FDA-SOL-1225400.pdf

5. NAME OF FIRM

PART I - CONTRACT-SPECIFIC QUALIFICATIONS

ARCHITECT - ENGINEER QUALIFICATIONS

A. CONTRACT INFORMATION

1. TITLE AND LOCATION (City and State)

2. PUBLIC NOTICE DATE 3. SOLICITATION OR PROJECT NUMBER

B. ARCHITECT-ENGINEER POINT OF CONTACT

C. PROPOSED TEAM

(Complete this section for the prime contractor and all key subcontractors.)

4. NAME AND TITLE

8. E-MAIL ADDRESS7. FAX NUMBER6. TELEPHONE NUMBER

(Check)

P R

IM

E

J- V

P

A R

TN

E

R S

U B

C O

N

TR

A

C

TO

R

9. FIRM NAME 10. ADDRESS 11. ROLE IN THIS CONTRACT

a.

b.

c.

d.

e.

f.

STANDARD FORM 330 (REV. 8/2016)

D. ORGANIZATIONAL CHART OF PROPOSED TEAM (Attached)

CHECK IF BRANCH OFFICE

CHECK IF BRANCH OFFICE

CHECK IF BRANCH OFFICE

CHECK IF BRANCH OFFICE

CHECK IF BRANCH OFFICE

CHECK IF BRANCH OFFICE

AUTHORIZED FOR LOCAL REPRODUCTION

12. NAME 13. ROLE IN THIS CONTRACT

18. OTHER PROFESSIONAL QUALIFICATIONS (Publications, Organizations, Training, Awards, etc.)

E. RESUMES OF KEY PERSONNEL PROPOSED FOR THIS CONTRACT

(Complete one Section E for each key person.)

14. YEARS EXPERIENCE

b. WITH CURRENT FIRMa. TOTAL

17. CURRENT PROFESSIONAL REGISTRATION (State and Discipline)16. EDUCATION (Degree and Specialization)

15. FIRM NAME AND LOCATION (City and State)

STANDARD FORM 330 (REV. 8/2016) PAGE 2

a.

b.

c.

d.

(1) TITLE AND LOCATION (City and State)

PROFESSIONAL SERVICES CONSTRUCTION (If applicable)

(1) TITLE AND LOCATION (City and State) (2) YEAR COMPLETED PROFESSIONAL SERVICES CONSTRUCTION (If applicable)

(1) TITLE AND LOCATION (City and State) (2) YEAR COMPLETED PROFESSIONAL SERVICES CONSTRUCTION (If applicable)

(1) TITLE AND LOCATION (City and State) (2) YEAR COMPLETED

PROFESSIONAL SERVICES CONSTRUCTION (If applicable) e.

Check if project performed with current firm

Check if project performed with current firm

(3) BRIEF DESCRIPTION (Brief scope, size, cost, etc.) AND SPECIFIC ROLE

(3) BRIEF DESCRIPTION (Brief scope, size, cost, etc.) AND SPECIFIC ROLE

(3) BRIEF DESCRIPTION (Brief scope, size, cost, etc.) AND SPECIFIC ROLE

Check if project performed with current firm

Check if project performed with current firm

(3) BRIEF DESCRIPTION (Brief scope, size, cost, etc.) AND SPECIFIC ROLE

19. RELEVANT PROJECTS

(1) TITLE AND LOCATION (City and State) (2) YEAR COMPLETED

PROFESSIONAL SERVICES CONSTRUCTION (If applicable)

(2) YEAR COMPLETED

(3) BRIEF DESCRIPTION (Brief scope, size, cost, etc.) AND SPECIFIC ROLE Check if project performed with current firm

F. EXAMPLE PROJECTS WHICH BEST ILLUSTRATE PROPOSED TEAM'S

QUALIFICATIONS FOR THIS CONTRACT

(Present as many projects as requested by the agency, or 10 projects, if not specified.

Complete one Section F for each project.)

a. PROJECT OWNER

21. TITLE AND LOCATION (City and State)

25. FIRMS FROM SECTION C INVOLVED WITH THIS PROJECT

24. BRIEF DESCRIPTION OF PROJECT AND RELEVANCE TO THIS CONTRACT (Include scope, size, and cost)

20. EXAMPLE PROJECT KEY

NUMBER

a.

b.

c.

d.

e.

f.

(1) FIRM NAME (2) FIRM LOCATION (City and State)

(3) ROLE(1) FIRM NAME (2) FIRM LOCATION (City and State)

(3) ROLE(1) FIRM NAME (2) FIRM LOCATION (City and State)

(3) ROLE(1) FIRM NAME (2) FIRM LOCATION (City and State)

STANDARD FORM 330 (REV. 8/2016) PAGE 3

(3) ROLE

(1) FIRM NAME (2) FIRM LOCATION (City and State) (3) ROLE

b. POINT OF CONTACT NAME

23. PROJECT OWNER'S INFORMATION

c. POINT OF CONTACT TELEPHONE NUMBER

(3) ROLE(1) FIRM NAME (2) FIRM LOCATION (City and State)

22. YEAR COMPLETED

PROFESSIONAL SERVICES CONSTRUCTION (If applicable)

TITLE OF EXAMPLE PROJECT (From Section F)

G. KEY PERSONNEL PARTICIPATION IN EXAMPLE PROJECTS

STANDARD FORM 330 (REV. 8/2016) PAGE 4

26. NAMES OF KEY

PERSONNEL

(From Section E, Block 12)

27. ROLE IN THIS

CONTRACT

(From Section E, Block 13) 1 2 3 4 5 6 7 8 9 10

29. EXAMPLE PROJECTS KEY

NUMBER TITLE OF EXAMPLE PROJECT (From Section F) NUMBER

28. EXAMPLE PROJECTS LISTED IN SECTION F

(Fill in "Example Projects Key" section below before completing table.

Place "X" under project key number for participation in same or similar role.)

H. ADDITIONAL INFORMATION

30. PROVIDE ANY ADDITIONAL INFORMATION REQUESTED BY THE AGENCY. ATTACH ADDITIONAL SHEETS AS NEEDED.

I. AUTHORIZED REPRESENTATIVE

The foregoing is a statement of facts.

31. SIGNATURE 32. DATE

33. NAME AND TITLE

STANDARD FORM 330 (REV. 8/2016) PAGE 5

PART II - GENERAL QUALIFICATIONS

(If a firm has branch offices, complete for each specific branch office seeking work.)

a. SIGNATURE

ARCHITECT-ENGINEER QUALIFICATIONS

2a. FIRM (or Branch Office) NAME

2b. STREET

2c. CITY 2d. STATE 2e. ZIP CODE

3. YEAR ESTABLISHED 4. UNIQUE ENTITY IDENTIFIER

5. OWNERSHIP

b. Discipline

c. Number of Employees

10. PROFILE OF FIRM'S EXPERIENCE

AND ANNUAL AVERAGE REVENUE FOR LAST 5 YEARS

b. Experience

c. Revenue Index

Number (see below)

STANDARD FORM 330 (REV. 8/2016) PAGE 6

1. SOLICITATION NUMBER (If any)

8a. FORMER FIRM NAME(S) (If any) 8b. YEAR ESTABLISHED

9. EMPLOYEES BY DISCIPLINE

Total

(1) FIRM (2) BRANCH

1. Less than $100,000

2. $100,000 to less than $250,000

3. $250,000 to less than $500,000

4. $500,000 to less than $1 million

5. $1 million to less than $2 million

11. ANNUAL AVERAGE PROFESSIONAL

SERVICES REVENUES OF FIRM

FOR LAST 3 YEARS

(Insert revenue index number shown at right)

7. NAME OF FIRM (If Block 2a is a Branch Office)

6a. POINT OF CONTACT NAME AND TITLE

6c. E-MAIL ADDRESS

8c. UNIQUE ENTITY IDENTIFIER

a. Federal Work

b. Non-Federal Work

c. Total Work

12. AUTHORIZED REPRESENTATIVE

The foregoing is a statement of facts.

b. DATE

c. NAME AND TITLE

a. Function Code

a. Profile Code

6b. TELEPHONE NUMBER

a. TYPE

b. SMALL BUSINESS STATUS

PROFESSIONAL SERVICES REVENUE INDEX NUMBER

6. $2 million to less than $5 million

7. $5 million to less than $10 million

8. $10 million to less than $25 million

9. $25 million to less than $50 million

10. $50 million or greater

Other Employees

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 Brief Description of Services/Supplies

This requirement is being procured in accordance with FAR 36.6 and selection will be non-project specific. Firms will be selected for negotiation, if necessary, based on demonstrated competence and qualifications for the required work. The project is at the FDA’s Jefferson Laboratories Campus in Jefferson Arkansas.

This is an Indefinite Delivery/ Indefinite Quantity (IDIQ) contract type for Architect & Engineering (A&E) Design Services contract obligating the contractor to provide all predesign, design and post-design services delineated and referenced in this contract. The Government may use a variety of contract types when issuing Task Orders (TOs) under this contract, including; firm fixed price (FFP), Time and Material, (T&M) Labor-Hour (LH), or a combination thereof.

The contract will require multiple disciplines as described herein on projects conceived to repair, improve and remodel buildings, utilities, electrical, energy audits, HVAC projects and other facilities. Asbestos removal and disposal may be included in some of these projects as a part of the demolition process.

This contract may include but is not limited to: architectural, interior design, landscape architectural, environmental, structural, civil, mechanical and electrical for the performance of planning, programming, surveys, studies, investigations, review of shop drawings, testing/collecting samples and equipment, and the preparation and development of reports, working drawings, specifications, cost estimates, other related documents and construction administrative services as required by the Food and Drug Administration at the Jefferson Lab Complex in Jefferson, AR.

B-2 Contract Minimum and Maximum

Contract Minimum Guarantee

As referred to in paragraph (b) of FAR 52.216- 22, INDEFINITE QUANTITY clause, the contract minimum quantity is $10,000. Should the Government fail to place orders totaling the amount of the contract minimum quantity, the provisions of Clause 52.249-2 entitled, Termination for Convenience of the Government” shall apply to the unordered amount of the contract minimum quantity.

Maximum Amount

The maximum contract amount, inclusive of the five (5) year ordering period under the contract, is estimated not to exceed $7,500,000.00. The estimated maximum anticipated under this contract is not intended to imply that it is an estimate of the total services that will be required. The maximum amount in no way guarantees that the volume of purchases through this IDIQ will be higher or lower than the said estimate over the term of the IDIQ. The one-time guaranteed minimum order amount for the entire five-year period is $10,000.00.

B-3 Schedule of Negotiated Contract Labor Rates

The following fully burdened hourly rates shall apply to all task orders and any modifications thereto.

Professional Personnel Ordering Period 1

Ordering Period 2

Ordering Period 3

Ordering Period 4

Ordering Period 5

Principal / Project Manager (Key Personnel) Lead Architect (Key Personnel) Architect Intern Architect CADD Operator Draftsperson Administrative Support Interior Designer Construction Inspector Lead LEED Consultant Civil Engineer - Sr Civil Engineer - Jr Specification Writer CADD Operator Landscape Architect Structural Engineer - Sr Structural Engineer - Jr Lead Mechanical Engineer (Key Personnel) Mechanical Engineer - Sr Mechanical Engineer - Jr Test and Balancing Tech Fire Protection Engineer Electrical Engineer - Sr Electrical Engineer - Jr Principal / Sr. Engineer Staff Engineer Environmental Scientist Environmental Professional AutoCAD Technician Technical Writer Surveyor (2 person crew)

Fixed price round-trip travel for full day on-site trip to JLC.

Service handling rate percentage for subcontracted services

B-4 Payment/Price

Payment will be made in accordance with the provisions of clause FAR 52.232-10 Payments under Fixed-Price Architect-Engineer Contracts (Apr 2010)”, on presentation of a proper invoice and after acceptance of each deliverable/item specified in each Task Order (TO).

Travel Expenses- Travel rates will be subject to the provisions of the Federal Travel Regulations in effect at the time of task order negotiations. Trips in excess of the approved number set forth in each TO will be at the Contractor’s expense. The contractor shall identify the estimated travel requirements by number, purpose and amount of time with the submission of each proposed TO.

Change Orders – The negotiated burdened hourly labor rates shall be used in negotiations of all change orders or contract modifications.

Direct Expenses – The FDA shall reimburse the contractor as direct expense, without markup for overhead or profit for:

• Transportation cost of documents delivered at the FDA request by other than parcel post delivery.

• All permits and licenses procured for the FDA.

• Document reproduction that is in addition to that required by each TO.

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C-1 Scope of Work

Independently and not as an agent of the Government, the Contractor shall provide the various disciplines, including but not limited to: mechanical, electrical, structural, civil, fire protection, estimating, construction management and otherwise do all things necessary for or incident to the performance of the work set forth herein and in Attachment No. J-1, Technical Requirements for A&E Design in Part II to this contract Section J- List of Attachments.

The contractor will be required to use multiple disciplines as described below on projects conceived to repair, improve and remodel buildings, utilities, electrical energy audits, HVAC projects and other facilities. Asbestos removal and disposal may be included in some of these projects as a part of the demolition process.

The Architect-Engineer (A/E) firm shall provide all professional services to cover a wide range of engineering services including furnishing structural, civil, mechanical, electrical, electrical, fire protection, energy audits, HVAC projects and engineering services for the performance of planning, programming, surveys, studies, investigations, review of shop drawings, samples and equipment, and the preparation and development of reports, working drawings, specifications, cost estimates, other related documents and construction administrative services, but are not limited to:

Preparation and development of Environmental Assessment (EA), Preparation and development of the project’s Program of Requirements (POR), Preparation and development of diagrammatic

(Conceptual) Design, Preparation and development of construction documents, sometimes in multiple packages for phased construction to include drawings, specifications, cost estimates, design analysis and calculations and other related documents, Performance of topographical survey services, Performance of geotechnical engineering services, Preparation of renderings and/or models, provide a full range of post design services, and Performance of other services that may be required.

The firm will be responsible for cost concepts to be employed during study and design phases of specific delivery order projects include life-cycle cost, design-to-cost, value engineering. The design firm shall select the product and/or system after performing a life cycle cost analysis.

SECTION D - PACKAGING AND MARKING

D-1 Marking Instructions for Reports

All information submitted to the Contracting Officer or to the Contracting Officer’s Representative (COR) shall clearly indicate on each shipment its organization name, and Contract and TO numbers.

D -2 Payment of Postage and Fees

All postage and fees related to distribution of deliverables including forms, reports, etc., shall be paid by the Contractor.

SECTION E - INSPECTION AND ACCEPTANCE

E-1 Inspection and Acceptance

The Government, through any authorized representative, has the right, at all reasonable times, to inspect, or otherwise evaluate the work performed or being performed hereunder and the premises in which it is being performed. If any inspection or evaluation is made by the Government on the premises of the Architect-Engineer or a subcontractor, the contractor shall be responsible to provide all reasonable facilities and assistance for the safety and convenience of the Government representative in the performance of their duties. All inspections and evaluations shall be performed in such manner as will not unduly delay the work.

The FDA COR or other authorized representative assigned at the task order level will inspect and make acceptance decisions for all materials, documents, and services provided under this contract. The FDA COR is the authorized representative of the Contracting Officer. The COR shall monitor the Contractor’s performance, evaluate the quality of services and perform the final inspection and acceptance of all deliverables.

E-2 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/these address(es):

https://www.acquisition.gov/far/

FAR

Clause No. Title and Date

52.246-4 Inspection of Services-Fixed-Price (Aug 1996) 52.246-6 Inspection-Time-and-Material and Labor-Hour (May 2001)

SECTION F - DELIVERIES OR PERFORMANCE

F-1 FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998) 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/these address (es):

https://www.acquisition.gov/far/

FAR

Clause No. Title and Date

52.242.14 Suspension of Work (APR 1984)

F-2 Period of Performance

The period of performance for this IDIQ contract shall consist of a five 1- year ordering periods estimated to be:

Ordering period 1: September 23, 2021 through September 22, 2022 Ordering period 2: September 23, 2022 through September 22, 2023 Ordering period 3: September 23, 2023 through September 22, 2024 Ordering period 4: September 23, 2024 through September 22, 2025 Ordering period 5: September 23, 2025 through September 22, 2026

A period of performance will be specified for each individual task order.

F-3 Ordering Period

Task Orders may be issued up to the final day of this contract inclusive of any extensions thereto, and the contract shall remain in force to allow for the completion of all task orders issued.

F-3 Delivery Information

Note: Actual deliverables, deliverable schedules, Progress Reports and Status meetings shall be established in the issuance of each individual task order. Additional Reporting Requirements may be included in each Task Order.

F-4 AAM 2018.06-005 Macro Functionality Disabled

Be advised that FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

SECTION G - CONTRACT ADMINISTRATION DATA

G-1 Contracting Officer’s Representative (COR)

The following COR will represent the Government for the purpose of this contract:

To be completed at time of award. The term ‘‘COR’’ means the person who monitors the technical aspects of contract performance. The COR is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the COR is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.

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.

G-2 Technical Guidance

A. Performance of the work under this contract shall be subject to the technical Guidance of the

Contracting Officer’s Representative (COR). The term "technical guidance" is defined to include the following:

1. Providing information to the Contractor for assistance in the interpretation of drawings, specifications, or technical portions of the work description, other technical performance requirements; and

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

3. Perform technical evaluation as required;

4. Perform technical inspections and acceptances required by this contract; and

5. Assisting in the resolution of technical problems encountered during performance.

B. Technical guidance must be within the general scope of work stated in the contract. The COR does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled "Changes," (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical guidance shall be issued in writing by the COR or shall be confirmed by him/her in writing within five (5) working days.

D. The Contractor shall proceed promptly with the performance of technical guidance duly issued by the COR in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

E. If, in the opinion of the Contractor, any instruction or direction issued by the COR is within one of the categories as defined in B.(1) through B.(4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall there upon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

The Contractor shall contact the FDA's COR prior to delivery to arrange for the following:

Access to the Facility

G-3 HHSAR 352.237-75 Key Personnel (DEC 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.

The individuals cited below are key personnel.

Name Title

___________________ Principal / Project Manager

___________________ Lead Architect

____________________ Lead Mechanical Engineer

(End of clause)

G-4 Placing and Processing of Task Orders

Task orders may be issued by the Government during the ordering period from the date of contract award. Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time period specified in the order.

The effective period for delivery of orders under this contract begins on the date of contract award and ends on the date following the date of final payment under this contract.

The Contractor shall prepare and submit a task order proposal addressing all areas of the requirement. The Contractor shall submit the task order proposal within the time period specified in the Request for Task Order Proposal (RFTOP) and adhere to the ceiling rates established in the contract. Ceiling rate discounts may always be proposed. Other direct costs shall be clearly identified, explained, and substantiated. Proposals shall include: (1) a schedule of performance; (2) a staffing plan including estimated manhours by labor category per task area. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal. The Government will evaluate task order proposals as specified in the individual RFTOP on a best value basis. The government reserves the right to insert anticipated travel by utilizing Other Direct Costs (ODC).

Travel (transportation, lodging, meals and incidental expenses) and ODC costs/pricing shall be included in each of the offeror’s overall task order pricing, noting however, (1) travel costs shall be limited to that authorized by FAR 31.205-46, (2) no fee/profit, overhead, or G&A will be allowed/paid, (3) all travel shall be authorized and requested in advance (minimum of 30 calendar days) to the COR, and (4) the Contractor will be responsible for making all required travel arrangements for its personnel.

Multiple task orders may be awarded with similar completion schedules and overlapping delivery dates. Specific projects, as they are approved, will be accomplished by the negotiation and issuance of individual fixed-price delivery orders. When agreement has been reached with respect to the services to be performed, the fee and time for completion, the Government shall execute the task order on an OF 347 reflecting all terms and conditions agreed upon for each TO.

A. Authorized Ordering Activities: The following activity(ies) or individual(s) is/are designated as

Ordering Officers under this contract:

1. Any Contracting Officer of the U.S. Food and Drug Administration-Office of Acquisitions and Grants Services (OAGS); subject to the limitations contained in their respective contracting officer warrants (SF 1402, Certificate of Appointment).

2. Others as authorized in writing by the Contracting Officer.

B. Content of Order: Each task order placed under this contract shall include the following minimum information:

1. The contract number, task order number, and date of order.

2. Description of the service to be provided.

3. Applicable accounting and appropriation data, and special invoicing instructions where applicable.

Additional Information can include:

1. Item number and description, quantity and unit price.

2. Cost and hours (as negotiated), extended amounts, fee (if applicable,) total estimated amount, and reporting requirements.

3. Delivery or performance date.

4. Place of delivery or performance (including consignee). Packaging, packing, and shipping instructions, if any.

5. Such other terms and conditions as may be pertinent and peculiar to the particular tasks thereby ordered.

6. Individual orders will reflect the requirement of particular circumstances as applicable.

Urgent orders will cite peculiar terms and requirements.

C. Pricing of Orders: The Contractor warrants that the prices charged under this contract shall not exceed the costs charged by the Contractor to its most favored customers for like items or services under comparable conditions.

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.

G-5 Contract Administration

a. Administrative Contracting Officer Warren Dutter, Contract Specialist 3900 NCTR Road

HFT-320

Jefferson, AR 72079 Phone: 870-543-7577 Email: Warren.Dutter@fda.hhs.gov

b. Contractor’s Point of Contact

To Be Completed at Award

c. Technical Point of Contact To Be Completed at Award

G-6 Invoice Submission

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 or Technical Point of Contact (TPOC). The COR/TPOC is (determined at time of award)

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 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 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 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.

G-7 Reporting Matters Involving Fraud, Waste, and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector Generals Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800- 447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W.

Washington, D.C. 20201

G-8 Property, Equipment, Supplies, Facilities, Personnel and Services

Except as otherwise specifically provided herein, all property, equipment, supplies, facilities, personnel and services required to perform the work called for shall be furnished by the Contractor.

G-9 Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at www.cpars.gov. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs 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 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation mailto:HHStips@oig.hhs.gov 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 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. Evaluations will also be stored for a 3 year period in the Contractor Performance Assessment Reporting System (CPARS) at www.cpars.gov.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/lc.htm. There is no fee for registration or use of the CPARS.

G-10 Additional Labor Categories

At any time and throughout the life of the contract, at the request of either the Contractor or the Government, the Contractor may propose additional labor categories, rates and descriptions in addition to the Government labor categories identified in the schedule to support the tasks as identified in the SOW or RFTOP. These additional labor categories, rates and descriptions will be negotiated on a case-by-case basis. The additional categories, rates and descriptions quoted, upon determination by the Government that they are necessary for performance and are both fair and reasonable, can be issued in the order/call. The new category will be may be incorporated by modification into the contract Labor Rate Tables of this contract.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H-1 FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998) 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/these address (es):

https://www.acquisition.gov/far/

FAR

Clause No. Title and Date 52.236-22 Design Within Funding Limitations (APR 1984) 52.236-23 Responsibility of the Architect – Engineer Contractor (APR 1984) 52.236-24 Work Oversight in Architect – Engineer Contracts (APR 1984) 52.236-25 Requirements for Registration of Designers (JUN 2003)

H-2 Security and Privacy A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

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.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute 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, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [x] Low [ ] Moderate [ ] High

Integrity: [x] Low [ ] Moderate [ ] High

Availability: [x] Low [ ] Moderate [ ] High

Overall Risk Level: [x] Low [ ] Moderate [ ] High

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[x] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the OMB Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.”

Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother’s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be:

[x] Low [ ] Moderate [ ] High

4) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re- using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for

Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf with NIST SP 800-88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media.

5) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

6) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

7) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

8) Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

9) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use are compliant with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the

COR.

e. Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee under this contract shall complete the Form FDA 3398 Commitment to Protect Non-Public Information Employee Agreement (“Non-Disclosure Agreement” or “NDA”), (will be included as an attachment to any resultant award), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

11) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M- 03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /information lifecycle, or when determined by the agency that a review is required based on a http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract.

Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures

(SOP).

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

C. Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

2) All Contractor employees performing on the contract must read and…