U.S. Department of Health and Human Services (HHS)
Compliance Contacts
Contact the following individual(s) to get more information on complying with the Deptartment of Health and Human Services regulations:
Debbie Ridgely
Small Business Director
Phone: 202-690-7235
TTY/TTD: 800-877-8339
mailto:debbie.ridgely@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
- 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 Institutes of Health
Centers for Disease Control
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