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Posted: 2008-11-06
Link to: Federal Outreach Start

May 10, 2007

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 45 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 2007 which published in the Federal Register on April 30, 2007 (72 FR 22490), can be found on the internet 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 "Spring 2007 Unified Agenda. . ."

  2. Via the Government Printing Office web site:

    1. Go to Internet site http:www.gpoaccess.gov
    2. On the right-hand size of the screen, under "Featured Items," click on "Unified Agenda April 2007 Edition"
    3. 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 HHS and scrolling down through the agenda looking for FDA documents)

  3. Via General Services Administration web site:

    1. Go to Internet site http://www.reginfo.gov
    2. Click on "Current and Past Agendas and Plans and How to Use Them"
      (You will be rerouted to another site, click on "Continue")
    3. Click on "Spring 2007 Unified Agenda of Federal Regulatory and Deregulatory Actions"
    4. Click on "Databases and Browseable List of the Spring 2007 Unified Agenda"
    5. Click on "Unified Agenda Tables of Contents"
    6. Click on "Department of Health and Human Services (HHS)" and scroll down 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 me.

Sincerely,



Edwin V. Dutra, Jr.
Director, Regulations Policy and Management Staff

Office of Policy and Planning
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 31 Rulemakings Identified by FDA with Impact on State or Local Governments in the Unified Agenda, and List of 14 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 April 30, 2007.

FDA IDENTIFIED RULEMAKINGS WITH IMPACT
ON STATE OR LOCAL GOVERNMENTS*

  1. "Package Size Limitation For Sodium Phosphates Oral Solution and Warning and Direction Statements for Oral and Rectal Sodium Phosphate for OTC Laxative Use," Sequence No. 795, page 22505

  2. "OTC Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use: Required Alcohol Warning," Sequence No. 796, page 22506

  3. "Status of Certain Additional OTC Drug Category II and III Active Ingredients," Sequence No. 797, page 22506

  4. "Food Labeling; Nutrient Content Claims: Definition for "High Potency" and Definition for "Antioxidant" for use in Nutrient Content Claims for Dietary Supplements and Conventional Foods," Sequence No. 802, page 22508

  5. "Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling," Sequence No. 806, page 22510

  6. "OTC Drug Review–Internal Analgesic Products," Sequence No. 808, page 22510

  7. "OTC Drug Review–Sunscreen Products," Sequence No. 809, page 22511

  8. "OTC Drug Review–Weight Control Products," Sequence No. 810, page 22511

  9. "OTC Drug Review–Stimulant Drug Products," Sequence No. 811, page 22512

  10. "OTC Drug Review–Antidiarrheal Drug Products," Sequence No. 813, page 22512

  11. "OTC Drug Review–Poison Treatment Drug Products," Sequence No. 814, page 22512

  12. "OTC Drug Review–Topical Antimicrobial Drug Products," Sequence No. 815, page 22513

  13. "Status of Certain Additional OTC Drug Category II Active Ingredients," Sequence No. 827, page 22516

  14. "Prevention of Salmonella Enteritidis in Shell Eggs," Sequence No. 836, page 22520

  15. "Exception from General Requirements for Informed Consent; Request for Comments and Information," Sequence No. 838, page 22521

  16. "Positron Emission Tomography Drugs; Current Good Manufacturing Practices," Sequence No. 840, page 22521

  17. "OTC Drug Review–Cough/Cold (Combination) Products," Sequence No. 848, page 22524

  18. "OTC Drug Review–Cough/Cold (Nasal Decongestant) Products," Sequence No. 849, page 22524

  19. "OTC Drug Review–External Analgesic Products," Sequence No. 850, page 22524

  20. "OTC Drug Review–Labeling of Drug Products for OTC Human Use," Sequence No. 851, page 22525

  21. "OTC Drug Review–Laxative Drug Products," Sequence No. 852, page 22525

  22. "OTC Drug Review--Skin Protectant Products," Sequence No. 853, page 22525

  23. "OTC Drug Review–Vaginal Contraceptive Products," Sequence No. 854, page 22526

  24. "OTC Drug Review–Overindulgence in Food and Drink Products," Sequence No. 856, page 22526

  25. "OTC Drug Review–Antacid Products," Sequence No. 857, page 22527

  26. "OTC Drug Review--Skin Bleaching Products," Sequence No. 858, page 22527

  27. "OTC Drug Review–Acne Drug Products Containing Benzoyl Peroxide," Sequence No. 863, page 22529

  28. "OTC Drug Review–Cough/Cold (Antihistamine) Products," Sequence No. 875, page 22533

  29. "OTC Drug Review–Ophthalmic Products," Sequence No. 876, page 22533

  30. "OTC Drug Review–Oral Health Care Products," Sequence No. 877, page 22533

  31. "OTC Drug Review–Urinary Analgesic Drug Products," Sequence No. 880, page 22534



    32. FDA IDENTIFIED RULEMAKINGS WITH UNDETERMINED IMPACT
    ON STATE OR LOCAL GOVERNMENTS



  32. "Medical Devices; Current Good Manufacturing Practices (CGMPs) Final Rule; Quality Systems Regulations," Sequence No. 794, page 22505

  33. "Beverages: Bottled Water," Sequence No. 801, page 22508

  34. "Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use with Medical Oxygen and Separate Classification of Oxygen Conserving Devices," Sequence 803, page 22509

  35. "Label Requirement for Food that has been Refused Admission into the United States," Sequence No. 812, page 22512

  36. "Medical Device Reporting; Electronic Submission Requirements," Sequence No. 821, page 22515

  37. "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements," Sequence No. 828, page 22517

  38. "Safety Reporting Requirements for Human Drug and Biological Products," Sequence No. 831, page 22518

  39. "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements," Sequence No. 834, page 22519

  40. "Food Standards; General Principles and Food Standards Modernization," Sequence No. 868, page 22530

  41. "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls," Sequence No. 869, page 22531

  42. "Health Claims," Sequence No. 870, page 22531

  43. "Food Labeling; Prominence of Calories," Sequence No. 873, page 22532

  44. "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," Sequence No. 874, page 22532

  45. "Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, and Pectin," Sequence No. 881, page 22535

*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 April 30, 2007. It may be found on the Internet (see letter for instructions).