Attachment 1 - PWS.docx

United States Department of Agriculture Agricultural Research Service

Performance Work Statement

NBAF Regulatory Compliance Support to the Responsible Official (RO), Biorisk Management (BRM) Support

National Bio and Agro-Defense Facility (NBAF) USDA-ARS, Manhattan, KS

Contents

Project NBAF Regulatory Compliance Support to the Responsible Official (RO), Biorisk Management (BRM) Support

General Information

1.0 Scope of Work

1.1 Regulatory Compliance Support to the RO/ARO Task

1.1.1 Contractor’s personnel shall work to appropriately guide and train designated staff on select agent regulations and develop those personnel in the RO/ARO roles., The contractor will holistically provide support with assigned tasks that include, but are not limited to, the review of the current select agent program and training on new regulatory changes, onsite support and planning, assessing gaps in regulatory compliance, assisting staff with addressing regulatory gaps, familiarizing staff with the select agent regulations, development and tracking of needed regulatory documentation, and regulatory inspection preparation. The schedule for all activities will be determined upon mutual agreement between the contractor and NBAF.

1.1.1.1 Deliverable: The deliverables under this will vary due to the constantly evolving nature of this support. Deliverables may include forms, training materials, plan reviews, plan revisions, scheduling, SOPs, monthly progress updates, and workflows

1.1.1.2 Expected delivery to USDA: Various time points throughout the period of performance (POP). Each document or hard deliverable will have a set turnaround time as decided upon by NBAF and at the time that it is tasked.

1.2 BRM Support Task

1.2.1 Contractor’s personnel shall provide ongoing technical support to NBAF’s BRM group in the form of document generation, reviews, and gap assessments. Additionally, the contractor will offer support to incoming scientists, or other members of the enterprise as appropriate, in the form of writing SOPs and workflows to support science transition activities. This task is the continuation of efforts previously executed in a BRM support contract. This Task provides flexibility to the NBAF enterprise for support for other technical or related tasks as issues arise or new challenges develop. The schedule and timelines for all activities will be determined upon mutual agreement between the contractor and NBAF

1.2.1.1 Deliverable: The contractor will draft manuals, plans, SOPs, and workflows at the direction of the BRM manager. Additional support can also be provided as defined by USDA.

1.2.1.2 Expected delivery to USDA: The deliverables under this task will vary due to the constantly evolving nature of this support. (Note: each document will have a set turnaround time as decided upon by the BRM manager and the contractor at the time the document is tasked to contractor).

1.3 Project Management (PM) Task

1.3.1 Contractor’s personnel shall provide support development of presentations reporting on task progress for NBAF as associated with this contract.

1.3.1.1 Deliverable: Monthly progress reports.

1.3.1.2 Expected delivery to USDA: The deliverables under this task will vary due to the constantly evolving nature of this support.

2.0 Background

The National Bio and Agro-Defense Facility (NBAF) is seeking a company with extensive knowledge and competence providing support on select agent regulatory matters. NBAF is a federally owned and operated biocontainment facility designed to house Biosafety Level 2 (BSL-2) through Biosafety Level 4 (BSL-4) work, arthropod containment at BSL-2 (ACL-2) and BSL-3 (ACL-3), small animal containment at BSL-4 (ABSL-4), and large animal containment spaces (i.e., Animal Biosafety Level 3 Agriculture [ABSL- 3Ag] and Animal Biosafety Level 4 Agriculture [ABSL-4Ag]). Contractors associated with personnel services within the facility should fully understand the complexities associated with select agent and biosafety requirements associated with high and maximum containment facilities. The facility will be occupied during this work. The NBAF campus address is 1980 Denison Ave., Manhattan, KS.

Contractor Requirements

3.1 Work Restrictions & Conditions

3.1.1 Site Security Access: Access to the site is controlled by a security fence and visitor/contractor check-in/check-out system. All contractor/subcontractor employees shall sign-in and out at the main entrance gate and always wear a contractor/visitor identification badge while on the site. The ID badges will be turned in at the end of the workday. A current government-issued identification with a picture ID is required for entry. See 8.0 for additional security information.

3.1.2 All persons accessing the site must complete the approximate two hour, NBAF Site Security and Safety Orientation. Site specific biosafety and select agent training is currently being developed. If development is completed during the duration of this contract the training may be required for all persons accessing the site.

3.1.3 Contractor vehicles and employee’s personal vehicles shall be parked in the facilities main parking lot.

3.1.4 Work shall be confined to the areas as directed by the Biorisk Management Group. Unless accompanied by a USDA employee, the Contractor, subcontractors, and their employees shall not enter buildings or facilities not specifically part of this contract. Reasons included, but are not limited to, disease control and health requirements.

3.1.5 Failure to comply with access requirements shall be adequate grounds for removal of the Contractor/subcontractor employees from the site and barring further site access to individuals.

3.1.6 Work Hours: Regular work hours for the site are 6:00 am to 6:00 pm, Monday through Friday, excluding Government holidays.

3.1.7 Federal Holidays are listed below:

3.1.8 Work Outside Regular Work Hours: Make application through the COR at least 5 calendar days prior to such work to allow arrangements to be made by the Government for access to the work area and inspection and monitoring arrangements. Requests shall include the exact dates, hours, location, and purpose of the exception. If approved, the COR will coordinate access with the site security office.

3.2 General Requirements / Tasks

3.2.1 The Contractor shall include one (1) week onsite for two (2) individuals each month of the contract. Travel can also be adjusted to allow for two (2) weeks onsite (contiguous or disjunct) for one (1) individual when requested. Onsite trips consist of three (3) onsite days, unless one induvial is onsite for two continuous week which allows for eight (8) onsite days. Travel expenses will be billed at cost, including actual transportation costs, GSA-approved meals and incidental per diem rates, and GSA lodging rates (where possible). Proposal shall indicate any associated travel cost. Proposal must be in whole dollars, no cents. Otherwise, bids will be rounded to the nearest dollar.

3.2.2 The expected breakdown of effort for the listed tasks:

· Regulatory Compliance Support Task – 35%

· BRM Support Task – 60%

· Project Management – 5%

3.2.3 The Contractor shall work with technical point of contact or their assigned representative to ensure project is accomplished in a timely manner.

3.2.4 The Contractor’s work shall adhere to the criteria stated within these project requirements. All services shall comply with applicable current industry standards, (i.e., BMBL, FSAP Select Agent Regulations, etc.), that are in effect when this contract is awarded.

3.2.5 The Contractor shall submit the following documents for monthly payment:

· Invoice

3.2.6 The work performed under this contract shall be subject to continuous audit by the CO/COR/DIRECTORS OFFICE/TECHNICAL POC. Quality control is the exclusive responsibility of the Contractor.

3.2.7 The Contractor shall ensure their onsite support staff follow all site safety and security procedures and policies.

3.2.8 Prior to submitting final payment, the following documents shall be submitted:

· Invoice

4.0 Government Furnished

4.1 The Government shall be afforded 14 calendar day review periods for submittals requiring approval and 7 calendar days for information only submittals.

4.2 The Government will furnish desk space with typical office space amenities. A Government furnished laptop will be provided.

5.0 Deliverables / Schedule

The Contract duration for this project is 365 days from Notice to Proceed issued by Contracting Officer. One option year is anticipated beyond the base year.

Key Deliverables

review

Section 4.1 PDF to

CO/COR

Each invoice submission

persons working onsite

Section 4.1

6.0 Travel

6.1 Travel for this scope of work would include one (1) week onsite for two (2) individuals each month of the contract. Travel can also be adjusted to allow for two (2) weeks onsite (contiguous or disjunct) for one (1) individual when requested. Onsite trips consist of three (3) onsite days, unless one individual is onsite for two continuous week which allows for eight (8) onsite days. Travel expenses will be billed at cost, including actual transportation costs, GSA-approved meals and incidental per diem rates, and GSA lodging rates (where possible).

6.1.1 Deliverable: The contractor’s team onsite for two person weeks each month. This may be split into two trips of one week each.

6.1.2 Expected delivery to USDA: Onsite support across all tasks.

7.0 Contractor’s Key Personnel

7.1 The contractor’s key personnel shall have extensive knowledge and competence in select agent requirements and how select agent regulations relate to the operation and maintenance of systems unique to NBAF. Key personnel shall have a minimum of 7-10 years of experience supporting a BSL-3 or higher laboratory in the United States and 3-5 years of experience serving as an RO or ARO in a FSAP registered facility, preferable Tier 1. Key Personnel shall have a M.S. or PH.D. in a related field or DVM.

8.0 Security Requirements

8.1 Personnel employed by the Contractor or any representative of, or agent of the Contractor, entering this facility shall conform to the facility security regulations. The Contractor shall provide all information required for background checks to meet facility access requirements as performed by the facility security office. Contractor personnel shall comply with all personal identity verification requirements as directed by USDA-ARS Security office. Each person accessing the site will be required to provide personal details, (full name, DOB, SSN, DL#) and will undergo a routine background check, such as a National Agency Check with additional inquiries, which may include a criminal and credit check. Details required for the check should be submitted the security office NLT 5 days prior to the visit. Results of this check may return earlier. However, it should not be planned to have results earlier than 5 days. If, while on site the contractor/vendor will have access to sensitive information, they must complete a National Disclosure Agreement (NDA), along with the required training. This training will most likely be completed by reviewing a series of slides covering the topics of the definition of controlled unclassified information (CUI), access, handling, distribution, storage, and destruction of CUI. Each person will acknowledge receiving and understanding the training on the NDA. The process should not exceed two hours. Acknowledgement and completion of the NDA will be turned in with the form required for the background check. Results will be returned through the Contracting Officer or Contracting Officer Representative. Contractors needs to follow Title 41, Code of Federal Regulations, Part 102- 74, Subpart C Rules and Regulation Governing Conduct on Federal Property.

8.2 Additional security requirements may be imposed when the Federal Government raises the Homeland Security Alert Level. Additional directions will be provided if the situation occurs.

8.3 The Contractor shall safeguard all USDA-ARS equipment, information and property provided for Contractor use. At the close of each work period, USDA-ARS facilities, equipment, and materials shall be secured.

9.0 Data Rights

Not Applicable

10.0 Section 508 – Electronic and Information Technology Standards Not Applicable

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