FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

August 7, 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 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*

1. “Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling,” RIN 0910-AF11
2. “Over-the- Counter (OTC) Drug Review–Stimulant Drug Products,” RIN 0910- AF56
3. “OTC Drug Review–Topical Antimicrobial Drug Products,”  RIN 0910-AF69
4. “Status of Certain Additional OTC Drug Category II Active Ingredients,” RIN 0910-AF95
5. “Prevention of Salmonella Enteritidis in Shell Eggs,” RIN 0910-AC14
6. “Exception from General Requirements for Informed Consent; Request for Comments and Information,” RIN 0910-AC25
7. “OTC Drug Review—Cough/Cold (Bronchodilator) Products,” RIN 0910-AF32
8. “OTC Drug Review–Cough/Cold (Combination) Products,” RIN 0910-AF33
9. “OTC Drug Review–Internal Analgesic Products,” RIN 0910-AF36
10. “OTC Drug Review–Labeling of Drug Products for OTC Human Use,” RIN 0910-AF37
11. “OTC Drug Review–Overindulgence in Food and Drink Products,” RIN 0910-AF51
12. “OTC Drug Review–Antacid Products,” RIN 0910-AF51
13. “OTC Drug Review–Cough/Cold (Antihistamine) Products,” RIN 0910-AF31
14. “OTC Drug Review–Cough/Cold (Nasal Decongestant) Products,” RIN 0910- AF34
15. “OTC Drug Review–External Analgesic Products,” RIN 0910-AF35
16. “OTC Drug Review–Laxative Drug Products,” RIN 0910-AF38
17. “OTC Drug Review–Ophthalmic Products,” RIN 0910-AF39
18. “OTC Drug Review–Oral Health Care Products,” RIN 0910-AF40
19. “OTC Drug Review--Skin Protectant Products,” RIN 0910-AF42
20. “OTC Drug Review–Sunscreen Products,” RIN 0910-AF43
21. “OTC Drug Review–Vaginal Contraceptive Products,” RIN 0910-AF44
22. “OTC Drug Review–Weight Control Products,” RIN 0910-AF45
23. “OTC Drug Review--Skin Bleaching Products,” RIN 0910-AF53
24. “OTC Drug Review–Antidiarrheal Drug Products,” RIN 0910-AF63
25. “OTC Drug Review–Poison Treatment Drug Products,” RIN 0910-AF68
26. “OTC Drug Review–Urinary Analgesic Drug Products,” RIN 0910-AF70
27. “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile,” RIN 0910-AF90
28. “OTC Drug Review–Acne Drug Products Containing Benzoyl Peroxide,” RIN 0910-AG00

FDA IDENTIFIED RULEMAKINGS WITH UNDETERMINED IMPACT ON STATE OR LOCAL GOVERNMENTS

1. “Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and Pectin,”  RIN 0910-AF99
2. “Current Good Manufacturing Practice for Combination Products,” RIN 0910-AF81
3. “Postmarket Safety Reporting for Combination Products,” RIN 0910-AF82
4. “Medical Device Reporting; Electronic Submission Requirements,” RIN 0910-AF86
5. “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements,” RIN 0910-AF96
6. “Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use with Medical Oxygen and Separate Classification of Oxygen Conserving Devices,” RIN 0910-AC30
7. “Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls,” RIN 0910- AF08
8. “Food Labeling; Prominence of Calories,” RIN 0910-AF22
9. “Food Labeling; Serving Size of Products that can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes,” RIN 0910-AF23
10. “Food Labeling:  Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution,” RIN 0910-AG06

*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).

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff