Department of Health and Human Services June 2013 – Federal Register Recent Federal Regulation Documents
Results 251 - 284 of 284
Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.''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 This draft guidance revises the guidance for industry entitled ``Antiretroviral Drugs Using Plasma HIV RNA MeasurementsClinical Considerations for Accelerated and Traditional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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
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 information collection requirements relating to the reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue- based product (HCT/P) deviations, and Forms FDA 3486 and 3486A.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revision of the Requirements for Constituent Materials
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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.
Lung Cancer Patient-Focused Drug Development; Public Meeting
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.
Announcement for the National Registry of Evidence-Based Programs and Practices (NREPP): Open Submission Period for Fiscal Year 2014
The mission of SAMHSA is to reduce the impact of substance abuse and mental illness on America's communities. Established in 1992, the Agency was directed by Congress to target effective substance abuse and mental health services to the people most in need and to translate research in these areas more effectively and more rapidly into the general health care system. NREPP is a key public resource SAMHSA has developed to help meet this directive. As of June 2013, approximately 290 interventions developed in the U.S. and abroad have been reviewed and added to the registry. This notice announces NREPP's open submission period for fiscal year 2014, during which program developers may submit a request to have their intervention reviewed. The notice provides information about the documentation that submissions must include to demonstrate that an intervention meets NREPP's minimum requirements; the responsibilities of the Principal during the review process; and the process for submitting materials for review during the open submission period.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
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.
Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program
This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) related to the Small Business Health Options Program (SHOP). Specifically, this final rule amends existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and implements a transitional policy regarding employees' choice of qualified health plans (QHPs) in the SHOP.
Announcement of Requirements and Registration for “Blue Button Co-Design Challenge”
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).
Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer's Research, Care, and Services
HHS is soliciting nominations for a new, non-Federal member of the Advisory Council on Alzheimer's Research, Care, and Services. Specifically, the position is for someone with a diagnosis of Alzheimer's disease or a related dementia. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume. Nominations submitted within the past 6 months for other positions on the Advisory Council on Alzheimer's Research, Care, and Services will be considered for this position.
Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments
The Food and Drug Administration (FDA) is seeking public comments from interested persons on the proposed availability of de- identified and masked data derived from medical product applications. Improving the efficiency and effectiveness of medical product development is a national priority. The ability to make available de-identified and masked clinical and preclinical data derived from marketing applications could make an important contribution to that goal by providing scientific data that may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products. The contribution of patients who participate in clinical trials should be maximized for the benefit of society. The Agency invites comments on the issues to be considered with regard to such availability and on any limitations that should be placed on the availability of these data.
Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets, held by Eli Lilly and Co. (Lilly), Lilly Corporate Center, Indianapolis, IN 46285. Lilly has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing.
Medicaid Program; Increased Federal Medical Assistance Percentage Changes Under the Affordable Care Act of 2010; Correction
This document corrects a typographical error that appeared in the final rule published in the April 2, 2013 Federal Register entitled ``Medicaid Program; Increased Federal Medical Assistance Percentage Changes Under the Affordable Care Act of 2010.''
Agency Information Collection Activities; Proposed Collection; Comment Request: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, National Institute of Neurological Disorders and Stroke (NINDS)
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.).
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2014: Proposed Additions and Deletions to the NIOSH Hazardous Drug List
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2014: Proposed Additions and Deletions to the NIOSH Hazardous Drug List.'' The document and instructions for submitting comments can be found at https://www.regulations.gov. This guidance document does not have the force and effect of law. Public Comment Period: Comments must be received by August 2, 2013.
Announcement of Requirements and Registration for “Continuity of Care and Follow-Up App Challenge”
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).
Prospective Grant of Co-Exclusive Licenses: Multi-Focal Structured Illumination Microscopy Systems and Methods
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.
Incentives for Nondiscriminatory Wellness Programs in Group Health Plans
This document contains final regulations, consistent with the Affordable Care Act, regarding nondiscriminatory wellness programs in group health coverage. Specifically, these final regulations increase the maximum permissible reward under a health-contingent wellness program offered in connection with a group health plan (and any related health insurance coverage) from 20 percent to 30 percent of the cost of coverage. The final regulations further increase the maximum permissible reward to 50 percent for wellness programs designed to prevent or reduce tobacco use. These regulations also include other clarifications regarding the reasonable design of health-contingent wellness programs and the reasonable alternatives they must offer in order to avoid prohibited discrimination.
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