FDA-RFP-1168344.pdf

FDA-RFP-1168344

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DATA RESOURCE FOR POST-MARKETING PRESCRIPTION DRUG ABUSE

SURVEILLANCE DATA FROM INDIVIDUALS ENTERING OR BEING ASSESSED FOR

SUBSTANCE ABUSE

TABLE OF CONTENTS

SECTION 1- SUPPLIES AND SERVICES AND PRICES

1.1. SOLICITATION DESCRIPTION

1.2. CONTRACT TYPE

1.3. CONTRACT FUNDING NOTICE

1.4. PRICING

SECTION 2- STATEMENT OF WORK

2.1. BACKGROUND

2.2. OBJECTIVES

2.3. SCOPE OF WORK

2.4. WORK REQUIREMENTS

2.5. DELIVERABLES

SECTION 3- PACKING AND MARKING

SECTION 4- INSPECTION AND ACCEPTANCE

SECTION 5- DELIVERIES AND PERFORMANCE

5.1. PUBLICATIONS AND PRESENTATIONS

5.2. ADDITIONAL RIGHTS IN DATA

5.3. ORDERING PERIOD

5.4. PERIOD OF PERFORMANCE

5.5. OPTION PERIODS

SECTION 6- CONTRACT ADMINISTRATION

6.1. ORDERING PROCEDURES

6.2. CONTRACTING OFFICERS REPRESENTATIVE (COR)

6.3. INVOICE SUBMISSION

6.4. KEY CONTRACTOR PERSONNEL

SECTION 7- SPECIAL CONTRACT REQUIREMENTS

7.1. ADVANCE UNDERSTANDING

7.2. CONTRACTOR PERFORMANCE EVALUATION(S)

7.3. SYSTEM OF AWARD MANAGEMENT REGISTRATION

SECTION 8- CONTRACT CLAUSES

8.1. FAR CLAUSES INCORPORATED BY REFERENCE

8.2. FAR CLAUSES IN FULL TEXT

8.3. HHSAR CLAUSES INCORPORATED BY REFERENCE

8.4. CONFLICT OF INTEREST

8.5. CONTRACTOR ADVERTISING OF CONTRACT AWARD

8.6. TRAVEL COSTS

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SECTION 9- LIST OF ATTACHMENTS

SECTION 10- REPRESENTATIONS, CERTIFICATIONS, AND OTHER

STATEMENTS OF OFFERORS

PART 11- INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

11.1. RESPONSE DATE AND TIME

11.2. PROPOSAL PREPARATION AND INSTRUCTIONS

PART 12- EVALUATION FACTORS FOR AWARD

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SECTION 1 – SUPPLIES AND SERVICES AND PRICES

1.1 SOLICITATION DESCRIPTION

The purpose of this solicitation is to obtain a contract which provides prescription drug abuse summary reports to the U.S. Food and Drug Administration (“FDA”), Center for Drug Evaluation and Research (“CDER”), Office of Surveillance and Epidemiology (“OSE”). In turn, OSE will use the reports to help inform pharmaceutical regulatory and oversight efforts, and abuse prevention programs.

This is a combined synopsis/solicitation for commercial services/items in accordance with FAR Parts 12 and 15. The contemplated contract will be a single-award IDIQ contract. Under the single-award IDIQ contract, FDA will issue fixed-price and labor hour task orders for specific reports. The expected duration of the contract will be a base year with four option years. The value ceiling for the contract is $10 Million. The guaranteed minimum is $200, which shall be provided as part of the compensation for the first task order. The source selection technique is lowest-price technically acceptable (“LPTA”). The solicitation is unrestricted.

The North American Industrial Classification System (“NAICS”) code for this procurement is 541990. The associated Small Business size standard is $15 Million.

1.2 CONTRACT TYPE

Single-award IDIQ with Fixed Price and Labor Hour Task Orders

1.3 CONTRACT FUNDING NOTICE

FAR Clause 52.232-18 (Availability of Funds (APR 1984)) is incorporated into the contemplated contract.

1.4 PRICING

As part of its proposal, an offeror shall determine its total price based on the pricing table provided at Attachment C. Accordingly, the offeror shall fill-in the blank fields in the Attachment C pricing table and return the completed attachment as part of the offeror’s proposal.

The pricing table requires that the offeror provides its best per hour labor rate for each labor category across all five years of contract performance. The labor rates must be fully loaded, as in each per hour rate must include applicable overhead costs, fringe costs, G&A costs, profit, taxes, surcharges, etc. The provided labor rates will be the labor rates which the contractor must apply during contract performance. Consequently, the awardee will not be able to propose cost adjustments or profit mark-up on top of its labor rates when it later proposes in response to each task order.

As per the pricing table, the offeror’s labor rates are multiplied by pre-set quantities in order to obtain sub-totals, and in turn those sub-totals are added together to obtain a total evaluated price. To be clear, the IDIQ total evaluated price is a price that is constructed

- 4 -for evaluation purposes to ensure that FDA can make an apples-to-apples comparison of offerors’ total prices. However, as already stated, the actual value ceiling for the contract is $10 Million, and the quantities (number of hours) provided in the Attachment C pricing table are not guaranteed quantities. The actual quantities will be determined as Agency needs arise during contract performance.

In view of the foregoing, do not adjust the pre-set quantities in the pricing table. If the offeror changes any of the pre-set quantities in the pricing table, fails to provide any per hour or per unit pricing, otherwise fails to provide a total price, or adds labor categories or activities to the pricing table, the offeror’s proposal shall be discarded as unacceptable and given no further consideration.

Additionally, the proposal must provide a fixed price, as in the pricing provided must not be conditioned upon taxes, surcharges, or some other reservation which would prospectively change the price. Of note, the proposal only being valid for 180 days is an acceptable exception to the preceding statement. However, during contract performance, the FDA making changes to the quantities ordered under the IDIQ portion of the contract will not justify an adjustment to a offeror’s labor rates.

In sum, the failure of a offeror to proposal a fixed price will result in the proposal being discarded as unacceptable.

In conclusion, please comply with the pricing table provided at Attachment C.

SECTION 2 – STATEMENT OF WORK

2.1 BACKGROUND

A vital part of the FDA’s and CDER’s mission is to protect the public health. As part of this, the mission of the Office of Surveillance and Epidemiology (“OSE”) is to evaluate drug risks and promote the safe use of drugs by the American people. The statutory provisions of the Federal Food, Drug, and Cosmetic Act of 1938, as amended by the Food and Drug Administration Modernization Act (“FDAMA”), Section 406, and 21 C.F.R. §§ 310.305 and 314.80, require FDA to ensure the safety and effectiveness of regulated marketed products. Additionally, Title IX of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) contains numerous provisions related to post-marketing safety and communication of safety information. A subset of those provisions calls for enhanced authorities for post-marketing studies, expanded pharmacovigilance, and active surveillance activities. This includes the authority to develop methods to obtain reports from disparate data sources, establish and improve procedures to identify data trends and patterns for pharmacovigilance and active surveillance activities, and improve transparency of information about drugs by providing summaries of data collected by pharmacovigilance systems.

By way of further background, FDA’s authority to fund research projects is set out in section 301 of the Public Health Service Act (“PHSA”) at 42 U.S.C. § 241. The enactment of the Prescription Drug User Fee Act V (“PDUFA V”) in 2012, Section XI, Enhancement and Modernization of the FDA Drug Safety System, Part D, Information Systems and Infrastructure, authorizes FDA to “continue the Agency’s effort on the standards-based information system to support how FDA obtains and analyzes post-market drug safety data and manages emerging drug safety information[.]” These statutory provisions provide FDA the authority to obtain and expand database resources

- 5 -that will enhance FDA’s post-market surveillance capabilities.

One area that has emerged in recent years as a high priority for post-marketing safety surveillance is abuse and overdose related to prescription drugs, particularly opioid analgesics (painkillers). The recent HHS report—“Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities”—summarizes both the current public health crisis with respect to opioids and actions that can be taken to address this epidemic. The annual number of drug overdose deaths has increased fivefold since 1980 and now outnumbers deaths due to motor vehicle crashes. Prescription opioid-related overdose deaths also now outnumber deaths due to all illicit drugs combined, including heroin and cocaine. The HHS report suggests a variety of actions that can be taken to combat prescription drug overdose, including building the evidence base for prescription drug abuse prevention programs, leveraging health information technology to reduce abuse, and improving analytic tools for regulatory and oversight purposes.

FDA is tasked with acquiring, assessing, and responding to post-marketing epidemiologic data related to the misuse and abuse of pharmaceutical products, including opioid analgesics. As such, the Agency has identified five abuse-related outcomes that are relevant to the post-marketing surveillance of opioid analgesics and other products with abuse potential: misuse; abuse; addiction; overdose; and death.

Studying prescription drug abuse presents unique challenges. The path from prescription to abuse and related adverse outcomes is more complicated than with other types of medications. Therefore, typical pharmacoepidemiologic data sources and study designs are not sufficient, and non-traditional data sources and methods must be employed. FDA currently does not have access to reports from any database capable of measuring the abuse of specific pharmaceutical products in an ongoing fashion. Although no single data source can capture all the abuse-related outcomes of interest, or all individuals at-risk for these outcomes, reports from data collected from individuals entering or being assessed for treatment of substance use disorders will be a source of valuable information on the abuse of individual pharmaceutical products as well as overall patterns and trends in prescription drug abuse in the United States.

2.2 OBJECTIVES

The specific objectives of this effort are for the FDA to obtain post-marketing prescription drug abuse surveillance data summary reports and analytical datasets generated from aggregated data from individuals entering or being assessed for substance abuse treatment.

Accordingly, the envisioned contract has the following programmatic goals.

A. Provide FDA personnel with bi-annual summary reports from post-marketing prescription drug abuse surveillance data from individuals entering or being assessed for substance abuse treatment.

B. On order, provide to the FDA ad-hoc reports and/ or analytical datasets as required or requested based on items of regulatory interest.

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2.3 SCOPE OF WORK

The FDA is seeking reports from a commercially available surveillance data resource on prescription drug abuse collected from individuals entering substance abuse treatment or being assessed for substance abuse disorders. Because of the unique clinical and cultural characteristics of substance abuse, the source population for the database is restricted to the United States. For the purposes of the contemplated contract, the United States is defined as the fifty states and the District of Columbia. It expressly excludes the U.S.

Virgin Islands, the Commonwealth of Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and Wake Island. For each task order report, FDA will define the parameters of the report—demographics of the population segment, the abused drug(s) or active pharmaceutical ingredient(s) (e.g., oxycodone, hydrocodone, oxymorphone, methadone, etc.), data on assessment/treatment facilities, descriptions of assessment tools and patient outcomes, and possibly other data elements as discussed below, in the Attachment B (Data Characteristics Table), or developed by FDA and the contractor later. Section 2.4.1.1 establishes minimum mandatory data requirements. To be clear, the data sought in reports may exceed the minimum mandatory data requirements. For example, FDA may request reports on more pharmaceutical products than buprenorphine, fentanyl, heroin, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, tapentadol, and tramadol. Indeed, any Orange Book prescription drug susceptible to abuse, other than the aforementioned, may fall within the parameters of a report. That said, the majority of abused prescription drugs are opioids and drugs that affect the central nervous system, so that is the anticipated focus of the reports. Additionally, FDA may seek a report which requests more demographic information than age, ethnicity/race, sex, and geographic location—such as employment status, education level, occupation, or gender. In sum, the minimum mandatory data requirements establish a floor for the sought data, but it is not a ceiling.

2.4 WORK REQUIREMENTS

2.4.1 GENERAL INFORMATION

To be clear, under the contemplated contract, FDA is not funding a contractor to develop a drug abuse surveillance system. Rather, FDA expects any qualified organization to already have access to the relevant data, as well as possess the means to manage the data collected from individuals being assessed for substance abuse treatment. Further, FDA expects any qualified organization to already have an effective system for collecting, validating, and analyzing the relevant data. The collected data shall contain subject-level demographic information including age, sex, ethnicity/race, etc., as well as product-specific primary and secondary substances of abuse. In addition, the assessment facility type and geographic location shall also be available. In sum, FDA is not trying to re-invent the wheel, but make use of a contractor that already commercially performs this type of work.

2.4.1.1 MINIMUM MANDATORY DATA REQUIREMENTS

• The Contractor shall own, or have access to and be able to use in reports, population-based, de-identified (does not include the person’s name or other PII) data collected from individuals either entering or being assessed for substance

- 7 -abuse treatment within the United States. The United States is defined as the fifty states and the District of Columbia. It expressly excludes the U.S. Virgin Islands, the Commonwealth of Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and Wake Island. The geographical location should be further categorized based upon the four census regions—Northeast (CT, ME, MA, NH, NJ, NY, PA, RI, and VT); Midwest (IL, IN, IA, KS, MI, MN, MO, NE, ND, OH, SD, and WI); South (AL, AR, DE, DC, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, and WV); and West (AK, AZ, CA, CO, HI, ID, MT, NV, NM, OR, UT, WA, and WY). Although not every state must be represented by the available data, the data must come from a majority of the states and represent large and diverse geographic regions from which results can reasonably be expected to represent national patterns and trends. The Contractor must maintain the data access capability throughout the entire period of performance.

• The database shall contain a minimum of 50,000 individual subjects as of

December 31, 2015, cover all four U.S. census regions, and shall continue prospective data collection throughout the duration of the contract. The individual subject data must, at a minimum, include the following—subject level information on particular abused pharmaceutical products by active pharmaceutical ingredient (e.g., molecule); subject demographic characteristics;

assessment/treatment facility information by subject; and relevant technical documents. At a minimum, covered pharmaceutical products must include buprenorphine, fentanyl, heroin, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, tapentadol, and tramadol. At a minimum, subject demographic characteristics must include age, ethnicity/race, sex, and geographic location. At a minimum, assessment/treatment facility information must include the facility type, geographic location, funding sources, description of services offered, and client counts/estimates by treatment program. Facility information should be consistent with what the treatment centers provide for the SAMHSA N-SSATS survey. Finally, the relevant technical documents should include information such as data dictionaries and collection instruments. A data dictionary describes the collected data, and how that data are organized, formatted, or used (e.g., a code key for classifying the data). A collection instrument is the exact means by which the data are collected. In the case of a survey or intake questionnaire, it is the battery of questions used to solicit the data.

• The Contractor shall own, or have access to and be able to use in reports, a minimum of six years of historical data (from 2010 to the present). That historical data must, at a minimum, include the following—subject level information on particular abused pharmaceutical products by active pharmaceutical ingredient (e.g., molecule); subject demographic characteristics;

assessment/treatment facility information by subject; and relevant technical documents. At a minimum, covered pharmaceutical products must include buprenorphine, fentanyl, heroin, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, tapentadol, and tramadol. At a minimum, subject demographic characteristics must include age, ethnicity/race, sex, and geographic location. At a minimum, assessment/treatment facility information by subject must include the facility type, geographic location, funding sources, description of services offered, and client counts/estimates by treatment program.

Facility information should be consistent with what the treatment centers provide

- 8 -for the SAMHSA N-SSATS survey. Finally, the relevant technical documents should include information such as data dictionaries and collection instruments.

A data dictionary describes the collected data, and how that data are organized, formatted, or used (e.g., a code key for classifying the data). A collection instrument is the exact means by which the data are collected. In the case of a survey or intake questionnaire, it is the battery of questions used to solicit the data.

2.4.1.2 GOVERNMENT DATA RIGHTS AND CONTRACTOR NON-

DISCLOSURE OF REPORTS

FAR Clause 52.227-14 (Rights in Data-General (MAY 2014)) shall be included in the contract. The clause provides that for any data developed elsewhere that the contractor includes in the reports, the Government shall receive the rights specified at FAR Clause 52.227-14(c)(1)(iii). These rights include a paid-up, nonexclusive, irrevocable, worldwide license to reproduce, prepare derivative works, perform and display publicly, and distribute copies to the public. Additionally, for all other aspects of the reports, including data first developed under the contract, the Government shall receive unlimited rights as specified at FAR Clause 52.227-14(b). In view of the foregoing, the FDA shall have the right to publish the reports, or any segment of the reports, or any of the data, as the FDA sees fit.

In keeping with FAR Clause 52.227-14(d)(2), the contractor has no right to use, release to others, reproduce, distribute, or publish any report, or any segment of any report, except as is necessary to perform the contract, or where given express permission by the FDA. Additionally, the contractor may not assert copyright to data first produced in the performance of the contract, or any FDA report, or publish scientific and technical articles based upon the FDA’s reports, unless the Contracting Officer has first granted express permission for the contractor to do so.

Basically, if the contractor wants to do anything with any of the reports, or any segment of the reports, or any data first developed under the contract, the contractor should first seek permission from the FDA.

If the contractor wishes the FDA to obtain less than the rights specified at FAR Clause 52.227-14(c)(1)(iii) for data which is not first produced in the performance of the contract, the contractor may make that request to the Contracting Officer during contract performance. Although the Contracting Officer may or may not grant the request, the Government understands that there could be significant issues with not limiting the Government’s data rights which the Government cannot anticipate.

2.4.2 CONTRACTOR LABOR CATEGORIES TO PERFORM THE

STATEMENT OF WORK

The following labor categories apply to the work to be performed under the contemplated contract. Each labor category description is somewhat general, allowing an offeror some flexibility as to the details of performance under each labor category. Nonetheless, at the formation of the master contract, an offeror will be asked to commit to per hour pricing for each labor category. Further, an offeror will respond to task orders by providing quantities of labor hours against these labor categories. Furthermore, because each task

- 9 -order shall either be a fixed price or labor hour task order, and the cost of materials is expected to be negligible and/or incidental, the per hour pricing for each labor category should be loaded with the costs of any materials necessary to perform the work.

Labor Category Description Project Manager - Leads team on large projects or significant segment of large complex projects

- Analyzes new and complex project related problems and creates innovative solutions involving finance, scheduling, technology, methodology, tools, and solution components

Senior Computer Systems Analyst

- Analyze science, engineering, business, and other data processing problems to implement and improve computer systems. Analyze user requirements, procedures, and problems to automate or improve existing systems and review computer capabilities, workflow, and scheduling limitations. May analyze or recommend contractor software usage/upgrades.

Statistician - Experience and training in statistics or related areas. Demonstrated record of supporting development and delivery of presentations, publications, and reports on specific programs or technically complex subjects.

- An economist/statistician is responsible for performing work of a technically complex nature in the areas statistics, including regulatory impact analysis, risk assessment, statistical analysis, sampling, survey design and implementation, reviews the work of other staff.

Pharmacist - Dispense drugs prescribed by physicians and other health practitioners and provide information to patients about medications they use. May advise physicians and other health practitioners on the selection, dosage, interactions, and side effects of medications.

Epidemiologist - Epidemiologists investigate the causes of disease and other public health problems to prevent them from spreading or from happening again. They report their findings to public policy officials and to the general public.

Survey Scientist - Survey scientists design surveys and analyze data and include conducting background research on survey topics, plan and design surveys and determine appropriate survey methods, test surveys to make sure that people will understand the questions, coordinate the work of survey interviewers and data collectors, account for and solve problems caused by non-respondents or other sampling issues, analyze data using statistical software and techniques, and summarize survey data using tables, graphs, and fact sheets.

Subject Matter Expert - Expert in the field of substance abuse and overdose prevention related to prescription drugs, particularly opioid analgesics.

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2.4.3 TASKS AND DELIVERABLES

2.4.3.1 KICK-OFF MEETING

The Contractor shall participate in a kick-off meeting following award. The kick-off meeting shall be at the contractor’s office/facility. Consequently, the contractor should plan accordingly. The kick-off meeting is currently planned to be within two weeks following award, but that may change depending on the circumstances. In order to ensure an equal footing for offerors, a block price for the kick-off meeting is provided on the Attachment C pricing table.

2.4.3.2 PROJECT PLAN

The contractor shall submit a Project Plan at the start of the collaboration that addresses the following areas: Risk Management; Requirements Management; Quality Management; Staffing and Project Organization. The Project Plan shall identify study team members and contact information (e-mail addresses and phone numbers). Further, the contractor shall provide a primary point of contact for the collaboration between the FDA and the contractor. Furthermore, to the extent that the FDA has provided sufficient detail regarding initial reports, the Project Plan shall include a timeline for the project clearly identifying major project activities and their expected duration. Please see the pricing table for more details.

The Project Plan shall also include a FAR 37.604 Quality Assurance Surveillance Plan (QASP). Accordingly, the contractor shall develop and maintain an effective Quality Assurance Surveillance Plan (QASP) to ensure that the reports being provided are in accordance with the SOW and applicable task orders. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of inaccurate, incomplete, or duplicative data, or flawed analysis of the data. The QASP shall be the means by which the contractor assures that work complies. As part of this, at a minimum, the contractor shall develop QASP procedures addressing the areas listed below. After FDA accepts the contractor’s QASP, the contractor must obtain the contracting officer’s acceptance in writing of any proposed change to the QC system.

Reporting Event Standard Method of Surveillance

For any circumstances resulting in loss of, or lack of, Contractor access to a significant data source as well as any other significant problems or changes the Contractor shall notify FDA

Within 14 business days of the contractor’s knowledge of the loss or lack of Contractor access to data from the database; notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics and provided in a written report to the FDA.

COR and staff shall review and document impact on dataset quality.

Full disclosure of any updates for data collection, coding, and configuration methods and changes

Within 14 business days of the contractor’s knowledge; notification shall include notification shall include percentage of missing or incomplete information for the basic

COR and staff shall review dataset quality and document impact to appropriately interpret findings

- 11 -data elements and details of the impact of these changes on data quality, data quantity, and overall data characteristics and provided in a written report to the FDA.

The Contractor shall provide answers to questions from FDA’s staff regarding technical aspects of the data resource.

The turnaround time for full response is three business days. Automated responses do not count as a full response.

COR and staff shall document and review turnaround times.

2.4.3.3 QUARTERLY TELECONFERENCES

The contractor shall coordinate and schedule quarterly teleconferences to discuss scientific research questions and FDA’s satisfaction with all deliverables. An agenda shall be provided to the COR at least 48 hours prior to meetings. Draft meeting notes and action items shall be submitted to the COR for review and comments within two (2) business days after teleconferences. The Contractor shall incorporate revisions into the notes and submit the final version to the COR within one (1) business day after receipt of the COR revisions.

2.4.3.4 SIX MONTH REPORT

Once every six months, the contractor shall provide a summary report that describes quarterly estimates and trends for the abuse of prescription drugs by molecule or active ingredient. The six month report will be issued as a task order that will give the contractor more definite instruction as to the focus of the six month report. However, the contractor can expect to provide the deliverable on a recurring six month basis. In each six month report, the contractor should expect to provide a window of data that covers the previous 12 months. This expectation also applies to the first six month report. For possible data elements for a six month report, please refer to the section 2.3. scope of work. Also, as part of a six month report, the contractor should expect to address new developments in industry, technology, academia, data collection, and analysis, and describing emerging drug products or safety issues of potential interest to the FDA.

2.4.3.5 TASK ORDER REPORTS

The FDA will issues task orders for specific reports. For each task order report, FDA will define the parameters of the report—demographics of the population segment, the abused drug(s) or active pharmaceutical ingredient(s) (e.g., oxycodone, hydrocodone, oxymorphone, methadone, etc.), descriptions of assessment tools and patient outcomes, and possibly other data elements as discussed in Attachment B (Data Characteristics Table) or developed by FDA and the contractor later.

As part of each report, the contractor shall furnish to the FDA an analytical dataset that is the basis of the report. The analytical dataset shall be limited to information needed to answer specific regulatory questions of interest. An analytical dataset is one where the collected information has been quality checked and formatted so it can be immediately used for further analysis. Analytical datasets shall be provided to the FDA in the SAS, MS Excel, MS Access, or ASCII format, from the contractor’s interface to FDA’s

- 12 -external storage device and/or directly to the FDA server. The contractor shall not use any software that requires key-logging and/or network capturing functionality to transmit any data to the FDA system, except for login information specific to the data and data access (e.g., SQL queries or similar methods) for the contractor’s application datasets.

As needed, contractor shall collaborate with and provide technical support to the FDA regarding changes in transmitted data and upgrades and other major changes to the database.

2.4.3.6 DATA VERIFICATION

In the first year of performance, FDA will issue a task order for the contractor to provide a report as to how the contractor’s data sources fit within, and relate to, the SAMHSA National Survey of Substance Abuse Treatment Services (“N-SSATS”). This will be done to better understand the data sources which the contactor is relying upon. More information shall be provided in the relevant task order.

2.4.3.7 DATA VALIDATION PARTICIPATION

On order, the contractor will be asked to review and advise on proposed announcements, reports, and other communications (whether to the public or intragovernmental communications) to help ensure that FDA is accurately representing contractor-provided data and reports, or that the Government is correctly surmising contractor-provided data and reports. The contractor shall respond within 24 hours. The overall intent behind this task is to include the contractor in the process of ensuring that FDA communications to other agencies or to the public which are intended to enhance awareness and safety are accurate and well founded. More information shall be provided in relevant task orders.

2.5. DELIVERABLES

As provided above, deliverables under the contract include a project plan, quarterly teleconference notes, six month reports, data validation participation, and task order reports.

SECTION 3 - PACKAGING AND MARKING

The Contractor shall identify the title of the document and contract number in the subject line of the email for all electronic deliverables.

SECTION 4 - INSPECTION AND ACCEPTANCE

The FDA COR will inspect and make acceptance decisions for all materials, documents, and services provided under this contract. For the purpose of this Section, the FDA COR is the authorized representative of the Contracting Officer.

SECTION 5 - DELIVERIES AND PERFORMANCE

Deliverables shall be established with the issuance of each task order. All deliverables shall be delivered F.O.B. Destination to the COR for acceptance. In accordance with FAR Clause 52.212-4(j) risk of loss remains with the Contractor until F.O.B. Destination.

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FAR 52.252-2, Clauses Incorporated by Reference (February 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

www.acquisition.gov/far/index.html.

FAR 52.247-34, F.O.B. DESTINATION (NOV 1991)

5.1 PUBLICATIONS AND PRESENTATIONS

As provided above, the Contractor shall not present, publish, or otherwise release any information arising out of the contract without the express prior written permission of the COR. The COR will determine what, if any, information may be releasable for publication, presentation, or through another means and will determine the content of the released information, including any authorship decisions.

5.2 ADDITIONAL RIGHTS IN DATA

The following data rights clause are specifically incorporated by reference in the contemplated contract—FAR Clause 52.227-14, Rights in Data - General (MAY 2014), Alternate V (DEC 2007), and FAR Clause 52.227-16, Additional Data Requirements

(JUN 1987).

5.3 ORDERING PERIOD

The FDA may issue task orders up to the final day of the contract, and the contract shall remain in force to allow for the completion of all task orders. The FDA will not issue, and the Contractor shall not accept, any new task orders issued after expiration of the contract’s period of performance.

5.4 PERIOD OF PERFORMANCE

The contract’s period of performance is one year from the effective date of the contract with four one year option periods.

5.5 OPTION PERIODS

The FDA has a unilateral right to exercise the following four one year option periods under the terms and conditions agreed to in the master contract.

The optional periods of performance, if exercised, shall commence as follows:

OPTION PERIOD OF PERFORMANCE

Option Year 1 TBD Option Year 2 TBD Option Year 3 TBD Option Year 4 TBD http://www.acquisition.gov/far/index.html

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SECTION 6 - CONTRACT ADMINISTRATION

6.1 ORDERING PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the services being ordered. Only duly warranted Contracting Officers in the FDA’s Office of Acquisitions and Grants Services (“OAGS”) are authorized to issue task orders against this contract and modifications to the master contract or task orders.

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

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

The general process for issuing individual task orders is as follows:

An OAGS Contract Specialist will issue a Request for Task Order Proposals (“RFTOP”) to the IDIQ stakeholder(s). Although a single-award IDIQ is contemplated by this solicitation, the Government reserves the right to make multiple awards. The RFTOP will include, at a minimum, a Statement of Work (“SOW”) with the following elements:

(1) Description of the work required in terms of its purpose(s) or objective(s);

(2) Description of how work performance will be assessed relative to objectives, goals, and/or outcomes;

(3) Tasks and deliverables required and how and when they shall be required.

(4) Period and place of performance; and

(5) The type of order, i.e., whether it will be fixed-price or labor hour.

The Contractor shall prepare and submit task order proposals in accordance with the RFTOP proposal instructions, addressing all areas of the requirement delineated in the RFTOP. The Contractor shall submit the task order proposals within the time period specified in the RFTOP and shall construct its pricing based upon, and not to exceed, the ceiling labor rates established in the master contract. No separate payment will be made to a Contractor for the costs associated with preparing, submitting, or negotiating a task order proposal.

The FDA will evaluate any task order proposal(s) and make order award decisions based upon the RFTOP.

6.2 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following COR will represent the FDA for the purpose of this contract: TBD

The COR is responsible for the following: (1) monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the FDA Contracting Officer changes in requirements; (2) interpreting Statements of Work and any other technical performance requirements; (3) performing technical evaluations;

(4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

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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 direct or negotiate any changes in a master contract or task order, including modifying or extending the period of performance, changing the delivery schedule, and authorizing reimbursement to the Contractor for any costs incurred during the performance of the contract.

The contact information for the FDA Contracting Officer is the following:

TBD

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 @fda.hhs.gov

Telephone:

The contact information for the FDA Contract Specialist is the following:

Sean Wybenga

Office of Acquisitions and Grants Services

5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov Telephone: (240) 402-76594

The contact information for the FDA Ombudsman is the following:

TBD

WO 1, Room 2314 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 @fda.hhs.gov Telephone: (301) 796-4700

In accordance with FAR 16.505(b)(8), TBD is the FDA’s task order ombudsman for reviewing complaints from Contractors and ensuring Contractors are given a fair opportunity to be considered for orders under this ID/IQ procurement.

6.3 INVOICE SUBMISSION

PAYMENT FREQUENCY: The contractor shall submit no more than one invoice per 30 day period/month for the Base Period. For the subsequent option periods, the contractor shall submit invoices no more frequently than quarterly.

PAYMENT SCHEDULE (FIXED-PRICE): Payment will be made upon successful completion of tasks and/or deliverables in accordance with the Pricing Table and Pricing Terms of this contract and upon receipt and acceptance of a proper invoice.

mailto:Sean.Wybenga@fda.hhs.gov

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PAYMENT SCHEDULE (IDIQ): Payment will be made on a task order basis. Final payment of a task order will occur upon verification by the FDA COR there is successful completion of the task order.

Proper invoice submission includes following the invoice instructions herein and the terms of the task order.

2-Way Invoicing:

A. The Contractor shall submit all invoices to the addresses and in the manners specified below:

(I) One original to the Contract Specialist:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: Sean Wybenga, Contract Specialist 5630 Fishers Lane Room 2129, HFA-500 Rockville, MD 20857

Email: Sean.Wybenga@fda.hhs.gov

(II) One copy to the COR clearly marked as a “Courtesy Copy Only:”

ATTN: (To be determined upon contract award); COR Address:

Email: XXXXX@fda.hhs.gov

Acceptable methods of delivery include mail, hand delivery, and email. Please submit all invoices by email in adobe portable document format (pdf) whenever possible.

B. Invoices submitted under these contracts must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer— System for Award Management (SAM) (Jul 2013)) and the other applicable FAR clauses specified herein.

The Contractor shall maintain current, accurate, and complete information in the SAM database, as displayed on the SAM website, until receipt of final payment under their contract.

To constitute a proper invoice, the invoice must be submitted on company letterhead and include the following:

(I) Name and address of the Contractor;

(II) Invoice date and number;

(III) Contract and task order numbers;

(IV) Description, quantity, unit of measure, unit price, and extended price for supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

mailto:William.Lee@fda.hhs.gov mailto:XXXXX@fda.hhs.gov

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(V) Shipping number and date of shipping, 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 contract, task order, or in a proper notice of assignment) (VIII) Name, title, and phone number of person to notify in event of a defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA COR; and (XII) Any other information or documentation required by the contract or task order.

The Contractor shall attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject order, including the following: (1) invoice number, amount, and date submitted to the Contract Specialist; and (2) corresponding payment amount and date received payment.

(b) Total estimated amounts yet to be invoiced under the task order.

D. Questions regarding invoice payments shall be directed to the FDA Payment Office at the following mail and email addresses and phone numbers:

Office of Financial Services

10903 New Hampshire Avenue W032, Second Floor Mail Hub 2145 Building 32, Room 2162 Silver Spring MD 20993-0002 Attn: Vendor Payments Phone Numbers: (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

6.4 KEY CONTRACTOR PERSONNEL

Key personnel as defined for this purchase order are listed below. Key personnel are considered essential to work performed. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employer of the Contractor), the Contractor shall notify the Contract Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contract Officer. The Government may modify the agreement to add or delete key personnel at the request of the Contractor or Government.

The Contractor personnel shall be identified and their responsibilities associated with the overall management of this contract, including coordination, direction and mailto:fdavendorpaymentsteam@fda.gov

- 18 -oversight of this contract to assure quality and timeliness of work performed. The Contractor personnel shall have previous experience in using the data in pharmacoepidemiologic or health care research.

LIST OF KEY PERSONNEL

NAME TITLE TASK RESPONSIBILITIES

SECTION 7 - SPECIAL CONTRACT REQUIREMENTS

7.1. ADVANCE UNDERSTANDING

Notwithstanding any of the above provisions, under certain circumstances, the Government may be required to share protected data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share protected data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government will take appropriate measures within its control in an effort to ensure that the non-public information will be shared in a manner intended to protect non-public information from public disclosure.

This Contract shall not constrain the FDA from releasing study results for regulatory issues of public health importance prior to formal publication or presentation in a scientific forum. Under these circumstances, FDA will work with the Contractor to avoid jeopardizing timely publication of results.

The Contractor shall assure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and must treat the information as confidential or otherwise privileged.

7.2. CONTRACTOR PERFORMANCE EVALUATION(S)

In accordance with FAR Subpart 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 the FDA’s Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon expiration of the contract.

FDA will utilize the Contractor Performance Assessment Reporting System (“CPARS”) to execute annual and final Contractor performance evaluations. CPARS is a secure Internet website located at the following address: https://cpars.cpars.gov/. FDA will register the Contractor in CPARS upon receipt of the names and email addresses of two 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 identification information and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contacts will receive an email instructing them to access CPARS to review the performance evaluation. The Contractor has, in accordance with FAR 42.1503, 14 days

- 19 -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 becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, the Contractor shall submit rebuttal comments via CPARS within 14 days from the date the evaluation was issued by the 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.

Copies of each performance evaluation and Contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions.

Evaluations will also be stored for a three year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

The Contractor may obtain CPARS training material and register for on-line training at the following website: https://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of CPARS.

7.3. SYSTEM OF AWARD MANAGEMENT REGISTRATION

In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the Central Contractor Registry (CCR), Federal Agency Registration (FedReg), Online Representations and Certifications Application (ORCA), Excluded Parties List System (EPLS), and the Catalog of Federal Domestic Assistance. If a new Contractor, you will need only your personal information to create an account in SAM. If you are a Contractor with an active record in CCR, you will not need to establish a SAM account.

The CCR record transfers to become the active SAM account.

(1) Definitions.

“Registered in the SAM database” means that-

(i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database;

(ii) The Contractor’s CAGE code is in the SAM database; and

(iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record “Active.” The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process.

“System for Award Management (SAM)” means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes-

(i) Data collected from prospective federal awardees required for the conduct of business with the Government;

(ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their Representations and Certifications and submit it with their proposal]; and

(iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the nonprocurement common rule by agencies, Government corporations, or by the Government Accountability Office.

The Contractor shall be registered in the SAM database prior to submitting an invoice http://www.ppirs.gov/

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