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January 9, 2008

Dear Colleague:

Small Business Outreach

This communication is part of our outreach to small businesses in response to the President’s 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 (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.

In addition, 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  The purpose of this review is to determine whether the rule should continue without change, be amended, or rescinded to minimize the impact on small entities.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 by the title of these rules FDA has placed the phrase "(610 section review)."   In the abstracts 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.  Currently, FDA has identified 6 rules for review under section 610(c).  We have included a separate list of these rules.  Submit any comments or questions you may have to the contact person listed.

Information for You on the Regulatory Plan (Plan) and 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 Plan and Agenda item also contain 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 Plan and Agenda that we have identified that will impact small entities, and a listing of 21 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.

The Plan and Agenda for the Food and Drug Administration for Fall 2007, published in the Federal Register on December 10, 2007.  Beginning with this edition of the Unified Agenda, the internet will be the basic means for disseminating this information.  The complete Agenda will be available online at www.reginfo.gov, and can also be found on the web at the following locations:

1. Via FDA’s web site:

2. Go to http://www.fda.gov/oc/industry/unifiedagenda/agenda.html
3. Click on "Fall 2007 Unified Agenda. . ."

2.     Via the General Services Administration web site:

a)   Go to Internet site http://www.reginfo.gov
b)   Under the heading "Unified Agenda & Regulatory Plan," click on "Current and Past Agendas and Plans and How to Use them"
c)   Under the heading "Current Agenda Agency Regulatory Entries," select Agency, "Department of Health and Human Services," click on "submit," and
d)   Scroll down to find FDA’s entries.

3.   Via the Federal Dockets Management System:

1. Go to Internet site http://www.regulations.gov
2. Go to "Site Features," and from drop down menu, click on "Regulatory Agenda"
3. Scroll down and click on "Department of Health and Human Services"
4. FDA’s portion starts on page 6.

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 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  http://www.fda.gov/ora/fed_state/Small_Business/sb_guide/default.htm.   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:  List of 35 Rulemakings Identified by FDA with Impact on Small Entities;  List of 21 Rulemakings Identified by FDA with "Undetermined" Impact on Small Entities; and List of 6 Rules to be reviewed under Section 610(c).  All of which can be found in the Regulatory Plan and Unified Agenda which published in the Federal Register on December 10, 2007.

FDA IDENTIFIED RULEMAKINGS WITH IMPACT
ON SMALL ENTITIES

5. "Electronic Submission of Data from Studies Evaluating Human Drugs and Biologics," RIN No. 0910-AC52
6. "Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling," RIN No. 0910-AF11
7. "Over-the-Counter (OTC) Review; External Analgesic Products," RIN No. 0910-AF35
8. "OTC Review; Internal Analgesic Products," RIN No. 0910-AF36
9. "OTC Review; Oral Health Care Products," RIN No. 0910-AF40
10. " OTC Review; Sunscreen Products," RIN No. 0910-AF43
11. "Label Requirement for Food that has been Refused Admission into the United States," RIN No. 0910-AF61
12. "OTC Review; Poison Treatment Drug Products," RIN No. 0910-AF68
13. "OTC Review; Topical Antimicrobial Drug Products," RIN No. 0910-AF69
14. "OTC Review; Urinary Analgesic Drug Products," RIN No. 0910-AF70
15. "Safety Reporting Requirements for Human Drug and Biological Products," RIN No. 0910-AA97
16. "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements," RIN No. 0910-AB88
17. "Prevention of Salmonella Enteritidis in Shell Eggs," RIN No. 0910-AC14
18. "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs," RIN No. 0910-AC35
19. "Positron Emission Tomography Drugs; Current Good Manufacturing Practices," RIN No. 0910-AC55
20. "Cochineal Extract and Carmine Label Declaration," RIN No. 0910-AF12
21. "Charging for Investigational Drugs," RIN No. 0910-AF13
22. "Expanded Access to Investigational Drugs for Treatment Use," RIN No. 0910-AF14
23. "OTC Review; Cough/Cold (Antihistamine) Products," RIN No. 0910-AF31
24. "OTC Review; Cough/Cold (Bronchodilator) Products," RIN No. 0910-AF32
25. "OTC Review; Cough/Cold (Combination) Products," RIN No. 0910-AF33
26. "OTC Review; Cough/Cold (Nasal Decongestant) Products," RIN No. 0910-AF34
27. "OTC Review; Labeling of Drug Products for OTC Human Use," RIN No. 0910-AF37
28. "OTC Review; Laxative Drug Products," RIN No. 0910-AF38
29. "OTC Review; Skin Protectant Products," RIN No. 0910-AF42
30. "OTC Review; Vaginal Contraceptive Products," RIN No. 0910-AF44
31. "OTC Review; Weight Control Products," RIN No. 0910-AF45
32. "Substances Prohibited from Use in Animal Food or Feed to Prevent the Transition of Bovine Spongiform Encephalopathy," RIN No. 0910-AF46
33. "OTC Review; Antacid Products," RIN No. 0910-AF52
34. "OTC Review; Skin Bleaching Products," RIN No. 0910-AF53
35. "Health Claims," RIN No. 0910-AF09
36. "OTC Review; Ophthalmic Products," RIN No. 0910-AF39
37. "OTC Review; Overindulgence in Food and Drink Products," RIN No. 0910-AF51
38. "OTC Review; Stimulant Drug Products," RIN No. 0910-AF56
39. "OTC Review; Antidiarrheal Drug Products," RIN No. 0910-AF63

FDA IDENTIFIED RULEMAKINGS WITH "UNDETERMINED"
IMPACT ON SMALL ENTITIES

1. "Reporting Information Regarding Falsification of Data," RIN No. 0910-AC59
2. "Blood Initiative: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use," RIN No. 0910-AF25
3. "Current Good Manufacturing Practice for Combination Products," RIN No. 0910-AF81
4. "Postmarket Safety Reporting for Combination Products," RIN No. 0910-AF82
5. "Medical Device Reporting; Electronic Submission Requirement," RIN No. 0910- AF86
6. "Laser Products; Amendment to Performance Standard," RIN No. 0910-AF87
7. "Electronic Registration and Listing for Devices," RIN No. 0910-AF88
8. "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements," RIN No. 0910-AF96
9. "Proposed Revisions to Implement Portions of Title XI of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and Other Changes," RIN No. 0910-AF97
10. "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 No. 0910-AA49
11. ‘Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002," RIN No. 0910-AC41
12. "Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements," RIN No. 0910-AC53
13. "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species," RIN No. 0910-AF67
14. "Use of Ozone Depleting Substances; Removal of Essential Use Designations (Epinephrine)," RIN No. 0910-AF92
15. "Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use with Medical Oxygen and Separate Classification of Oxygen Conserving Devices," RIN No. 0910-AC30
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 No. 0910-AC50
17. "Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; Revision of Certain Labeling Controls," RIN No. 0910-AF08
18. "Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and Condoms with Spermicidal Lubricant," RIN No. 0910-AF21
19. "Food Labeling; Prominence of Calories," RIN No. 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 No. 0910-AF23
21. "Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and Pectin," RIN No. 0910-AF99

FDA RULEMAKINGS BEING REVIEWED UNDER SECTION 610(C) OF THE REGULATORY FLEXIBILITY ACT

1. "Status of Certain Additional OTC Drug Category II and III Active Ingredients, " RIN No. 0910-AF75
2. "Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents," RIN No. 0910-AF76
3. "Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber-Containing Medical Device," RIN No. 0910-AF77
4. "Financial Disclosure by Clinical Investigators," RIN No. 0910-AF79
5. "Beverages; Bottled Water," RIN No. 0910-AF80
6. "Food Labeling; Nutrient Content Claims; Definition for "High Potency" and Definition of "Antioxidant" for use in Nutrient Content Claims for Dietary Supplements and Conventional Foods," RIN No. 0910-AF83

*Abstracts of these planned rulemakings appear in the Regulatory Plan and Unified Agenda of Federal Regulations.  The Plan and Agenda published in the Federal Register on December 10, 2007.   It may be found on the Internet (see letter for instructions).

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