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COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24220Q1057 Posted Date: 08/13/2020 Original Response Date:... COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24220Q1057 Posted Date: 08/13/2020 Original Response Date: 08/19/2020 Current Response Date: 08/19/2020 Product or Service Code: 6505 Set Aside (SDVOSB/VOSB): Unrestricted Set-Aside NAICS Code: 325412 Contracting Office Address Department of Veterans Affairs, Northport VAMC, 79 Middleville Rd., Northport, NY 11768-2200. Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a "request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-05. The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, with a small business size standard of 1,250 Employees. This procurement is being issued as Unrestricted Set-Aside. It is the Government s intent to issue a firm fixed price, single award as a result of this solicitation. The North American Industry Classification System (NAICS) code is 325412, Pharmaceutical Preparation Manufacturing, with a business size standard of 1250 Employees. All interested companies shall provide quotation(s), for the following: VA Department of Veterans Affairs, Northport VAMC, 79 Middleville Rd., Northport, NY 11768-2200, is seeking to purchase a Brand-Name or Equal of Amyvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer for the evaluation of veterans with dementia in the Radiology/Nuclear Medicine Service at four VA Medical Centers (VAMC) as listed below. Supplies: Brand Name or Equal for PET Radiopharmaceutical (Amyvid) Item # Description/Part Number* 1 Amyvid, East Orange 2 Amyvid, NYH, Brooklyn 3 Amyvid, Bronx 4 Amyvid, Northport *** Vendor covers all shipping and handling costs *** Requirements: This is a Brand Name or Equal procurement. The contractor shall deliver Amvvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer on an as needed basis to each of the participating VAMCs. The beta amyloid PET tracer must: Require imaging to begin within 30 minutes Require an imaging time of no more than 10 minutes. The contractor shall provide all labor, supervision and transportation necessary to meets the needs of deliveries for the various Radiology/Nuclear Medicine Services at the participating VAMCs. The contactor shall have an adequate supply of Amyvid (F18 florbetapir intravenous) or a similar beta amyloid PET tracer to meet the requirements of the participating VAMCs. Due to the critical need of these supplies in a timely manner, only vendors within a 60-mile radius of any given participating VAMCs need to respond. Technology Requirements All technology that transmits VA sensitive information must be FIPS 140-2 compliant. Contractor Contact Information: The contractor will provide with their proposal, the following information: The contractor s regular daily work hours. Instructions for placing orders over the phone, by fax and through a web-based ordering system. No veteran specific information will be transmitted through any web-based ordering system. Orders that are placed through any web-based system will not include veteran specific information. Veteran specific information will only be transmitted over the phone. The contractor s telephone number for phone orders during regular work hours. The contractor s telephone number for placing emergency orders after the contractor s regular working hours including weekends and holidays, 24 hours a day, 7 days a week, 365 days a year. The contractor s telephone number for expert advice about awarded products. The contractor s fax number for radiopharmaceutical orders. If there are any changes to the above, the contractor will immediately provide updates to each participating medical center in writing. Contractors shall provide copies of licenses and certifications along with their proposals. Package Inserts: The contractor will ship current a package inserts for the PET radiopharmaceutical to each participating veterans administration medical center at the inception of the contract. Any new or updated additions to the package inserts will be sent by the contractor to each participating medical center promptly. Available Product: The contractor must be able to supply the selected PET radiopharmaceutical. Orders and Delivery Delivery Locations: James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx, NY 10468 Veterans Administration New Jersey Health Care System 385 Tremont Avenue East Orange, NJ 07018 Northport VAMC 79 Middleville Road Northport, NY 11768 VA New York Harbor Health Care System Brooklyn Campus 800 Poly Place Brooklyn, NY 11209 Orders will be placed by 5:00 pm for delivery by the following workday. Orders can be placed orally by telephone, through a web-based system and/or fax transmission. Due to the demands of the VMACs patient care requirements, there shall be no restriction on the number of orders which may be placed by a participating VAMC, nor the number of deliveries required per day. Deliveries must be available Monday through Friday. Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the contractor s acceptance to the commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by ordering personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Invoice shall include period covered, billing date, name of preparation, quantity, and amount. The contractor is responsible for on time delivery of radiopharmaceuticals and must have back-up facilities/production options to maintain greater than 95% on time delivery or risk penalties that include no charge doses that, at a minimum, equal the amount of missed doses. The contractor must provide an emergency plan for deliveries during inclement weather. Deliveries of radioactive products must incorporate sufficient lead or other high-density material shielding to comply with applicable Federal and or State standards relating to shipment of radioactive material. Deliveries are to be made to Nuclear Medicine Hot Labs in each of the participating VAMCs. If the medical center has 2 Hot Labs, deliveries are to be made to the specified PET Hot Lab. Access to the Nuclear Medicine Hot Labs during non-business hours shall be obtained by contacting the VA Police Service. Drivers who make deliveries must present acceptable photographic identification to the VA Police Service. Drivers must have documentation of radiation safety training that is available to the receiving facility upon request. There will be no surcharges for any deliveries. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Labeling Doses: The contractor shall label all unit doses delivered radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc., and provide a bar code labeled insert to allow scanning data into the VAMC s nuclear medicine information management system (NMIS). If the contractor s system varies from the current NMIS information system in use at the participating medical centers, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government. A label must be affixed to each syringe, vial, or other container that is used to hold a radioactive radiopharmaceutical to be transferred for commercial distribution. The label must include a radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial or other container can be correlated with the information on the transport radiation shield label. Shipping and Radioactive Labels: All packaging of radioactive materials must be clearly labeled Caution, Radioactive Material and contain a radioactive symbol with the proper Transportation Class and exposure levels, preparation time, expiration time and date and order number on the outside of the shipping container in order to comply with specific regulatory requirements. All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling, shipment and storage. The contractor must supply with each shipment/order/delivery a system for spent (used) syringes, which meets OSHA s Biohazard Policy/Regulations and is needless. Nuclear Regulatory Commission License: The contractor must be licensed by the Nuclear Regulatory Commission (NRC) and must be in the business of delivering radiopharmaceuticals. Additionally, the contractor shall meet the Department of Transportation, NHPP, FDA, OSHA, and all other agency rules and regulations (Federal and State) including USP 797. Contractors shall provide copies of licenses and certifications along with their proposals. CFR10: The contactor shall abide by the Title Code of Federal Regulations (CFR 10). Sales Representative: The contractor shall assign to each participating VAMC an individual sales representative to (1) aid in the facilitation of a smooth coordination between each participating VAMC and the contractor and to (2) aide in the prompt resolution of discrepancies. Quality Control Manual: The contractor shall provide a copy of their laboratory s current quality control manual and shall be willing to discuss discrepancies in lab results which do not fit the clinical picture. The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to each participating medical center. The testing and the detailed report shall be furnished to each participating medical center at no additional cost. All contractor quality control testing/procedures shall be performed as required by Federal and State regulatory agencies. USP 797: The contractor must validate that they are in compliance with USP 797. Each vendor must provide clean room reports and evidence of satisfactory air quality in the clean rooms. Canceling orders and returned products: Each participating medical center may cancel ordered doses within a ten-hour (10) notice to contractor. The contractor shall accept returns for credit under the following conditions: Product(s) shipped in error. Product(s) damaged in shipment. Recalled product(s). Unused, unopened doses of product for patients who fail to keep their appointments. Unused, unopened nonradioactive products prior to expiration. The contractor will pick up radioactive and non-radioactive products to be returned for proper disposal at no cost to the government. Credit for the returned product will be reflected in the current month s invoice. The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at cost of the contractor. Replacements shall be received within 48 hours of notification. All charges for delivery shall be included in the fee schedule. Additional fuel surcharges will not apply. MSDS Sheets: When the contract is awarded, the contractor must provide MSDS sheets (Material Safety Data Sheets) for the contract radiopharmaceutical to each participating VAMC. Invoicing and Payments: The contractor must submit an invoice at least once per month that shows the period covered, the billing date, the name of each product delivered, the quantity delivered, the amount delivered, the date each product was delivered and the correct Veterans Administration purchase order number. All invoices are to be sent to (1) Austin vial electronic invoicing and (2) each participating medical center via secure e-mail. Payments shall be made in the arrears via Tungsten Network or government purchase credit card. HIPAA COMPLIANCE: The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs. Employees of the vendor who accept orders must complete two on-line courses on the VHA TMS System: VA Privacy and Information Security Awareness and Rules of Behavior Privacy and HIPAA Requirement The vendor must send copies of each involved employee to the COR for this contract. VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-2 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-3 f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-4 payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-5 Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall. d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. g. The contractor/subcontractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: (a) The Systems of Records (SOR); and (b) The design, development, or operation work that the contractor/subcontractor is to perform; (2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-6 (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. (1) Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. (2) Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. (3) System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days. k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days. MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-7 l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. d. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to ...