RFQ_75N98019R00002.doc

RFQ 75N98019R00002

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 applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation is being issued using Simplified Acquisition Procedures under the Authority of FAR Subpart 13.5.

This solicitation is a request for quotes (RFQ) under RFQ Number 75N98019R00002. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-101, dated October 26, 2018. The associated North American Industry Classification System (NAICS) code for this procurement is 339113-Surgical Appliance and Supplies Manufacturing with a size standard of 750 employees. This RFQ is a small business set-aside.

Contract Type

The National Institute of Health contemplates awarding a single firm- fixed price Indefinite-Delivery/ Indefinite-Quantity Contract with one base year and four one-year options.

Scope/Purpose:

The National Eye Institute Central Animal Facility (NEI CAF) has a requirement for laboratory animal emergency Personal Protection Equipment (PPE) to ensure the accessibility and availability of essential supplies throughout an emergency/disaster and Government shutdown. The supplies are required to support irreplaceable multidisciplinary animal research which is critical to the on-going mission of eight institutes at the NIH.

Statement of Work

1.0 INTRODUCTION

The Building 49 Central Animal Facility (CAF) located on the Bethesda campus of the National Institutes of Health contributes to the advancement of biomedical research by providing professional and technical support services related to laboratory animal care and use, and housing laboratory animals in support of eight institute’s intramural research program. To support our animals and the critical research programs they represent, we must ensure consistent supply of PPE materials, even during emergency and disaster situations. Due to the critical nature of these supplies, our program requirements have been incorporated into both our Facility and Institute disaster preparedness plans.

1.1

BACKGROUND

The Government’s requirement for supplies of a specific quality and quantity, which meet the specific specifications as outlined below, coupled with the potential for prolonged manufacturing times and a definitive product shelf life, underscores the critical need for this contract. It is the goal of this contract to establish a stable, cost effective, mechanism to ensure the immediate accessibility of up to a 365 days’ supply of material, as well as provide for the availability of material for rotation and replacement throughout the twelve (12) month contract period. The initial emergency/disaster reserve volume of all PPE will be determined at the time of award. The reserve volume for each category and product will be subsequently adjusted monthly in accordance with available resources and program requirements.

The value of disaster preparedness to laboratory animal facilities has been highlighted in recent years, because of several large-scale disasters that have impacted the U.S. research investment. The past several years have been marked by many humanitarian crises-including the unprecedented spread of Ebola in West Africa, outbreaks of Zika, chorea, yellow fever and others serve as a reminder of the importance of preparedness and a well-coordinated emergency response plan. Disaster preparedness in the laboratory animal industry seeks to reduce direct and indirect losses resulting from disasters. Losses are smallest when the disruptions to animal care and research are minimized. During emergency/disaster events, the normal supply and distribution channels will most likely be unavailable/or protracted due to the impact of the emergency and the rush of immediate orders. Our program’s disaster plan takes these factors into account; it is therefore our intention is to establish an offsite source of critical supplies with an established, laboratory animal PPE vendor with a proven track record of providing quality products and services. As outlined in our emergency plan it is the intention of our program to be able to house up to a one year’s supply of PPE products with a local vendor within a 60-mile radius of NIH in Bethesda, Maryland. The ideal vendor will need a strong disaster plan and have arrangements made with the state and federal agencies in the event of an emergency and or disaster to be able to arrange deliveries to the NIH. As a secondary backup, if the vendor is not able to transport the required supplies we will work with the local vendor to directly pick up the required items.

The Guide for the Care and Use of Laboratory Animals (8th Edition) defines animal biosecurity as “all measures taken to identify, contain, prevent and eradicate known or unknown infections that may cause clinical disease or alter physiologic and behavioral responses or otherwise make the animals unsuitable for research”. See the following for the website link: National Research Council (2011). Guide for the Care and Use of Laboratory Animals, 8th Edition. Pages 21, 22, 141. Institute of Laboratory Animal Resources, Commission on Life Sciences (https://www.nap.edu/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth#toc). The National Animal Health Emergency Management System Guidelines define biosecurity for animal production facilities similarly as “a series of management practices designed to prevent the introduction of and the spread of disease agents.” As part of our program’s “Biosecurity Program” we must ensure the provision of an uninterrupted supply of essential PPE supplies. This plan is a shared responsibility between our program and the selected vendor to ensure the consistent availability of high quality PPE products and services.

The vendor must meet and or exceed the National Institutes of Health Standard for Laboratory Animal Feed and Bedding Distribution Center Sanitation and Pest Management Guidance (Attachment A) as applicable.

This document covers the established sanitation, pest management, and quality assurance requirements applicable to the commercial storage and transport of laboratory feed and bedding. We understand the document was published for animal feed and bedding distribution, however, since the vendor’s warehouse will store supplies which will come into contact with our animals or their environment, the area must also be protected from the risk of contamination from animal pathogens, toxic and or hazardous substances. Ideally, the product(s) shall also be protected from dust which may carry or harbor potential pathogens, toxins or hazardous agents. The Vendor shall provide the name of the firm that provides vermin and pest control services as well as a description of their pest control program. They shall also provide a copy of the pesticides used, program for maintaining the stored product(s) free of pesticide residues, facility map, and the latest quality assurance report and service report. Provide the regularly scheduled and documented program of control and monitoring that exist.

The Vendor also must provide documentation about their quality assurance practices for all PPE products. All products supplied should be free of chemical or pathologic contaminants and the presence of natural toxicants. Areas used for storage should not be subject to elevated temperatures or elevated relative humidity for prolonged periods of time as outlined below. The Vendor must provide information on manufacturing, monitoring, and storage of PPE products, as well as quality assurance results as requested. As part of our programs’ responsibility, we will inspect the site(s) at least annually to ensure that they are meeting the above requirements.

It is our intent to incorporate within the contract the ability to secure space within the suppliers’ warehouse(s) that meets the biosecurity requirements listed above to store the emergency supply of PPE. As part of the agreement, we would meet with the vendor after to award and once a year thereafter for a site visit of the warehouse to ensure that the stated requirements outlined in this statement of work are met or exceeded. This will ensure that the facility is able to maintain up to a year’s reserve of PPE products at the respective location, as well as the vendor’s ability to meet or exceed the requirement of the SOW. The vendor would be required to provide a deliverable report on a quarterly basis of the current inventory, or more often if needed. In addition, provide documentation and or statement that the reserve stock is being rotated to ensure the integrity of all products.

All PPE clothing and equipment should be of safe design and manufacture and shall be maintained in a clean and reliable fashion. The Government has taken the usability and fit of the proposed PPE into consideration with the specifications outlined. The specifications are based on the requirements that the PPE fits well and is comfortable to wear. This encourages both our staff and researchers to use the PPE. The PPE specifications are available in multiple sizes and care should be taken to ensure that they meet the specifications so that the proper size for each employee is met. It is not uncommon for several different types of PPE to be worn together; the specifications found within this document, to ensure the compatibility of the different PPE. If PPE does not fit properly, it can make the difference between being safely covered or dangerously exposed. Ill-fitting PPE will fail to provide the required level of protection for the staff and the animals, as well as discouraging appropriate use.

The distinction between exam gloves and general-purpose gloves for this procurement has been clarified by the following. Exam grade gloves are different from general purpose gloves in that they must meet a series of Food and Drug Administration (FDA) regulations requiring a specific barrier to blood or infectious agents. Exam gloves are regulated by stringent FDA requirements requiring specific production and quality control standards. Our personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting more limited interactions with animals and equipment as well as when conducting surgery. Whereas, general purpose gloves are for use in food service, industrial or any other application that does not require a specific barrier to blood or infectious agents. General purpose gloves are the most common gloves found in the marketplace and popular uses include food service, packaging, automotive, painting and health & beauty.

FDA’s regulations require that medical gloves be correctly labeled and cleared for marketing through a premarket notification submission [510(k)] prior to being distributed in the U.S. FDA’s regulations at Title 21 Code of Federal Regulations Part 820 also require manufacturers to produce gloves according to the Quality System (QS) regulation (formerly Good Manufacturing Practices regulation) to assure that gloves are produced at an acceptable quality level, thus helping to assure their safety and effectiveness. The safety and effectiveness of medical gloves can be compromised by many kinds of defects. These defects can be controlled or eliminated through proper quality control procedures. The Agency has determined that glove defects, such as pinholes, which are not readily detectable by the users of gloves, can significantly compromise the effectiveness of the barrier and result in patients or health care workers being unnecessarily exposed to infectious agents.

1.2 Requirements/Specifications:

OSHA requires PPE to meet the following ANSI standards. All proposed PPE must meet the cited ANSI standards:

· Eye and Face Protection: ANSI Z87.1-1989 (USA Standard for Occupational and Educational Eye and Face Protection).

· Head Protection: ANSI Z89.1-1986.

· Foot Protection: ANSI Z41.1-1991.

· For hand protection, there is no ANSI standard for gloves, but OSHA recommends that selection be based upon the tasks to be performed and the performance and construction characteristics of the glove material. For protection against chemicals, glove selection must be based on the chemicals encountered, the chemical resistance and the physical properties of the glove material.

Salient Characteristics for Spun Bound Melt-Blown Synthetic (SMS) Lab Coats:

SMS Coveralls are made of a spun bound Melt-Blown Synthetic, a unique trilaminate material. SMS coveralls offer breathability, fluid resistance, and good hold-out for dry particulates. SMS Coveralls are autoclavable and offer good tear and puncture resistance. The micro-porous layer affords protection from splashed and particle contamination. The minimum acceptable standard shall be: The lab coats are sized for maximum comfort; the weight of 1.5 ounces per square yard with five Velcro closures front; the lab coats shall have a knit cuff and collar, three pockets, blue, and shall be available in Small to Six (6) XL. The Lab Coat size specifications is listed below.

Salient Characteristics for Polypropylene Coverall:

Polypropylene Coveralls are a lightweight, economical coverall that offers protection against non-hazardous, dirty environments. Polypropylene coveralls are ideally suited for use in minimal protection applications. The minimum acceptable standard shall be: Polypropylene coverall is sized for maximum comfort and fit per ANSI/ISEA Spec 101-1996 standard with weight of 1.4 ounces per square yard, and zipper fronts. Polypropylene Coveralls with elastic wrists, elastic thumb loops and elastic ankles are available from small to six (6) XL. These polypropylene coveralls are blue and have a snap front pocket. The coverall size specifications are listed below.

Salient Physical Property of the SMS Coverall:

SMS Coveralls are made of spun bound Melt-Blown Synthetic, a unique trilaminate material. SMS coveralls offer breathability, fluid resistance, and good hold-out for dry particulates. SMS Coveralls are autoclavable and offer good tear and puncture resistance. The micro-porous layer affords protection from splashed and particle contamination. The minimum acceptable standard shall be: SMS coverall is sized for maximum comfort and with elastic wrists, elastic ankles, 2 pockets with zipper front and weight 1.8 oz. are available from small to six (6) XL. These SMS coveralls are white. The coverall size specifications is listed above.

Salient Physical Property of the Suntech Microporous Film Coveralls:

Microporous Film Coveralls are made of a laminated microporous film that is spunbound Polypropylene reinforced with a nylon scrim core. As such, Microporous Film Coveralls are strong and flexible. Microporous Film Coveralls offer excellent fluid resistance and holdout. Microporous film coveralls pass blood borne pathogen and viral penetration tests for use in containment areas. The minimum acceptable standard shall be Microporous Film coverall is sized for maximum comfort and weight is 2.11 ounces, with elastic wrists, elastic thumb loops and elastic ankles are available from small to six (6) XL offer excellent fluid resistance and holdout. These Suntech Microporous Film coveralls are white. The coverall size specifications is listed above.

Salient Physical Property of the Non-Skid/Water Resistant Shoe Cover:

The fabric is polyethylene with a thickness of 2.25 mil. The sole is skid resistant, blue and is packed 200 pair per case rolled in pairs and available in sizes large and XL.

Salient Physical Property of the Guardian Nitrile Gloves:

Guardian Nitrile medical grade gloves are blue, powder-free, textured, and are five (5) mil thick. Guardian nitrile medical grade gloves are available with a 12-inch cuff. These 510K certified medical grade nitrile gloves are supplied 100 per box, 10 boxes per case and available in sizes small to two (2) XL.

Salient Physical Property of the Rhino Shield Latex Medical Grade Gloves:

Rhino Shield latex medical grade gloves are blue, powder-free, textured, 14 mil thick and have a beaded 12 inch cuff. These latex gloves are 510K certified medical grade gloves. Rhino gloves are supplied 50 per box and 10 boxes per case and are available in sizes from small to two (2) XL.

Salient Physical Property of the Rhino Shield Latex Medical Grade Gloves:

Rhino Shield latex medical grade gloves are blue, powder-free, textured, 14 mil thick and have a beaded 12 inch cuff. These latex gloves are 510K certified medical grade gloves. Rhino gloves are supplied 50 per box and 10 boxes per case and are available in sizes from small to two (2) XL.

Salient Physical Property of the PE Coated Polypropylene Protective Sleeves 18”:

PE Coated Polypropylene Protective Sleeves provide excellent fluid resistance and good hold-out protection for dry particulates. The protective sleeves have elastic band at both ends. These are 1670/171 certified.

Salient Physical Property of the Polypropylene Bouffant Caps 24”:

Blue Polypropylene Bouffant Caps are a lightweight, economical choice in non-hazardous, dirty environments. Polypropylene bouffant caps are disposable caps that are well suited for minimal protection applications.

Salient Physical Property of the Ear Loop Mask, Blue:

Procedure Mask blue pleated with elastic latex free ear loops

Salient Physical Property of the N-95 Respiratory Mask:

3M Respirator Dust/Mist N95 mask 8210 with elastic ear loops

In addition to establishing and maintaining PPE as an emergency and disaster resource, the vendor must provide high quality laboratory PPE that meet the salient specifications as outlined above. Since PPE products have a definitive shelf life, to maintain the integrity of the stocked items the vendor shall deliver requested items from the reserve to the facility on a routine basis or upon request as outlined below. In addition, the vendor shall reestablish the reserve as directed by the Government on a as needed basis. It shall be the vendor’s responsibility to manage the reserve to ensure the continued rotation of product to protect the integrity of the resource.

1. The proposed vendor must be able to supply the following goods or services:

2. Ensure that the lab coats and coveralls meet the minimum sizing specifications, salient characteristics and physical properties as outline above;

3. Ensure that the gloves meet the minimum salient characteristic as outline below;

4. The vendor must meet and or exceed the National Institutes of Health Standard for Laboratory Animal Feed and Bedding Distribution Center Sanitation and Pest Management Guidance, post award, within 30 days, See Attachment A;

5. Provide routine (weekly) deliveries to our research facility. Deliveries will be made Monday through Friday from 7:30 AM to 3:00 PM (excluding Federal Holidays);

6. Provide emergency deliveries and services in the event of an emergency or disaster within a 24-hour response time;

7. Ensure that the integrity of the products is maintained throughout storage and delivery. This includes, but is not limited to, protection from moisture and dust which may carry

8. unwanted pathogens;

9. Ensure that less than five percent (<5%) of boxes/items are torn, ripped, or damaged upon delivery; to include faulty zippers within the coveralls.

10. Provide a credit/replacement, at the contractor’s expense, for all broken, torn, ripped, or damaged PPE items;

11. Provide return trips to correct an incorrect product delivery/order or replace damaged items within 24 hours of the original required delivery date and time;

12. Unload pallets from the delivery truck and place them on the designated animal facility loading dock;

13. Maintain current and accurate product inventory details and controls to ensure the rotation of stock, timely dating, and delivery;

14. PPE items may be added, subtracted, or otherwise modified at the discretion of the Government to meet evolving program requirements;

15. Supply a copy of the current inventory, including inventory numbers of each product by manufacturer and production dates, to the COTR on a quarterly basis, by the 10th of day of each quarter, or upon request;

16. Provide an Operations Statement which includes the vendors program for maintaining the integrity of the stored and delivered products, as well as product rotation and inventory programs, post award, within 30 calendar days; and

17. Provide a Disaster Plan to include how the contractor shall ensure the provision of services and transportation of required supplies in the event of an emergency or disaster, post-award, within 30 calendar days.

18. The level of stock for the emergency supply will be dependent upon the available resources and funding levels at the base, and option years, of the contract. However, a minimum one (1) month supply will always be maintained. At a minimum the emergency/disaster reserve for each PPE product will be a 30-day supply; at a maximum a 365-day supply for each PPE product. All quantities stated, unless indicated otherwise are estimates and the Government reserves the right to increase or decrease the quantities at the unit price as best fits it needs.

2.0 PERIOD OF PERFORMANCE:

The anticipated period of performance for this contract is one (1) base year with four (4) option years (12/months each).

3.0 GOVERNMENT FURNISHED PROPERTY:

None

4.0 SECURITY REQUIREMENTS

None

5.0 DELIVERY:

In its order fulfillment process or procedure, the Vendor must accept orders via phone or by email. The Vendor must notify the Government immediately if a PPE product is out of stock to allow for alternate replacement if available.

No substitutions are allowed by the Vendor without explicit written permission from the Government at the time of ordering.

The Vendor must transport and store PPE materials off the floor on pallets, racks, or carts in a manner consistent with maintenance of quality and minimization of contamination, including dust, in strict accordance with the Guide for the Care and Use of Laboratory Animals and the National Institutes of Health Standard for Laboratory Animal Feed and Bedding Distribution Center Sanitation and Pest Management Guidance.

During the life of the contract, the Vendor shall notify the Contracting Officer Representative of any change in the address of the production facility and/or distributors warehouse. This notification shall also apply in the event the PPE production is performed by a subcontractor.

The Government reserves the right to perform inspections at the distributor’s and manufacturer’s production and/or warehouse facilities prior to contract award and during the contract to assure compliance as listed above.

All deliveries will be on a clean, commercially standard 48” x 40” (121.92cm x 101.6cm) pallet. Pallets will be inspected upon delivery and shall be clean and free of contaminants and damage. The total height of the pallet and goods shall not exceed 55” (139.7cm). In addition, each pallet shall be shrink-wrapped to assure safe and proper handling.

Unless otherwise specified, deliveries shall be made to the Building 49 Loading dock. Deliveries will be made Monday through Friday from 7:30 AM to 3:00 PM (excluding Federal Holidays); if necessary alternative arrangements can be made with the Contracting Officer Representative only. Trucks arriving after the specified time may not be allowed to unload the PPE. Supplies or services scheduled for delivery on a Federal Holiday shall be made the following workday. Satisfactory performance of this contract shall be deemed to occur upon delivery and acceptance by the Government or the duly authorized representative of the items described herein.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

Information Security and/or Physical Access A. Baseline Security Requirements

1. Applicability- The requirements herein apply whether the entire contract or order (hereafter "contract"), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor)will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

1. Safeguarding Information and Information Systems- In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

c. Protect government information and information systems in order to ensure:

· Confidentiality , which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

· Integrity , which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

· Availability , which means ensuring timely and reliable access to and use of information.

d. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party.

e. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov .

f. Comply with the Privacy Act requirements.

2. Information Security Categorization- In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Contractor Non-Disclosure Agreement and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ X ] Low [ ] Moderate [ ] High Integrity: [ X ] Low [ ] Moderate [ ] High Availability: [ X ] Low [ ] Moderate [ ] High Overall Risk Level: [ X ] Low [ ] Moderate [ ] High Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X ] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, "PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother's maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be:

[X ] Low [ ] Moderate [ ] High

3. Controlled Unclassified Information (CUI)- CUI is defined as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323.

All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

g. Marked appropriately;

h. Disclosed to authorized personnel on a Need-To-Know basis;

i. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

j. Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

4. Protection of Sensitive Information- For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

5. Confidentiality and Nondisclosure of Information- Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

k. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

l. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

m. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non- Public Information - Contractor Employee Agreement" located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

6. Internet Protocol Version 6 (IPv6)- All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

7. Government Websites- All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

8. Contract Documentation- The Contractor shall use provided templates, policies, forms and other agency documents provided by the Contracting Officer and the Contracting Officer's Representative to comply with contract deliverables as appropriate.

9. Standard for Encryption- The Contractor (and/or any subcontractor) shall:

n. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

o. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

p. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

q. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 65140-2. The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative within 15 days of the validation.

r. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

10. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

11. Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA)- The Contractor shall assist the NIH Office of the Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed. The NIH PIA guide is located at https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/NIH%20PIA%20Guide.pdf .

s. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the OpDiv SOP or designee with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

t. The Contractor shall assist the NIH Office of the SOP or designee in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

B. TRAINING

2. Mandatory Training for All Contractor Staff- All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

3. Role-based Training- All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. Read further guidance about the NIH Role-based Training https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx

4. Training Records- The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

C. RULES OF BEHAVIOR

5. The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and comply with the NIH Information Technology General Rules of Behavior https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx , which are contained in the NIH Information Security Awareness Training Course http://irtsectraining.nih.gov

6. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual NIH Information Security Awareness Training. If the training is provided by the contractor, the signed Rules of Behavior must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

C. INCIDENT RESPONSE

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/NIH IRT teams within 24 hours, whether the response is positive or negative. FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cyber security and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as "a suspected or confirmed incident involving PII" .

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

7. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

8. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send NIH approved notifications to affected individuals individuals in accordance with https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx

9. Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT) via email at IRT@mail.nih.gov , COR, CO, the NIH Office of the SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable NIH and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

u. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

v. not include any sensitive information in the subject or body of any reporting e-mail; and

w. encrypt sensitive information in attachments to email, media, etc.

12. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information HHS and NIH incident response policies when handling PII breaches.

13. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation within an hour of discovery.

D. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ X ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

E. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

For additional information, see HSPD-12 policy at: https://www.dhs.gov/homeland-security-presidential-directive-12) Roster-

x. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx .

y. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

z. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

aa. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

ab. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

ac. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

ad. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

ae. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

af. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

ag. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

F. CONTRACT INITIATION AND EXPIRATION

10. General Security Requirements- The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/documents/proplans.html

14. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

15. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/or COR to certify that, at the government's direction, all…