75N95022R00014_RFP_SAM-S.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service National Institutes of Health National Institute on Drug Abuse Bethesda, Maryland 20892

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

REQUEST FOR PROPOSAL (RFP) NUMBER: 75N95022R00014

PROJECT TITLE: NINDS Center for Clinical Trial Resources

ISSUED BY:

Shivani Patel Contract Specialist NINDS Section Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892 Email: Shivani.Patel@nih.gov Phone: (301) 594-0527

Nancy Lamon-Kritikos Supervisory Contracting Officer NINDS Section, Section Head Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892 Email: nancy.lamon-kritikos@nih.gov Phone: (301) 480-2447

DATE ISSUED: May 5, 2022

PROPOSAL DUE: June 6, 2022, at 10:00 A.M. (Eastern Time)

The National Institute of Drug Abuse (NIDA) on behalf of National Institute of Neurological Disorders and Stroke (NINDS) invites you to submit a proposal responding to the requirements of RFP No. 75N95022R00014 – NINDS Center for Clinical Trial Resources.

This Request for Proposal is released under FULL AND OPEN Competition Procedures.

NINDS prepared this Request for Proposal (RFP) in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, and III of the Uniform Contract Format.

All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

mailto:Shivani.Patel@nih.gov mailto:nancy.lamon-kritikos@nih.gov http://www.sam.gov/ http://www.sam.gov/

NINDS anticipates a single award cost reimbursement contract will be awarded.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in Sections C and L.

General Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III, which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Offeror Questions Requests for clarification, additional information, or correction must be made in writing to the Contract Specialist and Contracting Officer. Offeror questions must be submitted on or before 12:00 P.M. Eastern Time on May 18, 2022. Offeror questions must be submitted by e-mail to shivani.patel@nih.gov and nancy.lamon-kritikos@nih.gov with the subject line:

“RFI – RFP 75N95022R00014”

The Technical Proposal It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. Offerors may use extra sheets, as needed. NINDS will use this information to ensure that no conflicts of interest exist with the selected review committee members. Technical Proposal Instructions are detailed in Section L.

The Business Proposal Offerors must have an authorized organizational official sign the Business Proposal, which must contain a detailed breakdown of costs for all sample task orders included in the Business Proposal Budget Template. For each cost category/element, provide an explanation of the basis for all costs, and provide documentation to support these costs. Please submit business proposals with a spreadsheet in this format. Use of the above format will hasten review and award. A PDF copy of the spreadsheet must be included in the Business Proposal. Do not send encrypted files.

A completed Form NIH-2043, “Proposal Summary and Data Record” (see Attachment A8) must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Note that in addition to telephone numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

mailto:shivani.patel@nih.gov

The Offeror must submit its Small Business Subcontracting Plan, Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. See Section L.2.c. for additional detail.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) and received no later than June 6, 2022 at 10:00 A.M., Eastern Time.

Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an eCPS account to submit may take approximately three (3) business days.

Please plan accordingly.

Additional instructions on submitting a proposal via eCPS can be found at https://ecps.nih.gov/howtosubmit and in Attachment 1.

All notices related to this solicitation will be posted on SAM (https://www.sam.gov), and all offerors are responsible for monitoring this website for any amendments.

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

NOTE: Site visits may be requested.

Disclaimers This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The RFP shall take precedence if any of the content in this letter is contradictory.

The NINDS appreciates your interest in this RFP and looks forward to receipt of your proposal.

Requests for any information concerning this RFP should be directed to Shivani Patel at Shivani.patel@nih.gov. Discussions with any other individuals should not occur.

https://ecps.nih.gov/ https://ecps.nih.gov/howtosubmit https://www.sam.gov/ mailto:Shivani.patel@nih.gov

Sincerely, Nancy Lamon-Kritikos Supervisory Contracting Officer NINDS Section, Section Head Contracts Management Branch, Red Office of Acquisitions, NIDA 301 North Stonestreet Ave Bethesda, MD 20892

Email: nancy.lamon-kritikos@nih.gov Phone: (301) 480-2447

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: 42 U.S.C. 285 j

2. Request for Proposal (RFP) Number:

75N95022R00014

3. Issue Date:

5/5/2022

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : NINDS Center for Clinical Trial Resources

6. ISSUED BY:

National Institute of Neurological Disorders and Stroke (NINDS) Section Office of Acquisitions, NIDA National Institutes of Health

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal for Use with the NIH eCPS website," ATTACHMENT 1 of this Solicitation.

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 6/6/2022 local time on 10:00AM EST. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to submission of an offer.

Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Shivani Patel

PHONE: 301-594-0527

e-MAIL: shivani.patel@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer on or before 12:00 PM Nancy Lamon-Kritikos https://www.sam.gov/SAM/

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1. Requisition or other Purchase Authority: 42 U.S.C. 285 j EST on May 18, 2022. The proposal intent response sheet is due no later than 12:00 PM EST on May 18, 2022. Offeror questions may be submitted by e-mail to Shivani.patel@nih.gov with the subject line:

"RFP 75N95022R00014.

Contracting Officer, NINDS Section NIDA Office of Acquisitions, NIDA National Institutes of Health

RFP Number : 75N95022R00014-1

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

a. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Use of the Metric System of Measurement

8. Privacy Act - Treatment of Proposal Information

9. Selection of Offerors

10. Institutional Responsibility Regarding Investigator Conflicts of Interest

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11. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

12. Past Performance Information

14. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Data and Safety Monitoring in Clinical Trials

Registration and Results Reporting for Applicable Clinical Trials in ClinicalTrials.gov

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Cost and Pricing Data

5. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

6. Salary Rate Limitation

7. Total Compensation Plan

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. PAST PERFORMANCE FACTOR

6. OTHER NON-SCORED FACTORS

- SECTION 508 POLICY

- Evaluation of Data Sharing Plan

- Subcontracting Program

- 5 -

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS, IF NECESSARY, AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The NINDS Division of Clinical Research (DCR) is charged with ensuring the highest quality of each NINDS-funded clinical research project in terms of both conduct and the integrity of resultant data and ensuring compliance with DHHS/NIH/NINDS regulations regarding human subject protection and safety monitoring. To ensure the highest quality product and most efficient use of resources, DCR has established a programmatic requirement for clinical research-related scientific and technical support for NINDS-sponsored clinical research in the form of an NINDS Center for Clinical Research Resources.

The contractor shall provide scientific/technical support in quality assurance and quality control in the conduct of NINDS-sponsored clinical research to ensure that the data resulting from a clinical research project are of the highest quality and are considered valid and credible within the scientific and clinical community, as well as the general public;

Provide statistical and methodological support and analysis to the NINDS as related to the development of guidelines for NINDS programmatic staff, the resolution of methodological problems in ongoing clinical activities, and overall statistical analysis of the NINDS clinical research portfolio to aid NINDS strategic planning; Provide scientific/technical support, guidance and services in clinical data acquisition, archiving, and distribution activities, in accordance with current NIH data management and sharing policy, in order to store and share/provide secure access to NINDS-sponsored clinical research data with the scientific research community, and; Provide scientific/technical support and training for the ongoing development of a core set, and several disease-specific sets, of Common Data Elements (CDEs) for use in NINDS-sponsored clinical research.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

Payment shall be subject to the withholding provisions of the clauses ALLOWABLECOST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its term option (s) pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

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TERM

OPTION (S)

Level-of- Effort hours

Period of Performance

Cost ($) Fee ($) Total dollar value

Term Option 1 – Basic

Requirement

9,655 9/30/2023

– 9/29/2024

$ TBD $ TBD $ TBD

Term Option 2 – Basic

Requirement

9,655 9/30/2024

– 9/29/2025

$ TBD $ TBD $ TBD

Term Option 3 – Basic

Requirement

9,655 9/30/2025

– 9/29/2026

$ TBD $ TBD $ TBD

Term Option 4 – Basic

Requirement

9,655 9/30/2026

– 9/30/2027

$ TBD $ TBD $ TBD

e. If the Government intends to NOT exercise a subsequent Basic Requirement Option, as contained in paragraph(d), the Government intends to inform the Contractor 30 days prior to contract expiration in order to allow for any final deliverables, including but not limited to, the Final Report. Otherwise, the Government shall notify the contractor in writing at least 15 days in advance of its intent to exercise any subsequent Basic Requirement Option listed in paragraph d) above. See ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, FAR 52.217-9, Option to Extend the Term of the Contract, for full details.

f. If the Government exercises its option item(s) pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Period Item Estimated Level of

Effort

Estimated Number of Times Option Will Be

Exercised*

Estimated cost per Item ($)

Fee per Item($)

Total estimated cost ($)

Total Fee per item ($)

Base Period

Small Project

100 18 TBD TBD

Base Period

Large Project

500 5 TBD TBD

Option Period 1

Small Project

100 18 TBD TBD

Option Period 1

Large Project

500 5 TBD TBD

Option Period 2

Small Project

100 18 TBD TBD

Option Period 2

Large Project

500 5 TBD TBD

Option Period 3

Small Project

100 18 TBD TBD

Option Period 3

Large Project

500 5 TBD TBD

Option Period 4

Small Project

100 18 TBD TBD

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Period Item Estimated Level of

Effort

Estimated Number of Times Option Will Be

Exercised*

Estimated cost per Item ($)

Fee per Item($)

Total estimated cost ($)

Total Fee per item ($)

Option Period 4

Large Project

500 5 TBD TBD

Grand Total (Base and All Options)

*The Government estimates the Small Project Option may be exercised up to 18 times per year and the Large Project Option may be exercised up to 5 times per year. However, the Government reserves the right to exercise the Small Project Option more than 18 times during a performance period and the Large Project Option more than 5 times during a performance period, provided the total number of times exercised does not exceed 90 and 25 respectively.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

1. Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

2. Non-Personal Services and Inherently Government Functions.

Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Technical Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal

g. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period and all options is $___________ .

- 8 -services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

3. Site Visits.

The NINDS anticipates making visits to the Contractor facility. Contractor shall be responsible for making the facility available for a visit and arranging meetings with appropriate personnel. The Contractor may be required to make an approved reverse site visit to Bethesda, Maryland to meet with NINDS staff.

4. Confidential Treatment of Sensitive Information

The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. [DESCRIPTION-SPECIFICATION-WORKSTATEMENT-STATEMENT OF WORK]

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 3/31/2022, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 0 hard copies of these reports will be required as follows:

[ ] Monthly [X] Quarterly [ ] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

http://www.hhs.gov/web/508/index.html

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Reporting on Dual Use Research of Concern

a. Progress Report For work involving an agent or toxin identified in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern or "DURC policy" (see http://www.phe.gov/s3/dualuse/ Documents/durc-policy.pdf), the contractor shall report the following information in the Annual/Semi-Annual/ Quarterly/Monthly Progress report:

i. Identification of agents or toxins that are listed in the DURC policy and used in research funded in this contract, and;

ii. Proposed modifications, if any, to the risk mitigation plan.

b. Special Notifications The contractor shall report to the Contracting Officer's Representative, within 30 calendar days of:

i. Any change in the status of the DURC project funded under this contract (including whether the research is determined by the contractor's institutional review entity to no longer meet the definition of DURC);

ii. Details of any changes to risk mitigation plans (such changes need to be pre-approved by the Contracting Officer's Representative), or;

iii. Instances of noncompliance with the DURC policy, as well as mitigation measures undertaken by the contractor to prevent recurrences of similar noncompliance.

b. Other Reports/Deliverables

1. a. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

a. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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Expiration Date of Contract

b. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer / Contract Specialist shall be included as a contact for notification purposes at the following e-mail addresses:

Contracting Officer e-mail: [To be specified prior to award]e I.6. of the contract).

3. Invention Reporting

In accordance with contract Article C.3. "Invention Reporting Requirement", an Annual Invention Utilization Report shall be due on or before the anniversary date of the contract award and a Final Invention Statement will be due on or before the expiration date of the contract. Note: The same form is used for both the annual and the final report.

4. Service Contract Annual Report

In accordance with FAR 52.204-15 Service Contract Reporting Requirements for Indefinite- Delivery Contracts.", contained in full text in Article I.4. of the contract, the Contractor shall report annually by October 31, for services performed under this contract during the preceding Government fiscal year (October 1 - September 30) under this contract for orders that exceed the thresholds established in 4.1703(a)(2), the following information to http:// www.sam.gov , with an electronic copy to the Contracting Officer:

1) Contract number and order number.

2) The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract.

3) The number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year.

4) Data reported by subcontractors [if applicable] under paragraph (f) of the subject clause (see full text of clause FAR 52.204-15, “Service Contract Reporting Requirements for Indefinite-Delivery Contracts” at https://www.acquisition.gov/ ).

5. Contract Closeout Documents

In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for and provide the following items:

1) Indirect cost (IC) rate proposals for all years (in which an IC rate proposal was not previously submitted);

2) Final property inventory (excluding intellectual property) and Standard Forms 1428 and 1429 (if applicable);

3) Settling all subcontract costs and any issues thereunder;

4) Subcontracting compliance reports for all years to the electronic subcontract reporting system at http://www.esrs.gov (if applicable);

5) Final patent and royalty reports;

6) A contractor's release of claims, i.e., Contractor's closing statement; Contractor's Assignment of Refunds, Rebates, and Credits; and

7) A final invoice or completion voucher.

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HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

INFORMATION AND/OR PHYSICAL SECURITY

A. Security Assessment and Authorization (SA&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three

(3) months after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

B. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package.

● System Security Plan (SSP) - due within 30 days after contract award. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract.

The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

● Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies. The assessor will document the assessment results in the SAR.

The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment. Assessments of controls can be performed by contractor, government, or third parties, with third party verification considered the strongest. If independent assessment is required, include statement below.

Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

● Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all "high" deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

● POA&M - due 30 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within

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30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented. The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued.

Thereafter, the POA&M shall be updated at least quarterly.

C. Contingency Plan and Contingency Plan Test - due 60 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed.

Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

● E-Authentication Questionnaire - The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

D. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[X] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change.

The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx.

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

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b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

c. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

E. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology.

HHS EA requirements may be located here: https://ocio.nih.gov/PM/Pages/EPLC.aspx.

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

https://ocio.nih.gov/PM/Pages/EPLC.aspx

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4. Notification- The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within fifteen days before an employee stops working under this contract.

5. Contractor Responsibilities Upon Physical Completion of the Contract- The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or NIH policies.

6. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

F. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

G. Vulnerability Scanning Reports The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under a separate cover on monthly basis.

H. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

a. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract.

The Government includes but is not limited to the U.S. Department of Justice, U.S. Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

b. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity.