specimen and Investigational Product (BSIP) storage facility. The infrastructure should be sufficient for implementation of at least two (2) – four (4) simultaneous clinical trials. The purpose of the CSN is to advance development of MCMs by efficiently enabling rigorous clinical trials to assess safety and efficacy of drug, device and biological products. The solicitation presented here specifically requests proposals to establish, maintain and operate a SDCC and provide an archive for clinical trial data and documents.

This solicitation addresses requirements for the SDCC only. Offerors are encouraged to respond to one or all RFPs for which they are qualified. Any resultant contract awarded from this requirement will require close coordination with those contract(s) awarded for the BSIP and CTPE services. Collectively, awardees from all three (3) solicitations will form the revised infrastructure for the BARDA CSN.

FOR PROPOSAL PURPOSES ONLY: SDCC Offerors should provide capabilities for all items listed in the SOO even if it is duplicated in the CTPE RFP SOO. Post Award, specific requirements per RTOR will be assigned to the SDCC contractor or CTPE contractor in the RTOR SOO.

BARDA will award base contracts to support the CSN infrastructure. Task Orders will be issued for specific clinical study-related services when needed to support MCM development.

C.2. STATEMENT OF OBJECTIVES

The objective of this contract is to establish and sustain a stand-alone SDCC. The SDCC will work seamlessly with other CSN partners to provide essential statistical and data coordinating resources and services for the CSN. The SDCC will support the design and implementation of multiple clinical trials to further BARDA's mission of developing promising new MCM or evaluating existing MCM for new indications. These studies may be Phase 1, 2, 3, or 4 (as defined by the FDA) or combinations of these phases.

Objective 1: To establish the SDCC infrastructure to provide the following services:

1. study designs and data analyses;

2. a web portal for CSN-wide communication and document sharing/reviews;

3. CFR 21 Part 11 validated computer systems, standards/templates, standard operating procedures (SOPs), and project management;

4. archive for study data and Trial Master Files (TMF) of completed studies;

5. data governance, transfer, integration and reporting system;

6. BARDA CSN Operations Support.

Objective 2: To provide the full scope of statistical and data management services for clinical studies in both routine and emergency response settings.

C.3. TECHNICAL REQUIREMENTS

Independently and not as an agent of the government, the contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the government, as needed to perform the statement of objectives. The applicable privacy act system of records number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract.

C.3.1. Objective 1 – To establish the SDCC Infrastructure to provide the following services

1. Study Designs and Data Analyses

a. Provide statistical expertise in protocol development

b. Capability of providing innovative trial designs with acceptable statistical efficiency and operational feasibility

c. Provide data analytical support for the complete life-cycle of the study

d. Provide statistical and analytical support for integrated summary of efficacy and safety across studies

e. Data mining and integration capabilities in real-time through access to health care and social network databases to identify and monitor epidemics of influenza and emerging infectious diseases, and support implementation of response clinical studies

2. Web portal for CSN-wide communication and document sharing/reviews

a. Provide a secure environment and informatics support for CSN-wide communications and to acquire, store, catalogue, query, review and distribute documents and materials

3. 21 CFR Part 11 validated computer systems, standards/templates, standard operating procedures and project management

a. Computer systems for clinical study databases

b. Computer systems for randomization and investigational product management

c. Computer systems for safety databases

d. Standard Operating Procedures (SOPs) and Manual of Procedures (MOPs) to be used for routine and response SDCC activities and conduct of multiple clinical trials, including an SOP for updates of clinical trial information on ClinicalTrials.gov, as per policy

e. Harmonized clinical data standards (e.g. CDISC SDTM and ADaM)

f. Templates for the following

i. Protocols

ii. Data Safety Monitoring Plan (DSMP)

iii. Data and Safety Monitoring Board (DSMB1) Charter

iv. Organization/communication plan

v. CDASH compliant Case Report Forms and Completion Guidance

1 Within this document, DSMB is inclusive of any Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC), DSMB, or additional monitoring committee terminology.

vi. Data management plan

vii. Data validation plan

viii. Randomization plan/schedule

ix. Electronic data capture with risk-based monitoring functionality

x. Interactive web response system (IWRS) training

xi. User Acceptance Testing (UAT) manual

xii. Statistical analysis plan

xiii. Statistical programming validation plan

xiv. Site training plan

4. Archive for study data and trial master files (TMF) of completed studies

a. Plan for long-term storage and management in the archive of completed study data and possible other data (e.g.; SDTM, ADaM datasets, etc.) from BARDA-funded studies performed by the CSN as well as those not performed by the CSN

b. Plan for a centralized archive of clinical study records (i.e., TMF) from completed studies for indefinite long-term storage that meets regulatory requirements

5. Data governance, transfer, integration and reporting

a. Set up data transfer with BSIP, integrate BSIP specimen data with subject data, generate summary reports based on integrated data

b. Data integration plan across studies

c. Plans for data governance and transfer between SDCC and other CSN contractors

6. BARDA CSN Operation Support

As part of the “warm base” operations of the CSN, provide SDCC contractor support personnel to serve as “staff extenders” to the BARDA CSN Operations team. Supportive assignments and tasks may include administrative meeting set-up, developing and distributing communications, establishing shared resources and templates, developing CSN governance documents, charters, and related materials, and other similar as well as special assignments in support of CSN functions.

C.3.2. Objective 2 – To provide the full scope of statistical and data management services for clinical studies in both routine and emergency response settings The Offeror shall work closely with BARDA and other CSN contractors to coordinate efforts and shall cooperate in all areas of the CSN to maximize efficiency and effectiveness in conducting clinical trials. The following services in support of clinical studies are expected but not limited to:

1. Providing full-scope statistical support ranging from development of the study protocol and study related documents such as statistical analysis plan (SAP) and clinical study report (CSR) to providing data analysis and study result reports for regulatory submission and publishing purposes.

2. Providing full-scope statistical programming support for generating SDTM and ADaM datasets (including supporting documents such as annotated CRF, define.xml, Pinnacle 21 validation, and reviewer's study guide), and TLFs for the study.

3. Providing, managing, and supporting an independent DSMB.

4. Providing centralized data analytical support for site monitoring and medical/safety monitoring.

5. Administering and maintaining a web-based document/content management system and study portals for secure electronic communications of study data and reports.

6. Administering and maintaining a web-based study portal for secure electronic access to safety and laboratory data.

7. Providing full-scope data management support (e.g., clinical database development and support, safety database development and support, IWRS development and support, data cleaning review, data listings, data status metrics, preparation of study-related materials and instructions, medical and drug coding, Serious Adverse Event reporting, database training and the assessment of clinical site capabilities for data collection and management, etc.)

8. Providing regulatory operation services that include initial and amendment IND publishing and FDA submission in electronic Common Technical Document (eCTD) format.

9. Providing protocol development and other medical writing support.

C.4. 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.

1. The Contractor shall participate in the following:

a. Contract Initiation Meetings and kick-off

b. CSN Progress Meetings or Teleconferences

c. Annual Meetings

d. Ad Hoc Meetings and Teleconferences

2. Site Visits and BARDA Audits

The Contractor shall arrange and conduct site visits and independent audits of Contractor and subcontractor facilities as needed or as requested by the COR, to evaluate compliance with domestic and non-domestic laws and regulations and FDA regulations and guidance documents, including those required to meet cGCP standards, BARDA policies, and the terms of the contract.

C.5. 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. Qualified subject matter experts will perform program assessment.

C.6. CONTINUITY PLANNING REQUIREMENTS

Provide Continuity of Services Plan to manage archive during a business disruption. Within 30 days of contract, provide emergency contact list to identify time-sensitive or critical business functions and processes and the resources that support them. Offeror may use the Continuity of Services Plan template, Attachment 13, or use the Offeror’s template.

C.7. SECURITY PLAN

The contractor will prepare IT Security Deliverables in accordance with Sections F and H.

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D. PACKAGING AND MARKING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all deliverable items 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.

All deliverables shall be preserved, packaged and marked in accordance with normal commercial practices to meet the packaging requirements of the carrier, including that which is necessary to prevent deterioration and damages due to the hazard of shipping, handling and storing. The Contractor shall guarantee that all required supplies/services/documentation shall be delivered in immediate usable and acceptable condition.

E. INSPECTION AND ACCEPTANCE

E.1. FEDERAL ACQUISITION REGULATIONS INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://acquisition.gov/far/

The following FAR clause, pertinent to Section E, is hereby incorporated by reference:

FAR Clause Title Date

52.246-4 Inspection of Services – Fixed Price Aug 1996 52.246-5 Inspection of Services – Cost Reimbursement Apr 1984 52.246-9 Inspection of Research and Development (Short Form) Apr 1984 52.246-16 Responsibility for Supplies Apr 1984

E.2. GOVERNMENT RESPONSIBILITIES FOR INSPECTION AND ACCEPTANCE

All work under this contract may be subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the Government. The Contracting Officer’s Representative (COR) is a duly authorized representative of the Government and is responsible for the inspection and acceptance of all items/activities to be delivered and or completed under this contract. Inspection and acceptance will be performed at the destination of the supplies, services or documentation delivered for performance under this contract.

E.3. PERSON-IN-PLANT

The Government reserves the right to be present during the execution of task orders as a person-in-plant.

E.4. AUDITS

The Contractor shall allow for and provide requested information to support security, quality, regulatory, and cGMP audits conducted by USG on an ad hoc basis. The estimated frequency of audits under this paragraph is annually, unless an audit for cause is determined necessary at the discretion of the Contracting Officer. If the USG finds non-compliances or deficiencies during its audit(s) on firm fixed price line items, the Contractor, at its sole expense, shall take all necessary corrective action within a timely manner. In addition, the Contractor shall provide all information requested by the USG, including the FDA, to facilitate a cGMP inspection at the time of production of pharmaceutical lots.

http://acquisition.gov/far/

F. DELIVERIES / PERFORMANCE

F.1. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://acquisition.gov/far/

The following FAR clause, pertinent to Section F, is hereby incorporated by reference:

FAR Clause Title Date

52.242-15 Stop Work Order Aug 1989 52.242-15 Stop Work Order – Alternate I (Apr 1984) Aug 1989

F.2. PERIOD OF PERFORMANCE

The base period of performance (PoP) is anticipated to be two (2) years from date of award, with up to three (3) options periods, as listed in the table of CLINs in Section B. If exercised, the length of each option period shall be one (1) year.

In no event shall the contract’s period of performance exceed five (5) years from original date of award.

The Government is not obligated to exercise options periods under this contract.

F.3. DELIVERIES

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

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

F.4. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.4.1. Submission of Contract Deliverables Documents shall be delivered electronically via email to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR), listed in Section G.1 and G.2. When electronic deliverables are not preferred by the Contracting Officer, deliverables and reports furnished to the Government under the potential resultant contract (including invoices) shall be addressed as indicated in Section G.3.

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 resultant TO. These reports shall be subject to the technical inspection and requests for clarification by the COR and http://acquisition.gov/far/

CO, shall be brief and factual, and prepared in accordance with the formats described in the following section.

F.5. DELIVERABLE SCHEDULE

Deliverable Description Delivery Date

Kickoff Meeting The contractor shall complete a Kickoff meeting after contract award and/or within 30 calendar days of task/delivery order award to be held at a location determined by the COR. The purpose of the Task/Delivery Order initiation meeting will be to orient the contractor to HHS/BARDA task/delivery order procedures, review contract requirements, and to plan implementation of initial task/delivery order activities.

Within 30 calendar days of contract award a Kickoff meeting will be held.

Status Update Meetings

Status Update Meetings: Plan and conduct meetings of the contractor’s Program Director, Program Team, Contracting Officer’s Representative, and Contracting Officer. This will include other BARDA personnel deemed appropriate by the Contracting Officer’s Representative, at a minimum of quarterly intervals, either in person or via teleconference, to review status of approved work assignments, discuss any matters relevant to the scientific and financial administration of the contract and future activities. The contractor shall prepare and distribute the agenda as well as meeting/teleconference materials to all participants, provide a summary of all meetings, and teleconferences.

Status Update Meetings schedule will be established by the Contracting Officer’s Representative and Contracting Officer after contract award.

Annual Meeting Annual Meetings: The contractor shall arrange and may conduct an annual site visit for BARDA contracting and BARDA program staffs to review and discuss the following items: project progress; problems, obstacles, and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date;

and future plans. These site visits shall be attended by the Contractor’s business representative and all key personnel. The contractor shall be responsible for the following activities:

1.Planning and submitting the agenda to the Contracting Officer’s Representative for approval 2.Developing written and oral presentation materials of all task/delivery orders 3.Presenting summaries of all active task/delivery orders

Annual Meetings should occur once a year within 30 calendar days of the anniversary of the contract award date.

Program Review Meetings shall occur at least annually during contract period of performance.

4.Discussing timelines related to active and future task/delivery orders 5.Discuss methodologies and approaches

Periodic Site Visits Periodic Site Visits will include, if applicable, subcontractor facilities.

Periodic Site Visits will occur on an ad hoc basis.

Security and Quality Systems Audits

Security and Quality Systems Audits/QA audits The contractor shall take the necessary corrective action within a timely manner.

Security and Quality Systems Audits / QA audits may be conducted pre-award and on an ad hoc basis. A summary of these audits will be provided within 25 business days to the contractor.

Monthly/Quarterly / Annual, Task Order / Milestone / Final Technical Progress Reports

Monthly/Quarterly/Annual /Task Order/ Milestone Technical Progress Reports shall address each of the below items and be cross-referenced to the WBS. These reports are subject to the technical inspection and requests for clarification by the Contracting Officer’s Representative.

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

Quarterly Technical Progress Reports will include project summaries as well as performance metrics for the prime contractor.

The Technical Reports shall be submitted in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project or compatible, editable formats. Technical Progress reports shall include the following information:

• Title Page: The 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 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 percentage of total project plan completed, as well as percentage completed for the

All Technical Progress Reports shall be submitted on the 15th day of month for the previous calendar month/reporting period.

Annual Technical Reports shall be submitted on the 15th day of the final month of each contract year for the previous twelve calendar months.

Final Technical Progress Reports are due on/before the completion of the contract.

Technical Progress Reports are not required for the periods when the Annual Technical Report(s) and Final Technical Report are due.

In addition, a Monthly Technical Progress Report will not be required for the period when a Quarterly Technical Report is due.

month based on forecasted for the month.

Information supporting the summary shall also be provided. A summary of work planned for the next reporting period shall be included.

• 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.

Executive Summary The Executive Summary shall accompany each Technical Progress Report, be formatted as a Microsoft PowerPoint presentation, and include the following:

• Title page: Executive Title, the contract number and title, the period of performance or milestone being reported, the contractor’s name and the date of submission.

• Project Progress: Presented as milestone events, test results, tasks and other activities achieved during the reporting period as talking point bullets.

• Project Issues: Presented headings and each item as a talking point bullet.

Due at time of individual Technical Progress Reports

Final Closeout Report The Contractor shall submit a comprehensive Final Report that details, documents, and summarizes the results of the entire (base and all option periods) contract work. The report shall explain comprehensively the results achieved.

It shall also contain a summary of all Task Orders issued under the contract and a determination that everything under the contract has been completed and accepted.

A draft Final Report shall be submitted to the CO and COR, for review and comment at least 45 calendar days prior to contract expiration date. Upon final acceptance by the CO, an electronic copy shall be submitted to the CO not later than 30 calendar days following the expiration date of the contract.

Standard Operating Procedures

The contractor shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review electronically.

Upon request from the Contracting Officer’s Representative and Contracting Officer

FDA Audits The contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of all FDA's arrival to conduct site visits/audits by any regulatory agency. In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract. The contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483, and the Establishment Inspection Report (EIR). The contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

The contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of receipt from the CBER/CDER or subcontractor.

Contractor Audit / Site Visits

The contractor shall inform the Contracting Officer’s Representative and Contracting Officer in advance of upcoming audits/site visits of subcontractors (may be part of bi-weekly communications with BARDA), briefing goals of audit and providing the agenda. Upon completion of the audit/site visit, the contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, details and concerns for addressing areas of non-conformance to FDA regulations as identified in the audit report, must be provided to COR. The contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

Reports and responses relating to contractor audits/site visits are due to COR within 5 business days of report completion.

Publications Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to COR for review prior to submission

Within 30 calendar days for manuscripts and 15 calendar days for abstracts. Included in the annual report, the contractor shall provide a list of all publications and presentations resulting from Task Order awards.

Press Releases The contractor agrees to accurately and factually represent the work conducted under this contract in all press releases

The contractor shall ensure that the Contracting Officer has received, and approved an advanced copy of any press release to this contract;

not less than 5 business days prior to the issuance of the press release

Security Reporting The contractor shall report to the government any activity;

or incident that is in violation of established security standards; or indicates the loss or theft of government products

The contractor shall report within 24 hours after occurrence of activity or incident

Risk Mitigation Matrix

The contractor shall provide a Risk Mitigation Plan Matrix and shall describe a comprehensive plan outlining program and risk management.

The contractor shall provide a finalized plan 90 calendar days after contract award.

Continuity of Service Plan

The contractor shall provide a Continuity of Service Plan that describes a comprehensive plan managing and supporting service recovery in the event of a facilities (building) disruption or disaster. Conduct a business impact analysis to identify time-sensitive or critical business functions and processes and the resources that support them. Identify, document, and implement to recover critical business functions and processes. Organize a business continuity team and compile a business continuity plan to manage a business disruption. Conduct training for the business continuity team and testing and exercises to evaluate recovery strategies and the plan.

The contractor shall provide a finalized plan 90 calendar days after contract award.

Other Reports/Deliverables

Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format.

Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at:

https://www.ecfr.gov/cgi-bin/text-idx?%20c=ecfr&SID=0af84ca649a74846f102aaf664da1623 &rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL

RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL

CONFLICTS OF INTEREST Article in SECTION H of this contract.)

FCOI Reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part

RFP 75A50119R00027

https://www.ecfr.gov/cgi-bin/text-idx?%20c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 https://www.ecfr.gov/cgi-bin/text-idx?%20c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 https://www.ecfr.gov/cgi-bin/text-idx?%20c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

Quality Assurance/Quality Control (QA/QC) Plan

The contractor shall provide a comprehensive Quality Assurance/ Quality Control (QA/QC) Plan and shall describe a comprehensive plan outlining management and implementation of programmatic QA/QC.

The contractor shall provide the finalized QA/QC Plan 60 calendar days after contract award.

System Security Plan

(SSP)

See Section H Due within 30 calendar days after contract award

Security Assessment Plan Report (SAP/SAR)

See Section H Due within 30 calendar days after contract award

FIPS 199 Assessment See Section H Due within 30 calendar days after contract award

Independent Assessment and Authorization (A&A)

See Section H Due within 90 calendar days after the contract award.

Contingency Plan and Contingency Plan Test

See Section H Due within 60 days after contract award

Contractor - Employee Non-Disclosure Agreements

See Section H Due to the COR and CO prior to Contractor and/or Subcontractor employees perfoming work under the contract.

Vulnerability Scanning Requirements

See Section H Due monthly

Standard for Security Configurations Memo

See Section H Due within 90 calendar days of award and thereafter annually with the Annual Technical Progress Report

Standard for Encryption Language Memo

See Section H Due within 90 calendar days ofaward and thereafter annually with the Annual Technical Progress Report

Information Security Training and Report

See Section H Due prior to Contractor and/or Subcontractor employees performing any work on the contract and annually with the Annual Technical Progress Report.

Section 508 Annual Report

See Section H Due annually, with the Annual Technical Progress Report and Final Technical Progress Report

G. CONTRACT ADMINISTRATION

G.1. CONTRACTING OFFICER

The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds.