75F40122D00002 National Academy of Sciences.pdf

AWARD/CONTRACT

2. CONTRACT (Proc. Inst. Ident.) NO. 3. EFFECTIVE DATE

5. ISSUED BY CODE 6. ADMINISTERED BY (If other than Item 5)

UNDER DPAS (15 CFR 700)

4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

7. NAME AND ADDRESS OF CONTRACTOR (No., street, country, State and ZIP Code)

1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES

8. DELIVERY

9. DISCOUNT FOR PROMPT PAYMENT

10. SUBMIT INVOICES

(4 copies unless otherwise specified)

TO THE ADDRESS SHOWN IN

ITEM

CODE

CODE CODE

FACILITY CODE

11. SHIP TO/MARK FOR 12. PAYMENT WILL BE MADE BY

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

13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 14. ACCOUNTING AND APPROPRIATION DATA

75F40122D00002 See Block 20C 1250186

DAP

DHHS/FDA/OAGS/DAP

Attn: Daytona Philpotts 4041 Powder Mill Road Beltsville MD 20705

DAP

DHHS/FDA/OAGS/DAP

ATTN: Janice Heard 4041 Powder Mill Road Beltsville MD 20705

NATIONAL ACADEMY OF SCIENCES 340089

JAMES R BURKE ;500 FIFTH STREET NW

500 FIFTH STREET NW

WASHINGTON DC 200012736

OTHER (See below)FOB ORIGIN X

HHS NET 30P

CODE

FDA

FDA

US Food and Drug Administration 10903 New Hampshire Avenue Bldg 32, Rm 2162, Mail Hub 2145 Silver Spring MD 20993-0002

FDA

FDA

US Food and Drug Administration 10903 New Hampshire Avenue Bldg 32, Rm 2162, Mail Hub 2145 Silver Spring MD 20993-0002

X 1 2022.6999AUW.25235.B6006C0523CON18) )

340089

SCD-C

15A. ITEM NO 15F. AMOUNT15E. UNIT PRICE15D.

UNIT

15C.

QUANTITY

15B. SUPPLIES/SERVICES

Continued

15G. TOTAL AMOUNT OF CONTRACT $2,000.00

16. TABLE OF CONTENTS

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

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B

C

D

E

F

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PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

SOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECS./WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS M

L

K

J

I

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

CONTRACT CLAUSES

LIST OF ATTACHMENTS

REPRESENTATIONS, CERTIFICATIONS AND

INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

OTHER STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

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PAGE(S)

1 - 4

6 - 7 7 - 8

8 - 9 9 - 13 13 - 22

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17. CONTRACTOR' S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.)

No further contractual document is necessary. (Block 18 should be checked only when awarding a sealed-bid contract.)

documents: (a) the Government's solicitation and your bid, and (b) this award/contract.

sheets. This award consummates the contract which consists of the following in full above, is hereby accepted as to the items listed above and on any continuation including the additions or changes made by you which additions or changes are set forth

Solicitation Number

SEALED-BID AWARD (Contractor is not required to sign this document.) Your bid on18.

20C. DATE SIGNED

(Signature of the Contracting Officer)

20B. UNITED STATES OF AMERICA

20A. NAME OF CONTRACTING OFFICER

19B. NAME OF CONTRACTOR

19A. NAME AND TITLE OF SIGNER (Type or print)

BY

(Signature of person authorized to sign)

19C. DATE SIGNED

BY

STANDARD FORM 26 (Rev. 3/2013)

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

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is NOT usable

X

ERIKA A. EAM

CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE

NATIONAL ACADEMY OF

SCIENCES 340089

James Burke, Director, Office of Contracts and Grants

19 Jan 2022James Burke

Digitally signed by James Burke Date: 2022.01.19 13:00:26 -05'00'

Sandra Bellinger -S Digitally signed by Sandra Bellinger -S Date: 2022.01.19 14:43:45 -05'00'

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 41

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

NATIONAL ACADEMY OF SCIENCES 340089

75F40122D00002

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

Tax ID Number: 53-0196932

DUNS Number: 041964057

This is a cost reimbursement (no fee) Indefinite Delivery, Indefinite Quantity

(IDIQ) Type Contract with the National Academy of Sciences (NAS).

NAS will convene committees for assessment, evaluations, provide studies and other technical support services related to public health issues as specified in individual task orders.

COR: George Gonzalez

George.Gonzalez@fda.hhs.gov

Contract Specialist:

Janice Heard

Janice.Heard@fda.hhs.gov

The overall minimum for this contract is: $2,000.00

The minimum is guaranteed

The overall maximum for this contract is: $30,000,000.00

The minimum amount for an order against this contract is: $0.00

Appr. Yr.: 2022 CAN: 6999AUW Object Class: 25235 CenterTag: B6006C0523CON18

Period of Performance: 01/17/2022 to 01/16/2027

1 Guaranteed Minimum (CTP Funding) Research &

Development, Support Services for Scientific and

Technical Consulting Services

Obligated Amount: $2,000.00

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

Division of Payment Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

301-827-3742

FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

Provide a copy marked courtesy to the COR.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic

Funds Transfer - System for Award Management) and/or other applicable FAR clauses

Continued ...

AUTHORIZED FOR LOCAL REPRODUCTION OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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75F40122D00002

(A) (B) (C) (D) (E) (F) specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for

Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

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

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

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

(xi) Name and telephone number of the FDA Approving Official (i.e., Contracting

Officer (CO) or Contract Specialist (CS), as referenced in the award document);

(xii) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(xiii) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

Continued ...

AUTHORIZED FOR LOCAL REPRODUCTION OPTIONAL FORM 336 (4-86)

4 41

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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75F40122D00002

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

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

(xiv) Any other information or documentation required by the contract/order award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format.

All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. [amend/delete, as necessary]

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free

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

The total amount of award: $2,000.00. The obligation for this award is shown in box

15G.

AUTHORIZED FOR LOCAL REPRODUCTION OPTIONAL FORM 336 (4-86)

Contract Number: 75F40122D00002

SECTION B – Supplies or services and prices/costs

B.1 SERVICES

The Contractor shall provide the services described in Section C, Description, Specifications, Work Statement. Except as otherwise specified in the Contract, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for, or incident to, the performance of the work set forth herein. The Contractor shall be reimbursed for allowable, allocable, and reasonable costs for performance of these services.

B.2 CONTRACT TYPE AND PRICE SCHEDULE

Commodity: Research and Development, Indefinite Delivery/Indefinite Quantity, A. Contract Type is Indefinite Delivery Indefinite Quantity (IDIQ) Cost Reimbursement Cost Type (No Fee) B. Contractor guaranteed minimum will be obligated at time of award with the issuance of the IDIQ C. Period of Performance of the IDIQ: 01/17/2022 to 01/16/2027 D. The contract minimum and maximum value(s) over five (5) years and awarded under this contract are shown below:

Guaranteed Minimum Maximum Contract Value over 5 years $2,000 $30,000,000

B.3. TASK ORDERS:

A. Guaranteed minimum will be obligated at award of the IDIQ contract

B. The contract ceiling amount of all task orders shall not exceed the contract ceiling of $30million.

C. All task orders are non-competitive against this single-award IDIQ contract

D. Period of Performance of Task Orders: may be any duration during the period of performance of the IDIQ, but shall not exceed one year after end of the period of performance of the IDIQ

E. The FDA will issue a request for task order proposal. Proposal will be cost reimbursement and ceiling for task order will be established at task order level

SECTION C – DESCRIPTION/SPECIFICATION/WORK STATEMENT

Title of Project: Studies and Activities Related to Health Science and Technology

C.1 BACKGROUND AND NEED

The mission of the Food and Drug Administration (FDA) is to promote public health by promptly and efficiently reviewing clinical research and taking appropriate action of the marketing of regulated products in a timely manner.

FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science- based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

In the past, the National Academy of Sciences (NAS) and its subcomponents have undertaken several independent, objective studies and analyses of issues relevant to the FDA in carrying out its mission.

These studies have included assessment and evaluations that have provided valuable information which impacted public policy and/or programmatic decisions. Often these issues emerge with some degree of urgency.

The FDA has a continuing need to utilize the expertise of NAS, and its subcomponents, for the study of a wide variety of issues including food, agriculture, medical, biological sciences and technical/economics.

C.2 SCOPE OF WORK

The task orders issued will be for work addressing issues of interest or concern to the Government.

Work requested through individual task orders will address public health and may include (but not limited to):

C.2.1 Various program assessments and evaluation studies that examine existing research findings, explore gaps in information and determine research need both nationally and internationally.

C.2.2 Policy review and scientific research and analyses of current issues or long-range concerns of major initiatives.

C.2.3 Congressionally mandated studies.

C.2.4 FDA may attend the contractor sponsored conference, seminars, and workshops which pertain to a specific issue or may be general in nature.

C.2.5 Standing Committees of experts for strategic planning and program development as needed by FDA.

Detailed requirements related to the above areas will be specified in each individual task order.

FDA will issue separate task orders for each requirement, providing a Statement of Work (SOW) for each task order. Each task order shall have its own separate funding and period of performance. The National Academy of Sciences operates on a non-profit cost reimbursement basis, each task order shall be issued as a cost reimbursable order. Each task order developed through this contract shall be negotiated separately and contain its own indirect cost rates.

C.3 TECHNICAL REQUIREMENTS

The Contractor shall furnish all the necessary personnel, materials, services and facilities and otherwise do all things necessary in order to provide the technical support in the conduct of studies, assessments, policy review, analyses, evaluations, reviews, and may attend NAS sponsored conferences, seminars, forums, and workshops for a wide variety of issues related to health, sciences and technology.

Detailed technical requirements will be specified the Statement of Work for each individual task order.

C.4 REPORTING SCHEDULE

Reporting requirements, format, content, etc., will be specified in each individual task order.

C.5 GOVERNMENT FURNISHED INFORMATION

Individual task orders issued under this Contract may or may not require reference materials to be made available to the offeror. Any such materials will be identified in the task order request under Security and Privacy Language for Information and Information Technology Language.

SECTION D MARKING

D.1 PACKAGING (ONLY IF PHYSICAL DELIVERY REQUIRED BY TASK ORDER)

All deliverables shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier including that which is necessary to prevent deterioration and damages due to the hazards of shipping, handling, and storing. If the Contractor submits deliverables electronically, the title of the document and contract number shall be identified in the subject line of the email.

D.2 MARKING

Each package/deliverables shall be delivered to the COR at the address in each individual task order, and shall be clearly marked as follows:

A. Name of Contractor;

B. Contract Number;

C. Description of Items Contained Therein; and D. Consignee’s Name, Address, telephone number, and email address.

SECTION E – INSPECTION AND ACCEPTANCE

E.1 INSPECTION

The Contracting Officer’s Representative (COR), as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided and performing the final inspection of all deliverables.

E.2 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This Contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at www.acquisition.gov/far.

FAR Clause No. Date Title

52.246-9 Apr 1984 Inspection of Research and Development – Short Form

SECTION F – DELIVERIES OR PERFORMANCE

F.1 PERIOD OF PERFORMANCE

The period of performance for this IDIQ is five years beginning on 01/17/2022 and ending on 01/16/2027.

F.2 DELIVERABLES

Each task order will specify individual delivery requirements. Unless otherwise specified, all reports or copies of reports shall be delivered to the task order COR. Requirements for inspection are as follows:

The COR or the POC designated in each task order will inspect the services provided to ensure they meet the requirements detailed in the relevant IDIQ and task order.

F.3 PLACE OF PERFORMANCE

The place of performance will be specified at the task order level.

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

This Contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov/far.

FAR Clause No. Date Title

52.242-15 Apr 1989 Stop Work Order (ALT 1 – APR 1984)

SECTION G – CONTRACT ADMINISTRATION DATA

G.1. GOVERNMENT POINTS OF CONTACTS

The Contractor shall share sufficient information throughout the life of the contract and resulting task order(s), so that the FDA maintains oversight in the best interests of the FDA. The following individuals shall be the Government's points of contact during performance of the Contract:

A. CONTRACT SPECIALIST

All communications pertaining to contractual and/or administrative matters under the IDIQ contract should be addressed to the IDIQ Contract Specialist. All communication pertaining to contractual and/or administrative matters under the task orders should be addressed to the task order Contract Specialist.

B. COR APPOINTMENT AND AUTHORITY

The COR assigned to this IDIQ Contract is:

George Gonzalez 10903 New Hampshire Ave Bldg. 75. Room 3428 Email: George.Gonzalez@fda.hhs.gov Phone: (301) 796-9263

1. Performance of work is subject to the technical direction of the COR identified above, or at the task order level.

2. Technical direction must be within the scope of the specification(s)/work statement. The COR does not have authority to issue technical direction that: Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

• Constitutes a change as defined in the clause entitled “Changes”;

• In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

• Changes any of the terms, conditions, or specification(s)/work statement of the Contract;

• Interferes with the Contractor's right to perform under the terms and conditions of the Contract; or

• Directs, supervises or otherwise controls the actions of the Contractor's employees.

3. Technical direction may be oral or in writing.

4. The type of actions within the purview of the COR’s authority is to assure that the Contractor performs the technical requirements of the Contract, and to notify both the Contractor and the Contracting Officer of any deficiencies observed. A letter of designation shall be issued to both the COR and the Contractor at the time of the contract award setting forth in full the responsibilities and limitations of the COR.

G.2 ORDERING PROCEDURES

A request for task order proposal (RFTOP) will be issued via email to the IDIQ holder in accordance with the procedures of FAR 16.505(a) “Ordering”. The RFTOP will clearly describe the services required, the contract type (cost reimbursement) and the basis for award. The RFTOP will include notification for any task orders requiring Security or Confidential Information, which must be inserted into to task order award. The RFTOP will also include the standards required for compliance with HHSAR 352.239-71, Electronic and Information Technology Accessibility and Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998.

The contractor will have up to ten (10) calendar days to respond to any RFTOP. At a minimum the following required documents must be submitted with any proposal in response to a RFTOP:

Narrative of technical approach Resume of key personnel identified in the RFTOP Cost Proposal o Direct Labor (labor category, position, hours, rates) o Other Direct Costs (ODCs) o Indirect Rates/Costs (demonstrating application of the indirect rates) o Approved/current forward pricing rates from cognizant audit agency for the period of performance of the task order

Commitment letters may be required for some key personnel, signed by the recommended candidate and the point of contact at the company that has the authority to offer employment to commitment letters must include the following information. In addition, the Government reserves the right to request writing samples from key personnel in response to a RFTOP.

Only FDA is authorized to place task orders against this resultant IDIQ contract. All task orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order.

The resultant IDIQ contract will have an ordering period of five (5) years from the date of award. Each task/delivery order issued under this contract will specify:

• (i) Date of order

• (ii) Contract number and order number

• (iii) Task order period of performance may go beyond the end of the IDIQ period of performance by not more than one year.

G.3 FDA INVOICE SUBMISSION

The Contractor shall submit vouchers or invoices in accordance with the FAR 52.232-25, Prompt Payment, and FAR 52.232-33, Payments by Electronic Funds Transfer – System for Award Management. The Contractor is responsible for registering and remaining active in the System for Award Management at https:sam.gov. Payment shall be made to the Contractor’s financial institution designated in the Contractor’s System for Award Management Registration.

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION Attn:

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

MAIL HUB 2145

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

*** Acceptable methods of delivery include: E-mail (preferred). Provide a copy marked courtesy to the COR.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

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

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

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

(d) the contractor shall include the Contract Line Item/Funding line item for each description,

(e) quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

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

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

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

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

(i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A.

G.4 GOVERNMENT FURNISHED PROPERTY (GFP)

In addition to the applicable "Government Property" clause in Section I, the Contractor shall comply with the provisions of DHHS publication "Contractor's Guide for Control of Government Property," which is hereby incorporated by reference. The guide is available on the HHS website:

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

H.1. Procurements Requiring Information Security and/or Physical Access Security

Although it is not contemplated that Information Security or Physical Access Security will apply to any task orders under this IDIQ contract, if there is an occasion for information and/or physical access, this clause shall apply as needed. This clause will be specifically tailored and included in the task order and the National Academy of Sciences shall comply with the required information security and/or physical security requirements.

A. Baseline Security Requirements

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

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources. 2) Safeguarding Information and Information Systems. In accordance with the Federal Information

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

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

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

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

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

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

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

INFORMATION SECURITY CATEGORIZATION

[] Information Types: Use the National Institutes of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, (http://csrc.nist.gov/publications/) to determine the applicable information type(s). Enter information types in Table 1 below (add/remove rows as needed).

[] Mission/Program Based Information: For all selected information types from the NIST 800-60, rate the risk of all information types. The NIST-defined risk ratings may be changed to reflect the actual risk to the agency/program mission. If changing the NIST risk ratings, an explanation for changing the ratings must be included.

[] Information/Information System Categorization: Use the Federal Information Processing Standard (FIPS) Publication 199, Standards for Security Categorization of Federal Information and Information Systems, (http://csrc.nist.gov/publications/) to categorize the information and/or information system and determine the overall risk. The overall risk is based on the highest water mark (e.g., if Confidentiality is

Moderate, Integrity is Low and Availability is Low, the overall rating is Moderate.) Enter the overall risk rating in Table 2 below.

Security Categorization Level:

Information Type (Number and Title)

Confidentiality (Low, Moderate, High)

Integrity (Low, Moderate, High)

Availability (Low, Moderate, High)

Access to FDA research data

Moderate Moderate Moderate

Access to FDA policy on scientific research and Analysis

Moderate Moderate Moderate

Information/System Categorization:

Project/System Name Confidentiality

(Low, Moderate, High) Integrity (Low, Moderate, High)

Availability (Low, Moderate, High)

Overall Risk:

(Low, Moderate, High)

Moderate Moderate Moderate

E-A UTHENTICATION RISK ASSESSMENT

Conduct an E-Authentication Threshold Analysis (E-Auth TA) to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary by following the OMB 04-04, E-Authentication Guidance for Federal Agencies (https://www.whitehouse.gov/sites/default/files/omb/memoranda/fy04/m04-04.pdf) and NIST SP 800-63, Electronic Authentication Guideline. If a full E-auth RA is required, determine the level of assurance. The potential levels of assurance are:

(NOTE: This section only applies if the procurement involves the development or maintenance of an information system that is external facing.)

• Level 1: Little or no confidence in the asserted identity’s validity;

• Level 2: Some confidence in the asserted identity’s validity;

• Level 3: High confidence in the asserted identity’s validity; or

• Level 4: Very high confidence in the asserted identity’s validity.

Based on the required level of assurance determined by the E-auth RA, select the appropriate authentication level of assurance and authentication method required to access the information system, including remote authentication.

Level of Assurance: [ ] N/A [ ] Level 1 [] Level 2 [ ] Level 3 [ ] Level 4 Authentication Method: [ ] N/A [ ] Single-Factor[x] Two-Factor [ ]Multi- Factor

POSITION SENSITIVITY DESIGNATIONS

Office of Security Operations (OSO) Personnel Security, in coordination with the requiring activity representative and Personnel Security Offices, determine the applicable position designations using OPM’s Position Sensitivity Designation Automated Tool, which is located at:

https://www.opm.gov/investigations/. The following are position sensitivity levels that may apply to this solicitation/contract:

PROSPECTIVE OFFEROR NON-DISCLOSURE AGREEMENT

[] Offerors WILL NOT require access to sensitive information in order to prepare an offer.

[] Offerors WILL require access to sensitive information in order to prepare an offer. A Non- Disclosure Agreement (NDA) is necessary for a prospective offeror who will require access to Government information in order to prepare an offer (i.e., a prospective offeror must access an FDA computer room floor plan). [See Appendix B for Non-Disclosure Agreement form.]

DESCRIPTION OF SENSITIVE INFORMATION:

Include applicable position sensitivity designation below:

[] Level: Moderate

[] Sensitivity: Moderate

[] N/A (Select one of the two choices above.)

[] No privacy requirements apply to this solicitation.

[] Privacy Act (System of Records) does not apply.

[] Privacy requirements1 apply to this solicitation.

The E-Government Act of 2002 Section 208 (E-Government Act) and Office of Management and Budget (OMB) Memorandum M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government of 2002, form the core of the Privacy Impact Assessment (PIA) requirement. Together, they state that a PIA is an assessment of how information is handled within certain electronic systems. Each PIA should consider: 1) Whether the system complies with legal, regulatory, and policy requirements related to privacy; 2) The risks and effects of how that system handles personally identifiable information (PII); and 3) How the system could be changed to mitigate potential privacy risks.

The Department of Health and Human Service (HHS) has chosen to evaluate the privacy implications of all electronic systems regardless of whether the E-Government Act or OMB M-03-22 requires a PIA.

[] Privacy Act (System of Records) applies to this solicitation. Complete the information below and sign the checklist.

[] N/A

The following tailored information is required for RFP preparation.

PERSONALLY, IDENTIFIABLE INFORMATION (PII)

Select the PII Confidentiality Impact Level. For additional information, see NIST SP 800-122, Guide to Protecting the Confidentiality of Personally Identifiable Information (http://csrc.nist.gov/publications/PubsSPs.html).

PII2 Overall Level: [] No PII [ ] Yes PII [ ] N/A (Please select Yes or No)

If yes for PII, insert language from the following sections/sub-sections

• Section 2: All

• Section 3: Applicable language as determined by the FDA Senior Official for Privacy or Representative

PRIVACY ACT

If it is determined that Privacy Act requirements apply, complete the following:

TAILORED PRIVACY ACT INFORMATION: Provide the following information if the Privacy Act applies to this solicitation (this is needed to tailor the SOW as required by the HHSAR “Privacy Act” clause, 352.224-70):

• Applicable SORN number(s), or statement that a SORN will be developed:

• Description of design, development, or operation work:

• Records disposition instructions

PROSPECTIVE OFFEROR NON-DISCLOSURE AGREEMENT

[]Offerors WILL NOT require access to sensitive information in order to prepare an offer and will not need a Non- Disclosure Agreement.

[] Offerors WILL require access to sensitive information in order to prepare an offer. A Non- Disclosure Agreement (NDA) is necessary for a prospective offeror who will require access to government information in order to prepare the offer (i.e., a prospective offer must access an HHS/FDA computer room, floor plan).

[] N/A

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. This information will be provided on the e-Qip form that will be electronically sent to the employee. The FDA Personnel Security Specialist will use this information to enter each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed. Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

1. PERSONAL IDENTITY VERIFICATION (PIV) CARDS - All PIV Cards (and any other type of Government-issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer. The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government-issued

Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two

(2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document.

Acceptable forms of identification are listed in Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

Required background investigations may include, but are not limited to:

☐ Review of prior Government/military personnel records;

☐ Review of FBI records and fingerprint files;

☐ Searches of credit bureaus;

☐ Personal interviews; and ☐ Written inquiries covering the subject's background.

2. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS - Under the requirements for Homeland Security Presidential Directive-12 (HSPD-12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals. If any prospective foreign national contractor/subcontractor employee does not meet the residency requirements, he/she cannot qualify for a PIV Card under HSPD-12.

3. NON-PUBLIC DATA PROTECTION - The Contractor must protect the privacy of all information reported by or about Contractor employees and protect against unauthorized disclosure.

*Upon a favorable fingerprint return, the Contractor will be notified to return to the Badging and Credentialing Office for their building pass.

*Food and Drug Administration Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time 10903 New Hampshire Avenue

Building 32, Room 1205 Silver Spring, MD 20993

No appointment necessary Telephone: (301) 796-4000

H.2 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

During the life of this Contract, the Contractor’s performance shall be evaluated on an interim and final basis pursuant to FAR 42.15, Contractor Performance Information. The evaluation shall be conducted utilizing the Contractor Performance Assessment Reporting System (CPARS).

CPARS is a secure Internet website located at http://www.cpars.gov. FDA will register the contractor in CPARS upon receipt of the name and email address of the individual who will be responsible for serving as the Contractor’s CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS mail message which contains User ID and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 60 calendar days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 calendar days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions.

H.3 HHS Goals

FDA has the following subcontracting goals. In response to the HHS goals listed below, the National Academy of Sciences submitted its subcontracting plan to FDA on October 11, 2021.

FDA SB SBD WOSB HZ SDVOSB

PRIME CONTRACT TBD 5% 5% 3% 3%

SUBCONTRACT 33% 5% 5% 3% 3%

SECTION I – CONTRACT CLAUSES

I.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This Contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: FAR and HHSAR – http://www.acquisition.gov/far

A. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR

CHAPTER 1) CLAUSES

Reg Clause Date Clause Title

FAR 52.202-1 Jun 2020 Definitions

FAR 52.203-3 Apr 1984 Gratuities

FAR 52.203-5 May 2014 Covenant Against Contingent Fees

FAR 52.203-6 Jun 2020 Restrictions on Subcontractor Sales to the Government

FAR 52.203-7 Jun 2020 Anti-Kickback Procedures

FAR 52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

FAR 52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity

FAR 52.203-12 Jun 2020 Limitation on Payments to Influence Certain Federal Transactions

FAR 52.203-13 Jun 2020 Contractor Code of Business Ethics and Conduct

FAR 52.203-17 Jun 2020 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower

FAR 52.203-19 Jan 2017 Prohibition on Requiring Certain Internal Confidentiality Agreements

FAR 52.204-1 Dec 1989 Approval of Contract

FAR 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

FAR 52.204-9 Jan 2011 Personal Identity Verification of Contractor Personnel

FAR 52.204-10 Jun 2020 Reporting Executive Compensation and First-Tier Subcontract Awards

FAR 52.204-13 Oct 2018 System for Award Management Maintenance

FAR 52.204-14 Oct 2016 Service Contract Reporting Requirements

FAR 52.204-15 Oct 2016 Service Contract Reporting Requirements for Indefinite- Delivery Contracts

FAR 52.204-19 Dec 2014 Incorporation by Reference of Representations and Certifications

FAR 52.204-23 Jul 2018 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities

FAR 52.204-25 Aug 2020 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment

FAR 52.209-6 Jun 2020 Protecting the Government's Interests When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

FAR 52.209-9 Oct 2018 Updates of Publicly Available Information Regarding Responsibility Matters

FAR 52.209-10 Nov 2015 Prohibition on Contracting with Inverted Domestic

FAR 52.215-2 Aug 2016 Audit and Records – Negotiation (ALT II)

FAR 52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format

FAR 52.215-10 Aug 2011 Price Reduction for Defective Certified Cost or Pricing

FAR 52.215-11 Jun 2020 Price Reduction for Defective Certified Cost or Pricing

FAR 52.215-12 Jun 2020 Subcontractor Certified Cost or Pricing Data

FAR 52.215-13 Jun 2020 Subcontractor Certified Cost or Pricing Data –

FAR 52.215-14 Jun 2020 Integrity of Unit Prices

FAR 52.215-15 Oct 2010 Pension Adjustments and Asset Reversions

FAR 52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post- Retirement Benefits (PRB) other than Pensions

FAR 52.215-19 Oct 1997 Notification of Ownership Changes

FAR 52.215-20 Oct 2010 Requirements for Certified Cost or Pricing Data and Data

FAR 52.215- 21 Jun 2020 Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data-Modifications

FAR 52.215-22 Oct 2009 Limitations on Pass-Through Charges-Identification of

FAR 52.215-23 Oct 2009 Limitations of Pass-Through Charges (Alternate I)

FAR 52.216-11 Apr 1984 Cost Contract-No Fee

FAR 52.219-9 Jun 2020 Small Business Subcontracting Plan (Alternate II)

FAR 52.219-10 Oct 2014 Incentive Subcontracting Program

FAR 52.222-1 Feb 1997 Notice to the Government of Labor Disputes

FAR 52.222-2 July 1990 Payment for Overtime

FAR 52.222-3 Jun 2003 Convict Labor

FAR 52.222-26 Sept 2016 Equal Opportunity

FAR 52.222-35 Jun 2020 Equal Opportunity for Veterans

FAR 52.222-36 Jun 2020 Affirmative Action for Workers with Disabilities

FAR 52.222-37 Jun 2020 Employment Reports on Veterans

FAR 52.222-50 Oct 2020 Combating Trafficking in Persons

FAR 52.223-6 May 2001 Drug-Free Workplace

FAR 52.223-18 Jun 2020 Encouraging Contractor Policies to Ban Text Messaging While Driving

FAR 52.224-1 Apr 1984 Privacy Act Notification

FAR 52.224-2 Apr 1984 Privacy Act

FAR 52.225-13 Feb 2021 Restrictions on Certain Foreign Purchases

FAR 52.225-25 June 2020 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran- Representation and Certifications.

FAR 52.227-1 Dec 2007 Authorization and Consent

FAR 52.227-2 June 2020 Notice and Assistance Regarding Patent and Copyright

FAR 52.227-14 May 2014 Rights in Data-General (ALT IV – Dec 2007)

FAR 52.228-7 Mar 1996 Insurance – Liability to Third Person

FAR 52.230-2 Jun 2020 Cost Accounting Standards

FAR 52.230-3 Jun 2020 Disclosure and Consistency of Cost Accounting Practices

FAR 52.230-6 June 2010…