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Letter from Director, Regulations Policy and Management Staff Office of Policy


June 10, 2003

Dear Colleague:

Federalism Outreach

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 (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 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 three rulemakings in the Agenda that we identified that we believe will impact state or local governments and a listing of 18 rulemakings that have an “undetermined” impact. 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 2003, which published in the Federal Register on May 27, 2003, can be found on the web at the following two locations:

  1. Go to Internet site http://www.archives.gov
  2. On the left-hand side of the screen click on “Federal Register”
  3. Under the heading “Federal Register News and Events,” click on "Unified Regulatory Agenda”
  4. You can either enter a page number provided in our list in the “Quick Search” or browse the Table of Contents

Another way to access the Agenda is:

  1. Go to Internet site http://www.reginfo.gov
  2. Click on “Unified Agenda & Regulatory Plan”
  3. Click on “Spring 2003 Unified Agenda of Federal Regulatory and Deregulatory Actions”
  4. Click on “Databases and Browseable List of the Spring 2003 Unified Agenda”
  5. Click on “Unified Agenda Tables of Contents”
  6. Click on “Department of Health and Human Services (HHS)” and scroll to the Food and Drug Administration agenda.

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 to me.


Sincerely,


Edwin V. Dutra, Jr.
Director, Regulations Policy and Management Staff
Office of Policy
5600 Fishers Lane (HF-26)
Parklawn Building Room 12-A-17
Rockville, MD 20857

Phone: 301-827-3480
Fax: 301-827-1696
e-mail: EDUTRA@OC.FDA.GOV


Enclosures: List of Three Rulemakings Identified by FDA with Impact on State or Local Governments, and List of 18 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 27, 2003.


FDA IDENTIFIED RULEMAKINGS WITH IMPACT ON STATE OR LOCAL GOVERNMENTS*

  1. “Food Labeling; Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims,” Sequence No. 798, page 30239
  2. “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/PS),” Sequence No. 811, page 30244
  3. “Current Good Tissue Practice for Manufacturing of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/PS), Inspection and Enforcement,” Sequence No. 812, page 30244

FDA IDENTIFIED RULEMAKINGS WITH UNDETERMINED IMPACT ON STATE OR LOCAL GOVERNMENTS

  1. “Investigational Use New Animal Drug Regulations (Section 610 Review),” Sequence No. 766, page 30228
  2. “Part 110–Current Good Manufacturing Practice in Manufacturing, Packing, and Holding Human Food (Section 610 Review),” Sequence No. 768, page 30229
  3. “Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications,” Sequence No. 771, page 30230
  4. “Current Good Manufacturing Practice for Medicated Feeds,” Sequence No. 77, page 30231
  5. “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements,” Sequence No. 773, page 30231
  6. “Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Foods,” Sequence No. 774, page 30231
  7. “Prevention of Salmonella Enteritidis in Shell Eggs,” Sequence No. 775, page 30232
  8. “Use of Materials Derived from Bovine and Ovine Animals in FDA-Regulated Products,” Sequence No. 777, page 30233
  9. “Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed Animal Populations,” Sequence No. 778, page 30233
  10. “Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use with Medical Oxygen,” Sequence 781, page 30234
  11. “Medical Devices; Patient Examination and Surgeons’ Gloves; Adulteration,” Sequence No. 782, page 30234
  12. “Administrative Detention of Food for Human and Animal Consumption under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” Sequence No. 784, page 30235
  13. “Submission of Standardized Electronic Study Data from Clinical Studies Evaluating Human Drugs and Biologics,” Sequence No. 787, page 30236
  14. “Food Standards; General Principles and Food Standards Modernization,” Sequence No. 789, page 30236
  15. “Positron Emission Tomography Drugs; Current Good Manufacturing Practices,” Sequence No. 790, page 30237
  16. “Labeling for Human Prescription Drugs; Revised Format,” Sequence No. 796, page 30239
  17. “Presubmission Conference,” Sequence No. 807, page 30242
  18. “Safety Reporting Requirements for Human Drug and Biologic Products,” Sequence No. 810, page 30242

*Abstracts of these planned rulemakings appear in the Unified Agenda of Federal Regulations on the pages indicated. The Agenda was published in the Federal Register on May 27, 2003. It may be found on the Internet at http://www.archives.gov or at http://www.reginfo.gov (see letter for instructions).