FDA-2016-SOL-1166454__Off_Site_Repository_(4).doc

DOC document 175 KB Posted

Attached to
Off Site Freezer Repository Services. Federal contract opportunity
Solicitation number
FDA-RFP-2016-166454
Issued by
Department of Health and Human Services Food and Drug Administration

About this file

The Contractor shall provide a suitable storage facility within a 50-mile radius of Silver Spring MD to house and maintain thirteen -80C upright freezers three Harford Freezers and two Liquid Nitrogen freezers (eighteen in total).

View the file

Other files for this federal contract opportunity

Other files attached to Off Site Freezer Repository Services., newest first.
File Type Posted
Attachment_4.1_and_4.2_.doc DOC document

On GovTribe

Work with this file on GovTribe

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

Notice Type: Combined Synopsis/Solicitation Subject: Request For Proposal. FDA-RFP 2016 -166454 - Off Site Freezer Repository Services.

Section 1 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; quotes are being requested and a written solicitation will not be issued.

Solicitation Number FDA-RFP 2016 -166454 is being issued as a Request for Quotation (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005 – 89. This requirement is being solicited as a total small business set-aside (for small businesses only) using Simplified Acquisition Procedures per FAR Subpart 13.5. The associated NAICS Code is: 532210 – Consumer Electronics and Appliances Rental, with a small business size standard of 500 employees.

The U. S. Food & Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is seeking to procure Off Site Freezer Repository Services, for a Base Year (12 Months) plus 4 Option Years, totaling 5 years for the life of the contract. The listed Freezers are currently located at 4851 International Blvd., Suite -102, Fredrick MD 21703.

1.1 Contract Type

The Government intends to award a Firm Fixed Price Contract.

Section 2. Description and Specifications/Work Statement.

2.1. The Contractor shall provide a suitable storage facility within a 50-mile radius of Silver Spring, MD to house and maintain thirteen -80°C upright freezers, three Harford Freezers and two Liquid Nitrogen freezers (eighteen in total). The freezers range in size from 18 to 20 cubic feet. For the dimensions of each freezer (see attached list). The facility shall be completely air-conditioned and have adequate floor space to accommodate 5 additional freezers if required. The air conditioning system must be capable of providing an ambient temperature of 72 degree to 73 degree Fahrenheit when all freezers housed in this facility are operating. The storage space will be used to store containers of bulk biological material (see attached list) for short and long-range storage and should have capacity of at least 100 square feet each.

2.2. The contractor shall provide a relocation plan in the event that the biological material currently stored at Kamtek Inc. 4851 International Boulevard Frederick, Maryland 21703 need to be transported to the new location, if required.

2.3. The Contractor shall provide an adequate utility electrical power supply for the facility to safely operate all low temperature storage equipment, alarms, lights, HVAC systems and the immediate transfer of low temperature storage equipment for short or long term storage. The contractor shall have a liquid nitrogen tank with capability to operate the liquid nitrogen freezer.

2.4. The Contractor shall provide, as a safety measure, an emergency electrical generator system that is capable of providing electrical power to all systems in the event of a utility power failure.

2.5. The Contractor shall provide access to the facility for only authorized CBER employees on normal workdays during the hours of 8:00am to 4:30pm Monday through Friday. To this effect, the Contractor shall maintain a log of personnel accessing FDA/CBER inventory storage. The log shall include the name of the personnel accessing the inventory, date, time, freezer accessed and purpose of access. Details of authorized employees to have access to the freezers shall be provided during the initial kick-off meeting, after contract award. The Contractor shall also provide all necessary information for emergency access to the facility to a maximum of two employees of CBER.

2.6. The Contractor shall equip the freezer storage facility with a remote and central alarm security system. The system must have audible alarms that can be heard inside the facility by the Contractor’s personnel.

2.7. The central alarms shall monitor all freezers, communications systems, emergency generator service, fire and perimeter security systems. The system will contact a secondary facility personnel if primary personnel contact is not confirmed, this will also be documented and notification attempts will continue until either personnel is contacted by telephone. The central alarm systems shall be operational and monitored 24 hours a day, 365 days a year and have the capability to operate in the event of failure to traditional and line telephone system.

2.8. The Contractor shall ensure that designated CBER storage space shall be used for storing ONLY CBER material.

2.9. The Contractor shall maintain and perform routine preventative maintenance service on all cold storage equipment. The Contractor shall maintain and operate standby cold storage equipment in the event of loss of refrigeration capacity for all repository areas.

2.10. As necessary, or on a biannual basis the Contractor shall remove, transfer and temporarily hold the entire contents of each freezer for the purpose of defrosting and cleaning the freezers. This procedure shall be accomplished in a manner that causes no detrimental effect to the biologic material or storage equipment.

2.11. List of Freezers that are in need of storage.

Description
End User Point of Contact CBER
Description of what is being stored within each unit
Measurement
-80C Freezer
Dr. Meyer
50% full serum
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Mei Ying Yu, Arifa Khan
Anti HCV positive Plasma in Bottles
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Chris Anderson
Reference and standard preparations
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Judy Beeler
Monkey and human samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Judy Beeler
Monkey and human samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Judy Beeler
Monkey and human samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Judy Beeler
Monkey and human samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Surender Khurana, Hana Golding
Monkey and human samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Surender Khurana, Hana Golding
Monkey and human samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
James Kenney
Monkey and human samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
James Kenney
Pertussis CDC samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
James Kenney
Pertussis CDC samples
L 39" x W 39" x H 80"

Inside Dimensions

L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

-80C Freezer
Arifa Khan
Pertussis CDC samples
L 39" x W 39" x H 80" Inside Dimensions L 24" x W 34" x H 50"

Shelf Size

L 24" x W 33.5" (x4)

Harford 20°C Freezer
James Kenney
Reference standards, blood retesting agents, Mega 2
7'9" x 9'8" x 7'6-1/4" (add 20-1/2" compressor height)
Harford 2-8 °C Freezer
James Kenney
OVRR and OBRR reference standards
7'9" x 9'8" x 7'6-1/4" (add 20-1/2" compressor height)
Harford 2-8 °C Freezer
James Kenney
OVRR and OBRR reference standards
7'9" x 9'8" x 7'6-1/4" (add 20-1/2" compressor height)
MVE (Liquid N2)
James Kenney
STS reference standards
39-1/4" id x 37-1/2" deep
MVE (Liquid N2)
Arifa Khan, Konstantin Chumakov
Cell lines co-cultivated with TSE agents
39-1/4" id x 37-1/2" deep

**CBER End User Point of Contacts are FDA Personnel who have requested samples to be stored.

2.11. Period of Performance. The contract shall have a (twelve months) base year plus five option years.

CLIN
Description
Period of Performance
0001
Freezer Repository Services
Base Year - 09/30/2016 THRU 09/29/2017
0002
Freezer Repository Services
Option Year 1 - 09/30/2017 THRU 09/29/2018
0003
Freezer Repository Services
Option Year 2 - 09/30/2018 THRU 09/29/2019
0004
Freezer Repository Services
Option Year 3 - 09/30/2019 THRU 09/29/2020
0005
Freezer Repository Services
Option Year 4 - 09/30/2020 THRU 09/29/2021

2.12. Reporting:

i) The Contractor shall provide monthly reports.

ii) Monthly reports shall consist of a description of all repairs and routine maintenance services for the equipment shall be included in the monthly reports.

iii) The monthly reports shall be due on the 7th of every month, and must outline the previous month’s activities.

iv). Delivery Location. The original copy of the monthly reports shall be delivered via email to the following: Contract Specialist: Mr. Emmanuel Mbah, Email: Emmanuel.mbah@fda.hhs.gov, the Project Manager (TBD) and to the Contracting Officer Representative (COR-TBD), at the following address:

Food and Drug Administration

CBER, Office of the Director

10903 New Hampshire Avenue

White Oak 71, Room 6318

Silver Spring, MD 20993

2.13. Place of Performance

The vendor shall provide an off-site facility for the storage space.

SECTION 3 – CONTRACT CLAUSES

3.1 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 Contracting Officer will make their full text

3.2 FAR 52.212-4 – Contract Terms and Conditions – Commercial Items. (May 2015) available. Also, the full text of a clause may be accessed electronically at these addresses: www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301-1.html.

FAR Clause
Title
Date
Reference
52.203-3
Gratuities
(Apr 1984)
3.202,
52.203-17
Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights.
(Apr 2014)

3.908-9,

52.204-4
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
(May 2011)
4.303,
52.222.22
Previous Contracts and Compliance Reports.
(Feb 1999)
22.810(a)(2),
52.245-1
Government Property.
(Apr 2012)
45.107(a)
HHSAR
Title
Date
Date
352.203-70
Anti-Lobbying.
Dec, 2015
303.808-70
352.215-70
Late Proposals and Revisions
Dec, 2015
315.303-70
352.211-3
Paperwork Reduction Act.
Dec, 2015
311.7301
352.222-70
Contractor Cooperation in Equal Employment Opportunity Investigations
Dec, 2015
322.810(h)

3.3 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 within 10 (Ten) days, within which the Contracting Officer may exercise the option.

3.4 FAR 52.217-9 - Option to Extend the Term of the Contract. (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 10 (Ten) days, within which the Contracting Officer may exercise the option]; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 (Ten) days before the contract expires. The preliminary notice does not commit the Government to an extension.

(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 (Five) years.

3.5 Security and Privacy

Contractor personnel performing work under this 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 resulting 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 agrees 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 contract 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 COR, 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 this 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 COR or designee prior to performing any work under the contract. The COR 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.

3.6 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 Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

3.7 Invoice Submission: Payment shall be based on invoicing on a monthly basis for services provided.

RECEIPT AND ACCEPTANCE OF SUPPLIES/SERVICES:

Invoice Submission A. The Contractor shall submit vouchers or invoices in accordance with the following instructions:

B. The contractor shall submit all invoices to all:

10903 New Hampshire Avenue

Building 32, Room 2162

Mail Hub 2145

Silver Spring, MD 20993-0002

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

(I) one copy to the contracting officer representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

Food and Drug Administration (FDA)

10903 New Hampshire Avenue

White Oak Building 71, Room 6318

Silver Spring, MD 20993

ATTN: (COR TBD)

**Acceptable methods of delivery include: mail, hand delivery, or e-mail

C. Invoices submitted under this contract must comply with the requirements set forth in far clauses 52.232-27 (Prompt Payment for Construction Contracts) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable far clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) Itemized travel costs, including origin and destination;

(c) Any other supporting information necessary to clarify questionable expenditures;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(xi) Name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order;

(xii) Any other information or documentation required by the purchase order/award.

(xiii) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order and;

(c) for definitive contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance

D. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format all items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

E. Questions regarding invoice payments should be directed to the FDA payment office at:

FDA/OC/OA/OFO/OFS

Attn: Vendor Payments, OFS FDA

10903 New Hampshire Avenue

Building 32, Room 2162

Mail Hub 2145

Silver Spring, MD 20993-0002

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov Final payments shall occur upon verification by FDA COR and the FDA Technical Advisor, noting successful completion of all deliverables. Payment shall be made after acceptance and receipt of a proper invoice.

3.8. Holidays

FDA personnel observe the FDA following days as holidays:

· New Year's Day

· Columbus Day

· Washington's Birthday

· Veterans' Day

· Memorial Day

· Thanksgiving Day

· Independence Day

· Christmas Day

· Labor Day

· Martin Luther King's Birthday

· Any other day designated by Federal statue

· Any other day designated by Executive Order

· 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 will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will 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 will 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 contract work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

3.9 Disclosure of Information

Contractors are reminded that information furnished under this solicitation and resulting contracts and task orders 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 must 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 this contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and must 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 must 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.

3.10 Providing Accelerated Payments to Small Business Subcontractors: FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013).

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

3.11 Contract Administration Data

3.11.1 Contracting Officer’s Representative (COR) The Contracting Officers Representative (COR) responsible for the acceptance of work provided hereunder will be designated by separate correspondence.

3.11.2 Technical Direction

Performance of the work under this contract shall be subject to the technical direction of the COR. The term “technical direction: is defined to include, without limitation, the following:

Directions to the Contractor which redirect the contract effort, 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 statement of work.

Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

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

Technical direction must be within the general Scope of Work stated in this project. The COR does not have the authority to and shall not issue any technical directions which:

Constitute an assignment of additional work outside the general Scope of Work of the contract.

Constitute a change as defined in the applicable contract clause entitled: FAR 52.212 – 4 (c).

Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction shall be issued in writing by the COR or shall be confirmed by him/her in writing within 5 working days after issuance.

For guidance from the COR to the Contractor to be valid, it must be consistent with the description of work set forth in this contract;

1) Not constitute new assignment of work or change to the expressed terms, conditions or specifications incorporated into this contract;

2) Not constitute a basis for an extension to the period of performance or contract delivery schedule;

3) Not constitute a basis for any increase in the contract price or extension to the contract delivery.

The contractor shall process promptly with the performance of technical directions duly issued by the COR in the manner prescribed by this article and within his authority under the provisions of this article. If, in the opinion of the contractor, any instruction or direction issued by the COR is within one of the categories defined above, the Contractor shall not proceed but shall notify the Contracting Officer 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 opinion, the technical direction is within the scope of this article and does not constitute a change under the Changes Clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. A failure of the parties to agree upon the nature of the instruction or direction upon the contract action to take with respect thereto shall be subject to the provisions of the contract clause entitled “Disputes”.

3.12 Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of this task order. In the event the Contractor effects any changes at the direction of any person other than the CO or the COR, the changes shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall 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. No costs chargeable to the proposed task order can be incurred before receipt of a fully executed task order or specific authorization from the Contracting Officer.

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 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 this contract; or (5) otherwise change any terms and conditions of this contract.

3.13 Packing, Marking and Shipping:

3.13.1. At a minimum, all deliverables shall be marked with the contract number and contractor’s name.

3.13.2. The contractor shall deliver all items related to this requirement at the following address:

Food and Drug Administration (FDA)

10903 New Hampshire Avenue

White Oak Building 71, Room 6318

Silver Spring, MD 20993.

3.14 Inspection and Acceptance:

3.14.1. The Contracting Officer’s Representative (COR – TBD upon contract award) shall perform inspection and acceptance of materials and services to be provided. For the purpose of this SECTION, the COR is the authorized representative of the Contracting Officer.

3.14.2 Inspection and acceptance will be performed at: the locations identified here - in.

Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer or COR within 30 days of receipt.

3.14.3 This contract incorporates the following clause, 52.246-2: Inspection of Supplies Fixed Price (Aug 1996) by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available.

3.15. Contractor Access to Sensitive Information

All Contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise exempt from public disclosure may be disclosed to them.

3.16 Classified Information.

It is anticipated that the Contractor will have access to sensitive Agency information for data. The Contractor shall agree that contract personnel shall not divulge or release information or data developed or obtained in connection with the performance of this contract, unless made public by FDA or upon written approval by the Project Officer and the Contracting Officer’s Representative.

3.17 FAR 52.204-7 - System for Award Management (Jul 2013)

3.18 FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items. (Jun 2016).

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

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

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

[Contracting Officer check as appropriate.]

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

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

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

_x__ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

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

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

___ (10) [Reserved]

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

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

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

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

_ X _ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

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

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

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

X (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (Oct 2015) of 52.219-9.

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

___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

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

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

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

___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

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

X (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

_ X __ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

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

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

___ (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).

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

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

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

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

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

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

___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

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

___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

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

X (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

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

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

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

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

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

___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

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

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

[Contracting Officer check as appropriate.]

___ (1) 52.222-17, Non displacement of Qualified Workers (May 2014) (E.O. 13495)

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

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

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

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

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

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

___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).

___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

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

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

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

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

(e)

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

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

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Non displacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

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

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

(viii) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).

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

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

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

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

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

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

(xiv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, re-designate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the re-designated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause”.

Alternate II (Oct 2015). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)

(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

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

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

(C) 52.219–8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

(E) 52.222–26, Equal Opportunity (Apr 2015) (E.O. 11246).

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

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

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

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

(J) ____ (1) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (2) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

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

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

(M) 52.222–54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989).

(N) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E. O. 13658).

(O) 52.226–6, Promoting Excess…

This is the start of the file's text. The full file is on GovTribe.

File details come from the government source that posted it. Updated .