Department of Health and Human Services April 2015 – Federal Register Recent Federal Regulation Documents

This proposed rule would extend enhanced funding for Medicaid eligibility systems as part of a state's mechanized claims processing system, and would update conditions and standards for such systems, including adding to and updating current Medicaid Management Information Systems (MMIS) conditions and standards. These changes would allow states to improve customer service and support the dynamic nature of Medicaid eligibility, enrollment, and delivery systems.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Form FDA 3397, User Fee Cover Sheet, that must be submitted along with certain drug and biologic product applications and supplements.

The Food and Drug Administration (FDA) has determined the regulatory review period for AUBAGIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP) requests comments on a set of human genes that have been identified and prioritized as environmentally responsive genes. These genes will be used in toxicogenomics approaches to screen cells or tissues obtained from humans against large numbers of chemicals. The goal was to generate a set of approximately 1500 human genes to evaluate transcriptional changes in response to chemical exposures. Similar gene sets will be developed for screening cells or tissues from other species such as rats, mice, zebrafish, and Caenorhabditis elegans. The human gene set should provide maximal toxicogenomic information on effects from chemical exposures that reflect general cellular responses, independent of cell type or species, and gene expression changes that are specific by organ and/or cell type. Such a list of environmentally responsive genes may also be useful in biomarker development and basic research efforts. This list of genes, referred to as the ``S1500'' gene list, or gene set, is available for public comment.

This proposed rule would change the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting period in 2015 to a 90-day period aligned with the calendar year, and also would align the EHR reporting period in 2016 with the calendar year. In addition, this proposed rule would modify the patient action measures in the Stage 2 objectives related to patient engagement. Finally, it would streamline the program by removing reporting requirements on measures which have become redundant, duplicative, or topped out through advancements in EHR function and provider performance for Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs.

The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a Tribal Consultation to consult on ACF programs and tribal priorities.

This document corrects a notice that was published in the Federal Register on March 12, 2015 Volume 80, Number 48, page 13011. The times and dates should read as follows: Times and Dates: 9:00 a.m.-6:00 p.m., April 7-8, 2015 (Closed).

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance entitled ``Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.'' This guidance outlines FDA's new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and that are subject to premarket approval (PMA) applications or de novo classifications. FDA believes that the Expedited Access Pathway (EAP) program will help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval, consistent with the Agency's mission to protect and promote public health. The document also discusses how the EAP program approaches the balance of premarket and postmarket data collection and incorporates a benefit-risk framework. The EAP program will become effective April 15, 2015.

The Food and Drug Administration (FDA) has determined the regulatory review period for ELVITEGRAVIR (as a component of STRIBILD) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is amending a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations.