Combined_Syn-Sol_EMD_NIH-CC-16-005614.pdf

Combined Synopsis/Solicitation NIH-CC-16-005614

Electromyography (EMG) Machine

National Institutes of Health, Clinical Center, Rehabilitation Medicine Dept.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal

Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for

Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. The solicitation is being issued using simplified acquisition procedures under the authority of FAR 13.5 Test

Program for Certain Commercial Items.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2005-86, effective 01 Feb 2016.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 with a small business size standard of 500 employees. This acquisition is open to small businesses as defined under the

NAICS code 334510. Responses are due by 9:00 a.m., March 15, 2016. Only small business responses will be considered for award.

The National Institute of Health, Office of Purchasing and Contracts, is seeking to purchase upgraded sensors and add capabilities to the existing EMG System in the Rehabilitation Medicine Department, NIH, Clinical Center.

Only small business offers providing pricing for the following products and services, Brand Name or Equal, with the salient characteristics of the items described in the following Statement of Work will be considered for award.

Line

Item Description of Requested Items/Services

Quantity of Items U/I U/P Total ($)

Base Period: Wireless EMG System: Base

Station plus 12 pkgs Adhesive Interfaces

3/20/2016 to 3/19/2017

1 EA $_______ $_______

EMG +XYZ ACC, second gen. Standard

Sensor

24 EA $_______ $_______

0003 Spring Contact Sensor (fine wire electrodes) 4 EA $_______ $_______

0004 Trigger Module and Product Guide 2 EA $_______ $_______

0005 Shipping and Handling 1 EA $_______ $_______

Option for increased quantity: EMG + XYZ

ACC sensor

4-8 EA $_______ $_______

Option for increased quantity Adhesive

Interfaces (80 per pack) 12 Pkg $_______ $_______

Option for increased quantity; Spring Contact

Sensor (fine wire electrodes)

2-4 EA $_______ $_______

Option Period One (1): Extended warranty coverage plus 12 pkgs Adhesive Interfaces;

3/20/2017 through 3/19/2018

1 EA $_______ $_______

Option for increased quantity: EMG + XYZ

ACC sensors

4-8 EA $_______ $_______

Option for increased quantity Adhesive

Interfaces 12 Pkg $_______ $_______

Option for increased quantity; Spring Contact

Sensor (fine wire electrodes)

2-4 EA $_______ $_______

Option Period Two (2): Extended warranty coverage plus 12 pkgs Adhesive Interfaces;

3/20/2018 through 3/19/2019

1 EA $_______ $_______

Option for increased quantity: EMG + XYZ

ACC sensor

4-8 EA $_______ $_______

Option for increased quantity Adhesive

Interfaces 12 Pkg $_______ $_______

Option for increased quantity; Spring Contact

Sensor (fine wire electrodes)

2-4 EA $_______ $_______

Option Period Three (3) Extended warranty coverage plus 12 pkgs Adhesive Interfaces;

3/20/2019 through 3/19/2020

1 EA

Option for increased quantity: EMG + XYZ

ACC sensor

4-8 EA $_______ $_______

Option for increased quantity Adhesive

Interfaces 12 Pkg $_______ $_______

Option for increased quantity; Spring Contact

Sensor (fine wire electrodes)

2-4 EA $_______ $_______

Option Period Four (4): Extended warranty coverage plus 12 pkgs Adhesive Interfaces;

3/20/2020 through 3/19/2021

1 EA $_______ $_______

Option for increased quantity: EMG + XYZ

ACC sensor

4-8 EA $_______ $_______

Option for increased quantity Adhesive

Interfaces 12 Pkg $_______ $_______

Option for increased quantity; Spring Contact

Sensor (fine wire electrodes)

2-4 EA $_______ $_______

TOTAL including all Option Periods $_______

STATEMENT OF WORK

Background Information

The mission of the Clinical Center (CC) (defined as Warren Grant Magnuson Bldg (Bldg 10), Ambulatory Care

Research Facility (ACRF) and Clinical Research Center (CRC)) is to provide clinical research servicing the needs of the NIH Intramural Research Program by providing a safe and effective environment for the care and treatment of patients participating in structured biomedical research protocols. It consists of 3.5 million square feet of mixed occupancy space in three congruent buildings on the NIH campus. The Clinical Center (CC) is a 234 bed clinical research hospital. The CC employs approximately 2,000 employees, across 30 different departments. The Clinical

Center Complex consists of 3.5 million square feet of mixed occupancy space in three congruent buildings on campus.

The Functional & Applied Biomechanics Section (FAB) currently utilizes a wireless electromyography (EMG) system for its motion capture laboratory. The current EMG system is a Trigno Wireless EMG system that has 16 1 st generation surface electrodes. EMG is a major portion of data capturing in the Motion Capture Laboratory. EMG measures the muscle activation patterns during the studied motion and is a critical component of most of the FAB protocols and external protocols that we support.

Since we study bilateral motion, we are able to study up to 8 channels per side, which works well for lower extremity studies; however, when we require both lower and upper body motions than the 16 channels are not enough. In addition, deep or small muscles are unable to be studied with surface EMG. They require fine-wire electrodes. Many clinical referrals ask for FAB to study these deep muscles so we require that capability.

Wireless electrodes have small batteries in them, and like all batteries their usable life diminishes over time. The current 16 wireless electrodes (1 st generation Trigno wireless) are reaching the end of their battery life and need to be replaced. One electrode has already stopped functioning. Delsys has made improvements to their electrodes and now sells 2 nd generation Trigno wireless electrodes, so we wish to upgrade our 16 1 st generation sensors to the 2 nd generation sensors while increasing our capability from 16 surface electrodes to 20 surface and 4 fine-wire (total of

24 electrodes).

MINIMUM REQUIREMENTS / SPECIFICATIONS/ SALIENT CHARACTERISTICS:

The Functional & Applied Biomechanics Section (FAB) requires a wireless electromyography (EMG) system to allow simultaneous data collection from greater than 16 electrodes for its motion capture laboratory. The system must be able to collect data for biomechanical analysis for both surface and fine wire EMG collection, must be compatible with the currently utilized system, and when used in combination with the currently installed system, must be and be able to collect date from at least 24 muscles at one time. The wireless EMG system shall meet or exceed the technical specifications identified below. All items must be new. Used or remanufactured equipment will not be considered for award.

Nomenclature: Wireless electromyography system

Model No: Delsys Trigno Wireless EMG system including 24 2 nd generation electrodes– "brand name or equal."

Items Required:

o 20 2 nd generation Trigno EMG + XYZ ACC sensors (surface electrodes)(Brand name or equal)

FAB currently has 16 1 st generation Trigno EMG + XYZ ACC sensors that can be exchanged o Delsys Trigno EMG base station to allow total system housing of at least 24 the sensors (brand name or equal) o 4 spring contact sensors (fine wire electrodes) o Option to purchase between 4-8 additional surface or fine wire electrodes o Trigger module package to synchronize two base station EMG data with Vicon motion capture system o Software to collect EMG signals digitally; must be able to synchronize to Vicon motion capture system o Trigno Sensor Adhesive Interface to connect sensors to the skin (Brand Name or Equal) o Option to replace up to 24 2 nd generation electrodes when battery life diminishes below 3 hours

(new electrodes have 8 hours of battery life)

Functional Performance:

Must be a wireless EMG system with no variable signal delay or wires/packs that the patient must carry.

System must able to integrate with the current Vicon motion capture system so that we can synchronize the data.

A minimum of 24 EMG electrodes are required (20 surface and 4 fine wire);

Must come with at least a two year warranty.

Operational Characteristics:

A minimum of 24 EMG electrodes are required (20 surface and 4 fine wire);

If there is signal delay, it must be a fixed delay and not variable;

digital signals are preferred over analog;

sampling rate should be between 1000-3000 Hz;

minimal attachment of equipment to patient;

Dimensions: Base Station must fit on desktop so about 1 ft x 1 ft or less

Electrical Specifications:

Contractor shall comply with all applicable US electrical and associated safety and health code requirements relative to the proposed equipment, component, and/or system.

DELIVERY TERMS: Equipment shall be delivered to:

Program Staff: To Be Announced

Rehab Medicine Department

10 Center Dr, MSC 1604

Building 10, Bethesda, MD 20892

The Contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery.

INSPECTION AND ACCEPTANCE: Equipment Inspected and Acceptance will be determined by:

Contracting Officer’s Representative (COR) (To Be Determined at Time of Award)

Rehab Medicine Department

10 Center Dr, MSC 1604

Building 10, Room 1-1469

Bethesda, MD 20892

The government will inspect and accept goods and may perform operational tests to ensure the equipment performs in accordance with the original equipment manufacturer (OEM) specifications.

TRAINING: Training is not required, but the vendor should be available for technical support to assist FAB with installing and integrating the EMG system into our lab.

INSTALLATION: Installation will be performed by FAB.

WARRANTY: The contractor shall warrant the entire system for a period of at least two years, and may include four (4) 12 month Options to extend the Period of Performance of the Warranty at pre-negotiated rates. The warranty must include unlimited telephone/e-mail support for questions regarding operation. All costs including parts, labor, travel, and other expenses necessary to repair the system will be borne solely by the contractor at no additional cost to the U.S. Government.

OWNER’S MANUAL: “The contractor shall provide one (1) copy of the operating manual to include schematics, installation, operation and maintenance and any other applicable manuals for system. Documentation shall be provided in English in hard copy and/or CD/DVD ROM.”

SOFTWARE –Contractor shall provide software configuration and updates, as required, to the government.

REGULATORY COMPLIANCE:

All contractor furnished products must be UL and C-UL classified, ISO (International Organization for

Standardization), and CE (European Conformity) compliant. They must meet all FDA clearances, and have received ADA acceptance.

12.1 Proposed medical devices/equipment must be in compliance with the FDA Good Manufacturing Practices for medical devices and equipment. The equipment shall be in compliance with the FDA Safe Medical Devices Act, “Safety Medical Act of 1990” by Frank E. Samuel, Jr.

12.2 System components where required must possess 510K certifications and produced by a manufacturer with

ISO 13485 Certification or equivalent. Contractor shall provide a copy of their certification with their offer.

510k Certification:

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/d efault.htm and/or

ISO 13485 Certification:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_ca mpaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&ut m_content=1

Federal Regulations

Code of Federal Regulations (CFR) . The final regulations published in the Federal Register

(daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the

Federal Food, Drug and Cosmetic Act and related statutes. Section 21 of the CFR contains most regulations pertaining to food and drugs.

PERIOD OF PERFORMANCE:

The estimated Period of Performance of this contract will be twelve months from the award of contract, with four

(4) twelve month Options to extend the contract. If all Options to extend the contract are exercised, the estimated

Period of Performance will extend from March 20, 2016 through March 19, 2021.

The anticipated period of period of performance is as follows:

Base Period: 3/20/2016 – 3/19/2017

Option Period I: 3/20/2017 – 3/19/2018

Option Period II: 3/20/2018 – 3/19/2019

Option Period III: 3/20/2019 – 3/19/2020

Option Period IV: 3/20/2020 – 3/19/2021

(End of Statement of Work)

PROVISIONS AND CLAUSES

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items MAY 2015

CLAUSES INCORPORATED BY FULL TEXT

ADDENDUM TO 52.212-4

(v) The non-FAR Part 12 discretionary FAR, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found.

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=ISO%2013485%20Certification&utm_content=1 http://www.gpoaccess.gov/cfr/index.html http://www.gpoaccess.gov/fr/index.html http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-5 Covenant Against Contingent Fees MAY 2014

52.203-6 Restrictions On Subcontractor Sales To The Government (Sep 2006)

Alternate 1

OCT 1995

52.203-7 Anti-Kickback Procedures MAY 2014

52.203-8 Cancellation, Rescission, And Recovery Of Funds For Illegal Or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014

52.203-12 Limitation On Payments To Influence Certain Federal Transactions OCT 2010

52.203-17 Contractor Employee Whistleblower Rights And Requirement To Inform

Employees Of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper MAY 2011

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards OCT 2015

52.204-18 Commercial And Government Entity Code Maintenance JUL 2015

52.209-6 Protecting the Government's Interest When Subcontracting With

Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.217-5 Evaluation of Options JUL 1990

52.222-99 Establishing a Minimum Wage for Contractors (Deviation) JUNE 2014

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011

52.223-6 Drug Free Workplace MAY 2001

52.229-3 Federal State and Local Taxes FEB 2013

52.232-1 Payments APR 1984

52.232-17 Interest MAY 2014

52.232-23 Assignment of Claims MAY 2014

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.237-2 Protection Of Government Buildings, Equipment, And Vegetation APR 1984

52.237-3 Continuity of Services JAN 1991

52.242-13 Bankruptcy JUL 1995

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.245-1 Government Property APR 2012

52.245-9 Use And Charges APR 2012

52.253-1 Computer Generated Forms JAN 1991

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations DEC 2015

352.223-70 Safety and Health DEC 2015

352.227-70 Publications and Publicity DEC 2015

352.231-70 Salary Rate Limitation DEC 2015

352.237-74 Non-Discrimination in Service Delivery DEC 2015

52.211-6 -- Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

52.217-5 -- Evaluation of Options (Jul 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the

Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

(End of Provision)

52.217-7 -- Option for Increased Quantity -- Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within the Period of Performance of the Contract. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

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 30 calander days.

(End of Clause)

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 any time prior to the expiration of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 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 66 months.

(End of Clause)

52.219-28 -- Post-Award Small Business Program Re-representation (Jul 2013)

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in

SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code

_____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

(a) During the term of this contract, the Contractor shall post an employee notice, of such size and in such form, and containing such content as prescribed by the Secretary of Labor, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of the contract, including all places where notices to employees are customarily posted both physically and electronically, in the languages employees speak, in accordance with 29 CFR 471.2(d) and (f).

(1) Physical posting of the employee notice shall be in conspicuous places in and about the Contractor's plants and offices so that the notice is prominent and readily seen by employees who are covered by the National Labor

Relations Act and engage in activities related to the performance of the contract.

(2) If the Contractor customarily posts notices to employees electronically, then the Contractor shall also post the required notice electronically by displaying prominently, on any Web site that is maintained by the Contractor and is customarily used for notices to employees about terms and conditions of employment, a link to the Department of

Labor's Web site that contains the full text of the poster. The link to the Department's Web site, as referenced in

(b)(3) of this section, must read, ``Important Notice about Employee Rights to Organize and Bargain Collectively with Their Employers.''

(b) This required employee notice, printed by the Department of Labor, may be--

(1) Obtained from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S.

Department of Labor, 200 Constitution Avenue, NW., Room N-5609, Washington, DC 20210, (202) 693-0123, or from any field office of the Office of Labor-Management Standards or Office of Federal Contract Compliance

Programs;

(2) Provided by the Federal contracting agency if requested;

(3) Downloaded from the Office of Labor-Management Standards Web site at http://www.dol.gov/olms/regs/compliance/EO13496.htm; or

(4) Reproduced and used as exact duplicate copies of the Department of Labor's official poster.

(c) The required text of the employee notice referred to in this clause is located at Appendix A, Subpart A, 29

CFR Part 471.

(d) The Contractor shall comply with all provisions of the employee notice and related rules, regulations, and orders of the Secretary of Labor.

(e) In the event that the Contractor does not comply with the requirements set forth in paragraphs (a) through (d) of this clause, this contract may be terminated or suspended in whole or in part, and the Contractor may be suspended or debarred in accordance with 29 CFR 471.14 and subpart 9.4. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 471, which implements Executive Order 13496 or as otherwise provided by law.

(f) Subcontracts. (1) The Contractor shall include the substance of this clause, including this paragraph (f), in every subcontract that exceeds $10,000 and will be performed wholly or partially in the United States, unless exempted by the rules, regulations, or orders of the Secretary of Labor issued pursuant to section 3 of Executive

Order 13496 of January 30, 2009, so that such provisions will be binding upon each subcontractor.

(2) The Contractor shall not procure supplies or services in a way designed to avoid the applicability of Executive

Order 13496 or this clause.

(3) The Contractor shall take such action with respect to any such subcontract as may be directed by the Secretary of

Labor as a means of enforcing such provisions, including the imposition of sanctions for noncompliance.

(4) However, if the Contractor becomes involved in litigation with a subcontractor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United States, through the Secretary of

Labor, to enter into such litigation to protect the interests of the United States.

(End of clause)

52.232-25 -- Prompt Payment (Jul 2013)

(a) Invoice payments—

(5) Computing penalty amount. The Government will compute the interest penalty in accordance with the

Office of Management and Budget prompt payment regulations at 5 CFR part 1315.

(i) For the sole purpose of computing an interest penalty that might be due the Contractor, Government acceptance is deemed to occur constructively on the 15th day (unless otherwise specified in this contract) after the Contractor delivers the supplies or performs the services in accordance with the terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor compliance with a contract provision. If actual acceptance occurs within the constructive acceptance period, the Government will base the determination of an interest penalty on the actual date of acceptance. The constructive acceptance requirement does not, however, compel Government officials to accept supplies or services, perform contract administration functions, or make payment prior to fulfilling their responsibilities.

52.252-2 -- Clauses Incorporated By Reference (Feb 1998)

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

Regulations URLs: (Click on the appropriate regulation.)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

NOTE: After selecting the appropriate regulation above, at the "Table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference

(hyperlink).

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any HHSAR FAR Supplement (48 CFR Chapter 3) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause) http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

INVOICE REQUIREMENTS

1) One invoice for upon acceptance of the supplies or warranty

2) Itemized for supplies delivered

3) Total for entire invoice

A. The contractor shall submit the original and a copy of the invoices concurrently as follows:

a. An original mailed to the following designated payment office:

National Institutes of Health

Office of Financial Management

Commercial Accounts, Room 4B-432

2115 East Jefferson Street MSC 8500

Bethesda, Maryland 20892-8500

b. One copy e-mailed to the Contracting Officer’s Representative at:

National Institutes of Health

Department of Pharmacy

10 Center Dr, MSC 1196

Building 10, Room 1C166

Bethesda, Maryland 20892

Email: RDeCederfelt@mail.cc.nih.gov

(End of Addendum to 52.212-4)

PROVISIONS INCORPORATED BY REFERENCE

INSTRUCTIONS TO OFFERORS:

Addendum to FAR 52.212-1, Acceptance of Terms and Conditions

This is an Open-Market Combined Synopsis/Solicitation for equipment as defined herein. Offers will be reviewed exclusively based upon information submitted. If the information submitted does not address all the technical characteristics required in this combined solicitation-synopsis, the offer will be rejected. The Government intends to award a Fixed Price Contract as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL offers shall include a statement regarding the terms and conditions herein as follows:

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

OR

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included

In the award document with the exception, deletion, or addition of the following:

Offeror shall list exception(s) and rationale for the exception(s)

52.212-1 Instructions to Offerors--Commercial Items FEB 2016 mailto:RDeCederfelt@mail.cc.nih.gov

Please note that this procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits an offer based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Contract, not the terms and conditions of the offeror’s FSS or GWAC contract, and the statement required above shall be included in the offer.

(End of Addendum to FAR 52.212-1)

Addendum to FAR 52.212-1, Proposal Preparation Instructions

FAR 52.212-1 is hereby amended to reflect the changes shown below as to the specific paragraph revised.

Paragraph (b) Submission of Offers. The following amends this paragraph with respect to the information and documents required for submission in response to this solicitation.

(1) ELECTRONIC OFFERS. The offeror shall submit electronic offers in response to this solicitation unless otherwise specified herein. The offer must arrive by the time specified in the solicitation to the following email address: Lisa.Schaupp@nih.gov .

(2) PROCESS FOR AWARD. Award will be made to the Best Value Offeror consistent with the evaluation criteria discussed at FAR 52.212-2 and Addendum to FAR 52.212-2.

(3) BASIS FOR AWARD. Award will be made to the offeror that proposes: a technical proposal conforming to the requirements of the solicitation; has an acceptable record of past performance; its price is determined to be fair and reasonable by the contracting officer; and the contracting officer determines the offeror is responsible in accordance with FAR Part 9. The Contracting Officer intends to award without discussions, but reserves the right to do so in his or her sole discretion.

(4) The Government may reject a proposal if it is found that any information that has a negative impact on the offeror's past performance record has been deleted, misrepresented, or withheld.

(5) Offers shall remain valid for a period of 90 days from the date offers are due.

(6) Quotation shall include Certifications and Representations, Technical, Past Performance, and Price as separate parts in the submission.

CERTIFICATIONS & REPRESENTATIONS:

Provide pricing for each Contract Line Item Numbers (CLINS).

52.212-3 - Offeror Representations and Certifications -- Commercial Items(NOV 2015)

Valid ISO Certification and/or FDA Registration

QUOTATION COMPOSITION:

PART I: TECHNICAL

TECHNICAL CAPABILITY - The offeror shall provide sufficient information to demonstrate its understanding of the requirements, providing a concise, detailed, and thorough discussion of its technical capability to successfully provide the services as required in this solicitation.

The offeror shall submit with their proposal:

Certificate of compliance with all applicalble US electrical and associated safety and health code requirements for requested equipment.

mailto:Lisa.Schaupp@nih.gov

Sample GMP IQ/OQ validation report and a software validation test report

List of Tasks Contractor shall perform during the service of each Shimadzu Instrument.

Submissions shall meet at least, the criteria described in the Scope of Work above.

PART II: PAST PERFORMANCE.

Offerors shall submit past performance information on at least two (2) but not more than four (4) recent and relevant contracts (within the past three years from the date of the solicitation). If more than four contract references are submitted, only the first four will be evaluated. References may include performance on contracts for Federal, State and local Governments as well as private commercial firms of similar size and scope.

Section 1 – Contract Description Information:

Offeror’s CAGE Code and DUNS Number. Point of Contact (POC) (name, and current address, e-mail address, and telephone and fax numbers). Contracting activity/Administration and current address, Contracting Officer or

Technical Representative Name, e-mail address, telephone and fax numbers. Contract Number and, in the case of

Indefinite Delivery type contracts, GSA contracts, and Blanket Purchase Agreements, include Delivery Order

Numbers also; Awarded price; Final or projected final price; Original/Final delivery schedule, including dates of start and completion of delivery.

Section 2 – Performance (See FAR Provision 52.212-2 Addendum Government intends to evaluate.)

Offerors shall provide a specific narrative explanation of each contract listed in Section 1 above describing recency and relevancy of the requirements in this solicitation.

For any contracts that did not/do not meet original schedule or technical performance requirements, provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. The

Offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

PART III: PRICE.

Offerors shall provide pricing for all item/s specified on each Contract Line Item Number (CLIN) of the solicitation.

Para (g) Contract award. This paragraph is amended to state that the Government may conduct discussions prior to contract award.

Para (j) Data Universal Numbering System (DUNS)/CAGE Code. This paragraph is amended to state that the offeror shall obtain these Codes and include them in the proposal and confirm Registration in System for Award

Management and the Online Representations and Certifications, if you are a US firm. Award cannot and shall not be made to an offeror without these codes.

Para (m) Proposal Preparation Costs. This solicitation does not commit the Government to pay any costs incurred in the submission of an offer, in making any necessary studies for the preparation thereof, or for any visit(s) the

Contracting Officer may request for the purpose of clarification of the offer.

Para (n) The offeror is responsible for ensuring that its proposal is complete. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of any stated claims.

The proposal shall not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to perform the requirement. The offeror shall assume that the

Government has no prior knowledge of their experience and will base its evaluation solely on the information presented in the offeror's proposal.

Para (o) Protests received at a level higher than the contracting officer will be referred to the contracting officer.

Protestor may request a review by the contracting officer or an independent review at a level higher than the contracting officer. Requests for appeals or independent review will be addressed to the contracting officer for referral to the review authority. Questions on this process will be referred to the cognizant contracting officer identified in the solicitation.

Para (p) The non-FAR Part 12 discretionary FAR, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Addendum to FAR 52.212-1)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: See Addendum to 52.212-2

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

ADDENDUM TO 52.212-2

Paragraph (a) is hereby supplemented with the following:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Award will be made using the best value source selection process.

Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate the proposal and award a contract without discussions.

In the evaluation of all Offerors’ proposals, appropriate consideration is given to three (3) evaluation factors:

Technical, Past Performance and Price are in descending order of importance. Technical is more important than past performance. Technical and Past Performance, when combined, are significantly more important than Price. The importance of price in the evaluation will increase with the degree of equality among quotations of the non-price factors.

To receive consideration for award, a rating of no less than “ACCEPTABLE” must be achieved for the technical capability evaluation factor. For Past Performance, the offeror must receive a rating of no less than

‘SATISFACTORY confidence’ to be considered for award. However, offerors which receive an unknown

(neutral) past performance rating will be considered for award.

Questions may be sent to Lisa.Schaupp@nih.gov until 5:00 p.m. Eastern Time March 9, 2016. Responses to

Questions will be posted by 5:00 p.m. March 9, 2016.

EVALUATION FACTORS -- THE FOLLOWING FACTORS WILL BE EVALUATED:

PART I: TECHNICAL

Technical Capability reflects the Government’s confidence in the offeror’s ability, as demonstrated in its proposal, to supply brand name items or the equivalent of the items requested, and to perform the requirements as stated in the

Statement of Work in this Solicitation.

The following adjectival ratings will be used in evaluating each offeror’s technical proposal.

Color Rating Description

Blue Outstanding

Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses. Risk of unsuccessful performance is very low.

Purple Good

Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

Green Acceptable

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

Yellow Marginal

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths. Risk of unsuccessful performance is high.

Red Unacceptable Proposal does not meet requirements and contains one or more deficiencies. Proposal is un-awardable.

PART II: PAST PERFORMANCE

The past performance evaluation results is an assessment of the offeror’s probability of meeting the minimum past performance solicitation requirements. This assessment is based on the offeror’s record of relevant and recent past performance information that pertain to the products and/or services outlined in the solicitation requirements.

Offerors are cautioned that in conducting present and past performance evaluations, the Government may use data provided in the offeror's proposal, any other source available to the Government and data obtained from other sources to include, but not limited, to data independently obtained from other Government and commercial sources.

After the Government has evaluated Offerors’ past performance for recency and relevancy, the Government will evaluate Quality of Performance (how well the contractor has performed on contracts).

The Government will assign an Unknown /Neutral rating, meaning the rating is treated neither favorably nor unfavorably, to Offerors with no recent/relevant past performance record or the offeror’s performance record is not mailto:Lisa.Schaupp@nih.gov available or the information is inadequate such that no meaningful confidence assessment rating can be reasonably assigned.

In this context:

“Offeror” refers to the proposed prime contractor and all proposed major subcontractors or team members. A major subcontractor or team member is defined as one who will be providing at least 25 percent of the contract effort. In either case, the contract or delivery order of the proposed prime contractor and proposed major subcontractors will be assessed individually and the results will then be assessed in their totality to derive the prime offeror’s past performance rating. The Government may consider the offeror’s past performance as an entire team including subcontractors, joint ventures and/or teaming partners, aggregately, rather than an individual contractor basis.

“Recency” - To be recent, the performance effort must have occurred within 3 years from the date of issuance of this solicitation.

“Relevancy” – Relevant performance includes products or services that are the same or similar in scope, magnitude and complexity to the effort described in the solicitation.

The following ratings shall be used in assessing an offeror’s Past Performance Relevancy

Rating Description

Very Relevant Present/past performance effort involved essentially the same scope and magnitude of effort and complexities this solicitation requires.

Relevant Present/past performance effort involved similar scope and magnitude of effort and complexities this solicitation requires.

Somewhat Relevant Present/past performance effort involved some of the scope and Magnitude of effort and complexities this solicitation requires.

Not Relevant

Present/past performance effort involved little or none of the scope and magnitude of effort and complexities this solicitation requires.

The following ratings shall be used for the Performance Confidence Assessment.

Performance Confidence

Assessments

Rating Description

Substantial Confidence Based on the offeror’s recent/relevant performance record, the Government has a high expectation that the offeror will successfully perform the required effort.

Satisfactory Confidence Based on the offeror’s recent/relevant performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort.

Limited Confidence Based on the offeror’s recent/relevant performance record, the Government has a low expectation that the offeror will successfully perform the required effort.

No Confidence Based on the offeror’s recent/relevant performance record, the Government has no expectation that the offeror will be able to successfully perform the required effort.

Unknown Confidence (Neutral) No recent/relevant performance record is available or the offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned.

Note: In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror may not be evaluated favorably or unfavorably on past performance (see FAR 15.305 (a)(2)(iv)). Therefore, the offeror shall be determined to have “unknown” past performance and their performance confidence assessment rating will be “unknown confidence (neutral).”

PART III: PRICE

Price will be evaluated separately from the technical and past performance factors and will be evaluated for fairness and reasonability in terms of the Government’s requirement.

(End of Addendum)

52.212-3 -- OFFEROR REPRESENTATIONS AND CERTIFICATIONS-Commercial Items (NOV 2015)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.acquisition.gov . If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (p) of this provision.

(a) Definitions. As used in this provision—

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

http://www.acquisition.gov/

“Inverted domestic corporation,” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the

Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian…