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Request for Quote: 1186182 Page 24 of 39 Advanced Leadership Training for CDER/OCP

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13, as supplemented with additional information included in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplated issuing a firm-fixed price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95 and 95 dated January 19, 2017.

The associated North American Industrial Classification System (NAICS) code for this procurement is 611430 – Professional and Management Development Training, with a small business size standard of $11.0 million. This is a total small business set aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror’s responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to award a firm fixed-price purchase order resulting from this solicitation.

Pricing Table:

Line Item
Description
Total Price
1
Advanced Leadership Training
$

PART 3 – DESCRIPTION OF REQUIREMENTS

Background:

The Office of Clinical Pharmacology (OCP) includes approximately 250 scientific professional staff supporting other Offices within Center for Drug Evaluation and Research (CDER). Advanced Leadership training (ALP) specific content of each training module is offered from the “Leadership Training Topics Library”. This ALP training proposal “Strategic Implementation Skills or Project Mobilization” has expanded “Leadership training topics library”; which has 21 off the shelf training modules. These ALP elements will assist in ensuring the success of OCP mission and across CDER.

OBJECTIVES

The objectives of OCP advanced leadership training for ‘Strategic Implementation Skills or Project Mobilization’ requirement are to:

· Provide staff with opportunity to pick new topics relevant to their Individual Development Plan IDP or professional development needs. Support professional growth and development in leadership and supervisory skills.

· Complimentary leadership topics taught by the center so that the transfer of skills can be made to job specific functions; Offer modular leadership curriculum and coaching that maximizes participant strengths and targets skills that will improve job performance.

· Train students to remove barriers to implement long-term change or innovation; often initiatives fail to thrive because strategic planning and developing counter measures to address barriers are advanced skills that can be taught in an ALP

· Provide a comprehensive leadership assessment of participant assets and identify areas needing further growth and development.

· Provide ten targeted leadership training modules with corresponding individual coaching sessions that assure successful integration of leadership knowledge/skills to improve job performance.

· Offer advanced leadership training that complements the Office of Personnel Management (OPM) Executive Core Qualification (ECQ) competency model.

· Measure progress towards leadership goals and identify goals for continued professional development (360° reassessment).

Scope

2.1 The ALP training will consist of but not limited to the following training design:

The ALP will offer 11 participants (one cohort) the opportunity to receive targeted leadership training and individual coaching. This program has three major components: leadership assessment, e-learning training, and individualized coaching.

2.2 The assessment component of the ALP utilizes the Leadership Practices Inventory (LPI) assessment tool. The LPI 360° assessment tool is administered online and is based on Kouzes and Posner’s (Leadership Challenge) five practices of Exemplary Leadership model. The five practices of the Exemplary Leadership model approaches leadership as a measureable, learnable and teachable set of behaviors. The LPI assessment also complements the OPM ECQ leadership competency model. The LPI measures individual leadership competencies and offers insight into how leaders see themselves, how others view them, and what actions they can take to improve their leadership effectiveness. The 30 items LPI profile is completed at the beginning of the ALP by each student and six selected individuals, including: immediate supervisor, manager, two direct reports and two identified co-workers.

The second component of the ALP is to offer ten leadership training modules. The ten training topics will be individually selected from a comprehensive library of leadership training modules. The specific content of each training module is summarized in the “Leadership Training Topics Library” section of this proposal. The format of instruction and e-learning includes a combination of the following: topic specific streamed training videos with pre and posttests, selected readings and texts, completion of worksheets and personal assessment tests. After the LPI results are debriefed, the coach and student will jointly develop a leadership training plan (LTP). The developed LTP will be shared with the student’s immediate supervisor for input and validation. The LTP will form the blueprint of training activities for the duration of the ALP. Specifically, the LTP will identify nine specific leadership training modules the student will complete while active in the ALP. One training module will be completed per month and the ALP will run for a total of 10 consecutive months.

The final element of the ALP is individual coaching. Each student will receive 1½ hours of remote (web based) one-to-one coaching per month. Before each coaching session students will receive instructions to complete independent reading assignments, view training videos or complete other pre-coaching activities. Typically, students will spend 2-6 hours of guided independent preparation time prior to their coaching session. Their pre-coaching activities correspond to the leadership training modules selected and are based on their LTP. The coaching element of the ALP helps students to integrate and apply the e-learning objectives for each training topic. Each coaching session targets specific leadership behaviors and skills that correspond to the training topic and towards the ultimate goal of improving job performance. Once students have been identified for the ALP, a 10 month calendar of the one-to-one coaching sessions will be generated. Coaching sessions will be scheduled at regular monthly intervals (every 4 weeks) and completed on consecutive workdays. The ALP instructor will facilitate the scheduling of individual coaching sessions, e-learning logistics and program specific communications.

The texts associated with ALP include: Leadership Challenge*, Kouzes and Posner; Crucial Conversations: Tools For Talking When The Stakes are High*, Patterson, Grenny, McMilland, Switzler: Crucial Accountability, Patterson, Grenny, McMillan, Switzler; Ethics For Everyone: How to increase Your Moral Intelligence, Dobrin; Getting To Yes: Negotiating Without Giving In, Fisher, Ury; Self Leadership and The One Minute Manager, Blanchard, Fowler, Hawkins; Leadership Made Simple, Oakley, Krug: Working With You Is Killing Me, Crowley, Elster.

*All students receive these texts. Additional texts listed are topic specific based on the modules listed on each students LTP.

The contractor shall prepare the curriculum materials as outlined below.

Proposed Curriculum

Module 1Orientation/Introduction to ALP
“Leadership Challenge”

Module 2 LPI assessment and LTP

Module 3-9Select seven modules from the leadership training topics library
(7 modules)(see attached document and narratives)
Module 10LPI Reassessment: Accomplishments, and Future Leadership Goals

DELIVERABLES / SPECIFIC TASKS

Deliverable:

· The contractor shall provide all required texts to the government.

· An LTP report will be submitted to the student’s supervisor

· The contractor will provide monthly reports on progress to the COR and OCP management. The contractor shall initiate additional communication with the COR should developments arise.

· The contractor shall provide a final report to the individual and the OCP management after completion of the training

Deliverables
Advanced Leadership Program (ALP) training: Estimated Quantity/Frequency/COST
Review or Delivery Date

Tasks ALP leadership training

Module 1: Orientation/Introduction to ALP Leadership Challenge

Classroom Instruction: 3 hours; Individual Coaching: 1 ½ hours/student X 11 students September 12-14, 2017 monthly after award date

Module 2: LPI Assessment and LTP

Individual Coaching: 1½ hours/student X 11 students October 2017 monthly after award date

Module 3: Leadership Training Topic

Individual Coaching: 1½ hours/student X 11 students November 2017 monthly after award date

Module 4: Leadership Training Topic

Individual Coaching: 1½ hours/student X 11 students December 2017 monthly after award date

Module 5: Leadership Training Topic

Individual Coaching: 1½ hours/student X 11 students January 2018 monthly after award date

Module 6: Leadership Training Topic

Individual Coaching: 1½ hours/student X 11 students
monthly after award date

Module 7: Leadership Training Topic

Individual Coaching: 1½ hours/student X 11 students February 2018 monthly after award date

Module 8: Leadership Training Topic

Individual Coaching: 1½ hours/student X 11 students March 2018 monthly after award date

Module 9: Leadership Training Topic

Individual Coaching: 1½ hours/student X 11 students April 2018 monthly after award date

Module 10: LPI Reassessment: Accomplishments And Future Leadership Goals

Individual Coaching: 1½ hours/student X 11 students May 2018 monthly after award date

The Contractor will only be paid for the hours worked and must not surpass the number of hours stated in the above table Government Furnished Equipment (GFE)/ Government Furnished Information (GFI) Use Conference rooms and equipment at FDA White oak campus to conduct meetings, face to face and briefings as scheduled by the OCP staff/management.

Security Considerations The Contractor shall be required to comply with the FDA Security Authorization process. Security authorization is the approach FDA follows to fulfill Federal Information Security Management Act (FISMA) Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) requirements to ensure that information resources have adequate security to protect the Confidentiality, Integrity and Availability of information collected, processed, transmitted, stored, or disseminated by the agency.

In addition, the contractor shall ensure they comply with:

· National Institute of Standards and Technology (NIST) SP800-53, Recommended Security Controls for Federal Information Systems and Organizations

· All applicable FISMA, NIST, and OMB requirements

· FDA 3250 series of Staff Manual Guides (SMG) policies as well as HHS security policies

· The HHS Information Security Program: Contractor Oversight Guide – Section 2, Defining Contractor Systems and Related Security Requirements Travel OCP Staff work from FDA White Oak campus or designated duty station and contractor travels to FDA White Oak campus.

Special Material Requirements Any software required on FDA client computers, or in FDA data centers, shall not conflict with FDA technical standards. FDA’s Master Approved Technology List (MAT) contains a list of approved and not approved technologies, including applications (software), infrastructure and peripherals (hardware), and scientific software and devices.

Service Performance & Location Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in Section 3 of this statement of work and upon acceptance of all services required.

Training and retreat to be completed at the FDA White Oak Campus located at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 Period of Performance The period of performance for this requirement shall be for 12 months from date of award. 10 months is required to complete the training with an additional 2 months to accommodate student’s schedule and catch up on any scheduling conflicts.

Contract Point of Contact

The following personnel shall represent the Government for the purpose of this contract:

Technical Point of Contact (POC):

To be determined at time of contract award

The Technical POC 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.

Contracting Officer:Contract Specialist:
Gary KlaffJulio Espinoza
5630 Fishers Lane5630 Fishers Lane
Rockville, MD 20857Rockville, MD 20857
Gary.Klaff@fda.hhs.govJulio.Espinoza@fda.hhs.gov
Tel: (240) 402-7555Tel: (240) 402-7530

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has the authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

Conformance with Applicable Laws, Regulations, Policies, and Standards Contractor Compliance The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/.

Section 508 Standard Requirements The Contractor should be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools.

508 Standard Requirements include:

1194.21 Software applications and operating systems (a – l)

1194.22 Web-based intranet and internet information and applications (a - p)

1194.31 Functional performance criteria (a – f)

All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.accessboard.gov/sec508/508standards.htm - Part 1194

FDA 1335 PERSONNEL SECURITY CLEARANCE REQUIREMENTS (AUG 2006)
1.BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and Contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2.GENERAL - The Contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:
a.Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.
b."Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk level for this contract is Public Trust Position – Level 5.

There are two (2) potential position risk levels, which are:

a. Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 4 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate 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. The Personnel Security Specialist will use this information to initiate 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 suitability background investigation. The Project Officer for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

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.

3. BADGING PROCESS - The FDA COR will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a Contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints shall be submitted in one of two ways, depending on where the contract will be performed:

a.Contractor employees who will work in the Washington D.C. metro area shall, at the direction of the FDA Project Officer or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or
b.Contractor employees who will work in a field office shall submit fingerprints to:

Food and Drug Administration Physical Security Branch FDA White Oak Command Center 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone: 301-796-2414 Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two (2) forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

4. BACKGROUND INVESTIGATIONS - The Government will conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

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.

Background investigations will be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of Contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the Contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug Administration OSO/Office of Security Operations Physical Security Branch FDA White Oak Command Center 10903 New Hampshire Avenue Silver Spring, MD 20993 Phone: 301-796-2414

The Contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The Contractor shall advise its prospective employees that all standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff will resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a Contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the Contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor shall notify the Contracting Officer, and the Government will make a determination whether an additional security clearance is required.

In the event that a cleared individual is replaced, the Contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the Project Officer.

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

CHARTS A & B ARE APPENDED TO THIS CLAUSE (SEE BELOW).

For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided:

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE POSITIONS - LEVEL 1

FORM NAME

OBTAIN

FROM

WHEN REQUIRED
SUBMIT

TO

DATE REQUIRED

FDA Form 3391 - FDA Security Card Access Request
COR/Project Officer. Sponsorship must be provided by FDA COR/Project Officer.
All positions on DHHS property or leased space
Food and Drug Administration

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue, Building 32, Room 1205, Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprint appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement form
Contracting Officer
All positions with access to non-public privileged, proprietary, or trade secret information
Contracting Officer for retention

in contract file Ten (10) calendar days prior to commencement of work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act Release
Contractor-generated
All positions, including intermittent, per diem or

temporary *Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue, Building 32 Room 1205, Silver Spring, MD 20993

(301) 796-4000 Ten (10) calendar days prior to commencement of work

SF 85 - Questionnaire for Non-Sensitive Positions
Online via OPM’s e-QIP system
Non-Sensitive Positions - Level 1 Clearance
*Submit to OPM online via the e-QIP system
Ten (10) calendar days upon request of the Contracting Officer

FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only.

Call (301) 827-9527

Contracting Officer
Non-Sensitive Positions - Level 1 Clearance
*Food and Drug Administration

Fingerprinting & Personnel Security Office 10903 New Hampshire Avenue, Building 32, Room 1205, MD 20993

(301) 796-4000 Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the Contractor shall provide a cover letter that includes: Contractor’s name, contract number, Contractor employees’ names, and name of Contracting Officer.

*Upon a favorable fingerprint return, the Contractor will be notified to respond to the badging 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 Phone: (301) 796-4000

CHART B

Public Trust Positions - Levels 5 or 6

FORM NAME

OBTAIN

FROM

WHEN REQUIRED
SUBMIT

TO

DATE REQUIRED

SF 85P - Questionnaire for Public Trust Positions

Online via OPM’s e-QIP system

Public Trust Positions - Level 5 or 6 Clearance
*Submit to OPM online via the e-QIP system
Ten (10) calendar days prior to commencement

of work

FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only.

Call (301) 796-4600

Contracting Officer
Public Trust Positions - Level 5 or 6 Clearance
*Food and Drug Administration

Fingerprinting & Personnel Security Office 10903 New Hampshire Avenue, Building 32, Room 1205, Silver Spring, MD 20993

(301) 796-4600 Ten (10) calendar days prior to commencement of work

FDA Form 3391 - FDA Security Card Access Request
COR/Project Officer. Sponsorship must be provided by FDA COR/Project Officer.
All positions on DHHS property or leased space
Food and Drug Administration

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue, Building 32, Room 1205, Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement form
Contracting Officer
All positions with access to non-public privileged, proprietary, or trade secret information
Contracting Officer for retention

in contract file Ten (10) calendar days prior to commencement of work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act Release
Contractor-generated
All positions, including intermittent, per diem or temporary
*Food and Drug Administration

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue, Building 32, Room 1205, Silver Spring, MD 20993

(301) 796-400 Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the Contractor shall provide a cover letter that includes: Contractor’s name, contract number, Contractor employees’ names, and name of Contracting Officer.

*Upon a favorable fingerprint return, the Contractor will be notified to respond to the badging 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 Phone: (301) 796-4000

PART 4 – INSPECTION AND ACCEPTANCE

The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government shall rely on the Contractor’s assurances that the commercial item tendered for acceptance conforms to the contract requirements. The Technical Point of Contact (POC) (see Part 3) shall perform inspection and acceptance of equipment to be provided. For the purpose of this part, the Technical POC is the authorized representative of the Contracting Officer.

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 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, 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.

PART 5 – CONTRACT CLAUSES AND PROVISIONS

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/these address(es): www.acquisition.gov/browsefar

52.204-13 – System for Award Management Maintenance (Oct 2016)
52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016)
52.209-10 – Prohibited on Contracting with Inverted Domestic Corporations (Nov 2015)
52.212-4 – Contract Terms and Conditions – Commercial Items (Jan 2017)
52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013)
52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

(End of clause)

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items (Jan 2017)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved] _X_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

__ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

__ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

__ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (OCT 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

__ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016).

__ (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (41)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (48) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (49)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (57) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (58) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (61) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)).

__ (62)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

__ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

__ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

__ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

__ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(x) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xi) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(xii) _X_ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627).

__ (B) Alternate I (Mar 2015)…

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