Connection Between Epigenome, Selective Mutability, Evolution, and Human Disease
Li, Harris et al., PLoS Genetics
Researchers at the Baylor College of Medicine and elsewhere propose a "connection between the epigenome, selective mutability, evolution, and human disease" based on the findings of their study on associations of structural mutability with germline DNA methylation and with non-allelic homologous recombination mediated by low-copy repeats. "Combined evidence from four human sperm methylome maps, human genome evolution, structural polymorphisms in the human population, and previous genomic and disease studies consistently points to a strong association of germline hypomethylation and genomic instability," the Baylor-led team writes.
Final IVDMIA Rule Was 'Imminent' This Month, But Now is At Least 90 Days Away
FDA's final rule on how it plans to regulate in vitro diagnostic multivariate index assays was "imminent" as recently as this month, but has been delayed because the Office of Management and Budget said it first wants a notice of proposed rulemaking, according to two people familiar with the process.
NPRMs, which are published in the Federal Register, typically allow the public to comment for 60 days and give the federal government 30 days to respond. Therefore, a final IVDMIA rule could appear in at least 90 days.
The IVDMIA final rule was "imminent, but now I am hearing that OMB is saying, no — [it] needs an NPRM," according to a non-government source familiar with the development.
A second individual, also not a federal government employee but one with close ties to the IVDMIA rule-making process, agreed, adding that the guidance could appear sometime in mid- to late-summer.
The government can choose to bypass the NPRM process — which is required by law — by asking for an emergency rule-making procedure. It wasn't immediately clear whether this option is on the table, but to me it seems unlikely considering the delays the guidance has had to endure to date.
FDA released its most recent draft of the guidance in July 2007.
The fact that FDA had considered releasing the final guidance as recently as this month prompted a group of 58 stakeholders to issue an eleventh-hour letter Feb. 2 to FDA Commission Margaret Hamburg "oppos[ing] the release of the IVDMIA guidance."
Although OMB is generally known as the Cabinet-level office that helps the President craft the federal budget, it is also empowered to evaluate federal agency programs (including FDA's) and to help guide regulatory policies at manifold federal agencies.
Speaking at the Personalized Medicine World Conference in January, Elizabeth Mansfield, director of personalized medicine at the Office of In Vitro Diagnostic Evaluation in FDA's Center for Devices and Radiological Health, said the "IVDMIA guidance is still on the table."
And last December, the blog MyRAQA said "[t]he rumor mill has been buzzing today about the imminent release of the finalized IVDMIA guidance," saying it expected the final rule to appear that month.
Last month it updated that report with a post headlined "All Quiet on the IVDMIA Front."
Calls to FDA were not immediately returned in time for this post.