Department of Health and Human Services March 1, 2016 – Federal Register Recent Federal Regulation Documents

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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is publishing in this document the recommendations of the Blood Product Advisory Committee regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.

The Food and Drug Administration (FDA) has determined the regulatory review period for ANORO ELLIPTA 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.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Belinda Sims, Health Scientist, DESPR, PRB, NIDA, NIH, 6001 Executive Boulevard, Room 5153, Bethesda, Maryland 20892, or call non-toll-free number (301) 402-1533, or Email your request, including your address to: bsims@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: iWin: Navigating your Path to Well-Being, 0925-NEW, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: The overarching objective of this proposal is to conduct a randomized trial to evaluate the effectiveness of the Individual Well- Being Navigator (iWin) mobile application, a substance abuse prevention and well-being enhancement program designed specifically for military personnel. This mobile application provides an innovative, tailored mobile application using best practices in behavior change science and innovative technology to assist military personnel in preventing substance abuse and enhancing well-being by providing them with the most appropriate intervention content at the right time. It integrates Trans-theoretical Model of Behavior Change based tailoring, SMS messaging, stage of change matched activities, and engaging game-like features in a cutting edge multiple behavior change program. The first year of this project will focus on the completion of development and beta testing of the app. In year 2, the efficacy of the iWin program will be determined by tests of statistical significance indicating that participants in the Treatment condition had lower scores on an index of substance use and other behavioral risks than the control group at 6 and 9 month follow-up. The overall design is a 2 group (treatment and control group) by 3 Occasions with repeated measures across occasions. Once shown to be effective, the iWin program will assist organizations that serve military personnel to meet the directives of both the Department of Defense and the Chairman of the Joint Chiefs of Staff indicating that prevention programs be evidence based, evaluated by the specified populations and address full Total Force Fitness paradigm rather than a single behavior. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,557.

This proposed rule would implement sections of the Affordable Care Act that require Medicare, Medicaid, and Children's Health Insurance Program (CHIP) providers and suppliers to disclose certain current and previous affiliations with other providers and suppliers. This proposed rule would also provide CMS with additional authority to deny or revoke a provider's or supplier's Medicare enrollment. In addition, this proposed rule would require that to order, certify, refer or prescribe any Part A or B service, item or drug, a physician or, when permitted, an eligible professional must be enrolled in Medicare in an approved status or have validly opted-out of the Medicare program.

This notice fulfills obligations under the Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), which amended the Public Health Service Act (PHSA). Section 3003(b)(3) of the PHSA mandates that the Health IT Standards Committee (HITSC) develop an annual schedule for the assessment of policy recommendations developed by the Health IT Policy Committee (HITPC) and publish the schedule in the Federal Register. This notice fulfills the requirements of section 3003(b)(3) and updates the HITSC schedule posted in the Federal Register on August 10, 2015. This notice also meets the requirements under sections 3002(e) and 3003(e) for publication in the Federal Register of recommendations made by the HITPC and HITSC, respectively. Further, this notice serves to meet the requirements of section 3004(a)(3) for publication in the Federal Register of determinations by the Secretary of Health and Human Services regarding HITSC-recommended certification criteria endorsed by the National Coordinator for Health Information Technology.