HHS Guidance Portal
The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.
Federal guidance are documents that explain how a government agency understands and applies federal law. Guidance can include policy statements, manuals, FAQs, or other documents that help the public understand existing laws and regulations.
Guidance does not create new laws or legal requirements. Instead, it explains how HHS plans to carry out laws that were already passed by Congress or rules that were already finalized through the federal rulemaking process.
DISCLAIMER: 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.
Filter Guidance Documents by ...
| Title | OpDiv/StaffDiv | Guidance Status | Issue Date |
|---|---|---|---|
| Q1E Evaluation of Stability Data | Food and Drug Administration (FDA) | Final | |
| Q2(R2) Validation of Analytical Procedures | Food and Drug Administration (FDA) | Final | |
| Q2A Text on Validation of Analytical Procedures | Food and Drug Administration (FDA) | Final | |
| Q2B Validation of Analytical Procedures: Methodology | Food and Drug Administration (FDA) | Final | |
| Q3A(R) Impurities in New Drug Substances | Food and Drug Administration (FDA) | Final | |
| Q3B(R) Impurities in New Drug Products (Revision 3) | Food and Drug Administration (FDA) | Final | |
| Q3C Impurities: Residual Solvents_2011 | Food and Drug Administration (FDA) | Final | |
| Q3C Maintenance Procedures | Food and Drug Administration (FDA) | Final | |
| Q3C Tables and List Rev. 4 | Food and Drug Administration (FDA) | Final | |
| Q3C: Appendix 5 | Food and Drug Administration (FDA) | Final |
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.