Department of Health and Human Services June 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs for the treatment of HIV. This draft guidance revises the guidance for industry entitled ``Antiretroviral Drugs Using Plasma HIV RNA MeasurementsClinical Considerations for Accelerated and Traditional Approval'' issued in October 2002.

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 Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for lung cancer. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of lung cancer on daily life as well as the available therapies for lung cancer.

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 certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

Blue Button Plus represents the technical standards and policy levers that help patients make use of their clinical and financial data in technology such as personal health records and health apps. All patients whose providers use Meaningful Use Stage 2 certified technology have the ability to view, download, and securely transmit their clinical data from their provider's Electronic Health Record into another product or holding place of their choice. This is an enormous opportunity for patient-facing, data receiver applications that previously struggled to collect complete and accurate clinical data without manual patient entry. As part of the Department of Health and Human Services digital services strategy, the Office of the National Coordinator for Health Information Technology (ONC) is launching the Blue Button Co-Design Challenge, intended to increase the number of priority patient-facing applications able to receive clinical data via Blue Button Plus. The Challenge will also uniquely engage the patient community to teach us what patients most want to do with their clinical data by crowdsourcing application ideas and incorporating patients in product design. The Blue Button Co-Design Challenge builds upon previous ONC activities to support consumer health and patient access to their data. These include Challenges such as Blue Button for All Americans, the Blue Button Mash Up Challenge, and the Health Design Challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the National Institute of Neurological Disorders (NINDS) has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

The ``Continuity of Care and Follow-Up App Challenge'' challenges individuals and organizations with the development of an application for a mobile handheld device that will provide continuity of care and follow-up care linkages for a person at risk for suicide who was discharged from an inpatient unit or emergency department. Proposed activities can include but are not limited to: live chatting via the National Suicide Prevention Lifeline Web site, safety planning, SMS [you need to spell this out] functionality, scheduling functionality and appointment reminders, and mapping/transportation functionality showing locations of health care resources. At a minimum, entrants must include safety planning and utilize two resources to provide users with access to services through the crisis centers within the National Suicide Prevention Lifeline and the SAMHSA treatment locator. SAMHSA is not looking for an application that simply connects a user to a crisis line via a single button, as functionality is found in a number of other suicide prevention applications. Innovation is highly encouraged. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358), and Title V, Section 501 of the Public Health Service Act (42 U.S.C. 290aa).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of co-exclusive worldwide licenses to practice the inventions embodied in: E-005-2012/0, /1, /2; U.S. Provisional Patent Application 61/602,139 filed February 23, 2012, U.S. Provisional Patent Application 61/732,460 filed December 3, 2012, and International Patent Application PCT/ US2013/27413 filed February 22, 2013 to Andor Technology PLC. having a principle place of business in Belfast, Northern Ireland, and to Vutara, Inc. having a principle place of business in Salt Lake City, Utah. The United States of America is an assignee to the patent rights of these inventions. The contemplated co-exclusive license may be in a field of use directed to microscopy devices and systems.