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

The Consumer Health Data Aggregator Challenge is intended to spur the development of third-party, consumer-facing applications that use open, standardized Application Programming Interfaces (APIs) to help consumers aggregate their data in one place and under their control. This challenge will focus on solving the problem that many consumers have todaythe ability to easily and electronically access their health data from different health care providers using a variety of different health IT systems. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

The Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets that we believe are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3. On February 26, 2016, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves Zika virus. On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

This document corrects a notice that was published in the Federal Register on February 10, 2016, Volume 81, Number 27, pages 7123-7124. The meeting time and date should read as follows:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting'' 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 collection of information entitled ``Electronic User Fee Payment Request Forms'' 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 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Animation in Direct-to- Consumer Advertising.'' This study will examine how animation affects the comprehension of direct-to-consumer (DTC) television advertisements for prescription drugs.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (the Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the Web site https://www.hhs.gov/ash/carb/ and must be completed by March 21, 2016; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/ash/carb/ on the Meetings page.

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.