For Industry

Letter: Proper Consideration of Small Entities in Agency Rulemaking

July 19, 2016

Dear Colleague:

Small Business Outreach

This communication is part of our outreach to small businesses in response to Presidential Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking.”  In accordance with the principles set forth in this Executive Order, we want to provide you with the opportunity for meaningful and timely input in the development of regulatory policies that may have substantial direct effects on you.

The Food and Drug Administration (FDA) has adopted this process to enhance small entities' input by sending notice of the publication of the Regulatory Plan and Unified Agenda of Federal Regulations (Agenda).  With this notice and the information we provide on locating the Plan and Agenda on the Internet, we send a list of those regulatory items that we believe will be of particular interest to you.

Executive Order 13272 promotes compliance with the Regulatory Flexibility Act which requires Federal agencies to examine the impact of regulations on small entities.  As part of this analysis, an agency is required to determine whether or not a rule will have "a significant economic impact on a substantial number of small entities."  In the Plan and Agenda, there is a section where agencies can indicate whether or not a regulatory flexibility analysis is needed.  If the agency has either not made that determination yet or has determined that no analysis is required, it may still indicate that some impact on small entities is likely by indicating that in the “Small Entities Affected” section. Please note that the list that we have enclosed with this letter includes both those regulations for which FDA has determined that a regulatory flexibility analysis is required and those for which some impact is likely or “undetermined,” but which may not require a full analysis.

For your information, under section 610(c) of the Regulatory Flexibility Act, Federal agencies are required to review regulations that have or will have a “significant economic impact on a substantial number of small entities” within 10 years of publication in the Federal Register.  The purpose of this review is to determine whether the rule should continue without change, be amended or rescinded to minimize the impact on small entities. To comply with this requirement, FDA has implemented the process of identifying these rules to be reviewed under section 610(c) in the Agenda.  You will note that FDA has one regulation for which 610 (c) review is being conducted. 

Information for You on the Unified Agenda of Federal Regulations (Agenda)

The Plan and Agenda provide, among other things, abstracts of all proposed and final regulations currently planned by the FDA for the next six to twelve months, as well as abstracts of planned long-term actions and completed actions.  Eachentry also contains an indication as to whether or not small businesses may be affected.  The Agenda is published online at and in the Federal Register twice a year (in the Spring and Fall), with the Fall edition also containing the Regulatory Plan. Below is a listing of 25 rulemakings in the Agenda that we believe may impact small entities and a listing of 11 rulemakings with an “Undetermined” impact on small entities. 

We encourage you to review these abstracts and to provide any comments or raise any questions you may have with the contact person listed, or you may contact Brian Kehoe of the FDA’s Office of Intergovermental Affairs at 301-796-8913, or me.

The Agenda for the Food and Drug Administration for Spring 2016 was made available online on May 18, 2016, and published in the Federal Register on June 9, 2016 (81 FR 37294). Please note that the complete Agenda is only available online at  Only rulemakings that are likely to have a significant economic impact on a substantial number of small entities appear in the printed version in the Federal Register. 

The Agenda can be found on the internet at the following location:

  1. Go to Internet site
  2. Scroll down to “Resources,” and click on “Regulatory Agenda.”  (You will be re-directed; click “ok”.)
  3. Make sure that at “Select Publication Date” that “Spring 2016” is displayed.
  4. Under “Select Agency,” scroll down to “Department of Health and Human Services,” and click “Go.”
  5. Scroll through to see FDA’s portion and to see a specific entry, click on the RIN in blue.

Suggestions Are Welcome

We welcome suggestions and other comments from you on FDA’s activities to enhance your input in the development of FDA’s regulations, especially those regulations that have a substantial and direct effect on you.  Again, you may send your comments and suggestions to the contact person listed for a particular Federal Register document or by contacting Brian Kehoe of the FDA’s Office of Partnerships or to me.

In addition, we would like to take this opportunity to tell you about FDA's web site for small businesses.  It can be found at Small Business Assistance. This site provides information on FDA Small Business contacts, how to participate in various FDA forums, and provides guidance on how to get assistance from the agency.


Kenneth Cohen
Director, Regulations Policy and Management Staff
Office of Policy
10903 New Hampshire Ave
Bldg 32, Rm. 3324
Silver Spring, MD 20993
Phone: 301-796-7001
Fax: 301-847-8603

Enclosures: Lists of 25 Rulemakings Identified by FDA with an Impact on Small Entities, and 11 Rulemakings Identified by FDA with “Undetermined” Impact on Small Entities, all of which can be found in the Unified Agenda at (see instructions above).



610(c) Reviews (see letter for explanation

  1.  “Use of Ozone Depleting Substances,” RIN 0910-AH36

Rulemakings with Impact on Small Entities

  1. “OTC Drug Review; Cough/Cold (Antihistamine),” RIN 0910-AF31 

  2. “OTC Drug Review: Topical Antimicrobial Drug Products,” RIN 0910-AF69

  3. “Abbreviated New Drug Applications and 505(b)(2) Applications,” RIN 0910-AF97

  4. “Updated Standards for Labeling of Pet Food, ” RIN 0910-AG09

  5. “Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients and Additives,” RIN 0910-AG59

  6. “Format and Content of Reports Intended to Demonstrate Substantial Equivalence,”  RIN 0910-AG96

  7. “Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods ,” RIN 0910-AH00

  8. “Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System, ” RIN 0910-AH03

  9. “Mammography Quality Standards Act; Regulatory Amendments,” RIN 0910-AH04

  10. “Investigational New Drug Application Annual Reporting,” RIN 0910-AH07

  11. “General and Plastic Surgery Devices:  Sunlamp Products,” RIN 0910-AH14

  12. “Requirements for Tobacco Product Manufacturing Practice,” RIN 0910-AH22

  13. “ Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application and Animal Drugs, ” 0910-AA49

  14. “Food Labeling; Revision of the Nutrition and Supplement Facts Labels,” RIN 0910-AF22

  15. “Food Labeling; Serving Sizes of Foods that can Reasonably be Consumed at one Eating Occasion; Dual Column Labeling; Updating, Modifying and Establishing Certain RACCs, ” RIN 0910-AF23 

  16. “Laser Products; Amendment to Performance Standard,” RIN 0910-AF87

  17. “’Tobacco Products’ Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act,” RIN 0910-AG38

  18. “Human Subject Protection; Acceptance of Data From Clinical Studies for  Medical Devices,” RIN 0910-AG48

  19. “Foreign Supplier Verification Program,”  RIN 0910-AG64

  20. “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,”  RIN 0910-AG94

  21. “Focused Mitigation Strategies To Protect Food Against Intentional Adulteration,” RIN 0910-AG63

  22. “Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act,” RIN 0910-AH10

  23. “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements” RIN 0910-AC53

  24. “Postmarketing Safety Reporting Requirements for Human Drug and Biological Products RIN 0910-AA97



  1. Sunlamp Products; Proposed Amendment to the Performance Standard,” RIN 0910-AG30

  2. “Establishment Registration and Product Listing for Tobacco Products,” RIN 910- AG89

  3. “National Standards for Licensing of Prescription Drug Wholesaler Distributor and Third-Party Logistics Provider,” RIN 0910-AH11

  4. “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs or Devices,” RIN 0910-AH19

  5. “Investigational Tobacco Product Applications,” RIN 0910-AH06

  6. “Current Good Manufacturing Practice for Outsourcing Facilities,” RIN 0910-AH09

  7. “Patient Medication Information” RIN 0910-AH33

  8. “Direct Food Substances Affirmed as Generally Recognized as Safe; Partially Hydrogenated Menhaden Oil and Rapeseed Oil” 0910-AH28

  9. “Labeling Requirements for Approved and Conditionally Approved New Animal Drugs” 0910-AH27

  10. “Abbreviated New Drug Applications; Applications and Phased Review Process for New Animal Drug Applications” 0910-AG46

  11. “Renaming Various Devices as Powered Laparoscopic Tissue Fragmentation Devices; Designation of Special Controls” 0910-AH38


Page Last Updated: 07/19/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English