Department of Health and Human Services August 27, 2012 – Federal Register Recent Federal Regulation Documents

Disparities in prevention, early treatment, and final outcomes exist across the spectrum of cancer types and are often amplified in women's health when we look at breast cancer and gynecologic cancers primarily cervical, uterine, and ovarian cancer. With over 300,000 new cases combined and 68,000 deaths annually, the impact that these cancers have on the United States cannot be overstated. While the incidence and prevalence of these malignancies is as socially and geographically diverse as our nation, they strike minority and underserved women with a disproportionate lethality caused by many factors. In particular, the prevention strategies for these cancers cross the gambit of social and technical modalities from radiology (e.g., mammography) to advanced immunotherapy and vaccination (e.g., HPV vaccine). The clinical communities that treat and care for these patients is, likewise, among the broadest group of clinical disciplines that can be aggregatedfrom primary care and the surgical specialties to some of the most cutting-edge radiation oncology and medical oncology groups. But more importantly, any failure of our healthcare system to adequately prevent one of these cancers is most often a failure to address a myriad of social challenges, from education and access to health literacy and community support. The ``Reducing Cancer Among Women of Color Challenge'' is a call to developers to create a mobile device-optimized tool that engages and empowers women to improve the prevention and treatment of breast, cervical, uterine, and ovarian cancer in underserved and minority communities and interfaces with provider electronic health records (EHRs). The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

The Food and Drug Administration (FDA) is issuing this notice to provide applicants who are no longer seeking approval of their pending original abbreviated new drug applications (ANDAs) with an opportunity to withdraw them as soon as possible to avoid paying a fee. The fee in question is a one-time backlog fee that was established through enactment of the Generic Drug User Fee Amendments of 2012 (GDUFA). It will apply to any original ANDA that is pending (neither withdrawn nor tentatively approved) at FDA on October 1, 2012. This notice is intended to allow applicants to decide which ANDAs they do not wish to pursue and by timely notice of withdrawal avoid paying the new backlog fee on such applications.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA). GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable generic drug program enhancements and also requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. The purpose of the public meeting is to discuss recent communications concerning GDUFA implementation and to provide an opportunity for the public to present views on these materials.