For Industry

Letter: Proper Consideration of Small Entities in Agency Rulemaking

April 10, 2013

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 The purpose of this review is to determine whether the rule should continue without change, be amended or rescinded to minimize the impact on small entities.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. In the abstract in the Agenda for this rule, FDA explains section 610(c) reviews and solicits comments on a list of questions regarding the need for the rule.

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 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 6 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 Barbara Cassens of the FDA’s Office of Partnerships at 301-796-5875, or me.

The Plan and Agenda for the Food and Drug Administration for Fall 2012 published in the Federal Register on January 8, 2013 (78 FR 1574). 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 “Fall 2012”is displayed. Under “Select Agency,” scroll down to “Department of Health and Human Services,” and click “Go.”
  4. 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 Barbara Cassens 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. 3224
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 6 Rulemakings Identified by FDA with “Undetermined” Impact on Small Entities, all of which can be found in the Unified Agenda at or which published in the Federal Register on January 8, 2013.


610(c) Reviews (see letter for explanation)

  1. “Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures,” RIN 0910-AG14

Rulemakings with Impact on Small Entities

  1. “Over-The-Counter (OTC) Drug Review; Sunscreen Products,” RIN 0910-AF43
  2. “Food Labeling; Revision of the Nutrition and Supplement Facts Labels,” RIN 0910AF22
  3. “Food Labeling; Serving Sizes of Foods that can Reasonably be Consumed in one Eating Occasion; Dual Column Labeling; and Modifying the Reference Amounts Customarily Consumed,” RIN 0910-AF23
  4. “OTC Drug Review; Cough/Cold (Antihistamine),” RIN 0910-AF31
  5. “OTC Drug Review; Internal Analgesic Products,”RIN 0910-AF36
  6. “OTC Drug Review: Topical Antimicrobial Drug Products,” RIN 0910-AF69
  7. “Laser Products; Amendment to Performance Standard,” RIN 0910-AF87
  8. “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Benefit Preventive Controls for Food for Animals,” RIN 0910-AG10 (Regulatory Plan)
  9. “OTC Drug Review--Pediatric Dosing for Cough/Cold Products” RIN 0910-AG12
  10. “Electronic Distribution of Prescribing Information for Human Drugs Including Biological Products,” RIN 0910-AG18
  11. Produce Safety Regulation,” RIN 0910-AG35 (Regulatory Plan)
  12. “Hazard Analysis and Risk-Based Preventive Controls,” RIN 0910-AG36 (Regulatory Plan)
  13. “’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
  14. “General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps,” RIN 0910-AG54
  15. “Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives,”  RIN 0910-AG59
  16. “Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Components,” RIN 0910-AG70
  17. “Use of Symbols in Labeling,” RIN 0910-AG74
  18. “Requirement for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products,” RIN 0910-AG81
  19. “Food Labeling; Hard Candies and Breath Mints,” RIN 0910-AG82
  20. “Food Labeling; Serving Sizes; Reference Amounts for Candies,” RIN 0910-AG83
  21. “Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors,” RIN 0910-AF27
  22. “OTC Drug Review—Cough/Cold (Combination) Products,” RIN 0910-AF33
  23. “Unique Device Identification,” RIN 0910-AG31 (Regulatory Plan)
  24. “Food Labeling: Nutrition Labeling for Food Sold in Vending Machines,” RIN 0910-AG56 (Regulatory Plan)
  25. “Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments,” RIN 0910-AG57 (Regulatory Plan)

FDA Identified Rulemakings With “Undetermined” Impact On Small Entities

  1. Food Labeling; Dietary Guidance Statements,” RIN 0910-AG50
  2. Foreign Supplier Verification Program,” RIN 0910-AG64 (Regulatory Plan)
  3. Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages),” RIN 0910-AG88 (Regulatory Plan)
  4. Establishment Registration and Product Listing for Tobacco Products,” RIN 0910-AG89
  5. Public Information in Tobacco Marketing Applications,” RIN 0910-AG90
  6. Postmarket Safety Reporting for Combination Products,” RIN 0910-AF82

*Abstracts of these planned rulemakings appear in Unified Agenda of Federal Regulations. The Agenda published in the Federal Register on January 8, 2013, and at (see letter for instructions).


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