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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 30, 2019 FBO #6397
SOURCES SOUGHT

B -- Production of Bacteriophage for Clinical Trial

Notice Date

5/28/2019
 

Notice Type

Synopsis
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Office of Acquisitions 5601 Fishers Lane 3rd Floor, MSC 9821 Bethesda MD 20892
 

ZIP Code

20892
 

Solicitation Number

75N93019Q00002
 

Response Due

6/12/2019
 

Point of Contact

Jason Alexander Aroz, Contract Specialist, Phone 301-761-7468, - George Kennedy, Contracting Officer, Phone 240-669-5170
 

E-Mail Address

Jason.Aroz@nih.gov, kennedyg@mail.nih.gov
 

Small Business Set-Aside

N/A
 

Description

INTRODUCTION/SYNOPSIS This is a Small Business Sources Sought notice. 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 small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. BACKGROUND This National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) project involves the production of bacteriophages (phages) for use in a clinical trial. NIAID is intrigued by the recent use of phages in clinical settings. To date the clinical use of phages has been limited to eIND or compassionate use cases making it difficult if not impossible to make definitive conclusions regarding their clinical efficacy. Therefore, NIAID is seeking to promote efficacy testing of phages in controlled clinical trials. PURPOSE AND OBJECTIVES The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. The objective of this acquisition is to produce 2 X 1012 plaque forming units (PFUs) of phages suitable for use in a Phase 2 clinical trial. NIAID seeks an agency with the capability to produce high titer phage preparations which are ready to be used in a clinical trial. PROJECT REQUIREMENTS The NIAID intends to solicit proposals to produce 2 X 1012 PFUs of five different phages with the ability to kill Pseudomonas aeruginosa strains. Of critical importance is prior experience in the production of phage for use in clinical settings. Note the phages and the bacterial strains they will be grown in have already been identified. NIAID will arrange for them to be delivered to the site where the phage will be produced. CAPABILITY STATEMENT/INFORMATION SOUGHT Sources are expected to have the expertise, personnel, and facilities to meet the requirements of this project. Tailored Capability Statements submitted in response to this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas: - Knowledge of FDA requirements to produce phages for use in a clinical trial. - Demonstrated ability to produce phages for FDA approved clinical use at titers required for this study. HOW TO SUBMIT A RESPONSE / PAGE LIMITATIONS Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five pages, excluding resumes, describing the company's experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) a general description of the facilities and other resources needed to perform the work. Tailored capability 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. REQUIRED BUSINESS INFORMATION - DUNS; - Company Name; - Company Address; - Company Point of Contact, Phone and E-mail address; - Current GSA Schedules appropriate to this Sources Sought; - Small Business Status. NUMBER OF COPIES AND DELIVERY POINT Please submit one (1) electronic copy of your response to the following e-mail address: Jason Aroz jason.aroz@nih.gov 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 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). NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (28-MAY-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link To Document
(https://www.fbo.gov/spg/HHS/NIH/NIAID/75N93019Q00002/listing.html)
 

Place of Performance

Address: Office of Acquisitions DEA, NIAID, NIH, HHS 5601 Fishers Lane 3rd Floor, MSC 9821 Bethesda, MD

Zip Code: 20892

Country: US
 

Record

SN05323574-F 20190530/190528230017 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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