Expert/Consultant in Minor Use and Minor Species Animal Drug

General Information: Document Type: Sources Sought (FDA-1081954SS) Release Date: December 8, 2010 Response Date: December 14, 2010 at 4:30pm EST via e-mail to Contracting Specialist, Jacqueline Richardson at Jacqueline.richardson@fda.hhs.gov Contracting Office Address: Food and Drug Administration Description: Expert/Consultant in Minor Use and Minor Species Animal Drug Development This is a SOURCES SOUGHT NOTICE to be determine the availability and capability of small business (including certified 8(a), Small Disadvantage, HUB Zone one firms; veteran-owned small business, and women-owned small businesses. This information is being sought for information and planning purposes only and shall not be construed as an invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, 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). 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. **NO QUESTIONS WILL BE ENTERTAINED** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify Small Business with capabilities and prior experience in Professional Services providing consultation, advisory and project management services to FDA's Center for Veterinary Medicine CVM/Office of Minor Use and Minor Species Animal Drug Development (OMUMS) in order to facilitate the continuing establishment and execution of the Office's legislative mandate. Objective: The consultant shall work with CVM's Office of Minor Use and Minor Species (OMUMS) staff with critical subject matter expertise in order to ensure the Office can effectively meet its mission as directed by the MUMS Act of 2004. Examples of areas requiring specific expertise include: a. The provision of substantive direction, collaboration and advice in the development and issuance of regulations, evaluation of comments to public dockets, and related preparation of guidance for industry for the implementation of the Minor Use and Minor Species Animal Health Act passed by Congress in 2004. b. The consultation may represent a variety of critical public health issues facing the Center. Specific activities anticipated under this 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 regulatory systems and science venues as may be determined by the Center. Task May Include: - Providing critical in-depth advice, 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: o the Federal Food, Drug, and Cosmetic Act; o the Minor Use and Minor Species (MUMS) Animal Health Act; o the definition of - minor use' in a major species with regard to frequency of occurrence and limited geographical areas; o the criteria for selection of a qualified expert panel to address indexing; o medicated feeds, veterinary feed directives; and o the analysis of economic impacts, labeling, records, reports and guidance for industry. - Providing coordinating services to the OMUMS Director as requested to assist in meeting the mandates set forth in the MUMS Act; to include: o applying knowledge and skills in working with a wide network of contacts to facilitate the work of the OMUMS and the FDA Office of Chief Counsel; and o preparing written documents and/or otherwise providing assistance as may be requested by the OMUMS Director. - Providing advisory and consultative services to CVM on a variety of mission critical issues and policies, including CVM strategic and operational planning, and risk assessment and communications as follows: o Operational planning: This task shall encompasses planning for drafting of regulations, guidance documents, SOPs, and implementation of policies. o Risk assessment: This task shall encompasses certain issues associated with indexing and designation, but is not always a formal risk assessment. o Communications: This task shall includes communication across Offices Within CVM, across the Agency, and with numerous external stakeholders including consumers and pharmaceutical sponsors. - Participating in CVM/OMUMS strategy discussions and meetings providing scientific and technical policy assistance where appropriate. - Developing, evaluating, and editing, new and proposed regulations, guidance for industry, OMUMS Standard Operating Procedures, and responses to public comments and implementing strategies for same will also be provided by the Contractor, as requested. Reports and Meetings May Include: - Monthly Status Updates - Meetings with management Part A. Capability and Relevant Experience - Interested parties should submit capability statement describing adequate experience and training in Minor Use and Minor Species. 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 such as 8-A certifications.