75F40126R00020_OSIST_Draft RFP.pdf

75F40126R00020 / OC-2026-132216

Request for Proposal FDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST)

SECTION A - SOLICITATION/CONTRACT FORM (SF-1449)

This solicitation uses Standard Form 1449 (SF-1449), Solicitation/Contract/Order for Commercial Products and Commercial Services.

SAM.gov Registration Conflict Statement:

By submission of an offer, the Offeror acknowledges the requirement that a prospective awardee must be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract resulting from this solicitation.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Contract Pricing

The Standard Form 1449 represents the contract line-item number (CLIN) structure for this Indefinite Delivery Indefinite Quantity (IDIQ) contract. Individual task orders issued under this IDIQ may be firm-fixed-price, time-and-materials, labor-hour, or a combination thereof, as specified in each task order.

The negotiated hourly rates, services, profit, overhead, and general and administrative as reflected in the U.S. Food and Drug Administration’s Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) Pricing Structure will be incorporated into the award.

B.1.1 Labor Rates

The Contractor’s proposed labor rates, as set forth in Attachment C3 (Price_Workbook, Tab 1), shall serve as fully-burdened ceiling rates for labor hour and time-and-materials task orders issued under this IDIQ. These rates include all direct labor, indirect costs, overhead, general and administrative expenses, and profit.

Rate Escalation: Offerors shall propose labor rates in Attachment C3 by ordering period (Year 1, Year 2, Year 3, Year 4, Year 5). Rates may escalate between ordering periods but remain fixed within each ordering period. Once proposed and accepted, these rates become the ceiling rates for that ordering period and apply to all labor hour and time-and-materials task orders issued during that period.

B.1.2 Equipment Recertification and Decontamination Rates

The Contractor’s equipment recertification and decontamination rates, as set forth in Attachment C3 (Price_Workbook, Tab 2), are incorporated into this contract and shall serve as fully burdened ceiling rates for annual equipment recertification and associated decontamination services performed under this IDIQ.

These rates include all direct and indirect costs required to perform the services, including labor, supervision, tools, minor materials, documentation, calibration of test instruments, travel (unless otherwise specified at the task order level), overhead, general and administrative expenses, and profit.

Rate Structure: Rates are established as fixed unit rates by equipment category, service type, and ordering period (Year 1 through Year 5), as specified in Attachment C3.

Two primary rate groupings apply:

a. Annual Equipment Recertification Rates: Rates represent the total cost to perform required inspection, testing, verification, and documentation necessary to maintain compliance with applicable standards and certification requirements on an annual basis.

b. Decontamination Service Rates: Rates represent the total cost to perform equipment, room, or laboratory decontamination services (e.g., VHP or equivalent methods), including setup, execution, monitoring, and documentation of decontamination effectiveness.

Scope of Rates

Included:

• Annual certification testing, inspection, and verification

• Documentation, reporting, and certification records

• Calibration of testing instruments

• Minor adjustments necessary to achieve compliance

• Decontamination services, including:

o Equipment and laboratory decontamination o Placement and analysis of biological/chemical indicators o Documentation of decontamination results.

Excluded:

• Major repairs, system replacement, or capital upgrades

• Replacement parts or consumables exceeding task order thresholds

• Corrective actions requiring significant engineering modification.

Excluded items shall be addressed at the task order level (e.g., Other Direct Costs (ODCs) or separate CLINs).

Rate Applicability: These rates apply to labor-hour (LH) and time-and-materials (T&M) task orders requiring recertification and/or decontamination services.

For firm-fixed-price (FFP) task orders, these services shall be included in the total fixed price unless separately priced in the task order.

Rate Escalation: Rates are fixed within each ordering period and may escalate only between ordering periods as specified in Attachment C3. Rates established for an ordering period are ceiling rates for that period.

Adjustments: No adjustments to these rates are permitted during an ordering period unless expressly authorized elsewhere in the contract.

B.2 Task Order Pricing

Task orders issued under this IDIQ contract may use different pricing arrangements as specified in each task order:

(a) Firm-Fixed-Price (FFP): Fixed total price for specified scope of work

(b) Time-and-Materials (T&M): Ceiling hourly rates × actual hours worked

(c) Labor-Hour (LH): Ceiling hourly rates × actual hours worked

(d) Unit Pricing: Fixed unit rates × actual quantities delivered

(e) Combination: A task order may combine multiple pricing types

The Contractor’s proposed ceiling labor and service rate (for T&M and LH work) are incorporated in Attachment C3 and shall apply to all task orders requiring labor-hour or time-and-materials pricing.

These ceiling rates may not be exceeded without a contract modification approved by the Contracting Officer.

B.3 Minimum Guarantee and Maximum Dollar Ceiling (Master Contract)

The guaranteed minimum amount to be ordered under the contract is the obligated base period of the first task order. The contract maximum is $14,500,000 inclusive of all ordering periods.

B.4 Funding

Funds for the services provided will be obligated at the task order level as they become available. Each order will specify the amount presently available for payment by the Government and allotted to the contract line items included.

Except as required by other provisions of this IDIQ and the associated Task Orders, specifically citing and stated to be an exception to this term—

The Government is not obligated to reimburse the Contractor for costs incurred in excess of the total amount allotted by the Government to the Task Order(s); and

The Contractor is not obligated to continue performance under the contract (including actions under the Termination clause) or otherwise incur costs in excess of the amount then allotted to the Task Order(s) by the Government.

The Government may de-obligate funds as long as funds are still available in the task order for Contractor’s continuing performance.

B.5 Ordering

Any supplies and services to be furnished under the contract shall be ordered by issuance of task orders by the Contracting Officer. Such orders may be issued from date of award until expiration of the contract.

All task orders (TOs) are subject to the terms and conditions of the contract. In the event of conflict between a task order and the contract, the contract shall control.

A task order is considered “issued” when distributed via email to the Contractor’s email address.

B.6 Applicable Labor Categories and Contractor Furnished Property/Services

B.6.1 Labor Categories The labor categories, equipment certification and repair rates, and associated fully burdened hourly rates in Attachment C3 shall be used by the Contractor to develop task order pricing proposals and to invoice for time-and-materials and labor-hour task orders.

B.6.2 Contractor-Furnished Property and Services Unless a task order specifically identifies items as Government-furnished, the Contractor shall provide all property, equipment, tools, materials, supplies, and services required for performance at no additional cost to the Government.

B.7 Wage Determination Price Adjustments

Service Contract Labor Standards (SCLS) are not applicable to this contract. Accordingly, FAR 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts), does not apply, and no price adjustments based on Department of Labor wage determinations shall be authorized.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 IDIQ Performance Work Statement (PWS)

The Performance Work Statement (PWS) for this Indefinite-Delivery/Indefinite-Quantity (IDIQ) contract is provided as Attachment C1 – OSIST IDIQ PWS.

The IDIQ PWS establishes the enterprise-level scope, performance standards, and integrated service requirements for Occupational Safety, Policy, and Laboratory Quality Support services to be performed across FDA headquarters and nationwide laboratory and field facilities.

The IDIQ PWS defines the overarching framework for all work performed under this contract, including:

• Program objectives supporting the FDA Occupational Safety and Health (OSH) mission

• IDIQ-level program management and governance requirements

• Task Areas, including:

o Program and Order Management o Transition Services o Occupational Safety, Policy, and Laboratory Quality Support o Primary Barrier Equipment Maintenance and Certification o Industrial Hygiene Support Services o Information and Data Systems Support o Training Development and Management

• Enterprise-wide performance requirements and service expectations

• Deliverables and reporting requirements (e.g., Monthly Status Reports, technical reports, certification documentation)

• Quality control and quality assurance requirements

• Applicable regulatory, safety, and technical standards (e.g., OSHA, ANSI/ASSP Z10, NSF/ANSI 49, ISO, BMBL)

All task orders issued under this IDIQ shall be within the general scope and task areas defined in the IDIQ PWS.

C.2 Task Order Performance Work Statements (TO PWS)

Work under this IDIQ shall be ordered through the issuance of individual task orders. Each task order shall include a Task Order Performance Work Statement (TO PWS) that defines the specific scope, technical requirements, deliverables, performance standards, and place of performance applicable to that order.

Task Order 1 – CBER BSL-3 Annual Re-Verification

Attachment R1 provides the Performance Work Statement for Task Order 1 – CBER BSL-3 Annual Re-Verification and Decontamination Services.

Task Order 1 includes, but is not limited to:

• BSL-3 laboratory re-verification and certification support

• Primary barrier equipment evaluation and certification validation

• Heating, Ventilation, and Air Conditioning (HVAC) airflow and pressure differential testing, including failure scenario testing

• Vaporized hydrogen peroxide (VHP) decontamination services

• Biosafety compliance assessments aligned with CDC, NIH, USDA/APHIS, and applicable federal standards

• Deficiency identification, corrective action evaluation, and reporting

• Preparation of draft and final verification reports and certification documentation

Additional Task Orders

Future task orders may encompass any of the task areas defined in the IDIQ PWS, including but not limited to:

• Occupational safety and laboratory quality support services

• Primary barrier equipment maintenance, repair, and certification

• Industrial hygiene assessments and program support

• Information and data management system support

• Training development and delivery

• Policy, compliance, and programmatic support services

Task orders may be issued with varying levels of scope definition and may include firm-fixed-price, labor-hour, time-and-materials, or hybrid pricing arrangements, as specified in each task order.

C.3 Relationship Between IDIQ PWS and Task Order PWSs

The IDIQ PWS (Attachment C1) establishes the overall scope, framework, and performance requirements for this contract.

Task Order PWSs establish the specific requirements and performance obligations for individual task orders.

In the event of a conflict between the IDIQ PWS and a Task Order PWS:

• The Task Order PWS shall govern the specific task order; however,

• The IDIQ PWS shall govern overall contract scope and requirements, unless otherwise determined by the Contracting Officer.

Any inconsistencies or ambiguities shall be resolved by the Contracting Officer through written clarification or contract modification.

SECTION D – PACKAGING AND MARKING

Not applicable. Services are being acquired under this contract.

SECTION E – INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance

Services performed under this contract are subject to inspection and acceptance by the Government in accordance with FAR 52.246-4, Inspection of Services—Fixed-Price, and FAR 52.246-6, Inspection—Time-and-Material and Labor-Hour (as applicable based on task order type).

All services shall be performed in accordance with the requirements specified in the IDIQ Performance Work Statement (Attachment C1) and individual Task Order Performance Work Statements.

Performance Requirements Summary (PRS):

Individual task orders will include a Performance Requirements Summary (PRS) that establishes: - Specific performance objectives and standards for that task order - Acceptable Quality Levels (AQLs) for measurable performance metrics - Surveillance methods the Government will use to monitor performance - Consequences for not meeting performance standards.

The PRS is incorporated into each task order and serves as the basis for the Government’s quality assurance surveillance.

E.2 Contracting Officer’s Representative (COR)

A Contracting Officer’s Representative (COR) will be designated in writing for technical monitoring and acceptance of services. The COR will: - Monitor Contractor performance against PRS requirements - Conduct quality assurance surveillance as specified in the task order PRS - Accept or reject deliverables and services - Document performance issues and recommend corrective actions.

The COR does not have authority to modify contract terms, pricing, or scope.

E.3 Acceptance

Services will be accepted when the COR determines that: - All work has been performed in accordance with contract requirements - Performance meets or exceeds the standards specified in the task order PRS - All deliverables have been submitted and approved - Any deficiencies have been corrected to the Government’s satisfaction.

Acceptance may be on a deliverable-by-deliverable basis, monthly basis, or upon completion of the entire task order as specified in the individual task order.

SECTION F – DELIVERIES OR PERFORMANCE

F.1 Period of Performance

F.1.1 IDIQ Contract Ordering Period

The ordering period for this IDIQ contract is five (5) years from the date of contract award.

During this ordering period, the Contracting Officer may issue task orders for services within the scope of this contract.

The ordering period represents the period during which task orders may be issued, not the period during which task orders must be completed.

For purposes of this contract, “date of contract award” means the date the Contracting Officer signs the SF 1449 contract document in Block 27c (Award).

F.1.2 Task Order Performance Periods

Individual task order periods of performance will be specified in each task order and are subject to the following constraint:

No individual task order (inclusive of all option periods for that task order) may exceed five (5) years in duration from the date of task order issuance.

Task orders may be issued at any time during the IDIQ ordering period and may continue performance after the ordering period expires, provided the task order performance period does not exceed five (5) years from task order issuance.

F.1.3 Contract Expiration

Upon expiration of the five-year IDIQ ordering period, no new task orders may be issued.

However, task orders issued prior to expiration shall continue in accordance with their specified performance periods.

F.2 Place of Performance

F.2.1 Primary Place of Performance

The primary place of performance for services under this IDIQ contract is:

FDA Headquarters – White Oak Federal Research Center 10903 New Hampshire Avenue Silver Spring, MD 20993

F.2.2 Additional Locations

Individual task orders may specify additional or alternative performance locations within the Washington DC metropolitan area or at other FDA nation-wide facilities as required. Refer to Attachment C2 for OSIST locations.

F.2.3 Contractor Personnel Access

Contractor personnel requiring access to FDA facilities must comply with all security, badging, and credentialing requirements specified in Section H.1 and in individual task orders.

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 Contracting Officer

The Contracting Officer for this contract is:

L. Maria Finan Contracting Officer U.S. Food and Drug Administration Email: Linda.Finan@fda.hhs.gov

The Contracting Officer is the only person authorized to: - Modify contract terms, scope, or pricing - Issue task orders under this IDIQ - Make commitments or expenditures of Government funds - Approve Key Personnel substitutions or changes.

G.2 Contract Specialist

The Contract Specialist for this contract is:

Sheneil Green Contract Specialist U.S. Food and Drug Administration Email: Sheneil.Green@fda.hhs.gov

The Contract Specialist assists with contract administration but does not have authority to modify contract terms or obligate Government funds.

G.3 Contractor Points of Contact

The Contractor shall designate and provide contact information for the following positions within five (5) business days of contract award:

(a) Primary Contract Administrator: Individual authorized to receive official correspondence, task orders, and modifications from the Contracting Officer

(b) Program Manager: Key Personnel position responsible for overall contract performance and coordination with the COR

(c) Alternate Contacts: Individual authorized to act in the absence of the Primary Contract Administrator and Program Manager.

Contact information shall include: name, title, phone number, email address, and mailing address.

G.4 Contracting Officer’s Representative (COR)

A Contracting Officer’s Representative (COR) will be designated in writing in accordance with RFO FAR Part 1. The COR is responsible for technical monitoring of the Contractor’s performance. The COR does not have authority to change contract terms or prices.

COR Designation and Communication:

The Contracting Officer will designate the COR in the contract award.

The COR serves as the primary day-to-day technical point of contact for contract performance.

COR Authority Limitations: The COR does NOT have authority to: - Modify contract terms, pricing, or period of performance - Issue task orders - Approve changes that affect contract cost or scope - Make commitments that obligate Government funds beyond existing task orders.

G.5 Government Property

The Government will not provide property or equipment to the Contractor except as specifically identified in individual task orders.

G.6 Invoice Submission

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973- 3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301- 827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

G.7 Notification Requirements

The Contractor shall provide written notification to the Contracting Officer and COR for the following events:

(a) Key Personnel Changes: At least 30 calendar days advance notice for planned changes;

24 hours for emergency changes (per Section H.3)

(b) Change in Business Structure: Within 30 days of any merger, acquisition, sale, change of name, change in ownership, or change in business structure

(c) Financial Difficulties: Immediate notification of any bankruptcy filing, receivership, or financial condition that may impact contract performance

(d) Subcontractor Changes: At least 15 days advance notice of any changes to major subcontractors identified in the proposal

(e) Safety or Security Incidents: Immediate notification of any serious safety incidents, security breaches, or events that may impact Government personnel or property

Performance Issues: Immediate notification of any circumstances that may prevent the Contractor from meeting performance requirements or deadlines.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 Security and Background Investigation Requirements

All Contractor personnel requiring access to FDA facilities must undergo background investigations.

Background investigations will be conducted by the Defense Counterintelligence and Security Agency (DCSA) in accordance with FDA Security Clearance Standards (See Attachment C4).

The Risk Designation for this contract is Tier 1

H.2 Information Security Requirements

The Contractor shall comply with all FDA information security requirements, NIST cybersecurity framework, Federal Information Processing Standard (FIPS) and FDA IT security policies and procedures - Incident reporting requirements as referenced below.

H.2.1 FDA Information Security and/or Physical Access Security (May 2022)

1. Baseline Security Requirements

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

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

ii. 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 FDA 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.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with FDA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

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.

ii. Categorize all information owned and/or collected/managed on behalf of FDA and information systems that store, process, and/or transmit FDA information 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. Based on information provided by the System/Data Owner, ISSO, privacy representative, or other POC, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: [X] Low [ ] Moderate [ ] High Integrity: [ ] Low [X] Moderate [ ] High Availability: [X ] Low [ ] Moderate [ ] High Overall Impact Level: [ ] Low [X] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of FDA regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s). This includes notifying the FDA Cybersecurity and Infrastructure Operations Coordination Center (CIOCC) within one (1) hour of discovery/detection in the event of a cybersecurity or privacy incident.

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the 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 Protection (IS2P) policy, by contacting the CO/COR or emailing your ISSO.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailored FAR and HHSAR clauses as needed.

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

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable FDA privacy policies and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally

Identifiable Information (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.

ii. Based on information provided by the ISSO, System/Data Owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [X ] PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed.

If the results of the PTA show that a full PIA is needed, the Contractor must support the agency 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).

The Contractor must support the agency 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.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

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

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for 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

iv. Returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800- 88, Guidelines for Media Sanitization.

f. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Government Furnished Equipment (GFE) for Foreign Travel. FDA personnel are prohibited from taking GFE when participating in personal, unofficial travel to foreign countries. FDA personnel are strictly prohibited from teleworking using GFE in foreign countries. FDA personnel must also request loaner GFE from the FDA Foreign Travel program for official travel to any foreign country. Please see the FDA IS2P, Appendix T Government Furnished Equipment for Foreign Travel.

h. 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must 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 must 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 must be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS and FDA sanction policies and/or governed by the following laws and regulations:

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

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

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

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

j. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

k. 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 must 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, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

l. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents to comply with contract deliverables as appropriate.

m. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

Information to prevent unauthorized access to government information.

ii. 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 an encryption solution that is validated with current FIPS 140 validation certificates from the NIST

CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices 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).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificates from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. 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 http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

n. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the FDA non-disclosure agreement (3398 Form)], as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable FDA information security awareness, privacy, and records management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete FDA information security awareness, privacy, and records management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. 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.

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

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users, and FDA policies and standards.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Agency 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 above.

http://csrc.nist.gov/publications/

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of

Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA CIOCC/Incident Response Team 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. In accordance with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "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" and a privacy breach is "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." For additional information on the HHS breach response process, please see the FDA IS2P Appendix F: Incident Response and the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

ii. 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 must send FDA approved notifications to affected individuals as directed by FDA’s SOP.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the FDA CIOCC, COR, CO, FDA SOP (or his or her designee), and other stakeholders, including breaches 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 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, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

Cooperate and exchange any information, as determined by the

Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

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

Encrypt sensitive information in attachments to email, media, etc.

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

v. 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 on demand.

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 (e.g. tier 1, 2, or 4): Tier 1

6. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster

The Contractor (and/or any subcontractor) must 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 must 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 must be submitted within a timeline as directed by the COR and/or CO. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

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

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must 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 must follow the FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here:

http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCH ome.aspx and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, 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.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation in accordance with SMGs published by FDA’s Office of Acquisitions and Grant Services (OAGS) to the CO and/or COR to certify that, at the…