SOLICITATION NOTICE
A -- CVM Green Book
- Notice Date
- 7/10/2007
- Notice Type
- Solicitation Notice
- NAICS
- 519120
— Libraries and Archives
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-REQ1031964
- Response Due
- 7/25/2007
- Archive Date
- 8/9/2007
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement is a notice of intent to negotiate and issue a sole source purchase order to Virginia Tech. A written solicitation will not be issued. This synopsis, NAICS code 519120, identified as REQ1031964, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, to the sole source under the simplified acquisition procedures. The proposed contractor is Virginia Tech, 201 Church St, Blackburg, VA 24061. There are two main justifications for sole source of this contract. First, Virginia Tech ahs supported the update, maintenance and development of the Green Book database from it?s inception. Virginia Tech has the background, knowledge, and expertise to support the process of transition to systems within FDA. (The project requirements include establishing database relationships, web portal functionality and interaction with the database, and Quality Assurance (QA) functions).The purpose of creating this process within FDA/CVM is to consolidate governmental resources, improve efficiencies and interactions with others informational databases, and generate cost savings. Utilizing the support of Virginia Tech will support the project time line and budget constraints. Interested parties are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. Statement of Work for the Food and Drug Administration (FDA) / Center for Veterinary Medicine (CVM) Statement of Work for the Green Book 1. Background: On November 16, 1988, congress passed into Law the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988. GADPTRA ?Requires the Secretary to publish and update a list of the official and proprietary name of each new animal drug which has been approved and continues to be approved for safety and effectiveness, including patent information as it comes in.? The law also provided that within 60 days of enactment (January 15, 1989) CVM would make publicly available a list of all currently approved drugs. The first bound book, FDA Approved Animal Drug Products was published and made available on January 15, 1989; the green cover created the name the Green Book. In 1991 a database architecture (using MySQL) was created for the ?FDA Approved Animal Drug List.? In 1994, an additional resource was added, NADA-specific abstracts from the Code of Federal Regulations (CFR) for each approved NADA. Although the abstracts have never been part of the Green Book, with the approval of FDA/CVM, the Drug Information Laboratory (DIL) at the Virginia-Maryland Regional College of Veterinary Medicine combined them with elements of the Green Book and published them on the World Wide Web (WWW) as the ?FDA Approved Animal Drug Products Database.? In 1997, DIL added an electronic version of the Green Book to the FDA/CVM WWW site available to the public. The current Green Book contains eight sections that categorize all approved animal drugs: Trade names and sponsors, active ingredients, patent information, exclusivity periods, products subject to Notice of Hearing, voluntary withdrawals, suitability petitions and monthly updates made during the course of the year. The FDA/CVM web site usage statistics and printed Green Book subscriptions show that both the animal pharmaceutical industry and the general public are interested in the information that FDA/CVM has been providing. Between May 31, 2005 and June 1, 2006 the website recorded 1,492,831 hits as the result of 194,867 client sessions. Approximately 40 percent of these hits were for the Database of Approved Animal Drugs (DAAD) while the remainder was divided among patent, suitability petition and other information pages related specifically to the Green Book. Fifty subscribers are currently registered to receive one or more copies of the Green Book. Thirteen of these subscribers are out of the country including four from Canada, and three from Great Britain. FDA/CVM has a vested interest in maintaining these avenues of communication to its constituents. 2. Objectives: To provide funding for an expert to maintain and improve a searchable relational database for the Food and Drug Administration, Center for Veterinary Medicine of all New Animal Drug Applications (NADAs) and Abbreviated New Animal Drug Applications (ANADAs) in fulfillment of the requirements of GADPTRA. 3. Scope: This Statement of Work (SOW) defines the effort required for the design, maintenance, database development, and upgrading information systems for the FDA/CVM to facilitate communication with the Animal Health Industry and interested private individuals. This is done in accordance with the requirement to make publicly available a list of Approved Animal Drugs under GADPTRA. This also extends to the web interface for searching the ?Database of Approved Animal Drugs (DAAD).? The contractor is not responsible for generating the data that populates the database, printed or electronic queries. All data used in populating the data fields is received by the contractor from the FDA/CVM. 4. Key Project Deliverables: ? Print publication of monthly updates to the Green Book on the 15th day of each month ? Print publication of the entire Green Book on a yearly basis on the 15th day of January following year ? Update the FDA/CVM Database of Approved Animal Drugs with information provided by FDA/CVM on a monthly basis ? Update the FDA/CVM database related tables with new Patent and Exclusivity information ? Update the FDA/CVM database on Suitability Petitions, petition numbers, product information, and purpose of the petition for generic animal drug products submitted under the GADPTRA ? Maintain and update the database in a form that can be made searchable via the World Wide Web (WWW) ? Maintain the WWW interface allowing FDA customers to search and retrieve information from the ?Database of Approved Animal Drugs? and related tables. ? Maintain WWW interface allowing FDA customers to search and retrieve information from the Suitability Petition Database ? Provide a complete copy of the FDA/CVM database, including the Cold Fusion script, to CVM on a monthly basis once the monthly update has been incorporated. ? Technical support to FDA/CVM and CDER employees involved in the transition of bringing the DAAD?s under the responsibility and maintenance of CVM totaling no more than 5 hours per month. Compensation will be provided at an hourly rate beyond 5 hours over a 30 day period. 5. Roles and Responsibilities: i. Maintain the existing database of all approved New Animal Drug Applications (NADAs and ANADAs). The database will contain the following associated information: a) NADA (or ANADA) number b) Trade name(s) c) Sponsor d) Ingredient(s) e) Applicable Patent(s) f) Applicable Exclusivities g) Voluntary Withdrawals h) A list of all suitability petitions that are either pending or have been adjudicated. ii. Provide FDA/CVM with an MS-Word template for the Green Book monthly update. iii Provide a quality assurance review of the monthly updates (Chapter 8). The contractor will review the current database, FOI Summaries, pertinent sections of the Code of Federal Regulations, and the Federal Register Chapters that are the source of individual items in the update. Alterations in monthly update content will be made following consultation and approval of the primary FDA/CVM contact. The primary quality assurance review will be conducted by at least one Veterinary Clinical Pharmacologist. Additional content reviews may be conducted by other staff. iv At no cost to FDA/CVM, print chapters 1-7 of the Green Book and distribute them to subscribers in three-ring binders. v At no cost to FDA/CVM, print monthly updates (Chapter 8) and distribute to subscribers by mail. vi At no cost to FDA/CVM, manage subscriptions. This will include maintaining a database of subscribers, communicating with subscribers and setting subscription prices. vii Provide electronic versions of Green Book Chapters 1 ? 8, suitable for posting to the FDA/CVM web site. viii Maintain a internet portal to provide online searchable access to the ?Database of Approved Animal Drugs?. Microsoft Internet Information Server software and Cold Fusion?? server software will be used to provide the ability to search the Access database Search capabilities will be provided through standard HTML forms. The portal will include the following text-based search capabilities: a) NADAs by: i) NADA number. ii) SPONSOR iii) Ingredients iv) Tradename v) Dose Form vi) Route of Administration vii) Approved species viii) Indications b) Text-based search of the exclusivities based on: i) NADA number ii) Sponsor iii) trade name iv) reason for exclusivity c) Patents by: i) NADA Number ii) Ingredient iii) Patent number d) Suitability petitions by: i) Petitioner Name ii) Reason for Petition e) Sponsors by: i) Sponsor name f) Text-based search of all FEDERAL REGISTER Notices which describe Veterinary drug approvals iv Produce accurate abstracts of each NADA in the database. The abstracts will include: g) Representative tradenames h) The sponsor i) If ANADA, the Pioneer product j) Ingredients k) Animals for which the drug is approved l) Routes of administration m) Dose forms n) Drug forms (how supplied) o) Withdrawal times p) A view of indications from the CFR ordered by drug specifications (detailed product description to include concentrations and amounts), and conditions of use delineating the amount administered, the animals for which the indication is approved, specific indications for use, and limitations to include withdrawal times, cautions and precautions. q) A list of established tolerances if applicable. r) Acceptable daily intake (ADI) s) Links to applicable current CFR paragraphs describing the use of the drug as well as tolerance and ADI t) Links to any FR documents which have, through their publication, updated the most recent version of CFR connected via the links provided in 9m. v Provide onsite and off-site backup of the Database of Approved Animal Drug Products, supporting documents, and the internet portal. Intellectual Property Rights and Obligations Contractor i will publish the Green Book in a timely manner provided it receives the FDA/CVM monthly updates from FDA according to the following schedule: Chapters 1-7 will be mailed within 5 calendar days of the 15th of January of each year that the agreement is in force. Monthly updates will be mailed within 5 calendar days of the 15th of each month. ii will provide a copy of the ?Database of Approved Animal Drug Products? to FDA/CVM at no charge. The format for this copy will be negotiated between the contractor and FDA/CVM and may change depending on needs. iii will provide a printed copy of the Green Book at no charge to FDA/CVM. iv will provide electronic versions of the Green Book, suitable for posting to the FDA/CVM web site, at no charge to FDA/CVM. v will have the right to publish electronic derivatives of the Green Book and the ?Database of Approved Animal Drug Products? in whole or in part and to charge for such derivatives and services. The derivatives may include statements that the data has been received from FDA/CVM under terms of the Freedom of Information Act. vi will have the right to publish electronic derivatives of the ?Database of Approved Animal Drug Products? in whole or in part and to charge for such derivatives and the contractor?s services. The derivatives may include statements that the data has been received from FDA/CVM under terms of the Freedom of Information Act. vii Intellectual property represented by the MYSQL files storing the Database of Approved Animal Drug Products will rest with FDA/CVM viii Intellectual property represented by the Internet Portal used for public access to the Database of Approved Animal Drug products will be negotiated. 6. Location: The database, internet portal, and related programs and files will be housed at DIL, Veterinary Medical Informatics Laboratories, 1880 Pratt Drive, Suite 2006 B (0493), Blacksburg, VA 24060. The consolidation of information to create the monthly updates and management of the contract via the Project Officer will be done at FDA/CVM, 7500 Standish Place, Rockville, MD 20855. 7. Period of Performance: September 8, 2007 through September 7, 2008, with an option to extend the services for 6 months. 8. Equipment Use: DIL will be responsible for all hardware, server, and peripheral maintenance, upgrade, archiving systems. 9. Risk Analysis: DIL will provide back-up schedules for the data and process for ensuring data integrity. 10. Work estimate Contractor:1.4 FTE. Approximately, 96 hours per 40 hour work week. 12. Site Visit Schedule: September 2007 Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. The anticipated award date is07/25/2007. The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999), All information received by 2:00pm EST on July 27, 2007 will be considered by the Government. All questions must be emailed no later than July 16, 2007 to and roberta.richardson@fda.hhs.gov
- Place of Performance
- Address: Virginia Polytechnic Institute, 201 Church Street, Blacksburg, VA,
- Zip Code: 24061
- Country: UNITED STATES
- Zip Code: 24061
- Record
- SN01337959-W 20070712/070710220358 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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