Section H - Draft Agency Requirements.pdf

Section H

Packing, Marking and Shipping

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

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

Inspection and Acceptance The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Government’s COR specified at award. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer.

Deliveries and/or Performance The Contracting Officer’s Representative (COR), a duly authorized representative of the CO, shall monitor the Contractor’s performance, evaluate the quality of services, and perform the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the COR specified herein.

Reporting Requirements and Deliverables Deliverables required by this contract are outlined in the SOW.

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. The data shall be informational in character and its receipt by the Government shall not be construed as a waiver by the contractor or any other rights or remedies provided to the Government by law or under this contract.

Place of Performance Most of the work should be performed at the contractor’s facility, to include maximizing technology to minimize travel elsewhere; however, note Paragraph GB.4.1 Travel Costs should travel be required.

Observance of Federal Holidays A. Government personnel observe the following days as holidays:

New Year’s Day Labor Day Martin Luther King’s Birthday Columbus Day President’s Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

Inauguration Day for the DC metro Area.

B. Government Closures: When the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings, for other than firm-fixed-price contracts, the contractor will not be reimbursed when the government facility is closed for on-site work at the Government site.

CONTRACT ADMINISTRATION DATA

Government Personnel Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, 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:

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

The Contracting Officer for this contract is TBD.

Contract Specialist (CS) All communications pertaining to the solicitation process, contractual, and administrative matters under the contract shall be addressed to the CS electronically only at the following address:

TBD.

Contracting Officer’s Representative (COR).

The following COR will represent the Government for the purpose of this contract: (To be provided at contract award) Name:

Email Address:

Phone:

Mailing Address:

(a) Performance of the work under this contract shall be 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 services 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 the authority to issue any technical direction that:

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

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

(3) In any manner causes an increase or decrease in the total contract price, or 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 directions may be oral or in writing. The COR shall confirm oral direction in writing within five workdays, with a copy to the CO.

(d) The Contractor shall proceed promptly with the performance resulting from the technical directions 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 workday.

(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.

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

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

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

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the https://www.cpars.gov/ system.

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

Travel Costs and Other Direct Costs Travel and ODC costs/pricing shall be included in each of the offeror’s overall Task Order pricing, noting however, that (1) costs for travel within the area of Washington, D.C. (i.e., the District of Columbia;

Alexandria, Fairfax, and Falls Church Cities, Va.; Arlington, Fairfax, Loudon, and Prince Williams Counties, Va.; and Charles, Montgomery, and Prince Georges Counties, Md.) will not be allowed nor reimbursed, (2) travel costs shall be limited to that authorized by FAR 31.205-46, (3) no fee/profit will be allowed/paid,

(4) all travel outside of the Washington, D.C area shall be authorized and requested in advance (minimum of 30 calendar days) to the COR, and (5) the Contractor will be responsible for making all required travel arrangements for its personnel. Travel claims/invoices shall be include receipts required as attachments to the invoice to support travel claims:

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

2. Lodging receipt;

3. Parking/tolls receipts;

4. Rental car receipt including receipts for gasoline;

5. Receipts for taxi travel.

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

Tobacco Free Facilities In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties’’ includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees and any subcontractor staff is made aware of, understand, and comply with this policy.

Occupational Safety and Health Terms and Conditions

SECTION I – GENERAL OCCUPATIONAL SAFETY AND HEALTH TERMS AND CONDITIONS

1. The contractor is responsible for ensuring contractor personnel comply with applicable OSHA requirements, report unsafe conditions or activities to the Contracting Officer’s Representative (COR), and avoid actions and conditions that may result in an accident.

2. The contractor shall submit to the COR a site-specific safety and accident prevention plan and OSHA 300A reports from the past three calendar years.

3. The contractor shall report all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after discovery of the incident, illness or injury, or near-miss.

4. The contractor shall provide an investigation report at no cost to the Government for all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after the conclusion of the investigation of the incident, illness or injury, or near-miss.

5. The contractor shall report all activities or conditions that pose imminent danger or harm to persons, animals, or Government property immediately upon discovery to FDA Security or directly to local emergency services, as appropriate. In addition, the contractor shall report the incident to the COR immediately thereafter.

6. The contractor shall be responsible for any and all costs, expenses, and other obligations paid or incurred, due to the contractor’s noncompliance with federal, state, and/or local laws or ordinances.

7. As applicable, the contractor shall provide personal protective equipment (e.g., hard hats, safety glasses, work gloves) for anticipated hazards and ensure that contractor personnel wear the prescribed safety and health equipment within the work area, as prescribed by 29 CFR part 1910, Subpart I. The contractor shall provide instructions to personnel on the proper wear, maintenance, and limitations of the personal protective equipment prior to commencement of any work under the acquisition.

8. Prior to bringing any hazardous material to an FDA facility, the contractor shall provide the COR copies of any Safety Data Sheets (SDS) to obtain advance, written authorization.

8.1. Unless otherwise specified in the acquisition, the contractor is responsible for removing any hazardous material, or any material with an SDS, that the contractor brought with them for use at an FDA facility before or during performance of the acquisition.

Personnel Security Clearance Standards and Residency Requirements (October 2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that results in a favorable determination.

Contractor employees who will work in DHHS-owned or leased space for less than thirty (30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all times while in DHHS-owned or leased space.

2. GENERAL - The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

• A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

• Confirmation all individual employee security information has been submitted properly; and

• "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in the roster.

Pursuant to HSPD-12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

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

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting

Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

3. BACKGROUND INVESTIGATIONS - 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. Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

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

4. CONTRACT RISK DESIGNATION(S) - Contractor employees who will be in DHHS-owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive-12 (HSPD-12) in order to access to DHHS-owned or leased property without an escort. (See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered visitors, as described above, and 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 system (e-QIP) system. The FDA Personnel Security Specialist will provide access to the e-QIP as well as guidance as to which forms will be required. The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s): ___2___ There are three (3) potential position risk designations, which are:

• Non-Sensitive Low Risk (Tier 1) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non-Sensitive Low Risk Positions.

• Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust Positions - 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.

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. This information will be provided on the e-QIP form that will be electronically sent to the employee. The FDA Personnel Security Specialist will use this information to enter each Contractor employee into the e-QIP system.

Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation. A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed. Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

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

The Contractor must immediately return the PIV Card(s) to the COR. Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law. Unauthorized possession of a PIV Card, or any other type of Government-issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

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

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document. Acceptable forms of identification are listed in Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

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

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquiries covering the subject's background.

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

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

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

*Food and Drug Administration Badging and Credentialing Office 8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time Office of Regulatory Compliance and Risk Management 3900 NCTR Road Bldg. 54, Room 128

Jefferson, AR 72079 Appointment required A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

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:

Food and Drug Administration National Center for Toxicological Research Office of Regulatory Compliance and Risk Management 3900 NCTR Road Bldg. 54, Room 128 Jefferson, AR 72079 Appendix A:

Required 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.

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 to the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services

Attn: HOTLINE P.O. Box 23489 Washington, D.C. 20026

Non-Personal Services The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer employee relationship will exist between the Government and the Contractor. The Contractor and the Contractor’s employees are not employees of the federal Government and are not eligible for entitlement and benefits given federal employees.

Contractor personnel under this contract shall not:

• Be placed in a position where there is an appearance that they are employed by a Federal Officer, or are under the supervision, direction, or evaluation of a Federal Officer;

• Be placed in a position of command, supervision, administration or control over personnel or personnel of other Government Contractors, or become a part of the Government organization;

and,

• Be used in administration or supervision of procurement activities.

Work requirements shall flow only from the Contracting Officer or the COR to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All employee assignments, and daily work direction, shall be given by the applicable Contractor supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government Contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change this contract and that if the other Contractor believes this communication to be a direction to change their contract, they shall notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government’s rights in any way under the other provisions of this contract, including those related to the Government’s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

Conflicts of Interest and Confidentiality

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this IDIQ, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this IDIQ.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this BPA as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflicts. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this award for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the award for default or cause;

suspend or debar the contractor from Government contracting; or, pursue such other remedies as may be permitted at law or equity.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. The Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the BPA or Order to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after BPA or Order award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants any disclosures identifying any potential organizational conflicts of interest.

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(h) All contractor personnel involved in this requirement shall abide by the FDA Commitment to Protect Non-Public Information Agreement.

Data Disclosure Procedures Access to and Dissemination of Non-Public Information All contractor personnel involved in this requirement shall abide by the FDA’s Commitment to Protect Non-Public Information Employee Agreement included as Attachment 4 – Form 3398. Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor’s right to use data or information obtained from a non-restrictive source. Any questions concerning “privileged information” shall be referred to the Contracting Officer.

All persons authorized by FDA to work under this Contract, and all employees of the Contractor or any subcontractor who are directly involved in the inspection program under this Contract or who have access to any non-public information gathered under or related to this Contract, must sign a Commitment to Protect Non-Public Information Agreement (FDA Form 3398). FDA Form 3398 prohibits the release, publication, or disclosure of non-public information, except under specific circumstances.

The Contractor shall obtain signed copies of FDA Form 3398 for all Contractor and subcontractor personnel covered by this requirement, and shall provide a copy of each signed Form 3398 to FDA within 21 calendar days of award or ten (10) business days prior to commencement of any work under this Contract, whichever occurs first. Any new person assigned to this Contract shall sign the Form 3398 Agreement and shall submit it to the Contracting Officer and COR prior to commencement of work or access to non-public information under this Contract. If a person who has signed the Form 3398 Agreement resigns, is dismissed, or is otherwise no longer working on this Contract, the Contractor shall notify the COR and Contracting Officer within ten (10) business days of the departure of such person. No person working under this Contract shall be provided or possess non-public information in any form unless written approval and a facility clearance have been granted by the Contracting Officer. Disclosure of any confidential information in violation of the Form 3398 Agreement may subject that individual to civil or criminal sanctions.

The Contractor and its employees shall exercise the utmost discretion in regard to all matters relating to their duties and functions. They shall not communicate to any person any information known to them by reason of their performance of services under this contract which has not been made public, except in the course of their duties or by written authorization of the Contracting Officer. The Contractor shall include the substance of this provision in all contracts for employment and in all subcontracts hereunder.

Any questions about use or release of the data or information or handling of material under this contract shall be referred to the COR who must render a written determination to the Contracting Officer (CO). The COR’s determination will reflect the results of internal coordination with appropriate program and legal officials. After receipt of the COR’s written determination, the CO will make a final decision authorizing the release of information.

Designation of Task Order/Delivery Order Ombudsman In accordance with FAR 16.505(b)(5) and HHSAR 316.505(b)(5), the Director, Office of Acquisitions and Grants Services, has been designated as the FDA Ombudsman for Task Order and Delivery Order contracts.

Leonard Grant 4041 Powder Mill Road

RM42084

Phone: 240-402-7584 Email: Leonard.Grant@fda.hhs.gov (End of Clause)

Government Use of Data The Government will acquire the right to use, duplicate, or disclose in any manner and for any purpose whatsoever, and have or permit others to do so, all subject data required to be delivered under this contract. Contractor disclosure: Any disclosure/publication by the Contractor/subcontractor(s) of data provided under this contract shall require prior FDA review and clearance.

Incumbent Phase-Out The phase-in of incoming Contractor personnel may occur in conjunction with a phase-out of incumbent employees (last 30 days of existing contract). The Contractor shall not assume that incumbent employees will be able to guide, direct, or specifically orientate each incoming Contractor employee.

The in-coming Contractor shall cooperate with the incumbent during the phase-in period.

Continuity of Services The Contractor is expected to meet full performance requirements from the stated date of the contract.

The Contractor shall provide sufficient experienced personnel during the phase-in period to ensure that the services specified by this contract are maintained at the required level of proficiency.