Synopsis-Solicitation Req 1104848 120705.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1104848. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-58 dated 18 May, 2012.

The associated North American Industry Classification System (NAICS) Code is- 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This requirement is 100% set-aside for small businesses.

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Laboratory of Pediatric & Respiratory Viral Diseases in the Division of Viral Products requires two virus counters.

The virus counters are to be used in Laboratory of Pediatric & Respiratory Viral Diseases in the Division of Viral Products.

Minimum Performance Specifications The system shall meet or exceed the following performance specifications:

1. Virus Counter shall be able to count viruses larger than 25 nanometers

2. Exterior size shall be less than 18” long, 18” wide and 12” high

3. The virus counters shall be small enough to fit on a regular laboratory bench and in a biological safety hood when highly pathogenic virus are counted.

4. Minimum electrical requirements of 115V, 60Hz

5. The electronic components shall be shielded to provide protection against potential spills.

6. Shall be capable of measuring protein and nucleic acid concentration separately

7. Staining of protein and nucleic acid shall be simple to conduct, require no more than 1 step and take no more than 30 min to complete; a kit is preferred for ease of use and training requirements. Shall not require antibodies.

8. Shall provide results in clear, concise terms, without the need for additional data manipulations.

9. Shall not require more than 500 ul of sample.

10. Instrument shall be capable of limiting and measuring contamination between samples.

11. The counters shall be capable of measuring the number of influenza virus particles from different types of preparations.

12. System shall include a minimum one year manufacturer warranty.

13. Contractor shall provide on-site user training for 3-5 Government users within 2 weeks of delivery.

Post-Warranty Service Agreement While not required, the Government is interested in extended warranties and/or preventative maintenance services for the system. These warranties or services would be provided by the Contractor and would become effective upon expiration of the initial manufacturer warranty. The vendor’s quote shall state whether or not such services are available. If they are available shall include details regarding what types of services/coverages are included in the vendor’s offered price. There are no minimum requirements pertaining to the post-warranty service agreement, but the following are services that are commonly included in vendor quotes for preventative maintenance. Again, this list of commonly included services below is for reference only. The onus is on the Contractor to tell the Government what its extended warranty/PM services include and at what price. The price and services offered in the vendor’s extended warranty/PM services plans shall be considered when the Government makes its award decision based on a best value determination.

· Minimum of one (1) Preventative Maintenance visit per contract year;

· Unlimited on-site preventative maintenance, services, and repairs when necessary;

· Peak performance maintenance kits;

· Software updates as new versions are released;

· Preventative maintenance services, and repairs performed by an OEM trained and certified technician;

· Preventative maintenance, services, and repairs include all labor, travel, and new OEM factory-certified replacement parts, components, subassemblies, etc. (except consumables);

· Unlimited Priority Telephone and Email Support during regular business hours (8 a.m. to 5:00 p.m. Eastern Time, Monday through Friday);

· Priority scheduling for requests for service within 24 hrs;

· Adherence to and conformity with OEM specifications, manuals, bulletins, etc. in performing all preventative maintenance, services, and repairs FOB Point Destination. To be delivered, installed, and on-site training no later than 90 calendar days after receipt of order (ARO) FOB Point of Delivery for Services and Supplies is:

CBER/FDA HFM 445

Bldg 29A, Room 1B11

8800 Rockville Pike

Bethesda, MD 20892

Period of Performance Note: Service period start/end dates are contingent upon actual delivery, installation, training and the Government’s final acceptance of the instrument.

The estimated dates could potentially be as follows:

Award of contract- 7/20/12 Instrument delivered, installed, on-site training conducted, Government accepted at 90 calendar days ARO 10/20/12.

Minimum initial one year warranty would end on 10/19/13.

Subsequent option years for the PM service shall commence the day after the previous period’s coverage expires.

Option year 1: 20 October, 2013 through 19 October, 2014.

Option year 2: 20 October, 2014 through 19 October, 2015.

Option year 3: 20 October, 2015 through 19 October, 2016.

Option year 4: 20 October, 2016 through 19 October, 2017.

Actual dates are contingent upon the date of Government acceptance. Dates listed above are estimates only and actual dates for all four option years will be updated and formally documented in the contract award file via a contract modification when the first option period is exercised.

Preventative maintenance and repair visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV Federal holidays are as follows:

New Year’s Day

Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veteran’s Day

Thanksgiving Day

Christmas Day

Schedule of Items:

1. Qty TWO (2) Virus Counter Systems to include inside delivery, installation, on-site training as specified above, and a minimum of one year warranty for the fixed price of $_____________.

2. Option Year 1:– Extended Warranty and/or PM Service agreement as described in the vendor’s quote. For the various services and/or coverage that the Contractor shall provide, the Government will pay the contractor the fixed price of $____________.

3. Option Year 2:– Extended Warranty and/or PM Service agreement as described in the vendor’s quote. For the various services and/or coverage that the Contractor shall provide, the Government will pay the contractor the fixed price of $____________.

4. Option Year 3:– Extended Warranty and/or PM Service agreement as described in the vendor’s quote. For the various services and/or coverage that the Contractor shall provide, the Government will pay the contractor the fixed price of $____________.

5. Option Year 4:– Extended Warranty and/or PM Service agreement as described in the vendor’s quote. For the various services and/or coverage that the Contractor shall provide, the Government will pay the contractor the fixed price of $____________.

Contract clauses- The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been added to the clause.

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer’s representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

Other Terms and Conditions

Maintenance and Repair

All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/

The following FAR and HHSAR clauses, incorporated by reference, and apply to this acquisition.

FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper.(MAY 2011)

FAR Clause 52.204-7 Central Contractor Registration. (FEB 2012) FAR Clause 52.225-8 Duty-Free Entry. (OCT 2010)

FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) … within 1 day of contract expiration; …. at least 15 days before the contract expires...

(c) …shall not exceed 5 years.

The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm HHSAR Clause 352.202-1 Definitions

JAN 2006

HHSAR Clause 352.203-70 Anti-Lobbying

JAN 2006

HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

OCT 2009

HHSAR Clause 352.223-70 Safety and Health

JAN 2006

HHSAR Clause 352.231-71 Pricing of Adjustments

JAN 2001

HHSAR Clause 352.242-71 Tobacco-Free Facilities

JAN 2006

Contract Administration

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 any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

The Contracting Officer for this order is:

Aaron A. Glazier, Contracting Officer

3900 NCTR Rd

HFT-320

Jefferson, AR. 72079

Phone: (870) 543-7577

Email: aaron.glazier@fda.hhs.gov The COR is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

The COR for this order is: to be completed at time of award.

Invoice Submission

I. An original and two (2) copies shall be submitted to:

FDA/OC/OA/OFO/OFS

Attn: Division of Payment Services

3900 NCTR Road, HFT-324

Building 50, 6th floor, suite 616

Jefferson, AR 72079 Phone: (870) 543-7446

Fax 870-543-7224

An electronic invoice can be emailed to the following address:

nctrinvoices@fda.hhs.gov II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

To be completed at time of award.

Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above.

Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov.

The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAY 2012) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 Alt I, 52.204-10, 52.209-6, 52.209-10, 52.219-6, 52.219-8, 52.219-14, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-40, 52.223-18, 52.225-3, 52.225-13, and 52.232-33.

Solicitation provisions

Contract Type: Commercial Item-Firm Fixed Price.

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been added to this provision:

Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012.

The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

(i) Technical capability of the items/services offered to meet or exceed the Government’s requirement.

(ii) Past Performance

(iii) Price.

Technical and Past Performance, when combined, are approximately equal to price in determining the best value to the government. If the Government determines technical proposals to be essentially equal, price becomes more important as the discriminating factor.

Technical capability will be determined by review of information submitted by the offeror which shall provide sufficient technical information necessary for the Government to conclusively determine that the proposed system meets the technical requirements identified above. Offerors shall specifically address each performance requirements stated above to demonstrate that the proposal meets the technical requirements. Offerors may provide technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror.

Past Performance

Provide a list of prior transactions that demonstrate selling and servicing of like equipment and provide contact information for at least two references that can be contacted to verify that the contractor has provided similar services within the last two years. For each project, please include a thorough description of the project, and the name, telephone number, email address of someone who has knowledge of the project and would be available to answer any follow-up questions the Government may have.

The government is not responsible for locating or securing any information, which is not identified in the proposal, however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Please include the firm’s DUNS number with quote.

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).

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.

The government reserves the right to make an award without discussions.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2012), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov.

It is the offeror's responsibility to monitor https://www.fbo.gov for the release of any information related to this acquisition, e.g., questions and answers, amendments, award notice, etc.

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

All responsible sources may submit an offer, which if timely received, shall be considered. The offer shall reference solicitation number 1104848. The offers are due in person, by postal mail or email to the point of contact listed below on or before 17 July, 2012 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS, Attn: Aaron A. Glazier, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502.

For information regarding this solicitation, please contact Aaron Glazier at (870) 543-7577, FAX (870) 543-7990 or email aaron.glazier@fda.hhs.gov.