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FDA
September 21, 2004
Dear Colleague:
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 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 The purpose of this review is to determine whether the rule should continue without change, be amended or rescinded to minimize the impact on small entities.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 by the title of these rules FDA has placed the phrase "(610 section review)." 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. In this issue of the Agenda, FDA announced the completion of one such review. However, there are no new 610(c) reviews being undertaken by the agency at this time.
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 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 Agenda that we have identified that will impact small entities, and a listing of 18 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 Agenda for the Food and Drug Administration for Spring 2004, which published in the Federal Register on June 28, 2004, can be found on the web at the following two locations:
1. a) Go to Internet site http://www.archives.gov
b) On the left-hand side of the screen click on "Federal Register"
c) Under the heading "Sections," click on "Online Publications via GPO Access"
d) Scroll down to "Unified Agenda" and click
e) You can either enter a page number provided in our list in the "Quick Search" or browse the Table of Contents
2. a) Go to Internet site http://www.reginfo.gov
b) Click on "Unified Agenda & Regulatory Plan"
c) Click on "Spring 2004 Unified Agenda of Federal Regulatory and Deregulatory Actions"
d) Click on "Databases and Browseable List of the Spring 2004 Unified Agenda"
e) Click on "Unified Agenda Tables of Contents"
f) Click on "Department of Health and Human Services (HHS)" and scroll to the Food and Drug Administration agenda.
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 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 Legislation
5600 Fishers Lane (HF-26)
Parklawn Building Room 12-A-11
Rockville, MD 20857
Phone: 301-827-3480
Fax: 301-827-1696
e-mail: EDUTRA@OC.FDA.GOV
Enclosures: List of 35 Rulemakings Identified by FDA with Impact on Small Entities and List of 18 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 June 28, 2004.
FDA IDENTIFIED RULEMAKINGS WITH "UNDETERMINED" IMPACT ON SMALL ENTITIES
*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 December 22, 2003. It may be found on the Internet at http://www.archives.gov or at http://www.reginfo.gov (see letter for instructions).