W81XWH-17-R-0074-0002_Modification_Copy.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

This amendment is to provide answ ers to questions received about the Request for Proposal along w ith corresponding amendments.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 48

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 27-Apr-2018

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH-17-R-0074

X 9B. DATED (SEE ITEM 11)

12-Apr-2018

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

27-Apr-2018

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH-17-R-0074

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0003

The CLIN extended description has changed from:

The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and management thereof to accomplish all work under this contract.

To:

PLUG VALUE FOR PROPOSAL PURPOSES (TRAVEL ONLY): $247,045.00The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and management thereof to accomplish all work under this contract.

The cost constraint EST has been added.

CLIN 1002

The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and

PLUG VALUE FOR PROPOSAL PURPOSES (TRAVEL ONLY): $164,948.62The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and management thereof to accomplish all work under this contract.

CLIN 2002

The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and

PLUG VALUE FOR PROPOSAL PURPOSES (TRAVEL ONLY): $164,948.62The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and management thereof to accomplish all work under this contract.

CLIN 3002

The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and

PLUG VALUE FOR PROPOSAL PURPOSES (TRAVEL ONLY): $20,587.08The Contractor shall furnish the necessary equipment, supplies, and other applicable ODC's such as travel and management thereof to accomplish all work under this contract.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

UNITED STATES ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY (USAMMDA) REGULATORY,

CLINICAL, AND TECHNICAL SUPPORT SERVICES

1.0 GENERAL INFORMATION

This performance work statement (PWS) provides for regulatory, clinical, and technical services to support the U.S.

Army Medical Materiel Development Activity’s (USAMMDA) mission to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. These support services cover the full range of clinical, manufacturing, and regulatory professional disciplines necessary to perform the work efforts specified in this PWS.

The Contractor shall provide support services to include but not limited to all personnel, equipment, supplies, facilities, transportation, tools, materials, and supervision necessary to perform regulatory, clinical, and technical support services as defined in this Performance Work Statement except for those items specified as government furnished property and services. The Contractor shall perform to the standards in this contract.

1.1 Non-Personal Services

This PWS identifies services that are strictly non-personal in nature.

1.2 Severable / Non-Severable Services

This PWS identifies services that are severable in nature.

1.3 Inherently Governmental Functions

This PWS has been reviewed and contains no services that are inherently governmental functions.

1.4 Acquisition Functions Closely Associated with Inherently Governmental Functions This PWS identifies acquisition functions that are closely associated with inherently governmental functions as defined in Section 804 of the Fiscal Year (FY) 2005 National Defense Authorizations Act. Appropriate military or civilian personnel of the Department of Defense (DoD) cannot reasonably be made available to perform these functions. However, appropriate military or civilian personnel of the DoD will: (1) oversee Contractor performance of the contract; and (2) perform all inherently governmental functions associated with the functions to be performed under this contract.

2.0 BACKGROUND

USAMMDA is the Department of Army’s (DA), and often the Department of Defense’s (DoD) advanced development activity for medical products designed to protect and preserve the lives of Warfighters. USAMMDA develops drugs, vaccines, devices, and medical support equipment that enhance readiness, ensures the provision of the highest quality medical care to the DA and DoD and maximize survival of medical casualties on the battlefield.

USAMMDA guides the advanced development of medical products for the US Army Medical Department, other US Services, the Joint Staff, the Office of the Secretary of Defense and US Special Forces community. The process takes promising technology from within the DoD and academia, from the testing and manufacturing required for Food and Drug Administration (FDA) approval or licensing, to fielding of the finished product.

USAMMDA accomplishes its mission by exercising three core capabilities:

1. Program management for US Army Medical Research and Materiel Command (USAMRMC) advanced development projects.

2. Regulatory management of all activities associated with using Investigational New Drugs (INDs) applications or Investigational Device Exemptions (IDEs).

3. Coordinate the Army Surgeon General’s Executive Agent management of Force Health Protection’s (FHP) INDs.

USAMMDA is organized into the Office of the Commander; five Project Management Offices (PMO): Tissue Injury and Regenerative Medicine (TIRM), Hyperbaric Oxygen Treatment (HBO2), Medical Support Systems (MSS), Neurotrauma and Psychological Health (NPH), and Pharmaceutical Systems (PS); and three Support Divisions: Administrative Services (ASD), , Force Health Protection IND (FHP), and Office of Regulated Activities (ORA). Each PMO is managed by a Project Manager (PjM), who assigns product development efforts to individual Product Managers (PdM).

ORA is a multidisciplinary team of regulatory affairs and compliance professionals dedicated to supporting the USAMMDA mission of developing medical products for the Warfighter and supports The Surgeon General (TSG) Sponsor’s representative in the USAMRMC for the Army. ORA provides full-service regulatory support for TSG-sponsored products and contracted medical product development efforts throughout the DoD acquisition spectrum.

A short synopsis of each ORA branch is as follows:

The Regulatory Operations (RO) Branch provides world-class regulatory submissions, document control and medical writing support, which includes preparation, submission, storage and tracking of all Food and Drug Administration (FDA) regulated documents. All FDA Sponsor documents, including FDA submission and clinical trial master files, are maintained in an FDA-compliant electronic document management system by the RO Branch.

The Medical DD and Regulatory Science Branches provide expert regulatory knowledge, subject matter expertise, and strategic regulatory direction and support for USAMMDA, as well as external commands. Both the MDD and Regulatory Science Branches provide technical management of teams of Regulatory Affairs scientists who provide expert regulatory support to Integrated Product Teams (IPTs) which includes serving as the FDA liaison, development of regulatory strategies, providing of regulatory guidance, and review of regulatory submission documents prior to submission to FDA. The Regulatory System Manager also ensures regulatory compliance of clinical systems used in support of FDA regulated activities by overseeing validation and testing efforts of new and existing clinical research systems.

The Product Safety Surveillance Branch (PSSB) is responsible for ensuring all safety sponsor responsibilities for FDA regulated studies are met. This includes, but is not limited to, adverse event review and reporting, product safety surveillance, adverse event coding for safety analysis, sponsor medical determination of Serious Adverse Event (SAE) attribution and requirements for expedited reporting, coordination on safety reporting to FDA with regulatory affairs, management of Data Monitoring Committees (DMC) or Data Safety Monitoring Boards (DSMB). The TSG currently holds 4 DSMBs and it is not anticipated that this would increase.

The Clinical Operations Branch (CO) is responsible for ensuring all clinical monitoring sponsor responsibilities for FDA regulated studies are met, and providing clinical trial management activities for IPTs.

The Data Management (DM) Branch is responsible for ensuring all of the sponsor’s FDA regulated data management responsibilities are fulfilled, and maintaining the overall integrity of the study data throughout the clinical trial.

The Biostatistics Branch is responsible for statistical regulatory oversight of any organization (internal to DoD or external to DoD) that is providing full biostatistics support for the Surgeon General (TSG) sponsored clinical or non-clinical trials on behalf of USAMMDA or other DoD organizations. Statistical regulatory oversight is defined as “ensuring that all statistical regulatory requirements as defined by FDA, International Conference on Harmonisation (ICH) and other Health Authorities are complied with”. The Biostatistics Branch is responsible for ensuring all sponsor responsibilities related to biostatistics are met.

The Product Technical Operations (PTO) Branch ensures sponsor responsibilities are fulfilled for FDA regulated product manufacturing, testing and nonclinical activities. PTO is responsible for advising on product manufacturing strategy, assisting with drafting and/or reviewing the manufacturing (Quality module), product accountability, and shipping (cold chain management). PTO is also responsible for ensuring product testing is adequate to ensure that only safe and stable products are used in clinical research. PTO also assists in trouble shooting assays, manufacturing scale up, and validation issues, to provide a few examples. PTO is responsible for ensuring the nonclinical data presented in clinical protocols and Investigator brochures is accurate and complete. PTO is responsible for Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) oversight and compliance at the product level. PTO branch staff require in depth knowledge of technical requirements, and regulatory compliance requirements.

ORA provides support to both Tech Base and Advanced Development vaccine/drug/device programs of Medical Research and Materiel Command (MRMC). The majority of the support services are applicable to pre-marketing product development efforts; however, the TSG holds a small number of marketed products for the Medical Countermeasure Systems Joint Program Office. TSG currently has approximately 80 open FDA applications which include Investigational New Drugs, drug master files (MFs) and orphan drug applications with approximately 70 ongoing clinical trial efforts at any one time. Of the 70 ongoing clinical trial efforts, approximately 35 of those are actively enrolling, while the other ~35 are either in study start up or close out phases.

Additional information about USAMMDA can be found at the following website: www.USAMMDA.army.mil.

3.0 OBJECTIVE

The primary objective is to provide regulatory, clinical, and technical services as are necessary to facilitate full program coordination, management, policy development, execution, and oversight across all USAMMDA clinical, technical, and regulatory areas.

4.0 GENERAL INFORMATION

4.1 Period and Place of Performance

The period of performance is:

Transition In: 1 SEP 2018 – 30 SEP 2018 Base Period: 1 OCT 2018 – 31 AUG 2019, with full performance beginning 1 OCT 2018 1st Option Period: 1 SEP 2019 – 29 FEB 2020 2nd Option Period: 1 MAR 2020 – 31 AUG 2020 Transition Out: 1 SEP 2020 – 30 SEP 2020, with full performance ending 30 SEP 2020 http://www.usammda.army.mil/

The Contractor shall perform primary activity at the Government’s facility, located at 1430 Veterans Drive, Fort Detrick, MD 21702. The Contractor shall provide offsite office space for contract employees within the United States.

Contractors performing offsite shall have the capability of attending meetings in person at Fort Detrick, Walter Reed Army Institute of Research (WRAIR) or other Tech Based facilities as requested by the Government. Other meetings may be attended via teleconference.

For work performed in Government facilities, the Government will provide access to Government controlled facilities, equipment, and materials for daily business use of staff called for under this order. This shall include office space, desk, telephone, chair, computer, shared printer, and requisite consumable materials. The Contractor shall be provided keys, access badges and/or codes for access to the Government facility. These keys, access badges and codes shall be controlled, tracked, and protected. Upon termination of the period of performance, all Government Provided Equipment (GFE) shall be turned in to the Contracting Officer’s Representative (COR).

For work performed off-site, the Government will provide computers, monitors, printer and/or scanners.

Blackberries may be issued if required by the Government. The Contractor shall provide office space, desk, telephone, requisite consumable materials, and conference space. When working in Contractor provided space, Contractors shall use GFE laptops and Government issued virtual private network (VPN) accounts.

4.2 Hours of Operation

The Contractor is responsible for conducting business, Monday through Friday during the core business hours of 0900 – 1500, except recognized Federal holidays (see PWS section 4.3) or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

Contractor employees are expected to be present during core hours unless otherwise coordinated with COR and Contractor.

At the convenience of the Government, Alternate Work Schedules (AWS) and telecommuting may be considered for contracted employees on a case-by-case basis. The Contract Task Manager approves all AWS/telework requests and shall coordinate with the COR to ensure all contractors are performing per the contract. All of these schedules shall be provided to the COR from the Contractor Task Manager. The AWS and/or telecommuting arrangements will be reviewed on a quarterly basis to ensure that the Government's mission is not adversely impacted. When telecommuting, Contractors shall use GFE laptops and Government issued virtual private network (VPN) accounts.

4.3 Recognized Federal Holidays

The Contractor is not required to perform services on the following recognized Federal Holidays.

New Year’s Day Labor Day Dr. Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

4.4 Type of Contract

The government will award a Cost plus Fixed Fee Contract.

4.5 Contracting Officer’s Representative (COR)

The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor the Contractor's performance and notify both the Contracting Officer (KO) and Contractor of any deficiencies; coordinate availability of Government furnished property, and provide site entry of Contractor personnel. A COR Appointment letter will issued to the COR, a copy of which will be sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

5.0 PERFORMANCE OBJECTIVES AND STANDARDS

5.1 Task Management

The Contractor shall provide sufficient management to ensure that all tasks described in this PWS are performed efficiently, accurately, on time, and in compliance with the requirements of this document. Specifically, the Contractor shall designate a Contractor Task Manager (CTM) to oversee this task and supervise staff assigned to this contract, including transition in and out as described in PWS section 5.5.

The CTM is a Key Personnel position as described in PWS section 5.9.

5.2 Monthly Progress Report (MPR) – DELIVERABLE 1

The Contractor shall submit a MPR, that at a minimum, provides status of work in progress, problems or constraints encountered, suggested solutions, vacancy status, projected absence and travel summary for the current and next two months, status on Antiterrorism/Operations Security (AT/OPSEC) training required in PWS section 8.2, and status of Government Furnished Equipment as required in PWS section 16.0 (Deliverable 1) using a format agreed upon by the COR and Contractor. The Contractor shall require all Sub-Contractor’s to provide input to the MPR where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and Contractor.

The MPR shall include a Spend Plan which details how the Offeror expects to incur and invoice for costs, both labor and other direct costs (ODCs) against the contract. The Spend Plan shall detail costs to be incurred by contract year, starting with the first month of the contract period of performance. The spend plan shall include the labor hours expended, by labor category and Contract Line Item Number (CLIN), and include an estimated cost to period of performance completion.

5.3 Kick-off Meeting and Program Reviews – DELIVERABLE 2

The Contractor shall schedule and conduct a kick-off meeting in coordination with the Government within seven (7) business days after contract award. The Contractor shall meet with the Government to present an overview of their approach and establish schedules, procedures, and points of contact necessary to conduct the tasks outlined herein.

This meeting shall not exceed two (2) hours in length. The primary outcome of this meeting is to come to an agreement on the cost, schedule, and performance baselines.

The Contractor shall plan and conduct regular, routine meetings with a frequency of not less than quarterly with the Government to review progress and status of activities under this contract. Each review shall provide insight into expenditures, staffing, progress, risks, and status of GFE, including Contractor purchased, Government owned items. The Contractor shall provide project briefings addressing cost/price, schedule, performance, and status of each key element of this contract, noting any problems or risks and alternative and recommended solutions.

The Contractor shall ensure that meeting materials (Deliverable 2) are provided to Government participants prior to the meeting and that data presented at program reviews is current within not more than ten (10) days. The Government will provide a template for meeting materials after contract award.

5.4 Individual Subcontracting Report (ISR) – DELIVERABLE 3

The Contractor shall submit an Individual Subcontracting Report (ISR) and subcontracting accomplishments for Federal Government contracts in the Electronic Subcontracting Reporting System (eSRS) at www.esrs.gov. The Contractor shall provide confirmation of ISR submission in eSRS to the COR (Deliverable 3). If the eSRS system is unavailable for any reason, the Contractor shall provide the complete report to the COR and the KO in lieu of Deliverable 3.

5.5 Transition Support

5.5.1 Incoming Transition Plan – DELIVERABLE 4

The Contractor shall provide an Incoming Transition Plan (Deliverable 4) for 30 days incoming transition from contract to contract. The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Government will designate a transition period for the incoming Contractor to coordinate and work with the existing Contractor.

The transition plan shall describe in detail how the Contractor shall maintain continuity of services upon the first day of full performance. The transition in plan, at a minimum, shall include the following tasks:

Obtaining a Fort Detrick Identification (ID) and Common Access Card (CAC), scheduling and completing Government required training; orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes; coordination with Government representatives; review, evaluation, and transition of incumbent support services; transition of historic data to new Contractor system; transfer of hardware warranties and software licenses, if applicable; transfer of all necessary business and/or technical documentation; distribution of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.; transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance; and transfer of accountability for Government keys and security codes.

5.5.2 Outgoing Transition Plan– DELIVERABLE 5

The Contractor shall provide a plan (Deliverable 5) for 30 days outgoing transition for transitioning work from an active task order to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor, or to the existing Contractor under a new contract or task order. In accordance with (IAW) the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract and/or orders issued under this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required metrics and statistics. This transition plan may include tasks such as:

Ensuring continuity of services; coordination with Government representatives; transition of historic data to new Contractor system; transfer of hardware warranties and software licenses, if applicable, transfer of all necessary business and/or technical documentation; transfer of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.; transfer of GFE and GFI; and GFE inventory management assistance; coordinate with the Government to account for Government keys, ID/access cards, and security codes.

5.6 Program Management Plan (PMP) – DELIVERABLE 6

The Contractor shall develop a PMP (Deliverable 6) that shall require Government approval. It will be used to manage, track and evaluate the Contractor’s performance. The PMP shall consist of control policies and procedures IAW standard industry practices for project administration, execution and tracking. The PMP shall document how the Contractor will meet and comply with the requirements to control, coordinate, and direct performance; and http://www.esrs.gov/ organize and manage resources that will achieve the technical/scientific requirements as established elsewhere in the

PWS.

The PMP shall include the following:

a) Identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities;

b) A description of the Contractor’s overall management approaches, policies, and procedures including suggested project metrics, as well as the use of onsite Contractor leads; and,

c) A detailed staffing plan, which describes, the Contractor’s approach to ensuring continuity of services, coordination, direction, management of all Sub-Contractors, and meeting all security requirements. The staffing plan shall address recruitment and retention with an emphasis on filling vacancies with qualified individuals able to obtain required security clearances in a timely manner continuously throughout the term of the contract.

5.7 Quality Control Plan (QCP) – DELIVERABLE 7

The Contractor shall prepare and adhere to a QCP (Deliverable 7). The QCP shall document how the Contractor shall meet and comply with the quality standards established in this PWS. At a minimum, the QCP must include a self-inspection plan, an internal approval routing plan and an outline of the procedures that the Contractor shall use to maintain quality, timeliness, responsiveness, and customer satisfaction.

5.8 Accountability – DELIVERABLES 8 and 9

The Government cannot approve or disapprove leave or time off for any Contractors, however due to fire drills, active shooter exercises, occasions where USAMMDA is required to provide 100% accountability to higher headquarters due to real world incidents, etc., the Contractor shall notify the COR of all planned and unplanned employee absences (Deliverable 8).

5.8.1 Contingency Operations Plan (COP)

The Contractor shall prepare and submit a COP to the Government (Deliverable 9). The COP shall document Contractor plans and procedures to maintain USAMMDA support during an emergency. The COP shall include the following:

a) A description of the Contractor’s emergency management procedures and policy

b) A description of how the Contractor will account for their employees during an emergency

c) Planned temporary work locations or alternate facilities

d) How the Contractor will communicate with USAMMDA during emergencies

e) A list of primary and alternate Contractor points of contact, each with primary and alternate:

I. Telephone numbers II. E-mail addresses

f) Procedures for protecting Government Provided Equipment

g) Procedures for safeguarding sensitive and/or classified Government information (if applicable)

5.8.2 Operations during Emergency Situations

Individual COPs shall be activated immediately after determining that an emergency has occurred, shall be operational within 12 hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Task Manager(s) (CTM) to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency.

When any disruption of normal, daily operations occur, the CTM shall promptly open an effective means of communication with the COR and verify:

a) Key points of contact (Government and Contractor)

b) Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c) Means of communication available under the circumstances (e.g., email, webmail, telephone, facsimile, courier, etc.)

d) Essential work products expected to continue production by priority

The CTM, in coordination with the COR, shall make use of the resources and tools available to continue USAMMDA contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and KO prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately IAW the terms of this contract.

5.9 Contractor Personnel Performance/Replacement

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have experience identical to, similar to, or related to the services required to be performed under that position. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance.

The following positions are identified as Key Personnel:

5.1 Contractor Task Manager

6.1.5 Pharmacovigilance Physician (PVP)

6.1.8.2.1 NPH PMO Biostatistics Support

5.10 CONTRACTOR MANAGEMENT REPORTING (CMR) – DELIVERABLE 10

The Contractor shall report ALL Contractor labor hours (including Sub-Contractor labor hours) required for performance of services provided under this contract via a secure data collection site. The Contractor is required to completely fill in all required data fields using the following web address: https://cmra.army.mil/Login.aspx for Army. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the applicable help desk at: https://cmra.army.mil/Login.aspx.

The Contractor shall provide verification of CMR submission to the COR (Deliverable 10).

6.0 SPECIFIC TASKS

The Contractor shall ensure that all tasks listed below are performed in conformance with DoD, Army, USAMRMC, and USAMMDA regulations, policies, and procedures as well as FDA regulation and guidance. Specific to acquistion and product development projects and products, Contractors shall become familiar with and understand the DoD 5000 and the associated acquisition processes and procedures, as well as USAMRMC’s tailoring of those policies through the Decision Gate process. All tasks described below may require Contractors to support and participate in the development of contracting and regulatory strategies and associated documents in support of specific products.

6.1 ORA Support

https://cmra.army.mil/Login.aspx https://cmra.army.mil/Login.aspx

6.1.1 Regulatory Science Support

The contractor shall designate a team lead for the Regulatory Science Support. The team lead shall manage the operational day-to-day activities and as the subject matter expert on FDA regulated disciplines. The team lead shall serve as a liaison on task level communications between the branch’s Government leadership and other Contractors support the task.

The Contractor shall serve as a core member of integrated product teams (IPTs) and member of internal regulatory teams in support of drug, biologic, and medical device products, which includes:

• Reviewing of all regulatory documentation for the product development effort to include reviewing, editing, and coordination of document submissions to the FDA;

• Identifying regulatory issues that need input of other regulatory Subject Matter Experts (SMEs) and obtaining that input; aiding with clinical and nonclinical protocol development and review; providing guidance on regulatory pathway development and regulatory strategy;

• Providing guidance to IPTs in the conduct of meetings with the FDA;

• Providing guidance to IPTs for development of contract documents and statement of works for the development of medical devices, drugs or biologic products

• Ensure all FDA communications, both formal and informal are documented in the Sponsors Electronic

Document Management System (EDMS) for Army Surgeon General sponsored products;

• Ensuring timely receipt of and providing regulatory review of all FDA communications for externally sponsored products, serve as a point-of-contact with FDA and regulatory staff of external collaborators.

• Providing regulatory assessment, consult, and regulatory opinion for medical devices, drugs, biologics

• Understand and apply Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good

Manufacturing Practices (GMP) or Quality Systems Regulation (QSR) compliance for medical devices.

• Establishing and complying with standard operating procedures.

• Populating the sponsor’s trial master file for clinical studies and perform audits of trial master files to ensure all documentation is included

The Contractor shall assist in the tracking/reporting of the Army Surgeon General sponsored drug, biologic, and medical device products; as well as any required Annual Report due dates and maintenance of relevant file shares and the SERF. The Contractor shall assist in the completion of FDA forms (e.g. 1571, 1572, 2252) per 21 Code of Federal Regulations (CFR) and/or USAMMDA policy and/or regulations.

The Contractor shall support the Common Technical Document requirements (CTD) and electronic CTD (eCTD) publishing for drug/biologic product development efforts. The Contractor shall support the appropriate FDA premarket and postmarket regulatory requirements for medical device development efforts.

The Contractor shall assist in the preparation of document output that meets requirements for publishing documents that interact appropriately with sponsor and/or regulatory agency software systems/programs. The Contractor shall ensure that all final electronic deliverables meet current regulatory electronic document requirements and guidance.

Personnel performing in this task area shall have the capability of applying FDA Title 21 CFR for clinical research, regulatory compliance and quality review of submissions to the FDA relating to product approval; regulatory affairs guidance and policy document development, regulations and guidelines to ensure FDA clinical research compliance, and regulations and guidelines to ensure compliance to design controls for the development of devices.

Additionally, personnel performing in this task area for medical device development shall have the ability to understand the risk based device classification system for medical devices and regulatory requirements of the three classes of medical devices (Class I, II, III devices).

6.1.2 Regulatory Operations Support

The Contractor shall review in-progress and final work products to verify that internal Standard Operating Procedures (SOPs) are being/have been followed. The Contractor shall make recommendations to the Government to concur/accept products or to correct any deficiencies identified. The Contractor shall identify or provide plans for remediation. The Contractor shall evaluate SOPs and processes for continual development and improvement suggestions to the Regulatory Operations Branch functions and provide recommendations and support to the Government to increase group functionality.

6.1.2.1 Medical Writing Support

The Contractor shall write, review, edit, and/or advise during development of documents such as IND annual reports, protocols, Investigator’s Brochures, chemistry, manufacturing, and controls [CMC] information amendments, final study reports, Read-Ahead Packages for FDA meetings, meeting minutes, responses to FDA Requests for Information, and summary sections of INDs, MFs, IDEs, Biological License Application (BLAs), and New Drug Application (NDAs) in Common Technical Document (CTD) format. The Contractor shall use Microsoft Office (Word, Access, Excel, PowerPoint), Adobe software applications, and PDF editing software to be able to research and review content effectively. The Contractor shall interpret information into clear and concise scientific writing and apply applicable FDA regulations for the writing and publishing of regulatory submissions. The Contractor shall use project management principles to communicate effectively (written and verbal) within the Integrated Product Team (IPT) development framework. The Contractor shall write, review, edit multi-volume documents requiring advanced word processing and formatting, indexing, generation of table of contents, and manual pagination according to FDA regulations. The Contractor shall write, review, edit, electronic Common Technical Document (eCTD) submissions using knowledge of regulations and industry best practices for publishing.

6.1.2.2 Document Control Support

The Contractor shall administer, arrange, manage, track, and coordinate the storage and retrieval of regulatory documents. The Contractor shall control all documentation which supports regulatory requirements and oversee completion of the following within document control: word processing, revision processing, proof reading, photocopying, circulation and tracking of documents, final distribution of documents, and maintenance/security of regulatory documents. The Contractor shall use project management principles to accomplish archiving and document control goals within a 21 CFR Part 11 compliant system. The Contractor shall create and maintain “user-friendly” (simple and clear), accessible, retrievable computer archives and databases, incorporating current advances in electric information storage technology. The Contractor shall organize archival records and develop classification systems to facilitate access to archival materials. The Contractor shall possess a basic understanding of the roles and responsibilities of all parties involved in the development of medical products (drugs, biologics, and devices) and the Code of Federal Regulations (CFR) that oversee this development (21 CFR Parts 58 and 312 regulations, Office of Environmental Compliance and Documentation (OECD) principles and International Conference on Harmonization (ICH) guidelines (ICH E6) associated with the management of essential non-clinical, manufacturing and clinical records). The Contractor shall apply knowledge of archival and document control theory, methodology, and practices to review and apply the standards, FDA regulations, Army regulations, and industry best practices to work products. The Contractor shall establish and comply with standard operating procedures for maintaining documents and change control of documents. The contractor shall have the ability to lift up to 20 lbs. and shall obtain and use the appropriate protective equipment as required.

6.1.2.3 Submissions Support

The contractor shall assemble and publish submissions and documents that meet the requirements for publishing and working with ORA and/or regulatory agency software programs including but not limited to LiveLink, Liquent Insight Publisher (eCTD), and FDA Electronic Submission Gateway (ESG), and eSubmitter (eCOPY).

The contractor shall provide eCTD publishing services on short suspense regulatory submissions to all Food and Drug Administration (FDA) reviewing divisions to include weekend and evening hours, as necessary. The contractor shall publish regulatory documents using LIQUENT®SmartDesk and Adobe Acrobat Professional for CTD publishing input. The contractor shall validate regulatory submissions in eCTD format using LORENZ eValidator and InSight Validator. The contractor shall establish and comply with USAMMDA standard operating procedures for publishing, creating, providing and maintaining regulatory documents. The contractor shall monitor a central email inbox (USARMY Ft Detrick MEDCOM USAMMDA Mailbox USAMRMC REGULATORY AFFAIRS) for Food and Drug Administration communication for the intent of distribution to personnel and uploading to an electronic document management system. The contractor shall monitor regulatory submission status and ensure on time completion. The contractor shall facilitate Sponsor’s signature on regulatory documentation for input to regulatory publishing process. The contractor shall test and assist in software upgrade and integration related to publishing processes including but not limited to Java, Internet Explorer, FireFox, LIQUENT Insight®, LIQUENT®SmartDesk, LORENZ eValidator, and InSight Validator.

The Contractor shall provide the ability to submit eCTD applications through the FDA electronic submission gateway (ESG) and track FDA receipt and/or acknowledgement through project completion.

6.1.3 Safety Pharmacovigilance Support

The Contractor shall designate a team lead for the Product Safety Surveillance Branch (PSSB). The team lead shall manage the operational day-to-day activities and as the subject matter expert on FDA regulated safety related disciplines. The team lead shall serve as a liaison on task level communications between the branch’s Government leadership and other Contractors supporting this task.

The Contractor shall assist PSSB in the development and implementation of clinical safety and pharmacovigilance standards, processes, templates and forms (e.g., format and content of narrative descriptions, medical assessment and reporting requirements for serious adverse events (SAEs) to use in support of clinical safety reviews, etc.) as required.

The Contractor shall participate in developing standard output formats for standard tables and listings of safety data for annual reports, data reconciliation, safety committee reviews and final clinical study reports.

The Contractor shall provide support to IPTs, IPT working groups (WG), clinical study teams, investigative sites, and external customers, and partners with regard to product safety issues.

The Contractor shall assist with monitoring deliverables to and from partners, as outlined in safety data exchange agreements, or other applicable agreements (e.g., partners may require safety reports for their regulatory authorities), as required.

The Contractor shall participate as a consultant on IPTs, providing guidance and input and/or drafting and reviewing safety sections of clinical protocols, investigator’s brochures, Data Monitoring Committee (DMC) or Data Safety Monitoring Board (DSMB) Charters, Safety Management Plans (SMP), Safety Surveillance Plans, and other associated clinical safety documents. The Contractor shall draft and or review safety related meeting minutes and prepare agendas for safety related meetings. The Contractor shall develop and present general safety training to clinical sites, as required. The Contractor shall ensure a complete safety section of the trial master file is documented at the end of a clinical trial.

The Contractor shall work closely with data management to reconcile the clinical database with the safety database, and provide narrative information to regulatory affairs for reporting to the FDA.

The Contractor shall assist in assessment of SAE reports which may include data entry and preparation of SAE narratives, as directed by partner or Standing Operating Procedures (SOP) format, and coding of event terms in safety database utilizing the Medical Dictionary for Regulatory Activities (MedDRA) dictionary and concomitant medications using WHODrug.

The Contractor shall monitor the safety mailbox 7 days a week. The Contractor shall monitor the mailbox for new incoming unexpected and related SAEs once each day over the weekend or on holidays. If an expedited SAE is identified over the weekend or on a holiday, the Contractor shall begin the case processing process per USAMMDA SOPs.

The Contractor shall triage safety reports for regulatory reporting purposes (e.g. expedited report), interpret clinical data, perform regulatory evaluation and assign causality by obtaining the safety physicians input; define, initiate and track follow-up information /correspondence with clinical site staff, and IPT representatives, as required, through to case closure; ensure entry of SAEs into real-time safety database (Argus); prepare safety reports according to specified regulatory guidelines; and facilitate communication with clinical, regulatory and data management/biostatistics, the product manager, and other IPT members for individual clinical trial SAE reports, as required.

The Contractor shall assist in drafting data entry user guidelines and updating existing data entry user guidelines for the safety database.

Prior to the start of a clinical trial the Contractor shall provide an unblinding plan for TSG-sponsored blinded clinical trials. The unblinding plan shall include procedures for the following:

• unblinding a study subject in an emergency situation,

• managing accidental unblinding,

• unblinding data for the purpose of notification to DMC,

• unblinding data for analysis purposes at a pre-planned point during the trial (i.e., formal interim analysis of safety and/or efficacy) and/or at the end of the trial (i.e., the final analyses for safety and efficacy that are presented in the tables, listing and figures), and

• Unblinding for IND safety reports submitted to FDA.

Personnel performing in this task area shall have the capability of utilizing strong communication and conflict resolution sills. Additionally, personnel performing in this task area shall have the ability to apply demonstrated knowledge and use of FDA validated systems and associated processes, as they pertain to safety pharmacovigilance databases.

6.1.4 Safety Surveillance Support

The Contractor shall plan, coordinate, develop, implement and maintain a safety surveillance program for TSG products to be in compliance with FDA/ICH, Army/DOD regulations. The safety surveillance program will be a systematic approach, documented in a strategy recommendation report or safety surveillance plan and briefed to the appropriate personnel. The safety surveillance program will include a process for reviewing, evaluating, and managing accumulating data on adverse events (AEs) from the entire clinical trial database. The details of what AEs specifically and the frequency of the reviews will be determined as outlined by the program for each program.

The Contractor shall provide, prepare and/or produce necessary documents for the implementation and maintenance of the safety surveillance program to include but not limited to development of a project plan which includes requirements and task necessary for the planning, coordination, and training with timelines, SOPs, signal detection tools and templates, necessary to implement the safety surveillance program and specific product safety surveillance plans. The Contractors shall provide the necessary training needed to implement safety surveillance at USAMMDA. The Contractor shall develop individual safety surveillance plans for each product with the assistance of USAMMDA personnel, as required.

The Contractor shall perform safety surveillance of TSG-sponsored products through signal detection and clarification, preparation of periodic and ad-hoc safety reports, effective analysis and communication of safety related questions to internal and external customers, and to promote and advance the field of Global Patient Safety.

The Contractor shall perform safety surveillance of TSG-sponsored products through various sources to identify new signals including but not…