SOURCES SOUGHT
Q -- Yucatan Minipig NRTN gene therapy
- Notice Date
- 4/21/2016
- Notice Type
- Sources Sought
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-DE-2016-120-KEW
- Archive Date
- 5/17/2016
- Point of Contact
- Kyle Wisor, Phone: 3014023670, Rashida Ferebee,
- E-Mail Address
-
Kyle.Wisor@nih.gov,
(Kyle.Wisor@nih.gov, ontract)
- Small Business Set-Aside
- N/A
- Description
- A. Sources Sought Notice: NHLBI-CSB-DE-2016-120-KEW B. Title: Yucatan Minipig NRTN gene therapy C. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and (2) their size classification relative to the North American Industry Classification System (NAICS) code 622110 for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method. All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Kyle Wisor, Contract Specialist, at kyle.wisor@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by May 2, 2016, 9:00 AM, EASTERN TIME under Solicitation Number: NHLBI-CSB-DE-2016-120-KEW. FAXES ARE NOT ACCEPTED D. Information: 1. 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. 2. 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.   3. Project Requirements 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. Anticipated Period of Performance Base Year: May 18, 2016 - May 17, 2017 1. Capability Statement Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: a. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. b. Information as needed in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. c. The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc) pursuant to the North American Industry Classification System (NAICS) code: 622110, General Medical and Surgical Hospitals, Small Business Size $38.5 Million. d. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. e. The capability statement shall not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. f. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 2. Closing Statement All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Kyle Wisor, Contract Specialist, at kyle.wisor@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by May 2, 9:00 AM, EASTERN TIME under Solicitation Number: NHLBI-CSB-DE-2016-120-KEW. FAXES ARE NOT ACCEPTED. This Sources Sought Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
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