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Wednesday, February 23, 2011

FDA's Agenda for 2011


I hope that the first 2 months of 2011 are going well for you and your business.  The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. 

The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require that government agencies publish an inventory of rulemaking actions under development semi-annually so that we, the public, may be aware of and comment on the actions proposed on our behalf. (Not sure whether to grin or grimace here but that’s the story.)

There is something for everyone here.  FDA has been working since the 1960’s to update the monographs that regulate over the counter drugs—many of those remain on the agenda for 2011. In 2010 the agency proposed drastic changes to the process for medical device approvals and more ideas are noted on the agenda below.  Other highlights include upcoming rules on food labeling, infant formula GMPs, pet food labeling, and the use of cattle-derived ingredients in cosmetics as well as proposed rules affecting prescription drugs and biologics. New areas of FDA regulation—restaurant menus and tobacco products also made the agency’s ‘to do’ list.  The dietary supplement sector only makes the list for long term actions.

I have rearranged the agenda into product areas for your convenience.  To view the list as originally published visit and search the Federal Register, Vol. 75, No. 243, December 20, 2010, p.79765-75767. The numbers preceding each listing are the sequence number and can be used to find more information about each rule when you visit the Federal Register. 

I would be happy to address questions you submit about these topics in future updates.  You may read past updates here on our blog, Bioscience FDA Update ( . You are also invited to leave comments.
Food Pre-Rule Stage
311 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution

Food Proposed Rule Stage
328 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 
329 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants
Food Final Rule Stage
338 Use of Materials Derived From Cattle in Human Food and Cosmetics
339 Label Requirement for Food That Has Been Refused Admission Into the United States
Food Long Term Actions
355 Produce Safety Regulation .
356 Modernization of the Current Food Good Manufacturing Practices Regulation

Infant Formula Final Rule Stage
333 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements;
Records and Reports; and Quality Factors 

Dietary Supplement Long Term Actions
340 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements

Pet Food and Animal Feed Proposed Rule Stage
318 Import Tolerances for Residues of Unapproved New Animal Drugs in Food
320 Pet Food Labeling Requirements
321 Process Controls for Animal Feed Ingredients and Mixed Animal Feed

Cosmetic Final Rule Stage
338 Use of Materials Derived From Cattle in Human Food and Cosmetics

Over the Counter Drug Proposed Rule Stage
313 Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products
314 Over-the-Counter (OTC) Drug Review—Internal Analgesic Products
315 Over-the-Counter (OTC) Drug Review—Laxative Drug Products
316 Over-the-Counter (OTC) Drug Review—Sunscreen Products
317 Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products
322 Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products
Over the Counter Drug Final Rule Stage
334 Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products
335 Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products
336 Over-the-Counter (OTC) Drug Review—External Analgesic Products
337 Over-the-Counter (OTC) Drug Review—Skin Protectant Products
Over the Counter Drug Long Term Action
341 Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products
342 Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use
343 Over-the-Counter (OTC) Drug Review—Ophthalmic Products
344 Over-the-Counter (OTC) Drug Review—Oral Health Care Products
345 Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products
346 Over-the-Counter (OTC) Drug Review—Weight Control Product
347 Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products
348 Over-the-Counter (OTC) Drug Review—Antacid Products
349 Over-the-Counter (OTC) Drug Review—Skin Bleaching Products
350 Over-the-Counter (OTC) Drug Review—Stimulant Drug Products
351 Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products
352 Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products
353 Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients

Medical Device Proposed Rule Stage
319 Laser Products; Amendment to Performance Standard
324 Unique Device Identification
327 General Hospital and Personal Use Devices: Designation of Special Controls for Infusion Pumps
Medical Device Final Rule Stage
331 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements

Tobacco Product Proposed Rule Stage
325 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act
326 Cigarette Warning Label Statements

Prescription Drug & Biologics Proposed Rule Stage
312 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 
323 Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products
Prescription Drug & Biologics Final Rule Stage
330 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products
332 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and
Lactation Labeling
Prescription Drug & Biologics Long-Term Actions
354 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and
Administrative Procedures.

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