Compliance Contacts

Teresa Lewis
Small Business Director
Office of Small and Disadvantaged Business Utilization
Phone: 202-690-7235
TTY/TTD: 800-877-8339
sbmail@hhs.gov

Compliance Resources

The following agencies and offices provide compliance resources for small businesses:

• Indian Health Service
• Center for Drug Evaluation and Research
• Food and Drug Administration
• Office of Inspector General
• Health Resources and Services Administration
• Center for Medicare and Medicaid Services
• Center for Food Safety and Applied Nutrition
• National Institutes of Health
• Centers for Disease Control
• Office for Civil Rights
• Substance Abuse and Mental Health Service Administration

Indian Health Service

• Clinical Reporting System - Home
  Indian Health Service
• Indian Health Service Pharmacy Program
  Indian Health Service
• The IHS Data Warehouse - Home
  Indian Health Service
• Continuing Dental Education
  None
• Dental Directory
  None
• Self-Determination Services Team Website
  Indian Health Service
• Alaska Area Office - Home
  Alaska Area Indian Health Service

Center for Drug Evaluation and Research

• Drug Approval Application Process
  Center for Drug Evaluation and Research, Main Page
• Center for Drug Evaluation and Research Guidance Documents
  List of Guidance Documents for pharmaceutical companies

Food and Drug Administration

• FDA Guidance for Regulated Industries
  One-stop resource that provides links to FDA's regulatory guidance, forms, contacts, meetings and workshops.
• FDA Industry Systems
  Login page for FDA Industry Systems

Office of Inspector General

• Fraud Prevention & Detection
  Fraud Prevention & Detection

Health Resources and Services Administration

• Healthcare Integrity and Protection Data Bank
  Alerts users that a comprehensive review of a practitioner's, provider's, or supplier's past actions may be prudent

Center for Medicare and Medicaid Services

• HIPAA Administrative Simplification
  HIPAA is the acronym for the Health Insurance Portability and Accountability Act of 1996. It is responsible for improving efficiency in healthcare through the standardization of electronic data interchange, as well as providing measures to ensure confidentiality and security of health data.
• Clinical Laboratory Improvement Amendments
  All clinical laboratories must be properly certified to receive Medicare or Medicaid payments
• The CMS Online Manual System
  Transmittals, Internet-Only Manual Updates, Manual Updates
• Quarterly Provider Updates
  Medicare information
• CMS Rulings
  CMS rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation.
• Paperwork Reduction Act
  The Paperwork Reduction Act of 1995 significantly changes many aspects of Information Collection by the Federal government.

Center for Food Safety and Applied Nutrition

• Labeling of Dietary Supplements
  Labeling of Dietary Supplements
• Food Labeling Specific Topics and Categories
  Food Labeling Specific Topics and Categories
• Label Claims
  Food Labeling and Nutrition Label Claims page
• Dietary Supplements - Industry Information and Regulations
  Industry Information on Dietary Supplements including Proposed and final regulations, Current Good Manufacturing Practices (CGMPs), New Dietary Ingredients, Special Issues such as BSE and Ephedrine Alkaloids, Correspondence Related to Policy, Compliance Actions, General Compliance and Inspection Information, Codex Activities, and the FDA-DSFL Electronic Newsletter.
• Cosmetics - FDA Authority, Programs and Policy
  FDA Authority, Programs, and Policy regarding cosmetics.
• Information Materials for the Food and Cosmetic Industries
  A list of Information Materials for the Food and Cosmetic Industries
• Food Safety Laws and Regulations for New Businesses
  The U.S. Food and Drug Administration guidelines to complying with food safety laws and regulations for new business owners.
• Importing Food into the United States
  Importing Food into the United States
• Importing Cosmetics into the United States
  Importing Cosmetics into the United States
• Exporting Food and Cosmetics from the United States
  Export information for foods and cosmetics
• Information for Industry: Steps to Implementation of Electronic Submissions
  Beginning October 2001, the Office of Food Additive Safety began accepting electronic submissions for food and color additive petitions. This is an Overview of the process.
• EdNet: National Food Safety Educator's Network
  EdNet: National Food Safety Educator's Network (EDNET-L)
• Seafood HACCP
  Information and resources related to FDA's Seafood Hazard Analysis and Critical Control Point Program.
• Seafood Inspection, Compliance, Imports and Exports
  FDA-CFSAN Seafood Information, including background, foodborne pathogens and contaminants, methylmercury, Vibrio vulnificus in raw oysters, HACCP, inspections, compliance, imports and exports, EU export certificates, economic deception, federal-state programs, shellfish shippers, and more.
• Regulatory Fish Encyclopedia
  The Regulatory Fish Encyclopedia (RFE) is a compilation of data in several formats that can assist federal, state, and local officials and purchasers of seafood identify species substitution and economic deception in the marketplace. The RFE includes high-resolution digital images of whole fish and their marketed product forms descriptive taxonomic information, and as chemical taxonomic information consisting of species-characteristic isoelectric focusing patterns.
• Juice HACCP
  Information and resources related to FDA's Juice Hazard Analysis and Critical Control Point Program.
• Dairy Grade "A" Voluntary HACCP
  Resources and Information for the Dairy Grade A Voluntary HACCP program.
• Inspections, Compliance, Enforcements and Recalls
  Links to information on Inspections, Compliance, Enforcements and Recalls
• FDA FOOD CODE
  Information on the U. S. Food and Drug Administration's 'Food Code' a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry.
• Food, Nutrition, and Cosmetics Questions and Answers - Domestic/Import Food Industry
  Questions and Answers about FDA requirements for those in the Domestic and Imported Food Industry.
• Federal/State Food Programs
  FDA provides information on retail food protection, milk safety and seafood safety. It contains model national codes, FDA interpretative guidance, official procedures, Interstate Milk and Shellfish Shippers lists, food recall information, and foodborne illness information.
• Online Voluntary Cosmetic Registration Program
  Cosmetics Voluntary Registration Program
• Compliance Activities
  Compliance Activities
• Office of Regulatory Affairs Small Business Guide to FDA
  This site is from the FDA's Office of Regulatory Affairs. It offers links to a number of useful sites such as "What to do when marketing a new product," "recalling a product," "undergoing an FDA inspection," etc... It also provides an introduction to the Federal Register, information on obtaining FDA documents, frequently call numbers, and much more information.
• National Practitioner Data Bank
  Assists covered entities to comply with legal requirement to report health professional malpractice and disciplinary actions and to query data bank when hiring or granting privileges.
• Center for Devices and Radiological Health : Device Advice
  A self-service site for medical device and radiation emitting product information.
• FDA Center for Devices and Radiological Health : Guidance Documents Database
  Searchable database of guidance documents.
• Center for Devices and Radiological Health : Registration and Device Listing
  Information about registering medical devices with the FDA. Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA.
• Color Additives : Regulations and Compliance Resources
  FDA guide to color additive regulations and compliance resources.
• Bioengineered Foods : Regulatory Information
  Regulations and compliance guidance concerning the production of bioengineered foods.
• Acidified and Low-Acid Canned Foods
  FDA Requirements for establishment registration, thermal process filing, and good manufacturing practices for low-acid canned foods and acidified foods.
• Food and Cosmetic Industry Guidance Documents
  Comprehensive list of guidance documents concerning FDA regulations.
• Food Ingredients and Packaging : Approval and Notification Programs
  FDA approvals and notifications programs concerning the food processing industry.
• Infant Formula : Regulatory and Guidance Documents
  An overview of FDA regulations and requirements concerning the manufacturing of baby formula.
• Food Ingredients and Packaging : Information for Industry
  FDA guidance on providing food ingredient information on package labels.
• Protecting the Food Supply : FDA Actions on New Bioterrorism Legislation
  Protecting the Food Supply - FDA Actions on New Bioterrorism Legislation (Bioterrorism Act of 2002): Registration of Food Facilities, Prior Notice of Food Imports, Administrative Detention, Establishment and Maintenance of Records
• Pesticides, Metals, Chemical Contaminants and Natural Toxins
  FDA guidelines covering pesticide levels in food products.
• Cosmetics : Information for Industry
  Portal for the cosmetic industry to help regulated entities comply with FDA regulations.
• Food Labeling and Nutrition : Information for Industry
  Guidance on to comply with food labeling regulations.
• Small Pharmaceutical Business Assistance
  Guide to help ease the drug application process for small drug manufacturers.
• Center for Biologics Evaluation and Research : Manufacturers Assistance
  Provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

National Institutes of Health

• NIH Office of Administration
  The Small Business Program is located in the NIH's Office of Acquisition Management and Policy

Centers for Disease Control

• NPPTL: The National Personal Protective Technology Laboratory: NIOSH Health and Safety Topic: Respirators
  NIOSH Certification of Respirators: A summary of respirator use, selection, cleaning and maintenance, certification, standards, and rule-making; User notices and other sources (External Links)

Office for Civil Rights

• Office for Civil Rights - HIPAA
  Provides information on enforcement of the Privacy Rule issued under the Health Insurance Portability and Accountability Act (HIPAA) for the protection of medical privacy. Includes regulations, guidance, FAQs, links to other sources.

Substance Abuse and Mental Health Service Administration

• Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention, Division of Workplace Programs
  An extensive and inclusive list of Federal Drug-Free Workplace documents focused on Federal Agency requirements and regulations organized by subject area. Email and telephone contacts are given for obtaining further information on website content.
• SAMHSA/CSAT Opioid Treatment Program (OTP) Extranet
  An interactive website that houses information on the opioid treatment/methadone programs throughout the country and permits the regulated entities to submit required regulatory applications for approval.