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FBO DAILY ISSUE OF APRIL 13, 2008 FBO #2330
SOURCES SOUGHT

B -- Development of Immediate Release Oral Formulations Using the Concept of Quality by Design and Predicting In Vivo and In Vitro Correlations For Class II Drugs in Dogs and Humans

Notice Date
4/11/2008
 
Notice Type
Sources Sought
 
NAICS
541990 — All Other Professional, Scientific, and Technical Services
 
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
FDA1041864
 
Point of Contact
PatriciaWright,, Phone: 301-827-7217
 
E-Mail Address
patricia.wright@fda.hhs.gov
 
Description
This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses to provide services for the project titled: Development of Immediate Release Oral Formulations Using the Concept of Quality by Design and Predicting In Vivo and In Vitro Correlations For Class II (Low Solubility, Highly Permeable) Drugs in Dogs and Humans. The NAICS Code is 541990. 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 provide the required services. The potential small businesses must have the technical expertise which encompasses experience with generating in vivo/in vitro correlations (IVIVC), an understanding of the Biopharmaceutics Classification System (BCS) and its applicability to the factors influencing product performance, expertise in the manufacture of solid oral dosage forms and design space issues, experience with on/at line monitoring system (eg., near infra red spectroscopy (NIR) and chemometric modeling), expertise in developing in vitro dissolution methods, and an ability to develop and validate the analytical methods needed to quantify the drug concentrations in incurred (blood ) samples and the in vitro dissolution medium. Secondly, the potential small businesses must own or have access to the facilities needed to manufacture oral dosage forms, dose human volunteers [intravenous (IV) and oral (PO) drug administration), dose dogs (IV and PO), collect blood, and conduct in vitro test procedures. The facility MUST BE within the Washington, DC – Baltimore, Maryland metropolitan vicinity. Thirdly, the potential small businesses must have the staff needed to execute the blood sampling, dosing, assays and product testing and also support product formulation development and clinical studies. Responses to this notice shall be limited to 15 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 xxxxxx (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.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, a Request for Proposals, a Solicitation, a 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 to the attention: Patricia Wright, email: patricia.wright@fda.hhs.gov not later than 2:00 PM Eastern Standard time on April 18, 2008 for consideration. Responses to this announcement will not be returned, nor will there be 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 FDA may contact one or more respondents for clarifications and to enhance the Government’s 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
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=9ee0600f7c853fc286e2b70a1039327f&tab=core&_cview=1)
 
Record
SN01552586-W 20080413/080411221157-9ee0600f7c853fc286e2b70a1039327f (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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