FDA-15-223-SOL-00068.pdf

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Brief Descriptions of Supplies or Services

The Contractor shall provide pathology services in accordance with Section C, Attachment #1, NCTR On-Site Pathology Services Performance Work Statement and appendices thereto.

B.2 Not To Exceed (NTE) Value

The maximum dollar value for Contract Line Items 0001, 1001, 2001, 3001, and 4001 as set forth below shall be the annual ceiling amounts for each year of the contract. For each year, any combination of labor categories and hours (see Attachment #7, Pricing Schedule as an example) may be used, but total amount for labor and travel (maximum $4,000.00 per year) shall not exceed the established annual ceiling amount: $X,XXX (to be inserted at time of award).

B.3 Labor-Hour (LH) Price Schedule

Contract Period – Nine (9) months from date of contract award followed by four (4) additional one (1) year option periods for a total of four (4) years nine (9) months.

ITEM

NO

SUPPLIES/SER

VICES

MAX

QUANTITY

UNIT UNIT PRICE TOTAL AMOUNT

Dollars U.S.

$1.00

NTE $

Base - Onsite pathology services to be performed for the National Center for Toxicological Research (NCTR) in accordance with requirements as identified in Section B.1.

Period of Performance (POP) 8/1/2015 – 4/30/2016

ITEM

NO

SUPPLIES/SER

VICES

MAX

NTE $ 3,000.00

Base - Approved Travel

POP 8/1/2015 – 4/30/2016

SUPPLIES/SER

VICES

MAX

Option Period 1- Same as Item 0001 description.

POP 5/01/2016 – 4/30/2017

SUPPLIES/SER

VICES

MAX

NTE $ 4,000.00

Option Period 1 - Approved Travel

POP 5/01/2016 – 4/30/2017

SUPPLIES/SER

VICES

MAX

UNIT

UNIT PRICE

TOTAL AMOUNT

Option Period 2- Same as Item 0001 description.

POP 5/01/2017 – 4/30/2018

SUPPLIES/SER

VICES

MAX

Option Period 2 - Approved Travel

POP 5/01/2017 – 4/30/2018

SUPPLIES/SER

VICES

MAX

Option Period 3- Same as Item 0001 description.

POP 5/01/2018 – 4/30/2019

SUPPLIES/SER

VICES

MAX

Option Period 3 - Approved Travel

POP 5/01/2018 – 4/30/2019

SUPPLIES/SER

VICES

MAX

UNIT UNIT PRICE MAX AMOUNT

Option Period 4- Same as Item 0001 description.

POP 5/01/2019 – 4/30/2020

NO

SUPPLIES/SER

VICES

MAX

Option Period 4 - Approved Travel

POP 5/01/2019 – 4/30/2020

B.4 Travel Costs

1. Performance under this contract may require travel by contractor personnel. If travel is required, the Contractor is responsible for making all arrangements for their personnel.

The Contractor shall be reimbursed, not to exceed $3,000 for all travel in the base period (Item 1002) and $4,000.00 for each 1-year option period (Items 2002, 3002 and 4002), for all domestic (no overseas travel is anticipated under this contract) travel, incurred directly and specifically in the performance of this contract, claimed by the Contractor and approved by the Contracting Officer (CO).

Any required travel by the Contractor will be at the direction of the Government and will be reimbursed at cost in accordance with FAR 31.205-46. All travel shall be authorized by the Government in advance of any respective travel to be reimbursed. Travel is expected to be on rare occurrences only when necessary to testify in court on behalf of a study, mandatory meeting attendance, etc.

2. Travel reimbursement shall be billed separately from monthly services and shall identify the applicable Line Item for travel and shall further be supported with paid receipts in order to support travel reimbursement claims:

a. Copy of common carrier ticket reflecting class of travel, dates of travel and amount of fare;

b. Lodging receipt;

c. Parking/tolls receipt;

d. Rental car receipt including receipts for gasoline;

e. Receipts for taxi travel.

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

C.1. Scope

Independently and not as an agent of the Government, the Contractor shall provide onsite pathology services as set forth in Attachment #1, "NCTR Onsite Pathology Services Performance Work Statement" and appendices thereto, as identified in Section J - List of Attachments, to this contract.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1 Preparation for Delivery

All material to be delivered hereunder shall be afforded the degree of packaging (preservation and packing) required to prevent deterioration and damages due to the hazards of shipment, handling and storage. Best commercial practice will be accepted.

D.2 Prohibited Packaging Materials

The use of asbestos, excelsior, newspaper or shredded paper (all types including waxed paper, computer paper and similar hygroscopic or non-neutral material) is prohibited. In addition, loose fill polystyrene is prohibited for shipboard use.

SECTION E - INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance

The Contracting Officer’s Representative (COR), as a duly authorized representative of the CO, shall monitor the Contractor’s performance, evaluate the quality of services provided and perform the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the COR (see F.2).

CLAUSES INCORPORATED BY REFERENCE FAR 52.252-2 (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 CO will make their full text available. The full text of a clause may be accessed electronically at www.acquisition.gov/far.

52.246-6 Inspection of Services-Time-and-Material and Labor-

Hour

MAY 2001

http://www.acquisition.gov/far

SECTION F – DELIVERIES OR PERFORMANCE

F.1 POP

Base Period: August 1, 2015 through April 30, 2016 Option Period 1: May 1, 2016 through April 30, 2017 Option Period 2: May 1, 2017 through April 30, 2018 Option Period 3: May 1, 2018 through April 30, 2019 Option Period 4: May 1, 2019 through April 30, 2020

F.2 Reporting Requirements/Deliverable and Activity Schedule

All deliverables required by this contract shall be delivered to the COR except where indicated that both the CO and the COR receive copies. All deliverables shall be subject to the inspection and acceptance by the COR. All reports required under this contract shall be submitted in Microsoft Word or Microsoft Excel compatible format. All deliverables shall be submitted electronically to the address(es) specified in section G.3.2 below.

Schedule of deliverable items:

Scheduled Items Reference Location

Due Dates

1) Monthly Productivity Report

PWS Section 6.1

By the 15th of each month for the preceding month

2) Annual Report PWS Section 6.2

Within 30 calendar days after completion of each POP completion

3) Monthly Protocol Tracking Reports

PWS Section 6.3

Within 15 calendar days after the end of each month

4) Quarterly Safety/Accident Report

PWS Section 6.4

Within 15 calendar days after the end of each quarter

5) Annual Inventory of Contractor Use of GFP Report

PWS Section 4.2.1.3.2

Within 15 calendar days after the end of each contract year

6) Safety and Health Plan PWS Section 6.7

Prior to commencement of work under the contract

7) Required Insurance Certificate

Section H.4 Below

Prior to commencement of work under the contract

8) Security Clearance Forms

Section H.3 Below

By 10 calendar days prior to commencement of work

9) Pathology Reports PWS Section 6.5

As required by protocol

10) Biweekly Time Report PWS Section 6.6

By Friday of the Government pay week

11) Standard Operating Procedures (SOPs)

PWS Section 4.2.1.2

When new SOPs are created or when SOPs are updated

F.3 Place of Delivery

U.S. Food and Drug Administration National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079

F.4. Contractor Notice Regarding Late Delivery

In the event the contractor, for any reason, anticipates or encounters difficulty in complying with the contract delivery schedule or performance date or in meeting any of the requirements of the contract, the contractor shall immediately provide written notification to the CO giving pertinent details. This data shall be informational in character and its receipt by the Government shall not be construed as a waiver by the Government of (a) any delivery schedule or date or (b) compliance with other requirements by the contractor or (c) any other rights or remedies provided to the Government by law or under this contract.

F.5 Observance of Federal Holidays & Other Government Closings No services or deliveries shall be performed at the Federal sites on Federal legal holidays as shown below except as specifically required by an active protocol or need for unscheduled necropsy as approved by the COR. As consistent with the applicable wage determination, the Contractor shall be responsible for scheduling/managing the workforce to ensure the services/ studies are uninterrupted without additional compensation for overtime or holiday pay.

1. New Year’s Day January 1st

2. Martin Luther King Day Third Monday in January

3. President’s Day Third Monday in February

4. Memorial Day Last Monday in May

5. Independence Day July 4th

6. Labor Day First Monday in Sept.

7. Columbus Day Second Monday in Oct.

8. Veteran’s Day November 11

9. Thanksgiving Day Fourth Thursday in November

10. Christmas Day December 25

F.6. FAR 52.252-2--Clauses Incorporated By Reference 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 CO will make their full text available. The full text of a clause may be accessed electronically at this/these address(es): www.acquisition.gov/far.

FAR Clause No. Title Date

52.242.15 Stop Work Order (AUG 1989)

52.247-34 F.O.B. Destination (NOV 1991)

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 Contract Type

Type of contract is LH with a Not to Exceed Ceiling Amount.

G.2 ACCOUNTING AND APPROPRIATION DATA

The accounting and appropriation data for each CLINS shall be used for work completed within the POP for each of the CLIN. See invoicing instructions for assurance of appropriate funding application/disbursement for services performed.

G.3. AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of this contract shall require maximum coordination between the Government and the Contractor. The following individuals shall be the Government's points of contact during performance of the contract:

G.3.1 CO/CS

The CO for this contract is Jerry W. Martin.

All communications pertaining to contractual and/or administrative matters under the contract shall be addressed to the Contract Specialist (CS) at the following address: Attention: Crystal McCoskey, FDA/OAGS, 3900 NCTR Rd, Building 50, Room 426, Jefferson, AR. 72079 Phone (870) 543-7267 or electronically at crystal.mccoskey@fda.hhs.gov

G.3.2 COR Appointment and Authority

The COR assigned to this contract is:

Robin Stingley 3900 NCTR Road, Bldg 50, Rm 646, HFT-030 Jefferson, AR 72079 Phone: 870-543-7350 Email: robin.stingley@fda.hhs.gov

(a) Performance of work under this contract is subject to the technical direction of the COR identified above, or a representative designated in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement.

The COR does not have authority to issue technical direction that:

(1) Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

(2) Constitutes a change as defined in the clause entitled “Changes”;

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

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

(5) Interferes with the contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the contractor's employees.

(c) Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within five work days, with a copy to the CO.

(d) The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the contractor, any direction of the COR, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the CO no later than the beginning of the next Government work day.

(e) Failure of the contractor and the CO to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

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

G.4 HHSAR 352.242-70 Key Personnel (Jan 2006) The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the CO and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the CO. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The individuals cited below are key personnel:

Name:

Title: Pathologists Email:

Telephone:

Name(s):

Title: Onsite Managers/Supervisors Email(s):

Telephone(s):

G.5 Invoice Submission Instructions

The contractor shall submit monthly vouchers or invoices in arrears in accordance with the following clauses that are incorporated into this purchase order: 52.232-25, Prompt Payment (OCT 2003), and 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003).

These instructions provide for the submission of vouchers/invoices and personnel reporting required by HHSAR 342.7002.

1) Invoices/vouchers requests shall be submitted as follows

To be considered a "proper" invoice in accordance with FAR 32.9, Prompt Payment, each invoice shall clearly identify the ordering numbers that appear on the face page of the contract as follows:

Contract No. (17 digit number that appears in Block 1 or 2 of the SF-26 form)

2) The contractor shall submit an original and two (2) copies of the invoice to the designated CO at the following address:

Department of Health and Human Services Food and Drug Administration National Center for Toxicological Research Attention: Crystal G. McCoskey Office of Field Acquisitions, HFT-320 3900 NCTR Road Building 50, Room 426 Jefferson, AR 72079-9502

The invoice must be submitted on company letterhead and include the following:

(I) Name and Address of the Contractor;

(II) Invoice Date and invoice Number;

(III) Contract Number;

(IV) Description, CLIN number, Quantity, Unit of Measure, United Price and extended price supplies delivered or services performed, POP for which the hours are claimed;

(V) Shipping Number and Date of Shipment, Including the Bill of Lading Number and weight of shipment if shipment is shipped on Government Lading;

(VI) Terms of any Discount for Prompt Payment Offered;

(VII) Name and address of Official to whom payment is to be sent (Must be the same as that in the Purchase Order or in a notice of assignment);

(VIII) Name, Title, and Phone Number of Person to notify in event of effective invoice(s);

(IX) Taxpayer Identification number (TIN);

(X) Electronic funds Transfer (EFT) Banking information;

(XI) Name and Telephone Number of the FDA COR Referenced on the Contract; and

(XII) Any other information or documentation required by the contract;

In addition to the hard copy invoices that are to be sent to address identified above, the Contractor shall submit a copy of the invoice to the CO electronically at crystal.mccoskey@fda.hhs.gov

The Contractor shall furnish the following additional information in support of invoices submitted:

1. Labor Hours- include all persons, listing the person's name, title, number of direct labor hours worked, hourly rate, the total cost per person and a total amount for this category. The Contractor shall maintain documentation (payrolls, timesheets, etc.) to substantiate hours incurred for the invoice reporting period which shall be made available immediately upon the CO’s request;

2. Travel costs, itemized and identified including origin and destination.

3. Subcontractors (if applicable) - include, for each subcontractor, the same data as is being provided as identified above for the prime contractor;

4. The contractor shall include the billable hours for the current period and the cumulative hours for the current contract period of performance according to the labor categories established.

G.6 GOVERNMENT FURNISHED PROPERTY (GFP)

GFP shall be conducted in accordance with FAR 52.245-1 in Section I and Section 5 of the PWS.

G.7 Post Award Evaluation of Contractor Performance

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

The Contractor shall register in the CPARS upon contract award. The CPARS may be accessed by the Contractor at http://www.cpars.gov/.

mailto:crystal.mccoskey@fda.hhs.gov

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 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 General’s 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 e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

H.2 Access to Non-Public Information

All contractor and subcontractor employees are required to sign the Contractor's

Commitment to Protect Non-Public Information Agreement (Non-Disclosure Statement) form provided as an attachment to this contract (Attachment 4). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the contractor shall notify the FDA COR and CO. Any new contractor and subcontractor employees assigned to this contract shall sign the form, and the contractor shall hand-deliver it (ten (10) days prior to commencement of work) to the CO. Similarly, all Contractor employees shall be required to sign the Organizational Conflict of Interest Form (Attachment 6).

The prime contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval and a facility clearance have been granted.

Physical Security Requirements for Releasing Non-Public Information

FDA 1354.

Under the provisions of Title 21, United States Code, Section 331(j), the contractor shall establish and maintain comprehensive security measures for controlling access to non-public information released under a contract involving the processing of such information.

As part of its Quality Control Plan (QCP), the contractor shall include a physical security plan with established procedures in-place, designed to protect FDA/NCTR information in their possession and information that they have developed for NCTR.

This clause applies to the contractor, any subcontractors, and any consultants. Non-public information will be released to only those persons who will be using the contractor's approved facility unless the off-site facility has been reviewed by the FDA Physical Security Staff and approved in writing by the FDA Physical Security Office.

The FDA Physical Security Staff may review the contractor's facility at any time and assess the contractor's compliance. Recommendations for bringing noncompliant areas into compliance will be provided to the contractor by the FDA Physical Security Office.The Contractor shall make any changes necessary within thirty (30) calendar days after written notice from the FDA Physical Security Office in order to comply with FDA security requirements.

H.3 FDA Personnel Security Clearance Requirements

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that all 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 leased space for less than thirty

(30) calendar days are exempted from the background investigation requirement but shall still undergo a background check initiated by the NCTR RCRM Security Specialist.

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 CO, 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 the NCTR RCRM Security Specialist.

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 NCTR RCRM, 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 NCTR RCRM shall 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 following a successful background check initiated by the NCTR RCRM Security Specialist, 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 levels for this contract are 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 impact involving the duties are of limited effect. The forms set forth by CHART A are required for Non- Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a favorable preliminary check shall be required to provide additional security information for a background investigation as specified in Paragraph 5 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 a preliminary check as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the NCTR RCRM 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 COR for the contract will provide the name of the appropriate NCTR RCRM Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines shall result in the 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 NCTR RCRM Security Specialist 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 COR or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who will work on the National Center for Toxicological Research facility shall contact the following to arrange for fingerprinting:

National Center for Toxicological Research Office of Regulatory Compliance and Risk Management 3900 NCTR Road Bldg. 50, Room 304 Jefferson, AR 72079

Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two 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 shall 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 not be limited to:

Review of prior Government/military personnel records;

Review of FBI records and fingerprint files;

Searches of credit bureaus;

Personal interviews; and Written inquires 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 CO 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:

National Center for Toxicological Research Office of Regulatory Compliance and Risk Management, Security Specialist 3900 NCTR Road Bldg. 50, Room 304

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

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

NCTR RCRM 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 NCTR RCRM Security Specialist 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 http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf terminated or otherwise ceases work under the contract, the contractor shall immediately notify NCTR RCRM Security Staff, in writing, with copies to the respective FDA COR and CO.

The OPM background investigation will take approximately 120 days. The CO will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by the NCTR RCRM 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 CO, 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 CO 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 COR.

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.

For clarification purposes and to facilitate the flow of all required security forms, the following Chart A and B 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.

Sponsorship must be provided by

FDA COR.

All positions on DHHS property or leased space

Food and Drug Administration

Office of Security Operations, Policy & Planning Attn: Food and Drug

Administration National Center for

Toxicological Research

Safety Office, Building 50, Room

3900 NCTR Road

**Form must be submitted by Security

Rep.

Form must be received prior to making fingerprint appointment.

NON-

SENSITIVE

POSITIONS -

LEVEL 1

Contractor’s Commitment to

Protect Non- Public Information (NPI) Agreement form

CO All positions with access to non-public privileged, proprietary, or trade secret information

If requested by the government

CO 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

When

Requested by government

* Food and Drug Administration

Attn: Food and Drug Administration

National Center for Toxicological

Research Safety Office, Building 50, Room

3900 NCTR Road Jefferson, AR 72079 870-543-7193, -7941

Ten (10) calendar days prior to commencement of work

SF 85 -

Questionnaire for

Non-Sensitive Positions

Online via OPM’s e-

QIP system

For Non U.S. Citizens only Non-

Sensitive Positions -

Level 1 Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days upon request of the CO

FD 258 -

Fingerprint Chart

(2 Charts Required)

Fingerprinting services available by appointment only.

Call (870) 543-

CO Non- Sensitive

Positions - Level 1

Clearance When

Requested by government

* Food and Drug Administration

Attn: Food and Drug Administration

National Center for Toxicological

Research Safety Office, Building 50, Room

3900 NCTR Road Jefferson, AR 72079 870-543-7193, -7941

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

CO.

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

Food and Drug Administration Attn: Food and Drug Administration

National Center for Toxicological Research Safety Office, Building 50, Room 304

3900 NCTR Road

870-543-7193, -7941

CHART B

Public Trust

Positions - Levels 5 or 6

FORM NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT

TO

DATE

REQUIRED

SF 85P -

Questionnaire for

Positions

Online via OPM’s e- QIP system

For non U.S.

Citizens only 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.

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CO Public Trust Positions -

Level 5 or 6 Clearance

When requested by the government

* Food and Drug Administration

Attn: Food and Drug Administration

National Center for Toxicological Research Safety Office, Building

50, Room 304 3900 NCTR Road

Jefferson, AR 72079 870-543-7193, -7941

Ten (10) calendar days prior to commencement of work

FDA Form 3391 - FDA Security Card

Access Request

COR.

Sponsorship must be provided by

FDA COR.

All positions on DHHS property or leased space

Food and Drug Administration

Office of Security Operations, Policy & Planning Attn: Food and Drug

Administration National Center for

Toxicological Research Safety Office, Building

50, Room 304 3900 NCTR Road

**Form must be submitted by Security

Rep.

Form must be received prior to making fingerprinting appointment.

Positions - Levels

5 or 6

Contractor’s

Commitment to Protect Non-Public Information (NPI) Agreement form

CO All positions with access to non-public privileged, proprietary, or trade secret information government

CO 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 government

* Food and Drug Administration

Attn: Food and Drug Administration

National Center for Toxicological Research Safety Office, Building

50, Room 304 3900 NCTR Road

Jefferson, AR 72079 870-543-7193, -7941

Ten (10) calendar days prior to commencement of work

H.4 Required Insurance

FAR Clause 52.228-5, Insurance-Work on a Government Installation, in Part II, Section I, is supplemented to require the following minimum amount of insurance:

A. Worker's Compensation and Employer's Liability. Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

B. General liability. Bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence is required.

C. Automobile liability. The Contractor shall provide automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract. Policies covering automobiles operating in the United States, its possessions, and Puerto Rico shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

H.5 Applicable Wage Rate Decision

The Secretary of Labor has made a determination of the minimum prevailing wage rates which are to be paid to some classes of labor to be employed on this project which is identified in Attachment #2 in Section J.

H.6 Physical Examinations

The Government requires all laboratory personnel on this contract, including pathologists, to submit to the medical examinations or procedures listed below annually as a condition of employment. Possible adverse health outcomes as a result of exposures in the laboratory environment are monitored to ensure that contract employees may safely continue to work in the laboratory. All of these medical procedures will be provided by the NCTR, or a third party designated by NCTR at no cost to the Contractor or employee on an annual basis as long as the employee continues to work in the laboratory. Upon transfer to a non-laboratory position, one additional examination will be provided. Medical examinations or procedures other than those approved by the NCTR or an NCTR-designated third party will be at no cost to the Government.

- Periodic blood and urine samples as dictated by the safety and occupational health program.

- Periodic examination for the presence of potentially pathogenic bacteria and viruses.

- Follow-up examinations as determined necessary.

H.7 Conduct of Contractor Employees

The Contractor’s employees shall adhere to standards of competency, conduct, appearance, and integrity that reflect credit to the employee, the Contractor, and the Government. The Contractor shall be responsible for such disciplinary action with respect to their employees as may be necessary. The Contractor shall immediately report in writing any termination of contract personnel and the cause of such termination.

Contractor personnel shall comply with the NCTR’s traffic and safety rules and other regulations and instructions pertaining to conduct of persons on Government facilities.

Contractor personnel shall, in no event, enter any area to which access is restricted, unless such an area has been specifically identified as an area in which services are to be rendered. The Contractor shall place their employees on notice that infraction of any of the above rules, regulations, or prohibitions may be grounds for removal from Government property.

H.8 FDA Data Disclosure Clearance Procedures

1. PURPOSE:

As part of its regulatory activities, FDA may require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the contractor shall accept and adhere to the FDA

Data Disclosure Clearance Procedures (Attachment 5). In the event the contractor identifies Limited Rights Data in provision 52.227-15, this Limited Rights Notice authorizes FDA to disclose these Limited Rights Data for public health, safety, and regulatory purposes, provided that the disclosures of these data are made subject to prohibition against their further disclosure.

In accordance with the Limited Rights Notice, the purpose of this document is to establish timely clearance procedures for the FDA and contractor to follow when FDA seeks either

(1) to make Aggregated Limited Rights Data (see definition below) publicly available, or

(2) to disclose actual Limited Rights Data to specific third parties subject to prohibition against their further disclosure.

2. PROCEDURES

These clearance procedures do not apply to disclosure of information, including of Limited

Rights Data and/or Aggregated Limited Rights Data, made in response to an authorized request of Congress or any other government body of competent jurisdiction.

a. FDA and Contractor shall complete the Clearance Procedure Cover Sheet (located within

Attachment 5) upon execution of the Agreement. This form provides the names and contact information for individuals who shall serve as the primary contact (Contact) for each party.

Each party must update the Cover Sheet any time any of its contact information or its Contact changes.

b. For each proposed disclosure, FDA shall submit a Clearance Request Form, a copy of the materials to be disclosed, and a copy of the source data files cited in those materials.

c. FDA shall identify contractor as the data source when disclosing Aggregated Limited

Rights Data or Limited Rights Data.

d. Within 24 hours of receipt by the contractor's contact of the Clearance Request Form, contractor shall provide a clearance decision for the requested Public Release of Aggregated Limited Rights Data.

e. Within 48 hours of receipt by the contractor's contact of the Clearance Request Form, the

Contractor shall provide a clearance decision for disclosure of Limited Rights Data to a third party in accordance with the following conditions:

(1) The third party must be actively engaged in a project initiated by FDA;

(2) Clearance to share the data with the third party shall be granted only for purposes of the

FDA initiated project and shall not extend beyond the duration of the third party's active engagement in that project;

(3) The third party must execute in a timely manner the required contractor Third Party

Access agreement and agree in writing to return any copies of the data provided to, or made by, that party when the third party is no longer actively engaged in such project or at such earlier time as FDA may request in writing; and

(4) The third party must agree in writing not to release the Limited Rights Data to any additional party.

f. If a third party that received Limited Rights Data in accordance with paragraph 5 seeks to disclose materials that include Aggregated Limited Rights Data, the third party must submit an electronic copy of those materials and of the source data files relied upon to FDA for submission to Contractor for clearance approval.

g. Clearance to use Limited Rights Data and/or Aggregated Limited Rights Data does not grant any third party rights to use the (Name of Contractor) (Contractor) [Database Systems] software tools.

This policy shall be in effect for the calendar year for the length of the contract and thereafter until either party notifies the other of its termination or Contractor provides to the FDA a different policy.

h. Notwithstanding any of the above provisions, under certain circumstances, the

Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government will take appropriate measures within its control in an effort to ensure that the information will be shared in a manner intended to protect the information from public disclosure.

Contractors submitting proposals to perform work under this contract must assure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and must treat the information as confidential or otherwise privileged.

H.9 Post-Award Orientation Conference

The FDA will conduct an onsite post-award orientation briefing with the Contractor and key FDA employees (ie, CO, COR, Safety, Security, QA and IT). The briefing will include detailed information on: (1) Campus access, security checks, badging, etc.; (2) specified computer/ADP requirements and mandatory training; (3) the importance of protecting non-public information; (4) safety requirements; (5) reporting requirements; (6) deliverable schedule; and any other necessary onsite information for contract start-up.

Briefing updates may be conducted annually if necessary.

SECTION I - CONTRACT CLAUSES

I.1 FAR 52.252-2 Clauses Incorporated By Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. The full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far

I.2 Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses

FAR Clause No. Title Date 52.202-1 Definitions (NOV 2013) 52.203-3 Gratuities (APR 1984) 52.203-5 Covenant Against Contingent Fees (APR 1984) 52.203-6 Restrictions on subcontractor Sales to the

Government

(SEP 2006)

52.203-7 Anti-Kickback Procedures (OCT 2010) 52.203-8 Cancellation, Rescission, and Recovery

Funds for Illegal or Improper Activity

(JAN 1997)

52.203-10 Cost/price or Fee Adjustment for Illegal or Improper Activity

(JAN 1997)

52.203-12 Limitation on Payments to Influence Certain Federal Transactions

(OCT 2010)

52.203-14 Display of Hotline Poster(s) (DEC 2007) 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights

(APR 2014)

52.204-2 Security Requirements (AUG 1996) 52.204-4 Printed or Copied Double Sided on Recycled

Paper

(MAY 2011)

52.204-9 Personal Identity Verification of Contractor Personnel

(JAN 2011)

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

(JUL 2013)

52.204-13 System for Award Management Maintenance

(JUL 2013)

52.204-14 Service Contract Reporting Requirement (JAN 2014) 52.209-6 Protecting the Government’s Interest When

Subcontracting with Contractor’s Debarred Suspended, or Proposed for Debarment

(AUG 2013)

52.215-2 Audit and Records – Negotiations (OCT 2010) 52.215-8 Order of Precedence – Uniform Contract

Format

(OCT 1997)

52.215-10 Price Reduction for Defective Cost or Pricing Data

(AUG 2011)

52.215-11 Price Reduction for Defective Cost or Pricing Data - Modifications

(OCT 2010)

52.215-12 Subcontractor Certified Cost or Pricing Data (OCT 2010) 52.215-13 Subcontractor Cost or Pricing Data –

Modifications

(OCT 2010)

52.215-15 Pension Adjustments and Asset Reversions (OCT 2010) http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/52_000.htm#P450_67440

52.215-18 Reversion or Adjustment of Plans for

Postretirement Benefits (PRB) Other Than Pensions

(JUL 2005)

52.215-19 Notification of Ownership Changes (OCT 1997) 52.215-21 Requirements for Cost or Pricing Data or

Information Other than Cost Or Pricing Data-Modifications

(OCT 2010)

52.217-8 Option to Extend Services “…30 calendar days before the contract expires.”

(Nov 1999)

52.217-9 Option to Extend the Term of the Contract “(a)…thirty (30) calendar day before the contract expires;…60 calendar…

(c) (5) four (4) years and nine (9) months (exclusive of any extensions under FAR Clause 52.217-8).”

(Mar 2000)

52.219-6 Notice of Total Small Business Set-Aside (NOV 2011) 52.219-8 Utilization of a Small Business Concerns (OCT 2014) 52.219-14 Limitations on Subcontracting (NOV 2011) 52.219-28 Post-Award Small Business Program

Representation

(JUL 2013)

52.222-3 Convict Labor (JUN 2003) 52.222-4 Contract Work Hours and Safety Standards

Act – Overtime

(JUL 2005)

52.222-17 Nondisplacement of Qualified Workers (MAY 2014) 52.222-21 Prohibition of Segregated Facilities (April 2015) 52.222-26 Equal Opportunity (April 2015) 52.222-35 Equal Opportunity for Special Disabled

Veterans, Veterans of the Vietnam Era, and Other Eligible

(SEP 2010)

52.222-36 Affirmative Action for Workers with Disabilities

(JUL 2014)

52.222-37 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

(JUL 2014)

52.222-40 Notification of Employee Rights Under the National Labor Relations Act

(DEC 2010)

52.222-41 Service Contract Act of 1965 (NOV 2007) 52.222-42 Statement of Equivalent Rates for Federal (May 2014)

Employee Class Monetary Wage -- Fringe Benefits

General Clerk II (SCA Occupational Code 01112)

Medical Records Clerk (SCA Occupational Code 12160)

Laboratory Technician (SCA Occupational Code 30210)

Medical Record Technician (SCA Occupational Code 12190)

12.19 + 23%*

13.68+ 23%*

17.06 + 23%*

18.96+ 23%*

*Fringe Benefits for federal hires at NCTR are calculated at an average of 23% of rate of pay

52.222-43 Fair Labor Standards Act and Service Contract Act – Price Adjustment (Multiple Year and Option Contracts)

(MAY 2014)

52.222-50 Combating Trafficking in Persons (MAR 2015) 52.222-54 Employment Eligibility Verification (AUG 2013) 52.222-55 Minimum Wages Under Executive

Order 13658 (Dec 2014)

52.223-2 Affirmative Procurement of Biobased Products Under Service and Construction Contracts

(JUL 2012)

52.223-5 Pollution Prevention and Right-to Know Information

(MAY 2011)

52.223-6 Drug-Free Work Place (MAY 2001) 52.223-11 Ozone-Depleting Substances (MAY 2001) 52.223-14 Toxic Chemical Release Reporting (AUG 2003) 52.223-17 Affirmative Procurement of EPA-designated (MAY 2008) 52.223-18 Contractor Policy to Ban Text Messaging

While Driving

(AUG 2011)

52.224-1 Privacy Act Notification (APR 1984) 52.224-2 Privacy Act (APR 1984) 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) 52.227-1 Authorization and Consent (DEC 2007) 52.227-2 Notice and Assistance Regarding Patent and

Copyright Infringement

(DEC 2007)

52.227-14 Rights in Data – General (Alt II dtd Dec 2011 may apply if any limited data is identified in provision 52.227-15)

(MAY 2014)

52.227-23 Rights to Proposal Data (JUN 1987) 52.228-5 Insurance – Work on a Government

Installation

(JAN 1997)

52.2…