Department of Health and Human Services June 21, 2016 – Federal Register Recent Federal Regulation Documents

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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``AHRQ ACTION IIIMeasurement for Performance Improvement in Physician Practices.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 13, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Administration for Community Living (ACL) announces the intent to award a single-source supplemental to the current cooperative agreement held by the National Council on Aging (NCOA) for the National Center for Benefits Outreach and Enrollment (NCBOE). The purpose of the NCBOE is to provide technical assistance to states, area agencies on aging, and service providers to provide outreach and low-income benefits enrollment assistance, particularly to older individuals with greatest economic need for federal and state programs. The administrative supplement for FY 2016 will be for $6,657,383, bringing the total award for FY 2016 to $11,657,383. This supplement will fully fund the NCOBE project as stated in the reauthorization of NCBOE activities in section 110 of the Protecting Access to Medicare Act of 2014. With this funding NCOA will be expected to continue, expand, and complete the work they are currently undertaking with the NCBOE award without disrupting services. The additional funding will not be used to begin new projects but to expand the capacity of current activities to increase the number of beneficiaries and seniors reach by the NCBOE. Program Name: The National Center for Benefits Outreach and Enrollment (NCBOE). Recipient: National Council on Aging (NCOA). Period of Performance: The award will be issued for the final year of the current project period of September 30, 2014 through September 29, 2017. Total Award Amount: $11,657,383 in FY 2016. Award Type: Cooperative Agreement Supplement. Statutory Authority: The Medicare Improvements for Patients and Providers Act of 2008Section 119, Public Law (Pub. L.) 110-275 as amended by the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), reauthorized by the American Taxpayer Relief Act of 2012 (ATRA) and reauthorized by section 110 of the Protecting Access to Medicare Act of 2014. Basis for Award: The National Council on Aging (NCOA) is currently funded to carry out the NCBOE Project for the period of September 30, 2014 through September 29, 2017. Much work has already been completed and further tasks are currently being accomplished. This supplement will fully fund the NCOBE project as stated in the reauthorization of NCBOE activities in section 110 of the Protecting Access to Medicare Act of 2014. Since 2001, the NCOA has been a national leader in improving benefits access to vulnerable older adults. They have a strong history of working with community based organizations to develop and replicate outreach and enrollment solutions, while maintaining and enhancing technology to make it easier and more efficient to find benefits. The NCOA through NCBOE accomplishes its mission by developing and sharing tools, resources, best practices, and strategies for benefits outreach and enrollment via its online clearinghouse, electronic and print publications, webinars, and training and technical assistance. In addition, the NCOA has the BenefitsCheckUp which is, by far, the nation's most comprehensive and widely-used web-based service that screens older and disabled adults with limited incomes and resources and informs them about public and private benefits for which they are very likely to be eligible. Since the BenefitsCheckUp was launched in 2001, nearly 4 million individuals have been assisted to identify over $14.3 billion in potential annual benefits. In addition to a focus on Low-Income Subsidy and Medicare Savings Programs, the BenefitsCheckUp also includes more than 2,300 benefits programs from all 50 states and DC, including the recent addition of Medicaid expansion programs as part of the Affordable Care Act; over 50,000 local offices for people to apply for benefits; more than 1,500 application forms in every language in which they are available; and user-friendly mapping tools that allow streamlined access to program fact sheets and application forms based upon a person's locality.

The Administration for Community Living (ACL) is announcing supplemental funding for the Eldercare Locator program. The Eldercare Locator program helps older adults and their families and caregivers find their way through the maze of services for older adults by linking to a trustworthy network of national, State, Tribal and community organizations and services through a nationally recognized toll-free number. The Eldercare Locator also provides older adults and caregivers who require more in depth support the opportunity to speak with highly trained eldercare consultants who can better triage the situation. The purpose of this announcement is to award supplemental funds to the National Association of Area Agencies on Aging to support additional specialized staff and enhanced technology to better serve callers, mobile and after hour callers. Program Name: Eldercare Locator. Award Amount: $149,049. Budget Period: 6/1/2016 to 5/31/2017. Award Type: Cooperative Agreement. Statutory Authority: The statutory authority for grants under this notice is contained in Title IV of the Older Americans Act (OAA) (42 U.S.C. 3032), as amended by the Older Americans Act Amendments of 2006. Statutory authority specifically for the Eldercare Locator is contained in Title II of the Older Americans Act (202(a)(21).

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 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 a 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) has determined the regulatory review period for XOFIGO 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 Institutes of Health (NIH) is issuing this policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.