SOURCES SOUGHT
R -- Expert/Consultant in Minor Use of Minor Species Animal Drug FDA_1127360
- Notice Date
- 5/4/2014
- Notice Type
- Sources Sought
- 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_REQ_1127360
- Point of Contact
- Glacia A Holbert, Phone: 2404027587, Jennifer Fagan,
- E-Mail Address
-
glacia.holbert@fda.hhs.gov, jennifer.fagan@fda.hhs.gov
(glacia.holbert@fda.hhs.gov, jennifer.fagan@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- 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 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. Objectives: The purpose of this procurement is to assist CVM/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. Project Scope The contractor shall collaborate 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 MUMS Act of 2004. Specific activities anticipated under this contract option will also include, but not be limited to: acting as a scientific and policy liaison; participation in internal meetings and potentially as a liaison of CVM/OMUMS externally; and coordination with and between FDA Office of Chief Counsel and OMUMS. During the term of this contract the contractor is expected to contribute as principal author to Guidance Documents for industry concerning the designation and the indexing of MUMS drugs. This will include both the draft and final versions of the documents and analysis of public comments in response to their publication. The contractor shall collaborate and provide advice in the development and issuance of regulations, evaluation of comments to public dockets, and related preparation of guidance for industry supporting CVM in the regulation and oversight of animal drugs and feeds under general provisions of the Federal Food, Drug and Cosmetic Act (FD&C). Such consultations may represent a variety of critical public health issues facing the center. Specific activities anticipated under this contract 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. The contractor will be expected to be a major contributor to the drafting of important regulations for major program areas related to minor species but not directly under OMUMS control. These are related to the drug approval process and post approval reporting requirements. The contractor will also be involved in evaluation of requests for user fee waivers for minor uses in minor species and in periodic reassessment of the standards established by regulation for making such determinations. Operational Planning The contractor shall assist in planning and drafting regulations, guidance documents, Standard Operating Procedures (SOPs) and other policies/procedures. The contractor shall have significant participation in the design and writing of three (3) major regulations stemming from the following: 1. The Minor Use and Minor Species Animal Drug Act of 2004 - Conditional Approval Regulations 2. The Generic Animal Drug Patent Term Restoration Act - Generic Drug Regulations 3. International harmonization - Rewrite regulations for Records & Reports The contractor shall work through the drafting and clearance of each proposed regulation (clearance will be authorized by CVM Senior Management, the Policy and Regulation Group, and the Office of Chief Counsel prior to publication). The contractor shall also participate in the review of comments and the drafting and clearance of final rules. To draft these regulations, the contractor must have in-depth knowledge and experience of the new animal drug approval process and the requirements that are imposed post approval. The contractor shall be completely familiar with the FD&C Act and MUMS Act, and the implementing regulations. The contractor must have profound knowledge of veterinary medicine and husbandry practices regarding a wide range of minor species and medical considerations related to rare diseases in the major species. • The contractor shall author and update two (2) guidance documents for industry regarding significant programs (Designation and Indexing) affecting minor species and minor use drugs. This will require the contractor to have a complete understanding of the MUMS Act and implementing regulations. The contractor shall have experience in writing regulations/guidance in this subject area. The contractor also shall submit regulation/guidance documents to the clearance process, respond to public comments on the draft, and write the final version of the guidance documents. • The contractor shall also comment on and review proposed revisions to the Good Laboratory Practices regulations. The contractor shall review public comments and assist in the writing of the final version of the regulations and shall review and comment on the associated Agency-level guidance document(s). • The contractor shall also comment on and review proposed guidance documents related to Manufacturing Chemistry, the design of safety or effectiveness studies, combination new animal drugs, and administrative processes governing new animal drug evaluation. • The contractor shall provide background experience and skill in process development to assist with the development of new policies and procedures for managing procedural issues in OMUMS and for issues affecting OMUMS and the Office of New Animal Drug Evaluation (ONADE) jointly. Risk Assessment The contractor shall perform a risk assessment review of requests for proposed projects to be considered "minor uses" in major species. The contractor must have knowledge of veterinary medicine, computer macros, and the regulations for determining a statutory "small number" of animals. The contractor shall review the calculations and rationale for assignment of the "small number of animals" for each of the seven (7) major species and shall propose any changes necessary based on changes in animal populations and economic factors. The contractor shall also be responsible for review of the description of manufacturing process for drugs seeking addition to the Index. This requires the contractor to have some experience with the chemistry and systems associated with the manufacture of new animal drugs. Communications The contractor shall engage in communication across offices within CVM, across the agency, and with numerous external stakeholders including consumers and the regulated industry. • The contractor shall attend pre-submission conferences for minor use projects to present MUMS options to sponsors when requested. This requires the contractor to have an in-depth understanding of available incentives including user fee waivers, conditional approval, designation, and research partnerships with outside public and private entities. This also requires the contractor to have contacts in such research settings. • The contractor shall participate in development of agreements between agencies on issues of jurisdiction and harmonization of policies. The contractor shall have knowledge of statutes governing other agencies, such as Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the National Environmental Policy Act (NEPA). • The contractor must be conversant with labeling regulations for animal drugs and also with corresponding regulations for human drugs. The contractor shall be aware of precedents and policies guiding product labeling. This knowledge will mainly be applied to products intended for the Index. • The contractor shall be called upon to answer questions from stakeholders about MUMS incentives for drug approval by email or on the telephone. The contractor must have deep familiarity with all minor use and minor species incentives, the drug approval process, veterinary medicine, economic realities, and husbandry issues for a wide variety of species. • The contractor shall provide miscellaneous assistance across the center with issues requiring historical knowledge of precedents and policies. The contractor shall have significant experience with current issues and past precedents as they relate to current topics facing CVM. These topics include minor use and minor species drug approval and indexing, biotechnology issues related to new animal drug approval product labeling, Drug Efficacy Study Implementation (DESI) finalization and generic new animal drug issues. Program Planning The contractor shall provide expertise as required throughout the term of the contract and will advise, facilitate and assist in: a) clarification and identification of roles and responsibilities, b) identification and analysis of resources, c) development and documentation of processes, procedures and arrangements. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA_REQ_1127360/listing.html)
- Place of Performance
- Address: FDA, United States
- Record
- SN03356312-W 20140506/140504233202-69af4cd74e8f9ae0c877775b09af78d7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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