PWS IR .4 FDA SME Contractor v2_March 2025.pdf

Attachment 1 Page 1 of 8

Performance Work Statement

(PWS)

Air Force Research Laboratory

711 HPW/IR

Technical/Research Regulatory Affairs Specialist 17 March 2025

Introduction:

Air Force Research Laboratory (AFRL) employs extensive support for human research activity, from grants, to small business innovation contracts via AFWERX, to internally conducted research. The 711th Human Performance Wing (711 HPW), headquartered at Wright-Patterson Air Force Base in Ohio, is the first human-centric warfare wing to consolidate human performance research, education, and consultation under a single organization. Established under the Air Force Research Laboratory, the 711 HPW is comprised of the Human Effectiveness Directorate (RH) and the United States Air Force School of Aerospace Medicine (USAFSAM).

The Wing delivers unparalleled capability to the Air Force through a combination of world class infrastructure and expertise of its workforce of military, civilian and contractor personnel encompassing 75 occupational specialties including science and engineering, occupational health and safety, medical professions, technicians, educators, and business operations and support.

Description of Services:

The contractor shall meet all requirements per the basic contract and provide professionally and technically qualified individual(s) to perform all tasks in the following paragraphs to fulfill the requirements of this task order. This task order is for a part-time (.4 FTE) subject matter expert specialist Food and Drug Administration (FDA) regulatory affairs.

1.0 TECHNICAL PROGRAM MANAGER – .4 FTE

1.1 Qualifications

1.1.1 Mandatory Qualifications

1.1.1.1 Contractor shall have at least 5 years’ experience applying FDA research regulatory requirements within a research regulatory affairs program office. Work in preparing one’s own research proposals and one’s own submissions to an IRB office or to the FDA and managing one’s own research portfolio will not meet the qualifications required by this section.

1.1.1.2 3 years current (within the past 5 years) personal and direct experience in FDA clinical research protocol compliance administration and shall have personally conducted FDA focused regulatory affairs quality assurance audits of customer’s research projects.

1.1.1.3 Bachelor’s Degree in a technical science, engineering or medical area. Shall meet all technical and experience prerequisites to be qualified to test for Regulatory Affairs Professional certification, such as Certified Clinical Research Professional (CCRP), Attachment 1 Page 2 of 8

Research Regulatory Affairs Professional (RAP) or other like-kind industry standard certification. Current holder of regulatory affairs professional certification is preferred.

1.1.1.4 At least 1 year current (within the past 3 years) prior experience in developing or providing detailed consultation on the development of FDA-regulated device research trials, including, but not limited to research involving software as a medical device (SaMD), off-label research use of FDA-controlled medical devices, and bio-sensing wearable devices.

1.1.1.5 Contractor shall have prior experience either reviewing applications submitted to the FDA CDRH , or as a Sponsor preparing and submitting to the FDA for FDA-regulated devices for FDA review, determinations, or approval.

1.1.1.6 Contractor shall have prior experience in the development, planning, hosting and delivering FDA research regulatory affairs training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to administration of clinical trial research records.

1.1.1.7 Contractor shall have knowledge, skill, training, experience and ability to be proficient in the use of desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems.

1.1.2 Highly Desired Qualifications

1.1.2.1 Experience working directly for a Department of Defense research regulatory affairs program office. Or experience working with FDA Center for Devices and Radiological Health (CDRH).

1.1.2.2 Experience with the technical review and FDA research compliance review of non-clinical warfighter operational health and performance biosensing and human wearable bio-devices.

1.2 Tasks

1.2.1 Contractor shall provide expert technical research FDA-related regulatory review of others’ research proposals and be of the kind and sufficient experience that would enable the contractor to independently provide critical guidance to researchers, IRB Program Director, and executive staff regarding human subject research administration, processing, standards and regulations.

1.2.2 Contractor shall independently analyze/evaluate research protocols and coordinate/assist investigators’ efforts in submissions to the FDA as a drug or device research sponsor and assist researchers in compliance with FDA regulations in the performance of FDA-regulated research activity.

1.2.3 Tasks shall be of a specialized variety and Contractor shall independently apply knowledge of and discharge timely analysis of human subjects research related to a wide-

Attachment 1 Page 3 of 8 range of regulatory requirements including, but not limited to: 10 USC 980; HHS 45 CFR 46; DoD 32 CFR 219; DoDI 3216.02_AFI 40-402; DODI 6000.08, AFRLI 40-402, as well as 21 CFR, Food, Drug and Cosmetic Act (FD&C Act) and Food and Drug Administration (FDA) regulations and policy related to drug and device research.

1.2.4 Tasks require high degrees of proficiency in English writing and oral communication.

These capabilities, obtained through higher educational academics or experience, shall enable the Contractor to independently draft e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies.

1.2.5 Contractor shall develop, plan, host and deliver FDA research regulatory affairs training and education materials in various venues: web-site materials, workshops, training presentations, and quality assurance visits and discussions related to FDA regulatory requirements for researcher data controls.

1.2.6 Contractor shall use prior knowledge, skill, training, experience to independently use a desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems. The Contractor shall perform tasks for 711 HPW/IR within an electronic web-based system and shall train customers on the use of such a system.

1.2.7 Contractor shall interface with the following staff offices: 711th Human Performance Wing (HPW) (USAFSAM and RH), USAF Surgeon General Research Compliance (SGE-C), U.S. Food and Drug Administration (FDA), and their respective related staff/contractors, and other diverse research collaborators.

2.0 Services Summary

Contractor performance will be measured against the Acceptable Quality Levels in the Services Summary. Along with the quarterly surveillance conducted by the 711 HPW/OMP program managers, performance will be reported in the Contractor Performance Assessment Reporting System (CPARS).

Requirement Reference Acceptable Quality Level

Qualified personnel are present for duty on schedule

PWS Para 2.3.1, 3.1.2, and 3.3.1

95% of personnel are present for duty at start of performance

Replacement/substitute personnel are provided in a timely manner

PWS Para 2.3.2 and 2.3.3

95% of replacement/substitute personnel are present for duty such that position vacancies do not exceed 10 business days

Attachment 1 Page 4 of 8

Maintains a stable workforce

PWS Para 2.3.2 Turnover, defined as contractor personnel leaving a position before the task order end date, shall be less than 20% across all contracted positions.

Provide satisfactory customer service for each requirement

PWS Para 2.3.4 100% of validated customer complaints made and addressed via Corrective Action Reports are resolved within the timeframe provided

Compliance with security requirements

PWS Para 3.1.2, 5.1.1, 5.1.2, and 5.1.3

100% of contractor personnel meet security requirements

Company is complying with its own Human Resource Policy Handbook

PWS Para 2.3 100% of management decisions and resolution to government concerns follow the company’s legally compliant Human Resource Policy Handbook

Manages currency of qualifying factors (certifications, licensure)

PWS Para 2.3.3 and 3.1.2

100% of requirements are renewed before the expiration date

Submits deliverables and invoices on time

PWS Para 2.3.7 and 6.0 95% of all are deliverables are delivered on-time as defined in the CDRL; 95% of all invoices are submitted monthly; 100% of CDRLs and invoices must be submitted within 10 business days after deadline

3.0 Base Support:

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, parking, tools, materials, supervision, and other items and non-personal services necessary to perform Support Services as defined in this PWS except for those items specified as government furnished property in section 3.0.

3.1 The government shall provide a government laptop to facilitate needed access to the Virtual Private Network (VPN), .mil access, and shared file access. All software and hardware, passwords/access to military Internet/E-mail and applicable database shall be available within the scope of the contract. Data analyses software as necessary to perform tasks described in this

Attachment 1 Page 5 of 8 performance work statement, for example, accessing and storing data on AF network drives and communication via AF government email. The contractor shall comply with local, and DoD policies concerning information technology applications and connectivity to military systems, when using their government issued computer laptops.

3.1.1 The contractors will need Air Force network accounts to use the computers and shall be subject to the requirements for a normal computer account to include IA training that is current within the previous 12 months, a favorable NACI background investigation, and a signed AF 4394 (AF Network User Agreement). Non-compliance with IA policies and principles can result in computer access being suspended or withdrawn.

3.1.2 Any Controlled Unclassified Information on the computer must be encrypted at all times except during use; Encryption Wizard is provided on every computer. All Classified Uncontrolled Information (CUI), Personally Identifiable Information (PII), and HIPAA data MUST be sent encrypted. Outlook has digital encryption capabilities for this.

3.1.3 Computers may not connect to the contractor network or other systems, networks, or equipment. Computers may only be used by the personnel that have Air Force accounts on this contract; allowing anyone else to use the systems is considered "inappropriate use" and will result in loss of access.

3.1.4 Each user is required to connect the laptops to the Air Force network for a minimum of two days per week, for a minimum of 4 hours per day for updates and patches. The screen needs to be locked and device secured to prevent theft or unauthorized access, as applicable.

3.1.5 All maintenance and adjustments with the computers must be done by 711 HPW/OMC;

no contractor modifications or changes are authorized. NOTE: the computers need to be brought to the help desk for repair. Off-site support cannot be provided.

3.1.6 In the event of a network tasking order mandating compliance, e.g. validating users face-to-face, the user needs to report to the help desk upon request. If the computers become overdue with patches/updates or needs to be updated, user is required to report to help desk.

3.1.7 Nothing (flash drives, hard drives, and printers) may be connected to computers without 711 HPW/USAFSAM IAO approval (both functions are in OMCO). Policy questions should be directed to the IAO.

3.1.8 The Contractor shall assume responsibility for all Government provided equipment/property. Government-issued badges, identification cards, passes, and vehicle registration media are accountable forms and, as such, are U.S. Government property to be accounted for, protected, and returned to the Government. This responsibility shall extend to any subcontractors.

3.1.9 The office of 711 HPW/OMC shall be responsible for shipping the computers and will be the POC for returning computers.

Attachment 1 Page 6 of 8

3.2 The office of 711 HPW/OMC shall ensure that all training has occurred within 5 days or accounts will be turned off.

4.0 General Information:

4.1 Work shall be accomplished primarily as telework. Distance teleworking from different location of contractor’s choice may be available at the 711 HPW/IR Director’s discretion.

4.2 Work schedule is normally .4 FTE equivalent hours within M-F 0730-1630; however, there may be times when it is necessary for the contractor to work after duty hours in support of specific tasks. Although schedule may have to be flexible, it shall not exceed 24 hours per week.

4.4 The requirements in this section of the PWS are non-personal services. The requirements herein are the responsibility of the contractor. The Government has the right to reject the finished product or result in the event contractor performance does not meet the acceptable quality level listed in the PWS. Additionally, the Contractor shall manage its employees and guard against any actions that are of the nature of personal services or give the perception of personal services. If the Contractor believes that any actions constitute or are perceived to constitute personal services, or are outside the scope of this contract, the Contractor shall notify the Contracting Office (CO) immediately.

4.5 Information Regarding Non-US Citizens Assigned to this effort –

(a) Contractor employees requiring access to USAF bases, AFRL facilities, and/or access to U.S. Government Information Technology (IT) networks in connection with the work on this contract must be U.S. citizens. For base and network access, possession of a permanent resident card (“Green Card”) does not equate to U.S. citizenship. This requirement does not apply to foreign nationals approved by the U.S. Department of Defense or U.S. State Department under international personnel exchange agreements with foreign governments.

Any waivers to this requirement must be granted in writing by the Contracting Officer prior to providing access. The above requirements are in addition to any other contract requirements related to obtaining a Common Access Card (CAC).

(b) For purposes of paragraph (a) above, if an IT network/system does not require AFRL to endorse a contractor’s application to gain access, the organization operating the IT network/system is responsible for controlling access to its system. If an IT network/system requires a U.S. Government sponsor to endorse the application for access to the IT network/system, AFRL will only endorse the following types of applications consistent with the requirements above:

(1) Contractor employees who are U.S. citizens performing work under this contract.

(2) Contractor employees who are non-U.S. citizens and who have been granted a waiver.

Attachment 1 Page 7 of 8

Any additional access restrictions established by the IT network/system owner apply.

5.0 Other Direct Costs and Travel:

Contractor shall be required to travel when authorized to participate in customer business line related travel, to include meetings and conferences, to fulfill respective mission goals. Such travel shall only be as directed and coordinated through the COR two weeks in advance of all contractor travel to obtain proper authorizations. The specific travel locations, duration, and number of trips shall be upon direction of the Contracting Officer and/or Contracting officer Representative without modification to the task order, if adequate travel funding is available in accordance with the resulting task order. Contractor shall bill the government as reimbursable expense in accordance with the Joint Travel Regulation (JTR) applicable for the appropriate geographical area for non-local travel costs incurred because of a request by the government to execute the task requirements. When travel is identified, the contractor shall provide an estimate of all travel costs by location, broken out by item, to the Program Manager and COR for review prior to travel.

6.0 Security:

6.1 All contractor personnel require a minimum of a Tier 1 background check (T1)/SF85 for any position that requires access to the internet, use of automated information systems to cover standalone computers or unescorted entry into restricted or controlled areas prior to reporting for duty in support of any requirement. The investigation is not for a security clearance, it is for a position of trust. This is a mandatory requirement set forth in DoDM 5200.02_AFMAN 16- 1405, Air Force Personnel Security Program. All documentation required for security certification shall be the responsibility of the contractor. No foreign nationals shall be employed for any requirement issued under this contract without prior approval of the Government.

6.2 The contractor shall provide OPSEC protection for all sensitive/critical information and indicators involved in execution of this contract/Task Order, as defined by AFI 10-701 (Operations Security). 711 HPW Critical Information and Indicators are protected under the 711 HPW Operations Security Program and the 711 HPW Critical Information and Indicators List (CIIL). Contractor employees granted access to critical information and indicators shall be provided initial OPSEC training by the 711 HPW OPSEC Coordinator upon in-processing and prior to being granted access to CIIL items related to the contract/Task Order. The contractor shall also participate in 711 HPW’s annual OPSEC training and education programs, which includes periodic updates and refresher training on CIIL items applicable to the contract/Task Order. The 711 HPW OPSEC coordinator shall evaluate the OPSEC posture of AF contract activities and operations.

7.0 Deliverable:

Type of Deliverable Format/Media/Number of copies

Due Date/Time Frame Recipient(s)

Attachment 1 Page 8 of 8

Contractor Progress, Status and Management Report

CDRL A003

1 electronic copy to each recipient

First submittal shall be 45 days after the effective date of the task order and monthly thereafter.

711 HPW/OMP COR,

AFRL/PZLE

8.0 Applicable Documents: See basic contract PWS.

9.0 Continuation Of Essential DoD Contractor Services During A Crisis: The performance of these services is not considered to be mission essential during time of crisis. Should a crisis be declared, the Contracting Officer or his/her representative will verbally advise the Contractor or the revised requirements, followed by written direction.