Solicitation_Final_trl.pdf

SECTION B - Supplies or Services and Prices/Costs

B.1 BRIEF DESCRIPTION OF SERVICES

The contractor shall provide all personnel and services necessary to provide an updated report to highlight regulatory systems changes and progress since the 2012 NAS report as well as identify areas where regulatory gaps remain.

B.2 TYPE OF CONTRACT

Cost Reimbursable.

B.3 NONSEVERABLE SERVICES

The services specified in this contract have been determined to be nonseverable services - a specific undertaking or entire job with a defined end product of value to the Government.

B.4 CONSIDERATION AND PAYMENT

In consideration of performance of the non-severable work described in Section C, the Contractor shall be reimbursed a total amount not to exceed $TBD, for all reasonable costs, allowable costs, and allocable costs under this cost reimbursement contract. The contractor is required to provide backup detail for pricing of each of the Tasks in Section C and then a summary of each of those tasks to provide a final total price.

C. DESCRIPTION OF SERVICES TO BE PROVIDED

Ensuring Safe Foods and Medical Products through Stronger Regulatory Systems Abroad

“PART TWO”

Statement of Objectives

In 2011, the U.S. Food and Drug Administration, Office of International Programs awarded the Institute of Medicine, National Academy of Science resources to develop a report on the regulatory capacity in selected countries. The National Academy of Science published a report in 2012 entitled Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. It was a first-of-its-kind report that focused on regulatory systems around the globe.

At that point in time the U.S. FDA had growing appreciation that its ability to regulate the safety and quality of products depends on a complex array of systems far from U.S. shores and borders.

FDA estimated that +/- 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs came from abroad, as did 85 percent of its seafood, 50 percent of fresh fruits, and 20 percent of fresh vegetables. A more global approach to the regulation of commodities was warranted and FDA turned to the NAS for information collection and analyses.

The Institute of Medicine/National Academy of Science Committee (the Committee) identified main characteristics of a viable regulatory system, a set of common programs that cut across developing country product safety systems, and proposed a basic strategy for addressing these gaps. In support of its work, the Committee heard from an array of stakeholders from low- and middle-income countries at conferences and interviews in Beijing, Sao Paulo, Pretoria, and New Delhi, as well as Washington, D.C.

Since the publication of the 2012 Report, much has changed in the global regulatory context, for FDA and other regulators. These include but are not limited to:

• development of a Genome Trakr Network of laboratories to utilize whole genome sequencing for pathogen identification in foods, with labs in Argentina, Australia, Austria, Canada, Denmark, Germany, Italy, Ireland and the United Kingdom (2011-present day);

• a reconstituted International Medical Device Regulators Forum (IMDRF) focusing on regulators including the USA, Canada, Europe, Brazil, Russia, China and others that have voluntarily come together to harmonize the regulatory requirements for medical products that vary from country to country (2011);

• establishment of a Global Summit on Regulatory Science (2011) and the creation of a Coalition of Regulatory Science Research (GCRSR) as a forum to advance regulatory science, food safety, medical technologies and public health (2012);

• formation of a WHO Member State Mechanism for Substandard and Falsified medical products (Resolution WHA65.19 2012);

• development of a WHO Global Surveillance and Monitoring System for Substandard and Falsified (SF) medical products (launched July 2013);

• negotiation and passage of a 2014 World Health Assembly Resolution on Regulatory Systems

Strengthening for medical products (WHA67.20);

• establishment of an International Coalition of Medicines Regulatory Authorities (ICMRA) - a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to. address current and emerging human medicine regulatory and safety challenges globally, and strategically and identify areas for possible synergies; (2014)

• an expanded membership of the International Council for Harmonization of Technical

Requirements for Pharmaceuticals for Human Use where regulators from as Brazil and China are members, South Africa, Mexico and Russia and India are observers, and generic industry associations are participating; (2015)

• a collaborative multi-year project commissioned by the Asia Pacific Economic Cooperation

(APEC) to create a Supply Chain Security Toolkit for Medical products to maximize available global resources to prevent and detect substandard and falsified medical products before they reach consumers and address areas of vulnerability in the medical product supply chain (2016);

and

• a first-of-its-kind World Bank Report on making the case for investments in food safety systems

(2018 release) recognizing the impact food safety systems can impart on a wide-ranging socio-economic consequences of human welfare and economic performance.

While these and other efforts have undoubtedly contributed in large and small ways to regulatory systems strengthening, the Government needs to know if the regulatory landscape changed significantly since the 2012 NAS report. And if so, in what specific ways? And are there other areas policy makers and other stakeholders to consider? For example, have investments at national levels increased in support of regulatory systems, and/or have investment of others such as foundations, regulatory coalitions, academic institutions, multilateral organizations and the like, strengthened regulatory systems in notable and sustainable ways?

It is an opportune time for an updated report. While the NAS 2012 report focused on specific countries, a new NAS report could take a sub-regional approach or a grouping of countries for its analyses. For some sub-regions, one commodity such as medical products could be emphasized, while in others, food and medical products could be targeted. Specifically, the objective for the report is to highlight regulatory systems changes and progress since the 2012 NAS report as well as identify areas where regulatory gaps remain. And based on the analyses, the NAS would delineate specific regulatory areas and recommend time-bound and measurable outcomes as potential options for the global community to review, digest and take action. The deliverables would be the report itself and a conference which brings together stakeholders to discuss the report findings in ways that facilitate potential future action.

D. PACKAGING

Packages shall be clearly marked in accordance with normal commercial practices to ensure safe delivery to their destination. In addition, all packages shall be marked as follows:

1. Name of Contractor;

2. Order Number;

3. Description of items contained therein;

4. Consignee’s name and address.

E. INSPECTION AND ACCEPTANCE

FDA review of the final report will be performed after revision by the contractor and before formal acceptance. The final report submitted (following any revisions based on Section 6(b) compliance review) will be reviewed within 7 days of receipt of the report for formal acceptance.

F. PERIOD OF PERFORMANCE/DELIVERABLE/ACTIVITY SCHEDULE

F.1. Period of Performance will be from September 30, 2018 - March 31, 2019.

Period of Performance will be from date of award until completion.

F.2. Place of Performance

Performance will be on vendor site.

F.3. Observance of Federal Holidays

Deliverables due on a Saturday, Sunday, or the following Federal holidays shall be due on the following business day.

1. New Year’s Day 1 January

2. Martin Luther King’s Birthday 3rd Monday in January

3. President’s Day 3rd Monday in February

4. Memorial Day Last Monday in May

5. Independence Day 4 July

6. Labor Day 1st Monday in September

7. Columbus Day 2nd Monday in October

8. Veteran’s Day 11 November

9. Thanksgiving Day 4th Thursday in November

10. Christmas Day 25 December

G. CONTRACT ADMINISTRATION DATA

G.1 Method of Payment

The contractor shall use the invoicing procedures as specified in G.1.1- Invoice Procedures in the BOA, HHSP233201400020B, and detailed below:

G.1.1. Invoice Procedures

The Contractor shall submit invoices once per month. A complete invoice with all required back-up documentation shall be sent electronically, via email, to:

1. DAM mailbox: pscs.invoices@psc.hhs.gov. *

2. Financial Management Service (FMS): psc.invoices@psc.hhs.gov.*

3. COR-

4. Contract Specialist: Kristine.Zechman@psc.hhs.gov

* No other non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent to the DAM and FMS mailboxes, invoices only.

The subject line of your email invoice submission shall contain the contract number, contract line item number, the order number, if applicable, and the number of invoices. The Contractor shall send one email per contract per month. The email may have multiple invoices for the contract. Invoices must be in the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF or TIFF or Word).

Invoices shall be submitted in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc.

All calls concerning contract payment shall be directed to the COR.

In accordance with FAR 52.232-25 Prompt Payment, a proper invoice must include the following items:

(i) Name and address of the contractor.

(ii) Invoice date and invoice number. (Contractors should date invoices as close as possible to the date of mailing or transmission.)

(iii) Contract number or other authorization for supplies delivered or services performed (including order number and contract line item number).

(iv) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed.

(v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading.

(vi) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).

(vii) Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

(viii) Taxpayer Identification Number (TIN) and Dun & Bradstreet Number (DUNS).

The contractor must include its TIN and DUNS on the invoice.

(ix) Electronic funds transfer (EFT) banking information.

(A) The contractor must include EFT banking information on the invoice only if required by agency procedures.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the contractor must have submitted correct EFT banking information in accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(x) Any other information or documentation required by the contract (e.g., evidence of shipment).

In accordance with OMB Memorandum, M-11-32, Agencies shall make payments to small businesses as soon as practicable, with the goal of making payments within 15 days of receipt of a proper invoice. If a small business contractor is not paid within this (15 day) accelerated period, the contractor will not be given a late-payment interest penalty. Interest penalties, as prescribed by the Prompt Payment Act, remain unchanged by means of this memorandum. All small businesses shall label all invoices as “Small Business.”

Additionally, in accordance with OMB Memorandum, M-12-16, all prime contractors are encouraged to disburse funds received from the Federal Government to their small business subcontractors in a prompt manner. To assist prime contractors in expediting contractor payments to small business subcontractors, Agencies shall, to the full extent permitted by law, temporarily establish an earlier, accelerated date for making agency payments to all prime contractors. Consistent with OMB Memorandum M-11-32 above, Agencies shall have a goal of paying all prime contractors within 15 days of receiving proper documentation. In an effort to support small business growth, drive economic activity and job creation, the Contractor is encouraged to accelerate payments to their small business subcontractors.

In accordance with the requirements of the Debt Collection Improvement Act of 1996, all payments under this order will be made by electronic funds transfer (EFT). The Contractor shall provide financial institution information to the Finance Office designated above in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer – System for Award Management.

G.2 Minimum Cost Information for Cost Reimbursement Contracts

a. The Contractor shall provide a summary page showing the cost breakdown by element. The Contractor shall also provide a cost breakdown by element by task. The following minimum information in support of costs submitted:

i. 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;

ii. Fringe Costs - show rate, base and total amount;

iii. Overhead or Indirect Costs - show rate, base and total amount;

iv. Consultants - include the name, number of days or hours worked, daily or hourly rate, a total amount per consultant and a total amount for this category;

v. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs include ground transportation shown separately and the per diem costs. Other travel costs shall also be listed. A total amount for this category shall be provided;

vi. Subcontractors - include, for each subcontractor, the same data as is being provided for the prime Contractor. A total amount for this category shall be provided;

vii. Data Processing - include all non-labor costs, i.e., computer time, equipment purchase, lease or rental, data tapes. A total amount for this category shall be provided;

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

ix. G&A – show rate, base and total; and

x. Fee - show rate, base and total.

G.3 Authorities of Government Personnel

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of this task order will require maximum coordination between the Government and the Contractor. The following individuals will be the Government's points of contact during the performance of this task order:

G.3.1 Contract Administration

All communications pertaining to contractual and/or administrative matters under the task order shall be addressed to the Contract Specialist.

Contract Specialist Name: Kristine Zechman Address: Contract Specialist, Acquisition Management Services

Program Support Center U.S. Department of Health and Human Services 7700 Wisconsin Avenue Bethesda, Maryland 20857 Phone: (703) 995-9329 Email: Kristine.Zechman@psc.hhs.gov

Contracting Officer Name: Sam Layton Address: 350 Main Street Salt Lake City, Utah 84111 Phone: 385-285-7381 Email: Samuel.Layton@psc.hhs.gov

G.3.2 Contracting Officer’s Representative (COR) Authority

a. Performance of work under this contract must be subject to the technical direction of the Contracting Officer’s Representative identified in individual orders, or a representative designated in writing. The term “technical direction” includes, without limitation, filling in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

b. Technical direction must be within the scope of the specification(s)/work statement.

The Contracting Officer’s Representative does not have authority to issue technical direction that:

i. Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

ii. Constitutes a change as defined in the clause entitled “Changes”;

iii. In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

iv. Changes any of the terms, conditions, or specification(s)/work statement of the contract;

v. Interferes with the contractor's right to perform under the terms and conditions of the contract; or

vi. Directs, supervises or otherwise controls the actions of the contractor's employees.

mailto:Samuel.Layton@psc.hhs.gov

c. Technical direction may be oral or in writing. The Contracting Officer’s Representative shall confirm oral direction in writing within five workdays, with a copy to the Contracting Officer.

d. The contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officer’s Representative. If, in the opinion of the contractor, any direction of the Contracting Officer’s Representative, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government work day.

e. Failure of the contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

G.3.3 Contracting Officer’s Representative (COR):

Kristin Wedding International Policy Analyst

Office of Regional and Country Affairs Office of International Programs U.S. Food and Drug Administration Tel: 301-796-1026

BB: 240-506-8397

Kristin.Wedding@fda.hhs.gov

G.4 Government Furnished Property, Equipment and Materials

None.

G.5 Travel and Other Costs

The Contractor shall be reimbursed for all domestic travel as described below, incurred directly, and specifically in the performance of this contract, claimed by the Contractor, accepted in writing prior to incurring any costs, by the Contracting Officer and the Contracting Officer’s Representative (COR and CO) and not exceeding:

a. Cost of air travel by most direct route. “Air coach” or “Air tourist” accommodations on prop or jet aircraft constitutes the normal class of air travel, which shall be utilized.

First-class accommodations may be used if (1) less than first-class is not available providing reservation was requested within 24 hours after the traveler had knowledge of the trip; (2) less than first-class requires circuitous routing; (3) less than first-class requires travel to begin or end at unreasonable hours (i.e., if scheduled flight time is before 8:00 a.m. and schedule arrival is after 9:00 p.m.); (4) less than first-class would result in additional direct costs which would offset the transportation savings; or (5) less than first-class will not make mailto:Kristin.Wedding@fda.hhs.gov connections with other flights or means of transportation for continuation of the journey.

b. Cost of rail travel by most direct route, first-class with lower berth or nearest equivalent.

c. Travel by motor vehicle including rented automobile shall be reimbursed on a reasonable actual expense basis, or at the Contractor’s option, on a mileage basis at the current rate shown in the GSA Federal Travel Regulation, plus any toll or ferry charges.

d. Reasonable subsistence not in excess of actual itemized expenses not to exceed the ceiling in the Federal Travel Regulations in effect at the time of incurred cost.

G.6 Contractor Performance Assessment Report

During the life of this agreement, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov. The ordering Contracting Officer will evaluate Contractor performance on each individual order.

G.7 Printing and Duplicating/Copying

The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing, CFR Title 44. The regulations can be access at http://www.gpo.gov/pdfs/customers/sfas/jcpregs.pdf.

Printing:

No printing by the Contractor or any subcontractor is authorized under this contract. All printing required hereunder must be performed by the Government Printing Office, in accordance with CFR Title 44; Public Law 102-392, as amended by H.R. 4454; and The Legislative Branch Appropriations Act 2995. The Contractor shall complete Form HHS 26 and submit it along with all camera-ready copies to the Contracting Officer’s Representative (COR).

Duplicating/Copying:

If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10-3/4 by 14-1/4 inches. This page limit is per requirement and not per contract.

All printing, as well as duplicating/copying in excess of the stated limits, shall be obtained by the COR through the Publishing Services, Program Support Center. The cost of any unauthorized printing or duplicating /copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

H. SPECIAL CONTRACT REQUIREMENTS (AS NUMBERED IN BOA)

H.1. Organizational Conflict of Interest

a. General: The Contractor shall have programs in place to identify, report, and mitigate actual and potential conflicts of interest for itself, its employees, subcontractors and consultants. The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.

b. Disclosure: The Contractor shall report all actual and potential conflicts of interest pertaining to this contract to the Contracting Officer, including those that would be caused by a contemplated modification to this contact or another contract. Such reports shall be in writing (including by email). Upon request, the Contractor shall respond to a Contracting Officer’s request for an OCI mitigation plan.

c. Resolution: In the event the Contracting Officer determines that a conflict of interest exists, based on disclosure from the Contractor or from other sources, the Contracting Officer shall take action which may include, but is not limited to, requesting a mitigation plan from the Contractor, terminating part or all of the contract, modifying the contract or obtaining a waiver in accordance with applicable law, including FAR 9.503 as applicable.

H.2 Additional Clauses

H.2.1 Reporting:

The Contractor agrees that the final report containing the results of work performed under this contract (the “Report”) shall not identify by name a manufacturer, private labeler, or particular trademark or trade name of a consumer product. Prior to any public disclosure or publication of the Report, and solely to ensure that the Report does not identify by name a manufacturer, private labeler, or particular trademark or trade name of a consumer product, the Contractor shall submit the Report to the FDA for review in accordance with FDA regulations. In connection with this review, the FDA will redact from the Report the names of specific manufacturers and private labelers and the identity of a particular trademark or trade name of a consumer product.

The FDA, however, will not comment, opine, or redact any of the scientific findings, analyses, or conclusions contained in the Report. At all times, the FDA will comply with government-wide and agency-specific scientific integrity laws, regulations and policies.

H.2.2 Contractor Compliance:

The Contractor may be reimbursed for direct and indirect costs (indirect rates are not-to-exceed the currently approved HHS rates) incurred in the performance hereof as are allowable under the provisions of Subpart 31.7 of the Federal Acquisitions in the no-to-exceed amount of $1,069,760 which is subject to the Limitations of Cost Clause. The Contractor may request monthly interim payments for costs incurred during the performance of the contract. A statement of costs incurred by the Contractor in the performance of tasks under this contract and claimed to constitute allowable costs will support each monthly interim payment request. Each monthly interim payment request will be submitted in accordance with the below invoice instructions. Prior approval of the COR is required if the Contractor wishes to use a different payment request format.

In accordance with the clause 52.232-25, “Prompt Payment,” monthly interim payments will be made by the 30th day following receipt of proper request for payment by the designated billing office, unless audit or other review is considered necessary to ensure compliance with the terms and conditions of the contract. All interim payments hereunder will be made upon further determination by the COR that the Contractor is making adequate progress toward successful contract completion.

H.2.3 Contractor Compliance

a. General: The Contractor will have programs in place to identify, report, and mitigate actual and potential conflicts of interest for itself, its employees, subcontractors and consultants. The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.

b. Disclosure: The Contractor will report all actual and potential conflicts of interest pertaining to this contract to the Contracting Officer, including those that would be caused by a contemplated modification to this contact or another contract. Such reports will be in writing (including by email). Upon request, the Contractor shall respond to a Contracting Officer's request for an OCI mitigation plan.

c. Resolution: In the event the Contracting Officer determines that a conflict of interest exists, based on disclosure from the Contractor or from other sources, the Contracting Officer will take action which may include, but is not limited to, requesting a mitigation plan from the Contractor, terminating part or all of the contract, modifying the contract or obtaining a waiver in accordance with applicable law, including FAR 9.503, as applicable.

H.2.4 Conformance with Applicable Laws, Regulations, Policies, and Standards

Contractor Compliance

The Contractor will be responsible for knowledge of, and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at:

http://www.hhs.gov/oirm/ http://www.cio.gov/ http://www.hhs.gov/oirm/

H.2.5 Printing, Duplicating & Copying

Contractor Compliance

The terms "printing" and "duplicating/copying" are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing, CFR Title

44. The regulations can be access at http://www.gpo.gov/pdfs/customers/sfas/jcpregs.pdf.

a. Printing: No printing by the Contractor or any subcontractor is authorized under this contract. All printing required hereunder must be performed by the Government Printing Office, in accordance with CFR Title 44; Public Law 102- 392, as amended by H.R. 4454; and The Legislative Branch Appropriations Act 2995. The Contractor will complete Form HHS 26 and submit it along with all camera-ready copies to the Contracting Officer's Representative (COR).

b. Duplicating/Copying: If necessary for performance of the contract, the Contractor may duplicate or copy fewer than 5,000 production units of only one page, or fewer than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10-3/4 by 14-114 inches. This page limit is per requirement and not per contract.

All printing, as well as duplicating/copying in excess of the stated limits, will be obtained by the COR through the Publishing Services, Program Support Center. The cost of any unauthorized printing or duplicating /copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

http://www.gpo.gov/pdfs/customers/sfas/jcpregs.pdf

I. CONTRACT CLAUSES: (The BOA lists all Applicable Contract Clauses)

I. 1. FAR 52.217-8 Option to Extend Services

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days of contract completion.

I.2. FAR 52.203-99, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (FEB 2015) (DEVIATION 2015-02)

(a) The Contractor shall not require employees or subcontractors seeking to report fraud, waste, or abuse to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The contractor shall notify employees that the prohibitions and restrictions of any internal confidentiality agreements covered by this clause are no longer in effect.

(c) The prohibition in paragraph (a) of this clause does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(d)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), use of funds appropriated (or otherwise made available) under that or any other Act may be prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(2) The Government may seek any available remedies in the event the contractor fails to comply with the provisions of this clause.

I.3. HHSAR Anti-Lobbying

Pursuant to the current HHS annual appropriations act, Public Law 112-74, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

1. Publicity or propaganda purposes;

2. The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any State or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any State or local •government, except in presentation to the executive branch of any State or local government itself; or

3. Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any State government, State legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a State, local or tribal government in policymaking and administrative processes within the executive branch of that government.

The prohibitions in subsections (a), (b) and (c) above shall include any activity to advocate or promote any proposed, pending or future Federal, State or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

SECTION J - List of Attachments – N/A

SECTION K - Representations, Certifications, and Other Statements of Offerors or Respondents

K.1 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2017)

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is 541990.

(2) The small business size standard is $15,000,000.

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in the System for Award Management (SAM), and has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

□ (i) Paragraph (d) applies.

□ (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)(1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain

Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal

Confidentiality Agreements or Statements-Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

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(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations— Representation.

(vii) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(viii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(ix) 52.214-14, Place of Performance—Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(x) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xi) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(xii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xiv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xvi) 52.222-57, Representation Regarding Compliance with Labor Laws (Executive Order 13673). This provision applies to solicitations expected to exceed $50 million which are issued from October 25, 2016 through April 24, 2017, and solicitations expected to exceed $500,000, which are issued after April 24, 2017.

Note to paragraph (c)(1)(xvi): By a court order issued on October 24, 2016, 52.222-57 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

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(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals– Representation. This provision applies to solicitation that include the clause at 52.204-7.

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American—Free Trade Agreements—Israeli Trade Act Certificate.

(Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $77,533, the provision with its Alternate II applies.

(D) If the acquisition value is $77,533 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan—

Certification. This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certifications. This provision applies to all solicitations.

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.] __ (i) 52.204-17, Ownership or Control of Offeror.

__ (ii) 52.204-20, Predecessor of Offeror.

__ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End

Products.

__ (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment- Certification.

__ (v) 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification.

__ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material

Content for EPA–Designated Products (Alternate I only).

__ (vii) 52.227-6, Royalty Information.

__ (A) Basic.

__(B) Alternate I.

__ (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1197892 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137850 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1169013 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1192900 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1169071 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1169038 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1169193 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1169151 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1181379 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1188714 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1169667 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1152369 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1152940 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160855 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1152427 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162560 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1168892 https://www.acquisition.gov/sites/default/files/current/far/html/52_227.html#wp1139116 https://www.acquisition.gov/sites/default/files/current/far/html/52_227.html#wp1145584 https://www.acquisition.gov/ paragraph (c) of this provision have been entered or updated within 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 the changes identified below [offeror to insert changes, identifying change by clause number, title, date].

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.

FAR CLAUSE # TITLE DATE CHANGE

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 on SAM.

(End of provision)

K.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)

(a) Definitions. As used in this provision—

“Administrative proceeding” means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

“Federal contracts and grants with total value greater than $10,000,000” means—

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

“Principal” means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager;

head of a division or business segment; and similar positions).

(b) The offeror [ ] has [ ] does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

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(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in—

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if…