U.S. Department of Health and Human Services (HHS)
Small Business Director
Office of Small and Disadvantaged Business Utilization
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
- 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
- Dental Directory
- Self-Determination Services Team Website
Indian Health Service
- Alaska Area Office - Home
Alaska Area Indian Health Service
- 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
- 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
- Fraud Prevention & Detection
Fraud Prevention & Detection
- 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
- 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
- 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.
- 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
- 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.
- NIH Office of Administration
The Small Business Program is located in the NIH's Office of Acquisition Management and Policy
- 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 - 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 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.