JA-N62645-15-D-5048_Redacted.pdf

LOG# 15-10193

TDP 15-029-15/PR N6264515RCES044 Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of about Twenty-nine (29) Naval Medical Treatment Facilities (MTFs).

2. Nature and/or description of the action.

The requirement is for neodymium-doped yttrium aluminum garnet, Dental Laser for about Twenty-nine

(29) Naval MTFs. The Government intends on awarding a Firm Fixed Price Indefinite Delivery

Indefinite Quantity (IDIQ) contract. The proposed source is Millennium Dental Technologies, Inc., 10945 S St Suite 104-A Cerritos, CA 90703.

3. Description of the supplies/services required.

The requirement is for an IDIQ contract for neodymium-doped yttrium aluminum garnet Dental Laser for various Naval Medical Treatment Facilities. The configurations listed below shall be available via this contracting vehicle.

Vendor shall provide laser systems to be used for periodontal therapeutic procedures to treat periodontal disease. The systems shall be approved for use with the Laser Assisted New Attachment Procedure

(LANAP) and the Laser Assisted Peri-Implant Procedure (LAPIP). The system shall be capable of preforming LANAP, LAPIP and soft tissue laser procedures. This laser system shall promote the regeneration of bone, periodontal ligament and cementum by the LANAP Protocol. The system shall capable of operating using Neodymium: Yttrium Aluminum Garnet (Nd: YAG) emitting a 1064 nm wavelength with variable pulse duration. The free running (RF) pulsed laser shall be capable of ablation of the sulcular epithelium in an infected periodontal pocket by generating high peak powers of at least

250 megawatts. Vendor shall also provide annual maintenance coverage for the laser system. The power requirement is 220V and 60Hz.

The system shall include Original Equipment Manufacturer (OEM) end user training to perform LANAP and LAPIP protocol while executing periodontal procedures. Vendor shall provide training for three members of the Navy Post Graduate Dental School (NPDS) to become Institute for Advanced Laser

Dentistry (IALD) Certified Instructors for the LANAP and LAPIP protocols. These individuals shall be capable of training NPDS residents such that they may become certified to use the LANAP/LAPIP protocols and the associated laser system.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the

FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the

TDP 15-029-15/PR N6264515RCES044 Page 2 of 4 1 Nov 12 facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

The minimum number of units that shall be ordered is 3. The maximum number of units that shall be ordered is 40. The total anticipated award value of this requirement during the five (5) year period is about

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC

2304(c)(1) and FAR 13.501(a), Sole Source Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996).

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Only Millennium Dental Technologies, Inc. can provide a neodymium-doped yttrium aluminum garnet laser dental laser approved for periodontal therapeutic treatment using the use for the LANAP/LAPIP procedures. No vendor other than Millennium Dental Technologies, Inc. provide dental laser, neodymium-doped yttrium aluminum garnet laser that is FDA approved for periodontal therapeutic treatment using the use for the LANAP/LAPIP procedures. No vendor other than Millennium Dental

Technologies, Inc. meets the minimum requirements of the Government.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202. The Government will evaluate any responses received.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted by technical experts in January 2015. This research consisted of reviews of previous procurements for these types of dental lasers, Nd: YAG and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA advantage and ECRI sourcebook catalog. No vendor other than Millennium

Dental Technologies, Inc. meets the minimum requirements of the Government.

9. Other facts supporting the use of other than full and open competition.

None

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10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact

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TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Phone Date

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and find this J & A to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000-$12.5M)