Attachment_B_-Task_Order_1_SOW_.docx

FDA Food and Cosmetics Product and Packaging Data Access Indefinite Delivery Indefinite Quantity (IDIQ) Task Order 1 Statement of Work (SOW)

Attachment B:

Task Order 1 Statement of Work Access to Food and Cosmetic Product and Packaging Databases

United States Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN)

August 11, 2015

Contents

Note: All italicized terms are defined in the Glossary (Appendix A).

Introduction The United States (US) Food and Drug Administration (FDA) has a continuing need for current, cost effective, and accurate data on the exposure of consumers to processed food and cosmetic products that are either manufactured for sale or imported for sale into the US marketplace. FDA needs to continue to gather such data to have a complete and comprehensive knowledge of these manufactured products, their ingredients, labeling and packaging in order to better assess how they may affect human exposure as part of the agency’s ongoing mission to protect public health. FDA has devoted considerable resources to continuously monitor the safety of food ingredients, dietary supplements, infant formula, and cosmetics.

Purpose FDA has determined that a cost-effective means to advance the agency’s objectives is to obtain accurate, quality-assured, easily-validated processed food and cosmetic product and ingredient information and coding images, which has been well-organized within one or more relationally searchable database(s) for trend and other analyses. This task order is issued to provide for access to existing database system(s) that house data for processed food and cosmetic products and their ingredients as well as operations and maintenance support for all licenses under the task order.

Requirements Project Management The Contractor shall provide task order level project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. The Contractor shall provide a Management Plan to the Contracting Officer Representative (COR) outlining the strategy for supporting the task areas in the individual Task Orders. The Contractor shall ensure the work plan contains the management strategy for ensure full compliance to the contract.

The Contractor shall provide monthly status reports on all awarded tasks and their progress to the Task Order COR. Within the first 30 days after contract award, the Contractor will design and the COR shall approve a standard reporting format and proposed level of detail for the content for the monthly status reports that includes the following information at a minimum:

· Status and progress of tasks;

· Usage statistics for databases and other resources

· Usage statistics of technical support feature by FDA staff

· Technical issues reported by FDA

· Significant risks to scheduled deliverables and plans to mitigate them;

· Progress against task order service level metrics; and,

· Financial status report including Pricing variances

In addition to monthly reporting, the Contractor shall be proactive in informing the designated COR of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA staff, or other contractors, shall be clearly defined and communicated to the COR and have identified dates for completion.

The Contractor shall manage and provide up to ten (10) ad hoc data calls per each 12-month Period of Performance in accordance to the services under this task order to include the coordination, analysis, tracking and data gathering efforts as provided by the COR. The Contractor shall prepare data call responses as directed by the COR.

The Contractor shall provide a final written progress report and presentation meeting to the COR. The Final Report shall include a recap of all tasks achieved, a summary of what was successful as well as areas for improvement, and analysis of the risks and benefits and recommendations.

Data Access The Contractor shall provide direct electronic access to currently existing database system(s) that house data for processed food and cosmetic products and their ingredients (ref Appendix A).

3.2.1 Database Systems

The Contractor shall provide direct access to database system(s) with the following:

· Unlimited and concurrent access for up to 200 FDA personnel and <20 users in other Government agencies;

· Located external to FDA network (access via weblink) availability 365/24/7 and fully functional with 99.9% uptime;

· Universal access from any FDA computer hardware (desktops, laptops with docking stations and/or scientific workstations) using internet browsers compatible with FDA current standards;

· Access to all products and it shall not be restricted according to product price, or brand category (national vs private), or producer (e.g., Walmart products should be as accessible as Unilever products);

· Capability to perform relational searching and analyses of the processed food and cosmetic product labeling and packaging data;

· Coding images (legible images of all sides of product packaging) for all the labels for validation. Images shall be displayed with product data so that all product label and packaging information may be easily viewable by the user;

· All searches shall be downloadable and exportable into Microsoft’s Excel Spreadsheet and Microsoft Access, SAS (Statistical Analysis System) Software, and as a text file. Users shall be able to analyze and summarize their searches into summary reports using pivot tables;

· Data status updates shall be posted on the system website with the date. A full historical listing of updates should be available; and

· System usage statistics (including statistics regarding individual login usage, length of log in, whether downloads were made, etc.) available in monthly reports and upon COR request.

The Contractor shall ensure a graphical user-friendly interface that is transparent and has the capability to conduct a multi-variable search (i.e. searching a combination of factors concurrently). The Contractor shall ensure the user shall be able to search according to product category, name, brand, company, claims, ingredients, product attributes, year, and user-entered keywords in any and all fields as well as be able to browse the product category hierarchy.

The contractor shall provide electronic access to all available sales data and market research reports for all processed food and cosmetic products available in the database system.

3.2.2 Data

The contractor shall ensure all data is from a currently existing, commercially available database(s) that provides immediate automated access. The data shall include processed food and cosmetic products from all regions of the US (Appendix B indicates the US Census regions); be accurate, quality-assured, and easily-validated; be well organized; and stored as relationally searchable information for trend and other analyses. The contractor shall ensure database(s) are updated and maintained in a current state throughout the base and option periods.

The contractor shall ensure the database(s) shall contain current and historical data for products from the 1990s-to-the-present that are valid and verified

Data Information shall be required for the following product types:

· Processed food products (minimum 400,000 US products);

· Dietary supplements (minimum US 30,000 US products); shall be categorized according to the definition in Appendix A

· Infant formula;

· Cosmetics (minimum 160,000 US products); shall be categorized according to Appendix C

The following attributes of the data information shall be required:

· Coding images (legible images of all sides of product packaging)

· Information contained on product packaging – shall include the following at minimum (each data entry line in the database must be quality assured and -controlled (QA/QC’d) for accuracy as the database is populated)

· Nutrition and Supplement Facts labels (shall be displayed in format according to 21 CFR 101.9)

· Ingredients

· Food Additives

· Price and pack size

· Number of servings per package

· Brand

· Name and place of business of manufacturer, packer, or distributor

· Warning statements/icons

· Detailed product description on packaging

· Statements/icons/signages and similar information that features the nutrition, health, organoleptic, processing, and other properties of the product (e.g., nutrient content claim languages, front-of-pack language).

· Verbatim language from product packaging (if available)

· Product source where collected

· Date collected and date published

· FNDDS 8-digit and 7-digit food codes; SR 5-digit sub codes (8-digit food code shall be linked to food products and ingredients;7-digit food codes are mapped to 8-digit at the product level; 5-digit SR sub codes are mapped to 8-digit food codes at the ingredient level)

· GSFA (General Standard for Food Additives) categories

· Food packaging types (primary and secondary)

· Food content type

· Cosmetic claims (see Appendix C)

· Cosmetic physical form (see Appendix C)

· Allergen labeling (contains/may contain)

The Contractor shall provide additional valid and verifiable information on the product ingredient to include the product synonym name(s), allergen status, and technical or functional effect descriptors.

3.2.3 Operations and Maintenance

The Contractor shall provide maintenance and support for all licenses under the contract as follows.

· Updates to data to ensure it is the most current information

· Telephone and/or email access to technical expertise from 9 – 5 EST

· Access to user guides and technical specification via the internet

· Issue identification, tracking, analysis and resolution

· Installation of upgrades and patches

· Maintain and update technical and analytical documentation

3.2.4 Documentation

The Contractor shall provide documentation for database system(s) in electronic format (typically MS Word, Excel) to the COR. Documentation includes the comprehensive methodology of product data collection and the data assignments, user guides for the system, limitations & restrictions, data dictionary, technical specifications, disclosure policy, and interface documents. The Contractor shall keep originals and updated versions of the documentation and ensure their availability for access to all database system(s) users. The Contractor shall ensure all documentation is updated according to any changes in the database system(s) and/or data.

Training The Contractor shall provide up to 12 one hour training sessions per each 12-month Period of Performance on the procedures for the access and the usage of the databases systems via on-site (maximum 4 hours) instructor-led training or via web-based methods. The specific topics for the training sessions, method of delivery, and dates and times will be coordinated with the COR in order to meet the needs of FDA staff. FDA will provide a conference room at FDA’s location (current location is College Park, MD) for all on-site training.

Deliverables

Support (3.2.3)

Criteria for Acceptance The COR will review contractor deliverables in accordance with specifications and standards stated in the criteria stated above and in table below.

Acceptable Quality Level Standards

Place of Performance The place of performance shall be the Contractor’s site.

The Contractor shall participate in telephone meetings, as needed, to develop project requirements and plan. Planning meetings and progress reports with agency staff may be held at the FDA offices or by remote communication.

Period of Performance One (1) 12-month Base Period Four (4) 12-month Option Periods.

Travel Any travel costs incurred by the contractor within the Washington/Baltimore Metro area is considered local travel and will not be reimbursed. CFSAN does not anticipate travel will be required under this contract. If travel is required, all requests for travel shall be submitted to the CFSAN COR and CO. All costs shall be in accordance with the Federal Travel Regulations and the Contractor will be reimbursed based on number of trips, number of persons traveling, lodging, per diem, air / rail, / car transportation.

Federal Travel Regulation: http://www.gsa.gov/portal/content/104790

Contract Type

The contract type for this task order is Firm Fixed Price

Inspection and Acceptance

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the COR to ensure the services/products provided meet the requirements of the Statement of Work (SOW) at the time of delivery, and the contractor shall make changes as The Government will accept goods, reports and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

Invoice Submission The Contractor shall follow the below instructions:

(i) One original and one copy to the approving official:

Address will be indicated on individual task orders:

U.S. Food and Drug Administration Office of Acquisitions & Grants Services Attn: Kathy Harrigan 5630 Fishers Lane Room 1078, HFA-500 Rockville, Maryland 20857

*** Acceptable methods of delivery include: mail, hand Delivery “Electronic invoices are not accepted.”

(ii) One copy to the Contracting Officer Technical Representative (COTR) or other program center/office designee:

U.S. Food and Drug Administration ATTN: To Be Determined 9200 Corporate Blvd Rockville, MD 20850

*** Acceptable methods of delivery include: mail, hand delivery or electronic

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 – Central Contractor Registration) 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:

Period of performance for which costs are claimed;

Itemized travel costs, including origin and destination;

Any other supporting information necessary to clarify questionable expenditures Overall Task Order Amount, Overall Task Order Expended Amount, Overall Task Order Balance Summary Level - Grouped by Subtask, then O&M and DME – Subtask Budget, Subtask Expended Amount (for the period), Subtask Expended Amount to Date, Subtask Balance Contractor Name, Labor Category, Hours (for the period), Amount

(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; and

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

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

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

(xiii) Contractor is not required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

List of all invoices submitted to date under the subject award, including the following:

Invoice number, amount, and date submitted Corresponding payment amount and date received Total amount of all payments received to date under the subject contract or order And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance An electronic invoice is acceptable if submitted 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.

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

Division of Payment Services Food and Drug Administration 8455 Colesville Road 8th Floor

MAIL HUB 2145

Silver Spring, MD 20903 Attn: Vendor Payments

Appendix A: Glossary

Aggregated data – any data that has been re-formatted or derived from the original data report or data set, e.g., raw data. Aggregated data are typically presented in tables, charts, and text.

Allergen labeling – The Food Allergen Labeling and Consumer Protection Act (FALCPA) defines 8 major allergens that must be declared on a food product label (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106890.htm). Allergan-related data fields shall align with FDA definitions.

Coding images – High resolution images of a product in which all aspects of the label are visible and decipherable.

Commercially available – The data resource, or access to it, is available for sale or license or has been sold or licensed to the general public.

Cosmetics – Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are bath additives, fragrances (body spray, cologne, perfume), hair preparations (shampoo, conditioner, hair color, hair relaxer, wigs, artificial eyelashes, hair loss concealer), hair removal and shaving products (shaving lotion, aftershave, depilatory, hair wax), makeup, nail preparations (nail polish, nail care, nail polish remover, artificial nails), oral hygiene products (toothpaste, tooth whitening, mouthwash), personal cleanliness (cleansers, deodorants, feminine hygiene), skin care preparations (creams, lotions, facial masks, massaging preparations), suntan preparations (sunless tanning), tattoos (permanent and temporary), and other personal care product that contains a moisturizer or fragrance (razor blades, facial tissues, toilet paper, wipes, disposable wash cloth), as well as any material intended for use as a component of a cosmetic product. See Appendix C for list of cosmetic categories.

Cosmetic categories – Defined in Appendix C

Cosmetic claims – Defined in Appendix C

Cosmetic physical form - Defined in Appendix C

Currently existing – The data chosen for this award at onset of the installation of the software system must be a commercially available and/or federally available product at the time of the proposal.

Data dictionary – A glossary of terms document that describes the information available in the data resource. This information shall minimally include field or variable name, description, definition (including business rules for computed fields and missing data), and allowed values. All fields or variables in the data resource should be included in this document.

Database System- Data management system designed to collect, store, provide access to, manipulate, retrieve, report and manage data. May contain more than one set of data.

Dietary supplement – Defined in Dietary Supplement Health and Education Act (DSHEA) and considered a “food”. See http://www.fda.gov/Food/DietarySupplements/ .

Direct – Authorized FDA personnel should be able to access raw or sample numbers from the data source from their work station (i.e., no intervention on the contractors part should be necessary. In addition, output that consists of formatted reports only will not be acceptable).

Disclosure policy – The process of providing FDA written authorization to disclose information from this resource in public forums or sharing with third parties on collaborative projects initiated by FDA for public health safety and regulatory purposes. This process shall ensure that the information or data disclosed is accurate and does not violate any of the Contractor’s existing agreements.

FNDDS 8-digit food codes and 7-digit food subcodes – Defined in The USDA Food and Nutrient Database for Dietary Studies 2011-2012: Documentation and User Guide (http://www.ars.usda.gov/Services/docs.htm?docid=120868)

Food Additive – Defined as any substance which may become a component or affect the characteristics of any food. The definition includes substances intended for use in producing, manufacturing, packaging, transporting, or holding food; any source of radiation intended for use; and under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be Generally Recognized as Safe (GRAS) either through scientific procedures or, for a substance used in food before 1958, through experience based on common safe use in food.

Food Content Type – Defined by FDA in 21 CFR 176.170(c).

Food packaging type – Primary packaging is the packaging material that is in contact with the food product. Secondary packaging is the outer packaging of a food product. Packaging types include: glass, paper, metal, and plastic. Plastic sub-types include: LDPE (low-density polyethylene), HDPE (high-density polyethylene), PP (polypropylene), PS (polystyrene), Cellophane, PVC (polyvinyl chloride), PET (polyethylene terephthalate). Defined in regulatory terms as food contact substances (http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm)

Full disclosure of data collection – The FDA shall receive detailed information on how the sample is selected, how data are obtained and cleaned/edited for analysis, how the data was built, how variables are defined, and the relationship between variables within the data structure.

GSFA (General Standard for Food Additives) categories – The GSFA is a food category system that sets forth the conditions under which food additives may be used in foods. This hierarchal category system is defined in Annex B Part I of the most recent version of the GSFA (http://www.codexalimentarius.net/gsfaonline/index.html).

Immediate – Authorized FDA personnel should be able to access the data whenever needed.

Limitations and Restrictions – A document shall accompany the software system and data that explains the conditions of use and any limitations and restrictions of the software system and datas; the Limitations and Restrictions (L&R) document should be regularly updated and accessible indicating the date it was last modified. All previous versions of the L&R must indicate release date, available, and readily accessible as reference documents.

Multi-user environment – Two or more authorized FDA users should be able to access the data at the same time from different locations.

Processed food - The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines processed food as “any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling” [FD&C Act, sec. 201(gg)]. Typically altered from their natural state for safety and/or convenience, processed foods are aseptically processed and packaged. Drinks, dietary supplements, infant formula, bottled water, chewing gum, and pet food are included in the definition of processed foods.

Public forum(s) – Any communications, meetings, or interactions where FDA personnel have need to share summarized data reports with individuals outside of FDA. Typical public forums for FDA include but are not limited to advisory committee meetings (www.fda.gov/oc/advisory/default.htm), scientific journals, professional or scientific conferences, interactions with other domestic and foreign governmental entities, website postings for the general public, and meetings with manufacturers.

Raw data – data as supplied by the data vendor.

Reliable – The projection method used must yield the same or similar results in the same or similar situations (e.g., must be reproducible and repeatable).

Robust – A characteristic describing a database system's ability to effectively perform while its variables or assumptions are altered. A robust system can operate without failure under a variety of conditions.

Scientific database – Database is able to verify the data entry line(s) via product images, and the product’s contents may be analyzed, if the user chooses to have the item purchased and analyzed, to verify the accuracy/truthfulness of the product label.

Secure – At no time will passwords, login, or data be open to inspection or intrusion by unauthorized parties.

SR 5-digit sub codes – Nutrient Databank Number (USDA National Nutrient Database for Standard Reference) http://www.ars.usda.gov/main/site_main.htm?modecode=80-40-05-25

Unlimited – authorized FDA personnel shall have the ability to use any data element in the database in any combination or query that is necessary to address a specific issue.

Valid – an assessment of how well the projected values reflect what is actually happening in the entire population of interest.

Appendix B: Census Regions of the United States

Northeast: Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont

Midwest: Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin

South: Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, West Virginia

West: Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming

Appendix C: Cosmetic Product Categories, Claims, and Physical Form

Cosmetic Product Categories List

(1) Baby products.

(i) Baby shampoos.

(ii) Lotions, oils, powders, and creams.

(2) Bath preparations.

(i) Bath oils, salts, and other bath additives.

(ii) Bubble baths.

(3) Eye area preparations.

(i) Artificial eyelashes, adhesives, and removers.

(ii) Eyebrow preparations.

(iii) Eyeliner.

(iv) Eye shadow.

(v) Eye lotion and cream.

(vi) Eye makeup remover.

(vii) Mascara and eyelash preparations.

(viii) Eye makeup applicators.

(4) Fragrance preparations.

(i) Body sprays and mists.

(ii) Colognes and toilet waters.

(iii) Perfumes.

(iv) Powders.

(5) Hair preparations (noncoloring).

(i) Artificial hair, adhesives, and solvents.

(ii) Hair conditioners.

(iii) Hair straighteners and relaxers.

(iv) Hair styling preparations.

(v) Permanent waves.

(vi) Shampoos (including 2 in 1 shampoo and conditioner).

(6) Hair coloring preparations.

(i) Hair bleaches.

(ii) Hair color removers.

(iii) Hair dyes, lighteners, and other coloring preparations.

(7) Makeup preparations (not eye).

(i) Blushers and bronzers.

(ii) Concealers and correctors.

(iii) Face powders.

(iv) Foundations.

(v) Leg, body, and face paints.

(vi) Lip preparations.

(vii) Makeup removers.

(viii) Novelty makeup.

(ix) Temporary tattoos, stencils, and stick-on jewelery.

(x) Makeup Applicators (non-eye).

(8) Manicuring and pedicuring preparations.

(i) Artificial nails, adhesives, and removers.

(ii) Basecoats and undercoats.

(iii) Cuticle softeners.

(iv) Foot preparations.

(v) Nail creams and lotions.

(vi) Nail polish and enamel.

(vii) Nail polish and enamel removers.

(9) Oral hygiene products.

(i) Dentifrices (toothpaste).

(ii) Mouthwashes and breath fresheners.

(iii) Tooth whiteners.

(10) Personal cleanliness.

(i) Body soaps and washes.

(ii) Deodorants (underarm).

(iii) Facial cleansing preparations.

(iv) Feminine hygiene preparations.

(v) Wipes.

(11) Shaving and hair removal products.

(i) Aftershave preparations.

(ii) Depilatories.

(iii) Preshave preparations.

(iv) Shaving blades (with lubricant).

(v) Shaving cream.

(vi) Waxes.

(12) Skin care preparations.

(i) Body creams and lotions.

(ii) Body powders.

(iii) Exfoliants

(iv) Face creams and lotions.

(v) Masks.

(vi) Massaging preparations.

(13) Suntan preparations.

(i) Suntan gels, creams, and liquids.

(ii) Indoor tanning preparation