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Letter: Proper Consideration of Small Entities in Agency Rulemaking

April 5, 2018

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 The purpose of this review is to determine whether the rule should continue without change, be amended or rescinded to minimize the impact on small entities.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 does not have any 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. Each entry also contains an indication as to whether or not small businesses may be affected. The Agenda is published online at https://www.regulations.gov/ 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 24 rulemakings in the Agenda that we believe may impact small entities and a listing of 20 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 Nicholas Alexander of the FDA’s Office of Intergovernmental Affairs at 301-796-8893, or me.

The Agenda for the Food and Drug Administration for Fall 2018 was made available online on December 14, 2017, and published in the Federal Register on January 12, 2018 (83 FR 1664). Please note that the complete Agenda is only available online at Regulations.gov. 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 Regulations.gov
  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 “Fall 2017” 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
e-mail: Kenneth.Cohen@fda.hhs.gov

Enclosures: Lists of 24 Rulemakings Identified by FDA with an Impact on Small Entities, and 20 Rulemakings Identified by FDA with “Undetermined” Impact on Small Entities, all of which can be found in the Unified Agenda at Regulations.gov (see instructions above).



Rulemakings with Impact on Small Entities

  1. “OTC Drug Review; Cough/Cold (Antihistamine),” RIN 0910-AF31
  2. “Postmarketing Safety Reporting Requirement for Human Drug,” RIN 0910-AA97
  3. “OTC --Drug Review External Analgesic Products,” RIN 0910-AF35
  4. “OTC -- Drug Review Internal Analgesic Products,” RIN 0910-AF36
  5. “OTC -- Drug Review Laxative Drug Products,” RIN 0910-AF38
  6. “Sunscreen Drug Products for OTC Human Use,” RIN 0910-AF43
  7. “OTC -- Drug Review Weight Control Products,” RIN 0910-AF45
  8. “Label Requirement for Food that Has Been Refused Admission,” RIN 0910-AF61
  9. “Laser Products; Amendment to Performance Standard,” RIN 0910-AF87
  10. “OTC -- Drug Review Pediatric Dosing,” RIN 0910-AG12
  11. “Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products,” RIN 0910-AG18
  12. “Sunlamp Products; Amendment to the Performance Standard,” RIN 0910-AG30
  13. “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices,” RIN 0910-AG48
  14. “Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use,” RIN 0910-AH16
  15. “Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” RIN 0910-AH40
  16. “Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements,” RIN 0910-AH51
  17. “Requirement for Access or Safe Use of Certain Nonprescription Drug Products,” RIN 0910-AH62
  18. “Radiological Health; Amendments to Records and Report Regulations,” RIN 0910-AH65
  19. “Medical Devices; Amendments to Medical Software Regulations,” RIN 0910-AH67
  20. “Medication Guides; Patient Medication Information,” RIN 0910-AH68
  21. “Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods,” RIN 0910-AH00
  22. “Mammography Quality Standards Act; Regulatory Amendments,” RIN 0910-AH04
  23. “Investigational New Drug Application Annual Reporting,” RIN 0910-AH07
  24. “General and Plastic Surgery Devices: Sunlamp Products,” RIN 0910-AH14


  1. “Sunlamp Products; Proposed Amendment to the Performance Standard,” RIN 0910-AG30
  2. “National Standards for Licensing of Prescription Drug Wholesaler Distributor and Third-Party Logistics Provider,” RIN 0910-AH11
  3. “Investigational Tobacco Product Applications,” RIN 0910-AH06
  4. “Laboratory Accreditation for Analyses of Foods,” RIN 0910-AH31
  5. “Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease,” RIN 0910-AH43
  6. “Premarket Tobacco Product Applications,” RIN 0910-AH44
  7. “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” RIN 0910-AH52
  8. “Post Approval Changes to Approved Applications,” RIN 0910-AH55
  9. “Amendment of Certain Requirements Under 21 CFR 203,” RIN 0910-AH56
  10. “Establishment Registration and Product Listing for Tobacco Products,” RIN 0910-AH59
  11. “Kid-Appealing Flavors in Tobacco Products; Request for Information,” RIN 0910-AH60
  12. “New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator,” RIN 0910-AH64
  13. “Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices,” RIN 0910-AH66
  14. “Updating Public Information Regulations,” RIN 0910-AH69
  15. “Revision of Product Jurisdiction Regulations,” RIN 0910-AH71
  16. “Record Keeping Requirements Related to Tobacco Product Applications,” RIN 0910-AH74
  17. “The Food and Drug Administration Food Safety Modernization Act; Removing Written Assurance Requirements From the Customer Provisions in Certain Implementing Rules,” RIN 0910-AH77
  18. “Suspension of Registration of Food Facilities,” RIN 0910-AH79
  19. “Amendments to Registration of Food Facilities,” RIN 0910-AH82
  20. “Current Good Manufacturing Practice for Outsourcing Facilities,” RIN 0910-AH61


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