Nutrition and Food Safety Policy Analysis and Technical Assistance

Combined Synopsis/Solicitation: Nutrition and Food Safety Policy Analysis and Technical Assistance DESCRIPTION: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the solicitation; quotations are being requested and this solicitation is issued as an invitation request for quotation (RFQ). This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This solicitation is issued as request for quotation (RFQ). NOTICE OF INTENT The Government intends on soliciting from Dr. Kathleen Koehler, pursuant to FAR 13.106-1(b) because Dr. Kathleen Koehler is the only one source that is reasonably available to satisfy agency requirements. The anticipated period of performance will be for one year from the date of award. Dr. Kathleen Koehler is a world-renowned researcher in nutrition and food science and is a widely recognized authority on food safety, applied nutrition, risk analysis, and nutritional epidemiology. She served as an academic researcher, lecturer, and professor at the University of New Mexico for more than 15 years and is a licensed nutritionist. In addition, Dr. Koehler, served in senior level policy positions in both the Food and Drug Administration and the Office of the Secretary, HHS, working directly on food safety and applied nutrition for 15 years. Her pioneering research and analysis on trans fat resulted in changes in the Nutrition Facts Panel, requiring that trans fat be included on the panel. Her groundbreaking work examining the risks and benefits of fish consumption resulted in changes to advice to the American public on eating fish. Dr. Koehler has received many honors for her contributions to nutrition policy and science, including the Mary C. Egan Award for Public Health Nutrition from the American Public Health Association and Food and Drug Administration awards for conceiving, developing, and issuing a pioneering risk and benefit assessment and review of research on commercial fish products and for developing and writing the proposed rule, Trans Fatty Acids in Nutrition Labeling, Nutrition Content Claims and Health Claims. Dr. Koehler has written extensively and for nearly 40 years on food and human nutrition issues, including nutrients, food additives, and supplements and their role in health and health risk; metabolic diseases; nutritional support policies; nutrition trends in children and older adults; foodborne illness; food allergies; and dietary and biochemical data and its strengths and limitation for policy research. Her body of work includes the publications listed below. The nature of this contractor requires a direct and in-depth knowledge of FDA and Administration priorities on food safety and nutrition, expert knowledge of the epidemiology and nutrition literature related to dietary sodium and health, senior level experience working directly on major HHS initiatives related to sodium reduction and heart health, including the Million Hearts initiative, nutrition facts labeling, and front of pack labeling, and the Dietary Guidelines for Americans. Dr. Koehler has led and worked directly on all of these issues during her tenure at FDA and HHS - something no one else has done. Her extensive background experience in both academic and policy research, policy development and advising, and her knowledge of government regulation and policymaking within FDA and HHS make her uniquely qualified to provide expert advice to this effort. In addition to the fact that Dr. Koehler is uniquely qualified for this work, there is urgency in getting this procurement awarded and the work completed. The analysis that is required is time sensitive in that it is needed for imminent policy decisions and guidance and regulation development. HHS/FDA has been given statutory deadlines for developing regulations and guidance to implement FSMA. At this point, some of these deadlines have been missed and FDA has been required by the courts to complete its work by a certain date. Additionally, the White House and outside groups have been vocal about the need for HHS to take action in a number of these areas. A.1 TASK ORDER PRICE The services under this task order are Time & Materials, severable services. The total amount for this task order is tiny_mce_marker_TBD____. A.2 PAYMENT SCHEDULE The Contractor shall be paid upon completion and acceptance (if deliverable) or verification (if service) by the Contracting Officer's Representative (COR), of the deliverables and/or services for the reporting period. Invoices shall be submitted monthly in accordance with the instructions contained in FAR Clause 52.232-25, Prompt Payment, and Section E.1. The Contractor shall be paid upon completion, submission and approval of the deliverables described in Section B.4. In consideration of satisfactory performance of the work as described throughout this contract/order, the Contractor shall be paid in accordance with the fixed loaded hourly rates as shown herein for the specified categories of labor based on the number of actual hours incurred in the performance of the work specified. Fully loaded rates shall be all inclusive of direct labor, fringe benefits, applicable indirect costs, and any profit for each labor category. The Contractor shall be reimbursed up to the task order ceiling for hours actually worked. Additionally, the contractor shall be paid for materials directly chargeable to this contract/order. BASE YEAR Time and Materials Labor Categories Estimated Hours Fixed Loaded Hourly Rate Total Estimated Cost Per Category Total Direct Labor $TBD Travel $TBD Other Direct Costs $TBD Total Travel and ODCs $TBD Total Ceiling Price $TBD B. STATEMENT OF WORK The purpose of this professional services contract is to obtain expert nutrition and epidemiological advice from Dr. Kathleen Koehler, a leading authority on human nutrition, food safety, risk assessment, and epidemiological methods. The Office of the Assistant Secretary for Planning and Evaluation is conducting research and technical analysis to support HHS policymaking in several areas of applied nutrition and food safety, including sodium reduction in the U.S. food supply, nutrition information on food packages and in restaurants, consumption of fish by certain population groups, and risk-based methods for evaluating the safety of chemical substances in foods and reducing foodborne illness from consumption of domestically-produced and imported foods. Current efforts are focused on the development and use of novel methods for understanding challenges and benefits of specific policies. Additionally, there is a need to provide technical assistance to ASPE analysts on the use of these methods for future analytic studies. B.1. BACKGROUND HHS is currently implementing numerous federal statutes and Administration priorities related to food safety and nutrition, including provisions of the Food Safety Modernization Act (FSMA) and the Patient Protection and Affordable Care Act (ACA). The HHS Strategic Plan, Goal 3, Advance the Health, Safety, and Well-Being of the American People, includes Objective D: Promote prevention and wellness. Strategies for accomplishing this objective include helping American children and adults achieve and maintain healthy weight and educating and empowering individuals and families to lead healthy lifestyles and adopt behaviors that can prevent or delay chronic disease, disability, and secondary conditions. Also, the HHS Strategic Plan, Goal 2, Advance Scientific Knowledge and Innovation, includes Objective C: Invest in the regulatory sciences to improve food and medical product safety. Strategies for achieving this objective include implementing a new, public health-focused approach to food safety that sets priorities for prevention, strengthens surveillance and enforcement, and improves response and recovery; Food Safety Modernization Act About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable. The FDA Food Safety Modernization Act (FSMA) enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities. Congress has established specific implementation dates in the legislation. Some authorities will go into effect quickly, such as FDA's new authority to order companies to recall food, and others require FDA to prepare and issue regulations and guidance documents. The following are among FDA's key new authorities and mandates. Specific implementation dates specified in the law are noted in parentheses: Prevention For the first time, FDA has a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes: - Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise. (Final rule due 18 months following enactment) - Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. (Final regulation due about 2 years following enactment) - Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. (Final rule due 18 months following enactment) Inspection and Compliance The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge. FSMA provides FDA with important new tools for inspection and compliance, including: - Mandated inspection frequency: The FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. - Records access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans. - Testing by accredited laboratories: The FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards. (Establishment of accreditation program due 2 years after enactment) Response The FSMA recognizes that FDA must have the tools to respond effectively when problems emerge despite preventive controls. New authorities include: - Mandatory recall: The FSMA provides FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA. - Expanded administrative detention: The FSMA provides FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law (administrative detention is the procedure FDA uses to keep suspect food from being moved). - Suspension of registration: FDA can suspend registration of a facility if it determines that the food poses a reasonable probability of serious adverse health consequences or death. A facility that is under suspension is prohibited from distributing food. (Effective 6 months after enactment) - Enhanced product tracing abilities: FDA is directed to establish a system that will enhance its ability to track and trace both domestic and imported foods. In addition, FDA is directed to establish pilot projects to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or control a foodborne illness outbreak. (Implementation of pilots due 9 months after enactment) - Additional Recordkeeping for High Risk Foods: FDA is directed to issue proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that the Secretary designates as high-risk foods. (Implementation due 2 years after enactment). Imports The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include: - Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment) - Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment) - Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S. - Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment) - Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located. Enhanced Partnerships The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. In doing so, the statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals. Patient Protection and Affordable Care Act (ACA) The Affordable Care Act (ACA) includes a provision known as "menu-labeling". This provision, administered by FDA under the Food Drug and Cosmetic Act, requires restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to the Federal requirements by registering every other year with FDA. Providing calorie and other nutrition information in restaurants and similar retail food establishments would assist consumers in making healthier dietary choices. In April, 2011, FDA issued proposed regulations for public comment to implement the ACA menu-labeling provisions, and is currently developing final regulations, taking account of the numerous public comments received. Support for FSMA and ACA/Menu Labeling Implementation Significant analytical work is needed to support new rules and guidance to implement these provisions. While FDA is primarily responsible for conducting these activities, the Immediate Office of the Secretary and FDA rely heavily on ASPE to conduct objective policy and technical analysis to inform the development of regulations and sub-regulatory documents and to ensure that the regulatory and sub-regulatory work incorporates sound science and represents the best policy choices. For certain of these areas, very specialized expertise is needed to develop and/or employ methods of analysis. On January 16, 2013, FDA published for public comment a proposed rule on preventive controls for human food and a proposed rule on standards for produce safety. Although FDA has made steady progress in FSMA implementation, many of the deadlines for issuing FSMA-related rules have passed and there is much urgency for HHS to complete its work. Sodium Reduction in the U.S. Food Supply On September 13, 2011, the Department of Health and Human Services, with several key initial partners, launched Million Hearts, an initiative that aims to prevent one million heart attacks and strokes over the next five years. As one component of this initiative, the FDA and the USDA Food Safety and Inspection Service (FSIS) are launching efforts to identify opportunities to reduce sodium in food in order to put more control into consumers' hands. Excess sodium is a contributory factor in the development of hypertension, which is a major risk factor for heart disease and stroke. A 2010 report by the Institute of Medicine provided recommendations for strategies to reduce population sodium intake. Research shows that excess sodium consumption is a contributory factor in the development of hypertension, which is a leading cause of heart disease and stroke, the first and fourth leading causes of death in the United States, respectively. Research also shows that the increase in blood pressure seen with aging, common to most Western countries, is not observed in populations that consume low sodium diets and that the U.S. population consumes far more sodium than recommended. Moreover, dietary reduction of sodium can lower blood pressure as has been demonstrated in the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial. Because over three-quarters of sodium in the diet of the U.S. population is added during manufacturing of foods and preparation of restaurant foods, reduction in sodium consumption in the United States involves reduction in the sodium content of food in the U.S. marketplace. According to national food survey data from the "What We Eat in America, National Health and Nutrition Examination Survey (NHANES) 2007-2008," estimated average sodium intake from foods among persons in the United States aged 2 years or older is approximately 3,300 milligrams per day (mg/d) (excluding salt added at the table). Most of this sodium comes from salt used in the manufacture or preparation of foods. In 2005, the IOM set a Tolerable Upper Intake Level (UL) for sodium at 2,300 mg/d and an Adequate Intake (AI) at 1,500 mg/d for those 9 to 50 years of age, including pregnant and lactating women (AIs are lower for those 0-8 years of age and for those over 50 years of age). The 2010 Dietary Guidelines for Americans recommendations are to reduce daily sodium intake to less than 2,300 milligrams (mg) and further reduce intake to 1,500 mg among persons who are 51 and older and those of any age who are African American or have hypertension, diabetes, or chronic kidney disease. The 1,500 mg recommendation applies to about half of the U.S. population. Current sodium intake is substantially higher than what has been recommended by scientific and public health agencies and organizations in recent years. The Centers for Disease Control and Prevention (CDC) reported in 2010 that over 80 percent of adults (>=20 years) recommended to consume less than 2,300 mg/d of sodium in fact consumed more than 2,300 mg/d. An analysis of the potential savings from reduced sodium consumption in the U.S. adult population found that reducing average dietary sodium intake to 2,300 mg/d among adults 18 years or older could have substantial health and financial benefits. Estimates showed potential reduction of 11 million hypertension cases and an annual savings of $18 billion health care costs. Another assessment on the cost-effectiveness of reducing sodium intake found that an intervention achieving a reduction of 1,200 mg/d would save $10 to $24 billion in health care costs annually, comparable to benefits of population-wide reductions in tobacco use, obesity, and cholesterol levels. Furthermore, this analysis found that a modest reduction over 10 years of about 400 mg sodium/d would be more cost-effective than using medications to lower blood pressure in all persons with hypertension. HHS is considering potential ways to promote gradual, achievable and sustainable reduction of sodium intake over time. Research on a variety of issues, including the development of possible targets for the reduction of the sodium content of foods, is underway to assist in this effort. Additional Nutrition and Food Safety Priorities and Activities Additional detail about FDA activities encompassed by Goals 2 and 3 of the HHS Strategic Plan is outlined in the FDA Strategic Plan for Food and Veterinary Medicine (FVM). The FVM Strategic Plan presents the FVM Program Vision: Protect consumers and promote the public health by safeguarding America's food supply and enabling consumers to choose healthy diets. In addition to implementation of FSMA and menu labeling and reduction of sodium in the food supply, mentioned above, objectives and key initiatives include updating the Nutrition Facts label, exploring front-of-pack nutrition labeling opportunities, publishing a final rule for optional "gluten-free" labeling of food, and reducing industrially-produced trans fat in the food supply. Not every ongoing activity of the FVM Program is specified within the Strategic Plan. Notable ongoing activities include review of infant formula notifications, pre? and post?market regulation of ingredients and packaging, monitoring for chemical contaminants, authorization of nutrient content and health claims, cosmetics safety and labeling, and ongoing regulatory, enforcement, research, communications, education and outreach activities. B.3. TASKS The contractor shall conduct new analyses to support the development or refinement of new regulations and sub-regulatory documents. The contractor shall also conduct technical review of draft regulatory documents to assess the completeness and quality of the scientific findings and the policy options derived from those findings. Finally, the contractor shall deliver technical assistance on how to conduct these analyses and provide briefings to ASPE on the results of work conducted under this contract. ASPE anticipates that the contractor shall have the need to work on-site at our offices at 200 Independence Avenue, SW, Washington, DC, during some periods. During on-site work, ASPE will furnish computer equipment, office space and supplies; arrange access to library resources; and facilitate building access for the contractor. Task 1: Project Orientation Meeting Within two weeks of contract award, the contractor shall meet with the Contracting Officer's Representative (COR) and relevant ASPE staff. The purpose of the meeting will be to review and clarify the project's objectives and address any questions the contractor, ASPE staff, or the COR may have. The contractor shall create the meeting agenda and discussion topics shall include, but not be limited to: the general scope of the project; approach to the analysis and review tasks, timelines for analytical and review tasks, communication with the COR, and any other issues needing clarification or elaboration. The contractor shall provide to the COR a brief summary of no more than 2 pages within 2 weeks of the meeting date. Task 2: Conduct Research and Analysis to Inform HHS Regulatory Work Throughout the contract period as requested by the COR, the contractor shall conduct research and analysis to estimate the health impacts of draft regulations and guidances developed by FDA to improve nutrition, food safety, and associated human health. For example, it is expected that the contractor will be requested to estimate reductions in myocardial infarction, hypertension, stroke, and death from reducing sodium in the diet. Another current HHS need is an estimate of health impacts, such as reductions in overweight and obesity, from providing nutrition information for consumers on food packages and on restaurant menus. The contractor shall provide a State of the Science summary for each health impact estimate within 4 weeks of being requested by the COR. The State of the Science summary will include a statement of the problem, a summary of a preliminary review of the literature, recommended options for carrying out an estimate, preliminary estimates for each option where feasible, and the barriers to completing each option, including absence of needed data. After completion of the State of the Science summary, the contractor will carry out any additional analysis with a scope and timeline determined in consultation with the COR. The contractor shall also provide all related data tabulations and results to the COR within 2 weeks after submitting the State of the Science summary and after submission of any further written reports. Task 3: Review Nutrition and Food Safety Regulatory Documents Throughout the contract period as requested by the COR, the contractor shall conduct technical review of draft regulatory documents to assess the completeness and quality of the scientific findings and the policy options derived from those findings. The contractor shall meet with the COR prior to each review to agree on the scope and criteria for the review, timeline for review, and format of the review summary that will be submitted to the COR. The contractor shall submit the written review summaries to the COR according to the timelines established for each review. Task 4: Delivery of Technical Assistance and Briefings Throughout the contract period, the contractor shall provide expert technical assistance on nutrition and food safety issues to ASPE and other HHS staff. The contractor's technical assistance will draw from expertise in human nutrition and food issues, including nutrients, food additives, and supplements and their role in health and health risk; metabolic diseases; nutritional support policies; nutrition trends in children and older adults; foodborne illness; food allergies; and dietary and biochemical data and its strengths and limitation for policy research. This shall include briefings as well as small group sessions to explain the analyses conducted in tasks 2 and 3 as well as other nutrition and food safety issues identified by the COR. This work will provide regulatory history, context, principles and guidance as HHS technical and policy staff prepare to conduct the type of research and review conducted under this contract in the future. For budgeting purposes, offerors should assume a total of 150 hours for TA, including both preparation time and contact time. In general, this will be provided as an average of 8-12 hours per week during selected weeks of the contract, as determined in consultation with the COR. from week 4 to week 20 will be spent providing technical assistance to HHS staff. It is anticipated that the contractor may provide more technical assistance on some weeks than others, but that the total number of hours of TA will be 150 hours. The contractor shall report on the delivery of technical assistance in the monthly progress reports. Task 5: Monthly Reports The contractor shall prepare brief monthly memoranda, to be conveyed to the COR via e-mail, documenting the progress of the project. These reports shall summarize for each month the specific work done, problems encountered, work anticipated in the coming month, the proportion of labor hours expended each month. These reports shall be no more than 2 pages and shall be submitted to the COR within 15 days after the end of each month. B. 4. SCHEDULE OF DELIVERABLES AND ACTIVITIES All deliverables required under this contract shall be delivered to the COR for review and approval before final acceptance. Task Deliverable Due Date 1. Project Orientation Meeting Meeting summary 4 weeks after EDOC 2. Research and Analysis State of the Science Summary Related Data Further Analysis 4 weeks after requested by the COR Data 2 weeks after State of the Science summary Scope and timeline of Further Analysis determined in consultation with the CPR 3. Document Review Review summaries As determined by the COR 4. Technical Assistance and Briefings As requested by the COR 5. Monthly reports reports 15 days after the end of each month All deliverable products should be submitted electronically to the COR as attachments to e-mail. C. INSPECTION AND ACCEPTANCE C.1 OBSERVANCE OF FEDERAL HOLIDAYS The requested work schedule will be Monday - Friday, excluding all federal holidays generally, between 8:30 am - 7:00 pm. No services or deliveries shall be performed on Saturdays, Sundays or Federal legal holidays as shown below: Observance of Federal Holidays 1. New Year's Day January 1st 2. Martin Luther King's Birthday Third Monday in Jan. 3. President's Day Third Monday in Feb. 4. Memorial Day Last Monday in May 5. Independence Day July 4th 6. Labor Day First Monday in Sept. 7. Columbus Day Second Monday in Oct. 8. Veteran's Day November 11th 9. Thanksgiving Day Fourth Thursday in Nov. 10. Christmas Day December 25th C.2 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) Required Services/Tasks Performance Standards Method of Surveillance (Quality Assurance) Standard to be Met/Allowable Deviation Deduction Customer Satisfaction Contractor adheres to guidance provided by COR. COR and ASPE feedback Fewer than 4 complaints during the contract period, including COR comments Up to 1 percent of invoice Overall Contract Management, Including Timeliness Contractor maintains high level of quality assurance, responsiveness to COR and Contracts Officer, reliability, completeness of tasks. Contacts the COR immediately with any issues or problems, and meets time frames in the delivery schedule. COR and Contracting Officer monitoring; deliverables; monthly reports. COR makes no more than 4 valid complaints during the contract period. No more than a two week delay in agreed upon schedule. Up to 2 percent of invoice Written Products Contractor provides high-quality written materials. COR monitoring and other ASPE reviewe...