Department of Health and Human Services May 27, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for luprostiol injectable solution from Intervet, Inc., to Virbac AH, Inc.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Presenting Risk Information in Prescription Drug and Medical Device Promotion.'' This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and device promotional pieces to determine whether they adequately present risk information. The guidance describes and discusses the factors FDA considers when evaluating prescription drug advertisements (ads), restricted device ads, and prescription drug and device promotional labeling for their compliance with the Federal Food, Drug, and Cosmetic Act (the act) and relevant regulations. The guidance gives examples to illustrate FDA's thinking on these factors and is intended to help regulated industry gain a better understanding of what they should consider as they develop the content and format of their promotional communications.

This rule implements the statutory change to section 404(e) of the Social Security Act (42 U.S.C. 604(e)) as enacted by the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5). This change allows States, Tribes and Territories to use Temporary Assistance for Needy Families (TANF) program funds carried over from a prior year for any allowable TANF benefit, service or activity. Previously these funds could be used only to provide assistance. This interim final rule applies to States, local governments, and Tribes that administer the TANF program.