This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made because of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background / Purpose / Objective: The National Institute on Aging (NIA) require assay development karyotyping services to provide genetically engineered iPSCs for the purpose of creating a national cell repository as an open resource for the scientific community and as a tool to characterize how mutations change fundamental biological properties of disease-relevant cell types. Neurodegenerative diseases are common, debilitating, and often untreatable. It is known that mutations in ~50 genes cause the majority of inherited forms of Alzheimer's disease and related dementias (ADRD). In addition, some ADRD genes function together to regulate key cellular processes, strongly suggesting the presence of converging disease mechanisms in ADRD. Genetically-defined patient cohorts now exist and are growing, setting the stage for future precision medicine trials. However, in order to develop effective targeted therapies for these defined cohorts, we need a deeper mechanistic understanding of how individual gene mutations cause disease. In addition, we need to systematically identify and characterize converging ADRD disease pathways, which may be ideal drug targets because single drugs could be effective in patients with mutations in different, but functionally related, genes. To aid in this effort, we require the creation of isogneic panels of genome-engineered human iPSC lines harboring mutations associated with neurodegenerative diseases.

Project Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the specific requirements below.

Specific Requirements: (1) Cell culture and prep for dGH assay for 16 cell lines; (2) Assay, imaging, and scoring for human dosimetry for 16 samples, with 3 processed images per sample; and (3) transfer of original image files.

The platform used must provide: (1) Repeated karyotype analysis of cells in culture at various time, e.g. following low-density cell expansion that would mimic changes post genome editing/clonal outgrowth; (2) Chromosomal preparation technique that includes analog nucleotide incorporation during the DNA replication phase of the cell cycle to enable exonuclease daughter strand degradation that leaves dGH prepped chromosomes single-stranded; (3) For metaphase chromosomes, assay must be capable of providing sequence, location and orientation information in a single assay; (4) Enable inversion detection with a resolution that is orders of magnitude greater than any competing technique; (5) Query entire chromosomes or individual chromatids (single-stranded applications) in interphase or metaphase cells; and (6) In a single assay, must detect the broadest possible spectrum of chromosome rearrangements, including those assayable by standard FISH technologies (e.g. translocations between chromosomes) as well as intra-chromosomal rearrangements such as cryptic inversions

Key Personnel: The contractor shall designate a project manager as a contact point for Government's Contracting Officer's Representative.

Government Responsibilities: The government will provide iPSC starting material to vendor.

Delivery or Deliverables: The contractor shall delivery assay results for: (1) Cell culture and prep for dGH assay for 16 cell lines; and (2) Assay, imaging, and scoring for human dosimetry for 16 samples.

Reporting Requirements: The contractor is required to provide documentation regarding assay results for: (1) General method of Cell culture and prep for dGH assay for 16 cell lines; and (2) Assay, imaging, and scoring for human dosimetry for 16 samples
Assay, imaging, and scoring for human dosimetry for 16 samples electronically via reporting transfer through email to the Government's Contracting Officer's Representative.

Data Rights: The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Technical Criteria: Factor 1: Technical Approach. The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the efforts to be performed and the skill level required to perform them. Factor 2: Past Performance: The Contractor shall provide details of at least one prior project on similar in nature to the project specification outlined herein. Past Performance shall be evaluated for relevance to the current requirement.

Anticipated period of performance / delivery date: The Government anticipates the month of award is September 2019 for a 2-month period of performance.

Other important considerations: The response may cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition.

Capability statement /information sought. The government is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this effort. At a minimum, respondents to this notice must provide, as part of their response, a capability statement to include the following: (1) information regarding 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 a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (3) any other information that may be helpful in developing or finalizing the acquisition requirement.

INFORMATION SUBMISSION INSTRUCTIONS:
Respondents should provide responses accordingly: (1) submit information electronically. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) pages including references; (5) DUNS number; (6) respondents must send via email to Debra C. Hawkins Contractor, Acquisition Policy Analyst II, at [email protected]; (7) responses should be received no later than August 16, 2019, 12:00 Noon Eastern Time; and (8) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

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 provide the product or perform the services specified herein. 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 presolicitation 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).