B08 - Amendment 0001 Combined Synopsis_Solicitation_W81XWH22R0084_Molecule synthesis.docx

RFP W81XWH22R0084 Amendment 0001 Small Molecule Synthesis U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

Amendment 0001: The purpose of this amendment is to answer questions received from potential offerors and update the email addresses referenced in the Instructions to Offerors for receipt of proposals. The closing date and time remain unchanged.

Question 1 - We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services. If not brand new, could you please provide the current / previous contract number?

Answer 1 – This is a recompete of an existing requirement; the current contract number is W81XWH17C0264.

COMBINED SYNOPSIS/SOLICITATION W81XWH22R0084

U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice and FAR 13, Simplified Acquisition Procedures. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is W81XWH22R0084. The solicitation is issued as a Request for Proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2022-06 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clause may be access in full text at: https://www.acquisition.gov/.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a small business size standard of $35M. This action is set-aside 100% for small businesses.

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has a requirement for an IDIQ contract that provides for the synthesis of 350-450 novel small molecule inhibitor analogs, including nucleoside analogs, for a five (5) year ordering period. The estimated ordering periods are outlined below:

The U.S. Army Medical Research Acquisition Activity (USAMRAA) requests responses from qualified sources capable of providing services outlined in the Performance Work Statement (PWS).

PERFORMANCE WORK STATEMENT

U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

1. INTRODUCTION

Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information—that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command (MRDC) at Fort Detrick, located in Frederick, MD.

The number of US Food and Drug Administration (FDA) approved therapeutics has increased over the past 10 years; however, there are still no approved therapeutic treatments for various biothreat agents, such as alphaviruses, Burkholderia pseudomallei, and Klebsiella pneumonia. Various programs at USAMRIID have focused on the screening of various novel small molecules as potential therapeutics to treat these biothreat agents. The purpose of this requirement is to identify a source to conduct synthesis of lead candidates to support further evaluation of these molecules in vivo.

2. BACKGROUND

USAMRIID has an extensive program focused on the development of therapeutic medical countermeasures against high priority biothreat agents, including alphaviruses, Burkholderia pseudomallei, and emerging threat pathogens. This core team of individuals utilizes a pharmaceutical industry drug development model to design, screen and select those small molecules and multi-functional antibodies with the requisite properties to achieve regulatory approval from the FDA. Key activities include the design of new chemical entities (NCEs), in vitro screening against a panel of biothreat agents and supporting activities, such as in vitro absorption, distribution, metabolism, and excretion (ADME), in vivo pharmacokinetics (pK), toxicology profiles, and proof-of-concept in vivo studies. In order to support these key activities, it will be necessary to synthesize newly designed NCEs and scale-up many of the lead candidate small molecules.

3. SCOPE

Over a course of a minimum of three years, USAMRIID requires synthesis of 350-450 novel small molecule inhibitor analogs, including nucleoside analogs. The synthesis process may require anywhere between 1 and 5 synthetic steps for non-nucleoside analogs, or between 4 and 8 steps for nucleosides. Additionally, based on the characteristics of the inhibitor, the quantity needed to be synthesized may be different for each small molecule candidate.

4. CONTRACTOR REQUIREMENTS

4.1. Contractor shall have Standard Operating Procedures (SOP’s) in place for performing all relevant reaction, reaction workup, reaction product purification and product analysis processes.

4.2. Contractor shall provide a copy of their Quality Control Plan, including self-inspection plan, an internal staffing plan, and outline of the procedures that the offeror will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

4.3. Contractor shall have a Chemical Hygiene Plan and all relevant safety SOP’s in place.

4.4. Contractor shall have the proper facilities, infrastructure, instrumentation and equipment to carry out efficient syntheses, purifications and characterizations of target compounds.

4.5. For the synthesis of small molecules requiring 1-3 synthetic steps from a common intermediate, Contractor shall have the capability to perform the synthesis of 20-50 analogs in parallel.

4.6. Contractor shall have a demonstrated ability to perform multi-step synthesis, characterization and delivery of novel small molecules in a timely manner and of sufficient quantity and purity.

4.7. The Contractor shall have multi-year experience for synthesizing novel small molecules, and shall employ a team of experienced synthetic chemists working on the bench, each with either a MS or PhD degree in Organic Chemistry and >2 years of industry experience. In addition, the chemistry team should be managed by a PhD Organic or Medicinal Chemist with at least 8 years of industry experience.

4.8. The Contractor shall have access to the Organic/Synthetic chemistry literature and chemical databases such as Reaxys or SciFinder.

5. TECHNICAL / PERFORMANCE REQUIREMENTS

5.1. The Contractor shall synthesize novel small molecules defined by USAMRIID. USAMRIID will provide the Contractor with the structures of compounds to be synthesized over 3-6 iterative cycles per 12 month ordering period. The synthesis, purification, characterization and delivery of novel small molecules will occur in two (2) major Milestones.

The requirements for the services, data and materials to be provided by the Contractor are expected to meet the following performance characteristics for the following milestones for each ordering period:

5.1.1. Task 1 (Ordering Period 1) –

Milestone 1: Small molecule synthesis – synthesis of 100-150 novel small molecules (no less than 10 mg each at >95% purity; 1-5 synthetic steps from a common intermediate). In addition, the synthesis of up to 5 nucleoside triphosphate analogs (5 mg each at >95% purity; synthesized from their corresponding nucleoside) will be required. All products analyzed/characterized by LCMS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data (Deliverable 1).

Milestone 2: Re-synthesis of small molecule compounds – re-synthesis of 6-10 small molecule compounds (no less than 500 mg each at >95% purity; 2-6 synthetic steps). All products analyzed/characterized by HPLC, MS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data (Deliverable 1).

5.1.2. Task 2 (Ordering Period 2) –

Milestone 1: Small molecule synthesis – synthesis of up to 150 novel small molecules (no less than 10 mg each at >95% purity; 1-5 synthetic steps from a common intermediate). In addition, the synthesis of up to 5 nucleoside triphosphate analogs (5 mg each at >95% purity; synthesized from their corresponding nucleoside) will be required. All products analyzed/characterized by LCMS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data (Deliverable 1).

Milestone 2: Re-synthesis of small molecule compounds – re-synthesis of up to 10 small molecule compounds (no less than 500 mg each at >95% purity; 2-6 synthetic steps). All products analyzed/characterized by HPLC, MS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data (Deliverable 1).

5.1.3. Task 3 (Ordering Period 3) –

Milestone 1: Small molecule synthesis – synthesis of up to 100 novel small molecules (no less than 10 mg each at >95% purity; 1-5 synthetic steps from a common intermediate). Many of these molecular targets will be nucleoside analogs. All products analyzed/ characterized by LCMS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data (Deliverable 1).

Milestone 2: Re-synthesis of small molecule compounds – re-synthesis of up to 6 small molecule compounds (no less than 500 mg each at >95% purity; 2-6 synthetic steps). All products analyzed/characterized by HPLC, MS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data (Deliverable 1).

5.1.4. Tasks 4 and 5 (Ordering Periods 4 and 5) –

The Contractor shall continue to provide support for the synthesis, purification, characterization and delivery of novel small molecules defined by USAMRIID as outlined in Task 3.

USAMRIID will use the novel small molecules and nucleoside analogs to:

i. Evaluate the in vitro inhibitory effects against Burkholderia pseudomallei (Bp), Klebsiella pneumonia (Kp), and various viral targets including Alphaviruses, Orthopoxviruses, Filoviruses.

ii. Evaluate the in vitro ADME properties of active compounds.

iii. Evaluate the in vivo PK and tolerability of active compounds.

iv. Evaluate the in vivo efficacy and protection against Burkholderia pseudomallei (Bp), Klebsiella pneumonia (Kp), and various viral targets including Alphaviruses, Orthopoxviruses, Filoviruses.

5.2. The Contractor shall ship all completed synthesized final products to USAMRIID on a monthly basis, and provide to USAMRIID a corresponding monthly report (Deliverable 1) in electronic form of all synthesized small molecules produced during that month. The report shall include general synthesis protocols and spectral data (LCMS and 1H NMR) for each final product and their corresponding intermediates.

5.2.1. The Contractor shall confirm that all synthesized small molecules are characterized (LCMS and 1H NMR) before being shipped to USAMRIID for testing

5.3. The Contractor shall provide the compilation of all electronic and/or hard copy data to the USAMRIID Project Lead/PI and COR on an annual basis no later than 15 calendar days from the end date of each ordering period.

5.4. The Contractor shall provide a summary reports, within 15 days after the completion of each milestone, as detailed above.

6. DELIVERABLE/DELIVERY SCHEDULE

6.1. Delivery Address

All deliverables shall be submitted to the COR and others as specified by the COR.

6.2. Method of Delivery

Electronic copies shall be delivered using Microsoft Office Suite of tools (i.e., MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

6.3. Shipping

The Contractor shall use appropriate, GLP and/or GMP-compliant refrigerated shipping carriers for drug product shipments (FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the contractor shall use the US Postal Service standard delivery for delivery of all such shipments. The COR must approve the selected shipping method and any exceptions to these requirements.

6.4. Government Acceptance Period

6.4.1. The COR will have ten business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) business days for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

6.5. Deliverables. The contractor shall provide the following deliverables as listed:

7. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

7.1. The Government will utilize a QASP to monitor the quality of the Contractor’s performance. The oversight provided for in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required CPARS evaluations. The QASP is a living document and may be updated by the Government as necessary. Refer to Attachment 01 for a copy of the QASP.

7.2. Performance Evaluation Process

A CPARS evaluation assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each evaluation is based on objective data (or measurable, subjective data when objective data are not available) supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Completed performance evaluations are used by agency source selections officials and KOs from across the government in making award decisions. The contractor shall designate a Contractor Representative (CR) and provide this information to the KO within 10 calendar days of award. The CR shall have the authority to comment on the CPARS assessment on behalf of their company and within the timeframes established.

A CPARS assessment shall be completed within 120 calendar days after the end of the performance period or end of contract. The CR has the option to provide comments on the evaluation. The CR has a total of 60 calendar days following the Assessing Officials (AO) evaluation signature date and time to send comments. If the CR sends comments within the first 14 days following the AO’s signature date and the AO or Reviewing Official (RO) closes the evaluation, the evaluation will become available within 1 day. On day 15 following the AO’s evaluation signature date, the evaluation will become available for source selection with or without CR comments and whether or not it has been closed by the AO or RO. If no CR comments have been sent and the evaluation has not been closed, it will be marked as “Pending”. If the CR sends comments at any time prior to 61 days following the AO’s evaluation signature date, those comments will be reflected within 1 day. On day 61 following the AO’s evaluation signature date, the CR will be “locked out” of the evaluation and may no longer send comments.

The CR has the authority to access the Government evaluation; review/comment/return the evaluation to the AO within 60 calendar days after notification of the government’s assessment; request a meeting (in writing) with the government within seven calendar days from receipt of evaluation; and, request RO review. The evaluation will become available to source selection officials 15 days following the AO’s evaluation signature date. The evaluation will be available with or without contractor comments and whether or not it has been closed by the AO or RO. If no contractor comments have been provided at day 15, the evaluation will be marked as “Pending”. Contractor comments may be provided up to 60 days following the AO evaluation signature date and will be updated on a daily basis. Once the evaluation has been closed by the AO or RO, the “Pending” marking will be removed.

Training for CPARS can be found on the CPARS website: https://cpars.gov/lc.htm. Access to CPARS is coordinated on a contract number to contract number basis by the Focal Point. The contractor will need to work with the KO to obtain access.

CPARS will be assessed at the base contract level.

8. PLACE OF PERFORMANCE

The place of performance is the Contractor’s facility; no work is required to be conducted at USAMRIID by the Contractor.

9. GOVERNMENT FURNISHED INFORMATION, FACILITIES, SUPPLIES, AND SERVICES

9.1. USAMRIID will make available to the contractor the structures of small molecules to be synthesized. If needed, USAMRIID will provide potential synthetic routes for their preparation.

9.2. All structural, synthetic and biological information and data that is either shared or generated through this contract remains the sole property of the US Government and must not be shared with a third party.

10. MAINTAIN SAFETY, SECURITY, AND BIOSAFETY STANDARDS

10.1. General

Established in 1969, USAMRIID has decades of experience operating containment laboratories and has provided extensive training and consultation to other agencies setting up their own facilities. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies. The program, which enables USAMRIID to safeguard both the biological materials we use in our laboratories and the personnel who work here, consists of the four key areas of biological safety, physical security, personnel reliability, and agent accountability.

There are four levels of biological containment, ranging from BSL-1, the lowest, to BSL-4, the highest. BSL-1 would be comparable to an open bench laboratory found in a school classroom—no special precautions would be needed. At BSL-2, USAMRIID employees wear laboratory coats and observe other basic precautions. For BSL-3 work, personnel are required to wear approved PPE and comply with established biosafety standards. BSL-4 is the highest level of containment, and employees wear positive-pressure encapsulating suits and breathe filtered air as they work. Other personal protective equipment may be required, depending on the tasks to be performed and biosafety level.

In addition, a combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems is in place to protect laboratory workers. These measures also ensure the safety of those outside the suites. Investigators working in USAMRIID laboratories are and must be highly trained to follow and comply with established safety, biosafety and biosecurity procedures. Personnel may be required to demonstrate initial and continuous task proficiency with strict adherence to biosafety principles in order to conduct work in BSL-2 through BSL-4. Adherence to the USAMRIID Biosafety Program; Biosafety Plan, standard operating procedures, biocontainment suite specific manuals, biosafety training program and biosafety mentorship program will be ensured through a compliance program. As a part of this compliance program, all personnel are required to self-report any deviation to standard procedures and designated personnel may be required to observe work of others in the suites and document observations and adherence to the biosafety plan. Lack of adherence to any component of the Biosafety Program or lack of skill proficiency will be grounds for revocation of biocontainment access.

Investigators in the laboratories study amounts of infectious agents and the diseases they cause in order to develop vaccines, treatments and diagnostic tools. USAMRIID's research involving infectious agents is reviewed and approved by the Institutional Biosafety Committee, the Animal Care and Use Committee, the Portfolio Review Committee, and other internal and external reviewers as applicable. No studies can take place without careful examination of all protocols to assess risks.

Personnel with the appropriate, government-required training and certification to operate in biocontainment environments are not readily available in the commercial marketplace and are unique to the extremely small number of laboratories worldwide that perform research in BSL-3 and BSL-4. As described above, approved work in biocontainment suites and using Biological Select Agents and Toxins (BSAT) requires stringent background checks, health screening, enrollment in specialized reliability programs, and mentored hands-on training. It takes an extensive amount of time and government effort for a new staff member to become fully trained and operational, and there is inherent risk that new personnel will not meet the stringent security and reliability program requirements.

10.2. Security

USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies, which enables USAMRIID to safeguard both the biological materials used in the laboratories as well as the personnel who work here. USAMRIID is frequently inspected by those regulating agencies, and successful completion of those inspections is required for USAMRIID to continue its operation. It is therefore critical that all employees, including Contractor employees, meet standards and maintain compliance with all regulations, policies, and procedures that have been instituted for their protection and the protection of others. Security, training, and other requirements may be subject to change based upon changes in regulations and policies, and the Contractor shall be immediately responsive to those changes.

The Contractor shall not employ, or continue employment, of persons for work on this contract, if such employee is identified to the Contractor by the KO as a potential threat to the health, safety, security, general well-being, or operational mission of the installation or its population. All Contractor employees shall be screened before hiring for active participation in any group that opposes the use of animals in research; such candidates shall not be selected for work on this PWS (all contract employees shall support the humane use of laboratory animals in research). In addition, if it becomes known that an employee is an active member of any group that opposes animal research or in any other way demonstrates a desire to compromise the security or the mission of the Institute, the Contractor employee shall be removed from this requirement immediately.

10.3. Security Requirements

The Contractor shall protect all For Official Use Only (FOUO) and unclassified information involved in the performance under this contract.

10.4. Installation Access Requirements

10.4.1. All visitors must enter through the Nallin Gate which is open 24 hours per day, seven days per week. Contractors are to provide proof of identification to the Fort Detrick security staff at the Visitor Center located at the Nallin Gate. A Criminal History Check will be conducted on all Contractor and subcontractor employees requiring base access. Acceptable forms of Government issued identification include a passport or Driver’s License that complies with the REAL ID ACT. Non-U.S. citizens visiting Fort Detrick will require a Federal employee escort onto the Base. Non-U.S. Citizens visiting or working at USAMRIID will require MRDC approval. Vehicles entering the Base will be searched before being allowed to enter the Base. In addition to your vehicle, the trunk, boxes, bags, or other items located in the vehicle is subject to search. Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives and blades over 2 ½ inches, alcoholic beverages and open containers of alcohol. No photographs may be taken while on Fort Derick. Cell phones may be used while driving only if hands free.

10.4.2. The Contractor and all associated subcontractors’ employees shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures provided by the Government representative. The Contractor shall return all issued U.S. Government Common Access Cards, installation badges, access badges to the COR when the Contract is completed or when a Contractor employee no longer requires access to the installation and facility as defined in the contract.

10.4.3. Force Protection Condition (FPCON) impact on work levels. The Contractor employees must comply with all personal identity verification requirements as directed by DoD, and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON change, the Government may require changes in Contractor security matters or process. IAW DoDI 2000.16, the FPCON is defined as follows:

10.4.3.1. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher THREATCONS resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

10.4.3.2. FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

10.4.3.3. FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

10.4.3.4. FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this THREATCON is declared as a localized condition.

10.5. Security Clearance Requirements

10.5.1. The Contractor shall acquire the necessary security clearances. A facility clearance through a servicing Defense Security Service is required to be maintained and updated when applicable as established on the DD Form 254 (Not Applicable to this requirement). The Contractor shall initiate the necessary personnel background checks for successful processing of contract employees through the USAMRIID Personnel Security Office. USAMRIID is a restricted area and the minimum personnel background investigations will be a T1, previously known as a National Agency Check with Inquiries (NACI). A NACI is also acceptable provided the individual has not had a 24 month break-in-service from the previous Government employment. It is anticipated that the highest clearance required will be SECRET. A T3 or T5 investigation may also be required for other positions as required depending on the duties performed.

10.5.2. Contractor employees enrolled in the Biological Personnel Reliability Program (BPRP) will require a T3 investigation (NACLC/ANACI is acceptable if completed within 5 years prior to enrollment). A favorably adjudicated SECRET security clearance eligibility, with no access to classified, is required. Periodic reinvestigations will be completed every 5 years. An unfavorably adjudicated reinvestigation that renders an individual ineligible for a security clearance will result in termination from the BPRP. The Contractor will ensure personnel enrolled in the BPRP are affiliated with the Contract Company in the Defense Information System for Security (DISS) to prevent loss of eligibility.

10.5.3. All background investigation forms and fingerprints must be completed prior to start. “IAW DEPARTMENT OF DEFENSE (DOD) MANUAL 1000.13, VOLUME 1, DOD IDENTIFICATION (ID) CARDS: ID CARD LIFE-CYCLE, JANUARY 23, 2014 Army Regulation 380-67, Personnel Security Program, and the Department of Army, Trusted Associate Sponsorship System (TASS), Standard Operating Procedure and Army TASS policy, Contractor must have a valid Tier 1 or DoD-equivalent background investigation submitted to OPM and the completion of an Federal Bureau of Investigation (FBI) fingerprint check with the return of favorable results to obtain a Common Access Card (CAC) and begin work. If the background check is adjudicated and returned with unfavorably information found, the Contractor’s Common Access Card (CAC) will be revoked and the Contractor will not be permitted to work. Further, an unfavorable fingerprint result will require the completion of the required investigation or a favorable suitability determination by the security officer prior to the Contractor being on boarded.

10.5.4. USAMRIID will submit the investigation through the Personnel Security Investigations Portal (PSIP). Once the Security Office reviews the Questionnaire for Non-sensitive Positions (SF85) or Questionnaire for National Security Positions (SF86), the investigation is scheduled at the Office of Personnel Management (OPM), and favorable fingerprints have been obtained, the Security Office will notify the Contracting Agency and USAMRIID Human Resources that they are cleared for an EOD date.

10.5.5. Any delays in recruitment caused by security issues are the responsibility of the Contractor unless an exception is authorized by the KO. The security requirements for other USAMRDC laboratories or customers will be specified on each individual task order. Any additional security requirements will be provided in the individual task order PWS. The appropriate security clearance forms will be provided to the Contractor IAW FAR Clause 52.204-2 in Section I.

10.5.6. In order to retain a CAC, Contractor’s Site Security Manager will be required to complete the AHRC TASS Form, Contractor CAC Reverification/Retrieval Form every 180 days. The Contractor will be provided the form and must comply with completing the form within the specified timeframe (typically a 2-week timeframe). Failure to complete this form will result in the CAC being revoked.

10.6. Requirements for BPRP Enrollment

10.6.1. Contractors needing unescorted access to BSAT at USAMRIID will enroll in Army’s BPRP.

10.6.2. When entering a Federal Select Agent Program (FSAP)-registered space at the USAMRIID of Fort Detrick, MD, the Contractor shall comply with all applicable Federal, DoD, and Army regulations governing BSAT. In addition, the Contractor shall comply with any local biosecurity policies and procedures. The Contractor shall ensure that all subcontractors comply with the aforementioned.

10.6.3. Contractor personnel assigned to BPRP duty positions will enroll in the Army BPRP subject to occupational health screening at no additional cost to the government. The Contractor shall provide records of employment, medical and urinalysis required for BPRP screening to the Surety Officer IAW local procedures. The Contractor will provide drug abuse screening services consistent with AR 190-17 and AR 600-85 IAW local procedures at no additional cost to the government.

10.6.4. Personnel provided under the contract must successfully obtain and maintain a Department of Health and Human Services Security Risk Assessment (SRA), have a T3 investigation (as identified in para. 2.10.5), and shall be medically qualified to wear appropriate respiratory protection and personal protective equipment (PPE). When required, as a part of services being provided, Contractor personnel are eligible to receive vaccinations. Potentially Disqualifying Information (PDI) discovered during the contract period will be provided to the Surety Officer IAW local procedures.

10.6.5. Biosecurity Training Requirements for BPRP-Enrolled Personnel.

Contractor employees are required to complete biosecurity training(s) relative to his/her position or function and report any infractions of biosecurity procedures to the Contracting Officer Representative (COR) immediately. Training is designed to safeguard both the biological materials used in the laboratories (BSL-2 through BSL-4) and the personnel who work within and outside the laboratories. Training will cover, at a minimum, safety/biosafety, security (including security awareness), select agent and toxin training, incident response, insider threat and BPRP training.

10.6.6. Government Furnished Services

Contract employees in the Army’s BPRP are authorized medical examinations related to screening for infectious diseases and toxins at the BPRP Barquist Army Health Clinic, vaccinations as recommended, and personal protective equipment (PPE) as required.

10.6.7. Contractor Furnished Services

The Contractor shall provide drug screening services IAW AR 190-17 and AR 600-85 and provide testing results to the Surety Officer IAW local procedures at no additional cost to the government. If USAMRIID or Army Occupational Health and Safety personnel determine the need for a contract employee to be screened for infectious agents and toxins, the contract employee will obtain the required test(s), as determined by USAMRIID, in consultation with that employee's medical or Occupational Health provider.

10.7. Requirements for Escorted Entry to Federal Select Agent Program (FSAP)-Registered Spaces (Visitor)

Contractors not routinely working in FSAP registered areas will not be enrolled in the BPRP and will comply with USAMRIID Pamphlet 190-17-7, Escorted Entry into FSAP-Registered Areas within USAMRIID.

10.7.1. Biosecurity Training Requirements Escorted Entry to FSAP-Registered Space (Visitor).

Contractor employees are required to complete biosecurity training(s) relative to his/her position or function and report any infractions of biosecurity procedures to the Contracting Officer Representative (COR)/TPOC immediately. Training is designed to safeguard both the biological materials used in the laboratories (BSL-2 through BSL-4) and the personnel who work within and outside the laboratories. Training will cover, at a minimum, safety/biosafety, security (including security awareness), and incident response.

10.7.2. Services for Contractors Not Enrolled in BPRP (if applicable).

10.7.2.1. Government Furnished Services

USAMRIID will provide the contract employee a copy of the latest risk assessments and expected work conditions for the private Board-Certified Occupational Health Physician (BCOMP) to review. This will enable the private BCOMP to evaluate the health status of the Contractor for medical suitability for entry into USAMRIID’s containment laboratories and BSAT storage spaces.

10.7.2.2. Contractor Furnished Services (if applicable).

If USAMRIID or Army Occupational Health and Safety personnel determine the need for a contract employee to be screened for infectious agents or toxins, the contract employee will obtain the required test(s), as determined by USAMRIID, in consultation with that employee's medical or Occupational Health provider. This will be done at no additional cost to the government.

10.8. Workplace Safety

10.8.1. The Contractor employee must be able to maintain a safe workplace and comply with all occupational health and safety rules and regulations. Each Contractor employee is required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the COR/TPOC immediately.

10.8.2. At no additional cost to the government, the Contractor shall ensure all contract employees who work with laboratory animals have a required purified protein derivative (PPD) screening semi-annually. TB reactors shall undergo whatever testing is currently acceptable by the USAMRIID Occupational Health and Safety staff (Quantiferon Gold blood testing and/or chest X-rays plus medical evaluation, or equivalent). If required by position or if determined as necessary through Occupational Health and Safety Medical, a respiratory fit test may be required. In addition, all contract employees at USAMRIID must comply with USAMRIID Occupational Health requirements.

10.8.3. At no additional cost to the government, vaccinations required to work in identified USAMRIID Veterinary Medical Division controlled areas shall be provided and updated as required by medical and/or Centers for Disease Control and Prevention (CDC) recommendations (whichever standard is more stringent) including tetanus, hepatitis B, MMR, two documented MMR vaccinations or proof of adequate titer is required as it is medically considered to provide lifelong immunity, rabies (or proof of adequate titer based on CDC/industry standards), and annual flu vaccine. Contractor will provide dates when vaccinations or titers (rabies or MMR) were performed.

10.9. Foreign Nationals Requirements

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. The investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access may be approved, but the process has to be approved by the Fort Detrick Designated Approving Authority. Foreign Nationals with requirements for access to Tier 1 BSAT will be processed for a Limited Access Authorization.

10.10. Requirements for Controlled Substances PRP (CS-PRP) Enrollment.

10.10.1. Contractors needing unaccompanied access to controlled medical substances at USAMRIID will enroll in the CS-PRP.

10.10.2. When accessing controlled medical substances at the USAMRIID at Fort Detrick, MD, the Contractor shall comply with all applicable Federal, DoD, and Army regulations governing the use of controlled medical substances. In addition, the Contractor shall comply with any local controlled medical substances policies and procedures. The Contractor shall ensure that all subcontractors comply with the aforementioned.

10.10.3. Contractor personnel assigned to CS-PRP duty positions will enroll in the USAMRIID CS-PRP subject to medical screening provided by the government. The Contractor shall provide personnel, medical and urinalysis records required for the individual’s CS-PRP screening to the CS-PRP Surety Officer IAW local procedures. The Contractor will provide drug abuse screening services consistent with AR 600-85 IAW local procedures at no additional cost to the government.

10.10.4. Personnel provided under the contract must be assessed as qualified through personnel, security, medical, and law enforcement records checks and drug test information. The Certifying Official will interview the incumbent to appraise character, judgment, reliability, attitude, emotional and mental maturity, and sense of responsibility before enrollment into the CS-PRP. Personnel exhibiting financial irresponsibility will not be enrolled into the CS-PRP.

10.10.5. Contractor personnel requiring access to controlled substances must complete a USAMRIID Consent to Release Information and a Request for Background Check for Personnel Working with Controlled Substances Forms. These forms are provided by the Personnel Security Office and submitted to the Criminal Investigation Division (CID), Fort Meade for processing and approval.

10.10.6. Government Furnished Services

A contract employee in the CS-PRP is authorized medical consult or screening regarding medical treatments and/or medications that may affect their CS-PRP status.

10.10.7. Contractor Furnished Services

The Contractor shall provide drug screening services IAW AR 600-85 at no additional cost to the government and provide testing results to the CS-PRP Surety Officer IAW local procedures. If the Certifying Official or Competent Medical Authority determine the need for the incumbent to be screened for potential CS-PRP disqualifying factors, the contract employee will obtain the required screening, as determined by USAMRIID, in consultation with that incumbent’s medical or Occupational Health provider at no additional cost to the government. The Contractor will provide the incumbent’s performance evaluation and/or personnel records when requested by the Certifying Official for periodic review for disciplinary actions or other patterns of behavior that may indicate unreliability.

References (Available for review in USAMRIID library):

1. 7 CFR part 331, Possession, Use and Transfer of Biological Select Agents and Toxins

2. 9 CFR part 121, Possession, Use and Transfer of Biological Select Agents and Toxins

3. 29 CFR part 1910, OSHA General Industry Regulations

4. 42 CFR part 73. Select Agents and Toxins

5. Department of Defense Instruction (DODI) 5210.89, Minimum Security Standards for Safeguarding Biological Select Agents and Toxins

6. AR 40-400 Patient Administration

7. AR 190-17, Biological Select Agents and Toxins Security Program

8. AR 190-51, Security of Unclassified Army Resources (Sensitive and Nonsensitive)

9. AR 190-13, The Army Physical Security Program

10. AR 385-10, The Army Safety Program

11. AR 600-85, Army Substance Abuse Program

12. DA Pamphlet 385-69, Safety Standards for Microbiological and Biomedical Laboratories

13. MEDCOM Regulation 40-55, Guidance on Occupational Health Practices for the Evaluation and Control of Occupational Exposures to Biological Select Agents and Toxins (BSAT)

14. USAMRIID Regulation 385-69, Biological Safety Program

15. USAMRIID Pamphlet 190-17-7, Escorted Entry into FSAP-Registered Areas Within USAMRIID

16. USAMRIID Pamphlet 190-17-4, Biological Select Agents and Toxins Security Program

10.11. Network Security

10.11.1. Contractor personnel requiring access to DoD networks to perform work under this contract must have a NACI or an open, pending investigation prior to commencement of work. If the Contractor has a pending investigation, a copy of this investigation must be presented to the USAMRIID Personnel Security Manager at the time of in-processing for review and must contain no unfavorable information. The Contractor must maintain this level of security for the life of the contract. Citizenship will be verified by presenting an original birth certificate or a valid US Passport or the original Naturalization certificate to the USAMRIID Personnel Security Manager at the time of in-processing for all Contractor personnel assigned to the contract. Any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues must be reported to the USAMRIID Personnel Security Manager.

10.11.2. Contractor personnel shall use only Government-provided computer equipment; and shall follow all applicable statutes, regulations and policies governing DoD, MEDCOM, USAMRMC, and USAMRIID cyber security and information system assets. Personnel must provide proof of applicable training and certifications to include annual Cyber Awareness training. This training must be documented in the Army Training and Certification Tracking System (ATCTS) unless otherwise authorized by applicable policies. DoD Information System, IT service, and IT product acquisition or development must also adhere to applicable policies as described below:

10.11.3. It is DoD policy that Cybersecurity requirements shall be identified and included in the design, acquisition, installation, operation, upgrade, or replacement of all DoD information systems. This includes systems and processes developed within the Defense Acquisition System; systems and processes developed at private expense; outsourced business processes supported by private sector information systems; and outsourced information technologies. Information technology services provided under this contract must comply with statutory and regulatory IA policy. The source documents for this policy are (available in the USAMRIID library for review):

1. The National Security Act of 1947

2. Title 40/Clinger-Cohen Act

3. Executive Order 12333, “United States Intelligence Activities,”

4. National Security Presidential Directive-54/Homeland Security Presidential Directive-23

5. Subchapter III of chapter 35 of Title 44, United States Code (also known as the “Federal Information Security Management Act (FISMA) of 2002”)

6. National Security Telecommunications and Information Systems Security Policy No. 11, "Revised Fact Sheet National Information Assurance Acquisition Policy" and associated "Frequently Asked Questions"

7. National Institute of Standards and Technology (NIST) Special Publication (SP) 800-39

8. Federal Information Processing Standards

9. DoD Instruction 8500.01, “Cybersecurity,” March 13, 2014

10. DoD Instruction 8500.2, "Information Assurance Implementation"

11. DoD Instruction 8580.1, "Information Assurance in the Defense Acquisition System"

12. DoD Instruction 5000.02, “Operation of the Defense Acquisition System”

13. DoD Directive 8570.01, "Information Assurance Training, Certification, and Workforce Management"

14. Chairman of the Joint Chief of Staff Instruction 6510.01E, "Information Assurance (IA) and Computer Network Defense (CND)"

15. Defense Acquisition Guidebook – Chapter 7 Acquiring Information Technology and National Security Systems, Section 7.5 Information Assurance

16. DoD Instruction 8510.01, "Risk Management Framework (RMF) for DoD Information Technologies"

10.11.4. All requirements under the contract, will be screened for compliance with applicable Cybersecurity statutes, policies, and procedures. Specific requirements will be stated in the PWS. This special contract provision shall be updated by reference for any changes to source documents. Any new laws or policies applicable to Cybersecurity subsequent to issuance of this contract will be incorporated into the basic contract unilaterally without equitable adjustment to the basic contract. Any equitable adjustment shall be assessed by individual requirements that may be affected by the change as applicable.

10.11.5. Non-US citizens are not being adjudicated for USAMRIID trustworthiness determinations at this time. Non-US Citizens are not allowed access to DoD IT systems unless approved by an authority designated in Appendix 6, DoD 5200.2-R. Only US citizens shall be granted access and assigned to sensitive duties. Exceptions to these requirements shall be permitted only for compelling national security reasons (DoD 5200.2-R. C2.1.1, AP6.6.1).

10.12. Safeguarding Information

The Contractor shall properly and adequately safeguard sensitive (FOR OFFICIAL USE ONLY) or classified government materials IAW Department of Defense Directive (DoDD) 5230.09, DoDD 5200.1-R, DoDD 5200.1-PH AR 380-5, and AR 380-40. Work shall not be performed in classified areas unless appropriate clearances are received IAW DoDD 5220.22-M.

10.13. Physical Security

10.13.1. The Contractor shall comply with Force Protection Condition procedures, Random Antiterrorism Measures and local search/ identification requirements. The Contractor shall safeguard all Government property, including controlled forms, provided for Contractor use. At the close of each work period, Government training equipment, vehicles, facilities, support equipment, and other valuable materials shall be secured.

10.13.2. This contract includes activities that may require Contractor travel to destinations outside of the United States. These activities will be defined at the contract level. The Contractor shall ensure that assigned participants allow sufficient lead-time to obtain valid passports, country clearances, visas, and immunizations to support project activities. Contractors shall be responsible for providing their own security and coordinate with State Department and local authorities as required at the contract level.

10.13.3. DFARS Clause 252.225-7043, “Antiterrorism (AT)/Force Protection for Defense Contractors Outside the United States” shall be applicable to Contractors that require performance and delivery in a foreign county. This clause applies to both contingency and non-contingency support.