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FBO DAILY ISSUE OF JULY 22, 2012 FBO #3893
SOURCES SOUGHT

A -- Research Development - Package #1

Notice Date
7/20/2012
 
Notice Type
Sources Sought
 
NAICS
541711 — Research and Development in Biotechnology
 
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 
ZIP Code
20857-0001
 
Solicitation Number
FDA-SS-1108258
 
Archive Date
8/11/2012
 
Point of Contact
Natalie Mitchell, Phone: 3018279606, Gina Jackson, Phone: 301-827-1982
 
E-Mail Address
natalie.mitchell@fda.hhs.gov, gina.jackson@fda.hhs.gov
(natalie.mitchell@fda.hhs.gov, gina.jackson@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
Capability Requirement General Information: Document Type: Sources Sought - FDA-SS-1108258 Release Date: July 20, 2012 Response Date: July 27, 2012 at 4:00pm EST via email to Natalie.Mitchell@fda.hhs.gov Contracting Office Address: Food and Drug Administration, 5630 Fisher Lane, Rockville, Maryland 20857; Attn: Natalie Mitchell, Contract Specialist Description of Services/Supplies: Multi-faceted research to provide a basis for developing a test method and apparatus to verify accuracy of medical digital thermometers. CONTRACTING OFFICE U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) / Office of Acquisitions and Grants Services (OAGS) DESCRIPTION This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to be able to develop a test method and apparatus to verify accuracy of medical digital thermometers. The Contractor's capability statement shall demonstrate the company's ability to meet the following requirements. Please provide a detailed description of your company's (including its teammates, if applicable) experience and demonstrated abilities to deliver the following: Capability Requirement: (1) Contractor must be able to design and build a highly accurate reference thermometer for use in clinical and bench top thermal analyses. (2) Contractor must be able to perform a clinical study of measured skin temperatures, including both healthy and sick (elevated temperature) human subjects, different age ranges, both male and female, using both the reference thermometer (designed and built as step one of this project) and commercially available thermometers to provide the time-temperature response curves needed to evaluate the test apparatus. (3) Contractor must be able to develop a full-body computer model of both the body and skin temperatures under different environmental (boundary) and physiological, and body size conditions to provide the basis for the experimental design for taking clinical measurements of skin temperatures. (4) Contractor must be able to develop a skin phantom that replicates the behavior of actual skin for testing thermometers, a test apparatus and digital thermometer testing protocol. (5) Contractor must be able to test a wide range of digital thermometers under different simulated conditions to assess their accuracy over a wide range of measurement times. (6) Contractor must be able to be able to participate in teleconferences, workshops, and the preparation of reports and presentations as a member of the FDA Technical Working Group. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to deliver the specific equipment as required. Responses must directly demonstrate the company's capability, experience, and/or ability to develop a test method and apparatus to verify accuracy of medical digital thermometers while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541711 (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email to Contract Specialist Natalie Mitchell at email address Natalie.Mitchell@fda.hhs.gov no later than 4:00 PM Eastern Standard time on Friday, July 27, 2012 for consideration. Responses to this announcement will not be returned, nor any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1108258/listing.html)
 
Place of Performance
Address: 10903 New Hampshire Ave, WO62 Room2227, Silver Spring, Maryland, 20993, United States
Zip Code: 20993
 
Record
SN02810046-W 20120722/120720235036-c3f77f4ab644b55c84a80f9a7a7953e8 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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