SOURCES SOUGHT
D -- Technical / Administrative Support for FDA's Intranet Certificate Tracking System (iCERTs)
- Notice Date
- 4/16/2009
- Notice Type
- Sources Sought
- NAICS
- 541511
— Custom Computer Programming 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
- FDA-SS-09-1054961
- Archive Date
- 5/12/2009
- Point of Contact
- Jody L. O'Kash,, Phone: 301-827-5094
- E-Mail Address
-
Jody.O'Kash@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- CONTRACTING OFFICE U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) / Office of Acquisitions and Grants (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 provide Technical / Administrative Support for Operations and Maintenance on FDA's Intranet Certificate Tracking System (iCERTS) for the Center for Drug Evaluation and Research Division (CDER). The certificates are for export of products legally marketed, sold, offered for sale or distributed in the U.S. and they attest that the drugs (including therapeutic biologic products) being exported are subject to inspection by the FDA and are manufactured in compliance with current good manufacturing practices. These certificates enable American manufacturers to export their products to foreign customers and governments. 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 each and every one (address each separately) of the following general and specific requirements: GENERAL REQUIREMENTS: The ability to provide operational and technical support to maintain the Monday through Friday, business hours (8:00 a.m. – 4:30 p.m.) availability of the FDA iCerTS. This would involve analyzing system errors, troubleshooting, recovering the system when necessary, assisting CDER’s Office of Compliance with maintaining application connectivity to Field Accomplishments and Compliance Tracking System (FACTS), Regulatory Management System for Biological License Application (RMS-BLA) databases and CDER’s Electronic Orange Book, testing and installing software patches/upgrades, maintaining system documentation and meeting performance objectives. The contractor shall ensure that the iCerTS Web Application continues to provide an online data collection, auto-generation of all related documents including the required Export Certificate along with the necessary cover letter, review of a certificate QA process, wide re-use of previously entered applicant information, etc. Maintenance Tasks- include providing problem support, testing and installing future software upgrades, and interfacing with FDA Centers and the FDA’s Office of Information Management (OIM). Technical support Tasks- include assisting FDA with technical issues and questions, troubleshooting /analyzing iCerTS system errors, correcting technical problems, recovering the system when necessary and providing technical solutions and advice to the CERTS Team. iCerTS Administration Tasks- include maintaining trading partner data and security certificates (ensuring the latest versions are applied), updating system documentation as necessary, attending CERTS Team meetings, providing status reports to CDER, Office of Compliance Project Officer and updating the iCerTS website as appropriate. SPECIFIC REQUIREMENTS: • Operate and Maintain the system to allow users to enter and modify iCerTS data through a standard web browser • Perform automatic data validation based on pre-established rules • Ensure CDER staff can enter information online and save information in the data base • Operate and Maintain the iCERTs system to automate the workflow process of collecting, validating and storing iCerTS data • Operate and Maintain the iCerts system to automate the workflow process of reviewing, correcting and approving iCerTS reports • Operate and Maintain the iCerts system to automate the generation of all iCerTS related documents • Operate and Maintain the iCerts system to integrate with FDA/CDER application systems • Maintain iCerTS website information and system documentation • Resolve database errors The software architecture employed in the design and development of the iCerTS application includes Microsoft SQL Server 2000 as the back-end database. The Data Tier is a collection of SQL Stored Procedures and views which interact with the iCerTS database as well as external databases. The middle Business Tier is developed using C#,.NET and XML. The GUI, front-end tier consists of HTML/ASP.NET Web Forms, C# code, and custom controls. A firm fixed price type of contract is anticipated. The previous source for this requirement was Network Designs Incorporated (NDI). The NAICS Code is 541511, with a small business size standard of $25M. 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 perform the specific work as required. Responses must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above 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 541511 (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, 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 via email to Contract Specialist Jody O'Kash at email address jody.o'kash@fda.hhs.gov no later than 4:00 PM Eastern Standard time on Monday, April 27, 2009 for consideration. Responses to this announcement will not be returned, nor there 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 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=fbdf911934bb3db2092d830e7bdd31fd&tab=core&_cview=1)
- Place of Performance
- Address: Oveall, at the Contractor facilities. However, Contractor staff may be required to perform some activities at the FDA offices in Washington, DC area., United States
- Record
- SN01794870-W 20090418/090416221710-fbdf911934bb3db2092d830e7bdd31fd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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