19-BARDA-DRAFT-CSN-CTP&E_Combined_Package.pdf

19-BARDA-DRAFT-CSN-CTP&E

March 6, 2019

Dear Ladies and Gentlemen:

The Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) is requesting feedback (questions and comments) from Contract Research Organizations (CRO) and other similar entities who work in the Clinical Study area regarding the following three (3) BARDA DRAFT RFPs:

1. 19-BARDA-DRAFT-CSN-BSIP

2. 19-BARDA-DRAFT-CSN-SDCC

3. 19-BARDA-DRAFT-CSN-CTP&E

Combined, these three (3) DRAFT RFPs will form the revised Clinical Studies Network (CSN) Contract Research Organizations (CROs) for CBRNE Medical Countermeasures (MCMs).

Specifically, BARDA is seeking feedback form those interested entities involved in Clinical Trial Planning and Execution, Statistical and Data Coordinating Center activities, and Biological Specimen and Investigational Product Storage.

Questions and comments should be submitted by Close of Business (COB) on March 12, 2019 as outlined below, in preparation for a pre-proposal conference on March 15 (see below). Feedback from all capable and qualified sources would be appreciated.

The following are notices relating to this request for feedback:

- Feedback from prospective Responders will not provide them with an advantage nor disadvantage in future solicitations.

- All Feedback will be reviewed and responses to feedback and questions will be posted on the Federal

Business Opportunities Website (www.fedbizopps.gov).

- No company information will be revealed to the public to include which companies asked particular questions.

- The posting of information about this requirement does not express or imply any commitment by the

Government to issue a final RFP or the promise for any contract action.

- Any information and notices concerning the release of a final RFP will be posted on the Federal

Business Opportunities Website (www.fedbizopps.gov) when available.

http://www.fedbizopps.gov/ http://www.fedbizopps.gov/

19-BARDA-DRAFT-CSN-CTP&E

FORMAT

Responses shall adhere to the following formatting and outline instructions:

1. Format specifications include 8.5 by 11 inch paper. All submissions must be in a format compatible with the Microsoft Office or Adobe software package and electronically submitted as follows:

To: marcy.grace@hhs.gov Cc: enrique.manan@hhs.gov

2. Cover Page (1 page)

a. Title

b. Organization

c. Respondents’ technical and administrative points of contact (names, addresses, phones and fax numbers, and email addresses)

d. Respondents’ intent to participate either in person or via teleconference at the below identified pre-proposal conference.

3. Feedback to Draft RFP (19-BARDA-DRAFT-CSN-CTP&E) (no page limit)

a. Questions should be numbered with at least one line space between each question.

b. Please identify the DRAFT RFP No. and the RFP Section for each question.

The posting of information about this requirement does not express or imply any commitment by the Government to issue a final RFP or the promise for any contract action.

The point(s) of contact for this DRAFT RFP are as follows:

Marcy Grace: marcy.grace@hhs.gov Enrique Manan enrique.manan@hhs.gov

BARDA encourages open communication from all potential Responders.

A combined conference call (with all interested potential Responders) to discuss this DRAFT RFP has been scheduled as follows:

DATE: Friday March 15, 2019

TIME: TBD

LOCATION: Washington, DC

CALL IN INFO: TBD

Thank you for your interest in doing business with the Federal Government.

mailto:marcy.grace@hhs.gov mailto:marcy.grace@hhs.gov mailto:enrique.manan@hhs.gov

DRAFT

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

FAR (48 CFR) 53.214©

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

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 126

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED(RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE NO.

N/A

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

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

SOLICITATION

9. Sealed offers in original and 1 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 Section L for Instructions until 12:00 PM local time

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

a. TELEPHONE (NO COLLECT CALLS)

b. E-MAIL ADDRESS

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 46

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

X C DESCRIPTION/SPECS./WORK STATEMENT 08 X J LIST OF ATTACHMENTS 59

X D PACKAGING AND MARKING 12 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 13 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 14 X OTHER STATEMENTS OF OFFERORS 60

X G CONTRACT ADMINISTRATION DATA 24 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 63

X H SPECIAL CONTRACT REQUIREMENTS 29 X M EVALUATION FACTORS FOR AWARD 78

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 ___150___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.

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 because 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 multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) contracts for a Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTP&E) Contract Research Organization (CRO) to execute routine and/or response clinical services for advanced development of medical countermeasures (MCMs) in support of the Biomedical Advanced Research and Development Authority (BARDA) mission. With this solicitation, BARDA seeks to modify the current CSN infrastructure and extend services available for advanced clinical development of MCMs. The revised infrastructure will address additional requirements recognized during operation of the CSN since it was established. It will enhance the capabilities of the existing CSN and add services to be utilized across studies by adding a Biological Specimen and Investigational Product storage facility (BSIP) and a Statistical and Data Coordinating Center (SDCC).

In order to enhance BARDA’s preparedness and response to CBRN, PI and EID threats BARDA seeks a diverse pool of CROs or similar entities to provide CTP&E services as primary contactors. Service capabilities include project management, study start up, site training and support, site feasibility and selection, site monitoring and management, specimen and IP management, laboratory services, regulatory services including but not limited to Investigational New Drug Application (IND) and Amendment publishing and Food and Drug Administration (FDA) submission, Institutional Review Board services, quality assurance, as well as other services. During emergencies, services need to be rapid, adaptable, scientifically robust, and minimally disruptive to the course of patient care.

Considerations for executing such services need to include:

1. Phase of the study in relation to the development stage of the MCM investigational product (Phase 1, Phase 2, Phase 3, or Phase 4)

2. The type of study (e.g., interventional or observational studies)

3. The requirement for near real-time data availability

4. The scale of the emergency (e.g., national versus local versus international)

5. The class of MCM (e.g., drug, biologic, device, or combination product).

BARDA acknowledges that some Respondents may have strengths in providing these services in the conduct of routine studies, while others may have strengths preparing for and operating in response (i.e., emergency) scenarios. Therefore, BARDA intends to evaluate Respondents separately for these two capabilities. Respondents may respond to one or to both capability(ies).

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 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 Clinical Studies Network (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 for clinical trial preparation and execution (CTP&E) services, two (2) other separate and distinct solicitations will seek to address these gaps as follows:

1. RFP No. 19-….. – Seeks offers to address the requirements for a Centralized Statistical Services and Data Coordination Center (SDCC); and

2. RFP No. 19-….. – Seeks offers to address the requirements for a Biological Specimen and Investigational Product storage facility (BSIP)

The objectives of those two solicitations are to establish a BSIP storage facility (BSIP) and a Statistical and Data Coordinating Center (SDCC). This solicitation addresses additional requirements for CTP&E services on a routine basis without expedited timelines, as well as services to prepare for and execute clinical studies during emergencies when expedited timelines are crucial. Collectively, awardees from all three (3) solicitations will form the revised infrastructure for the BARDA Clinical Studies Network

(CSN).

B.2. SPECIFIC REQUIREMENTS

Clinical Studies Network Clinical Trial Planning & Execution (Routine and/Response)

With this solicitation, BARDA seeks to modify the current CSN infrastructure and extend services available for advanced clinical development of MCMs. With this solicitation, BARDA CSN seeks to:

1. Provide a clinical study core service for use on a routine or response basis by BARDA and by BARDA’s product development partners.

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

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

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

5. Reduce the risk associated with clinical development of investigational or repurposed products by expanding the available clinical data.

PLEASE NOTE:

Potential Offerors are not expected to be proficient in all areas mentioned in the Statement of Objectives (SOO).

Partnering and teaming arrangements are encouraged.

Multiple awards are anticipated with selection of large, full service, small, and specialty CROs.

B.3. CONTRACT TYPE

The Government 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); Cost Plus Fixed Fee (CPFF); and/or Cost-Sharing.

B.3.1. Base Period (CLIN)

Base Period of Performance: 2019 through 2021 (2 years).

Base Period Cost Reimbursement CLIN

Item Supplies/Services Estimated Cost

Fixed Fee

Cost + Fixed Fee (CPFF)

0001 Clinical Studies Network & Technical Reports on TOs

TBD*

* TBD – To Be Determined Business proposals shall include labor rate costs, facility costs, and all other costs necessary to complete clinical study services

B.3.2. Option Periods

The final contract will contain Option Contract Line Item Numbers (CLINs) agreed upon by the Government and the Offeror:

Item Supplies/Services Estimated Cost

Fixed Fee

Cost + Fixed Fee (CPFF)

0002 Option Year One: Clinical Studies Network & Technical Reports on TOs

TBD*

0003 Option Year Two: Clinical Studies Network & Technical Reports on TOs

TBD*

0004 Option Year Three: Clinical Studies Network & Technical Reports on TOs

TBD*

* TBD – To Be Determined.

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, Contract Clauses, this contract consists only of the base period.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

B.4.1. Minimum Ordering Amount

The Contractor(s) shall each be reimbursed by the Government a one-time amount not less than a total of $50,000 (regardless of Option years exercised).The Government is not obligated to order more than the stated minimum for the entire contract period including Option periods.

B.4.2. Maximum Ordering Amount – $100,000,000.00

The Contractor(s) shall not receive payment from the Government in an amount greater than $100,000,000.00 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.4.3. Minimum Order Guarantee

The total minimum guarantee under this IDIQ contract is $200,000. This one-time amount will be issued at the end of the contract. If no TOs are received during the base contract, 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 TO and providing a clear explanation for not submitting a proposal in response to TOs.

Funds for requested services provided will be obligated, at the task order level, as task orders are placed. Excess funds will be 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.4.4. 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:

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. Travel to attend general scientific meetings/conferences;

7. Foreign Travel Costs;

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 $150,000.00;

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.4.5. 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 below cost categories (as applicable). A sample invoice form SF- 1034 is provided as Attachment #7.

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 percentage 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 $TBD.

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. Invoice submission information is provided in SECTION G.6.

SECTION C – STATEMENT OF OBJECTIVES (SOO)

TITLE: Clinical Studies Network: Clinical Trial Planning and Execution (CTP&E)

C.1. INTRODUCTION/BACKROUND

The purpose of this Request for Proposals is to solicit applications for Clinical Trial Planning and Execution (CTP&E) services for the Biomedical Advanced Research and Development Authority (BARDA) Clinical Studies Network (CSN). The purpose of the CSN is to advance the development of life saving MCMs by efficiently enabling rigorous clinical trials to assess safety and efficacy of drugs, devices, and biological products. BARDA established the CSN as a core service in 2012 and awarded Indefinite Delivery/ Indefinite Quantity (IDIQ) Contracts to five (5) full service CROs in 2014 to form the CSN infrastructure. The CSN will provide a robust and readily accessible infrastructure for rapid implementation and high quality performance of clinical trials as well as provide other services in a breadth of indications related to development of MCMs. The infrastructure should be sufficient for performing approximately four simultaneous clinical trials. The CSN will consist of several clinical contract research organizations (CROs) for routine and response clinical studies. Two companion solicitations will address the need for a Statistical and Data Coordinating Center (SDCC) and for a Biological Specimen and Investigational Product storage facility (BSIP). Offerors are encouraged to respond to one, two or all three solicitations if they are able to provide the required services directly or indirectly through subcontractors.

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

Objective 1 The Offeror shall provide clinical trial planning and execution services 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.

Objective 2 There will be two types of RTORs:

1. For routine (i.e., preparedness) clinical trial planning and execution with non-expedited timelines

2. For response (i.e., emergency) clinical trial planning and execution in urgent situations with expedited timelines such as during an emergency.

BARDA acknowledges that some Offerors may have strengths providing services in the conduct of routine studies, while others may have strengths operating in response scenarios. Therefore, BARDA intends to make independent evaluations and separate awards for these two capabilities; in responding to this RFP, Offerors may respond to one or to both.

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. Disposition of records shall be in accordance with this document, and in Technical requirements, this section, Overall Contract Requirements.

This contract is for the establishment of CTP&E services on a routine basis without expedited timelines, as well as services to prepare for and execute clinical studies during emergencies when expedited timelines are crucial. All work performed under this contract must be done in compliance with federal and/or local regulations.

Task Orders may be issued for work substantially as follows:

A. Routine Clinical Trial Planning and Execution

Task Orders for routine clinical trial planning and execution will be for services to support activities related to the conduct of clinical trials without critically short timelines. Those services include but are not limited to those listed below.

BARDA will specify: 1) whether an IND/IDE (Investigational Device Exemption) application or equivalent should be submitted to an appropriate regulatory agency; 2) the entity that will hold the IND/IDE; and 3) whether a Data and Safety Monitoring Board1 (DSMB) is required.

The Contractor shall provide the following services (for each of the following, specify whether these are in-house or outsourced capabilities):

1. Project Management and Administration

1.1. Develop a Project Management Plan that describes the relationships, accountabilities, communications, and oversight of coordination of the collaborative activities of the CTP&E CRO as well as the SDCC and the BSIP CROs, BARDA, other partners and collaborators, vendors, and sub-contractors during study planning, start-up, execution, and close-out.

1.2. Development and maintenance of Responsible, Accountable, Copied, Informed (RACI)/Study Responsibility Matrix outlining responsibilities for key activities and deliverables (specific roles for BARDA, the CSN contractors and subcontractors will be established at the time of each Task Order)

1.3. Comprehensive study timelines in MS Project for each study

1.4. Secure (21 CFR Part 11 compliant validated), study-specific internet based portal that is password protected with managed user access roles

1.5. Written project status reports according to pre-specified schedules.

1.6. Schedule, develop agenda, and lead team meetings. Author and distribute meeting minutes documenting key discussions, decisions, action items and persons responsible.

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

2.0 Planning and Pre-study Activities

2.1 Establish an identified project team which may include a project manager, clinical trial manager, clinical research associate, medical monitor, pharmacovigilance specialist, regulatory specialist, medical writer, and quality specialist.

2.2 Protocol development and writing support services, including the development of protocol-related documents such as sample informed consents

2.3 Identification and establishment of contractual agreements with clinical research vendors to support studies as needed, including but not limited to clinical laboratories and investigational product packaging, labeling, and shipping

2.4 Negotiate and execute all clinical trial agreements and site budgets

2.5 Secure clinical trial insurance appropriate for the study and population

2.6 Author, as needed, internal Standard Operating Procedures (SOPs) associated with processes necessary to comply with the FDA and Sponsor established requirements, Provide BARDA access to CRO SOPs for review.

2.7 Purchase all necessary equipment and clinical/laboratory supplies

2.8 Provide sites with study supplies and materials

2.9 Develop study procedures manual and other manuals as necessary

2.10 Perform site feasibility and site selection including evaluation of investigator and research staff qualifications, facilities, and laboratory capabilities, site logistics, and infrastructure

2.11 Determine what type of IRB/EC can be utilized and coordinate all aspects or selecting IRB

2.12 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

2.13 Identify and establish contractual agreements with clinical research vendors to support studies as needed, including but not limited to:

2.13.1 Clinical laboratories for biological sample management and chain of custody

2.13.1.1 Pre-qualify central laboratories for validated assays

2.13.1.2 Establish a validated specimen tracking and report system

2.13.1.3 Establish processes in a study-specific manual for handling of specimens:

collection, processing, shipping and receipt, final specimen disposition and reconciliation

2.13.1.4 Ability to coordinate sample management and shipping to Biological Specimens and IP storage CSN vendor

2.13.1.5 Obtain local laboratory ranges, qualifications, and certifications, including CLIA

2.13.1.6 Conducted under current Good Clinical Laboratory Practice (GCLP) as necessary

2.13.1.7 Obtain necessary approvals for export of biological specimens as allowed by regulatory authorities

2.13.2 Investigational product or device management

2.13.2.1 Develop and implement a study supplies procurement and management plan as well as Investigational Product or Device Accountability Plan

2.13.2.2 Obtain necessary approvals for import of IP and clinical trial materials or devices including storage and shipment

2.13.2.3 Ensure IP or device is labeled as investigational, according to IND/IDE requirements

3.0 Medical and Safety Monitoring

3.1 Develop and implement plans for providing 24 hour medical monitoring support with qualified medical monitors trained in the appropriate therapeutic area.

3.2 Identify independent DSMB members and provide qualifications for sponsor approval

3.3 Develop and implement plans for safety assessment and safety monitoring/pharmacovigilance activities including identification, reporting and tracking systems for AEs, SAEs, study pausing/stopping rules, etc.

3.3.1 Including an unblinding plan consistent with E6 (R2) (e.g., to accommodate safety regulatory requirements).

4.0 Regulatory Services

4.1 Per BARDA’s request, author the following documents utilizing BARDA’s StartingPoint CTD templates for BARDA’s review and provide submission ready, including but not limited to the following:

4.1.1 Pre-IND

4.1.2 Original IND submission including, but not limited to general investigational plan;

study rationale; chemical, manufacturing and controls (CMC); preclinical and clinical documents and summaries

4.1.3 Protocol amendments

4.1.4 Safety reports

4.1.5 IND annual reports

4.2 Update CTD build list in real time for needed submission documents, delivery dates, and Offeror’s dates as submission build progresses

4.3 As directed by BARDA, perform quality control, publish, and transmit FDA submissions, which are compliant with eCTD specifications and all applicable regulatory requirements.

Submission documents shall include, but are not limited to the following:

4.3.1 Briefing documents

4.3.2 Meeting requests

4.3.3 Meeting packages

4.3.4 Pre-IND submissions

4.3.5 IND submissions

4.3.6 BLA Applications

4.3.7 510K Applications

4.3.8 Protocol amendments

4.3.9 Safety reports

4.3.10 Responses to FDA requests for information

4.3.11 IND annual reports.

4.4 Provide BARDA access to an eCTD viewing tool to view BARDA’s published submissions before submitting via the FDA gateway

4.5 Provide BARDA direct access to any sub-contractor preforming publishing and FDA submission activities

4.6 Allow BARDA cumulative review of submissions in the eCTD viewing tool when safety reports have been submitted and reviewers are blinded. (Note: BARDA will work with the Offeror to develop a process that ensures no inadvertent unblinding, and the viewing tool should be flexible to enable this.)

4.7 Validate eCTD submissions and provide to BARDA the complete validation report before final authorization to submit to FDA

4.8 Provide BARDA FDA Electronic Submission Gateway Receipt and Acknowledgement

4.9 Provide a concatenated submission document to BARDA to be used for BARDA printing and archiving

4.10 Provide key information to investigators required for conduct of the study including, but not limited to, Investigator brochure (IB), revised IB, and AEs

4.11 As directed by the Sponsor, provide information to manufacturer about investigational product

4.12 Collect and review Regulatory Essential Document Packet for site activation.

4.13 Manage electronic Trial Master File (eTMF), which includes the following:

4.13.1 Create eTMF index

4.13.2 Set up and maintain eTMF

4.13.3 Conduct periodic eTMF audits

4.13.4 Final eTMF Quality Control, archiving, and document return

4.14 Register and provide information for clinical studies to ClinicalTrials.gov Protocol Registration and Results System (PRS) as well as country-specific applicable registries.

4.15 Identify and contract with regulatory support personnel in US and possibly other countries to assist with obtaining necessary regulatory approvals

4.16 For countries outside the US, serve as primary in-country agent representing sponsor to the competent authorities, ethics committees and other regulatory bodies; manage and track all regulatory communications; serve as regulatory point of contact, interact with competent authority and negotiate on behalf of sponsor; track, manage, and implement plan for all regulatory deliverables

4.17 Submit study documents and obtain approval and annual renewals from a central Institutional Review Board (IRB) and as required from national and local Ethics Committee (EC) in other countries as appropriate

4.18 Perform protocol-specific clinical site monitoring, identification, assessments and selection plans

5.0 Quality Assurance and Audits

5.1 Development and implementation of an effective internal Quality Assurance and Quality Control and Audit plan for the Offeror’s coordinating and document preparation activities ensures compliance with federal and local regulations, and the ethics committee approved protocol.

5.2 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. on site and central monitoring activities, CTA essential records management) and the contractor/subcontractor staff.

5.3 Provide capabilities for on-site auditing of clinical trial sites and vendors (subcontractors) including drafting and submission of audit plans and reports.

5.4 Maintain inspection readiness state.

6.0 Clinical Site Management and Monitoring

6.1 Ensure the conduct of the trial is in compliance with approved protocol, cGCP, cGCLP, and all applicable regulatory requirements.

6.2 Organize and provide all site training (e.g. Investigator Meetings and Site Initiation Visits as well as ongoing training throughout the study).

6.3 Clinical Site Visits:

6.3.1 Site qualification visits to evaluate and perform gap analysis for clinical sites to ensure clinical trial is conducting in accordance with Good Clinical Practice (GCP) and all local regulations

6.3.2 Site Initiation Visit, Routine Monitoring Visits, and Site Close out Visits

6.4 Develop and implement a robust risk based monitoring plan with quality metric deliverables on an ongoing basis to evaluate site status

6.5 Ensure clinical sites have documentation of proficiency in: GCP, Investigator Responsibilities, Protection of Human Subjects

6.6 Ensure site and IRB/EC is in compliance with Federal Wide Assurance (FWA)

6.7 Assist sites with the development of recruitment and retention plans, monitor site recruitment and retention as well as visit compliance.

6.8 Initiate enrollment of eligible subjects in accordance with institutional and regulatory guidelines to complete studies.

6.9 Monitor participant enrollment and quality metrics. Establish and maintain centralized monitoring reporting systems to track individual site activities such as numbers of subjects screened, enrolled, withdrawn and completed.

6.10 Develop and implement risk management contingency plans for slow enrollment such as frequent meetings with the clinical sites and identification and pre-qualification of back-up clinical sites.

6.11 Manage investigator site payments, vendor payments, and other indirect/direct costs per contract and budget.

6.12 Utilize a clinical trial management system that includes a robust risk-based monitoring system integrated with central monitoring system tools using real-time data shared by the

SDCC.

6.13 Provide ongoing and active vendor management of all subcontractors.

6.14 Review site performance on an ongoing basis and work directly with site staff to improve processes and achieve best practices.

6.15 Develop and implement clinical site quality management programs including data quality assessments, source data validation, and quality audits.

6.16 Develop and implement clinical site quality checks on study personnel performance and on study specific regulatory and SOP documents.

6.17 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).

6.18 Coordinate biological specimen management with the central laboratory or other designated facilities, and coordinate shipment and storage at the Biological Sample and Investigational Product Archives (BS&IPA).

6.19 Coordinate and manage investigational product/device shipment, delivery, proper storage, and inventory at clinical sites. Conduct accountability procedures and coordinate and manage end of study disposition.

6.20 Procure study supplies, manage kitting, shipment, delivery, proper storage, and inventory at clinical sites.

B. Response Clinical Trial Planning and Execution

Task Orders for response clinical trial planning and execution will be for services to prepare for and support activities related to the conduct of clinical trials with unusual but critical expedited timelines.

Offerors shall commit to the following in addition to meeting all of the Technical Requirements outlined in Section A above:

1. Respond to RTORs by submitting a proposal to BARDA under expedited timelines (for example, within 72 hours during an emergency).

2. Initiate a clinical study under expedited timelines upon Task Order award. The protocols for these studies may be established prior to an emergency, or created at the time of an emergency.

3. Collaborate with BARDA to develop emergency response clinical trial design templates (for example, generic master protocols), provide expertise, compare and contrast potential trial designs and make recommendations, provide a global footprint, and enable rapid independent ethics reviews.

4. Have internal systems and processes in place to protect worker safety and security in austere settings.

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.

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 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. Continuity of Services Plan template, Attachment 15.

C.7. SECURITY PLAN

Contractor security deliverables. In accordance with the timeframes specified, the Contractor shall prepare and submit the following security documents to the Contracting Officer for review, comment, and acceptance:

1. IT Security Plan (IT–SP)—due within 30 days after contract award. The IT–SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT–SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT–SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT–SP applies.

(i) The Contractor's IT–SP shall comply with applicable Federal laws that include, but are not limited to, the Federal Information Security Management Act (FISMA) of 2002 (Title III of the E-Government Act of 2002, Public Law 107–347), and the following Federal and HHS policies and procedures:

(A) Office of Management and Budget (OMB) Circular A–130, Management of Federal Information Resources, Appendix III, Security of Federal Automated Information Resources.

(B) National Institute of Standards and Technology (NIST) Special Publication (SP) 800–18, Guide for Developing Security Plans for Federal Information Systems, in form and content, and with any pertinent contract Statement of Work/Performance Work Statement (SOW/PWS) requirements. The IT–SP shall identify and document appropriate IT security controls consistent with the sensitivity of the information and the requirements of Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems. The Contractor shall review and update the IT–SP in accordance with NIST SP 800–26, Security Self-Assessment Guide for Information Technology Systems and FIPS 200, on an annual basis.

(C) HHS–OCIO Information Systems Security and Privacy Policy.

(ii) After resolution of any comments provided by the Government on the draft IT–SP, the Contracting Officer shall accept the IT–SP and incorporate the Contractor's final version into the contract for Contractor implementation and maintenance. On an annual basis, the Contractor shall provide to the Contracting Officer verification that the IT–SP remains valid.

2. IT Risk Assessment (IT–RA)—due within 30 days after contract award. The IT–RA shall be consistent, in form and content, with NIST SP 800–30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS– OCIO Information Systems Security and Privacy Policy. After resolution of any comments provided by the Government on the draft IT–RA, the Contracting Officer shall accept the IT– RA and incorporate the Contractor's final version into the contract for Contractor implementation and maintenance. The Contractor shall update the IT–RA on an annual basis.

3. FIPS 199 Standards for Security Categorization of Federal Information and Information

Systems Assessment (FIPS 199 Assessment)—due within 30 days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard. After resolution of any comments by the Government on the draft FIPS 199 Assessment, the Contracting Officer shall accept the FIPS 199 Assessment and incorporate the Contractor's final version into the contract.

4. IT Security Certification and Accreditation (IT–SC&A)—due within 3 months after contract award. The Contractor shall submit written proof to the Contracting Officer that an IT–SC&A was performed for applicable information systems— see paragraph (a) of this clause. The Contractor shall perform the IT–SC&A in accordance with the HHS Chief Information Security Officer's Certification and Accreditation Checklist; NIST SP 800–37, Guide for the Security Certification and Accreditation of Federal Information Systems; and NIST SP 800–53, Recommended Security Controls for Federal Information Systems. An authorized senior management official shall sign the draft IT–SC&A and provide it to the Contracting Officer for review, comment, and acceptance.

(i) After resolution of any comments provided by the Government on the draft IT–SC&A, the Contracting Officer shall accept the IT–SC&A and incorporate the Contractor's final version into the contract as a compliance requirement.

(ii) The Contractor shall also perform an annual security control assessment and provide to the Contracting Officer verification that the IT–SC&A remains valid. Evidence of a valid system accreditation includes written results of:

(A) Annual testing of the system contingency plan; and

(B) The performance of security control testing and evaluation.

5. Personal identity verification. The Contractor shall identify its employees with access to systems operated by the Contractor for HHS or connected to HHS systems and networks. The Contracting Officer's Representative (COR) shall identify, for those identified employees, position sensitivity levels that are commensurate with the responsibilities and risks associated with their assigned positions. The Contractor shall comply with the HSPD–12 requirements contained in “HHS–Controlled Facilities and Information Systems Security” requirements specified in the SOW/PWS of this contract.

6. Contractor and subcontractor employee training. The Contractor shall ensure that its employees, and those of its subcontractors, performing under this contract complete HHS-furnished initial and refresher security and privacy education and awareness training before being granted access to systems operated by the Contractor on behalf of HHS or access to HHS systems and networks. The Contractor shall provide documentation to the COTR evidencing that Contractor employees have completed the required training.

7. Government access for IT inspection. The Contractor shall afford the Government access to the

Contractor's and subcontractors' facilities, installations, operations, documentation, databases, and personnel used in performance of this contract to the extent required to carry out a program of IT inspection (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the integrity, confidentiality, and availability, of HHS data or to the protection of information systems operated on behalf of HHS.

8. Subcontracts. The Contractor shall incorporate the substance of this clause in all subcontracts that require protection of Federal information and Federal information systems as described in paragraph (a) of this clause, including those subcontracts that—

i. Have physical or electronic access to HHS' computer systems, networks, or IT infrastructure; or

ii. Use information systems to generate, store, process, or exchange data with HHS or on behalf of HHS, regardless of whether the data resides on a HHS or the Contractor's information system.

9. Contractor employment notice. The Contractor shall immediately notify the Contracting Officer when an employee either begins or terminates employment (or is no longer assigned to the HHS project under this contract), if that employee has, or had, access to HHS information systems or data.

10. Document information. The Contractor shall contact the Contracting Officer for any documents, information, or forms necessary to comply with the requirements of this clause.

11. Contractor responsibilities upon physical completion of the contract. The Contractor shall return all HHS information and IT resources provided to the Contractor during contract performance and certify that all HHS information has been purged from Contractor-owned systems used in contract performance.

12. Failure to comply. Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause shall be grounds for the Contracting Officer to terminate this contract.

(End of clause)

The Contractor’s Security Plan will be included as an attachment to any contract awarded under this solicitation upon approval by the Contracting Officer. See Attachment 13.

SECTION D – PACKAGING, MARKING AND SHIPPING

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.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

1. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

2. For the purpose of this section, (to be filled-in at award), is the authorized representative of the

Contracting Officer.

3. Inspection and acceptance will be performed at the destination of the articles, services or documentation delivered for the performance of this contract.

4. The USG hold the right to be present during the execution of the tasks as a man-in-plant.

E.2. 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.