Department of Health and Human Services April 2, 2015 – Federal Register Recent Federal Regulation Documents

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 24, 2014 (79 FR 69865), and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), 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.

On February 9, 2015, the Administration for Children and Families (ACF) published a Notice of Proposed Rulemaking (NPRM) to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations to modify the requirements for title IV-E agencies to collect and report data to ACF on children in out-of-home care and who were adopted or in a legal guardianship with a title IV-E subsidized adoption or guardianship agreement. However, we did not propose that title IV-E agencies report data in AFCARS on American Indian and Alaskan Native children related to the Indian Child Welfare Act of 1978 (ICWA). In this notice, we are announcing that we intend to publish a supplemental notice of proposed rulemaking (SNPRM), which will propose that title IV-E agencies collect and report additional ICWA-related data elements in AFCARS. We will consider the public comments on that SNPRM (related to ICWA-related data elements) and the February 9, 2015 NPRM (related to all other data elements) and issue one final rule on AFCARS.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Abuse-Deterrent OpioidsEvaluation and Labeling''. This guidance explains FDA's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. This guidance also makes recommendations about how those studies should be performed and evaluated, and discusses how to describe those studies and their implications in product labeling. It is intended to assist sponsors who wish to develop opioid drug products with potentially abuse-deterrent properties and is not intended to apply to products that are not opioids or opioid products that do not have the potential for abuse.

This document corrects a notice that was published in the Federal Register on March 12, 2015 Volume 80, Number 48, page 13012. The time and date should read as follows: Time and Date: 11:00 a.m.-6:00 p.m., April 1, 2015 (Closed).

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.