Sol_75N95024R00106.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

National Institutes of Health National Institute on Drug Abuse Bethesda, Maryland 20892

REQUEST FOR PROPOSAL (RFP) NUMBER: 75N95024R00106

PROJECT TITLE: Clinical Support Services for the Research Efforts of the NINDS, Stroke Branch

ISSUED BY:

Marlene Milgram Contracting Officer NINDS Section Contracts Management Branch Red Office of Acquisition, NIDA

Email: marlene.milgram@nih.gov Phone: (301) 594-0864

DATE ISSUED: August 24, 2024

PROPOSAL DUE: September 9, 2024, 4:00 PM Eastern Time

The National Institute of Neurological Disorders and Stroke (NINDS) invites you to submit a proposal responding to this RFP No. 75N95024R00106 for “Clinical Support Services for the Research Efforts of the NINDS, Stroke Branch.”

This RFP is released under FULL AND OPEN Competition Procedures.

This Request for Proposal (RFP) is prepared 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, III of the Uniform Contract Format.

NIDA anticipates the award of two cost reimbursement contracts containing the following period of performance:

Baase Period: 09/28/2024 through 03/27/2025 (6 months) Option Period 1: 03/28/2025 through 03/27/2026 (!2 months) Option Period 2: 03/28/2026 through 03/27/2027 (!2 months) Option Period 3: 03/28/2027 through 03/27/2028 (!2 months) Option Period 4: 03/28/2028 through 03/27/2029 (!2 months) Option Period 5: 03/23/2029 through 09/27/2029 (6 months)

Option period may be exercised to extend the period of performance as needed. Funding of option periods will depend on contractor’s performance during the preceding period of performance and funding availability.

Interested offerors should respond by submitting technical and business proposals for the entire requirement, including option periods.

All offerors must be actively registered and have an active System for Award Management (www.sam.gov) account at the time of proposal submission. Additionally, all offerors registered in the System for Award Management must be in full compliance with FAR 52.204-13 System for Award Management Maintenance and FAR 52.207- 7 System for Award Management, to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement.

Offerors shall respond by submitting a Technical Proposal and a Business Proposal based on the assumptions and information provided in the RFP.

General Particularly direct your attention to Part IV – Representations and Instructions, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Review these parts as to the effects on performance capability, and technical and cost considerations in the development of your proposal.

Do not fill in blanks or otherwise complete portions of Parts I, II, and III which otherwise appear to require the insertion of data. The Government will complete those Parts prior to contract award.

Offeror Questions Requests for clarification, additional information, or correction must be submitted via written email to the Contracting Officer named on page 1 at email address marlene.milgram@nih.gov.

Offeror questions must be received no later than 5:00 PM Eastern Time on September 4, 2024 and include “RFP 75N95024R00106” in the Subject line of the email.

NOTE: Site visits will not be provided.

The Technical Proposal Please see pages 72 – 85 of the RFP for instructions, information, required content and forms of the Technical Proposal. It is important that you list all professional personnel and organizations named in the proposal that will perform any of the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. NINDS will use this information to ensure that no conflicts of interest exist with the selected review committee members

The Business Proposal Please see pages 86 - 98 of the RFP for instructions, information, required content and forms of the Business Proposal.

Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than 4:00 PM Eastern Time on September 9, 2024.

Proposals submitted by facsimile, e-mail, or hard copy will not be accepted nor evaluated for a possible award.

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

Additional instructions on submitting the technical and business proposals in eCPS is provided in Attachment of the RFP (See RFP, Section J – List of Attachments).

A representative of your organization who is authorized to enter into contract with the National Institutes of Health must sign your Technical Proposal and Business Proposal.

All notices related to this RFP will be published at www.sam.gov under RFP Number 75N95024R00106. Only organizations who are actively registered in SAM.gov will receive e-mail notifications of issued notices related to this RFP.

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

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 can legally commit the Government to the expenditure of public funds in connection with this RFP.

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

If any content in this document contradicts any content in the RFP, the content in the RFP shall take precedence.

The NINDS appreciates your interest in the subject RFP and looks forward to receipt of your proposals.

Marlene Milgram, Esq.

Contracting Officer NINDS Section, Office of Acquisition National Institute on Drug Abuse Email: marlene.milgram@nih.gov Phone: (301) 594-0864

Digitally signed by Marlene E.

Milgram -S Date: 2024.08.24 17:20:34 -04'00'

75N95024R00106

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 106

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 3304 (a) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

08/24/2024 X

NIDA-EXEC

National Institutes of Health National Institute on Drug Abuse Bethesda, MD 20892-7511

1600 ED 09/09/2024

MARLENE E MILGRAM +13 64

MILGRAMM2@NIDA.NIH.GOV

015-9408

PAGE(S)

MARLENE E. MILGRAM

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____0_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 106

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75N95024R00106

(A) (B) (C) (D) (E) (F)

Period of Performance: 09/28/2024 to 03/27/2025

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

SECTION A - SOLICITATION/CONTRACT FORM

2. Request for Proposal (RFP) No.:

75N95024R00106

3. Issue Date:

08/24/2024

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title: Clinical Support Services for the Research Efforts of the NINDS, Stroke Branch

6. ISSUED BY:

National Institute on Drug Abuse Office of Acquisition 6001 Executive Blvd., Room 4214, MSC 9657 Bethesda, Maryland 20892-9657

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal for Use with the NIH Electronic Contract Proposal Submission (eCPS) Website" (Attachment 1).

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 4:00 PM Eastern Time on 09/09/2024. Offers will be valid for 90 days unless a different period is specified by the offeror on the Attachment titled "Proposal Summary and Data Record, NIH 2043."

ALL QUESTIONS PERTAINING TO THIS RFP MUST BE SUBMITTED TO MARLENE MILGRAM AT

MARLENE.MILGRAM@NIH.GOV NO LATER THAN 2:00 PM Eastern Time on 09/04/2024.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY

OF THE PROPOSAL." PROPOSALS MUST BE SUBMITTED within the eCPS Website.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED IN THIS SOLICITATION, 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 award of a contract.

11. FOR INFORMATION, CONTACT:

Marlene Milgram Phone: (301) 594-0864 Email: Marlene.Milgram@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Marlene Milgram, Esq.

Contracting Officer NINDS Section, Office of Acquisition, National Institute on Drug Abuse mailto:MARLENE.MILGRAM@NIH.GOV mailto:Marlene.Milgram@nih.gov

RFP TABLE OF CONTENTS

SECTION A – SOLICITATION/CONTRACT FORM

PART I - THE SCHEDULE

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…………………………………………….……………..….… 59

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

B. INSTRUCTIONS TO OFFERORS……………………………………………………………………… 66

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposals

3. Proposal Summary and Data Record (NIH-2043

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act – Treatment of Proposal Information

11. Selection of Offerors

12. Past Performance Information

C. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussion

2. Technical Evaluation

3. Human Subjects………………………………………………………………

4. Section 508 Accessibility Standards for HHS Web Site Content and Communication

Materials

D. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information…………………………………………

2. Proposal Cover Sheet.……………………………………

3. Information Other than Certified Cost or Pricing Data – General Instructions

4. Certified Cost of Pricing Data – General Instructions …………………………….…

5. Cost Elements ………..………………………

6. Formats for Submission of Line Item Summaries……………………………

7. Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or

Pricing Data

8. Salary Rate Limitation

9. Total Compensation Plan…………………

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer’s Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. General

2. Cost/Price Evaluation

3. Human Subject Evaluation

4. Mandatory Qualification Criteria

5. Evaluation of Options

6. Evaluation of Data Sharing Plan

7. Technical Evaluation Factors

8. Past Performance Factor

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 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 contracts resulting from this solicitation will provide an acute care hospital setting and clinical support services to the NIH Team staff in studying, evaluating, treating, and enrolling acute stroke and traumatic brain injury (TBI) patients to develop acute stroke therapies. The NIH Team will recruit patients who present to the Contractor’s hospital with symptoms of an acute stroke or TBI and will employ the use of non-invasive MRI methodologies to evaluate the neurological disease and help develop new therapies for treating these diseases.

ARTICLE B.2. ESTIMATED COST – OPTION

a. The estimated cost to the Government for the Base Period, including all direct and indirect costs will be determined as a result of negotiations. In addition to the Base Period, the Government will have the right to exercise four successive option periods of 12 month each. The total estimated cost of the contract will be increased by the award of option periods, if exercised.

The award of any option(s) will be made pursuant to the terms and conditions set forth in Article H.13. Option Provision. The obligations associated with the exercise of any option, if any, will be made pursuant to the terms and conditions of the Limitations of Cost clause under Section I.

b. The total estimated amount negotiated for the Base Period services plus all possible option periods is as follows:

Estimated Cost ($)

Base Period: on or about 09/28/2024 - 03/27/2025 TBD Option Period(s):

Option Period 1: on or about 03/28/2025 – 03/27/2026 TBD Option Period 2: on or about 03/28/2026 – 03/27/2027 TBD Option Period 3: on or about 03/28/2027 – 03/27/2028 TBD Option Period 4: on or about 03/28/2028 – 03/27/2029 TBD Option Period 5: on or about 3/28/2029 – 09/27/2029 TBD Total [Base Period and All Option Periods]

TBD

Costs for the base period and each 12-month option period will be tracked separately and disbursements will correspond to the period in which those funds are properly chargeable.

c. Pursuant to FAR Clause 52.217-9 and FAR Clause 52.217-8 set forth in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in paragraph b., above as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), it shall notify the Contractor in writing at least 30 days in advance of its intent to exercise any subsequent Option Period in accordance with FAR clause 52.217-9 Option to Extend the Term of the Contract and FAR clause 52.217-8 Option to Extend Services, referenced in Section H and Section I of this this contract.

d. If the Government does NOT intend to exercise a subsequent Option Period as contained in paragraph b., above, the Contractor will be informed at least 45 days prior to contract expiration in order to allow for an orderly shutdown of activities. Otherwise, the Government shall notify the contractor in writing at least 30 days in advance of its intent to exercise any subsequent Option Period listed in paragraph (b) above and as addressed in the FAR clause 52.217-9 Option to Extend the Term of the Contract or FAR clause 52.217-8 Option to Extend Services, as referenced in Section H and Section I of this RFP.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article prohibits or restricts 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.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. 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 July 26, 2023, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number (SORN) is 09-25-0099 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 the direction of the Contracting Officer's Representative (COR).

All reports required herein shall be submitted in electronic format.

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."

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted electronically to the COR with one copy submitted electronically to the Contracting Officer (CO).

These reports 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: https://www.hhs.gov/web/section-508/index.html and at: https://www.section508.gov/create/documents, "Create Accessible Documents."

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 electronic version(s) of these reports will be required as follows:

[ ] Monthly [X] Quarterly [ ] Semi-Annually [ ] Annually https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents

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.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor, and FAR Clause 52.227-13, Patent Rights-Ownership by the Government including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following CO or his designee.

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the email address listed in the contract.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov/

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the NINDS Contracting Officer's Representative (COR) identified in Article G.1. is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Neurological Disorders and Stroke (NINDS)

d. The Government reserves the right to an Inspection period of 30 calendar days, unless a different time period is stated when (the Record of Call/elsewhere in the contract). The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).

e. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

1. The base period of performance of this contract shall be:

September 28, 2024 to March 27, 2025.

2. If the Government exercises its option(s) pursuant to the OPTION PROVISION Articles in Section H of this contract, the estimated period of performance will be extended as follows:

Option Period

Period of Performance

Option Period 1

March 28, 2025 through March 27, 2026

Option Period 2

March 28, 2026 through March 27, 2027

Option Period 3

March 28, 2027 through March 27, 2028

Option Period 4

March 28, 2028 through March 27, 2029

Option Period 5

March 28, 2029 through September 27, 2029

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Deliverable Delivery Schedule

1 Quarterly Technical Progress Report Three months from contract award date and quarterly thereafter

2 Roster of Employees Requiring Suitability Investigations

Due within 14 days after effective date of contract and on the 5th day of each month thereafter

3 Reporting of New and Departing Employees

Within 5 days of staffing changes

4 Contractor-Employee Non- Disclosure Agreement(s)

Within 30 calendar days after effective date of contract and as applicable thereafter.

5 Section 508 Annual Report Due within twenty-one (21) days following each reporting period

6 Annual Invention Utilization Report On or before the completion date of each reporting period

7 Final Invention Statement and Certification

On or before the expiration/ termination date of the contract

8 Subcontracting Report April 30th and October 30th of each Period of Performance

The above Deliverable Items shall be addressed and delivered electronically to:

Addressee Deliverable Item Number Contracting Officer's Representative (COR) - to be named in contract award

1-7

Contracting Officer (CO) - to be named in contract award 1-7

ARTICLE F.3. LEVEL OF EFFORT

a. In accomplishing the work set forth herein, the Contractor shall provide the direct labor (to be negotiated) as indicated below for the base period of the contract, and each option period thereafter. The labor commitment does include time-off absences for vacation, holiday, and sick leave. It is estimated that the direct labor commitment for this contract will be expended approximately as follows:

Possible Labor

Categories Percent of Effort/Labor Hours

Base Period

Option Period 1

Option Period 2

Option Period 3

Option Period 4

Stroke Medical Director/ Principal Investigator (PI)

50% 50% 50% 50% 50%

Research Nurse (RN) 100% 100% 100% 100% 100% Research Coordinator 100% 100% 100% 100% 100%

MRI Technologist TBD TBD TBD TBD TBD

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor Hours specified (and exercised by the Government) herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clauses.

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989), Alternate I (April 1984) is applicable to this contract.

https://www.acquisition.gov/?q=browsefar

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

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

[To be assigned]

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract.

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015).

The key personnel specified in this contract are considered to be essential to work performance.

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

(End of clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title TBD Stroke Medical Director/ Principal Investigator (PI)

a. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-

6088.

ARTICLE G.3. INVOICE SUBMISSION

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4 for NIH Cost-Reimbursement Type Contracts are attached to and made a part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

b. In addition to following the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The name of the Office of Acquisition for this contract is:

NIDA Office of Acquisition.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

c. Unique Entity Identifier (UEI) assigned by the System for Award Management (www.sam.gov).

d. Invoice Matching Option. This contract requires a “two-way match.”

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title. The Contract Title for this contract is “Clinical Support Services for the

Research Efforts of the NINDS, Stroke Branch.”

g. Contract Line Items as follows:

Line Item Number Line Item Description

1 Base Period: 09/28/2024 – 03/27/2025

Inquiries regarding payment of invoices shall be directed to the designated billing office at (301) 496- 6088.

The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds, subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

http://www.sam.gov/

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (MAR 2023)

(a)

(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared annually.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.gov

ARTICLE G.6. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA, MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the pre-award negotiation process the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," Appendix Q, which can be accessed at https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract %20of%20Government%20Property-Appendix%20Q.pdf https://www.cpars.gov/ https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (Dec. 2015)

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

c. Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Website at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).

d. If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN

RESEARCH PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: https://grants.nih.gov/grants/guide/notice-files/not-od-00-039.html

For any solicitation for research involving human subjects, the offeror shall provide in its technical proposal the following information: (1) a list of the names of the principal investigator and any other individuals proposed under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program completed (or to be completed prior to the award of the contract) for each named personnel; (3) a one sentence description of http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf https://grants.nih.gov/grants/guide/notice-files/not-od-00-039.html the program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Curricula that are readily available and meet the educational requirement include the NIH Office of Extramural Research (OER) online tutorial, entitled "Protecting Human Research Participants" at phrp.nihtraining.com. This course is also available in Spanish under the title "Protección de los participantes at pphi.nihtraining.com. You may take the tutorials on-line or download the information in PDF form at no cost. The University of Rochester has made its training program available for individual investigators. Completion of this program will also satisfy the educational requirement. The University of Rochester manual, entitled, "Protecting Study Volunteers in Research," can be obtained through Centerwatch, Inc. at http://store.centerwatch.com/c-29-training-guides.aspx.

If an institution already has developed educational programs on the protection of research participants, completion of these programs also will satisfy the educational requirement.

In addition, prior to the substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the Contracting Officer with the title of the education program and a one sentence description of the program that the replacement has completed.

ARTICLE H.3. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

a. Human subjects research as defined in the Federal Policy for the Protection of Human

Subjects (45 CFR 46),including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

b. Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

c. Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can http://store.centerwatch.com/c-29-training-guides.aspx http://store.centerwatch.com/c-29-training-guides.aspx readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

d. Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

The Contractor shall not:

a. Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

b. Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive…