FDA-19-RFP-119774.pdf

Document Type: Request for Proposal Solicitation Number: FDA-19-RFP-119774 Subject: Economic Studies of FDA Regulations Posted Date: May 14th, 2019 Questions Date: May 21st, 2019 Response Date: June 4th, 2019 NAICS Code: 541690- Other Scientific and Technical

Consulting Services

Contracting Activity

DHHS/FDA/OAGS/DAP

Attn: Christopher R. McGucken 4041 Powder Mill Road Beltsville, MD 20705-4304

PART 1: DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued. FAR Provisions and Clauses set forth herein are current though Federal Acquisition Circular (FAC) The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2019-01 effective Jan 22, 2019. The North American Industrial Classification System (NAICS) code for this procurement is 541690, Other Scientific and Technical Consulting Services.

PART 2: SUPPLIES /SERVICES AND PRICES

2.1 Brief Description of Supplies or Services

The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in a requirement titled, “Economic Studies of FDA Regulations” as further defined in the Statement of Work (SOW) contained herein.

2.2 Pricing Schedule

(See Attachment 1- Pricing Schedule)

2.3 Contract Type

The Government intends to make award to no more than two (2) awardees as a multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) contract with a five (5) year ordering period (i.e., base year and four 1-year option periods).

The Government may use a variety of task order types when issuing orders under this contract, including: Firm-fixed Price (FFP), Time and Materials (T&M), Labor Hour (LH), or a combination thereof. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of contract type.

2.4 Pricing Terms

The agreed upon negotiated labor rates shall be fixed for the duration of this contract. Labor rates proposed for each task order issued against the resulting IDIQ contract must be in accordance with the defined labor categories and fixed labor rates. If a task order’s stated period of performance must be extended as a result of a Government delay the Contractor may request that the most current labor rates be used to price the work effort during the extended period. However, in no event shall the Contractor perform, or be paid for any work which exceeds the stated not to exceed dollar amount of a task order.

For Firm-Fixed Price (FFP) task orders issued under this contract, the applicable FFP for a task order shall be based on a combination of the proposed level of effort and fixed labor rate for labor mix proposed. The total FFP is the amount agreed upon by the Government and the Contractor at the time the task order is issued.

Each Time and Material or Labor Hour task order shall contain a ceiling price. The Contractor shall comply with FAR 52.232-7 in regard to the ceiling price for the individual task order(s).

2.5 Minimum and Maximum Quantities

The minimum guarantee under this IDIQ Contract is $1,000.00. The maximum aggregate dollar value of task orders awarded over the 5-year IDIQ ordering period shall not exceed the established ceiling of $9.9 million.

Part 3: STATEMENT OF WORK/SPECIFICATIONS/DESCRIPTION

3.1 Background

The Economics Staff of the Food and Drug Administration’s (FDA) Office of Planning (OPl) has a requirement to provide accurate and timely economic assessments of FDA regulatory actions. These analyses have high public visibility and, therefore, must withstand intense scientific and technical review and scrutiny by diverse audiences including the public, regulated entities, Government agencies such as the Department of Health and Human Services and the Office of Management and Budget, the U.S.

Congress, professional economists, and the scientific and medical community. The need of the Economics Staff for support by a contractor arises from the variety and complexity of the work, the need to have access to specialized resources to rapidly gather data to meet tight deadlines, and the need for research involving direct contact with regulated entities.

3.2 Objective

The objective of this contract is to provide FDA with accurate information, data, and analytical models for use in assessments of the economic impacts of FDA actions or contemplated actions.

3.3 Scope of work

Activities under the proposed contract shall include, but are not limited to, the following:

A. Methods - While the economic impact of certain FDA regulatory actions can be analyzed via established methods, other FDA initiatives will require novel analytical approaches to evaluate potential effects. For example, estimating the societal effects of initiatives to modernize FDA’s regulatory oversight of product safety and efficacy may require innovative approaches to collect or generate data, such as Internet panels, laboratory or field experiments, expert elicitations, contingent valuation, and data-based simulations.

B. Baseline Measurement - The FDA needs data on the economic characteristics of regulated industries, so that changes in regulatory policies can be empirically examined. This data will include, for example, the number, size, and location (domestic or foreign) of firms and their employment, sales, and number of stock keeping units (labels). In some instances, industry profile studies require supporting documentation for OMB survey clearance procedures.

C. Estimating Effects of Potential Regulatory Actions. The agency’s planned regulatory agenda includes numerous potential regulations that would have economic consequences. The FDA requires data and models that can be used to estimate the effects likely to be associated with many different policies and provisions that could become regulations. These effects include the distribution of behavioral changes of consumers and producers in response to potential agency actions and the changes in risk that would result.

3.4 Statement of Work

A. Analyses and Evaluations to be performed by Contractor:

1. Conduct baseline assessment of industry characteristics, including, but not limited to, estimating employment levels, profits, prices, competitive structure, domestic and foreign location, and industry practices (or performance), including all international effects. The baseline should include projected changes over time.

2. Develop methods and collect data to estimate the economic costs of existing or potential regulatory actions. FDA regulations may alter the expected use of a product, as well as result in higher costs of manufacture or distribution. Each component of these costs shall be identified, defined, and quantified, with all data compiled and sorted to facilitate statistical analyses.

3. Develop methods and collect data to estimate the reduction in risk attributable to existing or potential regulatory actions and assess any potentially offsetting increases in risk.

4. Develop methods and measures of the effects of regulations and other exogenous factors on innovation and productivity. R&D and future innovation may be either encouraged or hindered by regulatory requirements.

5. Develop methods and measures of the effects on the competitive vitality of small business in accordance with requirements of the Regulatory Flexibility Act. Many of the firms FDA regulates are small. Record keeping and reporting requirements, for example, may impose disproportionate effects on smaller businesses, because fixed costs are spread over a smaller sales base. FDA is required by law to take these effects into account and to grant regulatory relief, where possible, to small firms.

6. Develop adaptable methods and databases that can cover various regulatory alternatives. Many new options to meet stated objectives arise during regulation development. A critical task is to develop general methods and databases that can be applied to assess the effects of these options as they are proposed or considered.

7. Develop methods and empirical measures for a section in regulatory analyses in which FDA states prospectively how it will measure the effectiveness of regulations over time. These measures will meet the need for retrospective reviews.

B. Anticipated Areas of Analyses for which Task Orders May be Issued to the Contractor:

The following list illustrates the kind of economic research that will be requested. Actual task orders will reflect agency priorities at the time of initiation. The contractor shall demonstrate the ability to conduct analyses for both quick response and long range studies.

1. FDA may implement new initiatives to strengthen the review of medical products throughout their life-cycle, to reduce medical product errors and to further protect the safety or integrity of food, human and veterinary drug products, biological products and medical and radiation emitting devices. Evaluating these actions may require surveying the industry (including domestic and foreign producers) to describe baseline conditions, collecting baseline risk information, assessing the potential of various interventions to reduce risk, and assessing the potential of various interventions to have unintended consequences that increase risks.

2. FDA regulates many retail products. To better assess baseline conditions in the markets for these products, FDA may need data on the number of products in one or more of these categories, including OTC drugs, retail medical devices, and traditional and non-traditional tobacco products.

3. FDA is interested in assessing the validity of the growing number of cost effectiveness analyses prepared by pharmaceutical companies. The contractor would assist in the development of appropriate methodologies.

4. FDA is interested in assessing the effects of requiring informational or warning labels on consumer labeling. The contractor would assess the behavioral responses of consumers and domestic and foreign industry to different proposed labels for the different product categories regulated by FDA.

5. The products and components of many products regulated by FDA are imported. FDA regulations apply equally to imported and domestically manufactured or processed goods. The behavioral responses of foreign firms to FDA regulations, however, may differ greatly from the responses of domestic firms. The contractor would design a model that would incorporate FDA data on foreign firms while predicting the response of foreign firms and imports to regulations that increase costs of production. The contractor would illustrate and validate the model for an existing FDA-regulated product or products.

6. Medical scientists are developing more sophisticated tools and novel technologies that might be used to produce or evaluate FDA regulated products. Such technologies include using pharmacogenomics in drug discovery and development or using advances in biotechnology to develop medical products. The contractor would assist in evaluating the costs and risks associated with regulating novel technologies.

3.5 LABOR CATEGORY DESCRIPTIONS

Project Director

Manages and is responsible for all aspects of a single project, including overseeing quality control.

Communicates clearly and articulately in written and oral form. Assesses complex research questions, applies appropriate economic, statistical and analytic methods, interprets data and presents study results.

The Government has a preference for a Ph.D. in economics or related field, at least ten (10) years of experience in economic analyses and five (5) years of experience managing research projects involving economic analysis, and quantitative methods for this position.

Program Manager

Leads the analysis team, applies appropriate economic, statistical and analytic methods, interprets data and presents study results.

The Government has a preference for an advanced degree in economics or related field, at least ten (10) years of experience in economic analyses and two (2) years of experience managing research projects involving economic analysis and quantitative methods for this position.

Senior Statistician

Plans data collection and sampling plans; analyzes numerical data from experiments, studies, surveys, and other sources; and applies statistical methodology to provide information for scientific research and statistical analysis. Shall assist in the preparation and presentation of results of statistical analyses in written reports.

The Government has a preference for an advanced degree in statistics or equivalent and extensive professional experience providing statistical analysis support for projects similar to the statement of work with at least seven (7) years of experience in statistics and statistical and analytical methods for this position.

Senior Economist

Plans data collection and work requirements with project director; collects and analyzes qualitative and quantitative economic data for studies; applies appropriate mathematical and statistical methodology.

Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a Ph.D. in economics, statistics or equivalent fields and extensive professional experience providing economic analysis support for projects similar to the statement of work with at least seven (7) years of experience in statistics and statistical and analytical methods for this position.

Junior Economist

Collects and analyzes qualitative and quantitative economic data for studies; applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a Bachelor’s degree in economics or related field with some experience in assisting with economic analysis support for projects similar to the statement of work for this position.

Senior Programmer

Plan and organize the computer modeling needs required to complete projects in the statement of work with the Project Director. Write, update and maintain computer programs developed for the economic or other quantitative models required by projects in the statement of work.

The Government has a preference for a Bachelor’s degree in computer science or information technology and professional experience providing IT support for projects similar to the statement of work with considerable experience in IT support.

Junior Programmer

Write, update and maintain computer programs developed for the economic or other quantitative models required by projects in the statement of work.

The Government has a preference for a Bachelor’s degree in computer science or information technology and must have experience with IT support for projects similar to the statement of work for this position.

Senior Analyst

Plans data collection and work requirements with project director; collects and analyzes qualitative and quantitative data for studies; applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a Bachelor’s degree and extensive professional experience providing analytical support for projects similar to the statement of work with at least seven (7) years of experience in providing analytic support for projects similar to the statement of work for this position.

Junior Analyst

Collects and analyzes qualitative and quantitative data for studies; applies appropriate mathematical and statistical methodology and assists in the preparation and presentation of results and written reports.

The Government has a preference for a Bachelor’s degree in a field related to the statement of work with experience in assisting with economic analysis support for projects similar to the statement of work for this position.

Senior Editor

Prepares reports, presentations, and written deliverables for publication by assuring reports are written clearly, adequately documented, well organized, and logically and grammatically correct.

The Government has a preference for a Bachelor’s degree or equivalent experience in technical report writing and editing with at least five (5) years of experience in editing technical documents that are similar to the requirements of the statement of work for this position.

Junior Editor

Assists with preparing reports, presentations, and written deliverables for publication by assuring reports are written clearly, well organized, and logically and grammatically correct.

The Government has a preference for a Bachelor’s degree or equivalent experience in technical report writing and editing with experience in assisting with reviewing and editing of technical documents for this position.

3.6 Inspection and Acceptance

The Contracting Officer’s Representative (COR) will, in accordance with FAR 52.212-4, perform inspection and acceptance of all the services. Inspection and acceptance will be performed at the location identified in individual task orders. Acceptance shall be communicated within 30 days of receipt in writing.

3.7 Deliveries and Performance

3.7.1 Anticipated Deliverables

Note: Actual deliverables and deliverable schedules shall be established in the issuance of each individual task order.

Periodic Progress Reports - The Contractor shall submit one (1) electronic copy of the Progress Report that includes a status update on deliverables, any problems encountered, and suggestions for addressing problems each period. The Periodic Progress Report shall be delivered in accordance with section 4.12 unless determined otherwise by the individual task order.

Interim Draft Work Product - The Contractor shall submit to the COR an Interim Draft Work Product.

Comments on this report will be provided by FDA within fifteen (15) calendar days after receipt. The interim draft work product shall also include:

• A prototype, example, or draft of the work product specified in the task order. The prototype should include preliminary data validation.

• An indication of any current problems which may impede performance and proposed corrective action.

• A description of personnel who have actually worked on this portion of the task and the number of hours worked. Include any current or proposed deviations from the original task proposal and a brief explanation as to why this change is in the best interest of the government.

Draft Final Work Product - The Contractor shall submit to the Contracting Officer a draft final work product, which will be after the completion and approval of FDA’s review of the interim draft work product. The contractor shall also submit, where applicable, PC-compatible raw data collected, software and computer programs for implementation of models, guidance to data and models, and in some instances a final report. Documentation to support datasets should include explanatory materials such as information about the data collection methods and sources, information about the structure of the dataset, complete list of variables, and full details of coding and classifications used. The Contractor shall be prepared to present results to FDA at this point. This draft final work product is subject to the review and approval of FDA. Such approval or disapproval, with any comments, will be provided by FDA within fifteen (15) calendar days after receipt. The draft final work product shall also include:

• An indication of any current problems which may impede performance and proposed corrective action.

• An outline of the work to be accomplished during the reporting period.

• A quantitative description of overall progress and how it relates to earlier work.

• A description of personnel who have actually worked on this portion of the task and the number of hours worked. Include any current or proposed deviations from the original task proposal and a brief explanation as to why this is in the best interest of the government.

Final Work Product - The Contractor shall submit to the COR the final work product which incorporates any recommended revisions and other changes. The Contractor shall also submit, where applicable, PC-compatible raw data, software and computer programs for implementation of economic models, a written guide to data and models, and in some instances a final report. Documentation to support datasets should include explanatory materials such as information about the data collection methods and sources, information about the structure of the dataset, complete list of variables, full details of coding and classifications used, and data validation. The final guide shall include tables, graphs, diagrams, curves, sketches, photographs and drawings as necessary and in sufficient detail to comprehensively explain the creation and use of the work product , which can be a database, model, survey, or a written report.

Deliveries shall be specified in the task orders released under this contract.

3.7.2 Period of Performance

The ordering period of this contract shall be 5 years (i.e., base year and four 1-year option periods).

The period of performance for each task order shall be cited on the task order.

3.7.2.1 Option Periods

The Government may elect to include four one (1) year option periods as described below (exact dates will be adjusted at award):

Option PERIOD BEGINNING Option Period One (1) 1 year after award.

Option Period Two (2) 2 years after award.

Option Period Three (3) 3 years after award

Option Period Four (4) 4 years after award.

3.7.3 Place of Performance

The place of performance will be at the Contractor’s site.

PART 4: Contract Administration Data

4.1 Observance of Federal Holidays & Other Government Closings

No services or deliveries shall be performed at the Federal sites on Federal legal holidays per the Office of Personnel Management (OPM), located at:

https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/#url=Overview

4.2 Key Personnel

Key Personnel will be identified in the individual task orders issued against the resulting IDIQ Contract(s).

4.3 Government Furnished Information (GFI)/Government Furnished Equipment (GFE)

The FDA will specify any GFI and/or GFE requirements in individual task orders (ITOs).

4.4 Contracting Officer

(a) For the IDIQ Contract:

The Contracting Officer for the IDIQ contract shall be:

Richard (Rob) W. Robinson

FDA/OFBA/OAGS/DAP

4041 Powder Mill Road Beltsville, MD 20705-4304 Telephone: (301) 976-6508 E-Mail: Richard.Robinson@fda.hhs.gov

The Contract Specialist for the IDIQ contract shall be:

Christopher R. McGucken

FDA/OFBA/OAGS/DAP

4041 Powder Mill Road Beltsville, MD 20705-4304 Telephone: (240) 402-7566 E-Mail: Christopher.McGucken@fda.hhs.gov

(b) For Task Orders:

The Contracting Officer executing the individual Task Order will retain cognizance of contract administration for that Task Order.

4.5 Contracting Officer’s Authority

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/%23url=Overview https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/%23url=Overview file://ocs04/groupe$/OFACS/OAGS/DAP/DAP2/SSB/FY19%20Actions/McGucken/-02-%20Pre-Solicitation/1197774%20Economic%20Staff%20IDIQ/C.%20Determinations%20and%20Presolicitation%20Clearances/Richard.Robinson@fda.hhs.gov file://ocs04/groupe$/OFACS/OAGS/DAP/DAP2/SSB/FY19%20Actions/McGucken/-02-%20Pre-Solicitation/1197774%20Economic%20Staff%20IDIQ/C.%20Determinations%20and%20Presolicitation%20Clearances/Christopher.McGucken@fda.hhs.gov statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

4.6 Contracting Officer Representative (COR)

The following COR(s) will represent the Government for the purpose of this IDIQ contract: (To be provided at Contract Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its COR designation.

4.7 Task Order Contracting Officer’s Representative (TO COR)

A Task Order Contracting Officer Representative (COR) will be assigned for each task order. The Task Order 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 evaluation as required; (4) performing technical inspections and acceptances required by this contract;

(5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing of invoices/vouchers.

The Task Order COR does not have authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Government may unilaterally change its COR designation.

4.8 Technical Direction

Performance of the work under this contract shall be subject to the technical direction of the Task Order COR. The term “technical direction is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

• Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general Scope of Work stated in the contract. The COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside the general Scope of Work of the contract.

• Constitutes a change as defined in the applicable contract FAR 52.243 clauses set forth herein.

• Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction shall be issued in writing by the COR or shall be confirmed by him/her in writing within 5 working days after issuance.

4.9 Ordering Procedures

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in FAR 52.216-18 “Ordering.” Only Contracting Officers within the Food and Drug Administration’s Office of Acquisitions and Grants Services are authorized to place orders under this contract.

4.10 Task Order Processing

All task orders issued hereunder are subject to the terms and conditions of this contract.

This contract shall control in the event of conflict with any task order. A task order shall be “issued” for purposes of this contract upon the effective date of the order.

The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work in accordance The SOW will include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance.

4. Reporting requirements and Deliverables

b) Requests for Task Order Proposals (RFTOP) shall only be issued by the Contracting Officer.

c) The Contractor shall prepare and submit a task order proposal addressing all areas of the requirement. The Contractor shall submit the task order proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

d) The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

4.11 Invoice Submission

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A. THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO

THE ADDRESS SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

C. Invoices submitted under this contract must comply with the requirements set forth in FAR

Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer / System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

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

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) The contractor shall include the Contract Line Item/Funding line item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment

(xi) Name and telephone number of the FDA Contracting Officer (CO) and the Contracting

Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

file://ocs04/groupe$/OFACS/OAGS/DAP/DAP2/SSB/FY19%20Actions/McGucken/-02-%20Pre-Solicitation/1197774%20Economic%20Staff%20IDIQ/C.%20Determinations%20and%20Presolicitation%20Clearances/fdavendorpaymentsteam@fda.gov

(xii) Any other information or documentation required by the purchase order/award.

C. An electronic invoice shall be in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742)

INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE

REQUIREMENTS SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND

52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER. SYSTEM FOR AWARD

MANAGEMENT (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES

SPECIFIED HEREIN.

4.12 Monthly Progress Reports

The Contractor shall submit progress reports to the COR and the Contract Specialist (CS). These reports shall be prepared on a monthly basis and submitted by the 15th of the month following the reporting period. Each progress report shall contain concise statements covering the activities relevant to the contract, including:

(a) A clear account of the work performed under each task during the report period.

(b) An outline of the work to be accomplished during the next report period.

(c) A description of any problem encountered or anticipated that will affect the completion of any work within the time and fiscal constraints set, together with recommended solutions to such problems;

or, a statement that no problems were encountered.

(d) A tabulation of the actual and cumulative percent of effort expended by the personnel.

The monthly progress reports shall be delivered via email to the Contract Administrator and the Contracting Officer’s Representative (COR) at the following email addresses:

COR: TBD

CA: Christopher.McGucken@fda.hhs.gov file://ocs04/groupe$/OFACS/OAGS/DAP/DAP2/SSB/FY19%20Actions/McGucken/-02-%20Pre-Solicitation/1197774%20Economic%20Staff%20IDIQ/C.%20Determinations%20and%20Presolicitation%20Clearances/Christopher.McGucken@fda.hhs.gov

PART 5: SPECIAL CONTRACT REQUIREMENTS

5.1 Organizational Conflicts of Interest (Simplified)

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

c. The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

5.2 Reporting Matters Involving Fraud, Waste, and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector Generals Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W. Washington, D.C. 20201

Information regarding procedural matters is contained on the HHS/OIG website at http://oig.hhs.gov/hotline.html

5.3 Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation mailto:HHStips@oig.hhs.gov http://oig.hhs.gov/hotline.html becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

5.4 Accountability and Security

All Contractor and subcontractor employees who will have access to Government information and/or sensitive materials must sign a Confidentiality Agreement. It is the responsibility of the Contractor to assure that such Agreements have been signed before access is permitted. Copies of signed agreements should be provided to the TO COR.

5.5 508 Standard Requirements

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm

The contractor is expected to use the existing FDA environment and tools which are already in compliance with 508 standard requirements.

PART 6 - Contract Clauses

FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at:

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018)(Deviation 2018- 01)(March 2018) applies to this acquisition. The following addenda apply:

52.217-8 Option to Extend the Term of the Contract (Mar 2000) “…The Contracting Officer may exercise the option by written notice to the Contractor within 10 days of contract expiration.”

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) “…written notice to the Contractor within 10 days of contract expiration; at least 60 days before the contract expires…” (b)” …shall not exceed Five (5) years…”

52.216-18 Ordering (Oct 1995) (a)” …Such orders may be issued from the first date of the stated contract period through the last date of the stated contract period.” 52.216-19 Ordering Limitations(Oct 1995) (a)” …Minimum order…. supplies or services covered by this contract in an amount less than $1,000.00…” http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(b)”…Maximum order…Contractor is not obligated to honor any order for a single item in in excess of the contract ceiling:…any order for a combination of items in excess of the contract ceiling or;…a series of orders from the same ordering office within three (3) days;

….unless that order (or orders) is returned to the ordering office within three (3) days after issuance…”

52.216-22 Indefinite Quantity (Oct 1995)

52.216-27 Single or Multiple Awards (Oct 1995) 52.232-7 Payments under Time-and-Materials and Labor Hour Contracts (Aug 2012) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.243-1 Changes-Fixed Price (Aug 1987)-Alt I (Apr 1984) 52.243-3 Changes-Time and Materials-Labor Hours (Sept 2000) 52.252-6 Authorized Deviations in Clauses (Apr 1984) (b)”…The use in this solicitation or contract of any

HHS FAR Class Deviation 18-01 (48 CPR Chapter 1, Subchapter H) clause with an authorized deviation is indicated by the addition of “(DEVIATION)” after the name of the regulation...”

HHSAR Clause 352.203-70, Anti-Lobbying (Dec 2015) HHSAR Clause 352.208-70, Printing and Duplication (Dec 2015) HHSAR Clause 352.211-3, Paperwork Reduction Act (Dec 2015) HHSAR Clause 352.219-70, Mentor Protégé Program (Dec 2015) HHSAR Clause 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR Clause 352.224-71 Confidential Information (DEC 2015) HHSAR Clause 352.227-70 Publications and Publicity (DEC 2015) HHSAR Clause 352.231-70 Salary Rate Limitation (DEC 2015) HHSAR Clause 352.237-75, Key Personnel (DEC 2015) HHSAR Clause 352.239-73, Electronic Information and Technology Accessibility Notice (Dec 2015) HHSAR Clause 352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (JAN 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

https://www.acquisition.gov/content/52203-19-prohibition-requiring-certain-internal-confidentiality-agreements-or-statements#i52_203-19 https://www.acquisition.gov/content/52204-23-prohibition-contracting-hardware-software-and-services-developed-or-provided#id189A70O0P1N

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(4) 52.233-3, Protest After Award (Aug 1996) (31U.S.C.3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X_(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C.4704 and 10 U.S.C.2402).

__(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

___(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_(4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub.

L. 109-282) (31 U.S.C. 6101 note).

___(5) [Reserved].

__(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_(8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

_X_(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim).

___(10) [Reserved].

___(11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.657a).

___(i) Alternate I (Nov 2011) of 52.219-3.

https://www.acquisition.gov/content/52209-10-prohibition-contracting-inverted-domestic-corporations#i1062680 https://www.acquisition.gov/content/52233-3-protest-after-award#i1048661 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52233-4-applicable-law-breach-contract-claim#i1048698 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52203-6-restrictions-subcontractor-sales-government#i1063319 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52203-13-contractor-code-business-ethics-and-conduct#i1063504 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52203-15-whistleblower-protections-under-american-recovery-and-reinvestment-act-2009#i1063607 https://www.acquisition.gov/content/52204-10-reporting-executive-compensation-and-first-tier-subcontract-awards#i1064087 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/52204-14-service-contract-reporting-requirements#i1064214 https://www.acquisition.gov/content/52204-15-service-contract-reporting-requirements-indefinite-delivery-contracts#i1064243 https://www.acquisition.gov/content/52209-6-protecting-government%E2%80%99s-interest-when-subcontracting-contractors-debarred-suspended#i1062590 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/content/52209-9-updates-publicly-available-information-regarding-responsibility-matters#i1062651 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/content/52219-3-notice-hubzone-set-aside-or-sole-source-award#i1057314 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/content/52219-3-notice-hubzone-set-aside-or-sole-source-award#i1057314

_X_(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

___(ii) Alternate I (Jan 2011) of 52.219-4.

___(13) [Reserved]

__(14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.644).

___(ii) Alternate I (Nov 2011).

___(iii) Alternate II (Nov 2011).

___(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___(ii) Alternate I (Oct 1995) of 52.219-7.

___(iii) Alternate II (Mar 2004) of 52.219-7.

_X_(16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

_X_(17)(i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4))

(ii) Alternate I (Jan 2017) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Nov 2016) of 52.219-9.

(v) Alternate IV (Aug 2018) of 52.219-9

__(18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__(19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C.637(a)(14)).

_X_(20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X_(22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C.

632(a)(2)).

https://www.acquisition.gov/content/52219-4-notice-price-evaluation-preference-hubzone-small-business-concerns#i1057352 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-4-notice-price-evaluation-preference-hubzone-small-business-concerns#i1057352 https://www.acquisition.gov/content/52219-6-notice-total-small-business-set-aside#i1057393 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-7-notice-partial-small-business-set-aside#i1057419 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-7-notice-partial-small-business-set-aside#i1057419 https://www.acquisition.gov/content/52219-7-notice-partial-small-business-set-aside#i1057419 https://www.acquisition.gov/content/52219-8-utilization-small-business-concerns#i52_219-8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/content/52219-9-small-business-subcontracting-plan#i52_219-9…