FDA-RFQ-ORA-2024-120488-Shredding Services For PHI-DO and Associated Resident Postses.docx

FDA-RFQ-ORA-2024-120488-Shredding Services For PHI-DO and Associated Resident Posts, for a base year (12 months) plus four (4) 12 (months) option years.

October 8, 2023 Part-A (b) Continuation pages 1 – General- NOTICE OF COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. A Quote is hereby requested, and no other written solicitation will not be issued.

Solicitation Number # FDA-RFQ-ORA-2024-120488, is issued as a Request for Quotations (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 20223-05. This is a solicitation for commercial items in accordance with the procedures of FAR Part 12 – Acquisition of Commercial Items. This requirement is being solicited as a total small business only set-aside 100% (for small businesses only) FAR 52.219-6, Notice of Total Small Business Set-Aside, using the Simplified Acquisition Procedures per FAR Subpart 13.5

The U. S. Food & Drug Administration, (FDA) Office of Acquisition and Grants Services (OAGS) has a requirement to procure: ORA-2024-120488-Shredding Services For PHI-DO and Associated Resident Posts, for a base year (12 months) plus four (4) 12 (months) option years.

2- Contract Type The Government intends to award a Firm Fixed-Price (FFP) Purchase Order to procure the requested Shredding Services, for a base year (12 months) plus four (4) 12 (months) option years.

The associated NAICS Code is: 561110-Office Administrative Services.

3.1. Background/Statement of Need

The Philadelphia District Office contains personnel responsible for regulated industry in the states of Pennsylvania and Puerto Rico. Previously, onsite shredding services were conducted at 5 different locations on an Ad-Hoc Basis. There is now a need to transition this requirement into a contract that provides a recurring onsite shredding service.

3.2. Purpose

The purpose of this request is for a flat rate shredding service provided onsite at the Philadelphia District Office and 4 Resident Posts located within the Philadelphia District. Shredding services are needed to properly dispose of sensitive documents that are past their primary mandatory retention date.

3.3. Scope of Work

Contractor Requirements:

The Contractor shall provide secured shredding storage bins and conduct onsite shredding services for the Food and Drug Administration’s Philadelphia’s District Office. Shredding documentation shall include, but not limited to, paper, folders, books, and pamphlets. The Contractor shall collect and shred highly sensitive documents onsite at the locations listed below. The Contractor shall collect and shred documents of the offices every 8 weeks for a total of 7 collections per location for the requested period of performance. Shredding shall be done during normal business hours, 8:00 AM to 4:30 PM Eastern Standard Time (EST), Monday through Friday, excluding federal holidays or as ordered by the Contracting Officer. Shredding done outside of normal business hours and/or ordered outside of this schedule must be approved by the Contracting Officer.

Bin Requirements:

The Contractor shall provide a total of 9 bins that can hold a minimum of 95 gallons of volume of paper for use during each onsite shredding service. The exact quantity of bins per location will be provided below.

Shredding Specifications:

Sensitive Document Shredding:

i. Sensitive Documents shall be shredded crosscut, to a maximum acceptable particle size of 3/8 inch by ½ inch in size (Minimum Requirement. Strip shredding is unacceptable).

ii. The Contractor shall address its shredding specifications capabilities with their proposal and identify if it can meet or exceed the standards listed above.

iii. Note****Sensitive documents shall be shredded in accordance with the schedule listed previously. Contractor shall address its ability to meet or exceed shredding specifications.

FDA Personnel Requirements:

Escorting & Access:

The Food and Drug Administration’s Office personnel shall escort Contractor personnel while conducting onsite shredding service. The Food and Drug Administration’s Office personnel shall witness the shredding of the documents onsite. All documents must be shredded on site. No documents shall be removed or shredded off-site.

4. Conditions: Note* that:

4.1. The Contractor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement. The Contractor shall demonstrate how the requested items or services, “MEET” or “DO NO MEET” the salient/functional characteristics and specifications listed. The Contractor shall annotate each salient/functional characteristics and specifications with the following: Meets (if it meets the specification) or Does not meet (if it fails to meet the specification).

4.2. Grey market or refurbished products will not be accepted.

4.3. The Vendor shall indicate if non-domestic items are included in the quote.

4.4. The Vendor shall provide all, of the items/services listed or none.

4.5. Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

5. Minimum Specifications and Salient Characteristics

5.1. The requested services shall at a minimum, meet the specifications/requirements listed in this RFQ:

5.2. FDA requires the following specifications: Primary criteria that shall be satisfied:

Onsite shredding services to be provided at the following locations:

i. Philadelphia District Office (200 Chestnut St, Philadelphia, PA 19106); 5 Bins Provided

ii. Wilmington, DE RP (800 N King St, Wilmington, DE 19801); 1 Bin Provided

iii. Wilkes Barre RP (7 N Wilkes Barre Blvd, Suite 308, Wilkes Barre, PA 18702) 1 Bin Provided

iv. Harrisburg RP (3605 Vartan Way, Suite 305, Harrisburg, PA 17110) 1 Bin Provided

v. Pittsburg RP (7 Parkway Center, Suite 250, Pittsburgh, PA 15220) 1 Bin Provided

5.3. DELIVERABLES

5.4. Period of Performance: Period of performance will be one year (12 months), plus four 4 (12 months) option years.

The Period of Performance shall be as follows:

This contract provides for an initial base period of one year and four potential option periods, each 365 calendar days. The options periods, if exercised, shall run consecutively and at the discretion of the Government.

5.5.1 Consideration and Payment

Independently and not as an agent of the Government, the Contractor shall provide the requested services and the necessary personnel, materials and otherwise do all things necessary for, or incidental to performing the requested tasks as described for each performance area in the SOW.

In consideration for successful performance of the requested services, the Contractor shall be paid upon the presentation of a proper invoice in accordance with the applicable FDA invoice instructions. Upon presentation of a proper invoice, payment will be made no more frequently than monthly or arrears, for services/supplies rendered to and accepted by the Government.

5.6. TRAVEL

Reimbursable travel and per diem for the Contractor’s employees performing work on a regular basis at the place of performance is not authorized.

5.7. SECURITY REQUIREMENTS

The services shall be performed during regular business hours, Monday through Friday, 8:00 AM – 2:00 PM Eastern Standard Time, excluding federal Government holidays. When the contractor’s employees arrive on site for services, they shall check in. The Project Officer or Contracting Officer’s Representative will grant the vendor access to the FDA suite. The Contractor’s employees shall receive an escort required temporary badge from the PO/COR which must be worn at all times in the building. When their work is complete, the Contractor’s employees shall turn in their temporary badge and check out.

5.8. SECTION 508 – ELECTRONIC AND INFORMATION TECHNOLOGY

STANDARDS

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services. There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites – including text, audio or video – must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following technical provisions within the Section of the Standard apply to this procurement:

The following Section 508 Standards apply:

1194.25 Self Contained, Closed Products

1194.31 Functional performance criteria

1194.41 Information, documentation, and support

5.9. Order of Precedence

The Contractor shall follow the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clauses 52.212-4, dated Jan 2017. Any governing law language appearing in any Contractor terms or conditions shall be treated as null, void, and stricken. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from this order (not the Schedule). The Contractor shall provide all terms and conditions with their quotations as attachments, appendixes, etc.

5.10. Packing, Marking, Delivery and Shipping

All deliverables shall be packaged and packed in accordance with normal commercial practice, including that which is necessary to prevent deterioration and damage due to the hazards of shipping, handling and storing. The Vendor shall call the TPOC, at least 24-hours prior to arrival or to perform any services. The delivery or services must be during regular business hours (Monday-Thursday) during the times of 8:00 AM – 4:00 PM Eastern Time, excluding holidays.

i. Delivery and Marking All deliverables shall be marked as follows:

(a) Name and address of the Contractor,

(b) Contract Number

(c) Description of item contained therein; and

(d) Consignee’s name and address.

(e) Each delivery location may provide specific delivery instructions.

ii. Shipment/Destination/Place of Performance:

Onsite shredding services shall be provided at the following locations:

i. Philadelphia District Office (200 Chestnut St, Philadelphia, PA 19106); 5 Bins Provided

ii. Wilmington, DE RP (800 N King St, Wilmington, DE 19801); 1 Bin Provided

iii. Wilkes Barre RP (7 N Wilkes Barre Blvd, Suite 308, Wilkes Barre, PA 18702) 1 Bin Provided

iv. Harrisburg RP (3605 Vartan Way, Suite 305, Harrisburg, PA 17110) 1 Bin Provided

v. Pittsburg RP (7 Parkway Center, Suite 250, Pittsburgh, PA 15220) 1 Bin Provided

iii. Payment of Postage and Fees All postage and fees related to distribution of deliverable including forms, reports, etc., shall be paid by the Contractor

5.11. Contracting Officer’s Technical Point of Contact (TPOC) The TPOC is responsible for the acceptance of the items or services requested.

Inspection and Acceptance:

Inspection is in accordance with FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items, part (a) Inspection/Acceptance.

Deliverables will be inspecting by the Contracting Officer’s Representative (COR). Completion of all deliverables, quality, and timeliness of delivery, as well as incidents and types of defects, will be used to evaluate the contractor’s progress and suitability. Inspection and Acceptance will be performed at the delivery location. The COR will inspect and accept the deliverables within 10 days of receipt. The contractor shall resubmit deficient deliverables within 15 days of the date that the rejection was issued.

5.12. Technical Direction

A. Performance of the work under the resultant contract shall be subject to the technical direction of the TPOC. The term "technical direction" is defined to include the following:

i). Technical directions to the Contractor which shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual scope of work, ii). Providing information to the Contractor for assistance in the interpretation of specifications, or technical portions of the work description, and iii). Reviewing and, where required by the contract, approving of technical reports, specifications, and technical information to be delivered by the Contractor to the Government under the requirement.

B. Technical direction shall be within the general scope of work stated in the contract. The TPOC does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled "Changes, FAR 52.212 – 4 (c)." (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

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

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

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

5.13. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

The Contracting Officer is the only person with authority to act as agent of the Government under the Contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (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 the Contract; or (5) otherwise change any terms and conditions of the Contract.

3.10. Groundskeeping: (if applicable), The Contractor shall use products made from biobased materials to the maximum extent possible.

All supplies and materials shall be of a type and quality that conform to applicable Federal specifications and standards. All supplies and materials to be used in the performance of work described herein are subject to the approval of the Contracting Officer’s Representative (COR).

The following are examples of products that may be used in this contract for which biobased options are available. The list is not all inclusive. It is desirable that Contractors be able to supply the greatest number of biobased products in the performance of this contract.

Hydraulic Fluids Penetrating Lubricants Diesel Fuel Additives Multi-purpose Lubricants Degreasers Lube Chain Lubricants Chain Bar Lubricants All Purpose Cleaners Fertilizers Erosion Control Mulch Soil Amendments

JANITORIAL: All supplies and materials shall be of a type and quantity that conform to applicable Federal specifications and standards, and to the extent feasible and reasonable; include the exclusive use of biobased products. The Contractor shall utilize the greatest number of biobased products possible. Examples:

All-purpose cleaner Heavy-duty cleaner Deodorizer Carpet shampoo Floor finish Floor finish restorer Disinfectant sanitizer Floor sealer / Floor stripper Grout Sealer Glass cleaner Liquid Hand Soap Hand sanitizers

Part B - Contract Clauses

1. FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Nov 2021).

2. FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far; https://www.acquisition.gov/hhsar

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1-InstructionsforUsingProvisionsandClauses

3. FAR 52.217-8 - Option to Extend Services. (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time before the contract expires.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

5. FAR 52.232-18-Availability of Funds (Apr 1984). In relation to the out years: Funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

6. Security and Privacy Contractor personnel performing work under the Contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. The Contractor agrees that Contractor personnel will not divulge, or release data or information developed or obtained in connection with the performance of the Contract, unless made public by FDA or upon written approval from the Government. Except as may otherwise be permitted by a data owner, the Contractor personnel agree not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the Contractor without such limitation.

The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the requirement that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the TPOC, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the Contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. Each Contractor/Subcontractor employee who may have access to non-public Department information and/or sensitive information under the Contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the TPOC or designee prior to performing any work under the Contract. The TPOC or designee will inform the Contractor of the forms and training that are required.

However, it is the responsibility of the Contractor to assure that such forms have been signed.

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

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at 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 30 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 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and Contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the Contractor Performance Assessment Reporting System (CPARS) 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. Contractors may obtain CPARS training material and register for on-line training at CPARS: a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. There is no fee for registration or use of the CPARS.

8. Holidays FDA personnel observe the FDA following days as holidays:

i) New Year's Day

ii) Columbus Day

iii) Washington's Birthday

iv) Veterans' Day

v) Memorial Day

vi) Thanksgiving Day

vii) Independence Day

viii) Christmas Day

ix) Labor Day

x) Martin Luther King's Birthday

xi) Juneteenth

xii) Any other day designated by Federal statue

xiii) Any other day designated by Executive Order

xiv) Any other day designated by the President's Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the Contract.

Except for designated around-the-clock or emergency operations, Contractor personnel shall not be able to perform on-site under the Contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the Contract In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor shall direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the Contract for employees whose regular time is normally a direct charge if they continue to perform on the work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

9. HHSAR 352.242-73. Withholding of Contract Payments (JAN 2006) Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays’’ or ‘‘Default,’’ as applicable. The Government will immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted.

10. Insurance Requirements. A. The Contractor shall, at his own expense, procure and maintain, during the entire performance period of this contract, insurance of at least the kinds and amounts set forth below:

1. Worker's Compensation and Employer's Liability:

Contractors are required to comply with applicable Federal and State worker's compensation and occupational disease statutes. Employer's liability coverage of at least $100,000 shall be required except in states with exclusive or monopolistic funds that do not permit worker's compensation to be written by private carriers.

2. General Liability:

Contractors are required to have bodily injury liability insurance coverage written on the comprehensive form of policy of at least $1,000,000 per occurrence.

3. Automobile Liability:

The Contractor is required to have 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 operated in the United States 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.

B. At all times during performance, the Contractor shall maintain with the Contracting Officer a current Certificate of Insurance showing at least the insurance required by the Schedule and providing for thirty (30) days written notice to the Contracting Officer by the insurance company prior to cancellation or material change in policy coverage.

11. 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 tollfree 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 Attn: HOTLINE 330 Independence Avenue, S. W.

Washington, D.C. 20201

For the latest information regarding fraud and abuse, please visit the HHS Inspector’s General web site at http://oig.hhs.gov/.

12. Non-Personal Services and Inherently Government Functions. Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the COR to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee 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.

13. 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 the contract and that if the other Contractor believes this communication to be a direction to change their contract, they should 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 of 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 the 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.

14. Disclosure of Information. Contractors are reminded that information furnished under the solicitation and contract may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information shall be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S. Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA. However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government shall be used only for the purpose of carrying out the provisions of the contract and shall not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of the contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. § 641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

15. Quality Control Plan The Contractor shall maintain and implement a workable and comprehensive Quality Control Plan (QCP) for all requirements defined in the SOW. The plan shall demonstrate how the Contractor will effectively monitor all aspects of the work they will provide for the Government. The plan shall be specific to the work described in the SOW and utilize a continuous improvement process that outlines specific procedures for corrective actions to be taken when quality measures are not being met. The plan shall also include the Contractor’s reporting process and provisions for delivering a monthly status report that includes a summary of the previous month’s findings and accomplishments, challenges encountered, and anticipated expenses for the following month. The QCP shall include realistic and comprehensive measures to identify and document problems, determine corrective actions, and determine improvement based upon corrective actions.

16. HHSAR 352.222-70. Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010)

(a) In addition to complying with the clause in FAR 52.222-26, Equal Opportunity, the Contractor shall, in good faith, cooperate with the Department of Health and Human Services (Agency) in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 C.F.R. Part 1614. For purposes of this clause, the following definitions apply:

(1) “Complaint” means a formal or informal complaint that has been lodged with Agency management, Agency EEO officials, the Equal Employment Opportunity Commission (EEOC), or a court of competent jurisdiction.

(2) “Contractor employee” means all current Contractor employees who work or worked under this contract. The term also includes current employees of subcontractors who work or worked under this contract. In the case of Contractor and subcontractor employees, who worked under this contract, but who are no longer employed by the Contractor or subcontractor, or who have been assigned to another entity within the Contractor’s or subcontractor’s organization, the Contractor shall provide the Agency with that employee’s last known mailing address, e-mail address, and telephone number, if that employee has been identified as a witness in an EEO complaint or investigation.

(3) “Good faith cooperation” cited in paragraph (a) includes, but is not limited to, making Contractor employees available for: (i) formal and informal interviews by EEO counselors or other Agency officials processing EEO complaints; (ii) formal or informal interviews by EEO investigators charged with investigating complaints of unlawful discrimination filed by federal employees; (iii) reviewing and signing appropriate affidavits or declarations summarizing statements provided by such Contractor employees during the course of EEO investigations; (iv) producing documents requested by EEO counselors, EEO investigators, Agency employees, or the EEOC in connection with a pending EEO complaint; and (v) preparing for and providing testimony in hearings before the EEOC and U.S. District Court.

(b) The Contractor shall include the provisions of this clause in all subcontract solicitations and subcontracts awarded at any tier under this contract.

(c) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

17. HHSAR 352.223-70. Safety and Health (Dec 18, 2015)

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the Federal, State, and local levels.

(1) In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR part 1910. These regulations are available at https://www.osha.gov/.

(ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001.

(2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities:

(i) Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at http://www.cdc.gov/biosafety/publications/index.htm.

(ii) Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285, Washington, DC 20055 (ISBN 0–309–05229–7). This publication is available at http://www.nap.edu/catalog/4911/prudent-practices-in-the-laboratory-handling-and-disposal-of-chemicals .

(b) Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer’s Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting Officer will make an equitable adjustment in accordance with the applicable “Changes” clause set forth in this contract.

(c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report citing all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

(d) If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall form the basis for a request for extension or costs or damages by the Contractor.

(e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause.

18. 352.224-71 Confidential Information. (Dec 18, 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the Government,

(i) The publication or dissemination of the following types of information are restricted under this contract: [INSERT RESTRICTED TYPES OF INFORMATION. If none, so state.]

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: [STATE WHY THE PUBLIC OR GOVERNMENT INTEREST REQUIRES THE RESTRICTION OF EACH TYPE OF INFORMATION. ANY BASIS FOR NONDISCLOSURE WHICH WOULD BE VALID UNDER THE FREEDOM OF INFORMATION ACT IS SUFFICIENT UNDER THIS CLAUSE.]

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The Contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

19. HHSAR 352.224-70. Privacy Act (JAN 2006) This contract requires the Contractor to perform one or more of the following:

(a) design; (b) develop; or (c) operate a federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) [5 U.S.C. 552a(m)(1)] and applicable agency regulations. The term ‘‘system of records’’ means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties [5 U.S.C. 552a(i)]. The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

20. HHSAR 352.242-71. Tobacco-Free Facilities (Jan 2006) 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.