Department of Health and Human Services March 5, 2015 – Federal Register Recent Federal Regulation Documents

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) Design by Biomedical Undergraduate Teams (DEBUT) Challenge is open to teams of undergraduate students working on projects that develop innovative solutions to unmet health and clinical problems. NIBIB's mission is to improve health by leading the development and accelerating the application of biomedical technologies. The goals of the DEBUT Challenge are (1) to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building and debugging solutions for such open-ended problems; (2) to generate novel, innovative tools to improve healthcare, consistent with NIBIB's purpose to support research, training, the dissemination of health information, and other programs with respect to biomedical imaging and engineering and associated technologies and modalities with biomedical applications; and (3) to highlight and acknowledge the contributions and accomplishments of undergraduate students.

The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Dr. Douglas M. Hargrave (Dr. Hargrave), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Hargrave for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Hargrave was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Hargrave's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Hargrave has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Dr. Steven M. Lynch, and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Lynch for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Lynch was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Lynch's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Lynch has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Dr. John D. Noonan (Dr. Noonan), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Noonan for 2 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Noonan was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Noonan's debarment, FDA has considered the relevant factors listed in the FD&C Act. Dr. Noonan has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.'' This guidance provides information in response to questions that FDA has received from manufacturers on demonstrating the substantial equivalence of a new tobacco product, including questions on when a modification to the label requires a premarket submission and review by FDA.

This FOA governs the proposed award of formula grants under the Family Violence Prevention and Services Act (FVPSA) to Native American tribes (including Alaska Native villages) and tribal organizations. The purpose of these grants is to: (1) Assist tribes in efforts to increase public awareness about, and primary and secondary prevention of, family violence, domestic violence, and dating violence; and (2) assist tribes in efforts to provide immediate shelter and supportive services for victims of family violence, domestic violence, or dating violence, and their dependents (42 U.S.C. 10401, et. seq.). This FOA announces formula awards and is not open for competition.