18-223-SOL-00058.docx

Access to National Market Share Data for Surveillance of Specific Consumer Packaged Goods in the U.S. Market 18-223-SOL-00058

SECTION B -SUPPLIES OR SERVICES AND PRICES / COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The US Food and Drug Administration (FDA) intends to place an open market firm-fixed-price order under commercial Simplified Acquisition Procedures to acquire access to and use of retailer scanner data from all national outlets for the purposes of surveillance of specific consumer packaged goods in the U.S. market, customer/technical support, training and reporting.

B.2 CONTRACT TYPE

This is an Indefinite Delivery Indefinite Quantity (IDIQ) type contract with a five (5) year ordering period. Task Orders may be Firm Fixed Price or Time & Materials/Labor Hour.

B.3 SUPPLIES OR SERVICES AND PRICES / COSTS

PRICING TERMS FOR LABOR HOUR TASK ORDERS

The fully burdened labor rates specified in labor hour task orders shall be in accordance with the negotiated and agreed upon labor rates identified in the IDIQ pricing schedule and apply to the effective task order period of performance. Labor rates are not subject to adjustment. The labor hour ceiling is not subject to an adjustment except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the task order. Labor Ceiling increases may only be approved via issuance of a fully executed bi-lateral modification by the Contracting Officer. However, in no event shall the Contractor perform, or be paid for any work which exceeds the labor hour ceiling or not-to-exceed amount identified in task order.

PRICING SCHEDULE: LABOR CATEGORIES AND RATES (Fully Burdened Hourly Rate) ORDERING PERIODS 1 – 5 September 1, 2018 THRU August 31, 2023

Ordering Period 5

Project Manager

Database Specialist

Market Analyst Specialist

Data Entry Specialist

Quality Assurance Analyst

Training Specialist

Statistician

Software Developer

PRICING TERMS FOR FIRM FIXED PRICE TASK ORDERS

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable unit price shall be in accordance with negotiated and agreed upon pricing identified in the IDIQ pricing schedule (Section B). Firm Fixed unit pricing shall be in effect for the time period in which the services are estimated to be performed, as agreed to by the Government and the Contractor at the time the task order is issued. The price(s) specified in FFP task orders issued under this contract is/are fixed and not subject to adjustment.

ACCESS STRUCTURES AND PRODUCTS (FIRM FIXED PRICE)

ORDERING PERIODS 1-5: September 01, 2018 THRU August 31, 2023

FDA Access to National Brand Sales Scanner Data for A Certain Number of Users per the requirements in the Statement of Work

2018-2019 Year 2 Price 2019-2020 Year 3 Price 2020-2021 Year 4 Price 2021-2022 Year 5 Price 2022- 2023

Enterprise – Access (50 users)

Enterprise – Access (30 users)

Enterprise – Access (15 users)

Enterprise – Access (1 user)

Data Report/Pulls

As needed

Scan Images/data entry

MINIMUM AND MAXIMUM CONTRACT VALUE

(a) Award of the base period of the initial task order is the guaranteed minimum for the IDIQ contract.

(b) Estimated maximum ceiling amount for this contract is $4.9 million over a 5 Year ordering period.

SECTION C: STATEMENT OF WORK

1. INTRODUCTION

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Additionally, the FDA is responsible for reducing and preventing tobacco-related harms. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information it needs to use medicines and foods to improve their health.

The Center for Food Safety and Applied Nutrition (CFSAN) at FDA in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. The Center regulates $417 billion worth of domestic food, $49 billion worth of imported foods, and over $60 billion worth of cosmetics sold across state lines. The FDA has heavily invested in systems to collect post market information, monitor trends, and produce data reports in order to achieve this responsibility and to maintain compliance with congressional mandates. Additional organizational information is provided in Appendix A.

2. BACKGROUND

CFSAN has been accessing and using weekly retailer scanner data to monitor market conditions and changes of the consumer packaged goods in the United States since 2003. The continuous monitoring has enhanced CFSAN’s ability to fulfill its mission of protecting and promoting public health. The availability of the data also has enabled CFSAN to conduct research and surveillance in the areas under its jurisdiction, including product labeling and ingredient safety. The latest data that CFSAN has access to will end in September 2017. It is vital for CFSAN to maintain its access to this data to improve our performance and contribute to the public health mission. Access to scanner data would serve to strengthen FDA’s post-market surveillance efforts by providing near real-time data with quality reporting standards for a litany of product categories it regulates.

3. PURPOSE

CFSAN requires access to and use of retailer scanner data (point of sale) from all outlets including Walmart and for past and future years for use in mission critical work and future surveillance efforts. Our past datasets consisted of categories/modules that were sent as raw files for a particular year as well as direct access to data over 5 years, which began in 2016. We are requesting direct access to data so that we can have the most current available data to run queries and extract data for reports. We also require specific data pulls of raw data. Data that are compatible with our existing scanner data are necessary to continue ongoing research projects that use data of identical characteristics and to develop new research projects. The data shall also allow FDA to expand time-series research projects by implementing the same analytical approach with the most recent data.

The objective of this acquisition is to obtain access to national retail sales scanner data from markets representing the total U.S. for the years 2013 – 2017. The access in conjunction with other sources of data available to FDA will allow us to continue monitoring packaged consumer goods in the U.S. market, conduct surveillance, and enable analyses that will inform health and safety policy decisions.

4. OBJECTIVES

· Obtain continued direct access to post market products through National Brand Sales Scanner.

· Obtain flat data files of National Brand Sales Scanner data based on specific requests.

· Obtain real-time access to post market surveillance data.

· Improve the accuracy and quality of information included in post market studies.

· Improve the accuracy and quality of research and publications.

· Obtain a cost effective solution for access to supplemental post market data at an enterprise level.

· Use the information to conduct post market surveillance on FDA regulated products to predict, identify and track emerging public health benefits and threats.

· Use the information to initiate appropriate response to ensure the safety of FDA regulated products and the public.

5. SCOPE

This contract encompasses access to National retail scanner data; additional services to obtain product label information and digital images and private label information; ensure system availability; ensure knowledge of the end user on how to use the system, the data, and available features.

6. TASK AREAS

6.1. Task Area 1: 6.1 Access to National Brand Sales Scanner Data

6.1.1 Enterprise Access

Enterprise Access is the ability of authorized FDA users (described below) to run queries, reports and analysis on products, time periods, geographies, measures, and syndicated attributes, to share National retail scanner data across the FDA enterprise including with HHS partners and contractors and to publicize aggregate data in support of public health issues tracked and regulated by the FDA. The Enterprise Access Structure shall provide the following online representative features and functionalities:

· Unlimited access to national retail scanner database which shall include Walmart.

· Concurrent enterprise access rights for up to 150 FDA users (which can be reassigned but not limited to people who leave the FDA or change jobs or job roles, etc.)

· Ability to purchase FDA user access in 1-user, 10-user, 15-user, 30-user and 50 user increments.

· Users shall have the ability to run queries and build reports online.

· Users shall have the ability to extract reports in the following formats: TXT, CSV, Excel, PDF, PowerPoint, and Word.

· Users shall have access to the database data dictionary, including definitions of all fields and data elements and what these fields and elements fully represent, any other data guides, and documentation on any abbreviations or acronyms used in the dataset.

· Shall provide access to information detailing sampling methodology, how data was projected, store participation lists, and any other data or information that is required by FDA users to perform data analysis.

· Notification of database or database-related information updates, changes, modifications, eliminations or additions.

· Provide written documentation about how the data compares (e.g sampling methodology, data representation, etc.) to data we have purchased from other vendors.

· Access to written documentation on how to appropriately work with differences in data availability between comparison years, including applying techniques for trend analyses.

· Access to written documentation on all quality control procedures.

· In-person training for Enterprise – Access levels of 150 users, 50 users, 30 users, and 15 users at Government facilities.

· Online access to audiovisual training resources for FDA users (e.g. webinars).

· Vendor shall provide data verification of reports run by FDA via phone or online chat.

· Provide consultation to registered FDA users on configuring/refining FDA-run queries, representative activities include general inquiries on how to build queries, filter, and run reports.

· Provide advice on using measures and attributes in the system.

· Contractor shall monitor, record, and report number of concurrent users that have access to the database, identities of users, training sessions provided and number of data reports generated under the pertinent access structure.

6.1.2 Enterprise Database Access Technical Support

The Contractor shall provide Enterprise Database Access Technical Support. Technical support will be available Monday-Friday 9:00 am – 6:00 pm EST. Representative activities for technical support include the following:

· Provide system administration activities.

· Phone, online, or email support on system access issues (e.g. account login, password, etc.).

· Maintain an issue log which shall be made available to the COR on demand.

· Notify, address and resolve system availability and functionality issues.

· Provide advice on technical report errors, format, and export issues, etc.

· Respond to general inquiries on how to use the database system.

6.2. Task Area 2: Contractor-provided Data Report of National Brand Sales Scanner Data

6.2.1 Report Requests

Contractor shall provide flat file data reports to include, but not limited to, product categories, product data elements, data years, geographies, measures (e.g. total unit sales, volume sales, dollar sales, etc.), and various descriptive attributes (e.g. type of food attributes, descriptive characteristics of foods, health and nutrition attributes, etc.) The data reports shall provide the following representative features and functionalities:

· Data reports shall be available in formats that we request (e.g.pipe-delimited, TXT, CSV, Excel, etc.

· Data Reports shall be available at different levels of hierarchy

· departments (attributes determined at task order level)

· types (attributes determined at task order level)

· categories (attributes determined at task order level)

· The report shall contain a summary on how the data was collected, data elements selected and how the data compares (e.g sampling methodology, data representation, etc.) to data we have purchased from other vendors.

· Vendor shall provide a point of contact for data report requests Monday through Friday from 09:00 a.m. to 6:00 p.m. EST, not including federal holidays.

· Participation in necessary meeting and conference calls to ensure data reports requests are understood and to clarify questions.

6.3. TASK AREA 3: Product Images and Information

FDA’s goal is to obtain package information from products that is current, accurate, quality-assured, and easily-validated. All of the information available on packages, including Nutrition Facts Label (NFL), claims, allergen and ingredient information, etc. (any text on packages) as well as images of the package shall be available in awell-organized searchable database(s) for trend and other analyses. This task area is enables image capture and data from images of food packages and collection of food product label information from products selling at the time of collection.

6.3.1. Scan Images

The Contractor shall acquire product information (e.g. scanning, images, data, etc.) for a defined number of products and provide information on the methodology of collection. As identified in task order requirements, the FDA shall provide a sampling plan, agree upon a sampling plan with the Contractor, or provide customized lists of product information requiring collection. Representative specifications for images are as follows:

· The images may include all sides of the package (i.e., front, back, top, bottom, left, right) or all surfaces for a round or odd-shaped package. The digital images shall be full-color with legible resolution. All texts on packages shall be legible.

· Access to written documentation on all image scan quality control procedures (e.g. Quality control of the images for their legibility, accuracy, and completeness).

· A pilot for acquiring product information and/or images shall be included, consisting of acquiring the images.

· Participation in necessary meeting and conference calls to align on approach, clarify questions, provide updates, etc.

Specific image scanning requirements will be identified at the task order level.

6.3.2. Data Collection

The Contractor shall collect product information data (e.g. scanning, images, data, etc.) for a defined list of FDA-identified products which may include food, drug, cosmetic, and veterinary products. Example requests may include product sales or purchase information based on UPCs, listing of products, product categories, etc. Representative activities include:

· The Contractor shall work with the FDA to determine an acceptable sampling methodology (e.g. sampling plan) to be used. Access to written documentation regarding data collection methodology shall be included.

· Access to written documentation on all sampling quality control procedures (e.g. Quality control of the images for their legibility, accuracy, and completeness).

· A pilot for acquiring product information and/or images shall be included, consisting of acquiring the data and data entry (below).

· Participation in necessary meeting and conference calls to align on approach, clarify questions, provide updates, etc.

· Provide written documentation of agreed upon management plan for data collection (e.g. general timeline).

· Access to written documentation regarding data collection methodology, data entry into the database, and information on the metadata for each data field/attributes, including all date stamps and which date represents the product on the retail shelf.

· Access to written documentation on all quality control procedures (eg: data quality).

· Purchasing items.

6.3.3. Data Entry

The Contractor shall enter collected information and/or images into an FDA-defined format as identified in individual task orders. Representative files types may include Excel or Access. Additional representative activities under this task area include:

· FDA shall provide or agree upon the data structure, fields, and metadata captured in the database.

· Access to written documentation regarding data entry into the database (e.g. for foods, drugs, or cosmetics - information on the metadata for each data field/attributes, including all date stamps and which date represents the product on the retail shelf.)

· Access to written documentation on all quality control procedures (e.g. Quality control of data entry process).

· A pilot for data entry shall be included, consisting of acquiring the data (above) and data entry.

· Provide written documentation of agreed upon management plan for data entry (e.g. general timeline.)

6.4. Task Area 4: Access to Consumer Panel Data

Access to granular, longitudinal consumption data from US households containing purchase panel, consumer survey, shopper segment and transaction information, etc. The data provides information on consumer and shopper intelligence and buyer demographics enabling a better understanding of shopper attitudes and behaviors surrounding purchases, insights on consumer understanding of products, and innovation of productsSpecific task order requests for access and custom projects added for additional fees.

· Training and support to answers questions on any purchased Consumer Panel data.

· Access to written documentation on survey methodology, etc.

· Access to written documentation on panel data terminology (data dictionary) and measures, etc.

6.5. TASK AREA 5: Training and Support

6.5.1. Training

The Contractor shall provide training utilizing National retail scanner data. Representative training activities include: onsite training, webinars, individual training on specific questions, and development of training materials for users on working with the data and the direct access platform. The Contractor is required to update training material to represent changes from upgrades and releases. The Contractor shall work with the FDA to develop additional training based on the needs and interest of the enterprise, centers, and/or offices. Representative activities include:

· Working with the data (e.g. performing analysis using sales scanner data, specific questions related to analysis by individuals)

· How to run detailed queries and reports

Training on Data

· Overview of available data elements and how they can be used

Training on Platform

· Features/functionalities of the direct platform

6.5.2. Data Analysis Services

The Contractor shall provide data analysis services to support and collaborate on data used and collected by the FDA. This may include subject matter expert support for assessing suitability, utility, and usability of data for calculations, trend analysis, statistical modeling, development of sampling plans, review of completed analyses, etc.

· Response times to data inquiry requests will be identified at the task order level.

6.5.3 Monthly Status Reports

Including the following:

Changes to the System or Data

· Additions or removal of access to data based on Contractor relationships

· Updates to metadata elements

· Updates regarding rolling access to historical data

Progress and Usage

· Record of data usage (i.e. and month-over-month and aggregate totals)

· Number of data pull requests, including size of request

· Number and log of issues and resolution of the issue

· Usage statistics of technical support requests (number and type)

· Status and progress of ongoing tasks (e.g. progress of data collection or data entry, etc.)

· The current month’s planned progress (as needed depending on tasks)

· Program risks, risk mitigation plans, risk mitigation actions taken and resolution of risks

Correspondence and Training

· Number and log of inquiries, questions, and responses

· Number and log of requested webinars and individual trainings

Performance and Cost

· All recurring and non-recurring costs

· Cumulative cost

· Total labor hours

· Cumulative labor hours for each task area for the previous month

6.6 APPENDIX:

APPENDIX A:

BACKGROUND ORGANIZATIONAL INFORMATION

Center for Food Safety and Applied Nutrition (CFSAN)

CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

Consumers spend twenty-five cents of every consumer dollar on products regulated by the FDA. Of this amount, approximately 75 percent is spent on foods.

The Center regulates $417 billion worth of domestic food, $49 billion worth of imported foods, and over $60 billion worth of cosmetics sold across state lines. This regulation takes place from the products' point of U.S. entry or processing to their point of sale. There are over 377,000 registered food facilities (including approximately 154,000 domestic facilities and 223,000 foreign facilities) that manufacture, process, pack, or hold food consumed by humans or animals in the United States and several thousand cosmetic firms. These figures do not include restaurants, institutional food service establishments, or supermarkets, grocery stores, and other food outlets regulated by state, local, and tribal authorities that receive guidance, model codes, and other technical assistance from FDA. FDA enhances its programs by supporting these authorities with training and guidance to direct uniform coverage of food establishments and retailers. The economic importance of the American food industry is enormous. It contributes about 20 percent of the U.S. Gross National Product, employs about 14 million individuals, and provides an additional 4 million jobs in related industries.

FDA's responsibility in the food area generally covers all domestic and imported food except meat, poultry, and frozen, dried and liquid eggs, which are under the authority of the U.S. Department of Agriculture (USDA's Food Safety and Inspection Service (FSIS), the labeling of alcoholic beverages (above 7% alcohol) and tobacco, which are regulated by the U.S. Department of the Treasury's Alcohol and Tobacco Tax and Trade Bureau (TTB), and the U.S. Environmental Protection Agency (EPA), which establishes tolerances for pesticide residues in foods and requirements for drinking water. FDA’s responsibility in the area of cosmetics covers all domestic and imported products.

The Center's primary responsibilities include:

Food

· the safety of substances added to food, e.g., food additives (including ionizing radiation) and color additives

· the safety of foods and ingredients developed through biotechnology

· seafood and juice Hazard Analysis and Critical Control Point (HACCP) regulations

· 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 (e.g., ingredients, nutrition health claims)

· regulations and policy governing the safety of dietary supplements, infant formulas, and medical foods

· food industry postmarket surveillance and compliance

· industry outreach and consumer education

· cooperative programs with state, local, and tribal governments

· international food standard and safety harmonization efforts

Cosmetics

· regulations and policy governing the safety of cosmetic ingredients and finished products

· regulations, policy, and other activities dealing with proper labeling of cosmetics

· regulatory and research programs to address possible health risks associated with chemical or biological contaminants

· post-market surveillance and related compliance activities

· industry outreach and consumer education

· international standard-setting and harmonization efforts

Although the U.S. food supply is among the world's safest, the increase in variety of foods and convenience items available has brought with it public health concerns. The complexity of the food industry, and the technologies used in food production and packaging, is increasing.

Sources of food contamination are almost as numerous and varied as the contaminants themselves. These include everything from preharvest conditions to contamination introduced during processing, packaging, transportation, and preparation. Some of CFSAN's current areas of food safety concern are:

· biological pathogens (e.g., bacteria, viruses, parasites)

· naturally occurring toxins (e.g., mycotoxins, ciguatera toxin, paralytic shellfish poison)

· dietary supplements

· pesticide residues

· toxic metals (e.g., lead, mercury)

· decomposition (e.g. histamine formation) and filth (e.g., insect fragments)

· food allergens (e.g., milk, eggs, peanuts, tree nuts, soybeans, wheat, fish, shellfish)

· nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity)

· dietary components (e.g., fat, cholesterol)

· radionuclides

· Transmissible Spongiform Encephalopathy-type diseases (e.g., chronic wasting disease in elk)

· product tampering

As with foods, the complexity of the cosmetic industry and the technologies and ingredients used in production of cosmetics is increasing. The increase in global trade of cosmetics has also increased the challenges in a number of areas, as products and ingredients are entering the U.S. from a wide variety of countries with different regulatory frameworks and safety standards. Some of the current areas of focus for cosmetics include:

· microbiological contaminants

· chemical contaminants

· drug vs. cosmetic products

· use of nanoscale materials as ingredients

· botanical ingredients

· alternatives to animal testing

Office of Food Additive Safety (OFAS) The Office of Food Additive Safety (OFAS) within FDA's Center for Food Safety and Applied Nutrition (CFSAN) is FDA's one-stop shop for questions about the safety of food ingredients, food packaging and food processing equipment, including sources of radiation used to treat or inspect food, and foods derived from bioengineered plants. OFAS is the lead for FDA's food and color additive petition processes, the consideration of independent determinations of GRAS status, and review of notifications for food contact substances. For more information see the OFAS Functional Statement. [copied in full text below]

Office of Food Additive Safety's Functional Statement (Staff Manual Guide 1231.16 Effective Date 07/08/2011) The Office of Food Additive Safety (OFAS) within FDA's Center for Food Safety and Applied Nutrition (CFSAN) is FDA's one-stop shop for questions about the safety of food ingredients, food packaging and food processing equipment, including sources of radiation used to treat or inspect food, and foods derived from bioengineered plants. OFAS is the lead for FDA's food and color additive petition processes, the consideration of independent determinations of GRAS status, and review of notifications for food contact substances.

The Office of Food Additive Safety:

A. Serves as the Center focal point for scientific and policy support for the development of Agency-initiated regulations on matters pertaining to the provisions of the food and color additive sections of the Federal Food, Drug, and Cosmetic Act B. Manages the Center's petition review processes (both those conducted in-house and under extramural contract) for food additives and color additives, and consultation/notification processes for GRAS (Generally Recognized As Safe) substances, food contact substances, and foods and food ingredients derived from recombinant DNA biotechnology. Evaluates safety information, compiles the administrative record supporting actions on petitions and other agency actions, and prepares Federal Register documents relating to petitions C. Prepares and/or reviews documentation required by the Center to implement the National Environmental Policy Act (NEPA). Coordinates the Center review of documents prepared under NEPA by other Federal agencies D. Serves as the principal Agency liaison on safety testing methodologies and protocol standards needed to evaluate the safety of food ingredients and on other aspects of regulatory decisions E. Develops compliance policy, position papers, procedural regulations, regulatory guidelines, and advisory opinions on issues related to the safe uses of food additives, food contact substances, color additives, GRAS substances, biotechnology derived foods, and prior sanctioned substances. Responds to stakeholder inquiries and processes Freedom of Information requests in a timely and efficient manner. Consults with FDA laboratories regarding research relevant to the regulation of food and color additives and food ingredients F. Manages the Agency's review and monitoring of identity, probable human exposure to, and toxicity information on food additives and color additives, food contact substances, and GRAS substances in current use. Recommends enforcement action or regulatory change as needed. Provides expert scientific and technical advice to other Office, Center, and Agency components as needed G. Provides evaluation and participates in bioresearch monitoring of non-clinical laboratory studies and facilities to assure quality and integrity of data submitted to the Agency in accordance with good laboratory practices H. Serves as the Center’s focal point for scientific and policy support for the development of Agency-initiated regulations on matters pertaining to the provisions of the food additive and color additive sections of the Federal Food, Drug, and Cosmetic Act I. Ensures the scientific integrity and consistency of the Center's petition review processes (both those conducted in house and under extramural contract) for food additives and color additives, and consultation/notification processes for generally recognized as safe (GRAS) substances, food contact substances, and foods and food ingredients derived from recombinant DNA biotechnology J. Consults with FDA laboratories regarding research relevant to the regulation of food and color additives and food ingredients K. Ensures that the Agency’s compliance policy, position papers, procedural regulations, regulatory guidelines, and advisory opinions on issues related to the safe uses of food additives, food contact substances, color additives, GRAS substances, biotechnology derived foods, and prior sanctioned substances are consistent and based on sound science L. Ensures the Agency's review and monitoring of identity, probable human exposure to, and toxicity information on, food additives and color additives, food contact substances, and GRAS substances in current use. Recommends enforcement or regulatory change as needed. Provides expert scientific and technical advice to other Office, Center, and Agency components as needed M. Provides toxicology, chemistry, and pathology expertise to the Center, develops guidelines for toxicological studies and establishing specifications of identity and purity of food additives and estimating dietary exposure, and monitors newly developed testing methodologies that may prove useful in toxicological assessments of novel food additives and other food ingredients and contributes to the Agency’s overall safety assessment of food ingredients N. Provides evaluation and participates in bioresearch monitoring of non-clinical laboratory studies and facilities to assure quality and integrity of data submitted in accordance with good laboratory practices

Office of Nutrition, Labeling and Dietary Supplements (ONLDS) The Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) is responsible for developing policy and regulations for dietary supplements, nutrition labeling and food standards, infant formula and medical foods as well as for scientific evaluation to support such regulations and related policy development. ONLDS staff also support compliance/enforcement actions and is responsible for the clinical review, data summaries, and, as appropriate, follow-up and research related to adverse events associated with dietary supplements and infant formula.

ONLDS is organized by product categories and features separate units for dietary supplements, nutrition labeling and program activities, and infant formula and medical food (see below).

Division of Dietary Supplement Programs The Division of Dietary Supplement Programs is responsible for agency activities concerning dietary supplements. The Division has primary responsibility for developing and implementing policy, regulations, guidance documents, and compliance activities intended to ensure the safety, proper labeling and quality standards per current Good Manufacturing Practices (cGMPs - 21 CFR Part 111) of dietary supplements and works closely with other units throughout FDA to accomplish these tasks. The Division reviews: dietary supplement adverse event reports; safety information in 75-day premarket notifications for new dietary ingredients to ensure that such products are reasonably expected to be safe; and provides policy review for administrative and enforcement actions taken against adulterated (including failure to meet dietary supplement cGMPs) or mislabeled domestic and imported dietary supplements. It also works with other CFSAN offices, CDER, ORA, FDA field organizations, and the regulated industry to ensure that products comply with all applicable labeling, quality and safety standards. The Division also works with other Federal scientific agencies to identify dietary supplement research topics to be undertaken. The Division consists of a New Dietary Ingredients Review Team, a Dietary Supplement Regulations Implementations Team, and other appropriate specialists.

Food Labeling and Standards Staff The Food Labeling and Standards Staff is responsible for developing policy, regulations, guidance documents, and enforcement strategies governing all aspects of food labeling, including warning statements and safe handling practices, and food standards. The Staff works closely with other enforcement arms in FDA and FDA District Offices to ensure enforcement of FDA regulations on conventional foods, infant formula and medical foods. The Staff issues warning letters to firms that have violative products on the market, issues special field assignments, reviews and provides technical input on domestic and imported legal actions from FDA District Offices and the Office of Compliance, and participates in foreign inspections. The Staff also participates in international activities such as the Codex Committee on Food Labeling and the U.S./Canada/Mexico Trilateral Technical Working Group on Food Labeling, Packaging and Standards. This staff consists of a Product Evaluation and Labeling Review Team, and a Labeling Regulations Implementation Team.

Office of Analytics and Outreach (OAO) The Office of Analytics and Outreach (OAO) promotes and protects public health through the development and coordination of policies, programs and activities involving food defense, communication, education, and risk assessment; and provides emergency response to food, nutrition, and cosmetic safety and security issues.

Office of Regulations, Policy, and Social Sciences (ORPSS) Mission Statement CFSAN's Office of Regulations, Policy and Social Sciences (ORPSS) is responsible for coordinating the development of all CFSAN regulations and guidance documents, and reviewing and clearing draft regulations developed by CFSAN, other Centers in FDA, or by other agencies. ORPSS also provides economic analyses and conducts consumer studies to provide information about the impact and/or effectiveness of various options that are used by CFSAN managers throughout the decision making and evaluation processes. We also lead the development of legislative proposals related to food and cosmetic safety and defense, review draft Congressional bills and proposed legislation, upon request, and coordinate the Center's technical assistance to Congressional or FDA's Office of Legislation staff developing bills related to food and cosmetics, upon request. ORPSS also serves as the Center focal point and provides a centralized monitoring, coordinating, and advisory function for the Center and U.S. government on policies involving sensitive, controversial, and complex food issues, including policies involving food derived from biotechnology.

FDA CFSAN’s Statutory Authority

FDA's regulatory authority for food and cosmetics comes from:

· The Federal Food and Drugs Act of 1906

· The Federal Import Milk Act (1927)

· The Federal Food, Drug, and Cosmetic Act of 1938, as amended

· The Public Health Service Act (1944)

· The Fair Packaging and Labeling Act (1966)

· The Infant Formula Act of 1980, as amended

· The Nutrition Labeling and Education Act of 1990

· The Dietary Supplement Health and Education Act of 1994

· Food Allergen Labeling and Consumer Protection Act of 2004

· Food and Drug Administration Amendments Act of 2007

· Other Related Statutes

APPENDIX B: Department Product Attributes and Measures

Access to National Market Share Data for Surveillance of Specific Consumer Packaged Goods in the U.S. Market 18-223-SOL-00058

Appendix B Departments Product Attributes and Measures.xlsx

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

E.1 SECTION E - 52.252-2 CLAUSES INCORORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

The Contracting Officer Representative or the duly authorized representative shall perform inspection and acceptance of materials and services to be provided.

Inspection and acceptance will be performed at a specified location identified in each Task Order.

Acceptance may be presumed unless, otherwise indicated in writing by the Contracting Officer or the duly authorized representative Contracting Officer Representative (COR) within 10 days of receipt.

Access to National Market Share Data for Surveillance of Specific Consumer Packaged Goods in the U.S. Market 18-223-SOL-00058

SECTION F - DELIVERIES OR PERFORMANCE

F.1. SECTION F - 52.252-2 CLAUSES INCORORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

F.2. PERIOD OF PERFORMANCE

The ordering period for this contract is five (5) years from the effective date of the contract. Although task orders may be issued at any time during this ordering period, two constraints apply to the period of performance for task orders. First, the period of performance for a task order may not go beyond one (1) year after the end of the ordering period. Secondly, a Task Order CO may not award a task order with a period of performance that exceeds five (5) years (inclusive of all options).

F.3. PLACE OF PERFORMANCE

It is anticipated that the preponderance of work to be performed shall be conducted at the contractor’s site. Some meetings will be schedule in the Washington DC district area.

Each Task Order will specify the location of where the work is to be performed.

F.4. DELIVERIES

Satisfactory performance of this contract shall be deemed to occur upon performance of the work and upon delivery and acceptance by the Contracting Officer Representative or the duly authorized representative.

a. Unless otherwise specified, deliveries shall be made in each task order Mondays through Fridays (excluding Federal Holidays & Executive Order) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 CONTRACTING OFFICER

The contact information for the Contracting Officer is:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: Matthew Bucher, Room 2044 5630 Fishers Lane Rockville, MD 20857 Phone: (240) 402-7570 Matthew.Bucher@fda.hhs.gov

G.2 CONTRACTING SPECIALIST

The contact information for the Contracting Specialist is:

Tara Hobson

Tara.Hobson@fda.hhs.gov

(240) 402-7586

G.3. CONTRACTING OFFICER REPRESENTATIVE (COR)

The contact information for the Contractor Point of Contact is: (at the time of award)

Damus Almoza Jr.

University Station 4300 River Road Room 3061 College Park, MD 20740 Damus.Almoza@fda.hhs.gov

(301) 796-1811

G.4. KEY PERSONNEL

The contractor shall provide the names and resumes of the key personnel assigned to this contract. The individuals cited below are key personnel.

Name Title

Principal Investigator

In the event that any of the personnel listed as key personnel are unable to perform because of health, resignation from the contractor’s employ, or any other reasons, the contractor shall promptly submit to the Contract Officer, a detailed written explanation of the situation, the proposed substitution, complete resumes for the proposed substitute, and any other information necessary for the approval of the substitution. No substitutions shall be made without prior written approval of the Contract Officer. No increase in contract pricing will be allowed when substitutions are authorized by the government.

G.5. GOVERNMENT FURNISHED PROPERTY

The Government may provide Government Furnished Property for use in direct performance of each task order. Each task order will specify if Government Furnished Property will be provided.

In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated into this contract by reference.

G.6 INVOICE SUBMISSION

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A. THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer / System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) The contractor shall include the Contract Line Item/Funding line item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment

(xi) Name and telephone number of the FDA Contracting Officer (CO) and the Contracting Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

(xii) Any other information or documentation required by the purchase order/award.

C. An electronic invoice shall be in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742) (Amend as necessary) INVOICES SUBMITTED UNDER THIS CONTRACT MUST COMPLY WITH THE REQUIREMENTS SET FORTH IN FAR CLAUSES 52.232-25 (PROMPT PAYMENT) AND 52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER. SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

G.7. TRAVEL COSTS

Any required travel by the Contractor will be at the direction of the Government and will be reimbursed at cost in accordance with the Federal Travel Regulation.

(a) Area of Travel - Performance under this Agreement may require travel by contractor personnel. If travel, domestic or overseas, is required, the Contractor is responsible for making all needed arrangements for Contractor’s personnel. This includes but is not limited to the following:

(b) Travel Policy - The Government will reimburse the Contractor for allowable travel costs incurred by the Contractor in performance of the contract and determined to be in accordance with FAR subpart 31.2, subject to the following provisions:

Travel required for tasks assigned under this contract shall be governed in accordance with rules set forth for temporary duty travel in FAR 31.205-46.

(c) Travel - Travel, subsistence and associated labor charges for travel time are authorized, whenever a task assignment requires work to be accomplished at a temporary alternate worksite. Travel performed for personal convenience and daily travel to and from work at Contractor’s facility will not be reimbursed.

(d) Per Diem - Per diem for travel on work assigned under this contract will be reimbursed to employees consistent with company policy, but not to exceed the amount authorized in the Joint Travel Regulations.

(e) Air/Rail Travel - In rendering the services, the Contractor shall be reimbursed for the actual costs of transportation incurred by its personnel not to exceed the cost of tourist class rail, or plane fare, to the extent that such transportation is necessary for the performance of the services hereunder and is authorized by the Contracting Officer. Such authorization by the Contracting Officer shall be indicated in the order or in some other suitable written form. NOTE: To the maximum extent practicable without the impairment of the effectiveness of the mission, transportation shall be tourist class. In the event that only first class travel is available, it will be allowed, provided justification therefore is fully documented and warranted.

(f) Private Automobile - The use of privately owned conveyance within the continental United States by the traveler will be reimbursed to the Contractor at the mileage rate allowed by Joint Travel Regulations. Authorization for the use of privately owned conveyance shall be indicated on the order. Distances traveled between points shall be shown in standard highway mileage guides. Any deviations from distance shown in such standard mileage guides shall be explained by the traveler on the expense sheet.

(g) Car Rental -…