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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 18, 2014 FBO #4619
SOURCES SOUGHT

B -- A replication effort to evaluate a therapeutic approach to Alzheimer’s disease

Notice Date

7/16/2014
 

Notice Type

Sources Sought
 

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-SBSS-2014-455
 

Archive Date

8/12/2014
 

Point of Contact

Brian Lind, Phone: 3014021635, Andriani Buck, Phone: 3014021677
 

E-Mail Address

lindbj@nida.nih.gov, andriani.buck@nih.gov
(lindbj@nida.nih.gov, andriani.buck@nih.gov)
 

Small Business Set-Aside

N/A
 

Description

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. 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 as a result 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: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) Surgical Neurology Branch (SNB) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The project is replication effort to evaluate a therapeutic approach to Alzheimer's disease (AD) using a synthetic peptide rescuing AD phenotypes in a transgenic mouse model. Neurodegenerative disorders leading to dementia, such as Alzheimer's disease 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). Purpose and 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 SSN and the Shukla et al paper provide detailed guidance to enable an Independent Contractor to replicate the methods used in the published study. Scope of Work: 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. The published results in the Shukla et al paper 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. 1. Shukla V(1), Zheng YL, Mishra SK, Amin ND, Steiner J, Grant P, Kesavapany S, Pant HC. A truncated peptide from p35, a Cdk5 activator, prevents Alzheimer's disease phenotypes in model mice. FASEB J. 2013 Jan;27(1):174-86. doi: 10.1096/fj.12-217497. 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. Capability statement /information sought. The respondent response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted, to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described. The respondent must also provide their 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 any other information that may be helpful in developing or finalizing the acquisition requirements. The information submitted must be must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (15) page limit. The 15-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically (facsimile responses are NOT accepted ) to: Brian J. Lind Contract Specialist NIH\NIDA\SSSA lindbj@nida.nih.gov and Andriani Buck Contract Specialist NIH/NIDA/SSSA Andriani.buck@nih.gov The response must be received on or before July 28, 2014, 10:00 AM (EST). 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 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).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-SBSS-2014-455/listing.html)
 

Place of Performance

Address: National Institutes of Health, National Institute of Neurological Disorders and Stroke, 31 Center Drive Building 31 1B59, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN03427979-W 20140718/140716235740-05b5f737f76fe121dff1920e33cbdedd (fbodaily.com)
 

Source

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

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