MODIFICATION
B -- Advisory and Consultative services to CVM
- Notice Date
- 3/5/2007
- Notice Type
- Modification
- NAICS
- 541690
— Other Scientific and Technical Consulting 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-07-00165
- Response Due
- 4/5/2007
- Archive Date
- 4/20/2007
- Point of Contact
- Roberta Richardson, Contract Specialist , Phone 301-827-7175, Fax 301-827-7106, - Patricia Pemberton, Contracting Officer, Phone 301-827-1022, Fax 301-827-7106,
- E-Mail Address
-
roberta.richardson@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Date: 05 Mar 2007 The Food and Drug Administration intends to issue a Sole Source contract to Dr. Andrew Beaulieu for advisory and consultative services to CVM on mission critical issues and policies, directly related to the regulation of animal drugs, foods and devices, and implementation of Minor Use and Minor Species Animal Drug Development activities, including strategic planning, risk assessment and communications. A sole source fixed price contract will be awarded to Dr. Andrew Beaulieu in accordance FAR Part 15. One award will be made for a 12 month contract period with an option for six additional months. The associated NAICS code is 541690 ?Other Scientific and Technical Consulting Services and the small business size standard is $6.5M. The synopsis was posted Feb 7, 2007, on the FedBizOpps website at http://fedbizopps.gov. The proposed contract actions are for services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. Deliverables will be required and established from requirements contained in the Statement of Work. The anticipated award date is Apr 5, 2007. STATEMENT OF WORK PROJECT TITLE: Advisory Services to the Center for Veterinary Medicine A. BACKGROUND The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet or companion animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.) The Center for Veterinary Medicine (CVM) mission is to protect the public health through regulation of animal drugs, food additives, and devices. This mission is accomplished through the following activities: ? Review of new and abbreviated animal drug applications, investigational new animal drug applications and related submissions, medicated feed applications, and food additive petitions. ? Assessment of the environmental/food safety impact of CVM regulatory decisions/actions. ? Surveillance of marketed products through review of drug experience reports and compliance programs ? Research programs designed to provide a scientific basis for Agency decision making. There are approximately 400 Food and Drug Administration (FDA) employees assigned to CVM, and they are organized into five offices in addition to the Office of the Center Director: ? Office of New Animal Drug Evaluation (ONADE) - responsible for the review and approval of new and generic drug applications for the marketing and manufacture of animal drugs ? Office of Surveillance and Compliance (OS&C) - monitors approved drugs and feeds for continued safety and effectiveness ? Office of Research (OR) ? conducts applied research in support of current and evolving FDA regulatory issues to provide solutions that ensure the safety of animal derived food and animal health products ? Office of Minor Use and Minor Species (OMUMS) - established in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004, the Office declares MUMS designations (i.e. seven years of marketing exclusivity) for new animal drugs; it will add drugs to an index of legally marketed unapproved new animal drugs; and will approve grant money to assist in defraying the costs of safety and effectiveness testing expenses in the development of designated new animal drugs once final regulations providing for designation are published. ? Office of Management (OM) - provides administrative, budget, and information resources support across all CVM activities. Most of CVM?s operations are divided between the Metro Park North 2 (MPN 2), and Metro Park North 4 (MPN 4) locations on Standish Place in Rockville, Maryland. However, OR is located in laboratory/office space at the MOD II building located in Laurel, Maryland. B. OBJECTIVES OF THE PROJECT The two fold objective of this contract is to address a compelling need during a period of transition for critical subject matter expertise relative to: 1. The provision of substantive recommendations, collaboration and advice in the process for development and issuance of regulations, evaluation of comments to public dockets, and related preparations of guidance for industry for the implementation of the Minor Use and Minor Species Animal Health Act that was passed by Congress in 2004. Specific activities anticipated under this contract option will also include, but not be limited to, scientific and policy liaison; participation in internal and external meetings on behalf of the Center; and and contribute to coordination with and between FDA Office of Chief Counsel and OMUMS. 2. The provision of substantive recommendations, collaboration and advice in the process for development and issuance of regulations, evaluation of comments to public dockets, and related preparations of guidance for industry supporting the Center for Veterinary Medicine in the regulation and oversight of animal drugs and feeds under the Federal Food, Drug and Cosmetic Act (FFDCA). Such consultations may represent a variety of critical public health issues facing the Center, such as antimicrobial resistance, bovine spongiform encephalopathy, emerging policies on the regulation of genetically engineered animals, and deliberations/deliverables as may be necessary supporting negotiations for the reauthorization of the Animal Drug User Fee Act. Specific activities anticipated under this contract option may also include, but not be limited to, participation in strategic planning, management and/or scientific evaluation activities, meetings both internal and public, and other and the regulatory systems and science venues as may be determined by the Center. C. SERVICES TO BE SUPPLIED 1. The contractor shall provide critical in-depth advice, historical perspectives, knowledge, technical and scientific guidance regarding the working procedures of the Center for Veterinary Medicine applicable to OMUMS regarding subjects including, but not limited to, the Federal Food, Drug, and Cosmetic Act, the Minor Use and Minor Species (MUMS) Animal Health Act, the definition of ?minor use? in a major species with regard to frequency of occurrence and limited geographical areas, criteria for selection of a qualified expert panel to address indexing, medicated feeds, veterinary feed directives, analysis of economic impacts, labeling, records, reports and guidance?s for industry. A second major role and/or responsibility of the contractor will be to provide coordinating services to the OMUMS Director as requested to assist in meeting the mandates set forth in the MUMS Act. Specifically, the contractor will apply knowledge and skills in working with a wide network of contacts to enhance the effectiveness and efficiency of activities managed by OMUMS and the FDA Office of Chief Counsel. In performing this consultative role, the contractor will assist and/or prepare written documents and/or otherwise provide assistance as may be requested by the OMUMS Director. Requests to travel will be limited to local travel. 2. The Contractor shall provide advisory and consultative services to CVM on a variety of mission critical issues and policies, including support during negotiations for reauthorization of the Animal Drug User Fee Act (ADUFA), CVM strategic and operational planning, risk assessment and communications, and will participate in CVM strategy discussions and meetings providing scientific and technical policy assistance where appropriate. Recommendations on the evaluation and editing of new and proposed regulations, guidance for industry, and responses to public comments and implementing strategies for same shall also be provided by the Contractor, as requested. D. OVERVIEW OF TASKS, MILESTONES, AND DELIVERABLES 1. The following timetable for the remaining mandated deliverables on the MUMS Act are: Section 572 Indexing Proposed???? 8/22/06 Final rule due??. 8/2/07 Section 571 Conditional Proposed due??.2/2/07 Approval Final rule due??..2/2/08 The public comment period on Section 572 (Indexing) closed 12/20/06; all comments received must be read and then the final regulations drafted, finalized and published by 8/2/07. The proposed regulations for Section 571 (Conditional Approval) are to be ready for publication by 2/2/07. The guidance for industry regarding Section 573 (Designation) needs to be developed and cleared through FDA-Office of Chief Counsel. Guidance?s are to be written following completion of the mandated documents as outlined in the MUMS Act. The process maps (flow charts) for the handling of an application/submission to the OMUMS is a work in progress but needs to be completed by 8/31/07. This requires review of documents prepared during bi-monthly meetings with IT staff who will modify existing screens in the STARS modules. Preparation time: 745 hours E. PERIOD OF PERFORMANCE AND PAYMENT The contractor will begin the project upon approval of the contract by the FDA. The contractor will have one year from the award to complete all tasks and deliverables. The contractor will invoice the FDA for the fee on a monthly basis at a rate not to exceed 20 hrs. per week, except under unusual circumstances. Of that amount, it is further intended that work specific to MUMS implementation shall not exceed 16 hours per week, except under unusual circumstances. F. RESPONSIBILITIES The Project Officer shall direct and provide overall guidance on specific activities and tasks assigned to the contractor in support of CVM and its Office of Minor Use and Minor Species (OMUMS) Director, including the MUMS Act mandates, other FFDCA activities, and in participating in the process for developing necessary policies, guidance, and strategies. The contractor will adhere to all schedules and will report monthly on the progress of projects and tasks, and more often at the FDA?s request. Both the FDA and the contractor shall communicate as frequently as possible to keep each other abreast of all aspects of activities assigned in order to ensure their timely and effective completion. This notice is issued for informational purposes and not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this posting can be met, no later than 15 days from the date of this announcement. A determination by the Government not to compete the proposed contract based on responses from this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses to this notice must be sent via email to Roberta.richardson@fda.hhs.gov and patricia.pemberton@fda.hhs.gov. No phone calls will be accepted.
- Place of Performance
- Address: 7519 Standish Place, Rockville, MD
- Zip Code: 20855
- Country: UNITED STATES
- Zip Code: 20855
- Record
- SN01243646-W 20070307/070305220228 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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