CB SYN_SOL 1227660 05222020.pdf

75F40120Q00052 Wide Field Fluorescence Inverted Microscope

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13.5 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2020-06.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is

75F40120-Q-00052 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 333314 and as full and open competition. Prospective Offerors are responsible for downloading the solicitation and any amendments through Beta.Sam.Gov. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

Contract Type- Commercial Supply – Firm Fixed Price.

The U.S. Food and Drug Administration (FDA) requires the following:

***************************BRAND NAME OR EQUAL**************************

A. OBJECTIVES/PURPOSE

The purpose of this requirement is to obtain a Wide Field Fluorescence Inverted Microscope for investigating flow issues in microfluidic channels

B. BACKGROUND AND OVERVIEW

The Food and Drug Administration (FDA), Center for Devices and Radiological Health

(CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Applied

Mechanics (DAM), Microfluidics Program requires a state-of-the-art, Inverted Fluorescence

Microscope System.

C. STATEMENT OF WORK (SOW)

1. SCOPE OF WORK

The FDA, CDRH, Office of Science and Engineering Laboratories (OSEL), Division of

Applied Mechanics (DAM), Microfluidics Program requires a state-of-the-art, Inverted

Fluorescence Microscope System with the following features, and functionality.

a. Characterize the behavior of particles, cells, and blood in static and flow base conditions, and, simulate flows in microfluidic devices and microvasculature.

b. In order to better understand flow related complications in the diagnostic and therapeutic devices.

c. The features of the proposed microscope shall enhance the Center’s scientific capabilities and support efforts to effectively evaluate emerging technologies such as microfluidic-based devices, bubble dynamics, and organ-on-chips.

d. The ability to study bubbles dynamics to open the blood-brain barrier and evaluate coatings/surfaces/biofilms on medical devices. Also, study bubble dynamics, formation, and collapse for applications such as opening the blood-brain barrier or in digital droplet formation and evaluate the interactions between physiological flows and coatings/surfaces/biofilms on medical devices.

e. Understand complex flows and device-related complications in the diagnostic and therapeutic spaces.

f. The microscope shall require a built-in incubator which shall enable long term imaging of flow/cell viability studies in a well-controlled environment, a capability that the program does not currently possess. To have the capability to possess and to support an incubator (small and large) which shall allow the Center to perform longer term imaging of flow studies in a well-controlled environment. The incubation chamber shall also enhance the Center’s scientific capabilities and support efforts to effectively evaluate emerging technologies such as microfluidics-based devices and organ-on-chips.

g. The two high-speed cameras shall improve OSEL’s ability to evaluate high velocity flows and bubble dynamics on the micro-scale. A precise programmable XY stage, powerful LED light source, image analysis software, and stabilizing air table shall ensure high-quality image capture and analysis. The high magnification (≥60X) lenses shall enable visualization of cells and particles down to the micro and nanoscale levels.

h. In addition, the software shall be able to remove background blurring from the images.

i. To enhance the Center’s scientific capabilities and support efforts by obtaining features in a microscope can provide a high-speed camera, precise programmable XY stage, powerful LED light source, Differential Interference Contrast (DIC), phase contrast imaging,

2. SALIENT CHARACTERISTICS

Wide-Field Fluorescence Inverted Microscope shall have the following Salient

Characteristics.

A, Inverted Microscope

1. A touchscreen display interface on the microscope

2. Shall be able to synchronize camera, illumination, motorized stage and focus for high-speed imaging

3. At a minimum shall have a tiltable or removable brightfield source for ≥

7” working space above the stage

4. Reproducible focusing with precision ≤ 30 nm in the Z-direction

5. A direct access point into the infinite light path for easy addition of fluorescence techniques

6. A motorized objective turret with ≥ 6 positions

7. All necessary components for differential interference contrast (DIC) and phase contrast imaging

8. A motorized condenser and slider for phase contrast and DIC

9. Hoffman modulation contrast

10. A minimum 2 camera ports (left/right)

11. The capability of having 2 cameras operate simultaneously

12. Triggering: capable of acquiring ≥ 8 external signals simultaneously

B. Objective Lenses (9)

1. One 4x or 5x, Fluor, numerical aperture (NA) ≥ 0.13, working distance ≥ 13 mm objective

2. One 10x, phase contrast, Fluor NA ≥ 0.3 working distance ≥ 10 mm objective

3. One 10x, DIC, Fluor, NA ≥ 0.3, working distance ≥ 10 mm objective

4. One 20x, DIC, Apo, NA ≥ 0.8, for glass objective

5. One 20x, phase contrast, Fluor, NA ≥ 0.4, for plastic objective

6. One 40x, phase contrast, NA ≥ 0.6, for plastic, dry objective

7. One 40x, DIC, Apo, NA ≥ 0.95, dry objective

8. One 60x or 63x, DIC, Apo, NA ≥ 1.4, oil objective

9. One 100x, DIC, Fluor, NA ≥ 1.3, oil objective

C. High Speed Cameras (2)

1. Camera 1: Third party sCMOS camera, FOV ≥ 21 mm Speed ≥ 89 fps at full view, max speed of ~800 fps Dynamic range ≥ 20,000:1, bit depth:

8, 12 and 16 Imaging Array of Minimum 2300 x 2048 pixels Achievable readout noise (e-rms) ~0.7.

a. Max QE ≥ 80%, QE at 450 nm ≥ 70% and at 620 nm ≥ 70%

2. Camera 2: sCMOS camera, ≥ 4MP FOV ≥ 19 mm, monochrome Speed of ~90 fps at full view, max speed of Minimum of 800 fps Dynamic range ≥ 30,000:1, bit depth: 12 and 16.

Imaging Array: The system at a minimum shall be used by multiple users and the number of users shall change overtime.

a. Minimum 2048 x 2048 pixels

b. Max QE ≥ 82%, QE at 450 nm ≥ 60% and at 620 nm ≥ 70%, pixel size ≥ 6 µm

3. Includes a C-mount adapter for each sCMOS camera

4. Include all connectors necessary for high-speed image acquisition with each camera

5. Both cameras be compatible with the software provided

6. Microscope be compatible with another existing lab camera (NAC

Memrecam GX3, (NAC Image Technology, Simi Valley, CA, USA)

D. Fluorescent Light Sources

1. Shall have ≥ 8 Independent LEDs (mercury-free light source)

2. LED lifespan ≥ 20,000 hours

3. Emission wavelengths: encompass 450-800 nm

4. Excitation wavelengths: encompass 400-730 nm

5. Filter set includes DAPI/TRITC/FITC/Cy5

E. Microscope Stage and Sample Holder

1. At a minimum 2-axis travel range of: X ≥ 120 mm and Y ≥ 75 mm

2. X- and Y-position resolutions ≤ 5 nm

3. Absolute X- and Y-precisions ≤ 1 µm

4. Maximum stage velocity > 450 mm/s

5. Automated and joy-stick controlled movement

6. A programmable entire-sample scan mode

7. A holding frame for multi-well plates

8. Universal holding frame enable fixing Petri dishes with diameters ranging from 20 mm to 68 mm, or slides with a maximum length of 120 mm

9. Four SMB to BNC cables

F. Computer

1. One workstation with ≥ HP Z4 Tower, 64 GB DDR4-2666 RAM, 4

TB SSD, 4 TB HDD, Intel (4 cores, 3.6 GHz) or equivalent processor, 4 USB3 ports, up-to-date Win10 operating system, DVDWR, Turbo

GeForce RTX 2080 Ti 11 GB graphics card

2. Two 32” LED monitors, minimum of 2560 x 1440 pixels, with

HDMI port(s), landscape orientation

3. Software:

a. Image processing software with 2D and 3D particle tracking pre-installed on the computer

b. The ability to do size-based particle differentiation

c. The ability to do particle velocity measurements and particle counting

d. An experiment (workflow) designer

e. real-time autofocus

f. Time lapse image capture

g. Z-stack resolution < 70 nm over a minimum of 12 mm range

h. Apparent spatial resolution with 40x obj. ≤ 120 nm at 400 nm wavelength

i. Apparent spatial resolution with 40x obj. ≤ 180 nm at 630 nm wavelength

j. Apparent spatial resolution with 63x obj. ≤ 80 nm at 400 nm wavelength

k. Apparent spatial resolution with 63x obj. ≤ 120 nm at 630 nm wavelength

l. Triggered multi-channel imaging

m. 3D deconvolution pre-installed on the computer

n. Real-time rendering module with the following features: iso-surface rendermode, 3D crop tools, 3D annotations, stereo display mode, movie editor to generate 3D movies

o. At a minimum to have an ability to incorporate simple programming scripts in ImageJ, MATLAB

p. At a minimum ability to output individual particle positions in three dimensions

q. Software control of external triggers

r. A software clearing mode to remove non-relevant out of focus background blurriness and to produce confocal like images while preserving all important details.

s. The ability to zoom in and out of an overview image to a highly magnified image at a selected location.

t. Customizable regions of interest (e.g. square and rectangular

ROIs) when using high framerates.

u. Provide all Software updates released within the past 2 years.

The system shall be used by multiple users and the number of users shall change over time.

v. 3D Analysis features including an interactive measurement tool and a processing toolbox,

w. Numerical results be able to be exported as Microsoft Excel files together with histograms and images,

x. The process Toolbox include smoothing and morphological filters, segmentation tools, powerful image calculator,

y. A software module with true 3D real time rendering,

z. 2D image analysis capabilities even on multi-dimensional data sets (e.g. time series or Z stacks) be able to display particle trajectories.

G. Small Incubator

1. CO2/air mixer for combining 100% CO2 gas with room air.

2. A specimen feedback mode to control environmental parameters.

3. Include a temperature and humidity controller.

4. Temperature control resolution shall be ≤ 0.5°C.

5. Temperature accuracy to the nearest 0.2 °C in chamber feedback mode.

6. Include a K-frame insert size of 160 mm x 110 mm with a sliding lid.

7. Include a 24-well magnetic plate holder.

8. Include a 96-well magnetic plate holder.

9. Include a magnetic 35 mm petri dish holder.

10. Include a magnetic 1” by 3” chamber slide holder be easily removable from the microscope.

H. Large Incubator

1. Laser safety interlocks, black upper housing, laser safe doors, LED illumination, mounting plate, and a warm air duct tube to not exceed 1m.

2. Two black door sets, each with right, left and front doors,

3. A temperature controller with a display resolution of 0.1°C, a resolution of internal loop control of 0.01°C, and set point values not to exceed

60°C

4. Contain a heating unit that can increase temperature to minimum

20°C above ambient temperature,

5. At a minimum shall come with one USB 3.0 hub,

6. Shall be easily removable from the microscope,

7. Include an extra transparent door set for sample viewing.

I. Antivibration Air Table

1. Tabletop dimensions be minimum 29” deep x 35” wide x 1.5” thick

2. Tabletop dimensions not exceed 60” deep x 60” wide

3. Antivibration air table height be between 26” and 42” tall

4. Include an air compressor to isolate and dampen vibrations

5. Shipping weight of table not exceed 900 lbs

3. DELIVERABLES

LINE ITEM 1

1a Wide-Field Fluorescence Inverted Microscope with Accessories

100% completion

1b Shipping and Handling 100% completion

1c Installation 100% completion

1d On-Site Training 100% completion

1e 1-Year Warranty on all parts and labor Included

1f Application support via phone/email Included

1g Software Updates Included

The Original Equipment Manufacturer (OEM) shall provide the standard warranty (or as stated by manufacturer (OEM) on all parts and labor. The OEM shall also provide continuous application support via phone and/or email for the equipment on weekdays

(except federal holidays)

4. INSTALLATION:

The OEM shall provide 100% completion of installation and perform functionality testing before government acceptance with final approval by the Technical Point of Contact

(TPOC).

5. TRAINING

The Certified (OEM) personnel shall provide training as needed for the instrument following its installation and as requested (Industry Standard).

SECTION 508 STANDARD COMPLAINCE

Deliverables shall conform to 36 CFR Part 1194.41, "Information, Documentation and

Support," and 36 CFR Part 1194.24 "Video and Multimedia Products" which are of particular importance with regard to all written, graphical or broadcast, video materials or products produced for HHS (to include training). 36 CFR Part 1194.41 outlines the requirements supporting services for products accommodating the communication needs of end-users with disabilities. The deliverables shall be provided in Microsoft Word and

Adobe PDF formats and compatible with versions currently used at FDA.

C.A. Section 508

This language is applicable to Statements of Work (SOW) or Performance Work

Statements (PWS) generated by the Department of Health and Human Services (HHS) that require a Contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The

Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation

(FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information

Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at

Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition

Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - shall conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All Contractors (including Subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site shall comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the Contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS:

Subpart B, 1194.21 - Software Applications and Operating Systems

Subpart C, 1194.31 - Functional Performance Criteria

Subpart D, 1194.41 - Information, Documentation, and Support http://www.access-board.gov/ http://www.acquisition.gov/ http://www.section508.gov/

D. DELIVERY ADDRESS

Ship the equipment to the following location:

U.S. Food and Drug Administration’s

10903 New Hampshire Ave

Silver Spring, Maryland 20993

FOB: Destination Inspection/Acceptance: Destination

E. DELIVERY DATE/

Delivery and install of equipment 60 days after award

F. LINE ITEM AND PRICES:

Description Quantity PRICE

Line Item 1

Wide Field

Fluorescence Inverted

Microscope

1 Each $

Total:

Provide a fixed price quote in accordance with the Statement of Work identified and the above template for the pricing in Section F.

G. GENERAL INFORMATION

For all on-site maintenance, the Contractor’s personnel are required to report to the security guards at the and who shall contact the TPOC or his/her designated FDA employee.

The Contractor’s personnel shall be escorted by the TPOC or his or her designated FDA employee at all times while working on-site under this order.

The Contractor shall perform all on-site maintenance service during the hours of 9:00 am to 5:00 pm ET, Monday through Friday, unless otherwise indicated by the TPOC.

H. SECURITY AND PRIVACY

H.1. 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:

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

a. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) shall 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.

3) 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:

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

1. 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.

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

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

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA 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. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA 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 FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the

TPOC or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

4) 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, Appendix C, and based on information provided by the ISSO 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 Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[ x ] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the 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: [ ] Low [ ] Moderate [ ]

High

5) 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:

http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. 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

d. Returned to FDA 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 and the FDA IS2P Appendix T:

Sanitization of Computer-Related Storage Media.

6) 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.

7) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA 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 FDA 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 FDA policies. Unauthorized disclosure of information shall be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

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

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

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

8) 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).

9) 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.

10) Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

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

a. Comply with the HHS Standard for Encryption of Computing Devices and

Information to prevent unauthorized access to government information.

b. 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.

c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-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).

d. Verify that the encryption solutions in use are compliant with FIPS 140-2. The

Contractor shall provide a written copy of the validation documentation to the

COR.

e. 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 (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

12) 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 FDA non-disclosure agreement (3398 Form), as applicable.

A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

13) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The

Contractor shall assist the procuring activity representative, program office and the FDA http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf

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.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M-03-22, Guidance for

Implementing the Privacy Provisions of the E-Government Act of 2002. The

PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC)

/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.

H.2 Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable

FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract.

Thereafter, the employees shall complete FDA 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 and FDA training policies.

2) 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 and FDA policy and FDA Role-Based

Training (RBT) of Personnel with Significant Security Responsibilities Standard

Operating Procedures (SOP).

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA 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.

H.3 Rules of Behavior

1) 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.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA 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 FDA

Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

H.4 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)/FDA SMC

/Incident Response Team (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 cybersecurity 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 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:

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

2) 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 FDA approved notifications to affected individuals as directed by FDA’s SOP.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, 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 of discovery/detection, and consistent with the applicable FDA 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:

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

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

and

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

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of

Personally Identifiable Information and HHS and FDA incident response policies when handling PII breaches.

5) 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 demand.

H.5 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:

H.6 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.

Roster. 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 shall develop, have the ability to access, or host and/or maintain a government information system(s). The roster and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction.

Any revisions to the roster as a result of staffing changes. The COR shall notify the

Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government shall determine the appropriate suitability level.

H.7 Contract Initiation and Expiration

1) 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 FDA EPLC framework and methodology 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

2) 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.

3) 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 FDA OAGS SMGs to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR as soon as it is known that an employee shall stop working under this contract.

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and

IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or FDA policies.

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, coping the Contract Specialist, to ensure that the appropriate person performs and http://www.hhs.gov/ocio/ea/documents/proplans.html documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSyste m/default.htm as soon as it is known that an employee shall terminate work under this contract within days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

H.8 Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and

HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

H.9 ISSO – Section 6 (Other IT Procurements)

1) Card Readers. The Contractor (and/or any subcontractor) shall include Federal

Information Processing Standard (FIPS) 201-compliant smart card (access card) readers

(referred to as LACS Transparent Readers) with the purchase of servers, printers, desktops, and laptops.

2) Mobile Devices. The contractor shall follow FDA security requirements and NIST 800-

124, Rev. 1, Guidelines for Managing the Security of Mobile Devices in the Enterprise when using mobile devices that process or store FDA data

I. FDA 1335 Personnel Security Clearance Requirements

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human

Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who shall be working in a DHHS-owned or leased space and/or who shall have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who shall be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm

Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

a. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in the paragraph above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA

Personnel Security Office, the Government shall conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA

Personnel Security Office shall be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees shall be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of

Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk levels for this contract are Non-Sensitive Positions (Level 1).

There are two (2) potential position risk levels, which are:

Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive

Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge shall be required to provide additional security information for a background investigation as specified in

Paragraph 5 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned

Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel

Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel

Security Specialist shall use this information to initiate each Contractor employee into the e-QIP system.

Once this is done, each Contractor employee shall receive an email that contains a web link to access the e-

QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Project Officer for the contract shall provide the name of the appropriate Personnel

Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines shall result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

3. BADGING PROCESS

The FDA Project Officer shall sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a

"favorable" fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten

(10) days prior to the commencement of work. Fingerprints shall be submitted in one of two ways, depending on where the contract shall be performed:

Contractor employees who shall work in the Washington D.C. metro area shall, at the direction of the FDA

Project Officer or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who shall work in a field office shall submit fingerprints to:

Food and Drug Administration

Fingerprinting and Personnel Security Office

10903 New Hampshire Avenue, Building 1, Room 1201

Silver Spring, MD 20993

Upon the receipt of a "favorable" fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form

3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk

Levels 1, 5 and 6 serving under this contract.

Required background investigations may include, but not be limited to:

Review of prior Government/military personnel records;

Review of FBI records and fingerprint files;

Searches of credit bureaus;

Personal interviews; and

Written inquiries covering the subject's background.

Background investigations shall be conducted by the Office of Personnel Management (OPM).

http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all

Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug Administration

Badging and Credentialing Office

10903 New Hampshire Avenue, Building 1, Room 1201

The contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The contractor shall advise its prospective employees that all standard forms submitted to the FDA shall be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff shall resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel

Security Staff of the details of such clearances to determine if a…