U.S. flag
        An official website of the United States government
          Here’s how you know
        Here's how you knowDot gov**The .gov means it’s official.**
              
              Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.
        Https**The site is secure.**
              
              The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.  *U.S. Dept. of Health & Human Services
        Guidance Portal*
Menu


    close

        
        
                      

          
                      Enter the terms you wish to search for.
    Search HHS Guidance Submissions
Why do we have a Guidance Portal?

On December 3, 2020, HHS released a Final Rule governing the agency's release and maintenance of guidance documents. See Good Guidance Practices Final Rule. These regulations will help to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.


HHS Good Guidance Rule

Additional HHS guidance is incorporated throughout the preambles to proposed and final rules. These preambles are available at Department of Health and Human Services Federal Register entries, then performing a keyword search.

As explained in the Good Guidance Practices Final Rule, guidance documents issued by the Food and Drug Administration (“FDA”) will be subject to the requirements of the Final Rule until the Secretary amends FDA’s existing good guidance practices regulation. FDA has obtained two exemptions from the Director of the Office of Management and Budget that exempt the following types of guidance documents from the requirement that they be posted to the guidance repository: (1) Product-Specific Guidances for Generic Drug Development, and (2) Mammography Quality Standards Act (MQSA) Policy Guidance Help System (PGHS). These exemptions will be incorporated into the FDA’s amendments to its good guidance practices regulation. In the meantime, copies of these guidance documents can be found here:

Product-Specific Guidances for Generic Drug Development.
	Mammography Quality Standards Act Policy Guidance Help System
	FDA Guidance Documents Search PageDISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.


Announcements

Guidance Document Rescinded For Non-Compliance With Allina and the Administrative Procedure Act (Dec. 3, 2020)
	OGC Advisory Opinion 20-05
Search HHS Guidance Documents

Keyword Search
Filter Guidance Documents by ...Topics
          



  Health CareHuman ServicesManagementPublic HealthScience and Research
HHS Division or Office
          



  Administration for Children and Families (ACF)Administration for Community Living (ACL)Administration for Strategic Preparedness and Response (ASPR)Agency for Healthcare Research and Quality (AHRQ)Agency for Toxic Substances and Disease Registry (ATSDR)Assistant Secretary for Administration (ASA)Assistant Secretary for Financial Resources (ASFR)Assistant Secretary for Health (ASH)Assistant Secretary for Legislation (ASL)Assistant Secretary for Planning and Evaluation (ASPE)Assistant Secretary for Public Affairs (ASPA)Center for Faith-Based and Neighborhood Partnerships (CFBNP)Centers for Disease Control and Prevention (CDC)Centers for Medicare & Medicaid Services (CMS)Departmental Appeals Board (DAB)Food and Drug Administration (FDA)Health Resources and Services Administration (HRSA)Immediate Office of the Secretary (IOS)Indian Health Service (IHS)National Institutes of Health (NIH)Office for Civil Rights (OCR)Office of Global Affairs (OGA)Office of Inspector General (OIG)Office of Intergovernmental and External Affairs (IEA)Office of Medicare Hearings and Appeals (OMHA)Office of National Security (ONS)Office of the Chief Technology Officer (CTO)Office of the General Counsel (OGC)Office of the National Coordinator (ONC) of Health Information TechnologyOffice of the Secretary (OS)Public Health Service (PHS)Substance Abuse and Mental Health Services (SAMHSA)The Center for Faith and Opportunity Initiatives (the Partnership Center)
Language
          



  ArabicArmenianCambodianChineseEnglishFarsiFrenchFrench CreoleGermanGreekGujaratiHaitian-CreoleHindiIndonesianItalianJapaneseKoreanLaoNavajoPolishPortugueseRussianSamoanSpanishTagalogThaiTonganUrduVietnamese

  

  Title
                                                            OpDiv/StaffDiv
                                                            Guidance Status
                                                            Issue DateSort descendingCPG Sec. 305.100 - Acupuncture Devices and Accessories - Revoked-Deletion 01/24/2000
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalCPG Sec. 300.500 *Reprocessing of Single Use* Devices
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalGuidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalCHAPTER 48 - 7348.809 Bioresearch Monitoring
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        Final340B Drug Pricing Program Duplicate Discount Prohibition
                                                                                                        Health Resources and Services Administration (HRSA)
                                                                                                        FinalCPG Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalSSBG Q & As General and Supplemental Information
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        FinalSample WHO Certificate for Quality of a Pharmaceutical Product
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalCompliance Policy Guide Sec. 390.100 Definition of “Commerce” -21 CFR 1000.3(d) 2
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinaleCTD v4.0 Implementation Package DRAFT Specification for Submission Formats v2.0
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        Proposed

      Pagination
    First page
            « First
                          Previous page
            ‹‹
                                              Page1

                      Page2

                      Page3

                      Page4

                      Current page5

                      Page6

                      Page7

                      Page8

                      Page9

                                Next page
            ››
                          Last page
            5010This Guidance Portal contains 50095 documents.
Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

Petition Responses

CDC

Petition Response to RB with Exhibit A*CMS

Good Guidance Petition Response No. 21-01** This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties. Return to top



      Connect with Us
            
            Sign Up for Email Updates
						  To sign up for updates or to access your subscriber preferences, please enter your contact information below.
              Email

            HHS Guidance Repository
						  A federal government website managed by the
						  U.S. Department of Health & Human Services
              200 Independence Avenue, S.W.
						  Washington, D.C. 20201
						  Toll Free Call Center: 1-877-696-6775​
  


      Column 1
            HHS.gov
                              
                    
      
              Contact HHS
                              
                    
      
              Careers
                              
                    
      
              HHS FAQs
                              
                    
      
              Column 2
            Nondiscrimination Notice
                              
                    
      
              HHS Archive
                              
                    
      
              Accessibility
                              
                    
      
              Privacy Policy
                              
                    
      
              Column 3
            Viewers & Players
                              
                    
      
              Budget/Performance
                              
                    
      
              Inspector General
                              
                    
      
              EEO/No Fear Act
                              
                    
      
              Column 4
            FOIA
                              
                    
      
              The White House
                              
                    
      
              USA.gov
    
    
  


    
          Column 1
            Español
                              
                    
      
              繁體中文
                              
                    
      
              Tiếng Việt
                              
                    
      
              한국어
                              
                    
      
              Column 2
            Tagalog
                              
                    
      
              Русский
                              
                    
      
              العربية
                              
                    
      
              Kreyòl Ayisyen
                              
                    
      
              Column 3
            Français
                              
                    
      
              Polski
                              
                    
      
              Português
                              
                    
      
              Italiano
                              
                    
      
              Column 4
            Deutsch
                              
                    
      
              日本語
                              
                    
      
              فارسی
                              
                    
      
              English