SOURCES SOUGHT
B -- Development of Fact Sheets for Preventative Controls for Human Foods
- Notice Date
- 6/6/2015
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- 1149746
- Point of Contact
- James G. Whitt, Phone: 2404027627
- E-Mail Address
-
james.whitt@fda.hhs.gov
(james.whitt@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this sources sought synopsis is to gain knowledge of potential qualified small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code 541990. Responses to this sources sought synopsis will be used by the Government to make appropriate determinations about potential sources. Project Title: Development of Fact Sheets for Preventative Controls for Human Foods Background: On January 4, 2011, President Barack Obama signed into law the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA; Pub. L. 111- 353), which, among other things, requires that FDA establish standards for conducting a hazard analysis, implementing preventive controls for the hazards, and documenting the implementation of the preventive controls by facilities that manufacture, process, pack, or hold food ("preventive controls regulation"). The provisions within the statute require the FDA to issue guidance documents related to hazard analysis/preventive controls. The FDA intends to issue guidance that will explain the new requirements, including making recommendations for how to conduct a hazard analysis and determine appropriate preventive controls. The FDA anticipates that guidance specific to food types will also be needed. Technical information for development of such guidance documents has been obtained through prior FDA contracts. To successfully implement FSMA, the FDA must also provide technical support to its own inspectors and compliance staff, as well as corollary staff in the states. The preventive controls rule that the FDA is developing will recognize that, within the new regulatory framework, there is frequently more than one way to comply and achieve FSMA's food safety purpose. Assessing compliance, thus, requires that the FDA and state regulators make well-informed judgments based on expert knowledge of industry production systems and food safety practices. Some of these judgments about ways to comply will be reflected in published guidance and some will be made in the context of individual inspections, where inspectors will need real-time support and technical input from qualified FDA experts. Information is needed on typical processes for a variety of product commodities to provide a "refresher" to investigators on a specific process/product commodity during preventive controls based inspections. Summary of Requirements: The Contractor will be required to develop eight (8) draft preventive control fact sheets for human food that will provide an overview of the typical process (product flow) from receiving ingredients to shipping the finished product, summarize typical hazards (biological, physical, chemical) associated with these products and processes, describe key control measures to protect the product from contamination, note key sanitation/GMP requirements, and note any other relevant considerations, such as those related to transportation. The Contractor will be required to develop one (1) fact sheet for each of the following commodities: 1. Bakery products (focus on control of allergens) 2. Nuts/Nut Products 3. Fresh cut produce 4. Spices / Seasonings 5. Dairy Products - (Soft, unripened, fresh cheese; Semisoft cheese; Soft ripened cheese) 6. Chocolate/confections/candy (focus on control of allergens) 7. Breakfast cereals 8. Pasta (dry and fresh) Draft fact sheets shall be developed for the commodities listed. Any change in the scope of the commodities (e.g., selecting a specific type of product within a commodity such as bakery products) must be approved in advance by FDA. The fact sheets must include specific information about the primary hazards of concern, the types of equipment involved in processing the commodity, the mitigation strategies that are key in controlling the hazards of concern, the types of sanitation procedures applicable to the commodity (e.g., dry cleaning vs. wet cleaning) and the types of cleaning equipment/procedures likely to be used (e.g., vacuums vs. CIP systems), specific areas for inspectional focus, and conditions of concern. In performing the work, the Contractor will need to apply its working knowledge of the food supply system infrastructure, food science, food safety regulations, industry and regulatory guidance documents, policies, and processes. Scientific references used by the Contractor must be documented for each fact sheet. The period of performance is anticipated to be nine (9) months from the contract effective date. Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size - Times New Roman 11 or larger). A copy of the company capability statement will also be accepted (but not in place of providing responses to the questions). After review of the responses received, a combined synopsis/solicitation may be published in the Federal Business Opportunities. Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions: 1. Is your business a small business under the NAICS code? 2. Does your firm qualify as a small disadvantaged business? 3. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small Business Act. 4. Are you considered a certified HUBZone firm? 5. Are you considered a woman-owned or operated business? 6. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business? 7. Is your company familiar with the Food Safety Modernization Act (FSMA) and the Good Manufacturing Practice (GMP)? If so, please explain in detail. 8. Does your company have the subject matter experts in hazard analysis/preventive controls regulations to meet FDA's needs? If so, explain in detail. 9. Does your company have any prior experiences with FSMA requests (Government or Commercial)? If so, explain in detail. 10. Does your company have the necessary personnel, services, facility and materials to perform the services stated in this source sought notice? If so, explain in detail. This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this notice can be mailed to: U.S. Food and Drug Administration Attn: James G. Whitt Office of Acquisitions and Grant Services 5630 Fishers Lane, Room 2107 Rockville, MD 20857 Electronic mail responses will also be accepted at: james.whitt@fda.hhs.gov. Telephone responses will not be accepted. Responses must be received in writing, by no later than June 15, 2015, 4:30 PM, Eastern Time. No solicitation is currently available. Responses to this sources sought synopsis will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors' list, or a request to receive a copy of the solicitation. Reference No. 1149746.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1149746/listing.html)
- Place of Performance
- Address: Contractor's facility., United States
- Record
- SN03755785-W 20150608/150606233036-3214e1e47cc3cb23f284b8d2da2d98d0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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