Department of Health and Human Services April 2016 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of State Assistance announces a single-source program expansion supplement in the amount of $50,000 to Community Action Partnership in Washington, DC 20036. The supplement will support the creation of a new learning cluster focused on addressing child poverty in rural communities and tribal lands and increasing access to multi-generational programs. This effort supports a recent Administration initiative, Rural Impact. Rural Impact is a new effort, overseen by the White House Rural Council, to bring together federal agencies and public and private partners to support a multi- generational approach to investing in rural families, communities, and tribal places.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Environmental Public Health Tracking Network, an information system which collects data from (1) other CDC programs such as the National Center for Health Statistics, (2) other federal agencies such as the Environmental Protection Agency, (3) publically accessible systems such as the Census Bureau, and (4) funded and unfunded state and local health departments (SLHD).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 27, 2015, Pages 7411574116, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) has determined the regulatory review period for ADEMPAS 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 or the Agency) is announcing the availability of a guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), and abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error.

The Food and Drug Administration (FDA) has determined the regulatory review period for APOQUEL 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 U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

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 FDA's Animal Feed Regulatory Program Standards (AFRPS).

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 U.S. Centers for Disease Control and Prevention (CDC) is providing $3,700,000 in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the Puerto Rico Department of Health (PRDOH) to combat the current outbreak of Zika virus.

The Administration for Children and Families published a document in the Federal Register on March 8, 2016, requesting comments on a National toll-free hotline and Web site for child care. The document contained an incorrect email address for responses. Because the email address was incorrect, the Administration for Children and Families is extending the deadline for submission of comments as well.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In section 106(b)(1) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015), Congress declares it a national objective to achieve widespread exchange of health information through interoperable certified electronic health record (EHR) technology nationwide by December 31, 2018. Section 106(b)(1)(C) of the MACRA provides that by July 1, 2016, and in consultation with stakeholders, the Secretary of Health and Human Services (HHS) shall establish metrics to be used to determine if and to the extent this objective has been met. ONC intends to consider metrics that address the specific populations and aspects of interoperable health information described in section 106(b)(1)(B) of the MACRA. ONC is issuing this RFI is to solicit input on the following three topics: (1) Measurement population and key components of interoperability that should be measured; (2) current data sources and potential metrics that address section 106(b)(1) of the MACRA; and (3) other data sources and metrics ONC should consider with respect to section 106(b)(1) of the MACRA or interoperability measurement more broadly.