Amendment1_75N95022R00050.pdf

NSN 7540 - 01 - 152 – 8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

OMB No. 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

1 1

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

01 See Block 16C

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

NIDA Section, Contracts Management Branch Blue Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH c/o 3WFN MSC 6012 301 N Stonestreet Ave, Bethesda, MD 20892 Bethesda,8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

75N95022R00050

9B. DATED (SEE ITEM 11)

June 16, 2022

10A. MODIFICATION OF CONTRACT/ORDER NO.

VIN # DUNS # 10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Item 8 and 15, and returning 1 copies of the amendment; (b) acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDG- MENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hours and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT/ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Purpose: To amend the Request for Proposal (RFP) to incorporate attachments referenced in the solicitation.

Proposal Due Date: Monday, August 15, 2022. 2:00pm EST (Unchanged)

Note: The Offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Khurram Shaikh, Contracting Officer, NIDA Section, CMB Red

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY

(Signature of Contracting Officer)

X

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

March 12, 2018 Page 1 of 2

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with [Contract specialist must select either: FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition or HHSAR 352.215-70, Late Proposals and Revisions (December 18, 2015)].

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

Attachment 1

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

March 12, 2018 Page 2 of 2

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS: [Contract specialist must include Section II if page limitations will be used. Otherwise, Section II may be deleted].

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed _200_ pages. [Contract specialist must specify a page limit].

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not exceed ____ pages. [Contract specialist may specify a page limit].

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

Attachment 1

Attachment 2 the following date:

Description/Specification/Statement of Work (SOW)

Title: Research and Development for Clinical Studies in the Blueprint MedTech (BPMT)

Initiative

1. Introduction/Background

Background:

The Blueprint MedTech (BPMT) initiative is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).

Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to accelerate the development of cutting-edge medical devices to diagnose and treat disorders of the nervous system by providing appropriate support to innovators. The mission of the program is to support innovators in the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. Support to innovators will be provided in the form of (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:

Planning resources to support concept development, team building, needs assessment, and other early translational activities.

Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, clinical studies/trials, medical monitoring).

Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).

Advice from industry experts (e.g., meetings with an external oversight committee).

The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.

Objectives:

BPMT requires a contract research organization(s) to support and provide resources to the participating grantees (referred to as Sponsors/Contributors for this SOW) for completing clinical feasibility studies of novel medical devices in the neurotechnology field. The clinical studies may include both feasibility and larger safety and efficacy assessments in patients affected by the condition being studied. BPMT anticipates running 5 to 15 clinical studies per year over the next 5 years. Most, but not all, are likely to be NIH-defined Clinical Trials https://grants.nih.gov/policy/clinical-trials/definition.htm.

2. Scope

The scope of activities to be performed by the Contractor shall include the provision of a clinical research unit, the conduct of clinical studies, and the provision of a full range of services to support the clinical studies for investigational diagnostic and/or therapeutic neurological medical devices, safety monitoring, and reporting of the results to NIH. The contractor will be responsible for developing the study design and obtaining approval before starting the study.

Attachment 3

The contractor will also manage policies and regulations regarding human subjects protections, including, but not limited to, Institutional Review Board (IRB) approvals, informed patient consent, and applicable security and privacy standards in handling study data.

These studies shall be designed to evaluate biological effects and/or assess safety and efficacy of the investigational medical device, which will be used to inform regulatory filings for market approval and reimbursement. All clinical studies shall be carried out in a timely fashion and in compliance with all FDA regulations and International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidelines. Studies involving more than one site are expected to comply with the NIH Single Institutional Review Board for Multi-Site Research policy.

3. Contract type

This contract is an indefinite delivery/indefinite quantity (ID/IQ) type contract. The Contractor shall perform work as directed in task order awards. Task Order awards will cover the following:

3.1. Performance Area A: Overall Clinical Operations Support. The Task Order for Performance Area A will be a fixed-price order with a term of five years.

3.2. Performance Area B: Clinical Project. Task orders for individual clinical studies of investigational devices will be competed through a Task Order Request for Proposal (TORFP) process under Performance Area B. It is anticipated that these task orders will be cost reimbursement, completion-type task orders OR fixed price at the discretion of the Government and will have variable periods of performance. NIH anticipates issuing up to 5-15 TORFPs under Performance Area B during each year of the contract. The actual number of TORFPs issued will depend upon programmatic needs and funding availability, and may vary from year to year. Due to changes in priorities within BPMT, the projected workload cannot be precisely described for each year. The Contractor shall initiate work only when authorized by issuance of an approved task order.

4. Specific Technical Requirements

The Contractor shall provide a Principal Investigator (PI) who is primarily responsible and accountable for the overall implementation of the awarded contract, who serves as the central contact for scientific and technical aspects of the contract, and one who has significant experience in the conduct of medical device clinical studies and trials.

The Contractor shall provide an investigative team with all the required core expertise including but not limited to project management, medical writing, clinicians, research associates, data manager, data management support staff, regulatory associates, and other personnel with medical device clinical study expertise. The Contractor shall provide established facilities and the clinical research infrastructure, with the appropriate number and mix of clinical, laboratory and support personnel to conduct these clinical studies. Subcontracted facilities and subcontractors can be utilized as needed to meet contract needs.

All clinical studies to be conducted under this contract must be completed as per the protocols developed and finalized for each study requirement. Time duration for a clinical study from recruitment initiation to the last subject’s protocol exit will vary based on the specific device being investigated. All devices will be provided by the Sponsor/Contributor manufacturing the device.

The Government shall be responsible for providing the following for each clinical study supported under this contract:

• A clinical study outline, synopsis, or draft protocol, including stopping rules;

• A draft of the instructions for use;

• IDE approval letter from the FDA for the study, if applicable (held by

Contributor/Sponsor);

• Investigational device;

• Access to device safety information from preclinical animal safety studies;

• Scientific information on the investigational device and the indication under study.

The Contractor shall carry out the scope of work and activities as defined for the following two performance areas:

Performance Area A: Contract Kick-off

The Contractor shall:

i. Conduct Teleconferences and in-person Meetings for the following. Prepare minutes of all site visits and teleconferences/webinars and submit to the COR for review and approval within 5 business days of the meeting.

a. Contract kick-off meeting to review the task order requirements, timelines, milestones and deliverables; discuss task order plans and approaches and identify any anticipated difficulties in completing the task order requirements;

b. Ad hoc Site Visits: Host a one-day meeting as requested by COR and/or CO. It is anticipated that this will occur no more than once or twice per year;

c. Ad hoc teleconference as requested by the COR and/or CO.

Performance Area B: Clinical Project

NOTE: NIH will issue TORFPs for individual clinical projects of investigational devices under Performance Area B. Performance Area B activities are defined below and are to be considered general Technical Requirements that will be executed following issuance of individual Performance Area B Task Order awards. Each individual Performance Area B Task Order award will also define specific and additional technical requirements as appropriate for that Task Order Statement of Work.

Under Performance Area B, the Contractor shall perform all activities associated with the conduct of medical device clinical studies as specified below. Task Orders issued under Performance Area B, “Clinical Project” will consist of a base requirement for “Protocol Development and Study Preparation” and a quality-type option for “Clinical Study Implementation”.

The technical requirements for the base and quantity option components are as described below.

Base Requirement: “Protocol Development and Study Preparation” This requirement includes activities up to study initiation. Continuation of study activities is covered by the “Clinical Study Implementation” quality option.

i. Collaborate with Sponsor/Contributor to finalize a protocol and submit to NIH and the

Sponsor/Contributor for review and approval in compliance with the timelines specified within the task order. When possible, input from patients and/or patient advocacy groups should be considered when developing the protocol. Provide all necessary documentation for the proposed clinical study to the Sponsor/Contributor required to secure the IDE approval and work with Sponsors/Contributors to submit documents for all requisite regulatory approvals (e.g., IRB and FDA submissions). Prepare the informed consent form (ICF) which contains appropriate reference to the NIH Privacy Act system germane to data collection for awarded task orders and all other protocol specific supporting documents (e.g., subject recruitment advertisements), and submit the final protocol, any protocol amendments, ICF and other documents to the institutional review board (IRB) for review and approval.

ii. Throughout the process essential regulatory documents as specified in ICH guideline should be generated and stored in files/folders and be available for monitors and for use in the subsequent quantity option when executed. Essential regulatory documents may include but are not limited to: signed IRB approved protocol; informed consent form and advertisement for subject recruitment; IRB approval letter; IRB membership list; PI and sub-investigators curriculum vitae; licenses for PI and sub-investigators; investigator’s brochure; documentation outlining responsibilities for each key person listed in protocol;

personnel training documentation (PHS/GCP); normal laboratory ranges; laboratory certification; financial disclosure documents; conflict of interest declaration;

indemnification/insurance documents.

These and all relevant data/documents must be maintained with compliance with all Information Technology preparedness, security and compliance with contract requirements e.g., FISMA and 508 of the Rehabilitation Act of 1973, as amended by the Workforce Investment Act of 1998.

iii. Prepare and deliver a Project Management Plan (PMP) within 60 calendar days after task order award and before consenting of the first subject. The PMP must be a single, well-organized document or folder that clearly connects document elements with the sections below. The PMP shall address and include, at a minimum, the following:

a. Project timelines including all contract deliverables;

b. Project-specific standard operating procedures (SOPs) for the conduct of clinical studies and for all other integrated and collaborating services;

c. Personnel listing including their roles and responsibilities to include an organizational chart;

d. Human subject considerations (e.g., federal wide assurance (FWA), initial and continuing human subject training/education for personnel, data and safety monitoring plan, consenting procedures, procedures for managing medical emergencies on-site, reporting of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events, hospitalizations and procedures for prompt reporting of SAEs in compliance with FDA regulations and NIH policies);

e. Develop Data Safety and Monitoring Plan (DSMP) in accordance with NIH guidelines and policies for DSM (https://grants.nih.gov/policy/humansubjects/policies-and-regulations/data-safety.htm) for review and approval by the IRB;

f. Establish and coordinate an Independent Safety Monitor (ISM) or Data Safety Monitoring Board (DSMB) when applicable in accordance with NIH guidelines and policies for DSM for review and approval by the IRB;

g. Training program for clinicians, clinical site staff, data management staff and other support staff in the protocol procedures with every task order protocol in order to ensure reliability of evaluation, treatment and assessment procedures;

h. Recruitment and retention plan (e.g., enrollment of a diverse subject pool, including women and minorities, across the lifespan (if applicable), rate of subject accrual, subject retention, plans for deficient enrollment). Enrollment data shall be collected using categories required for the NIH Inclusion Enrollment Report Form (https://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf);

i. Data management procedures and systems planning that is in compliance as specified with the contract terms and conditions including but not limited to development of database and case report forms (CRFs), data collection, data monitoring, data safety review;

j. Plan and timeline for development of the statistical analysis plan (SAP);

k. Management procedures for receiving, storing, and implanting/applying investigational devices; also to be included a procedure for randomization and if appropriate stratification of eligible subjects;

l. Blinding plan, including during device use, clinical and data management activities, as appropriate;

m. Clinical and laboratory quality monitoring procedures;

n. Procedures for preventing, identifying, handling, reporting and resolving protocol deviations;

o. Quality control plans and procedures;

p. Establishment and demonstration for independence of oversight including quality assurance procedures;

q. Protection of Contributors’/Sponsors’ intellectual property and data procedures;

r. Archival plans for securing completed trial data according to regulatory requirements;

s. Contingency planning;

t. The plan for quality control and quality assurance, e.g., monitoring plans, data quality plans and audits; and

u. Close-out plan

iv. Regulatory preparations and compliance:

a. If the study is either an NIH-defined or FDA-defined clinical trial, register the clinical trial in the National Library of Medicine’s Clinical Trials registry (http://www.clinicaltrials.gov);

b. Ensure all requisite regulatory approvals are in place (e.g., IRB and FDA submissions) including that the investigational device has appropriate FDA approval (e.g., IDE) confirming the device’s suitability for testing in humans prior to initiating recruitment;

c. Obtain any necessary Material Transfer Agreement (MTA) from Contributor/Sponsor;

d. Throughout the studies essential regulatory documents should be generated and stored in files/folders and be available for monitors and, at the end of the studies, all essential regulatory documents at the clinical research unit should be placed in the master regulatory file for archiving. Regulatory documents may include but are not limited to: IRB approved protocol, ICF and advertising; IRB approval letter; IRB membership list; PI and sub-investigators curriculum vitae; licenses for PI and sub-investigators; investigator’s brochure, normal laboratory ranges, laboratory certification, financial disclosure documents, indemnification/insurance documents, investigational device shipment receipts, etc. During the conduct of the clinical trial, all new relevant information/data must be appended to the essential documents as it becomes available;

e. Ensure that the conduct of the clinical trials performed is in compliance with all FDA and ICH GCP regulations and guidelines;

f. Prepare a complete clinical study report in submission ready format for FDA unless otherwise specified. Additionally, the IDE report for annual filing requirements to the IDE application, as needed;

g. Ensure the confidentiality of all clinical records and information about subjects enrolled in the clinical trial conforms to all Privacy Act requirements (http://www.justice.gov/opcl/privacy-act 1974 and http://www.hhs.gov/ocr/privacy). This acquisition will require the Contractor to do one or more of the following: design, develop or operate a system of records on individuals to accomplish an agency function. Therefore, the Contractor shall comply with the Privacy Act of 1974 as amended at 5 U.S.C. 552a, FAR Clause 52.224-2, applicable agency regulations, and provisions of the NIH Privacy Act System of Record Notice (SORN) applicable to work under this contract. The Privacy Act SORN applicable to this contract is System No. 09-25- 0200, Clinical, Basic and Population-based Research Studies of the NIH, HHS/NIH/OD. The SORN is attached and made a part of this contract. Violation of the Act may involve the imposition of criminal penalties. Information and records obtained from subject volunteers who have consented to participate in performance of work under this contract will be subject to the provisions of the Privacy Act. The Contractor shall explain to participants exactly how information is to be collected, the purpose and use for which the information is being collected and how the information will be protected pursuant to the Privacy Act of 1974 (P.L. 93-579) and accompanying Privacy Act System Notice made a part of this contract, both of which are applicable to the performance of work under this contract. All participants must be made to understand, through use of the informed consent form and careful education, that the extent of their participation is entirely voluntary and that they may provide all, some or none of the information which the Contractor is intending to collect. Upon completion of each clinical study, the system of records generated in performance of that study shall be disposed of in accordance with instructions to be furnished by the COR.

v. Database Build

a. As required for the conduct of the study specified in the Task Order, the Contractor shall develop and validate a database for the clinical study for relevant data including Case Report Forms (CRF), adverse event (AE) and significant adverse event (SAE) logs, and other data as required for the clinical study.

b. The Contractor shall provide any required licenses, software, or dictionaries for the database.

Quantity Option “Study Implementation”

A) Protocol Implementation: Compliance and Oversight

i. Clinical Study Initiation

The Contractor’s clinical study team and support staff shall participate in a clinical study initiation meeting at the Contractor’s clinical research facility. The Contractor shall provide an invitation to NIH and the Contributor/Sponsor to participate in person or via video conferencing. Prepare and deliver a summary report of the initiation meeting to include but not be limited to the agenda and the list of participants.

ii. Protocol Amendments:

a. Prepare all protocol amendments and modifications;

b. Upon COR approval, the Contractor shall submit the amended protocol and ICF to the lRB for review and approval;

c. The Contractor shall provide the amended protocol to the COR and the

Contributor/Sponsor;

d. Upon IRB approval, the amended protocol and revised ICF shall be archived in the master regulatory file;

e. The Project Management Plan (PMP), case reports forms and other supporting documents will be modified to reflect the protocol amendments; and

f. If necessary, the PI or designee shall conduct a training session describing the protocol amendment and its impact on clinical study procedures and assessments.

iii. Protocol Oversight:

a. Oversee and ensure adherence to the protocol all clinical activities conducted at the clinical research facility and all collaborating sites including, clinical laboratory, data management center, imaging center and subcontracting sites;

and

b. Ensure that each participant: meets protocol entry criteria; has given informed consent and has undergone all the screening and baseline assessments as specified in the protocol

iv. For each Task Order protocol:

a. Track subject enrollment and adherence to defined recruitment goals;

b. Review and assess participant data as specified within the data management plan, protocol requirements and/or quality assurance requirements. For example:

i. Promptly provide all data reports for monitor review prior to the initiation of any device parameter changes;

ii. Monitor continuously for the validity and integrity of the accumulating data;

iii. Monitor continuously protocol adherence and compliance with current

ICH GCP guidelines, DHHS Protection of Human Subjects regulations (45 CFR Part 46) and FDA regulations and report all protocol deviations;

iv. Report of any serious adverse events and/or unexpected adverse events to FDA, IRB and COR;

v. Report all performance-related issues and proposed resolutions or corrective actions taken; and

vi. Database summary tables for monitoring and tracking purposes throughout the course of the clinical study including subject enrollment updates

c. If the study is either an NIH-defined or FDA-defined clinical trial, update clinicaltrials.gov as required by NIH policy and Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (summarized here:

https://prsinfo.clinicaltrials.gov/FinalRuleChanges-16Sept2016.pdf)

v. Data Management and Quality Control:

a. Maintain and update the clinical database throughout the study;

b. Modify the database to support any protocol amendments that are implemented during the conduct of the clinical study, as required; and

c. Provide quality control to ensure initial data entry within 24 hours and to correct or issue a data query within 48 hours and inform promptly the clinical research staff of any missing, incomplete and erroneous data

vi. Audit Compliance

The NIH at their discretion may undertake an audit of the Contractor’s facility including all collaborating sites. The Contractor shall make available all facilities, records and files as related to any activity under Performance Area A or B. The Contractor shall submit a report describing the implementation of the corrective actions.

B) Investigational Devices and Clinical Specimens

i. Investigational Device:

a. Maintain inventory records of investigational device in accordance to SOPs;

b. Maintain documentation that the investigational device will be stored and quarantined under appropriate conditions according to the Sponsor/Contributor and regulatory requirements; and

c. Mechanism for the return and/or destruction of unused investigational devices.

ii. Clinical Specimens (if applicable)

a. Ensure collection, processing, labeling, temporary storage under appropriate conditions and management of all collected biological specimens;

b. Ensure shipping of biological specimens for testing and/or repository deposition, as specified in the protocol, in compliance with current Good Laboratory Practice (cGLP), cGCP and domestic laws and regulations; and

c. Maintain current Clinical Laboratory Improvement Amendment certification (http://www.cms.gov/clia/ and The Joint Commission approval (http://www.jointcommission.org/)) or local equivalent, as appropriate

C) Clinical Study Analysis, Close-out and Final Clinical Study Reporting

i. Close-out and Analysis Following the last subject’s completion of clinical study procedures including any outpatient follow-up visits, the Contractor shall:

a. Continue to monitor any residual safety concerns (i.e., AEs & SAEs) until complete resolution;

b. Establish long-term follow-up plan for any patients retaining permanently implanted device;

c. Complete data editing/cleanup;

d. Finalize and lock the database;

e. Conduct the statistical analysis as described in the manual of operations;

f. Deliver the locked deidentified database in agreed upon format (e.g., R, SAS, SPSS, ASCII) and schedule as requested by the COR;

g. Provide to the COR with the final enrollment report using the NIH Inclusion

Enrolment Report form:

https://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf;

h. Provide support to Sponsor/Contributor during drafting/publishing of manuscript;

i. Provide annual IDE reports to the FDA and the COR within 60 days of the anniversary date the IDE went into effect for as long as the IDE remains open, or as recommended by current FDA guidance; and

j. If the study is either an NIH-defined or FDA-defined clinical trial, report trial results to clinicaltrials.gov prior in alignment with requirements.

ii. Completion:

a. Prepare for archiving the final dataset and all associated clinical study records.

Clinical study records are considered case report forms and detailed documentation necessary to assess the final dataset with specific codes for all variables including all transformation that have been created (i.e., data dictionary);

b. Prepare and deliver draft and final clinical study report; the study report must be in a format suitable for submission to the FDA; and

c. Archive the final locked dataset with de-identified data for each clinical study conducted under each task order in Performance Area B in an agreed upon format (e.g., R, SAS, SPSS, ASCII) that is readily usable by NIH and Contributor/Sponsor.

D) Facilities, Equipment and Other Resources

The Contractor shall be responsible for the adequacy and availability of all facilities, equipment, and other resources necessary for the conduct of a clinical study which may include but is not limited to the following.

i. Provide Clinical Research Facilities:

a. Accreditation with a national or state accreditation board for the conduct of clinical studies;

b. Areas to allow for waiting, check-in and discharge;

c. Examination rooms to allow for protocol-related assessments;

d. Standard clinical support services for inpatient care, twenty-four hours/day, seven days/week;

e. Capability to recruit target populations;

f. Adequate and secure computing resources for communication and data management (e.g., entry editing, quality control);

g. Adequate and secure electronic access to the data management center;

h. Emergency care and a definitive plan for management of life-threatening adverse events including on-site resuscitation equipment and hospitalization procedures in the event a participant requires these services;

i. Adequate equipment, staff and services for performing routine safety evaluations (e.g., vital signs, ECG, neurologic exam), precisely timed phlebotomy, collection of cerebrospinal fluid (CSF), urine and other bodily fluids as necessary;

j. Capabilities for the collection of cerebrospinal fluid (CSF) via lumbar puncture or with a temporary in-dwelling catheter if required by the TOFRP;

k. Ability to provide experienced research staff to perform cognitive testing, using paper or computer based systems;

l. Ability to provide experienced staff to quantify activities of daily living;

m. Staff with expertise in the conduct of medical device clinical studies including but not limited to physicians, clinical specialists, registered research nurses, study coordinators, clinical research associates, research assistants, and Independent Safety Monitor(s) (ISM);

n. Documentation of staff qualifications for completion of specific outcome measures where such qualification is required or appropriate

o. Access to clinical specialists in the therapeutic and diagnostic areas covered by NIH and the NIH Blueprint MedTech program for additional safety and efficacy assessments that may be required in select clinical studies, such as ophthalmology exam or detailed neurologic examination; and

p. Capabilities for composition of serious adverse event reports and narratives

ii. Provide cGLP Clinical Laboratory Facility:

a. Adequate space for the processing and temporary storage of biological specimens;

b. On-site sample storage facilities at room temperature, 4, -20 and -70 degrees

Celsius;

c. Clinical laboratory support services with provisions of 24 hours/day testing if required by the protocol;

d. Histology/pathology capabilities, if required by the protocol;

e. Adequate and secure electronic access to the data management center; and

f. Have current certification and licensure for the performance of biological specimen assays and analyses

iii. Provide Clinical Imaging Facility:

a. Adequate and secure electronic access to the data management center;

b. Adequate facilities and equipment for conducting protocol-required diagnostic and/or imaging procedures for diagnosis or special safety evaluations, including computerized tomography (CT), magnetic resonance imaging (MRI), proton emission tomography (PET), electromyography (EMG), and electroencephalography (EEG); Electroretinography (ERG);

c. Ability to compare investigational diagnostic devices against gold-standard imaging listed above, when applicable; and

d. Have current certifications and licensures for the performance of imaging procedures.

iv. Provide Data Management Center:

a. Adequate computing resources to support data collection activities;

b. Personnel knowledgeable about data management activities and operations but not limited to data management planning and reporting, performance reporting, quality assurance and administrative support;

c. Clinical data warehousing capabilities/facilities in order to provide a centralized, integrated system for data storage, analysis, reporting and ad hoc query of clinical data;

d. Data management capabilities necessary to support the conduct of clinical research, such as case report form (CRF) design, data dictionary development, database programming, data base design and development in compliance with Good Clinical Practice (GCP) guidelines and Clinical Data Interchange Standards Consortium (CDISC); and

e. Provide other facilities and equipment, as may be specified by the task order protocols (e.g., biosafety laboratory facilities in compliance with Federal and state regulations)

E) Insurance The Contractor and all collaborating sites participating in the conduct of approved protocols shall provide sufficient malpractice insurance and indemnification for study related injuries to volunteers. The Government will not provide third party liability insurance.

NOTE: The Government will not provide medical care or financial compensation for research-related injuries to clinical study volunteers. This issue should be addressed by the Sponsor/Contributor.

F) Reporting Requirements and Deliverables

1. Technical Performance Reports

Performance Area A

The Contractor shall be required to prepare and deliver the following reports during the base year of the initial task order award and all option years for Performance Area A:

a) Contract Kick-off Meeting Minutes and Slides (year 1 only).

This is due five (5) business days after the kick-off meeting.

b) Quarterly Progress Report These reports are due five (5) calendar days after the end of month 3, month 6, month 9 and the last day of month 12 after award of the option extending the term of the task order period for out years 2 through 10. These reports shall address, but are not limited to, all performance activities related to FISMA requirements and security plan updates; IDE requirements and submissions;

PMP updates; staff training and updates; human subject training; copies of minutes from meetings, teleconferences, webinars and site visits; summary of all activities conducted for each active and completed study (to be reported individually for each study); list of all final archived locked data sets for all studies performed under the contract.

Performance Area B

The Contractor shall prepare and deliver the following reports for each Task Order awarded under Performance area B:

SOW Deliverable Delivery Schedule

Base Requirement – Protocol Development and Finalization

Final protocol and any related amendments/modifications, to include all required regulatory forms for Contributor/Sponsor to obtain open IDE for proposed study and evidence of IRB approval.

3 weeks after award of the task order for the final protocol;

3 weeks after COR request for the amendment or modification

Quality Option - Study Preparation

Project Management Plan 60 days after exercise of task order option and before consenting the first subject

Clinicaltrials.gov registration

60 days after exercise of task order option and before consenting the first subject, if required

Quality Option - Study Implementation

Summary Report for each Clinical Study Initiation meeting

Will be determined by terms of each study Task Order

Draft clinical study report Within 45 calendar days after locking database

Final clinical study report

Within 15 calendar days of receiving comments from the NIH and/or its Contributor/Sponsor

Final Inclusion Enrollment Report

Within 30 days last subjects’ last study visit

Annual report for each IDE application

Within 7 days of submission to FDA

Final Statistical Analysis Plan Within 2 months of final device implant/use

Finalized database provided to Contributor/Sponsor

Within 2 months of final device implant/use

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

Update per FAC 2021-03 Last updated: 02/2021

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (Mar 2020), FAR Provision 52.204-8

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is__________________ [insert NAICS code].

(2) The small business size standard is _____________ [insert size standard].

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

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

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

(i) Paragraph (d) applies.

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

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

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

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

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

Attachment 4

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

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. This provision applies to all solicitations.

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

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

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

(B) Exceed the simplified acquisition threshold; and

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

(vi) 52.204-26, Covered Telecommunications Equipment or Services-Representation. This provision applies to all solicitations.

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

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

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

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

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

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

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

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

(C) The provision with its Alternate II applies to solicitations that will result in a multiple-award contract with more than one NAICS code assigned.

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

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

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

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

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

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

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

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

(xxi) 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225-3.

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

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

(C) If the acquisition value is $50,000 or more but is less than $83,099, the provision with its Alternate II applies.

(D) If the acquisition value is $83,099 or more but is less than $100,000, the provision with its Alternate III applies.

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

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan- Certification. This provision applies to all solicitations.

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

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

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

[Contracting Officer check as appropriate.]

__ (i) 52.204-17, Ownership or Control of Offeror.

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

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

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

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

__ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA–Designated Products (Alternate I only).

__ (vii) 52.227-6, Royalty Information.

__ (A) Basic.

__ (B) Alternate I.

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

(d) The offeror has completed the annual representations and certifications electronically…