Dear
Colleague:
Federalism Outreach
This communication is part of our outreach to state and local officials in response to
the Presidents 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 governments 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 FDAs 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:
- Go to Internet site http://www.archives.gov
- On the left-hand side of the screen click on Federal Register
- Under the heading Federal Register News and Events, click
on "Unified Regulatory Agenda
- 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:
- Go to Internet site http://www.reginfo.gov
- Click on Unified Agenda & Regulatory Plan
- Click on Spring 2003 Unified Agenda of Federal Regulatory and Deregulatory
Actions
- Click on Databases and Browseable List of the Spring 2003 Unified Agenda
- Click on Unified Agenda Tables of Contents
- 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 FDAs activities to enhance your input in
the development of FDAs 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 FDAs 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*
- Food Labeling; Trans Fatty Acids in Nutrition Labeling,
Nutrient Content Claims, and Health Claims, Sequence No. 798, page 30239
- Eligibility Determination for Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/PS), Sequence No. 811, page
30244
- 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
- Investigational Use New Animal Drug Regulations (Section 610
Review), Sequence No. 766, page 30228
- Part 110Current Good Manufacturing Practice in
Manufacturing, Packing, and Holding Human Food (Section 610 Review), Sequence No.
768, page 30229
- Applications for FDA Approval to Market a New
Drug; Complete Response Letter; Amendments to Unapproved Applications, Sequence No.
771, page 30230
- Current Good Manufacturing Practice for
Medicated Feeds, Sequence No. 77, page 30231
- Current Good Manufacturing Practice in Manufacturing,
Packing, or Holding Dietary Ingredients and Dietary Supplements, Sequence No. 773,
page 30231
- Requirements Pertaining to Sampling Services and Private
Laboratories Used in Connection with Imported Foods, Sequence No. 774, page 30231
- Prevention of Salmonella Enteritidis in Shell Eggs,
Sequence No. 775, page 30232
- Use of Materials Derived from Bovine and Ovine Animals in
FDA-Regulated Products, Sequence No. 777, page 30233
- Chronic Wasting Disease: Control of Food Products and
Cosmetics Derived from Exposed Animal Populations, Sequence No. 778, page 30233
- Medical Devices; Anesthesiology Devices; Proposed
Reclassification of Pressure Regulators for Use with Medical Oxygen, Sequence 781,
page 30234
- Medical Devices; Patient Examination and Surgeons
Gloves; Adulteration, Sequence No. 782, page 30234
- 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
- Submission of Standardized Electronic Study Data from
Clinical Studies Evaluating Human Drugs and Biologics, Sequence No. 787, page 30236
- Food Standards; General Principles and Food Standards
Modernization, Sequence No. 789, page 30236
- Positron Emission Tomography Drugs; Current Good
Manufacturing Practices, Sequence No. 790, page 30237
- Labeling for Human Prescription Drugs; Revised
Format, Sequence No. 796, page 30239
- Presubmission Conference, Sequence No. 807, page
30242
- 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). |