Department of Health and Human Services May 24, 2013 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel) August 26-27, 2013
This notice announces the second semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel) for 2013. The purpose of the panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and hospital outpatient therapeutic services supervision issues.
Medicare and Medicaid Programs; Survey, Certification and Enforcement Procedures; Extension of Comment Period
This notice extends the comment period for the Survey, Certification and Enforcement Procedures proposed rule, which was published in the April 5, 2013 Federal Register (78 FR 20564 through 20581). In the proposed rule, we proposed to revise the survey, certification, and enforcement procedures related to CMS oversight of national accreditation organizations (AOs). These revisions would implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The proposed revisions would also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the Social Security Act. The comment period for the proposed rule, which would have ended on June 4, 2013, is extended to July 5, 2013.
Announcement of Requirements and Registration for the “Technology-based Products to Prevent High-Risk Drinking Among College Students Challenge”
The Substance Abuse and Mental Health Services Administration (SAMHSA), an operating division of the U.S. Department of Health and Human Services, announces a new opportunity for individuals and organizations to help prevent high-risk drinking among college students. Excessive and underage drinking among college students are significant public health problems on college and university campuses across the United States, which often result in life-altering consequences such as death, injury, assault, sexual abuse, unintended pregnancy, sexually transmitted diseases, academic difficulties, suicide attempts, and alcohol dependence. This challenge seeks technology-based products to decrease the acceptability of and engagement in high-risk drinking among college students. SAMHSA is seeking solutions to this problem through cost-effective, portable, technology-based products that effectively reach a diverse population of college students and their parents, as well as administrators, faculty, and staff, and that can be adapted to meet the local needs of these institutions throughout the United States. Technology-based products may include, but are not limited to, web applications, mobile apps, short message services (SMS), and podcasts. This challenge aligns with SAMHSA's mission to reduce the impact of substance abuse and mental illness on America's communities. SAMHSA recognizes that preventing high-risk drinking among college students will save lives, improve academic success, and decrease other risks to students' health and safety. The statutory authority for this challenge competition is Section 105 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Reauthorization Act of 2010 (COMPETES Act).
Proposed Collection; 60-day Comment Request: Autism Spectrum Disorder Research Portfolio Analysis
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: The Office of Autism Research Coordination, NIMH, NIH, Neuroscience Center, 6001 Executive Blvd., MSC 9663, Room 6184, Bethesda, MD 20892 or Email your request, including your address to: iaccpublicinquiries@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Autism Spectrum Disorder (ASD) Research Portfolio Analysis, 0925NEWNational Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the ASD portfolio analysis is to collect research funding data from U.S. and international ASD research funders, to assist the Interagency Autism Coordinating Committee (IACC) in fulfilling the requirements of the Combating Autism Act, and to inform the committee and interested stakeholders of the funding landscape and current directions for ASD research. Specifically, these analyses will examine the extent to which current funding and research topics align with the IACC Strategic Plan for ASD Research. The findings will help guide future funding priorities by outlining current gaps and opportunities in ASD research as well as serving to highlight annual activities and research progress. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 419.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.
Prospective Grant of a Start-Up Exclusive Patent License Agreement: Treatment of Graves' Disease, Hyperthyroidism and Thyroid Cancer
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 a Start-Up Exclusive Patent License to Nova Therapeutics LLC, a company having a place of business in Delaware, to practice the inventions embodied in the following patent applications:
Ryan White HIV/AIDS Program Core Medical Services Waiver; Application Requirements
Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White Program or RWP), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the statute. The statute also grants the Secretary authority to waive this requirement if there are no waiting lists for the AIDS Drug Assistance Program (ADAP) and core medical services are available to all individuals identified and eligible under Title XXVI in an applicant's service area. Prior to this policy announcement, grantees seeking a waiver of the 75 percent requirement have been required to submit core medical services waiver requests at the same time as the annual grant application. Recognizing RWP grantees' request for additional flexibility in the timing of waiver applications, the Health Resources and Services Administration (HRSA) is providing grantees additional options for making waiver requests. HRSA is amending the uniform waiver standards for RWP grantees requesting a core medical services waiver for fiscal year (FY) 2014 and beyond. The amended standards will allow grantees to apply for a waiver (a) at the same time as their annual Part A, B, or C application submission, (b) at any time up to their annual Part A, B, or C application submission, or (c) up to four months after their grant award for that funding year. This Federal Register notice seeks to make public the revised policy and provide an opportunity for public comment before its implementation.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS Program Part C funds award to the Genesis Health Group (GHG), Davenport, Iowa.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Discretionary Grant Program
HRSA will be issuing a non-competitive award to the National Center for Community Based Services program. The 1-year award for $449,125 will be made available in the form of a cooperative agreement to the current grantee, University of Massachusetts, during the budget period July 1, 2013, through June 30, 2014. This will provide feasible time for the Maternal and Child Health Bureau (MCHB) to align fiscal resources and programmatic goals with the least disruption to the states, communities, and constituencies that currently receive leadership, assistance, and services.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Medicare Program; Public Meeting in Calendar Year 2013 for New Clinical Laboratory Test Payment Determinations
This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2014.
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