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Dear Colleague:
This communication is part of our outreach to state and local officials in response to the President’s Executive Order 13132, “Federalism.” In accordance with federalism principles, we want to provide you with the opportunity for meaningful and timely input in the development of regulatory policies that have substantial direct effects: (1) on the states; (2) on the relationship between the national government and the states; or (3) on the distribution of power and responsibilities among the various levels of government.
The Food and Drug Administration (FDA) has adopted this process to enhance state and local government’s input by sending state and local officials and their organizations 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 think will be of particular interest to state and local governments.
Information for You on the Unified Agenda of Federal Regulations
The Agenda provides, among other things, abstracts of all proposed and final regulations currently planned by 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 what government level may be affected, e.g., state or local. 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 38 rulemakings on the Agenda that we identified that will impact state or local governments. We encourage you to review these abstracts and to provide any comments or raise any questions you may have to the contact person listed, Mr. Richard Barnes of FDA’s Division of Federal-State Relations at 301-827-6906 or me.
The Agenda for the Food and Drug Administration for Spring 2008 which published in the Federal Register on May 5, 2008 (73 FR 24678). However, the version printed in the Federal Register only contains selected rulemakings, and does not contain information on Federalism. The complete Agenda is only available online at www.regsinfo.gov. Please note that the rulemakings are identified by the Regulatory Information Number (RIN).
They can also be found on the internet at the following locations:
1. Via FDA’s web site:
a) Go to http://www.fda.gov/oc/industry/unifiedagenda/agenda.html
b) Click on “Spring 2008 Unified Agenda. . .”
2. Via the Government Printing Office web site:
a) Go to Internet site http:www.gpoaccess.gov
b) On the right-hand size of the screen, under “Featured Items,” click on “Unified Agenda May 2008 Edition”
c) You can either enter a page number provided in our list in the “Quick Search” or browse the Table of Contents (and then clicking “text” or “pdf by Heath and Human Services and scrolling down through the agenda looking for FDA documents)
3. Via General Services Administration web site:
a) Go to Internet site http://www.reginfo.gov
b) Click on “Current and Past Agendas and Plans and How to Use Them” c) Under “Current Agenda Agency Regulatory Entries,” select Department Health and Human Services, press “submit”,” and scroll down to FDA’s portion.
Suggestions Are Welcome
We welcome suggestions and other comments from you and others at the state and local government level 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.
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 28 Rulemakings Identified by FDA with Impact on State or Local Governments in the Unified Agenda, and List of 10 Rulemakings Identified by FDA with Undetermined Impact on State or Local Governments. All of which can be found in the Unified Agenda which published on May 5, 2008.
FDA IDENTIFIED RULEMAKINGS WITH IMPACT
ON STATE OR LOCAL GOVERNMENTS*
FDA IDENTIFIED RULEMAKINGS WITH UNDETERMINED IMPACT ON STATE OR LOCAL GOVERNMENTS
*Abstracts of these planned rulemakings appear in the Unified Agenda of Federal Regulations. The Agenda was published in the Federal Register on May 5, 2008. It may be found on the Internet (see letter for instructions).