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January 10, 2008

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 Regulatory Plan (Plan) and the Unified Agenda of Federal Regulations (Agenda).  With this notice and the information we provide on locating the Agenda and Plan 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 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 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 Plan.  Below is a listing of 42 rulemakings on the Plan and Agenda that we identified that we believe will or may impact state or local governments.  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 Unified 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:

1. Go to http://www.fda.gov/oc/industry/unifiedagenda/agenda.html
2. 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"
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 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, 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 30 Rulemakings Identified by FDA with Impact on State or Local Governments in the Unified Agenda, and List of 12 Rulemakings Identified by FDA with Undetermined Impact on State or Local Governments.  All of which can be found in the Regulatory Plan and Unified Agenda which published on December 10, 2007.

FDA IDENTIFIED RULEMAKINGS WITH IMPACT
ON STATE OR LOCAL GOVERNMENTS*
   

5. "Status of Certain Additional Over-the-Counter (OTC) Drug Category II and III Active Ingredients," RIN No.  0910-AF75
6. "Beverages; Bottled Water," RIN No. 0910-AF80
7. "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
8. "Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling," RIN No. 0910-AF11
9. "OTC Drug Review; External Analgesic Products," RIN No. 0910-AF35
10. "OTC Drug Review; Internal Analgesic Products," RIN No. 0910-AF36
11. "OTC Drug Review; Oral Health Care Products," RIN No. 0910-AF40
12. "OTC Drug Review; Sunscreen Products," RIN No. 0910-AF43
13. "OTC Drug Review; Poison Treatment Drug Products," RIN No. 0910-AF68
14. "OTC Drug Review; Topical Antimicrobial Drug Products," RIN No. 0910-AF69
15. "OTC Drug Review; Urinary Analgesic Drug Products," RIN No. 0910-AF70
16. "Status of Certain Additional OTC Drug Category II Active Ingredients," RIN No. 0910-AF95
17. "Prevention of Salmonella Enteritidis in Shell Eggs," RIN No. 0910-AC14
18. "Exception from General Requirements for Informed Consent; Request for Comments and Information," RIN No. 0910-AC25
19. "OTC Drug Review; Cough/Cold (Antihistamine) Products," RIN No. 0910-AF31
20. "OTC Drug Review; Cough/Cold (Bronchodilator) Products," RIN No. 0910-AF32
21. "OTC Drug Review; Cough/Cold (Combination) Products," RIN No. 0910-AF33
22. "OTC Drug Review; Cough/Cold (Nasal Decongestant) Products," RIN No. 0910-AF34
23. "OTC Drug Review; Labeling of Drug Products for OTC Human Use," RIN No.  0910-AF37
24. "OTC Drug Review; Laxative Drug Products," RIN No. 0910-AF38
25. "OTC Drug Review; Skin Protectant Products," RIN No. 0910-AF42
26. "OTC Drug Review; Vaginal Contraceptive Products," RIN No. 0910-AF44
27. "OTC Drug Review; Weight Control Products," RIN No. 0910-AF45
28. "OTC Drug Review; Antacid Products," RIN No. 0910-AF52
29. "OTC Drug Review; Skin Bleaching Products," RIN No. 0910-AF53
30. "OTC Drug Review; Acne Drug Products Containing Benzoyl Peroxide," RIN No. 0910-AG00
31. "OTC Drug Review; Ophthalmic Products," RIN No. 0910-AF39
32. "OTC Drug Review; Overindulgence in Food and Drink Products," RIN No. 0910-AF51
33. "OTC Drug Review; Stimulant Drug Products," RIN No.  0910-AF56
34. "OTC Antidiarrheal Drug Products," RIN No. 0910-AF99

FDA IDENTIFIED RULEMAKINGS WITH UNDETERMINED IMPACT ON STATE OR LOCAL GOVERNMENTS

1. "Current Good Manufacturing Practice for Combination Products," RIN No. 0910-AF81
2. "Postmarket Safety Reporting for Combination Products," RIN No. 0910-AF82
3. 
   
4. "Medical Device Reporting; Electronic Submission Requirements," RIN No. 0910-AF86
5. "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements," RIN No. 0910-AF96
6. "Positron Emission Tomography Drugs; Current Good Manufacturing Practices," RIN No. 0910-AC55
7. "Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile," RIN No. 0910-AF90
8. "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
9. "Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls," RIN No. 0910-AF08
10. "Health Claims," RIN No. 0910-AF09
11. "Food Labeling; Prominence of Calories," RIN No. 0910-AF22
12. "Food Labeling; Serving Sizes of Products that can Reasonably be Consumed at one Eating Occasion; Updating Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes," RIN No. 0910-AF23
13. "Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and Pectin," RIN No. 0910-AF99

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

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