SOURCES SOUGHT
A -- Structured Product Labeling Initiative
- Notice Date
- 5/27/2009
- Notice Type
- Sources Sought
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- 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
- 1054070
- Point of Contact
- Vida - Niles, Phone: 301-827-2476
- E-Mail Address
-
vida.niles@fda.hhs.gov
(vida.niles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: R#EQ # 1054070 Document Type: Sources Sought Release Date: May 27, 2009 Response Date: June 3, 2009 at 4:30pm EST via e-mail to Contract Specialist: Vida Niles at Vida.Niles@fda.hhs.gov Contracting Office Address: Food and Drug Administration 5600 Fisher Lane Rockville, Maryland 20857 Description: Structured Product Labeling Initiative This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses. This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quote, or an indication the Government will contract for the items or services herein. This notice 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 notice. The Government does 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 source sought. Any response received will not be used as a proposal. No official solicitation currently exists in connection to this request for information (RFI). Also, if in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities and prior experience in the evaluation of Biopharmaceutical Classification System (BCS) Class 3 drugs, specifically, drugs with transporter involvement during absorption. Project Title: Structured Product Labeling Initiative The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) is seeking interested sources. The requirement shall provide FDA/CVM with guidance, expertise and training in expanding and adapting the existing bioinformatics-derived series of nomenclatures of veterinary and technical terms. This project shall require adaptation of the adapted and expanded veterinary bioinformatics into the dictionary for the Structured Product Labeling initiative for the new animal drug pre-approval environment and current FDA/CVM databases. These veterinary dictionaries are based upon broadly accepted medical dictionary standards (e.g., Veterinary Dictionary for Drug Regulatory Activities (VEDDRA), Systematized Nomenclature of Medicine (SNOMED) and the Center of Drug Evaluation and Research’s (CDER) SPL), so experience these related informatics dictionaries is also desirable. DRAFT Statement of Work: The objective of this requirement is to develop and improve the implementation of the Structured Product Labeling (SPL) initiative for the new animal drug pre-approval environment. In addition, assistance may be provided to FDA in adapting and integrating common veterinary industry medical nomemclature dictionaries into the current FDA databases. The objective of this requirement may require the following expertise: •A Doctor of Veterinary Medicine (DVM) or equivalent degree, i.e., Veterinary Medical Doctor (VMD), obtained at a school or college of veterinary medicine accredited by the American Veterinary Medical Association (AVMA) Council on Education and demonstrated expertise in the current clinical practice of veterinary medicine. This person should have recognized expertise in the field of veterinary informatics and have worked experience in managing government award contracts, preferably dealing with medical informatics. And •Support personnel with specialized training in the field of veterinary medical informatics. It is preferred that the personnel have a Bachelor of Science or a Master of Science in the field of medial informatics. Deliverables: The Vendor shall provide all documentation/artifacts to FDA in a format specified and approved by the Project Officer. All preliminary, intermediate and final task order deliverables in electronic formats to the FDA. For automated formats, the following software packages shall be used: Reports – Microsoft Work; Spreadsheet – Microsoft Excel; Project Management – Microsoft Project; Presentations – Microsoft PowerPoint; and Database Management System – Microsoft Access. Period of Performance The Government anticipates a base year plus four option years. Part A. Capability and Technical Experience – Viable parties should submit a capability statement describing adequate training and experience in the following areas: QUALIFICATIONS: Veterinarian: Qualifications •A Doctor of Veterinary Medicine (DVM) or equivalent degree, i.e., Veterinary Medical Doctor (VMD), obtained at a school or college of veterinary medicine accredited by the American Veterinary Medical Association (AVMA) Council on Education and demonstrated expertise in the current clinical practice of veterinary medicine. This person should have recognized expertise in the field of veterinary informatics and have worked experience in managing government award contracts, preferably dealing with medical informatics. Medial Informatics Specialist: Qualifications: •Support personnel with specialized training in the field of veterinary medical informatics. It is preferred that the personnel have a Bachelor of Science or a Master of Science in the field of medial informatics. Part B. Size of Business – Please provide your business size and submit copies of any documentation such as letters of certifications to indicate the firm status. Part C. Organizational Conflict of Interest (OCI) – If any; provide disclosure of business activities of your company, your affiliates, and your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of the objectives listed above Part D. Cost Estimate – Please provide a cost estimate for the prospective services to be conducted under the potential study and evaluation of BCS Class 3 drugs. Cost should consist of the type of labor categories, hourly rate/days and materials and travel. Part E. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation of Subcontracting. Responses shall adhere to the following: 1. Reference the Sources Sought number when submitting the capability statement. 2. The capability statement shall be no more than five (5) pages in length. 3. Marketing materials shall not be included. 4. The Capability Statement shall be e-mailed to the attention of the Contract Specialist listed above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned. 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 must be sent to this notice no later than 10:00 a.m. EST on June 4, 2009 submitted by email to vida.niles@fda.hhs.gov, Vida Niles, Contract Specialist 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.
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