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U.S. Department of Health and Human Services

For Industry

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Letter: Proper Consideration of Small Entities in Agency Rulemaking

April 27, 2012

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 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  The purpose of this review is to determine whether the rule should continue without change, be amended or rescinded to minimize the impact on small entities.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 three  regulations for which 610 (c) reviews are being conducted.  In the abstract in the Agenda for these rules, 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.  Each entry 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 22 rulemakings in the Agenda that we believe may impact small entities and a listing of 13 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 Anita MacMullan of the FDA’s Division of Federal-State Relations at 301-796-5875, or me.

The Plan and Agenda for the Food and Drug Administration for Fall 2011  published in the Federal Register on February 13, 2012 (77 FR 7946).   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 2011” is displayed.
  4. Under “Select Agency,” scroll down to “Department of Health and Human Services,” and click “Go.”
  5. To see all entries on one page, to the right of “Number of Results to Display” select the maximum number
  6. 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 Anita MacMullan of the FDA’s Division of Federal-State Relations 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
e-mail: Kenneth.Cohen@fda.hhs.gov

Enclosures:  Lists of 22 Rulemakings Identified by FDA with an Impact on Small Entities, and 13 Rulemakings Identified by FDA with “Undetermined” Impact on Small Entities, all of which can be found in the Unified Agenda at Regulations.gov or which published in the Federal Register on February 13, 2012.


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
  2. “Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents,”  RIN 0910-AG61
  3. “General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification,” RIN 0910-AG62

Rulemakings with Impact on Small Entities

  1. “Over-The-Counter (OTC) Drug Review; Sunscreen Products,” RIN 0910-AF43
  2. “Electronic Submission of Data from Studies Evaluating Human Drugs and Biologics,” RIN 0910-AC52 
  3. “OTC Drug Review; Internal Analgesic Products,”  RIN 0910-AF36
  4. “OTC Drug Review: Topical Antimicrobial Drug Products,” RIN 0910-AF69
  5. “Import Tolerances for Residues of Unapproved New Animal Drugs in Food,”  RIN 0910-AF78
  6. “Laser Products; Amendment to Performance Standard,” RIN 0910-AF87
  7.  “Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals,” RIN 0910-AG10 (Regulatory Plan)
  8. “OTC Drug Review--Pediatric Dosing for Cough/Cold Products”  RIN 0910-AG12
  9. “Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products,”  RIN 0910-AG18
  10. “Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Second Phase,”  RIN 0910-AG20
  11. “Unique Device Identification,” RIN 0910-AG31  (Regulatory Plan)
  12. “Produce Safety Regulation,” RIN 0910-AG35  (Regulatory Plan)
  13. “Hazard Analysis and Risk-Based Preventive Controls,” RIN 0910-AG36  (Regulatory Plan)
  14. “’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
  15. “Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices,”  RIN 0910-48
  16. “General Hospital and Personal Use Devices:  Issuance of Draft Special Controls Guidance for Infusion Pumps,”  RIN 0910-AG54
  17. “Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives,”  RIN 0910-AG59
  18. “Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals—Components,”  RIN 0910-AG70
  19. “Infant Formula:  Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors,” RIN 0910-AF27  (Regulatory Plan)
  20. “Label Requirement for Food that Has Been Admission into the United States,” RIN 0910-AF61
  21. “Food Labeling:  Nutrition Labeling for Food Sold in Vending Machines,”  RIN 0910-AG56  (Regulatory Plan)
  22. “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. “Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products,” RIN 0910- AG43
  2. “Reports of Distribution and Sale Information for Antimicrobial Active Ingredients used in Food-Producing Animals,” RIN 0910-AG45
  3. “Proposed Revisions To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other Changes,” RIN 0910-AF97
  4. “Amendment to Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,” RIN 0910-AG40
  5. “Foreign Supplier Verification Program,” RIN 0910-AG64 (Regulatory Plan)
  6. “Use of Symbols in Labeling,” RIN 0910-AG74
  7. “Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products,” RIN 0910-AG81
  8. “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, “ RIN 0910-AA49
  9. “Current Good Manufacturing Practice for Combination Products,” RIN 0910-AF81
  10. “Postmarket Safety Reporting for Combination Products,” RIN 0910-AF82
  11. “Electronic Registration and Listing for Devices,” RIN 0910-AF88
  12. “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submissions Requirements,” RIN 0910-AF96
  13. “Administrative Detention of Food for Human or Animal Consumption,” RIN 0910-AG67


*Abstracts of these planned rulemakings appear in Unified Agenda of Federal Regulations. The Agenda published in the Federal Register on February 13, 2012 and at Regulations.gov (see letter for instructions).