FDA-RFP-116104.docx

RFP Number: FDA-RFP-116104_Amendment#1 Page 33 of 102 Clinical Site Monitoring for Human Subject Research Studies Table of Contents

1. Solicitation Information Background The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by ensuring that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs.

CDER’s regulatory decisions must be based on the best available scientific data and utilize the best tools and methods available in order to ensure products meet the highest quality standards for consumers, while at the same time fostering and advancing innovation in the products it regulates. An integral part of this process is the direct support offered by FDA funding of relevant scientific programs in the form of grants, cooperative agreements, or contracts. These programs supply both research support and, in many cases, collaborative engagement with and guidance from CDER scientists, in order to advance scientific knowledge and to accomplish FDA’s mission to protect and promote the health of our nation.

Effective monitoring of clinical investigations is critical to the protection of human subjects and the conduct of high-quality studies. CDER is responsible for overseeing and assuring the safety and quality of all FDA-funded CDER research in human subjects’ research projects and clinical site monitoring is a vital segment of that responsibility.

It is the FDA’s intent to award an indefinite delivery-indefinite quantity (IDIQ) contract, with a performance period of five (5) years. The Government anticipates awarding an IDIQ contract with a ceiling of $1,100,000.00. The minimum guarantee due to the contractor will be provided for via the first task order.

Notice of Combined Synopsis/Solicitation This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in FAR 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 is a request for proposal (RFP) for commercial items IAW the procedures of FAR Part 12 – Acquisition of Commercial Items, in conjunction with FAR Part 15 – Contracting by Negotiation. This acquisition is issued as a Request for Proposal (RFP) Notice of FAC This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2023-02, effective March 16, 2023.

Notice of NAICS/Set-Aside The associated Product Service Code (PSC) is R410 (Support – Professional: Program Evaluation/Review/Development). The associated North American Industry Classification System (NAICS) code is 541690 (Other Scientific and Technical Consulting Services). Offerors must have an active registration in SAM.gov (https://sam.gov/), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by offerors not registered in SAM.gov will not be considered.

2. Description of Requirements/Statement of Work Purpose The purpose of this IDIQ contract is to obtain Contractor services for scientific/clinical support for monitoring the conduct and progress of extramural FDA-funded CDER research in human subjects. The clinical site monitoring reports will be utilized by CDER staff charged with oversight of these clinical research projects to ensure adequate protection of the rights, welfare, and safety of human subjects and to ensure that the data resulting from the clinical research projects are of the highest quality.

Scope/Objectives Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, and facilities to do all things necessary for the performance of this requirement.

Clinical site monitoring for extramural CDER research in human subjects research projects includes verification that: the rights and well-being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practice (GCP), and with the applicable regulatory requirement(s)[footnoteRef:1]. The scope of activities to be performed includes: [1: ]

1. Site initiation visits prior to clinical study implementation to ensure compliance with FDA, U.S., and, where appropriate, country-specific regulatory requirements and guidelines.

2. Routine site monitoring visits for active select clinical studies to ensure compliance with FDA, U.S., and, where appropriate, country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical study data, and assess adherence to protocol-specific requirements.

3. Specialized site monitoring visits for a variety of purposes, including regulatory audits, assessments of overall and protocol-specific research pharmacy operations and management of investigational products, and remedial or for-cause site visits to implement and ensure adherence to corrective actions required to address site or study deficiencies identified through routine site monitoring.

4. Site closeout visits to ensure appropriate completion of clinical studies, storage of clinical records and disposition of investigational products.

5. Preparation of written reports of all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial actions.

6. The development and implementation of Standard Operating Procedures for the conduct of clinical site and study monitoring functions or site monitoring plans, including the components to be reviewed/assessed and the processes to be used for each type of site visit.

7. The development and implementation of a Quality Assurance/Quality Control (QA/QC) Plan to ensure the efficient and effective performance of monitoring functions and the appropriate management of the project.

Description of work The Contractor shall conduct both routine and specialized visits to FDA-funded domestic and foreign clinical sites to ensure compliance with: (i) 21CFR312-GCP; (ii) 45 CFR 46- "Human Subjects Protection"; (iii) the ICH E6R2-GCP Guidelines (http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucml55713.htm)(iv) country-specific requirements governing human subjects research; (v) protocol-specific requirements; and (vi) Office of Human Research Protections (http://www.hhs.gov/ohrp/). The frequency and intensity of clinical site monitoring visits will be determined by FDA on the basis of protocol risk and individual clinical site characteristics. The contractor shall conduct on-site and/or remote monitoring evaluations for the specified site where the clinical study is being conducted and submit a detailed written report. The contractor shall comply with all applicable HHS travel policy and regulations.

Preparation and Planning for Clinical Site Monitoring Visits will include

· Preparation of a monitoring plan and complete agenda, including a checklist of items to be reviewed, data and information to be collected. FDA will provide a list of any special requirements and will review final planning documents prior to each visit (a general list is provided below):

· Review of specific study documents and study history

· Coordination with study site for available dates

· Travel and lodging arrangements Clinical Site Visits

· Conducting the following type of site visits as directed by FDA (not all types will be required for each study):

· Conduct site initiation visits prior to clinical trial implementation

· Conduct routine site monitoring visits for active clinical trials to ensure compliance with corrective actions required of the study site and address deficiencies identified during routine site monitoring

· Conduct for-cause site visit

· Conduct a specialized site visit including an unblinded pharmacy visit and an mock audit as needed

· Conduct close-out site visit to ensure clinical trial has been completed, all adverse events have been resolved

· Site visits will be conducted in accordance with planning documents reviewed and approved by FDA.

· Communicating the finding with a site and following up as needed in a timely manner

· Drafting and finalizing the monitoring reports as appropriate

A description of the various clinical site monitoring visits are described below:

1. Site Initiation Visits:

Visits for any new clinical sites prior to clinical study implementation to ensure site compliance with all Federal and country-specific regulatory requirements, GCP and ICH guidelines, and FDA policies and procedures. In addition, assess the adequacy of all site facilities, personnel, and operating procedures to be used for the conduct of clinical research studies, including:

a) detailed research pharmacy review to include organization, qualifications and training of pharmacy staff and adequacy of facilities and equipment, communication between clinical and pharmacy staff, and pharmacy establishment plan;

b) clinical research facilities, including: space for patient screening, administration of investigational products, patient follow-up, outpatient surgical and testing facilities; inpatient facilities; clinical laboratory facilities and accreditations; patient record storage areas; and storage facilities for biological samples and record keeping; and

c) education and training of site personnel with respect to: Federal regulations governing informed consent, Institutional Review Boards (IRBs), responsibilities of sponsors and investigators, and protection of human subjects from research risks; GLP; and packing and shipping of biological samples. This includes verification that site personnel have completed required human subjects and other training.

2. Routine Site Visits:

More or less frequent interim site monitoring visit schedules may be used for clinical research studies commensurate with the anticipated level of protocol risk and the characteristics of the individual participating clinical sites as determined by the COR or his/her designees. Interim site monitoring assignments shall be developed quarterly by the COR with input from the Contractor. Interim site monitoring visits shall assess the following:

a) the accuracy, completeness and timeliness of data collection and entry;

b) adherence to inclusion and exclusion criteria;

c) accuracy and completeness of reporting of Serious Adverse Events (SAEs) and protocol violations;

d) documentation of informed consent and adherence to informed consent procedures;

e) documentation of objective findings, including verification of endpoints;

f) maintenance of appropriate source documentation;

g) adherence to Federal and country-specific regulatory requirements, GLP, GMP, GCP and ICH guidelines, and established FDA and other program-specific policies and procedures, and completeness of regulatory files;

h) adequacy of pharmacy operations, performance and management related to protocol-specific requirements, including study product accountability;

i) the appropriate collection, storage and transport of patient samples;

j) clinical records maintenance; and

k) various components of the operation and management of the clinical sites, including: site management, organization and utilization of the site staff; communication among clinical, technical and administrative staff; and the adequacy of site clinical and laboratory facilities and study equipment.

3. For Cause Site Visits:

Remedial and for cause site visits may be performed at any time and without advance notice to clinical sites in instances of suspected non-performance and/or non-compliance with Federal regulatory requirements.

For all such visits, the site visit report must contain a complete description and chronology of the problem, retraining (if performed), corrective actions to be taken by the site, and a monitoring plan to ensure correction of the problem.

4. Closeout Site Visits:

Closeout site visits shall be conducted for any clinical site that discontinues participation in the FDA research project to assess that the site has properly closed out all studies and has followed proper procedures for the storage of records and the disposition of remaining supplies of investigational agents.

For all such visits, the clinical sites involved shall be provided with a description of the site-specific documents, facilities and other information to be reviewed/assessed, and instructions on the clinical site personnel and materials to be made available. This information shall be provided to the clinical site no less than 1 week prior to the scheduled visit.

The on-site evaluations will include some or all of the following assessments:

· Confirm Site Adequacy / Site Status – verifying that resources remain adequate throughout the study period and that facilities, including laboratories, equipment, and staff, are adequate to safely and properly conduct the study and remain adequate throughout the study period

· Review Investigational Product (IP) – verifying that the IP is stored, dispensed, returned and disposed of as specified in the protocol

· Review Protocol Compliance – verifying that the investigator follows the approved protocol and all approved amendment(s), if any

· Informed Consent Form (ICF) Review – verifying that the correct version of the informed consent was appropriately obtained and documents before each subject's participation in the trial

· Enrollment Review – verifying that the investigator is enrolling only eligible subjects and reporting the subject recruitment rate

· Data Extraction: Research data captured on the CRF, which are extracted from source documents, should be consistent with the source documents or the discrepancies should be explained.

· Records Management: ensure the accuracy, completeness, legibility, and timeliness of the data recorded in the Case Report Forms (CRFs) and any applicable reports

· Regulatory Binder / Essential Documents Review – verifying that all essential documents for the conduct of the study are present and up-to-date (GCP E6 Section 8)

· Adverse Events (AEs) Review – verifying that all adverse events (AEs) are appropriately reported and documented within the required time periods and check for serious AEs

· Other Study-Specific Monitoring Tasks – depending on the protocol additional tasks may be necessary and will be provided by FDA

3. Contract Type and Minimum/Maximum Amounts Contract Type It is anticipated that a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type Contract, per FAR 16.5, will be awarded as a result of this solicitation. Authorized contract types under this IDIQ contract are: Firm-Fixed-Price (FFP).

Minimum and Maximum Contract Value IDIQ Minimum: The minimum guarantee for this IDIQ contract is $2,500.00, which will be obligated through a separate Task Order following the IDIQ award.

IDIQ Maximum: The maximum aggregate dollar value of all task orders awarded over the 5-year ordering period of this IDIQ shall not exceed the IDIQ ceiling amount of $1,100,000.00.

See FAR Clause 52.216-19 for individual order limitations.

4. Pricing and Ordering of Services Overview of Pricing Schedule Offerors shall propose labor categories and labor rates as a completed version of Attachment 1 – Pricing Schedule, to be included in the “Volume II – Business Proposal” submission.

The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly rates. The fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit. Hourly rates shall apply to services at both Government and non-Government sites.

By mutual agreement of the parties, additional labor categories may be added to this IDIQ contract to support the tasks of this contract.

Key personnel are subject to HHSAR clause 352.237.75. Key Personnel may be identified in any resulting Call Orders issued. These Key Personnel positions shall be considered essential to the work to be performed thereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer required by this RFQ. The contract may be modified from time to time during the contract to either add or delete personnel, as appropriate.

The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within fifteen (15) calendar days after receipt of all required information of the decision on substitutions.

Pricing Terms The total amount specified in Firm-Fixed Price (FFP) task orders shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the order. The Contractor shall comply with FAR Clause 52.232-1 Payments (APR 1984) in regard to the firm-fixed-prices for individual task orders.

Ordering A request for task order proposal (RFTOP) will be issued via email for individual task orders. Task orders against the IDIQ contract will be issued via email and will be in accordance with FAR 16.505 and FAR clause 52.216-18.

Ordering Procedures Any Contracting Officer of the Food and Drug Administration (FDA) is authorized and may place orders under this IDIQ contract. Each individual task order will describe the specific performance requirements. When a need for services within the scope of this IDIQ contract arises, the process for issuing task orders is as follows:

1. The FDA CO will issue a RFTOP via email. The RFTOP will include the following information:

a. SOW

b. Period of performance

c. Anticipated contract type

d. Reporting requirements and deliverables

e. Key Personnel

f. Any special terms and conditions specifically applicable to the task order

2. The Contractor will typically have a minimum of ten (10) business days, unless otherwise specified, to provide a proposal in response to the RFTOP. The proposal shall include:

a. Brief description of the technical approach to the task order requirements

b. Price buildup (including labor categories, hours for each labor category, extended pricing, total task order pricing, and concurrence with the anticipated contract type)

c. Resumes of any key personnel identified in the RFTOP

3. The FDA will evaluate the task order proposal for technical acceptability and price reasonableness. If the FDA has questions or concerns, the Contracting Officer will contact the Contractor and may request a revised proposal.

4. If the task order proposal is determined acceptable, the Contracting Officer will issue a task order. All task orders will, at a minimum, include the following:

a. Task Order number

b. Date of Task Order

c. Funding for the Task Order

d. Task order SOW and specific deliverables and due dates

e. Task order pricing

f. Period of performance of the task order

g. Any terms, conditions, and instructions specific to the task order Any work that the Contractor undertakes prior to receiving a fully executed task order that has been signed by the Contracting Officer (or the Contractor has received prior authorization to proceed from the Contracting Officer) shall be at the Contractor’s risk.

Pricing of Orders

a. Proposals submitted in response to a RFTOP must be in accordance with the Ordering Period rates in the IDIQ Price Schedule based on the performance start date of the task order, and that rate must be used for the duration of the task order performance period. The Contractor may propose lower rates in response to a RFTOP.

b. RFTOPs may include option periods in accordance with FAR clause 52.217-9. However, option periods must utilize the Ordering Period rates listed in the IDIQ Price Schedule, based on the performance start date of the option period.

c. If a task order’s stated period of performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period.

These Ordering Pricing terms and conditions apply to all task orders issued against this IDIQ contract.

Emergency Orders In emergency situations or other times when it is not practical to prepare a written work plan prior to the commencement of work, the Contracting Officer may verbally authorize performance to commence immediately, so long as the work to be performed in the emergency situation is within the scope of this contract. In those instances, a written work plan shall be submitted within 10 days following the authorization to commence work. When work is authorized to commence prior to the submission and negotiation of a work plan, the Contracting Officer will indicate, at time of authorizing work, a dollar ceiling that may not be exceeded except at the Contractor's own risk.

5. Deliverables and Acceptance Deliverables Specific deliverables and a schedule of deliverables will be identified in each task order. Anticipated deliverables include:

1. Development of Monitoring Standard Operating Procedures (SOP) and check lists With input from FDA, contractor will prepare general SOPs for planning, conducting and reporting on clinical site visits, to include the components to be reviewed/assessed, the processes to be used for each type of site visit, site visit checklists and a site visit report template. The plan elements may be adjusted as needed to accommodate each clinical site.

Within 30 calendar days of the contract effective date, submit, for COR review and approval, Draft SOPs governing all aspects of the conduct of both routine and specialized clinical site monitoring visits. The COR will review and provide comments and revisions to draft SOPs within 10 business days of receipt. The Contractor shall finalize SOPs within 5 business days of receipt of COR comments.

1. Separate SOPs shall be provided for:

a. site initiation visits prior to clinical study implementation

b. routine site visits to monitor compliance with Federal and country specific regulatory requirements, GCP and ICH guidelines, protocol specific requirements, and FDA policies and procedures

c. for cause visits

d. investigational pharmacy operations assessments

e. protocol-specific investigational drug audits

f. regulatory reviews

g. site close-out visits at the completion of clinical studies

2. Each SOP shall address the components listed below.

a. a description of each aspect of clinical study conduct and clinical site operations to be reviewed

b. the sources of data and other information to be used to monitor each aspect of clinical study conduct and clinical site operations

c. detailed work instructions

d. the types of clinical site personnel required to participate

e. scheduling process and procedures for the preparation of participating clinical site staff, including questions and other materials to be provided to clinical site staff in advance of site visits, as well as data, documents and other information to be gathered and made available by clinical sites

f. the average length of the site visit and the number of Contractor monitors required

3. SOP Updates: Keep abreast of all changes in Federal and country specific requirements governing human subjects research, GCP and ICH guidelines, and FDA policies and procedures; update SOPs, as necessary, within thirty (30) calendar days of the effective date of all such changes, and submit updated SOPs for COR review and approval. Updated SOPs shall be implemented by the Contractor only after receipt of written COR approval.

2. On-site Monitoring Visit Agenda / Checklist Clinical Site Monitoring Visits will include preparation of a monitoring visit plan and complete agenda, including a checklist of items to be reviewed, data and information to be collected. FDA will provide a list of any special requirements and will review final planning documents prior to each visit (a general list is provided below):

· Review of specific study documents and study history

· Coordination with study site for available dates

· Travel and lodging arrangements

3. Development of a Quality Management System The contractor will assist in the development and implementation of an FDA quality management system for FDA funded, human subject’s research activities. This system will define the organizational structure, responsibilities, procedures, processes and resources for implementing quality management.

The Contractor shall develop and implement a Quality Assurance/Quality Control (QA/QC) Plan designed to: (i) standardize contract processes; (ii) ensure that the conduct of all contract activities complies with domestic and country-specific regulations governing human subjects research, GCP and ICH guidelines, and FDA policies and procedures; and (iii) provide for the assessment of Contractor performance and the quality of clinical site monitoring activities conducted.

Specifically, the Contractor shall:

a. Within 30 calendar days of the contract effective date, develop and submit, for COR review and approval, a Draft QA/QC Plan detailing the following:

1. Standard processes to be used to ensure internal QA/QC with respect to the timeliness, accuracy and completeness of the clinical site monitoring activities performed

2. Measures/metrics to be used to assess performance and the quality of clinical site monitoring activities

3. Approaches/methods to document and address problems and deficiencies identified, including improvements in the internal QA/QC Plan

b. Any major QA/QC deficiencies/problems (e.g., lack of training as provided for in the approved Training Plan, late submission of clinical site monitoring visit reports, inadequate technical knowledge of the Federal and/or country-specific regulations, etc.), as defined in approved SOPs, shall be reported to the COR within 24 hours of identification and shall include Contractor recommendations for resolution. A brief report on the implementation of COR-approved resolution actions shall also be submitted within time frames to be specified in the approved QA/QC Plan.

c. Provide quarterly reports on the results of internal QA/QC to the CO and COR, including all deficiencies and problems identified recommended approaches/actions to be taken to correct deficiencies and resolve problems, and any recommended modifications to the QA/QC Plan. All QA/QC Plan modifications must be approved by the COR prior to implementation The COR may authorize, at any time during the contract period of performance, independent audits, including: (i) review of both routine and specialized visits at clinical sites; (ii) review of Contractor processes, procedures and operations at the central office; and (iii) review of processes, procedures and operations at regional domestic and foreign offices. The COR will notify the Contractor of plans for independent audits two (2) weeks in advance of the scheduled audit. For audits conducted at Contractor facilities, the Contractor shall ensure that appropriate staff and all necessary information/documentation are available. For cause audits may be performed at any time and without advance notice to the Contractor in instances of suspected non-performance and/or non-compliance with Federal and/or country-specific regulatory requirements.

4. Clinical Site Visit Monitoring Report Contractor will provide a detailed site visit report within 15 calendar days of each site visit, using the template approved by FDA. All Clinical Site Monitoring Reports shall detail the findings of each site visit, identify site specific problems and deficiencies, and provide recommendations for improvements and, where necessary, corrective/remedial actions. Critical findings (e.g., any findings of fraud, invalid signatures, and unreported SAEs) shall be reported to the COR within 24 hours of discovery.

5. Status Reporting The contractor shall prepare and deliver monthly status reports to the Contracting Officer Technical Representative or designated government representative in accordance with the delivery schedule.

The monthly report shall contain the following:

· Brief summary of accomplishments during the reporting period and significant events regarding the contract.

· Deliverables submitted or progress on deliverable products.

· Any current or anticipated problems.

· Summary of plans/required activities for the month ahead.

· The monthly narrative report and contract summary report shall be submitted to the FDA by the fifteenth of each month.

· Status of the previous month’s invoice (e.g. was it paid or not)

A. Be advised that the FDA does not accept documents which contain the use of “macros.” Document submissions required throughout the period of performance of this IDIQ contract including any task orders under this IDIQ shall not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

B. All non-electronically submitted deliverables required under this contract shall be packaged, marked and shipped in accordance with the requirements and specifications contained herein this contract. At a minimum, all deliverables shall be marked with the Contract Number and Contractor Name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

C. Reports not submitted electronically shall be delivered F.O.B. Destination, as set forth in FAR Clause 52.247-35, F.o.b. Destination, Within Consignee’s Premises, and as specified in the delivery schedule in the task order.

D. Unless otherwise specified, deliveries shall be made to the COR on Mondays through Fridays (excluding Federal Holidays and Executive Order), between the hours of 8:00 a.m. and 5:00 p.m., Eastern Time, only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

Inspection and Acceptance A. Satisfactory performance of this contract shall be deemed to occur upon performance of the work and upon delivery and acceptance by the Task Order Contracting Officer’s Representative (TO COR). The TO COR will perform inspection and acceptance of materials and services to be provided in each task order. For the purpose of this section, the Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer.

B. If a deliverable is found by the COR to be sub‐standard, it may require that alterations be made until the deliverable meets the standard expectations at which point it is considered delivered. In some task orders, the deliverable must be 100% accepted by the delivery date. The deliverables and delivery dates will be specified in the task order.

C. A Quality Assurance Surveillance Plan (QASP) may be included in individual task orders.

D. Acceptance may be presumed within 10 days of receipt, unless otherwise indicated in writing by the COR. Unless otherwise specified in individual task orders, inspection and acceptance will be performed at the Place of Performance in Section 6.2.

6. Contract Administration Data Period of Performance The anticipated period of performance for this contract consists of five (5), 12-month ordering periods, as follows:

The period of performance for task orders will be specified in individual orders. Two (2) constraints apply to the period of performance for task orders:

1. Individual task orders may not exceed five (5) years (inclusive of option periods)

2. The period of performance end date of the last option period on individual task orders may not extend more than 60 months beyond the IDIQ Ordering Period end date Place of Performance The place of performance will be identified in individual task orders. For each task order, the contractor’s primary work location will be at the designated clinical study site(s) that will principally be domestic but may include some international sites. FDA facilities are predominantly located and may include but are not limited to: in the Washington DC metropolitan area, St. Louis, MO and Baltimore, MD.

Specific working arrangements, such as work approved for performance at alternate contractor locations, will be described in individual task orders.

Hours of Operation Unless otherwise specified in the individual task order, Contractor staff must be available during normal FDA business hours, from 8:00 am – 5:00 pm Eastern Time (ET), Monday through Friday, except on Government Closures.

The Contractor may be required to deliver documents and records materials outside of normal FDA business hours. If working outside of normal business hours, the Contractor will have the flexibility to use management tools (i.e., swing shifts) to successfully meet individual task order requirements. Any overtime incurred must be approved in advance, in accordance with FAR 52.232‐ 7 Payments under Time and Materials and Labor Hour Contracts (Aug 2012). Normal FDA business hours are defined as being from 8:00 am – 5:00 pm ET, Monday through Friday, with deliveries on some weekends and holidays.

Observance of Government Closures The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure under this contract or any task orders under this contract that include labor-hour or time-and-materials contract types. In the event Contractor personnel work during a holiday observed by the Contractor other than those below, no form of holiday or premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

Recognized Federal Holidays: Contractor coverage is expected during all Federal workdays. Except for designated around-the-clock or emergency operations and after-hour courier services, Contractor personnel shall not perform on-site under this contract on Federal holidays or any other day designated as a Federal holiday for the Washington, DC area. No services or deliveries shall be performed at Federal sites on Federal holidays unless specifically requested by the Contracting Officer.

Inclement Weather and other Government Closures: The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather, government closures or other emergencies. The COR will notify the Contractor of Government Closures due to inclement weather, government closure or emergencies (man-made or otherwise).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management (OPM) for any reason, the agency is closed, or the Center or FDA building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

If adverse weather conditions develop after the Federal Government has opened for normal business, upon notification of early release from OPM, the COR and/or CO will notify the Contractor of Facility closings and specify the time for a final document pickup.

Additional specific inclement weather plans may be specified at the task order level.

Contracting Officer (CO) Contracting Officer’s Authority: The Contracting Officer is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is, or may be, outside the scope of the contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

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

The following person is the Contracting Officer for this contract:

Contract Specialist (CS) The Contract Specialist supports the Contracting Officer. The following person is the Contract Specialist:

Contracting Officer’s Representatives (CORs) Contracting Officer’s Representative’s Authority:

The Contracting Officer (CO) may designate other Government personnel, known as the Contracting Officer’s Representative (COR) to act as his or her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the contract. CORs do not have authority to act as agent of the Government under the contract or task order. The Government may unilaterally change its COR designation.

IDIQ Contracting Officer’s Representative (IDIQ COR):

The IDIQ COR, to be designated at time of contract award, will represent the Government for the purpose of the IDIQ. The IDIQ COR will be responsible for the following:

· Tracking compliance with Limitations on Subcontracting clause across task orders

· Tracking and monitoring contract ceiling

· Tracking and monitoring staff allocation across task orders

· Reviewing changes to staffing matrix

· Secondary point of contact for issues that need to be escalated

· Reviewing Task Order SOWs for scope compliance

· Completing annual CPARs evaluations The following person has been identified as the IDIQ COR:

TBD at time of contract award Task Order Contracting Officer’s Representative (TO COR):

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

Task Order Project Managers (TO PMs):

Task Order project managers may assist the CORs, but will not have the authority to provide technical direction as described in Section 6.9; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances then reporting to the COR of the acceptance as required by this performance; and (4) reviewing of invoices/vouchers.

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

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

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

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

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

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

· Constitutes a change as defined in the applicable contract clause FAR 52.212-4.

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

All technical direction will be issued in writing by the COR or will be confirmed by him/her in writing within five (5) business days after issuance.

If, in the opinion of the Contractor, any instructions or direction issued by the COR is within one of the categories described above, the Contractor shall not proceed but shall notify the Contracting Officer in writing within 5 working days after the receipt of any such instructions or direction and shall request the Contracting Officer to modify the task order, accordingly. Upon receiving such notification from the Contractor, the Contracting Officer will issue an appropriate contract modification or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract. The Contractor shall proceed immediately with the instructions or directions and shall be subject to the “Disputes” clause within FAR 52.212‐4(d), Contract Terms and Conditions – Commercial Items.

Invoicing procedures Specific invoicing instructions may be provided in each individual task order. See attachment 3 – FDA IPP Invoicing Instructions.

Government Furnished Property Specific Government furnished property will not be provided.

Government Furnished Data The Government shall retain all rights and privileges, including those of patent and copy, to all Government-furnished data and materials. The Contractor shall neither retain not reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data.