change to address new safety information. it prohibits a person from introducing into interstate commerce a new drug or biological product for which a risk evaluation and mitigation strategy is required if the person fails to maintain compliance with the requirements of such strategy. it requires a proposed risk evaluation and management strategy to include a timetable for assessment of the strategy and allows the fda to require such a strategy to include additional elements, including distribution to each patient of a medication guide and a patient package insert, a communication plan to health care providers, and assurances of safe use. it establishes the drug safety oversight board. it authorizes the fda to require the submission of any tv advertisement for a drug for review before it can be broadcast, to make recommendations with respect to information included in the label of the drug or on statements for inclusion in advertisements but not require changes in such advertisements, and to require inclusion in advertisements of certain disclosures about a serious risk listed in the labeling of the drug. it requires the fda to issue special guidance for clinical trials of antibiotics. it prohibits interstate commerce of any food that has an approved drug, licensed biological product, or certain other drugs or biological products added, unless the drug or biological product was marketed in food prior to approval, licensure, or clinical investigation, the fda has approved the use of such drug or biological product in the food, or the use of the drug or the biological product is to enhance the safety or preservation of the food and not intended to have biological or therapeutic effects and the use is in conformity with specified regulations. it requires the fda to develop standards to secure the drug supply chain against counterfeit, diverted, substandard, adulterated, misbranded, or expired drugs, to prioritize and develop standards for the identification and validation of prescription drugs, to develop a standardized numerical identifier for prescription drugs, and to expand resources and facilities for securing the drug supply chain. it requires the advisory committee on risk communication to regularly perform a comprehensive review of the types of risk information provided on the website and to recommend ways for the fda to work with outside entities to help facilitate communication of risk. it requires that certain information related to a new drug application be published on the fda's website, including documents related to the review of an application and a summary of conclusions from all reviewing disciplines about the drug. it stipulates that a scientific review of an application is considered the work of the reviewer and prohibits the altering of such work by management or the reviewer once it is final. it directs the fda to publish and update quarterly a complete list of all authorized generic drugs on the fda's website. title x: food safety title x requires the fda to work with companies, professional associations, and other organizations during an ongoing recall of food regulated by the fda to collect and aggregate information, to use existing networks to enhance the quality and speed of public communication, and to post information regarding recalled food on the fda's website in a single location. it requires the fda to work with states to assist in improving the safety of food. it requires a responsible person who determines that an article of food is a reportable food to submit a report to the fda within 24 hours and to investigate the cause of the adulteration if the adulteration may have originated with the responsible person. it requires the fda to immediately notify the secretary of homeland security if the fda believes food reported to the registry may have been deliberately adulterated. it requires the fda to produce a report on any environmental risks associated with genetically engineered seafood products and sets forth reporting requirements with respect to food products regulated by the fda. title xi: other provisions title xi requires the fda to identify and periodically update clinically susceptible concentrations (specific values that characterize bacteria as clinically susceptible, intermediate, or resistant to the drug tested). it directs the fda to convene a public meeting regarding which infectious diseases potentially qualify for available grants and contracts under the orphan drug act or other incentives for development, and amends the orphan drug act to reauthorize appropriations for grants and contracts to defray the costs of testing for the development of drugs, medical devices, and medical foods for rare diseases. it allows an applicant for a non-racemic drug containing as an active ingredient a single enantiomer that is contained in a racemic drug approved in another application to elect to have the single enantiomer considered the same active ingredient as that contained in the approved racemic drug under certain circumstances. it requires the hhs secretary to enter into a contract with the institute of medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that includes recommendations to improve federal oversight and regulation of genetic tests. priority review voucher program title xi also created the priority review voucher program. this requires the fda to award a transferable, priority review voucher to the sponsor of a tropical disease product application upon approval by the secretary of such application and establish a priority review user fee program. in this act, only tropical diseases were covered under this program to incentivize the development of neglected tropical diseases. in 2012, this was expanded to include rare pediatric conditions. as of 2017, 13 priority review vouchers have been awarded.