SOLICITATION NOTICE
B -- A replication effort to evaluate a therapeutic approach to Alzheimer’s disease using a synthetic peptide rescuing AD phenotypes in a transgenic mouse model - Statement of Work
- Notice Date
- 9/10/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-(SSSA)-14-721
- Archive Date
- 10/7/2014
- Point of Contact
- Andriani Buck, Phone: 3014021677
- E-Mail Address
-
andriani.buck@nih.gov
(andriani.buck@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOW and Evaluation Criteria COMBINED SYNOPSIS / SOLICITATION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HHS-NIH-NIDA-(SSSA)-14-721 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-76 effective August 25, 2014. This acquisition is unrestricted. The associated NAICS code 541380 and the small business size standard $15.0. STATEMENT OF OBJECTIVES The Contractor shall undertake a replication effort as described in the Shukla et al. publication in an attempt to corroborate the findings espoused in this paper. This combined solicitation/synopsis, the Statement of Work, and the Shukla et al paper provide detailed guidance to enable an Independent Contractor to replicate the methods used in the published study. Title: A replication effort to evaluate a therapeutic approach to Alzheimer's disease using a synthetic peptide rescuing AD phenotypes in a transgenic mouse model CONTRACTOR REQUIREMENTS Scope of Work Neurodegenerative disorders leading to dementia, such as Alzheimer's disease (AD) are chronic, long term processes resulting from an accumulation of various lesions and insults to the brain. Investigators at The National Institute of Neurological Disorders and Stroke (NINDS) of the National Institute of Health (NIH) reported a therapeutic approach to neurodegenerative disorders such as AD using a truncated peptide derived from the cyclin-dependent kinase 5 (Cdk5) activator P35, which specifically inhibits the deregulation activity of Cdk5, thereby rescuing the cortical neuronal phenotypes responsible for neuronal damage in AD model mice. A transgenic mouse model (5XFAD) was used for this study since the brains of these mice display the hallmark AD tau and Aβ pathology accompanied by significant behavioral defects. Age-matched wild-type (WT) mice were identified by genotyping and used as a control group. These results were published by Shukla, V et al: A truncated peptide from p35, a Cdk5 activator, prevents Alzheimer's disease phenotypes in model mice. FASEB J. 27, 174 186 (2013). The Contractor shall undertake a replication effort as described in the Shukla et al. publication in an attempt to corroborate the findings espoused in this paper. There are two components to the replication effort and they are: 1) preliminary phenotypic characterization, and 2) assessment of TFP5 effects. Both components will be performed in 5XFAD mice in accordance with the protocol previously used by the NINDS. The Shukla et al paper is hereby incorporated and made an operational addendum to this Statement of Work. This SOW and the Shukla et al paper provide detailed guidance to enable an independent Contractor to replicate the methods used in the published study. The published results indicated that a modified truncated 24 amino acid custom synthesized peptide (TFP5), derived from the Cdk5 activator p35, when injected intraperitoneally (i.p.) in 5XFAD mice: a)Penetrates the blood-brain barrier b)Inhibits abnormal Cdk5 hyperactivity c)Rescues AD pathology d)Rescues behavior These observations were absent in control groups of mice injected with either saline or a scrambled peptide. Rigorous replication methods including randomization of animals and blinding of evaluators (where possible) shall be employed. The outcome measures will be compared descriptively between the 5XFAD and wild type mice, and to historical data for 5XFAD and wild type mice available from NINDS. General Requirements Applicable to the Replication Effort: a)Good laboratory practices (GLP) None of the proposed experiments require performance under GLP guidelines. b)Replication Rigor All animal and laboratory experiments performed under this contract must follow, without exception, the methods as expounded herein, and as published in the Shukla et al paper. c)Use of Live Vertebrate Animals Performance of work under this contract shall involve the use of live vertebrate animals, and the Contractor shall be required to adhere to and comply with the current Public Health Service Policy on Humane Care and Use of Laboratory Animals. Government-furnished Property: a)TFP5 and Control Compound The NINDS shall be responsible for providing the required quantities of the TFP5 compound and scrambled control peptide to be used in the replication effort under this contract. The term TFP5 denotes a 24 amino acid sequence which is a truncated fragment of the p35 modulator of CDK5 conjugated at the C terminus to a transactivator of transcription (TAT) and at the N terminus to a FITC label. The proposed study in 5XFAD mice must be performed with a single batch of TFP5 and scrambled control, which might consist of single or pooled manufacturing lots. The NINDS shall be responsible for providing Instructions and Guidance regarding handling, storage and shipping conditions associated with these compounds. b)Animal Strain The NINDS shall be responsible for providing the required quantities of the 5XFAD mouse model necessary for the replication effort under this contract. The NINDS shall be responsible for facilitating access to the 5XFAD mouse model. It is expected that the NINDS shall arrange drop shipment of the mouse model to the Contractor's facility. All animal testing will be performed in 12 month old 5XFAD mice (MMRRC#034840-Jax). These 5XFAD mice were used in the original study because they recapitulate many of the hallmarks of Alzheimer Disease including cognitive deficits, phosphorylated tau and neurofilament accumulation in the brain, increased p25 expression and increased CDK5 activity. Wild type (WT) mice should be unaffected littermates of the 5XFAD mice. Both males and females will be included in approximately equal proportions. Acceptance Final acceptance shall be upon the final receipt of the results of the replication study that meet the aforementioned requirements and the requirements detailed in the attached Statement of Work. Please refer to the attached Statement of Work for further detail, specifications, specific requirements, and evaluation criteria. FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, with its offer. FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR clause 52.212.-2, Evaluation - Commercial Items, is applicable to this requirement. Offers will be evaluated on (1) the capability of the system quoted and whether it meets the essential features as specified in the statement of work; and (2) price. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by September 22, 2014, 8:00 am EST and must reference number HHS-NIH-NIDA-(SSSA)-14-721. Responses may be submitted electronically to andriani.buck@nih.gov or by U.S. mail to the National Institute of Drug Abuse (NIDA), Station Support / Simplified Acquisition Branch (SS/SA), 31 Center Drive, Building 31, Room 1B59, Bethesda, Maryland 20892-2080, Attention: Andriani Buck. Fax responses will be accepted at (301) 480-1358. Contact Andriani Buck at 301-402-1677 for information regarding the solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-(SSSA)-14-721/listing.html)
- Place of Performance
- Address: TBD, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03504862-W 20140912/140910235648-aa85cbe5914736067c72bfa29c3106f4 (fbodaily.com)
- Source
-
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