E.coli O157:H7 Positive Raw Beef, May 7, 2010, Closing Date -- Following its recent public meeting, the Food Safety and Inspection Service (FSIS) is seeking comments on ways to improve Agency procedures for identifying product that may be positive for E. coli O157:H7. FSIS is also interested in procedures for identifying suppliers of source material used to produce raw beef products that FSIS has found positive for Escherichia coli (E. coli) O157:H7.
PDUFA, May 12, 2010, Closing Date -- In anticipation of reauthorization in 2012 of the Prescription Drug User Fee Act (PDUFA), FDA is seeking public comment on the PDUFA program and suggestions regarding the features FDA should propose for the next PDUFA program.
Fresh Produce, May 24, 2010, Closing Date -- FDA is seeking comments on current practices and conditions for the production and packing of fresh produce that will inform the development of safety standards for fresh produce at the farm and packing house, as well as strategies and cooperative efforts to ensure compliance.
National Organic Program, May 25, 2010, Closing Date -- The Agricultural Marketing Service (AMS) is seeking comments on its advance notice of proposed rulemaking related to the sunset review and renewal of a series of exemptions on the use of certain substances under the National Organic Program. AMS also seeks comment on whether the identified existing exemptions and prohibitions should be continued.
E-Prescriptions for Controlled Substances, June 1, 2010, Closing Date -- The Drug Enforcement Administration (DEA) is revising its regulations and seeking comments on an interim final rule to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense and archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules.
Adaptive Trial Design, June 1, 2010, Closing Date -- FDA is seeking comments on its Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics. The draft guidance gives advice on various topics, such as what aspects of adaptive design clinical trials (i.e., clinical, statistical, regulatory) call for special consideration, when to interact with FDA while planning and conducting adaptive design studies, what information to include in the adaptive design for FDA review and issues to consider in the evaluation of a completed adaptive design study. The draft guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA review.
Non-Inferiority Clinical Trials, June 1, 2010, Closing Date -- FDA is seeking comments on Draft Guidance for Industry on Non-Inferiority Clinical Trials that provides sponsors and review staff in CDER/CBER with the agency's interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or therapeutic biologic product. The draft guidance offers advice on when NI studies can be interpretable, how to choose the NI margin and how to analyze the results.
Bisphenol A, June 4, 2010, Closing Date -- FDA is seeking comments on the four documents prepared by FDA's Center for Food Safety and Applied Nutrition (CFSAN). These documents do not represent an agency opinion or position on BPA, on which an interim update was recently provided. Rather, these documents provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA for food contact applications.
Pediatric Uses of Medical Devices, June 15, 2010, Closing Date -- FDA is seeking comments on its direct final rule amending its regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose or cure. FDA also published and is seeking comments on a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event it receives significant adverse comment and withdraw this direct final rule. Comments for both the direct final and proposed rules are due by June 15.
DTC Prescription Drug Ads, June 28, 2010, Closing Date -- The FDA, is seeking comments on its proposed rule to amend its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act, as added by FDAAA, that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous and neutral manner.
Children's Online Privacy Protection Rule, June 30, 2010, Closing Date -- The Federal Trade Commission (FTC) is seeking comments on its implementation of the Children's Online Privacy Protection Act (COPPA or "the Act"), through the Children's Online Privacy Protection Rule ("COPPA Rule" or "the Rule"). The Commission requests comment on the costs and benefits of the Rule, as well as on whether it, or certain sections, should be retained, eliminated or modified.
Bottled Water, June 1, 2010, Closing Date -- FDA is reopening the comment period to seek additional comments on its 1993 proposed rule for bottled water finalizing the allowable level for the chemical di(2- ethylhexyl)phthalate (DEHP).