Letter: Proper Consideration of Small Entities in Agency Rulemaking

June 8, 2009

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 Unified Agenda of Federal Regulations (Agenda).  With this notice and the information we provide on locating the 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  The purpose of this review is to determine whether the rule should continue without change, be amended or rescinded to minimize the impact on small entities.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 this time FDA has 2 regulations for which 610(c) reviews are being conducted.  We have created a separate list of these regulations for your convenience.  In the abstract in the Agenda for these rules, FDA explains the 610 section review 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 Agenda provides, 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 Agenda item 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 (usually in April and October), with the Fall edition also containing the Regulatory Plan.  Below is a listing of 35 rulemakings in the Agenda that we believe may  impact small entities, and a listing of 23 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 Mr. Richard Barnes of the FDA’s Division of Federal-State Relations at 301-827-6906, or me.

The Agenda for the Food and Drug Administration for Spring 2009 published in the Federal Register on May 11, 2009 (74 FR 21920).   Please note that the complete Agenda is only available online at www.reginfo.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. 

To access www.reginfo.gov:

1. Go to Internet site http://www.reginfo.gov
2. Click on “Current and Past Agendas and Plans and How to Use Them”
3. Under “Current Agenda Agency Regulatory Entries,” select “Department of Health and Human Services (HHS),” press “submit,”  and scroll down to the Food and Drug Administration portion.

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 Mr. Richard Barnes 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.

Sincerely, Edwin V. Dutra, Jr. 
Director, Regulations Policy and Management Staff 
Office of Policy, Planning, and Preparedness 
5600 Fishers Lane (HF-26) 
Parklawn Building Room 12-A-11 
Rockville, MD 20857

Phone: 301-827-3480 
Fax: 301-827-1696 
E-mail: edwin.dutra@fda.hhs.gov 

Enclosures:  Lists of 2 Regulations under 610(c) Review, 35 Rulemakings Identified by FDA with an Impact on Small Entities, and 23 Rulemakings Identified by FDA with “Undetermined” Impact on Small Entities.  All of which can be found in the Unified Agenda which published in the Federal Register on May 11, 2009 and at www.reginfo.gov.

FDA IDENTIFIED RULEMAKINGS WITH IMPACT ON SMALL ENTITIES

610(c) Reviews (See letter for explanation of 610(c))

1. "Food Labeling; Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution," RIN 0910-AG06
2. "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. "Electronic Submission of Data from Studies Evaluating Human Drugs and Biologics," RIN 0910-AC52
2. "Over-The-Counter (OTC) Drug Review; Cough/Cold (Antihistamine) Products," RIN 0910-AF31
3. "OTC Drug Review; Laxative Drug Products," RIN 0910-AF38
4. "OTC Drug Review; Sunscreen Products," RIN 0910-AF43
5. "OTC Drug Review; Weight Control Products," RIN 0910-AF45
6. "Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use; Proposed Amendment to the Final Monograph,"  RIN 0910-AG12
7. "Prevention of Salmonella Enteritidis in Shell Eggs," RIN 0910-AC14
8. "Medical Gas Containers and Closures; Current Good Manufacturing Practices," RIN 0910-AC53
9. "Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling," RIN 0910-AF11
10. "OTC Drug Review; Cough/Cold (Bronchodilator) Products," RIN 0910-AF32
11. "OTC Drug Review; Cough/Cold (Combination) Products," RIN 0910-AF33
12. "OTC Drug Review; External Analgesic Products," RIN 0910-AF35
13. "OTC Drug Review; Internal Analgesic Products,"  RIN 0910-AF36
14. "OTC Drug Review; Skin Protectant Products," RIN 0910-AF42
15. "Substances Prohibited from Use in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy," RIN 0910-AF46
16. "Use of Materials Derived from Cattle in Human Food and Cosmetics," RIN 0910-AF47
17. "Label Requirement for Food that has been Refused Admission into the United States," RIN 0910-AF61
18. "OTC Drug Review; Acne Drug Products Containing Benzoyl Peroxide," RIN 0910-AG00
19. "Postmarketing Safety Reporting Requirements for Human Drug and Biological Products," RIN 0910-AA97
20. "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements," RIN 0910-AB88
21. "OTC Drug Review; Cough/Cold (Nasal Decongestant) Products," RIN 0910-AF34
22. "OTC Drug Review; Labeling of Drug Products for OTC Human Use," RIN 0910-AF37
23. "OTC Drug Review; Ophthalmic Products," RIN 0910-AF39
24. "OTC Drug Review; Oral Health Care Products," RIN 0910-AF40
25. "OTC Drug Review; Vaginal Contraceptive Products,"  RIN 0910-AF44
26. "OTC Drug Review; Overindulgence in Food and Drink Products," RIN 0910-AF51
27. "OTC Drug Review; Antacid Products," RIN 0910-AF52
28. "OTC Drug Review; Skin Bleaching Products," RIN 0910-AF53
29. "OTC Drug Review; Stimulant Drug Products," RIN 0910-AF56
30. "OTC Antidiarrheal Drug Products," RIN 0910-AF63
31. "OTC Drug Review: Poison Treatment Drug Products," RIN 0910-AF68
32. "OTC Drug Review: Topical Antimicrobial Drug Products," RIN 0910-AF69
33. "OTC Drug Review: Urinary Analgesic Drug Products," RIN 0910-AF70
34. "Status of Certain Additional OTC Drug Category II Active Ingredients," RIN 0910-AF95
35. "Process Controls for Animal Feed Ingredients and Mixed Animal Feed," RIN 0910-AG10

FDA Identified Rulemakings With "Undetermined" Impact On Small Entities

1. "Reporting Information Regarding Falsification of Data,"  RIN 0910-AC59
2. "Current Good Manufacturing Practice for Combination Products," RIN 0910-AF81
3. "Postmarket Safety Reporting for Combination Products," RIN 0910-AF82
4. "Medical Device Reporting; Electronic Submission Requirements," RIN 0910-AF86
5. "Laser Products; Amendment to Performance Standard," RIN 0910-AF87
6. "Electronic Registration and Listing for Devices," RIN 0910-AF88
7. "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements," RIN 0910-AF96
8. "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
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," RIN 0910-AG20
11. "Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, including Drugs that are Regulated under a Biologics License Application, and Animal Drugs," RIN 0910-AA49
12. "Medical Devices; Anesthesiology Devices; Reclassification of Pressure Regulators for Use with Medical Oxygen and Separate Classification of Oxygen Conserving Devices," RIN 0910-AC30
13. "Charging for Investigational Drugs Under an Investigational New Drug Application," RIN 0910-AF13
14. "Expanded Access to Investigational Drugs for Treatment Use," RIN 0910-AF14
15. "Premarketing Safety Reporting Requirements for Human Drug and Biological Products," RIN 0910-AG13
16. "Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements," RIN 0910-AC50
17. "Food Standards:  General Principles and Food Standards Modernization,"  RIN 0910-AC54
18. "Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; Revision of Certain Labeling Controls," RIN 0910-AF08
19. "Food Labeling; Prominence of Calories," RIN 0910-AF22
20. "Food Labeling; Serving Sizes of Products that can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes," RIN 0910-AF23
21. "Blood Initiative: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use," RIN 0910-AF25
22.  "Conditional Approval of New Animal Drugs for Minor Use and Minor Species," RIN 0910-AG07
23. "Pet Food Labeling Requirements," RIN 0910-AG09

*Abstracts of these planned rulemakings appear in the Unified Agenda of Federal Regulations on the pages indicated.  The Agenda published in the Federal Register on May 11, 2009 and at www.reginfo.gov (see letter for instructions).