Regulatory Information

How to Use Regulations.gov

How to Search for FDA Federal Register Documents, Dockets, and Daily Listings and Submit Electronic Comments

Contents

Find a Docket

In the search area of the regulations.gov home page:

  1. SEARCH for: Rules, Comments, Adjudications or Supporting Documents:
  2. Type Docket ID (docket mumber) if known, (e.g., FDA-2000-D-0002) in the search box and enter or click the "Search" button.
  3. Type the docket number (i.e., 2000D-1418 legacy docket ID format) in the search box and enter or click the "Search" button.
    • If the docket is prior to 2008 (as example above for a legacy docket), docket will appear with a different number  (FDA-2000-D-0002), please know it is the same docket.
    • You may also search by keyword, for example a word or words in a Docket title, if known.
  4. Narrow search results by filtering results by "Comment Period," "Document Type," "Comment Due," "Agency," "Category," and "Docket Type."
  1. Show number of "results per page," "view results by list or table," and "sort by" (select from drop-down menu). Best options to sort by are Document ID A-Z and Title A-Z.
  2. Once satisfied with your Search Results, view results by list (by default) or table by selecting the icon and then click on "Open Docket Folder"
  3. View "Docket Folder Summary," "View all documents and comments....," and "View more docket details."

Generate Daily Listings

To find FDA documents posted to regulations.gov on a given day:

  1. Go to regulations.gov and click on "Advanced Search" (right below the "Search" button).
  2. Under "In these date ranges," Select the desired date for both the  “Received Date falls in the range From”  and "To" from pop-up calendar.
  3. Under "By Agency," select "FDA-FOOD AND DRUG ADMINISTRATION."
  4.  Show number of results per page, view results by list or table and sort by (select from drop-down menu). Best option to sort by is Title A-Z.  
  5. View search results by list (by default) or table by selecting the icon and then click the "Open Docket Folder."

Access the Federal Register (FR)

Advance Display: Office of the Federal Register Electronic Public Inspection Desk or Office of the Federal Register enhanced public inspection website

Today's FR: Today's Federal Register Table of Contents 

Historical to Present FRs: GPO Federal Register Database (1994 to present)

Generate a list of the FDA Federal Register documents open for public comment

  1. Go to regulations.gov and click on "Advanced Search" (right below the "Search" button).
  2. Type "Federal Register" in "Search" box.
  3. Filter Results By..."Comment Period," check Open, "Document Type," check "Notices" or "Proposed Rules," "Agency," select (drop-down menu) "FDA-FOOD AND DRUG ADMINISTRATION." 
  4.  Show number of results per page, view results by list or table and sort by (select from drop-down menu). Best option to sort by is Title A-Z. 
  5.  View search results by list (by default) or table by selecting the icon.
  6. Click the "Open Docket Folder." 

Submit an Electronic Comment

To find a docket on regulations.gov and submit an electronic comment:

  1. Go to regulations.gov and click on "Advanced Search" (right below the "Search" button).
  2. Type keyword(s) or Docket ID in the "Search" box.
  3. Select "Open for Comment" (directly under Search box).
  4. Select by Document Type "Notice," "Proposed Rule," and "Rule."
  5. Scroll down page To "Find Agency" and Select "FDA-FOOD AND DRUG ADMINISTRATION."
  6. Click the "Search" button.
  7. Show number of results per page, view results by list or table and sort by (select from drop-down menu). Best options to sort by are Document ID A-Z and Title A-Z. 
  8. View search results by list (by default) or table by selecting the icon.
  9. Click on "Commen Now!" button if you view results by list (by default) or in the "Actions" column if you view results by table.

More Tips on searching, navigating and commenting found at regulations.gov:

 

Page Last Updated: 09/04/2015
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