• Solid Oral Dosage Form Anticounterfeiting, October 13, 2009, Closing Date -- The Food and Drug Administration (FDA) is soliciting comments on its Draft Guidance entitled "Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting." This Draft Guidance provides recommendations to drug manufacturers for incorporating physical identifiers into solid oral dosage forms, including supporting documentation to be submitted in new drug and abbreviated new drug applications.
  • Postmarketing Studies and Clinical Trials, October 13, 2009, Closing Date -- FDA is soliciting comments on its Draft Guidance entitled "Postmarketing Studies and Clinical Trials - Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act," which implements the new provisions of the Food and Drug Administration Amendments Act of 2007 giving FDA the authority to require certain postmarketing studies and clinical trials for drugs and biologics.
  • Beer Labeling, October 16, 2009, Closing Date -- FDA is soliciting comments on its Draft Guidance entitled "Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration."
  • Organics Standards, October 19, 2009, Closing Date -- The Agricultural Marketing Service (AMS) is soliciting comments on the recommendations of the National Organic Standards Board (NOSB) prior to the upcoming meeting of the NOSB on November 3-5, 2009. The NOSB will be reviewing the continued use of 12 materials in organic production or handling set to expire after September 12, 2011. In addition, the NOSB will begin reviewing the continued use of 37 agricultural products not organically available set to expire June 27, 2012. The NOSB will also begin its review pertaining to the continued exemption (use) and prohibition of 166 substance listings used in organic production and handling scheduled to expire after October 7, 2012.
  • Combination Products, October 26, 2009, Closing Date -- This is a proposed information collection on which FDA is soliciting comments on the procedure by which an applicant may obtain an assignment or designation determination for combination products.
  • FDA Transparency, November 6, 2009, Closing Date -- In anticipation of its second public meeting on transparency on November 3, FDA is reopening its earlier comment period and soliciting comments on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public.
  • Cooperative Meat/Poultry Inspection Programs, November 16, 2009, Closing Date -- The Food Safety and Inspection Service (FSIS) is soliciting comments on its proposed regulations to implement a voluntary cooperative program under which state-inspected establishments with 25 or fewer employees will be eligible to ship meat and poultry products in interstate commerce.