14-day dose range-finding in mice Tender in USA - 3261248

Procurement Summary

Country: USA

Summary: 14-day dose range-finding in mice

Deadline: 20 Jul 2015

Posting Date: 13 Jul 2015

Other Information

Notice Type: Tender

TOT Ref.No.: 3261248

Document Ref. No.: HHS-NIH-NIDA-SSSA-SBSS-2015-595

Competition: ICB

Financier: Self Financed

Purchaser Ownership: -

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

Introduction

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.
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.
Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a small business social-economic set-aside, competitive or non-competitive method is possible, and to determine the availability of all qualified small business companies technically capable of meeting the government s requirement. An organization that is not considered a small business under the applicable naics code should not submit a response to this notice.
North american classification system (naics) code

the naics code applicable to this requirement is 541990 - all other professional, scientific and technical services with associated business size standard 15.0 million dollars.
Project requirements

the mission of the national center for advancing translational sciences (ncats) at the national institutes of health (nih) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
The ncats division of preclinical innovation (dpi) chemistry thymine team is developing the compound ml246 (metarrestin) as a therapy targeted against metastasis or the spread of cancer from its primary site. The compound has shown very good efficacy without toxicity after dosing for 7 weeks in a pancreatic mouse model as demonstrated in the labs of prof udo rudloff at the national cancer institute. However, a preliminary dose range finding (drf) study in any animal has not been done. This is the first step towards determining the therapeutic window and maximum tolerated dose. The dpi would like to do this study in mouse as this in the animal of choice in dpi s efficacy study. The same study has been designed from lead compounds in other projects as well.
Specifically, this small business sources sought notice intends to determine eligible sources with the capability to achieve the potential government requirement described in this notice. The essential government features from which the ncats dpi chemistry group requires contractor support is based on the following study parameters of which contractor support will be ordered in any purchase order contract resulting from this potential requirement.
7 day dosing (n=10 male, n=10 female) at 25, 75, 250 mpk by oral gavage (subject to change depending on final selection and observation)
observation: visual, body weight, food consumption, clinical
observations: twice daily (mortality/moribundity)
clinical observations: daily
experimental design: animals will be dosed daily for 14 days at doses indicated above
dose route/frequency: oral (gavage)/once daily for 14 consecutive days
body weights: twice weekly
food consumption: twice weekly
clinical pathology: hematology and clinical chemistry evaluations on 5 mice/sex/group (hematology) and 5 mice/sex/group
(clinical chemistry) at termination on day 15
necropsy: all animals sacrificed on day 15, with collection of full set of tissues
histopathology: heart, liver, kidneys, brain, spleen, lungs, thymus, stomach from 5 mice/sex from control and high dose groups
toxicokinetics (optional): day 1; 6 time points post-dose (30, 60 min., 2, 4, 8 and 24 hrs); 3 mice/sex/time point; 36 samples; tk modeling (cmax, tmax, auc, t1/2)
offerors to this small business sources sought notice must indicate capability to provide the essential government requirement described in this notice. The period of performance for which delivery of results will be required is six weeks from date of any order resulting from this requirement. Ncats will provide samples for analysis as determined by it s research needs.
Capability statement / information sought

interested parties are expected to review this notice to familiarize itself with the requirements of this product or service. Failure to do so will be at your firm s own risk.
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.
One (1) copy of the response is required and must be in microsoft word or adobe pdf format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing.
The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required.
The response is limited to fifteen (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 to the contract specialist and contracting officer. Facsimile responses are not accepted.
The response must be submitted to hunter tjugum, at [email protected] prior to the closing date specified in this announcement. The response must be received on or before july 20, 2015 at 4:00 pm, eastern time.
Concluding statements

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).
R -- professional, administrative, and management support services

naics code:

541 -- professional, scientific, and technical services/541990 -- all other professional, scientific, and technical services
541 -- professional, scientific, and technical services/541990 -- all other professional, scientific, and technical services

for help: federal service deskaccessibility

added: jul 12, 2015 12:32 pm

Documents

 Tender Notice