SRCSGT | R | Operation and Maintenance of Several Document Control Rooms, Includes Document Management, Operations and Processing of Both Paper and Electronic Documents.

FBO DAILY ISSUE OF FEBRUARY 22, 2003 FBO #0447
SOURCES SOUGHT

R -- Operation and Maintenance of Several Document Control Rooms, Includes Document Management, Operations and Processing of Both Paper and Electronic Documents.

Notice Date: 2/20/2003
Notice Type: Sources Sought
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Division of Construction and Agency Support Contracting, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: 223-03-3001
Response Due: 3/7/2003
Archive Date: 3/22/2003
Point of Contact: Ed Arnold, Contract Specialist, Phone (301) 827-7161, Fax (301) 827-7151, - Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
E-Mail Address: earnold@oc.fda.gov, hbrown@oc.fda.gov
Small Business Set-Aside: Total Small Business
Description: This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. Qualified sources are limited to 8(a) or small business concerns only, who have the interest and ability to provide FDA?s Center for Drug Evaluation and Research (CDER) with the services detailed below. Other social economic programs such as woman owned, veteran owned, HUBZone, etc, may further limit competition. Contractor personnel are currently performing the services. The NAICS code for this procurement is 514191. This is not a request for a formal proposal This synopsis seeks to identify the interest from potential 8(a) and small business contractors for the operation and maintenance of several document control rooms within CDER. Contractors expressing an interest should identify their capabilities in providing such services by identifying their capabilities in operating and maintaining complete control of projects from inception to completion at government furnished facilities. Capability statements should include a description of the organization?s experience in document management, operations and processing of both paper and electronic documents. CV?s for key personnel should be included in the capability statement. Interested contractors shall also provide (1) an outline of specific work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement (3) any other specific and pertinent information as pertains to this Sources Sought Notice that would enhance our consideration and evaluation of the information submitted Responses must reference Request for Information (RFI) number 223-03-3001 and include the following: (1) name and address of firm, (2) type of business (i.e.: small business, small disadvantaged 8(a) certified, woman-owned small business, small disadvantaged business (not 8(a) certified), veteran-owned small business, etc.) (3) two points of contact: name, title, phone, fax and e-mail, (4) DUNS number, (5) NAICS codes, (6) contractor?s capabilities statement: providing the information stated above, (7) list of customers covering the past 5 years: highlight relevant work including a summary of work performed, contract number, contract type, dollar value for each customer, reference and customer point of contact with phone number, and identify your role as either the Prime or Subcontractor. Responses shall be submitted via e-mail to: earnold@oc.fda.gov. not later than February 28, 2003. Scope of Work This requirement is designed to meet the Government?s Paperwork Reduction Act (GIPA) through management and development of strategic processing including increase in quantity and range/type of electronic submissions while maintaining a high level of security during the review process and post-marketing product life. The contractor will be required to provide services and support resources capable for evaluating, processing and managing paper and electronic drug documents (applications and submissions). The contractor must be able to provide support in a dynamic and changing environment, ideas to improve the receipt and handling process, offering innovative approaches that result in time and cost efficiencies. A major objective of CDER is to reduce paper usage thus relieving document storage space, document distribution cost, distribution time to reviewers and document maintenance necessary in managing drug application as well as giving expanded flexibility to the FDA review and possible outside reviews. CDER is involved in a major effort to enhance CDER drug reviewers? productivity and quality of work by requiring submissions to be received electronically. It is anticipated that this will result in a decreasing dependency on paper processing activity during application review. The contractor will also need to be able to manage documents in a timely and secure manner during day-to-day planned activities and facility relocation. The contractor shall provide all personnel, equipment, tools, materials, supervision and other items and services necessary to perform the daily activities in the operation and management of four of CDER?s document rooms. The contractor shall provide qualified staff responsible for technical support services necessary for the management of on-line information systems designed to evaluate, receive, track, disseminate application and supplementary information submitted by pharmaceutical firms and researchers in the form of electronic and/or paper applications all in accordance with FDA guidelines. The contractor must be capable in managing all regulatory submission types: Investigational New Drug Applications (INDA), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Drug Master Files (DMF) and supporting regulatory submissions. The contractor shall develop and explain a quality control team approach based on government provided schema. The contractor should be capable of developing and demonstrating an electronic (text and image) compatible system for receiving, maintaining, distributing, and archiving DMF material. This will include both new submissions and ones currently maintained by CDER as paper DMF. The system will be compatible with current e-document systems. As a future project, the contractor must be capable in the development and execution of an internal Library service that enables the distribution and management of electronic application material from the DDR?s to the Review community. This Library service would function as a repository for the Review community. THIS SYNOPSIS IS FOR INFORMATION AND PLANNING PURPOSES AND IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. RESPONDENTS WILL NOT BE NOTIFIED OF THE RESULTS OF THE EVALUATION. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT MUST ARRIVE ON OR BEFORE THE CLOSING DATE. THE CLOSING DATE FOR RESPONSES IS FEBRUARY 28, 2003. Point of Contact - Ed Arnold, Contract Specialist ? Phone 301-827-7185 or Hamilton Brown, Contracting Officer ? Phone 301-827-7043. Food and Drug Administration OFACS/DCASC/COB Attn: Ed Arnold 5630 Fishers Lane, Room 2117, HFA-512 Rockville, Maryland 20857-0001
Place of Performance: Address: Food and Drug Administration, 5630 Fishers Lane, Rockville, Maryland 20857-0001,; Zip Code: 20857; Country: US
Record: SN00262040-W 20030222/030220213239 (fbodaily.com)
Source: FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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R -- Operation and Maintenance of Several Document Control Rooms, Includes Document Management, Operations and Processing of Both Paper and Electronic Documents.