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

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 a newly proposed information collection entitled ``Formative and Summative Evaluation of the National Diabetes Prevention Program''. Mixed methods will be used to describe program performance.

HHS gives notice of a decision to designate a class of employees from the Hanford site in Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

HHS gives notice of a decision to designate a class of employees from the Grand Junction Facilities site in Grand Junction, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

This document corrects a notice that was published in the Federal Register on May 18, 2015, Volume 80, Number 95, page 28273. This meeting is canceled in its entirety.

The Food and Drug Administration (``FDA'' or ``we'') is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs. This action is in response to two color additive petitions (CAPs) submitted separately by EMD Millipore Corp. and by Signature Brands, LLC.

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 Assessing and Evaluating Human Systems Integration needs in mining. CDC objective is to conduct research to improve working conditions to prevent accidents and occupational disease in underground coal and metal/nonmetal mines in the U.S.

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 a Monitoring and Reporting System for the National Tobacco Control Program. CDC will use the information collected to monitor cooperative agreement awardees and to identify facilitators and challenges to program implementation and achievement of outcomes.

The Indian Health Service (IHS) is seeking broad public input as it begins efforts to advance and promote the health needs of the American Indian/Alaska Native (AI/AN) Lesbian, Gay, Bisexual, and Transgender (LGBT) community.

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 the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations), one of which was amended after initial issuance, for in vitro diagnostic devices for detection of the Ebola virus in response to the Ebola virus outbreak in West Africa. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and Cepheid. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the September 22, 2006, determination by then- Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Blood Establishment Registration and Product Listing, Form FDA 2830'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 PRA).

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA). This action is being taken at the sponsors' request because this product is no longer manufactured or marketed.

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA), RFA-CE-15-002, The CDC National Center for Excellence in Youth Violence Prevention: Building the Evidence for Community- and Policy-Level Prevention.