Statement of Work.pdf

FDAT2/ Patent and Licensing Analytical Tool Statement of Work_Jul 2020

Request for Quote (RFQ): FDA-SOL-20-1222409

RFQ Issue DATE: 09/14/2020

RFQ Closing Date: 09/21/2020 at 03:00 PM, Eastern Time

Contract Type: Firm Fixed Price

General Instructions:

This is a combined synopsis/solicitation to acquire Brand Name or Equal Computer-Assisted Patent and Licensing Research Tool prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED.

The solicitation number for this acquisition is FDA-SOL-19-1229081 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 511210 – Software Publishers. The Small Business Size Standard is $35.5 million. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

All responsible sources must submit a quote via email to the Contract Specialist at Jacquelyne.Ngegba@fda.hhs.gov by the closing date.

Statement of Work

Computer-Assisted Patent and Licensing Research Tool Brand Name or Equal Solution

1.0 Introduction

The Food and Drug Administration’s Technology Transfer Program (FDAT2) requires access to Computer-Assisted Patent and Licensing Research Tool to carry out its work mandated under 15 USC 3710 and other related legislation.

2.0 Background

The U.S. Food and Drug Administration (FDA) Technology Transfer Program (FDATT) within the Office of the Chief Scientist (OCS) has the Agency-level responsibility for overseeing, directing, and implementing the Federal Technology Transfer Act (FTTA).

FDATT responsibilities include administering activities relating to collaborative agreements, inventions, patents, royalties and associated matters; providing advice, guidance and assistance to Agency-level and Center staff on intellectual property and collaborative agreements; management and administration of intellectual property and royalties; transfer of research materials; interpretation and implementation of policies, rules and regulations related to the implementation of the Federal Technology Transfer Act of 1986 and subsequent legislation; and reviewing and analyzing planned collaborative agreements to ensure that they are in accord with applicable FDA and Public Health Services (PHS) procedures.

3.0 Scope

This tool will provide information about high-tech and biomedical industry and consumer trends. This information will be used by the T2 staff to make decisions on whether inventions and patents derived from FDA scientific research are commercially viable. The tool shall also provide information about global the intellectual property landscape, along with the ability to compare patented and patent pending properties with new FDA inventions to assist with decision making on investments. Finally, the tool shall allow staff to identify potential licensing and collaboration partners worldwide through identifying overlaps or contrasts in protected intellectual property or industry sectors of interest.

4.0 Objective

The solution proposed shall meet the following Salient Characteristics:

The contractor solution shall provide unlimited access, downloading and reporting capabilities to their online service. Use of the tool shall enable FDAT2 staff to evaluate the commercialization, patentability, and licensing potential of FDA inventions. The tool shall also enable the FDAT2 staff to monitor the progress of its patent portfolio (as well as those of collaborators and licensees) and enable FDAT2 to evaluate technology trends applicable to FDA inventions. In addition, the tool shall provide information about potential partners and licensees, notably companies that are active in similar technology areas.

5.0 Specific Task or Deliverables

The Contractor shall provide 10 User Licenses for duration of contract.

6.0 Government Furnished Property

None

7.0 Contractor Furnished Property

None.

8.0 Performance Period

The Contractor shall deliver equipment within 30 days of award.

The warranty and technical support period of performance is:

September 30, 2020 through September 29, 2021.

9.0 Contract Type

Firm Fixed Price

10.0 Travel

None

11.0 Inspection and Acceptance

The COR/designee shall review all Reporting Requirements/Deliverables in accordance with specifications and standards identified in the task order. The acceptance of equipment and satisfactory work performance, required herein, shall be based upon the timeliness, accuracy, quality of the deliverables.

The COR/designee shall perform inspection and acceptance of materials and services.

Inspection and acceptance shall be performed at 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 (FDA Campus). The FDA will have 10 days for inspection and acceptance, after which the deliverable will be deemed, accepted. The Contractor shall have 5 business days to fix the deliverable if FDA deems it unacceptable.

12.0 Security and Privacy Requirement

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

2) Access (Physical or Logical) to Government Information: A Contractor

(and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

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

3) Safeguarding Information and Information Systems. In accordance with the Federal

Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

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

• 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.

4) Information Security Categorization. In accordance with FIPS 199 and National

Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [x] Low [ ] Moderate [ ] High Integrity: [x] Low [ ] Moderate [ ] High Availability: [x] Low [ ] Moderate [ ] High Overall Risk Level: [x] Low [ ] Moderate [ ] High

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[x] No PII [ ] Yes PII

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

PII Confidentiality Impact Level has been determined to be: [x] Low [ ] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI.

32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the information.” 81 Fed. Reg. 63323.

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

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

a. marked appropriately;

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

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

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer- Related Storage Media.

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

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).

7) 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).

8) 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.

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

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee under this contract shall complete the FDA non-disclosure agreement (3398 Form, RFP Attachment D), 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.

A. 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: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

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

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

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

B. RECORDS AND MANAGEMENT AND RETENTION

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 - Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

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

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

C. FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS.

Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that results in a favorable determination.

Contractor employees who will work in DHHS-owned or leased space for less than thirty (30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all time while in DHHS-owned or leased space.

2. GENERAL - The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

• A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

• Confirmation all individual employee security information has been submitted properly;

and

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

Pursuant to HSPD-12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor must notify the COR, and the Government will make a determination whether an additional security clearance is required.

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

3. BACKGROUND INVESTIGATIONS - With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor. Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

Note: Background investigations will be conducted by the Office of Personnel Management

(OPM)

4. CONTRACT RISK DESIGNATION(S) - Contractor employees who will be in DHHS-owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive-12 (HSPD-12) in order to access to DHHS-owned or leased property without an escort. (See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered visitors, as described above, and allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing system (e-Qip) system. The FDA Personnel Security Specialist will provide access to the e-Qip as well as guidance as to which forms will be required. The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s):

Tier(s) 1.

There are three (3) potential position risk designations, which are:

• Non-Sensitive Low Risk (Tier 1) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non-Sensitive Low Risk Positions.

• Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust Positions - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. This information will be provided on the e-Qip form that will be electronically sent to the employee. The FDA Personnel Security Specialist will use this information to enter each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed. Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

5. PERSONAL IDENTITY VERIFICATION (PIV) CARDS - All PIV Cards (and any other type of Government-issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer. The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government-issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

6. PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document. Acceptable forms of identification are listed in the chart below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

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

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquiries covering the subject's background.

7. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS - Under the requirements for Homeland Security Presidential Directive-12 (HSPD-12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals. If any prospective foreign national contractor/subcontractor employee does not meet the residency requirements, he/she cannot qualify for a PIV Card under HSPD-12.

8. NON-PUBLIC DATA PROTECTION - The Contractor must protect the privacy of all information reported by or about Contractor employees and protect against unauthorized disclosure.

*Upon a favorable fingerprint return, the Contractor will be notified to return to the Badging and Credentialing Office for their building pass.

*Food and Drug Administration Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time

10903 New Hampshire Avenue

Building 32, Room 1205 Silver Spring, MD 20993

No appointment necessary

Telephone: (301) 796-4000

13. Government Point of Contacts Contracting Specialist/Officer:

Jacquelyne Ngegba Jacquelyne.Ngegba@fda.hhs.gov 301-796-6761

Contracting Officer Representative:

To Be Determined

14. Information Technology Investment Management/Master Approved Technologies List The item acquired may require approval by the Food and Drug Administration (FDA) Office of Information Management (OIM) for operation in FDA’s Information Technology environment (IT Investment Management Process/Master Approved Technologies List). Any item proposed not previously tested and approved for IT environment operations may require testing by OIM before award. Quoters must provide a full set of technical specifications with their offer. FDA will determine if further testing of the item is required. Consequently, the offeror shall be prepared to provide FDA with a demonstration unit within 2 days of offer submission.

15. 508 Standard Requirements

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping)

• 302 Functional Performance Criteria (Appendix C, Application and Scoping Requirements)

• Chapter 4 Hardware

• 352.270-12 Tobacco Free Facilities

16. FAR/HHSAR Clauses and Provisions:

The below Federal Acquisition Regulation (FAR) Clauses apply. FAR Clauses can be viewed in full text at: http://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482

52.211-6 Brand Name or Equal (Aug 1999) 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-23 - Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018)

52.223-16 IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products. (ALT I)

52.232-18 Availability of Funds (Apr 1984) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.227-19 Commercial Computer Software License (Dec 2007) 52.217-5 Evaluation of Options (Jul 1990) 52.212-4(a) Contract Terms and Conditions – Commercial Items (Feb 2012) mailto:Jacquelyne.Ngegba@fda.hhs.gov http://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/52_000.htm#P930_136316 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/52_000.htm#P930_136316

(End of clause)

The below Health and Human Services Acquisition Regulation (HHSAR) Clauses apply.

HHSAR Clauses can be viewed in full text at:

http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1--Instructions for Using Provisions and Clauses

352.201-Definitions ( Jan. 2006) 352.270-12 Tobacco Free Facilities 352.203-70 Anti-Lobbying (December 2015) 352.224-70 Privacy Act (December 2015) 52.224-71 Confidential Information (December 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 2015) 352.237-74 Non-Discrimination in Service Delivery (December 2015) 352.239-74 Electronic Information and Technology Accessibility (December 2015) 352.270-12 Tobacco Free Facilities

(End of clause)

Clause Regarding Use of Macros The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

(End of clause)

HHSAR Provision 352.239-73 Electronic and Information Technology Accessibility Notice (December 2015)

(End of Provision) http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1--Instructions%20for%20Using%20Provisions%20and%20Clauses http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1--Instructions%20for%20Using%20Provisions%20and%20Clauses

Clause Regarding Use of Macros The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

17. Other Pertinent Information or Special Consideration

17.1 Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the government during the performance of the task order. The Government has determined that the information/data that the Contractor will be providing during the performance of the task order is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting officer. Whenever the contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

17.2 Contracting Officer’s Authority

The Contracting Officer identified above has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationship. The CO is the only individual who has the authority to enter contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve change to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO. No statement, whether oral or written, by anyone other than the CO shall be interpreted as modifying the terms and condition of this requirement. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for any work not authorized by the CO including work outside the scope of the Contract.

18. Instructions to Quoters:

All quotes shall demonstrate compatibility and interoperability with these existing hardware systems that are listed below and their existing management tools.

If an alternate configuration is proposed, the Contractor shall attest that the alternate solution is compatible with the HIVE system (see attached Salient Characteristics). Compatibility for this RFQ means that there will be no communication, performance, or maintainability issues in the interconnection of solutions with different configurations and that the solution will allow for seamless (no application change) interoperation including active/passive or active/active processing. In addition, the Contractor shall provide examples of actual implementations where their proposed alternative solution has been successfully implemented.

Equal to quotes must meet all the salient characteristics in order to be considered technically acceptable. If the part numbers are different from the vendors’ part numbers, Quoters shall map their part numbers to the vendor’s part numbers.

Equal to quotes must submit a separate Technical quote with detailed point-by-point description of how the equal to product meets all the salient characteristics of this SOW. Quotes with the specified software license and maintenance service meeting all the salient characteristics of this SOW are not required to submit a separate Technical Quotes. Technical quotes shall not contain pricing information.

All Quoters providing quotations must clearly state the overall cost to the Government.

Quoters shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits.

Quoters shall submit all assumptions in their quotation.

The Government reserves the right to include some or none of the quoters additional terms and conditions into any possible orders, especially when the quoter’s terms and conditions would conflict with the Federal Acquisition Regulation or any of the terms or conditions of the quoter’s award vehicles.

Quoters must clearly state the overall cost to the Government.

Quotes must be firm-fixed-priced, and include all quantities listed, all or none.

Quoters shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the Original Equipment Manufacturer (OEM).

Quoters are advised that additional terms and conditions submitted with their quotation that is in conflict of the terms and conditions of this solicitation may be deems as technically unacceptable and may not be considered for award.

Quoters shall submit Product Accessibility Templates (PAT) in full text with their quotations:

https://www.hhs.gov/web/section-508/contracting/index.html

Licensing Agreements: Quoters are notified that the Government will not sign any licensing agreement or similar user agreement provided by the Quoters. The Government may choose to incorporate an agreement into the contract resulting from this solicitation.

For the warranty and technical support pricing, a completed version or a similar version of the chart below shall be included in the quote. An incomplete quotation or pricing with omission will be considered unacceptable.

Computer-

Assisted Patent and Licensing Research Tool

Product Description

Quantity Unit of Issue

Period of Performance

Unit Price

Total Price

Base Year:

19. Evaluation Criteria:

All quotations will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. The award will be made to the lowest price vendor who demonstrates that all requirements of the solicitation are met. Failure to demonstrate meeting any of the requirements or instructions will result in a rating of technically unacceptable and will not be considered for award. Incomplete quotations will not be considered for award.

END OF SOLICITATION

https://www.hhs.gov/web/section-508/contracting/index.html