Attachment A SOW.pdf

REQUEST FOR QUOTE

INTERNET MONITORING SERVICES

SOLICITATION NUMBER: 75F40124Q00348

ATTACHMENT A

STATEMENT OF WORK – INTERNET MONITORING SERVICES

1.0 BACKGROUND

FDA is responsible for regulating products to ensure the safety of foods, prescription and over-the-counter drugs, biological products such as vaccines and blood, medical devices, cosmetics, radiation-emitting products, and more.

Since 1993, Office of Criminal Investigation (OCI) has investigated thousands of criminal schemes involving the distribution of potentially dangerous FDA-regulated products. These investigations have involved a wide variety of criminal conduct, including street level distribution of counterfeit, unapproved, and designer drugs, major organized illicit diversion of prescription drugs, fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures, large scale product substitution conspiracies, application and clinical investigator fraud, and health frauds involving harmful FDA-regulated drugs and medical devices. As FDA’s criminal law enforcement arm, OCI protects the American public by conducting criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution.

The Food and Drug Administration (FDA) requires contractor support to further its on-going efforts to counter the widespread illicit trafficking and/or marketing of FDA-regulated products over the Internet. These products include prescription drugs; dietary supplements; tobacco; medical devices; blood and biologics; vaccines;

cosmetics; radiation-emitting products; animal and veterinary medicines; and foods.

2.0 OBJECTIVE

The objective of the Internet Monitoring Program is to support protecting the public health by obtaining Internet analysis support services to assist FDA in identifying illegal marketing and/or sale of FDA-regulated products via the Internet including, but not limited to, websites, social media platforms, and chat/messaging services.

The contractor shall provide monitoring of the Internet to capture relevant data, as well as the targeting of:

A. Illicit pharmaceutical and active pharmaceutical ingredient (API) websites, operators, and facilitators. This includes instances where prescription drugs and/or API are being offered for sale in any manner which would violate Federal law.

B. Illegal/unapproved medical device websites, operators, and facilitators. This includes medical devices that are not approved for use in the United States by the FDA, are stolen, or expired.

C. Illicit tobacco product websites, operators, and facilitators. This includes the sale of flavored cigarettes to US-based consumers, as well as the sale of tobacco products by entities not licensed to sell such products (located both domestically and/or internationally), or any other activities which would violate Federal law.

D. Illicit food and/or dietary supplement websites, operators, and facilitators. This includes the sale of dietary supplements which contain undeclared ingredients or are not approved for use/sale in the United States by the FDA. This also includes the sale of food products which may be potentially harmful to consumers (i.e., counterfeit, stolen, adulterated, etc.).

E. Illicit cosmetics websites, operators, and facilitators. This includes the sale of counterfeit, unapproved, misbranded or adulterated cosmetic products intended for sale to individuals in the United States.

F. Illicit animal and veterinary product websites, operators, and facilitators. This includes the sale of counterfeit, unapproved, misbranded or adulterated veterinary products intended for sale to consumers in the United States.

G. Illicit vaccine, blood and / or biologics websites, operators, and facilitators. This includes the sale of stolen, counterfeit, unapproved, adulterated and/or misbranded vaccines, blood and/or biologic products regulated by the FDA.

H. Illegal / unapproved medical device and radiation-emitting product websites, operators, and facilitators.

This includes medical devices and/or radiation-emitting products that are not approved for use in the United States by the FDA, are stolen, or expired.

I. Other Internet entities not detailed above, such as Registrars, Web host providers, transaction launders and others actively involved in or facilitating illicit activities associated with the manufacturing, sale, marketing and/or distribution of FDA-regulated products.

3.0 REQUIREMENTS

4a. Contractor Requirements

A. The contractor shall have the ability to collect and analyze data associated with the above-mentioned entities in section two (2) which may result in the identification of specific trends/patterns of the activities of the individuals engaging in illegal activities. These patterns may include usage of specific domain name registrars and web hosting services (either domestically or abroad) and the ability to collect and maintain historical data on networks of rogue internet-based sellers of FDA regulated products.

B. Regarding the monitoring of activities, the contractor shall have the ability to report on an established basis of new trends/emerging threats. This monitoring shall include identifying vendors/networks engaged in the sale of the identified emerging threat substance.

C. The contractor shall have the ability to assess the status of an online seller on leads provided by OCI. The contractor shall have the ability to assess a lead and make an educated determination if the vendor is selling products or is running a non-delivery type scam and be able to justify this assessment with evidence of why the contractor made a particular determination.

D. The Contractor shall possess an archive of research data that contains at least five (5) years of web artifacts about illegal sales of FDA regulated products. These data can be leveraged to provide historical context when creating reports for OCI requests.

E. The Contractor shall maintain all production reports for the duration of the order to include images/catalogs of products and web pages. The archived production reports shall serve as a reference to demonstrate any changes to product labeling, availability and/or medical claims.

F. Primarily the contractor will be proactively and reactively monitoring the open internet as directed by FDA-OCI staff in writing or verbally. Monitoring activities may change frequently based on emerging threats and trends. Therefore, the contractor must be prepared to be flexible and have the capacity to quickly modify their search efforts within 24hrs of notification. The Government anticipates that the contractor will monitor a maximum of 10,000 websites annually.

4b. Description of Tasks (Task Areas)

Task Area 1 – Project Management

A. Program Management Plan (PMP)

1. The Program Management Plan is an evolutionary document that describes the proposed management approach and includes the following:

a. A baseline for this contract after the FDA has had an opportunity to comment.

b. Detailed Standard Operating Procedures (SOPs) for all tasks.

c. Milestones, tasks, and subtasks required in this contract.

d. An overall Work Breakdown Structure (WBS) and associated responsibilities and partnerships between Government organizations.

2. During completion of the PMP, the Contractor shall consult with and advise the COR in tailoring and mapping various project management artifacts/documents to ensure adequate visibility, accountability, and compliance.

3. Contractor shall provide the Government with an updated PMP template within two (2) weeks after the Kick-Off meeting. The FDA will have an opportunity to comment and provide necessary changes, if necessary.

4. Contractor shall update and present the PMP monthly for FDA approval.

B. Kickoff Meeting: The contractor shall participate in a kickoff meeting with the COR within one week of contract period of performance start date.

C. Status Meetings: The Contractor shall interact with the COR telephonically or virtually on an ongoing basis at least once a month to discuss Data Form Reports (work product results) or other issues within this Scope of Work. This interaction can also be accomplished by providing the COR with a status report for work completed during the past 30 days.

D. Monthly Status Reports (MSR): The Contractor shall provide a MSR using MS Office Suite applications, by the 10th of each month via electronic mail to the FDA COR. The report shall include the following:

1. Activities during reporting period, by task (including: on-going activities, new activities, activities completed; progress to date on all above-mentioned activities);

2. Monthly result of deconfliction efforts;

3. Problems and corrective actions taken. Also include issues or concerns and proposed resolutions to address them;

4. Personnel gains, losses and status;

5. Government actions required;

6. Schedule (shows major tasks, milestones, and deliverables; planned and actual start and completion dates for each);

7. Any change request and level of efforts; and

8. Accumulated invoiced cost for the previous month.

Task Area 2 – Informational Requests

A. Initial Information Requests

1. Upon an Initial Information Request from FDA-OCI the contractor shall attempt to determine, to the best of their ability, if the target of FDA request is a viable vendor of FDA regulated products or is operating a non-delivery type scheme. If the contractor can reasonably determine that the vendor is indeed operating a non-delivery scam this information shall be relayed back to FDA. The FDA will then decide on whether a full report on the target is required or if the request will be forwarded to another law enforcement agency and can be closed out.

2. The contractor shall attempt to determine if an affiliate network exists, or a viable target can be identified. If so, the contractor shall document the size and scope of the operation, including any affiliate network. An initial report regarding the target and/or affiliate network and relevant data and statistical information shall be provided to FDA-OCI within ten (10) business days, and shall indicate if the identification process has been completed, or will require additional time to be completed. If additional time is required, the contractor shall submit the final report within fourteen (14) days from the submission of the initial report.

3. Upon an Initial Information Request from FDA-OCI, the contractor shall provide to FDA-OCI a report highlighting relevant data and statistical information on any website, affiliate network, social media presence, online chatter, email address, IP address of any other cyber-related request for information.

4. The following relevant and statistical data shall be submitted in a format subject to FDA-OCI approval (primarily PDF and Database Reports) for inspection:

a. Website domain names

b. Social Media/blogging presence

c. IP address for each identified URL

d. Name server utilized for each URL

e. Mail exchange server utilized for each URL

f. WhoIs information to include IP address, Registrar, Registrant and Web host

g. Geographical identification of website

h. Associated affiliate network

i. Anchor site for each identified network

j. Sub-networks identified

k. FDA-regulated product(s) offered for sale

l. Source of supply, when identified

m. Methods of payment accepted

n. Point-of-contact information identified on website; i.e., email addresses, telephone numbers; fax numbers

o. Merchant processor and merchant acquirer information, when identified

p. Results of deconfliction efforts

q. Online reviews/chatter concerning a target website/product

r. Identification of website owner/operator if possible

5. The contractor shall provide a maximum of 500 Initial Informational Reports (which may include other associated attachments [i.e., spreadsheets, etc.]) annually under the scope of this contract.

B. Secondary Informational Requests

1. After review of the Initial Informational Request, FDA-OCI will determine if it is necessary for the contractor to provide a further analysis of their findings via a Secondary Informational Request.

2. The Secondary Informational Requests shall provide a strategic overview of the individual project request and shall highlight significant findings and matters of concern related to the illegal marketing, trafficking, and/or sale of FDA-regulated products. The specific information requested will be defined by the COR.

3. The report shall be prepared through detailed analysis of the information obtained by the contractor in the Initial Information Request in conjunction with any additional information which may be supplied by FDA-OCI in support of the request.

4. The request shall be designed to provide FDA-OCI with a focused discussion of key issues and developments associated with the request as defined by the COR.

5. OCI does not anticipate more than 200 Secondary Informational Requests will be needed annually.

6. The Secondary Informational Request is not considered to be included in the 500 Initial Informational

Request report maximum limit and is considered supplemental information to the data form report.

C. Straw Purchases – At the direction of FDA-OCI, the contractor shall:

1. Conduct a maximum of 200 straw purchases annually from websites in an effort to identify the purchase process and the movement of funds.

2. Straw purchases shall be conducted with "zero balance" credit cards, which will allow the contractor to complete the straw purchase.

3. While the transaction will ultimately be declined by the credit card company, the straw purchase shall allow for FDA-OCI to identify the Internet payment service provider, merchant processor and/or involved financial institution(s).

4. FDA-OCI will provide the "zero balance" credit cards to the contractor, which shall be used exclusively for and at the direction of FDA-OCI. These shall remain the property of FDA-OCI and shall be returned to FDA-OCI within 24 hours of request.

5. There shall be no costs incurred by FDA-OCI or the contractor associated with straw purchases.

6. Straw purchases shall be conducted as a part of an Initial Information Request or a Secondary

Information Request. Details regarding the straw purchase will be included in either the Initial or Secondary Information Request.

D. Deconfliction Services

1. The contractor must establish a system to notify the COR of any instances where an Initial

Information Request involves or is related to a previous Initial or Secondary Information Request.

2. All Initial and Secondary Data Form requests must undergo internal deconfliction.

3. Upon written or verbal authorization from the COR, the contractor must securely deconflict information contained in Initial and Secondary Data Form Requests with other federal law enforcement agencies or relevant private-sector stakeholders as directed by the COR.

Task Area 3 – Special Projects

A. As requested by the COR, the Contractor shall provide services for Special Projects related to internet monitoring services provided.

1. Occasionally, the COR will request research be conducted pursuant to a special project or operation.

This may include requests related to incidents of national security.

2. These requests can involve searching for emerging threat products identified by OCI to determine the number of online sellers, identification of the top sellers, chatter concerning the identified product/s and the locations these products are offered for sale. This can also include ongoing monitoring for identified emerging threat products.

3. OCI anticipates that the number of these special requests will not exceed 15 per calendar year.

4. This task shall be included in the firm fixed price of this contract.

4.0 DELIVERABLES

The Contractor shall deliver the following to the Contracting Officers Representative (COR) on a yearly basis except for those indicated otherwise:

Description of Deliverable Frequency Quantity Due Date

Contract kickoff Meeting

(Base period only)

Once 1 To be scheduled within one week of contract POP start date.

Program Management Plan Monthly 12 Initial PMP due fourteen (14) days after contract kick-off meeting. Updated monthly PMP due by the 10th day of each month.

Status Meetings with COR At Least Monthly

12 As scheduled with the COR

Monthly Status Reports

Monthly 12 By the 10th day of each month.

Initial Informational Requests Maximum Annual Amount:

As requested by the COR.

The initial report is due within 10 calendar days of the initial informational request.

Secondary Information Requests Maximum Annual Amount:

As requested by the COR.

Report for secondary requests shall be due 14 days after initial report. Priority Requests require immediate work and delivery.

Straw Purchases

Maximum

As needed in the informational requests.

As reported in Initial or secondary Information Requests.

Special Projects as requested by COR

Maximum

Up to fifteen

(15) special projects at thirty

(30) hours each

As needed and as requested by the

COR

Priority Requests require immediate work and delivery.

Security Deliverables See Section 16.3

All deliverables shall be developed using Microsoft Office products that are compatible with the versions currently utilized by the FDA. Monthly, interim, informal, and working-copy products shall be provided by email upon request by FDA CO, COR, and designated SMEs.

The Contractor shall deliver all products to the COR and other technical customers, as appropriate per policy and/or agreed upon when assigned. For the formal reports the COR or other technical staff will notify the Contractor of deliverable acceptance regarding overall compliance with the guideline’s requirements of the task.

The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction by the contractor at no additional cost to the Government. Unless specified otherwise, the COR will review and approve all deliverables, which may require multiple revisions by the Contractor prior to being finalized.

Unless specified otherwise, the Contractor shall provide a copy of each deliverable listed in DELIVERABLES section to the COR for review. The Government will review all de l iverab les and recommend any changes if necessary. If changes are required, unless specified otherwise, the Contractor shall resubmit the revised deliverable to the COR five (5) business days after receiving the Government's input, unless otherwise agreed to in advance.

5.0 KEY PERSONNEL

The following position is designated as key personnel under this purchase order. The contractor shall refer to HHSAR clause 352.237-75 Key Personnel for any required changes to key personnel.

Labor Category Project Manager

6.0 INSPECTION/ACCEPTANCE CRITERIA

Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). The Contracting Officer’s Representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement.

7.0 OTHER DIRECT COSTS (ODC)

Aside from travel, other direct costs are not anticipated under the purchase order. However, ODC’s will be included as needed under this purchase order.

ORDER ADMINSTRATION

8.0 CONTRACT TYPE

Firm-Fixed Price Purchase Order

9.0 PERIOD OF PERFORMANCE

The period of performance (POP) is for a base period of one (1) year with four (4) one-year option periods.

**Normal hours of operation shall be business hours Monday through Friday, 8am-5pm EST. However, in matters dealing with National Security and/or significant public health and safety issues, the contractor may be required to provide services outside of normal business hours to meet the timely reporting requirements specified in the deliverables table.

10.0 PLACE OF PERFORMANCE

A. The majority of contractor services shall be performed at the Contractor's Site.

B. Requests which result in the collection of large amounts of data may require the contractor to present the findings to FDA-OCI in-person at a Government site within the United States.

C. The contractor may also be required to testify in court.

11a. Federal Holidays/Government Closures

FEDERAL HOLIDAYS

The Government will not require support for the Federal Holidays listed below. Specific dates for can be found on https://www.opm.gov/.

• New Year's Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Juneteenth National Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day https://www.opm.gov/

• Christmas Day

GOVERNMENT CLOSURES

Government operating statuses for offices nationwide can be found on https://www.opm.gov/.

Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures. If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level.

In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status. If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO.

11.0 TRAVEL

Performance under this purchase order may require travel by Contractor personnel. The need for travel will be determined and accepted by the COR and CO. All travel will be managed at by the COR and CO and in accordance with the requirements set forth within the purchase order. If travel is required, the Contractor is responsible for making all needed arrangements for Contractor ’s personnel. All travel shall be in accordance with the Federal Travel Regulations (FTR) and FAR 31.205-46(a)(2). If there are any discrepancies between language under this agreement and the FTR, the FTR shall take precedence.

12.1 Local Travel

Travel performed for personal convenience or daily travel to and from work at the Contractor’s facility or local Government facility (i.e., designated work site) will not be reimbursed hereunder. Additionally, local travel within the Washington DC metro region will not be reimbursed.

12.2 Before Conducting Travel

Prior to booking or conducting Government-direct travel, the Contractor shall provide a written request for travel to the COR and CO. The Contractor ’s request for travel shall be in writing and contain the dates, locations, and estimated costs of the travel. The Contractor shall then coordinate specific travel arrangements with the COR and must obtain advance, written COR approval for the travel to be conducted. The Contractor shall, to the maximum extent practicable, minimize overall travel costs by taking advantage of discounted airfare rates and other travel-related expenses available through advance purchase.

12.0 CONTRACTING OFFICER’S REPRESENTATIVE (COR) AUTHORITY

The Contracting Officer may designate other Government personnel (known as the Contracting Officer’s Representative) to act as her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set https://www.opm.gov/ forth in the contract. The Contractor shall immediately contact the Contracting Officer if there is any question regarding the authority of an individual to act on behalf of the Contracting Officer under this contract.

13.0 INVOICING INSTRUCTIONS

The following are the addenda invoicing instructions to FAR clause 52.212-4.

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.

• 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.

• 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.

• 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.

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

• 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.

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.

• 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;

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

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

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

• 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;

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

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

• 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:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

(c) 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 task 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.

14.0 SECURITY & PRIVACY

16.1 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:

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

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

2) 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:

• 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.

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 CO/COR or emailing your ISSO.

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

3) 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, 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 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: [ ] Low [X] Moderate [ ] High Integrity: [ ] Low [X] Moderate [ ] High Availability: [ ] Low [X] Moderate [ ] High Overall Risk Level: [ ] Low [X] 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

4) 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:

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.

5) 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.

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 will 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).

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

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

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

9) 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 http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf 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.

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the 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.

11) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA 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.

B. 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.

C. 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.

D. 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, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “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.

E. 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: Tier 2 - Moderate

F. 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…