U S Small Business Administration

This table lists small business size standards matched to industries described in the North American Industry Classification System (NAICS), as modified by the Office of Management and Budget effective January 1, 2012. The latest NAICS codes are referred to as NAICS 2012. The size standards are for the most part expressed in either millions of dollars (those preceded by "$") or number of employees (those without the "$"). A size standard is the largest that a concern can be and still qualify as a small business for Federal Government programs. For the most part, size standards are the average annual receipts or the average employment of a firm. How to calculate average annual receipts and average employment of a firm can be found in 13 CFR 121.104 and 13 CFR 121.106, respectively. SBA also includes the table of size standards in the Small Business Size Regulations, 13 CFR 121.201. This table includes size standards that have changed since the last publication of 13 CFR 121.

The purpose of this guide is to help small businesses - usually those with fewer than 500 employees - successfully navigate the realm of regulatory measures with which he U. S. Food and Drug Administration (FDA or the Agency) protects and promotes the health of the American public. Familiarity with FDA requirements is very important for a small firm that manufactures or plans to manufacture, sell, warehouse, transport, or import any of the thousands of FDA regulated products. To reach the U. S. interstate market, these products must comply with the applicable laws and the science-based public health rules developed and enforced by FDA. Although this obligation is routinely fulfilled by hundreds of thousands of American businesses, FDA is aware that for a small firm it can present a challenge. The Agency's responsibilities are defined in some 200 federal laws, and the resulting requirements, which can be complex, cover hundreds of pages in the Code of Federal Regulations. To find their way in this extensive domain of requirements, small and start-up businesses are likely to need expert assistance. The purpose of this guide is to help satisfy this need. Chapters I-IV provide an overview of FDA's responsibilities and operations and outline the main areas where small firms are most likely to come in contact with the Agency. Chapter V provides links to information that small businesses most frequently request from FDA's product centers and the Agency's Office of Regulatory Affairs. Chapter VI lists the Agency's offices and individuals who are ready to help small firms resolve their regulatory problems. This guide is designed to help make the small firms' contacts with FDA as efficient and productive as possible. We present this document as a blueprint that firms can follow to achieve their business aims while helping FDA accomplish its public health mission.

Owning a business is the fulfillment of a lifetime dream for many people. The SBA works with you to pursue your dream of financial and personal prosperity through small business ownership. Our experience shows that understanding exactly what you're getting into before you begin your venture helps significantly. The Small Business Resource Guide is created, in partnership with SCORE "Counselors to America's Small Business" to help you start or expand a business. Please take time to thoroughly review this material. The Guide includes pages of helpful ideas, references and suggestions. Topics include: SBA programs and services, business licensing, state and local government regulations, steps in preparing a business plan and selecting a legal structure for your business. In addition, you will find a listing of small business resources offering technical assistance and loan options.