Solicitation_FedbizOps_Aug_11.docx

United States Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN)

Indefinite Delivery Indefinite Quantity (IDIQ) For Access Food and Cosmetic Product and Packaging

August 11, 2015

Request for Quote: FDA-SOL-15-5361

Contents

Note: All italicized terms are defined in the Glossary (Appendix A).

General Information U.S. Food and Drug Administration intends to enter into one (1) Indefinite Delivery Indefinite Quantity (IDIQ) in accordance FAR 16.5 under a Full and Open Competition for Commercial of the Shelf Software as a Services (SAAS) access as well as other services to obtain accurate, quality-assured, easily-validated food and cosmetic product and ingredient information for the purposes of performing trend and other statistical analyses to identify potential food and cosmetic borne risks to the public. FDA will issue task orders against this IDIQ, which will have a twelve-month base ordering period with four twelve-month optional ordering periods, and a combined ceiling value of $5,900,000.

Background The US Food and Drug Administration (FDA) has a continuing need for current, cost effective, and accurate data on the exposure of consumers to processed food products and food ingredients that are either manufactured for sale or imported for sale into the United States (US) marketplace and presumed consumed by the US population. Dietary supplements, infant formula, bottled water, chewing gum, and pet food are examples of food items included in the definition of processed foods. Additionally, FDA has a continuing need for current, cost effective, and accurate data on the exposure of consumers to food and color additives, generally recognized as safe (GRAS) substances and food allergens in processed food products; to color additives and other substances in cosmetic products; and to processed food and cosmetic packaging sold in US retail stores, online as mail order or door-to-door and presumed consumed by the US population.

FDA needs to continue to gather such data to have a complete and comprehensive knowledge of these manufactured products, their ingredients, labeling and packaging in order to better assess how they may affect human exposure as part of the agency’s ongoing mission to protect public health. FDA has devoted considerable resources to continuously monitor the safety of food ingredients, dietary supplements, infant formula, and cosmetics. FDA has determined that the most cost-effective means to advance the agency’s objectives is (1) to obtain accurate, quality-assured, easily-validated processed food and cosmetic product and ingredient information and coding images, which has been well-organized within one or more relationally searchable database(s) for trend and other analyses; and/ or 2) to collect processed food and cosmetic product and ingredient information as tasked.

Purpose The purpose of the Indefinite Delivery Indefinite Quantity (IDIQ) is to issue individual task orders to meet CFSANs business objectives, constraints, applicable scope and task areas and acquire the full range of technical, management and support services necessary to develop and maintain access to food and cosmetic product and ingredient information.

Objective Through this IDIQ, FDA seeks to gain access to accurate, quality-assured, easily-validated food and cosmetic product and ingredient information for the purposes of performing trend and other statistical analyses to identify potential food and cosmetic borne risks to the public.

Scope The scope of this contract is to acquire the full range of technical, management and support services necessary to obtain and maintain access to food and cosmetic product and ingredient information.

The IDIQ is divided into the following task areas:

· Project Management

· Data Access

· Data Collection

· Training Support

Description of Task Areas Project Management For the task orders released under this contract, the Contractor shall provide task order level project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. The Contractor may be tasked to prepare a Management Plan outlining the strategy for supporting the task areas in the individual Task Orders. The Contractor may be tasked to conduct face-to-face presentation meetings with the Contracting Officer Representative (COR) and other FDA staff as well as deliver final written progress reports about contract performance for the preceding period of performance.

The Contractor shall provide monthly status reports on all awarded tasks and their progress to the Task Order COR. Within the first 30 days after contract award, the Contractor will design and the COR shall approve a standard reporting format and proposed level of detail for the content that includes the following information at a minimum:

· Status and progress of tasks;

· Usage statistics for databases and other resources

· Usage statistics of technical support feature by FDA staff

· Technical issues reported by FDA

· Significant risks to scheduled deliverables and plans to mitigate them;

· Progress against task order service level metrics; and,

· Financial status report including pricing variances

In addition to progress reporting, the Contractor shall be proactive in informing the designated COR of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA staff, or other contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.

Data Access As tasked, the Contractor shall provide direct electronic access to currently existing database system(s) that house data for processed food and cosmetic products and their ingredients.

6.2.1 Database Systems

The Contractor shall provide access to database system(s) with the following:

· Unlimited and concurrent access for up to 250 FDA personnel and <50 users in other Government agencies;

· Located external to FDA network (access via weblink) availability 365/24/7 and fully functional with 99.9% uptime;

· Universal access from any FDA computer hardware (desktops, laptops with docking stations and/or scientific workstations) using internet browsers compatible with FDA current standards;

· Access to all products which shall not be restricted according to product price, or brand category (national vs private), or producer (e.g., Walmart products should be as accessible as Unilever products);

· Capability to perform relational searching and analyses of the processed food and cosmetic product labeling and packaging data;

· Ability to support disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public;

· Coding images (legible images of all sides of product packaging) for all the labels for validation and other research purposes. Images shall be displayed with product data so that information may be easily verifiable by the user.

· All searches shall be downloadable and exportable into Microsoft’s Excel Spreadsheet and Access Data Base Software, SAS Business Analytics Software, and other common formats. Users shall be able to analyze and summarize their searches into summary reports using pivot tables.

· Data status updates shall be posted on the system website with the date. A full historical listing of updates should be available; and

· System usage statistics (including statistics regarding individual login usage, length of log in, whether downloads were made) available in monthly reports and upon request

The Contractor shall ensure a graphical user-friendly interface that is transparent and has the capability to conduct a multi-variable search (i.e. searching a combination of factors concurrently). The Contractor shall ensure the user shall be able to search according to product category, name, brand, company, claims, ingredients, product attributes, year, and user-entered keywords in any and all fields as well as be able to browse the product category hierarchy.

As tasked, the Contractor shall customize the database system to provide enhancements and modifications of functionality and features.

The Contractor shall provide electronic access to all available sales data and market research reports for all processed food and cosmetic products available on the database system. The contractor shall also provide available restaurant menu information.

0. Data The contractor shall ensure the data is from a currently existing, commercially available database(s) that provides immediate automated access. The data shall include processed food and cosmetic products from all regions of the US (Appendix B indicates the US Census regions); accurate, quality-assured, and easily-validated; well organized; and stored as relationally searchable information for trend and other analyses. The contractor shall ensure database(s) are updated and maintained in a current state throughout the base and option periods.

The contractor shall ensure the database(s) shall contain current and historical data for products from the 1990s-to-the-present that are valid and verified.

Dataset Information shall be required for the following product types:

· Processed food products (minimum 400,000 US products);

· Dietary supplements (minimum 30,000 US products); shall be categorized according to the definition in Appendix A

· Infant formula;

· Cosmetics (minimum 160,000 US products); shall be categorized according to Appendix C

The following attributes of the data information shall be required:

· Coding images (legible images of all sides of product packaging)

· Information contained on product packaging – shall include the following at minimum (each data entry line in the database must be quality assured and -controlled (QA/QC’d) for accuracy as the database is populated)

· Nutrition and Supplement Facts label (shall be displayed in format according to 21 CFR 101.9)

· Ingredients

· Food Additives

· Price and pack size

· Number of servings per package

· Brand

· Name and place of business of manufacturer, packer, or distributor

· Warning statements/icons

· Detailed product description on packaging

· Statements/icons/signages and similar information that features the nutrition, health, organoleptic, processing, and other properties of the product (e.g., nutrient content claim languages, front-of-pack language).

· Verbatim language from product packaging (if available)

· Product source where collected

· Date collected and date published

· FNDDS 8-digit and 7-digit food codes; SR 5-digit sub codes (8-digit food code shall be linked to food products and ingredients;7-digit food codes are mapped to 8-digit at the product level; 5-digit SR sub codes are mapped to 8-digit food codes at the ingredient level)

· GSFA (General Standard for Food Additives) categories

· Food packaging types(primary and secondary)

· Food content type

· Cosmetic claims (see Appendix C)

· Cosmetic physical form (see Appendix C)

· Allergen labeling (contains/may contain)

The Contractor shall provide additional valid and verifiable information on the product ingredient to include the synonym name(s), allergen status, and technical or functional effect descriptors. As tasked, the Contractor shall customize the datasets to modify product data information and attributes.

6.2.3 Operations and Maintenance

As tasked, the Contractor shall provide maintenance and support for all licenses under the contract as follows.

· Updates to data

· Telephone and/or email access to technical expertise from 9 – 5 EST

· Issue tracking to track any issues to resolution

· Access to user guides and technical specification via the internet

· Issue identification, tracking, analysis and resolution

· Installation of upgrades and patches

· Maintain and update technical and analytical documentation

6.2.3.1 Service-Level Agreement

The Contractor shall ensure the Service Level Agreement below for the response of different levels of urgency. For the purposes of the goals shown, response is defined as acknowledging receipt of the issue/incident from the user and initiating investigation of the issue. Resolution is the point at which the problem has been addressed such that the system is functioning normally with users able to complete routine data access and analysis.

Urgency Level

Goal

Business operations have been severely disrupted.

Cosmetic issues, including errors in the documentation.

6.2.4 Documentation

As tasked, the Contractor shall provide documentation for database system(s) in electronic format (typically MS Word, Excel) to the COR. Documentation may include the comprehensive methodology for obtaining data and for other assignments, user guides for the system, limitations & restrictions, data dictionary, technical specifications, disclosure policy, update logs and interface documents. The Contractor shall keep originals and updated versions, and ensure their availability for access to all database system(s) users.

6.3 Training Support

As tasked, the Contractor shall plan, develop and deliver specific training services in support of the database systems.

Representative activities under this task area may include:

· Development of a training plan

· Development of training material

· Providing on-demand training

· Development and implementation of web-based training

6.4 Data Collection

As tasked the Contractor shall:

· Collect information for COR selected products and data fields. The list of exact products and data fields to be collected shall be defined by the COR. The Contractor shall provide the product information and plans to the COR as defined in the task order which may include the actual product.

· Conduct search(es) and collect information for products using specific search criteria defined by the COR to include but not limited to ingredients, packaging, or physical form. The Contractor shall provide the product information and plans to the COR as defined in the task order which may include the actual product.

The Contractor shall validate and ensure the integrity and accuracy of the data collected. Deliverable options include incorporation of collected information into the database(s), electronic format as defined by the COR and shipment of the products to the COR.

Data Disclosure Clearance As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and form found in Attachment A.

Deliverables Deliverables shall be specified in the task orders released under this contract. Deliverable products shall be reviewed, validated and tested as appropriate to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

Period of Performance One (1) 12-month Base Period Four (4) 12-month Option Periods.

Contract Type It is anticipated that under the IDIQ that task orders will be award as Firm-Fixed Price, Time and Materials and Labor Hour or a combination.

Place of Performance The place of performance shall be the Contractor’s site.

The Contractor shall participate in telephone meetings, as needed, to develop project requirements and plan. Planning meetings and progress reports with agency staff may be held at the FDA offices or by remote communication.

Travel Any travel costs incurred by the contractor within the Washington/Baltimore Metro area is considered local travel and will not be reimbursed. CFSAN does not anticipate travel will be required under this IDIQ contract. If travel is required, all requests for travel shall be submitted to the CFSAN COR and CO. All costs shall be in accordance with the Federal Travel Regulations and the Contractor will be reimbursed based on number of trips, number of persons traveling, lodging, per diem, air / rail, / car transportation.

Federal Travel Regulation: http://www.gsa.gov/portal/content/104790

Key Personnel and Staffing The Contractor shall ensure that all Contractor personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this IDIQ SOW prior to being assigned to this task order. Key personnel will be indentified under the task order.

Inspection and Acceptance

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the COR to ensure the services/products provided meet the requirements of the Statement of Work (SOW) at the time of delivery, and the contractor shall make changes as The Government will accept goods, reports and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

Conformance with Applicable Laws, Regulations, Policies, and Standards All work performed under this IDIQ shall comply with the directions laid out in the FDA Information Management Strategic Plan, Version 1.1, FY2012-FY2016. The plan is found at the following link: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM325437.pdf In addition, all work shall be accomplished in accordance with the FDA, HHS, OMB standards described below. In the event the Contractor is unable to meet the standards, they shall immediately notify the COR.

FDA Approved Technologies List: The FDA Master Approved Technology (MAT) List contains a list of approved and not approved technologies including applications (software and tools), infrastructure and peripherals (hardware), and scientific software and devices. The list is on an FDA website and allows users to enter criteria, e.g., software name, to determine if it is on the list, along with any restrictions, e.g., contained to a specific FDA Center/Organization. Access to this is GFI will be provided after award. The contractor is not limited to the MAT List; however, if the contractor proposes a technology that is not on the MAT List, they must work with the COR or COR designee to get the technology on the MAT List before proceeding with implementation.

FDA Security Authorization Process: Security Authorization is the approach FDA follows to fulfill Federal Information Security Management Act (FISMA), Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) requirements to ensure that information resources have adequate security to protect the Confidentiality, Integrity and Availability of information collected, processed, transmitted, stored, or disseminated by the agency. For further information see Attachment 8: SP 800-37 Rev. 1: Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach.

National Institute of Standards and Technology (NIST) SP800-53: This publication was developed by the Joint Task Force Transformation Initiative Interagency working Group with representatives from the Civil, Defense, and Intelligence communities in an ongoing effort to produce a unified information security framework for the federal government— including a consistent process for selecting and specifying safeguards and countermeasures (i.e., security controls) for federal information systems. SP 800-53 Rev. 3: Recommended Security Controls for Federal Information Systems and Organizations.

Federal Information Security Management Act (FISMA): The E-Government Act (Public Law 107-347), passed by the 107th Congress and signed into law by the President in December 2002 recognized the importance of information security to the economic and national security interests of the United States. Title III of FISMA requires each federal agency to develop, document, and implement an agency-wide program to provide information security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, Contractor, or other source.

NIST: The E-Government Act [Public Law 107-347] passed by the 107th Congress and signed into law by the President in December 2002 recognized the importance of information security to the economic and national security interests of the United States. Title III of the E-Government Act, entitled the Federal Information Security Management Act of 2002 (FISMA), included duties and responsibilities for the Computer Security Division in Section 303 of the National Institute of standards and Technology document: NIST: Computer Security Division - Computer Security Resource Center.

FDA 3250 series of SMG policies: FDA 3250 series of Staff Manual Guide (SMG) policies, as well as HHS security policies, is GFI to be provided after contract award. Note: SMG 3251.4 Outsourcing and Third Party Arrangements - The FDA Staff Manual Guides (SMGs) are the Agency directives that document organizations and functions; delegations of authority; and administrative and program policies, responsibilities and procedures.

FDA Security Program: Contractor Oversight Guide - Section 2, Defining Contractor Systems and Related Security Requirements – Information systems subject to Departmental and Federal requirements are predominantly maintained by Department personnel within HHS facilities; however, there exist a substantial number of Contractor-run systems. This section clarifies security requirements for these Contractor-based systems as well as defines the related roles of Contractors and Departmental personnel.

FDA’s Project Management (PM) processes: FDA’s Project Management (PM) processes include a variety of project management methodologies which may be employed in the task orders released under this contract including, but not limited to, the Project Management Body of Knowledge (PMBOK).

508 Standard Requirements: All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.access-board.gov/sec508/standards.htm. The Contractor shall abide by the requirements described in HHSAR Clause 352.270-19. Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by Public Law 105–220 under Title IV (Rehabilitation Act Amendments of 1998), all Electronic and Information Technology (EIT) developed, procured, maintained, and/or used under this contract shall be in compliance with the ‘‘Electronic and Information Technology Accessibility Standards’’ set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the ‘‘Access Board’’) in 36 CFR part 1194. The complete text of Section 508 Final Standards can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards. Any amendment or modification to the Section 508 standards shall be applicable.

Section 508 requires that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

The Contractor shall comply with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that deliverables generated as part of the tasks are fully Section 508-accessible using the available COTS tools.

508 Standard Requirements include:

1194.21 Software applications and operating systems

1194.22 Web-based intranet and internet information and applications

1194.31 Functional performance criteria

1194.41 Information, documentation, and support

All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at: http://www.section508.gov/summary-section508-standards.

All deliverables must meet HHS 508 compliance formatting based on the criteria available on HHS’s Making Files Accessible web page: http://www.hhs.gov/web/508/accessiblefiles/index.html Performance Metrics Performance measures designed to measure the Contractor’s effectiveness will be utilized. The Contractor’s performance shall be evaluated annually, at the end of the period of performance. This evaluation shall become a part of the file and shall be used as past performance information in evaluating the Contractor’s past performance on future contracts. The Contractor shall be given a minimum of 30 days to submit comments, rebutting statements, or additional information. The contractor shall adhere to the performance metrics as defined by the task order.

Security

The Contractor shall follow all FDA security requirements as defined by FDA Staff Manual Guides (SMG) for 3250 Information Technology Security on FDA’s internal web-site, which will be available post-award, at http://inside.fda.gov:9003/PolicyProcedures/StaffManualGuide/VolumeIIIGeneralAdministration/default.htm:

Contractor Overall Point of Contact

Point of Contact:

Contracting Officer Kathy Harrigan 5630 Fishers Lane Rockville, MD 20857 kathy.harrigan@fda.hhs.gov 240-402-7686

IDIQ Contracting Officer Representative:

TO BE PROVIDED AT CONTRACT AWARD

Contracting Officer’s Authority The Contracting Officer (CO) 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 relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this IDIQ and is the only person authorized to approve changes to any of the requirements under this IDIQ and resulting orders, and notwithstanding any provision contained elsewhere in this IDIQ, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this IDIQ. 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 IDIQ. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the IDIQ.

IDIQ Contracting Officer’s Representative The Contracting Officer may designate other Government personnel (known as the Contracting Officer’s Representative, or COR) to act as his or her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the IDIQ or resulting orders. 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 forth in the IDIQ.

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.

The Government may unilaterally change its COR designation.

The following person has been appointed as the IDIQ COR:

To be provided at contract award

IDIQ Task order Contracting Officer’s Representative For each IDIQ Task Order all, a Contracting Officer’s Representative (COR) will be assigned. The COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluations as required; (4) performing technical inspections and acceptances required by this IDIQ; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction in accordance with section 13; and (7) reviewing invoices/vouchers.

The Government may unilaterally change its COR designation.

Technical Leads may assist the COR. The Technical Leads will not have the authority to provide technical direction in accordance with section 15; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances as required by this performance; and (5) reviewing invoices/vouchers Issuance of Request for Task Order Proposal (RFTOP)

Task Order Procedures – When a need for services within scope of this contract arises, the FDA will issue a Request for Task Order Proposal (RFTOP). The process for awarding tasks orders will be as follows:

FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue an RFTOP via email. The RFTOP will include at a minimum a SOW, the period of performance, the anticipated order type (LH, T&M or FFP), reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

Within five (5) business days (unless another time frame is specified in writing) the contractor will provide a proposal to the Contracting Officer. The proposal will include a brief description of the technical approach and a price build up. The price build up should include the labor categories to be utilized, the number of hours within each labor category, extended pricing for each labor category and a bottom line price/ceiling.

FDA will evaluate the task order proposal for technical acceptability and price reasonableness. FDA will consider the following technical factors: technical approach, whether the labor mix is appropriate; and whether the level of effort is sufficient. If the FDA has questions or concerns the Contracting Officer will contact the contractor and may ask for a revised proposal.

Once the proposal is acceptable, the Contracting Office will issue the task order.

Orders will include the following:

· Task Order Number

· Date

· Accounting Information

· SOW

· Price/Ceiling

· Period of Performance

· Any terms, conditions, or instructions unique to the order. Any work that the Contractor undertakes prior to receiving a fully executed task order signed by the Contracting Officer is undertaken at risk.

The guaranteed minimum shall be $3,000.00.

Any FDA Contracting Officer may issue task orders against this IDIQ. The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer (CO) for any of the Centers within the FDA.

Data Rights Pursuant to the clause FAR 52.227‐14, the Government will have unlimited rights to all components, documentation, and other deliverables produced under this contract.

FAR Provisions

52.212-3 Offeror Representations and Certifications—Commercial Items. (Dec 2014) The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website accessed through http://www.acquisition.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (p) of this provision.

(a) Definitions. As used in this provision— “Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation”, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in Federal Supply Classes (FSC) 1000-9999, except—

(1) FSC 5510, Lumber and Related Basic Wood Materials;

(2) Federal Supply Group (FSG) 87, Agricultural Supplies;

(3) FSG 88, Live Animals;

(4) FSG 89, Food and Related Consumables;

(5) FSC 9410, Crude Grades of Plant Materials;

(6) FSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) FSC 9610, Ores;

(9) FSC 9620, Minerals, Natural and Synthetic; and

(10) FSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Small disadvantaged business concern”, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

“Women-owned business concern” means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program” (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

(b)

(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website.

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through http://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (p) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it o is, o is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it o is, o is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it o is, o is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it o is, o is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it o is, o is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that—

(i) It o is,o is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It o is, o is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: __________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that—

(i) It o is, o is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It o is, o is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it o is a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that—

(i) It o is, o is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and

(ii) It o is, o is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture.