State System Development Initiative (SSDI) Grant Program; Single-Case Deviation From Competition Requirements
HRSA will be issuing a non-competitive program expansion supplement for one State SSDI Grant. Approximately $82,332 in supplemental funding will be made available in the form of a grant to the Department of Health Care Services, Sacramento, California, Grant Number H18MC24474, during the budget period of December 1, 2012, through November 30, 2013. The SSDI Grant program, CFDA No. 93.110, is authorized by Title V, Social Security Act, Section 501(a)(2); as amended (42 U.S.C. 701(a)(2)). The SSDI Grant program was developed to complement the Title V MCH Services Block Grant program by assisting state MCH and Children with Special Health Care Needs (CSHCN) programs in the building of state data capacity and infrastructure that support comprehensive, community- based systems of care for all children and their families. SSDI grants to states are intended to not only advance and strengthen data capacity by directing grant resources towards Title V MCH Block Grant program's Health Systems Capacity Indicator (HSCI) 09A (i.e., the ability of states to assure that the MCH programs and Title V agency have access to policy and program relevant information and data), but also to move states forward in developing improved capacity for reporting standardized and quality data that is timely.
Unique Device Identification System
The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
Global Unique Device Identification Database; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Global Unique Device Identification Database (GUDID).'' FDA is issuing this draft guidance to communicate our current thinking of how the GUDID will operate. The guidance includes both information about how device labelers (in most instances, the device manufacturer) will interface with the GUDID, as well as information on the database elements that must be submitted to the GUDID and their definitions. We intend to publish a final guidance after the close of the comment period and our implementation of the GUDID.
Submission for OMB Review; 30-day Comment Request: The Framingham Heart Study (FHS)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 7, 2013, pages 26639-41 and allowed 60-days for public comment. No public comments were received. The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Fibromyalgia Public Meeting on Patient-Focused Drug Development
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for fibromyalgia. Patient-Focused Drug Development is part of FDA's performance commitments in 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 fibromyalgia on daily life as well as the available therapies for fibromyalgia.
Federal Tort Claims Act (FTCA) Medical Malpractice Program Regulations: Clarification of FTCA Coverage for Services Provided to Non-Health Center Patients
This final rule amends the current regulatory text of the regulations for FTCA Coverage of Certain Grantees and Individuals with the key text and examples of activities that have been determined, consistent with provisions of the existing regulation, to be covered by the FTCA, as previously published in the September 25, 1995 Federal Register Notice (September 1995 Notice). Additionally, HRSA has added examples of services covered under the FTCA involving individual emergency care provided to a non-health center patient and updated the September 1995 Notice immunization example to include events to immunize individuals against infectious illnesses. The amended regulation will supersede the September 1995 Notice.
Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral
This proposed rule would establish methodology and payment rates for a prospective payment system (PPS) for federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. This proposed rule would also establish a policy which would allow rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and make other technical and conforming changes to the RHC and FQHC regulations. Finally, this proposed rule would make changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral.
Tribal Consultation Meeting
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of two 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, 640(l)(4)].
Draft NIH Genomic Data Sharing Policy Request for Public Comments
The National Institutes of Health (NIH) is seeking public comments on the draft Genomic Data Sharing (GDS) Policy that promotes sharing, for research purposes, of large-scale human and nonhuman genomic \1\ data generated from NIH-supported and NIH-conducted research.
Medicare Program; Obtaining Final Medicare Secondary Payer Conditional Payment Amounts via Web Portal
This interim final rule with comment period specifies the process and timeline for expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to conform to section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The interim final rule specifies a timeline for developing a multifactor authentication solution to securely permit authorized users other than the beneficiary to access CMS' MSP conditional payment amounts and claims detail information via the MSP Web portal. It also requires that we add functionality to the existing MSP Web portal that permits users to: notify us that the specified case is approaching settlement; obtain time and date stamped final conditional payment summary forms and amounts before reaching settlement; and ensure that relatedness disputes and any other discrepancies are addressed within 11 business days of receipt of dispute documentation.
Nominations to the Report on Carcinogens; Request for Information
National Toxicology Program (NTP) Office of the Report on Carcinogens (ORoC) requests information on 20 substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') nominated for possible review for future editions of the Report on Carcinogens (RoC).
Prospective Grant of Exclusive Patent License: Oral Treatment of Hemophilia
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an Exclusive Patent License to ProGenetics, LLC, a company having its headquarters in Blacksburg, Virginia, to practice the inventions embodied in U.S. Patent No. 7,220,718, issued 27 February 2007 (HHS Ref. No. E-281-2001/ 0-US-03]), European Patent Application No. 02756904.5 (HHS Ref. No. E281-2001/0-EP-04), filed August 2, 2002, and U.S. Patent No. 7,867,974, issued 11 January 2011 (HHS Ref. No. E-281-2001/0-US-05), entitled respectively, ``Oral Treatment of Hemophilia'' and ``Induction of Tolerance by Oral administration of Factor VIII and Treatment of Hemophilia''. The patent rights in these inventions have been assigned to or exclusively licensed to the Government of the United States of America. The prospective Exclusive Patent License territory may be ``worldwide'', and the field of use may be limited to: ``Treatment of Hemophilia A and B and immunotolerization using oral delivery methods''.
Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.'' This draft guidance provides recommendations to sponsors on the parameters that should be routinely assessed in toxicology studies for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) regulated by the Center for Drug Evaluation and Research to determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses factors to consider in determining the need for additional studies to characterize potential endocrine disruptor properties of a drug.
Announcement of Requirements and Registration for “System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies Ideation Challenge”
The ``System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies'' Ideation Challenge seeks ideas to establish a system for monitoring the location and status of life-sustaining durable medical equipment (DME) during a prolonged power outage or disaster situation. This information would be used by a network of family and friends, formal caregivers, emergency responders and others responding to a disaster to better assist individuals who are dependent on DME. The current Challenge focuses on obtaining information about DME; however, this is part of a larger effort to ensure that these people get the necessary help as quickly as possible. Submissions can be existing applications, or applications developed specifically for this challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of its Rural Health Clinic Accreditation Program
This proposed notice acknowledges the receipt of an application from the Compliance Team for initial recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
World Trade Center Health Program; Addition of Prostate Cancer to the List of WTC-Related Health Conditions
On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. In this final rule, the Administrator adds malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.
Request for Comments on Pediatric Planned Procedure Algorithm
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. This effort includes development of several new pediatric quality measures, including a pediatric readmission measure. The Agency for Healthcare Research and Quality (AHRQ) is requesting comments from the public on an algorithm for identifying pediatric planned procedures as part of the readmission measure. The purpose of the algorithm is to identify, using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes, pediatric procedures that are usually planned so that admissions for these procedures can be excluded from calculations of readmission rates. To identify planned procedures, expert pediatric clinicians in 14 different procedure-oriented specialties reviewed procedures typically performed by their specialty. The reviewers indicated which procedures (1) are usually planned (defined as planned in more than 80% of cases) and (2) could require hospitalization. Admissions for which the primary procedure coded was one of these procedures are excluded from the count of readmissions. The list of ICD-9-CM codes and code descriptions for the planned procedures is available at: http://www.ahrq.gov/policymakers/chipra/ pedprocedurecodes.html.