Department of Health and Human Services July 2012 – Federal Register Recent Federal Regulation Documents
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Notification of Single Source Cooperative Agreement Award for Project Hope
In FY2012, HHS/ASPR/OPP plans to provide a single source cooperative agreement award to Project Hope to strengthen emergency care delivery in the United States healthcare system through health information and promotion in support of the Homeland Security Presidential Directive-21 (2007) and the National Health Security Strategy (2009) and Implementation Plan (2012). In the past decade, numerous studies have described the delivery of emergency care in the United States as fragmented, overburdened, underfunded, and challenged in its efforts to provide an appropriate level of high quality and cost effective emergency care for Americans on a daily basis and in response to a public health emergency or disaster. These studies have recommended that the emergency care delivery system be redesigned and more broadly integrated into the U.S. healthcare system and healthcare sub-systems. As these changes will have implications for the broader healthcare community, particularly the primary care sub-system, it is essential that both expert and non- expert healthcare professionals, across the healthcare continuum, be informed and engaged in these key policy discussions. Project Hope will plan the publication of a Health Affairs thematic issue that will identify, explore and propose policy options for developing, strengthening and preparing a regionalized, accountable and coordinated system of emergency care that is broadly integrated into the United States healthcare system and capable of responding to a public health emergency or disaster. The project will serve to educate non-emergency medicine healthcare policy professionals and providers about the current state of emergency care delivery in the United States. It will also promote an interdisciplinary dialogue between emergency and other healthcare professionals and providers regarding policy options for the coordinated and integrated delivery of acute unscheduled care that might result from an acute onset of symptoms, exacerbation of a chronic disease, or a public health emergency or disaster. This project will focus on exploring, identifying and proposing policy options regarding workforce, finance, organization and medical care delivery that are essential to redesigning emergency care delivery and supporting its full integration into other healthcare sub- systems as well as the broader U.S. healthcare system. This work will be performed in the context of Homeland Security Presidential Directive-21 and Strategic Objective (4) of the National Health Security Strategy (2009) and Implementation Plan (2012) that seek to foster integrated, scalable healthcare delivery systems that can meet both daily demands and medical surge demands resulting from a public health emergency or disaster.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medical Device User Fee Rates for Fiscal Year 2013
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (Title 2 of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144, which was signed by the President on July 9, 2012) (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for establishments subject to registration. The FY 2013 fee rates are provided in this document. These fees apply from October 1, 2012, through September 30, 2013. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2013 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Senior Medicare Patrol (SMP) Program Outcome Measurement
The Administration for Community Living (ACL) 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 Senior Medicare Patrol Program outcome measurement.
Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Acceptance and Filing Review for Premarket Approval Applications (PMAs).'' The purpose of the acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete. This guidance document is intended to clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research. This draft guidance is not final nor is it in effect at this time.
Announcement of Requirements and Registration for “The Million Hearts Risk Check Challenge”
In communities across America, there are thousands of convenient and inexpensive ways to know your risk for heart-related conditionsoften, all it takes is making an appointment for a screening with your doctor or pharmacies. But, according to recent studies, up to 1 in 3 people at risk for cardiovascular disease (CVD) have not been screened and are therefore less likely to take preventative action. Through an initiative sponsored by Million Hearts and the Office of the National Coordinator for Health IT, we are reaching out to the millions of Americans who have significant risks for CVD and do not know it, and those that suspect it but have not yet overcome the inertia to act on their concern. By connecting these individuals to pharmacies for lipid and blood pressure screenings, we are intending to make it easy for them to turn their back-of-mind worries into personal knowledge and then help them hook into the delivery system if necessary. This new campaign and technology product will follow three steps: 1. Reach out to individuals across the country, taking special aim at those who may be at risk for CVD and don't know it. 2. Conduct a ``light'' health risk assessment that roughly estimates risk in an engaging interface and then ``hooks'' the user by showing that with the addition of LDL and BP readings, the accuracy of the risk assessment could be much more robust. This is done to drive folks to scale the next hurdle: The BP and blood test. 3. Direct individuals to nearby, convenient options for biometric screenings. National pharmacies and others will offer locations and special offers for this step. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Public L. 111- 358).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
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 Paperwork Reduction Act of 1995.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2013
This notice updates the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2013 (for discharges occurring on or after October 1, 2012 and on or before September 30, 2013) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face to Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013; Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Quality Improvement Organization Regulations; Proposed Rules
This major proposed rule addresses changes to the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It would also implement provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it would implement statutory changes regarding the termination of non-random prepayment review under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Finally, this proposed rule also includes a discussion regarding the Chiropractic Services Demonstration program.
Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Quality Improvement Organization Regulations
This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2013 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, we are proposing updates and refinements to the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program. We also are proposing revisions to the electronic reporting pilot for the Electronic Health Record (EHR) Incentive Program, and the various regulations governing Quality Improvement Organizations (QIOs), including the secure transmittal of electronic medical information, beneficiary complaint resolution and notification processes, and technical changes.
Antimicrobial Animal Drug Sales and Distribution Reporting
The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.
Medicare Program; Hospice Wage Index for Fiscal Year 2013
This notice sets forth the hospice wage index for fiscal year (FY) 2013 and will continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction through FY 2013 of 55 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2014 through FY 2016. This notice clarifies that providers should report additional diagnoses on hospice claims. This notice also updates the public on the status of hospice payment reform and the quality reporting program.
Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k) Submissions To Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small- bore Connectors Intended for Enteral Applications.'' The use of common connector designs, such as luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k) submitters regarding the submission expectations regarding design and testing to reduce the risk of unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in effect at this time.
Medicare Program; Application by the American Association of Diabetes Educators (AADE) for Continued Recognition as a National Accreditation Organization for Accrediting Entities To Furnish Outpatient Diabetes Self-Management Training
This final notice announces the approval of an application from the American Association of Diabetes Educators for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries.
Draft Policy on Conferring With Urban Indian Organizations
This Notice sets forth the Indian Health Service policy for conferring with urban Indian organizations and invites comments within 45 days. In March 2010, the Indian Health Care Improvement Act was reauthorized and amended as part of the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act (together, the Affordable Care Act), Public Law 111-152. One of the changes made to the IHCIA was to create a new requirement that the IHS ``confer'' with UIOs, to the maximum extent practicable, in carrying out the Act as defined by the Indian Health Care Improvement Reauthorization and Extension Act, as enacted and amended by the Affordable Care Act.
International Workshop on Alternative Methods for Leptospira
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an ``International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward.'' This workshop, the second in a series of specialized vaccine workshops, will review recent advances and innovations in science and technology that can be applied to Leptospira vaccine potency testing. The goal is to promote development of innovative testing methods and approaches that may provide improved accuracy, efficiency, and worker safety and that are more humane and use fewer or no animals. The workshop will also address global acceptance and implementation of scientifically valid alternative methods. The workshop is open to the public at no charge with attendance limited only by the available space; however, advance registration is required (see DATES). NICEATM also invites submission of abstracts for scientific posters for display at the workshop (see SUPPLEMENTARY INFORMATION).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
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; Irradiation in the Production, Processing, and Handling of Food
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; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794
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 concerning collection of information using Form FDA 3794 entitled ``Generic Drug User Fee Cover Sheet.''
National Institute of Allergy and Infectious Diseases (NIAID); Notice of Workshop
The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health; the Food and Drug Administration (FDA); the Transformational Medical Technologies (TMT); and Biomedical Advanced Research and Development Authority (BARDA) are holding an Animal Model Development Workshop to explore the scientific and regulatory challenges of developing medical countermeasures (MCM) under the ``Animal Rule'' (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products). The goals of this workshop are to highlight the significant progress made in animal model development for MCMs, review recent case studies of products under development using animal models, and capture lessons learned to inform future animal model development efforts. In addition, the workshop will provide a forum to discuss current challenges and identify potential solutions or mitigation strategies.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive License: Use of Glucocerebrosidase Activators for the Treatment of Gaucher Disease and Central Nervous System Proteinopathies, Including Parkinson's Disease
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, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to Lysosomal Therapeutics, Inc., a company having a place of business in Boston, Massachusetts, to practice the inventions embodied in U.S. Provisional Patent Application No. 61/420,946, filed December 8, 2010 (HHS Ref. No. E-257-2010/0-US- 01) and PCT Patent Application No. PCT/US2011/063928, filed December 8, 2011 (HHS Ref. No. E-257-2010/0-PCT-02), both entitled ``Substituted Pyrazolopyrimidines as Glucocerebrosidase Activators.'' The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive evaluation option license territory may be ``worldwide'', and the field of use may be limited to ``Treatment of Gaucher disease and human central nervous system proteinopathies, including without limitation Parkinson's disease.'' Upon the expiration or termination of the exclusive evaluation option license, Lysosomal Therapeutics, Inc. will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the evaluation license.
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