SOURCES SOUGHT
A -- Anaylsis and Review of topics of Food Protection and Human Health
- Notice Date
- 5/5/2009
- Notice Type
- Sources Sought
- NAICS
- 813920
— Professional Organizations
- 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-09-1055892
- Point of Contact
- Karen R. Petty,, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Solicitation: FDA-09-1055892 Agency/Office: Food and Drug Administration Project Title: Analysis and Review of Topics of Food Protection and Human Health. Request for Information (RFI): This is a RFI in accordance with FAR 15.201 (e) to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication that the Government will contract for the items contained 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. This RFI is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited. 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 RFI. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any sources with capabilities or prior experience that can perform the following: Background: The Food and Drug Administration (FDA) is responsible for protecting and promoting public heath. Primary responsibilities of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) include: •Scientific assessment of claims made about nutritional properties of foods •Regulatory and research programs to address health risks associated with foodborne chemical and biological contaminants •Regulations and activities dealing with the proper labeling of foods and cosmetics •Regulations and policy governing the safety of dietary supplements, infant formulas, and medical foods •Food industry surveillance and compliance •Consumer education and industry outreach FDA Objectives: Please consider: 1.Independently, and not as an agent of the Government, establish personnel, materials, services and facilities, as described below. 2.Establish a strong working knowledge of the food supply system infrastructure, food science, relevant food safety and defense (protection) regulations, guidance documents, policies, processes, theories, educational initiatives, to include: a.NIPP / Food and Agriculture Sector Collaborative Efforts b.Homeland Security Presidential Directives pertaining to the Food & Agriculture Sector c.Bioterrorism Act of 2007 d.Food Protection Plan e.Food Sector Vulnerability and Risk Assessments 3.Launch focus groups, research, surveys using current technological matrices to support interaction with requisite food system stakeholders. 4.Create training materials, plans, documents and educational tools for subsequent use by food system stakeholders related to the following elements, but not limited to: a.Nutrition b.Food Safety c.Food Defense 5.Examine and assess food system stakeholder’s utilization of existing FDA guidance tools, in an attempt to determine: a.saturation and penetration of guidance tools and materials b.additional guidance / information needs relative to food protection and c.to assist in future marketing and distribution mechanisms / approaches d.relevance of existing documents or necessary updates 6.Begin Comprehensive Reviews, Abbreviated Reviews, and Technical Investigation and Analysis for Potential Solutions. Conducting reviews and analysis on a variety of food protection topics, in response to specific questions developed by the FDA. The reviews and analyses would utilize the following three formats: a.Comprehensive reviews i.emphasize the essential components of an independent scientific review and evaluation, ii.make every effort to minimize bias in the review of scientific information and account for complexities in issued raised and iii.submit a final report that clearly and carefully documents divergent scientific opinions. iv.Within thirty days of initiation of each Comprehensive Review, a detailed Scientific Plan that describes a reasonable approach to address the scientific questions posed by FDA. This plan would take into account the complexities of the issues raised. A project schedule would be included in the Plan to indicate how the contractor shall organize the work to be performed for each Comprehensive Review. b.Abbreviated Reviews i.provide rapid analysis and summarize findings of emerging issues, using either a “Quick Response Action on Request” (see 1. below) or a Predictive Response (see 2. below) upon direction from the FDA. 1.quick response action on request would address scientific issues such as the scientific merit of research proposals, new research, food processing and technological developments and food protection concerns. 2.predictive response would provide perspectives on issues in the field of food protection for approaching scientific areas of science evaluation which are relevant to FDA’s mission. c.Technical investigation and analysis: i.identify potential solutions to specific food protection issues identified by the FDA, ii.perform investigations and analysis of the food processing, production, distribution and service systems to evaluate these issues and iii.assist in the determination and validation of preventive measures that can be applied to industry, particularly small to medium businesses, to minimize, to the extent possible, food protection vulnerabilities. iv.Technical investigation and analysis of potential solutions to specific food safety or food defense issues would be requested under the terms of this contract. These investigations and analysis will utilize approximately twenty (20%) percent of the contract resources. These investigations involve a review of the food processing systems and activities and determination and validation of the preventive measures that can be applied by industry, particularly small and medium business, to eliminate or minimize food safety hazard or food defense vulnerability. RFI Submission Instructions: FDA will not award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses will be separated from, and have no bearing on subsequent evaluations of proposals submitted in response to any resulting formal RFP. Eligibility in participating in a future acquisition does not depend upon a response to this notice. Proprietary information is not being solicited. Information considered proprietary, if any, should be identified as such. Responses will be reviewed only by FDA personnel and will be held in a confidential manner. Responses to the RFI should address the following: Companies are encouraged to respond if they have the capability and capacity to provide the services with little or no disruption of services to the current users at the FDA. However, be advised that generic capability statements are not sufficient for effective analysis of respondents' capacity and capability to enable FDA to examine, analyze, review, verify, improve upon existing and develop, if necessary, mechanisms related to food safety and defense (protection) to protect, promote and preserve the public’s health and well-being. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Part A: Technical and Capabilities--Provide a capability statement describing how your institution would enable FDA to examine, analyze, review, verify, improve upon existing and develop, if necessary, mechanisms related to food safety and defense (protection) to protect, promote and preserve the public’s health and well-being. Part B: Cost Estimate--Provide a cost estimate for the services and the number of hours to enable FDA to examine, analyze, review, verify, improve upon existing and develop, if necessary, mechanisms related to food safety and defense (protection) to protect, promote and preserve the public’s health and well-being. Part C: Organizational Conflict of Interest--If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest to enable FDA to examine, analyze, review, verify, improve upon existing and develop, if necessary, mechanisms related to food safety and defense (protection) to protect, promote and preserve the public’s health and well-being. Part D: Security Requirements--At project completion, while the generated data, information and recommendations are considered public property, describe your ability to provide cleared contractor personnel for the project ensuring data accuracy and integrity. Part E: Business Size—Provide your business size, ie. Small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. Although anticipated NAICS code is identified in the Fedbizopps posting, all NAICS codes will be reviewed. Part F: Small Business--Describe your ability to meet the requirements in accordance with 52.219.14—Limitation on Subcontracting. Responses shall be: 1.Identified with the RFI number; and include: Company’s name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.No more than ten (10) pages in length; 3.NOT submitted using the marketing materials; 4.Submitted to the email as indicated above. SUBMISSIONS ARE DUE no later than 5:00pm, on May 12, 2009, Eastern Standard Time. The RFI response shall be e-mailed to: Karen.petty@fda.hhs.gov. All information received in response to this notice that is marked proprietary will be handled accordingly. FDA makes no implied or in fact contracts by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=8ac7275b8458bb4ed131123713bd3b09&tab=core&_cview=1)
- Place of Performance
- Address: 5600 Fishers Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01809447-W 20090507/090505221520-8ac7275b8458bb4ed131123713bd3b09 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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