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

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requests for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic (IVD) tests when a premarket review is not needed.

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). FDA is interested in obtaining patient input on the impact of HIV on daily life, available therapies to treat the condition, and patients' views on issues related to HIV cure research, such as perceived benefits and acceptable risks for participating in HIV cure research and clear communication of benefits and risks through informed consent.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6).

The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces a public webcast that will address the new import permit regulations for infectious biological agents, standards, and vectors; import permit inspections; and import permit exemptions. The purpose of this notice is to inform all interested parties, including those individuals and entities already possessing an import permit of the webcast.

The Secretary of Education and Secretary of Health and Human Services (``the Secretaries'') propose priorities, requirements, definitions, and selection criteria under the Race to the TopEarly Learning Challenge (RTT-ELC) Grant program. The Secretaries may use one or more of these priorities, requirements, definitions, and selection criteria for competitions in fiscal year (FY) 2013 and later years. The U.S. Department of Education (ED) and the U.S. Department of Health and Human Services (HHS) (collectively, ``the Departments'') conducted the first competition under the RTT-ELC program in FY 2011 and awarded grants to nine States. In FY 2012, the five next highest- rated applicants on the slate of high-scoring applications from the FY 2011 competition were funded at up to 50 percent of the funds each requested in their FY 2011 applications. We propose to maintain the overall purpose and structure of the FY 2011 RTT-ELC competition in future competitions. These proposed priorities, requirements, definitions, and selection criteria are almost identical to the ones used in the FY 2011 competition. We describe the changes at the beginning of each section of this document.

This notice announces an open period for additional organizations to be considered for participation in Model 1 of the Bundled Payments for Care Improvement initiative.

Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on April 11, 2012. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created six (6) workgroups to analyze the areas of clinical quality, clinical operations, implementation, consumer technology, nationwide health information networks and privacy and security. Other groups will be convened to address specific issues as needed. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or other special group to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) an assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) a timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a report from a workgroup or other special group, the HIT Standards Committee will: (1) accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. The standards and related topics which the HIT Standards Committee is expected to address over the coming year include, but may not be limited to standards to support: Transport of data to and from patients, image exchange, current content gaps, securing data at rest, digital signature, longitudinal record sharing, advanced care preferences, application programming interfaces, measuring and reporting quality, clinical decision support, defect reporting and registry support. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at https://healthit.gov. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This draft document provides CDRH's proposed interpretation of key provisions of the Federal Food Drug and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as those provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH. This draft guidance is not final nor is it in effect at this time.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for postmarket surveillance of medical devices.

The ``Data Rx: Prescription Drug Abuse Infographic Challenge Concept'' challenges the general public to create an infographic that presents information, rooted in the current research, concerning the growing trend of prescription drug abuse. The infographic should be designed to inform and educate the general public in interesting, novel, and creative ways about the dangers involved with the abuse of prescription drugs.

This document is a request for comment on the revised draft of the Federal Guidelines for Opioid Treatment. These guidelines elaborate upon the Federal opioid treatment standards set forth under 42 CFR part 8.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the existing reporting requests in CVM Guidance 108, ``How to Register with the CVM Electronic Submission System to Submit Information in Electronic Format using the FDA Electronic Submissions Gateway.''

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 is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Advanced Personalized Diagnostics, LLC, a company having a place of business in Alexandria, Virginia, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/976,732, entitled ``Stably Transfected Multicolored Fluorescent Cells'', filed October 1, 2007 (HHS Ref. No. E-281-2007/0-US-01); U.S. Patent Application No. 12/ 060,752, entitled ``Multiplex Assay Method for Mixed Cell Populations'', filed April 1, 2008, (HHS Ref. No. E-281-2007/0-US-02); and U.S. Patent Application No. 12/802,666, entitled ``Methods of Monitoring Angiogenesis and Metastasis in Three Dimensional Co- Cultures'', filed June 10, 2010 (HHS Ref. No. E-281-2007/1-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``The use of the Licensed Patent Rights limited to an FDA-approved Class III in vitro diagnostic device for prediction of therapeutic efficacy in cancer and other angiogenesis-mediated diseases.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Advanced Personalized Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.