Sol Doc_1227793.pdf

FDA-RFP-1227793

Document Type Request for Proposal Solicitation Number FDA-RFP-1227793 Subject Oncology Center of Excellence (OCE) Drug Labelling Initiative

Post Date June 23, 2020 Questions Due July 06, 2020 at 14:00 Eastern Time Proposal Due July 23, 2020 at 14:00 Eastern Time NAICS Code 541611 (Administrative Management and General Management

Consulting Services)

PART I

SECTION A

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-05. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541611 (Administrative Management and General Management Consulting Services). Its associated Small Business Size Standard is $15M.

This requirement is for full and open competition. All responsible offerors are permitted to submit a proposal as a result of this combined synopsis/solicitation.

SECTION B - SUPPLIES OR SERVICES AND PRICES

B.1 SOLICITATION DESCRIPTION

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,” Oncology Center of Excellence (OCE) Drug Labelling Initiative”.

B.2 CONTRACT TYPE

The Government anticipates the award of a Time and Materials (T&M) contract to a single Contractor as a result of this solicitation. The structure of the contract shall consist of a Base Year plus one (1) 12-month Option Period.

B.3 COMMERCIAL SERVICES

The services specified in this contract have been determined to be commercial.

B.4 SEVERABLE SERVICES

The services acquired under this contract are severable services. Funds are only available for use for the contract line item (CLIN) to which they are obligated. Unused funds from one CLIN may not rollover for use in other CLINs.

B.5 CONSIDERATION AND PAYMENT

In consideration for satisfactory performance of the work as described throughout this contract, the Contractor shall be paid in accordance with the fixed burdened hourly rates as shown in Section B.7 for the specified categories of labor based on the number of actual hours incurred in the performance of the work specified. Fully burdened rates shall be all inclusive of direct labor, fringe benefits, applicable indirect costs, and any profit for each labor category. Additionally, the contractor shall be paid for materials and travel directly chargeable to this contract. If the option period is exercised, funding will be obligated by modification to the contract.

B.6 CONTRACT LINE ITEMS (CLINS)

The table below outlines the contract line item structure for the total period of performance. The Contractor shall provide services in accordance with the Statement of Work (Section C), in compliance with all other sections of this solicitation on a Time and Materials (T&M)

Line Item Description 0001 Base Period - Oncology Center of Excellence (OCE) Drug Labelling Initiative, in accordance with the Statement of Work [Time & Materials] 1001 Option Period 1 - Oncology Center of Excellence (OCE) Drug Labelling Initiative, in accordance with the Statement of Work [Time & Materials]

The Government shall not be obligated to pay any amount in excess of this ceiling price nor is the Contractor obligated to continue performance if to do so would exceed this ceiling price. In the event that the Government chooses to exercise optional CLINS, unused funds from a previous CLIN may not be used to fund any services taking place in a subsequent CLIN. The ceiling price may be modified by the Government if it is determined that the estimated hours or estimated materials are insufficient for the work required.

B.7 LABOR CATEGORIES, ESTIMATED LEVEL OF EFFORT AND PROPOSED LABOR RATES

The Labor Categories anticipated to be required for successful performance of this effort are shown below. Offerors shall propose equal or similar Labor Categories and estimated annual hours per labor category shown below are for budgeting purposes only. The number of hours actually used for each category may exceed or be less than the estimate by category as long as the ceiling price for the CLIN is not exceeded. The ceiling amount for each CLIN will be identified in any resulting contract. Offerors shall insert their proposed fully burdened rates in the table below and submit this in their Volume II Price proposal. Offerors’ fully burdened rates shall be all inclusive of direct labor, fringe benefits, applicable indirect costs, and any profit for each labor category. Offerors are advised that it may be necessary to add or change labor categories during performance of this contract in order to carry out the services described in Section C. If new labor categories are added, or existing labor categories revised, the parties will negotiate the labor category(ies) prior to the incorporation into the contract. Any new labor rate proposed will be evaluated for reasonableness in accordance with FAR 15.4.

Base Period Labor Categories/Rates Labor Category Estimated

Annual Hours Hourly Rate Total

Project Director 384 Senior SME II 1450 Senior SME III 2900 Project Manager II 1440 Project Management Support 1920 Project Manager Support 1 1920 Implementation Plan Manager 1920 Strategic Change Management Specialist II 1920 Project Manager 1 3840 Implementation Analyst VI 1920 Implementation Analyst V 1920

Base Period Total Labor Option Period 1 Labor Categories/Rates Labor Category Estimated

Annual Hours Hourly Rate Total

Project Director 384 Senior SME II 1450 Senior SME III 2900 Project Manager II 1440 Project Management Support 1920 Project Manager Support 1 1920 Implementation Plan Manager 1920 Strategic Change Management Specialist II 1920 Project Manager 1 3840 Implementation Analyst VI 1920 Implementation Analyst V 1920

Option Period 1 Total Labor

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 Introduction

The U.S. Food and Drug Administration (FDA) established the Oncology Center of Excellence (OCE) in 2017 to promote the advancement of oncology-related science and regulation. OCE unites clinical expertise across the Center for Drug Evaluation and Research (CDER)/Office of Oncologic Drugs (OOD), the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) to foster high quality and efficient clinical review of oncology drugs, biologics and devices to better serve the oncology community.

OCE is addressing a public health challenge regarding outdated product labeling. Patients and healthcare providers rely on accurate medical product labeling for patient management and treatment decisions.

.All NDA holders must ensure that product labeling contains a summary of the essential scientific information needed for the safe and effective use of the drug; changes to FDA-approved product labeling must be initiated by the New Drug Application (NDA) holder. However, labeling can become outdated over time when new information (on the drug’s pharmacology, toxicology, safety, drug interactions, and clinical trials) is generated in the post-marketing setting by academic groups or consortia is not made available to the manufacturer of the drug for inclusion in product labeling. Such information can support labeling updates, including new indications based on trials demonstrating substantial evidence of effectiveness. Additionally, NDA holders may not have the financial incentive to include new information, including new indications or dosage regimens, available in the public domain (e.g., peer-reviewed publications). In addition, the identification of public information that supports changes to update to older product labeling is beyond the scope of FDA’s responsibilities and requires substantial FDA resources, which are finite.

Project Renewal was initiated in 2017 to create a scientifically rigorous, efficient and repeatable process to review existing information for older oncology drug products in order to include new, non-essential information, in such older product labels. Initial work has created the first version of a repeatable process and template for a product report generated by an independent third party contractor resulting from the identification and analysis of publicly available information for new uses (indications or dosage regimens) and proposed updates to product labeling that can serve as the basis for a supplement request letter issued by FDA to the NDA holder for the referenced listed drug. The product report can also be used by the NDA holder to support an efficacy supplement submitted under the provisions of 505(b)(2) seeking updated labeling. The second phase of the pilot program will focus on process improvement and standard operating procedures to improve the quality and scope of the labeling evidence evaluation process and product report. Prior to issuing a supplement request letter to an NDA holder, FDA briefly assesses the product report to remove any information not compliant with statutes, regulations, and applicable guidances.

Accurate product labeling is critical, but to have the greatest impact on public health the awareness and usability, FDA-approved product labeling should be re-evaluated and updated as new information becomes available. Earlier work with the Project Renewal Team surveyed healthcare providers and noted that FDA-approved product labels are trusted sources of information used directly by healthcare providers, and indirectly as the source document for many digital drug information resources. Further work on assessing the awareness and utility of FDA-approved product labeling can assist in making sure that accurate product labeling is easily accessible and useful for healthcare professionals. This may include public awareness efforts, assessing the ability to digitize the FDA-approved product label and identifying methods to easily access and navigate the product label.

C.2 Objectives

To address the public health challenge of updating labeling for older drugs, this initiative aims to accomplish five key objectives:

• Review and iteratively improve established objectives and the scientific and efficient repeatable processes to identify and analyze publicly available data for drugs approved prior to 2005

• Engage the cancer community in a collaborative scientific environment to advance regulation of oncology products for patients with cancer

• Increase awareness in the oncology community of FDA’s role in drug development and the utility of FDA-approved product labels as a source of trusted information on approved drugs

• Use the labeling update process to educate external subject matter experts and clinical fellows on FDA regulations, evidence evaluation and risk-benefit assessment.

• Identify and explore opportunities for the healthcare providers and other stakeholders to access and navigate the FDA-approved product label.

C.3 Task Areas

C.3.1 Deploy and iteratively improve the repeatable, scientific-based Labeling Evidence Evaluation Process developed by the initial Project Renewal pilot program

The Contractor shall work with the FDA and organizations such as the American Association of Cancer Research (AACR), American Society of Hematology (ASH), and American Society of Clinical Oncology (ASCO) to identify key stakeholders for review panels, through an open solicitation process. The Contractor will select subject matter experts (SMEs) based on optimal qualifications as defined within an open solicitation call. The Contractor will work with FDA to define the contractor’s roles and responsibilities (to include but not limited to:

hematologists, oncologists, etc.), to perform functions that may include:

• For a total of up to 6 identified products (up to 3 per year):

o Suggest new indications for use or new dosage regimens, supported by publicly available data that meet evidentiary standards or revisions to approved indications for use based on current standards of care in the U.S. medical oncology community o Identifying sources of data and key supporting information for new indications and other updates to product labeling o Assess and make suggestions for updates to other sections of the product label, including BOXED WARNINGS and WARNINGS AND PRECAUTIONS, based on publicly available data o Review the format and consistency of the product label to identify recommendations for updates to adhere to current FDA guidance o Complete at least 1 conversion of labeling to new formats (Physician Labeling Rule (PLR) and Pregnancy and Lactation Labeling Rule (PLLR)) over the 2-year period o Generate a concise product report based on publicly available information and labeling considerations o Generate a draft updated product label

• Continual process improvement for labeling evidence evaluation process meetings and product report generation detailed in section 3.2

• Pre- and Post- product surveys on regulatory and labeling knowledge for fellows and new SMEs to develop metrics on educational impact of project renewal

C.3.2 Operations

The Contractor shall establish operations for the development, execution, and documentation of processes throughout the drug labeling evidence evaluation. The Contractor shall use sustained risk management and performance measurement to identify and capture lessons learned for continuous process improvement - to reduce process time, lower cost, and improve quality of project processes and deliverables. Activities include:

• Developing and maintain a project management plan

• Providing progress updates (e.g., weekly and monthly status updates)

• Creating and maintaining standard operating procedures (SOPs) and process maps

• Developing performance metrics, measures, and indicators to measure project success

• Documenting and implementing lessons learned for continual process improvement

C.3.3. Automation of Data Collection and Document Development for Use Data and Evidence to Support Labeling Updates

The Contractor shall work with the FDA to develop an overarching process for collecting and annotating data supporting labeling changes including current claims/labels, number of prescriptions written for products, types of clinical data needed to support expanded labels:

• Iteratively improve methods for literature identification, review and evaluation, focusing on evidence necessary to support labeling changes

• Investigate and leverage data sources and tools to describe usage data. Examples include ConvergeHealth Team, payers and hospital systems including community and hospital pharmacies to obtain information on number of prescriptions filled

• Conducting an analysis of clinically relevant data/information needed for potential label expansion

• Seek FDA advice on evidentiary standards and compliance with applicable regulations and guidance during reviews conducted by Project Renewal in order to communicate Project Renewal output internally and externally (see section 3.4)

C.3.4 Communications/Change Management

The Contractor shall develop a holistic communications strategy to raise awareness and educate the oncology community on product labeling, FDA regulations, and medical advancements through various forms of media and outreach. Activities include:

• Establishing a communications plan that includes a framework for sharing the initiative's impact, value, and accomplishments

• Publishing impact and findings of the evidence evaluation process in scientific journals and at medical conferences

• Educating and engage the healthcare provider community through innovative digital and traditional media (to include but not limited to podcasts, webinars, etc) to discuss the highlights of the product report(s)

• Engaging academic and professional medical organizations to raise awareness around product labeling

C.3.5 Stakeholder Engagement and Meeting Facilitation

The Contractor shall identify and engage external Subject Matter Experts (SMEs) to participate in drug evaluations and provide recommendations: Activities include:

• Identifying practicing oncologists and other SMEs to support the initiative

• Providing an educational experience for practicing clinicians and clinical fellows

• Building strategic partnerships with expert organizations to contribute to the initiative

• Facilitating meetings with multiple key stakeholders to support the initiative.

• As needed, revising the process for working with stakeholders to help define the indications for use and establishing a process for identifying, collecting, assembling and submitting the necessary clinical evidence

• Scheduling, coordinating, organizing, and managing convening sessions for review panels

C.3.6 Digital Strategy

The Contractor shall develop a digital strategy to enhance healthcare providers and other user's interactions with FDA-approved drug labeling and monitor the strategy for continual improvement of the digital strategy. Design content based on recommendations from stakeholder research and implement the appropriate channels. Activities Include:

• Conducting a user research assessment to identify key target user groups and identify digital product features

• Establishing Key Performance Indicators (KPls) to monitor the success of the digital product

• Performing testing of the digital platform with the target user groups

• Considering appropriate digital channels to drive interaction from the user community with the digital product

C.3.7 Product Project Closeout

The Contractor shall create a transition plan for “hand-off” to FDA. Activities include:

• A summary of lessons learned and recommendations for process improvements as part of the repeatable framework

• Updating framework processes as part of on-going evaluations

• Describing how to “run” additional products through a Post Pilot process

C.3.8 Publication and Meeting Presentation Support

The Contractor shall provide at request of FDA, graphic arts support for FDA presentations and for possible use in publications. Representative items include, but not limited to:

• PowerPoint Slide Decks

• Fact Sheets

• Flow Charts

C.3.9 Product Report Requirements

The Contractor shall submit the final product reports according to the outlined requirements:

• Product Report complies with format of the most recent version of the template generated by FDA

• The completed product report that includes all of the following:

o Provides the results of literature searches that identifies all relevant publications addressing safety and efficacy of the drug.

o Addresses all sections of labeling other than Quality (i.e., excludes sections 3, 11, and 16 of product labeling), based on literature search identifying new information o Includes the analysis of publicly available information for each proposed new indication that adheres to FDA’s statutory requirements to demonstrate substantial evidence of effectiveness taking into account the totality of the information o Includes proposed updates to existing indications and dosage regimens that reflect the current practice of medical oncology in the U.S., to include remove of an outdated indication or restriction of the indication to a medically appropriate population o Appropriate hyperlinks in the text portion of the product report to documents contained in the appendices o Appendices should include an electronic copy (PDF format) of each reference and detailed information on the project renewal search strategy, project renewal team selection and training, and summary of meeting minutes o Proposed labeling considerations clearly supported by rational and links to supporting evidence o Draft product labeling to be provided as an appendix in Word Format, both as a clean document and as tracked changes with annotations and hyperlinks to supporting evidence

Representative List of Candidate Drugs (in no priority order)

RLD

505b2 s PLR PLLR

# of Indication s year approved last updated oxaliplatin Yes Yes 2 2002 2019 epirubucin No Yes 2 1999 2012 doxorubicin No Yes 3 1974 2019 procarbazine No no 1 1969 1969 leucovorin (injectatble) No yes 2 1952 2018 irinotecan No yes 4 1996 2018

C.3.11 Key Personnel

The following positions at a minimum shall be designated key personnel subject to HHSAR Clause 352.237-75:

Position Title:

Project Manager II

Project Manager II: Directly supports the Program Manager as the single point of contact for client Project Managers. Prepares and maintains the project management plan; manages scope, schedule, cost, risk, and timely submission of deliverables across the project by guiding day-to-day project activities. Identifies risk or issues as they arise and communicates accomplishments and concerns to client leadership at status meetings.

Minimum Experience: At least 18 years of experience managing initiatives in the life sciences, R&D, scientific regulatory or similar field. Must have at least 5 years of relevant work experience in consulting, including an advanced degree in business or relevant area. Strong facilitation skills preferred.

Offerors must, at a minimum, provide resumes for all proposed Key Personnel candidates and include these with the Volume I (Factor 1) proposal.

In accordance with HHSAR 352.237-75 (Key Personnel), the key personnel specified in this Statement of Work and any resulting contract are considered to be essential to work performance. At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

SECTION D - PACKAGING AND MARKING

All deliverables required under this contract shall be packaged, marked and shipped/submitted in accordance with the Government specifications below. At a minimum, all deliverables shall be marked with the contract number and contractor name.

1. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

2. The Contractor shall scan all deliverables for viruses before submitting to the FDA.

3. Deliverables under this contract shall be prepared and packaged for shipment using standard shipping practices to ensure safe and timely delivery.

Electronic delivery is the preferred method of delivery and all deliverables shall assume to be submitted electronically, unless otherwise specified by the COR.

SECTION E - INSPECTION AND ACCEPTANCE

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

Review of Deliverables ---

(a) The COR will provide written acceptance, comments and/or change requests, if any, within thirty (30) business days from receipt by the Government of the initial deliverable.

(b) Upon receipt of the Government comments, the Contractor shall have fifteen (15) business days to incorporate the Government's comments and/or change requests and to resubmit the deliverable in its final form.

(c) If written acceptance, comments and/or change requests are not issued by the Government within thirty (30) calendar days of submission, the draft deliverable shall be deemed acceptable as written and the Contractor may proceed with the submission of the final deliverable product. The Contractor shall provide all deliverables to the COR in Microsoft Excel, PowerPoint or Word format.

E.1 Deliverables

The Contractor shall submit all deliverables to the COR by the due date specified in the table below.

Deliverables are not considered accepted by the government until the COR provides written notification of acceptance. In the event the Contractor’s deliverable is determined to be unacceptable to the government, the Contractor shall revise deliverables as requested until written acceptance is received.

In the event the government does not respond with formal acceptance or request for revisions within seven (7) business days of receipt, the Contractor’s deliverable shall be determined to be accepted by default. The list of deliverables are as follows:

Deliverable Due Date Interim milestones for each Product Report, including but not limited to

• literature search;

• identification, selection, and training of

Project Renewal team;

• interim meetings between Project Renewal team and FDA to obtain FDA advice regarding evidentiary standards, regulations, and guidance

As per agreed-upon process plan for generation of product reports

Agenda, including questions for FDA staff, for each interim meeting between FDA and Project Team

2 weeks before scheduled meeting(s)

Meeting Minutes from each meeting between FDA and Project Team

Within 1 week after meeting is held

Weekly and Monthly Status Reports Weekly and Monthly Project Renewal Handbook Updated Version Biannually Communications Plan Quarterly Graphic Arts Materials Per Request Draft Product Report Every 4 months (3 per year) Final Product Report Every 4 months (3 per year) Annual Report Calendar year (12/1 of each year) Update and Revise Standard operating Procedures (SOPs) and Process Maps

Per Request

Labeling Usage Pre and Post Survey With each product report

SECTION F - DELIVERIES OR PERFORMANCE

F.1 Period of Performance

Base Period: September 30, 2020-September 29,2021

Option Period 1: September 30, 2021- September 29, 2022

F.2 Place of Performance and Travel

FDA Silver Spring Campus 10903 New Hampshire Avenue Silver Spring, MD 20993

The work involved in the execution of this task order shall be at the Government sites primarily in Silver Spring, Maryland with some work performed at various FDA field and center locations. Appropriate workspace will be provided at the Government site. It is expected that the staff is on-site during the core hours. Some limited work with COR approval may be performed at the contactors site.

The Government anticipates there will be travel associated with this contract and travel shall only be applicable to work performed on a time and material basis. When travel is required, the Contractor shall submit a travel request to the COR for approval prior to incurring any travel cost. All non-local travel will be reimbursed in accordance with the provisions of the Federal Travel Regulations. The Federal Travel Regulations and current per diem rates can be accessed at: www.gsa.gov/portal/content/104790.

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 Contract Administration Data

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

Contracting Officer:

Richard Robinson Phone: 301-796-6508 Email: Richard.Robinson@fda.hhs.gov

Contract Specialist:

Benjamin Golway Phone: 301-837-7464 Email: Benjamin.Golway@fda.hhs.gov

Note: The Contracting Officer is the only individual authorized to request contract changes from the Contractor through a formal contract modification. No other FDA program official has the authority, implied or expressed, to request performance changes, changes in contract terms, or any other change that financially binds the Government.

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

COR:

Amy Akparewa Phone: 240-402-0360 Email: Amy.Akparewa@fda.hhs.gov

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) http://www.gsa.gov/portal/content/104790 mailto:Richard.Robinson@fda.hhs.gov mailto:Benjamin.Golway@fda.hhs.gov mailto:Amy.Akparewa@fda.hhs.gov 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.

G.2 INVOICE SUBMISSION

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is:

Amy E. Akparewa Sr. Regulatory Health Project Manager Oncology Center of Excellence U.S. Food and Drug Administration 10903 New Hampshire Ave Bldg 32, Room 3151 Silver Spring, MD 20993 Phone: 240-402-0360 Email: Amy.Akparewa@fda.hhs.gov

B. 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) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite- Quantity Contracts or Blanket Purchase Agreements);

(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;

mailto:FDAVendorPaymentsTeam@fda.hhs.gov mailto:Amy.Akparewa@fda.hhs.gov

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

(d) the contractor shall include the award 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 (Prompt Payment terms other than NET 30);

(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 persons to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to 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 award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in

(i) through (xiii) 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 Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

SECTION H. – SPECIAL CONTRACT REQUIREMENTS

H.1 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 14 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 becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 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.

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 3-year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

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

H.2 CONFLICT OF INTEREST

As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees.

In contracting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of the contractor.

http://www.cpars.csd.disa.mil/cparsmain.htm http://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm

(a)Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b)Scope. The restrictions described herein shall apply to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the activities covered by this clause as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity. For the purpose of this clause, affiliation occurs when a business concern is controlled by or has the power to control another or when a third party has the power to control both.

(c)Warrant and Disclosure. The warrant and disclosure requirements of this paragraph apply with full force to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d)Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e)Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement at any tier expected to exceed the simplified acquisition threshold. The terms “contract,” “contractor,” and “Contracting Officer” shall be appropriately modified to preserve the Government's rights.

(f)Prime Contractor Responsibilities. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507-1 and shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk.

(g)Waiver. The parties recognize that this clause has potential effects which will survive the performance of this contract and that it is impossible to foresee each circumstance to which it might be applied in the future. Accordingly, the contractor may at any time seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

H.3 DISSEMINATION, PUBLICATION AND DISTRIBUTION OF INFORMATION

Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor’s right to use data or information obtained from a non-restrictive source. Any questions concerning “privileged information” shall be referred to the Contracting Officer.

Some data or information may require special consideration with regard to the timing of its disclosure so that preliminary findings which could create erroneous conclusions are not stimulated. Also, some data or information, which relate to policy matters under consideration by the Government, may also require special consideration with regard to the timing of its disclosure so that the open and vigorous debate, within the Government, of possible policy options is not damaged.

Any questions about use or release of the data or information or handling of material under the contract shall be referred to the COR who must render a written determination to the Contracting Officer. The COR’s determination will reflect the results of internal coordination with appropriate program and legal officials. After receipt of the COR’s written determination, the Contracting Officer will make a final decision authorizing the release of information.

Written advance notice of at least forty-five (45) days shall be provided to the COR of the Contractor’s desire to release findings of studies or research or data or information described above. If the Contractor disagrees with the COR’s determination and if the disagreement cannot be settled by the Contractor and the CO in a mutually satisfactory manner, then the issue will be settled pursuant to the “Disputes” clause.

Any presentation of any report, statistical or analytical material based on information obtained from this contract shall be subject to review by the COR before dissemination, publication, or distribution.

Presentation includes, but is not limited to, papers, articles, professional publications, speeches, testimony or interviews with public, print or broadcast media. This does not apply to information that would be available under the Federal Freedom of Information Act.

The COR’s review shall cover accuracy, content, manner of presentation of the information, and the protection of the privacy of individuals. If the review finds that the Privacy Act is or may be violated, the release/use of the presentation shall be denied until the offending material is removed or until the

Contracting Officer makes a formal determination, in writing, that the privacy of individuals is not being violated.

If the review shows that the accuracy, content, or manner of presentation is not correct or is inappropriate in the light of the purpose of the project, the COR shall immediately inform the Contractor, in writing, of the nature of the problem. If the Contractor disagrees, the COR may insist that the presentation contain, in a manner of equal importance, materials which show the government's problem with the presentation.

The Contractor agrees to acknowledge support by FDA whenever reports of projects funding, in whole or in part, by this contract are published in any medium. The Contractor shall include in any publication resulting from work under this contract, an acknowledgement substantially, as follows:

“The analyses upon which this publication is based were performed under Contract Number [ ], entitled, “[ ],” sponsored by the Food and Drug Administration, Department of Health and Human Services.”

H.4 PROCUREMENTS REQUIRING INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements

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

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

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

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

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

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

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

[ ] No PII [ x ] Yes PII

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

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

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

4) Controlled Unclassified Information (CUI).