The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of The National Institute of Dental and Craniofacial Reseach (NIDCR) intends to negotiate and award a Purchase Order without providing for full and open competition (Including brand-name) to Allegheny Singer Research Institute for Yucatan Minipig NRTN gene therapy.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 622110, General Medical and Surgical Hospitals, with a Size Standard of $38.5M.

REGULATORY AUTHORITY
The resultant Purchase Order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-87 effective 06 APR 2016.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000).

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. FAR Subpart 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1), provides the authority to sole source. 

DESCRIPTION OF REQUIREMENT

Background
The National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting, supporting and making medical discoveries that improve people's health and save lives. The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to improve dental, oral, and craniofacial health through research, research training, and the dissemination of health information. In 2015, the NIDCR conducted a pilot study to use a nerve growth factor, AAV2-NRTN, in a gene therapy protocol in irradiated minipigs to repair salivary gland damage. Only one dose of the factor was used for the pilot study. Now, the NIDCR plans to test a range of doses of AAV2-NRTN (Cere120), in a large animal (Yucatan minipig) model of salivary gland irradiation damage.

Purpose and Objectives
The purpose of this acquisition is to procure services to study the effect of virus effects on minipig salivary glands. The objective is to confirm and extend the pilot study results showing the potential usefulness of NRTN gene therapy to repair salivary gland damage .

Period of Performance
Base Year: May 20th, 2016 - May 19th, 2017

Performance Location
On Contractor Location:
Gene Therapy Program
Allegheny Health Network
Room 841, South Tower
320 East North Avenue
Pittsburgh, PA 15212-4772

Project Description

Tasks:

1: The contractor shall provide five (5) groups of four (4), 20 total, Yucatan Minipigs and facilities to house the pigs for 100 days;

2: The contractor shall use the contralateral gland of the pig as a non-irradiated control. The right hand side parotid salivary glands will be cannulated and 3 ml AAV2-NRTN, AAV-control or buffer/gland will be infused into the gland. One week after AAV2-NRTNinfusion the right hand side parotid gland will be irradiated with a single dose of 15 Gy electron beam irradiation.
The 5 groups will be:
1) Non-IR + Buffer-control
2) IR + AAV-Control
3) IR + AAV-NRTN Dose 1
4) IR + AAV-NRTN Dose 2
5) IR + AAV-NRTN Dose 3;

3: The contractor shall measure the salivary flow at baseline, and 2 weeks after irradiation, concomitant with blood draws, up to 90 days after irradiation. Salivary flow will be measured after pilocarpine stimulation.

4: The contractor shall, at the end of the study period, take biopsies of the salivary glands, the lymph nodes in the head and neck, and other internal organs including the liver to measure virus levels and NRTN levels.

Reporting Requirements:

1: The contractor shall report (by email) the saliva flow results to NIDCR within 1 week of them being collected, to enable monitoring of the experimental outcome.

Contractor Requirements:

1: The contractor shall have an approved protocol from and Institutional Animal Care and Use Committee to conduct the research

2: The contractor shall have access to a Radiation Oncology Branch with expertise in irradiating pig salivary glands

3: The contractor shall have expertise in injecting viral vector into the duct of the salivary glands of pigs before irradiation

Government Requirements:

1: Post-experiment analyses including histological analysis, analysis of saliva and serum, alterations in gene expression, changes in protein expression will be conducted at the NIDCR after collection of all samples. Procedure details are to be included in an Animal Care and Use Committee protocol.

Other Important Considerations
1) The contractor must comply with Provision 352.270-5 Care of Laboratory Animals and the 352.270-5b Care of Live Vertebrate Animals Clause. Full text versions are attached.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION
Justification Rationale: Only one source is available: The determination by the Government to make a single-sole source is based upon the market research conducted as prescribed in FAR Part 10-showing that Allegheny Singer Research Institute is the only responsible source. This research project is an ongoing experiment since 2013 when Allegheny singer received an RO1 award to establish an irradiated minipig model at the institution. The institute in 2015 performed a study in which two (2) Yucatan MiniPigs received AAAV-NRTN and IR + AAV-NRTN Dose 3 to determain the protection provided to their salivarly glands from radiation. Since then, the NIDCR has performed a pilot study using one dose of an adeno-associated virus that produces NRTN (AAV-NRTN) to protect minipig salivary glands from irradiation damage. This requirement is a continuation of the experiment needed to conform and extend the results of the prior award and study showing the results of the unsefullness of NRTN gene therapy to repair salivary gland damage. To use a different lab would introduce variables in the research methods invalidating the prior work performed. Allegheny Singer is the only responsible source to continue this research, their lab is the only known lab that uses the experimental MiniPig Model and that has the unique expertise in using gene therapy to restore salivary function in minipigs after radiation.

CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by May 16th, 2016 9:00 AM EST and must reference number NHLBI-CSB-DE-2016-130-KEW. Responses may be submitted electronically to Kyle Wisor, [email protected], or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch,6701 Rockledge Drive, Suite 6150B, Bethesda, MD 20892-7902, Attention: Kyle Wisor. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."