Department of Health and Human Services June 2008 – Federal Register Recent Federal Regulation Documents
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Cooperative Agreement to Establish and Support the Western Center for Food Safety (U01)
The Food and Drug Administration (FDA) is announcing a Request for Application (RFA) Number RFA-FD-08-004 and its intention to receive and consider a new sole source application for the award of a cooperative agreement in fiscal year 2008 (FY 2008) to establish and support the Western Center for Food Safety (WCFS). The WCFS will be located at the Western Institute for Food Safety and Security (WIFSS) on the University of California, Davis (UCD) campus in Davis, CA.
Prescription Drug User Fee Act IV Information Technology Plan
The Food and Drug Administration (FDA) is announcing the availability of the information technology (IT) Plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan'' to achieve the objectives defined in the PDUFA Performance Goals. This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the review process of human drug applications.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. app. 2 10(a), this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Medicare and Medicaid Programs; The Joint Commission for Continued Deeming Authority for Ambulatory Surgical Centers
This proposed notice acknowledges the receipt of a deeming application from the Joint Commission for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
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; Medical Device Labeling Regulations
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; New Animal Drugs for Investigational Use
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.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 20, 2008
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee'') will be held on Wednesday, August 20, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will focus on the oncologic indications of 2-[F-18] Fluoro-D-Glucose (FDG) positron emission tomography (PET) for nine cancers (brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder, and kidney). The panel will review the scientific evidence of the impact of PET as part of a management strategy to improve patient-centered outcomes. The panel will also consider data generated under a current national coverage determination that provides coverage for PET for specified cancers when additional data are prospectively collected. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare and Medicaid Programs; Application by the Accreditation Association for Ambulatory Health Care for Continued Deeming Authority for Ambulatory Surgical Centers
This proposed notice acknowledges the receipt of a deeming application from the Accreditation Association for Ambulatory Health Care (AAAHC) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier Performance During Fiscal Year 2009
This general notice with comment period describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries (FIs) and carriers in the administration of the Medicare program. The results of these evaluations are considered whenever we enter into, renew, or terminate a FI agreement, carrier contract, or take other contract actions, for example, assigning or reassigning providers or services to a FI or designating regional or national intermediaries. We are requesting public comment on these criteria and standards.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
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.
Medicare Program; Appeals of CMS or CMS Contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges
This final rule implements a number of regulatory provisions that are applicable to all providers and suppliers, including durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. This final rule establishes appeals processes for all providers and suppliers whose enrollment, reenrollment or revalidation application for Medicare billing privileges is denied and whose Medicare billing privileges are revoked. It also establishes timeframes for deciding enrollment appeals by an Administrative Law Judge (ALJ) within the Department of Health and Human Services (DHHS) or the Departmental Appeals Board (DAB), or Board, within the DHHS; and processing timeframes for CMS' Medicare fee-for-service (FFS) contractors. In addition, this final rule allows Medicare FFS contractors to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary. This final rule also specifies that a Medicare contractor may establish a Medicare enrollment bar for any provider or supplier whose billing privileges have been revoked. Lastly, the final rule requires that all providers and suppliers receive Medicare payments by electronic funds transfer (EFT) if the provider or supplier, is submitting an initial enrollment application to Medicare, changing their enrollment information, revalidating or re- enrolling in the Medicare program.
Medicare Program; Special Enrollment Period and Medicare Premium Changes
This final rule provides a special enrollment period (SEP) for Medicare Part B and premium Part A for certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and who have health insurance that covers them while outside the United States. Under the SEP provision, qualifying volunteers can delay enrollment in Part B and premium Part A, or terminate such coverage, for the period of service outside of the United States and reenroll without incurring a premium surcharge for late enrollment or reenrollment. This final rule also codifies provisions that require certain beneficiaries to pay an income-related monthly adjustment amount (IRMAA) in addition to the standard Medicare Part B premium, plus any applicable increase for late enrollment or reenrollment. The income- related monthly adjustment amount is to be paid by beneficiaries who have a modified adjusted gross income that exceeds certain threshold amounts. It also represents the amount of decreases in the Medicare Part B premium subsidy, that is, the amount of the Federal government's contribution to the Federal Supplementary Medicare Insurance (SMI) Trust Fund.
Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-August 27-29, 2008
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2008. The purpose of the Panel is to review the APC groups and their associated weights and 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) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2009.
Medicare Program; Use of Repayment Plans
This final rule modifies Medicare regulations to implement section 935(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 pertaining to the use of repayment plans (also known as extended repayment schedules or ``ERS'') for Medicare provider and supplier overpayments. Under this provision, we are granting a provider or a supplier an ERS under certain terms and conditions as defined in the statute. This final rule establishes criteria and procedures to apply this requirement and to define the concepts of ``hardship'' and ``extreme hardship.''
Medicare Program; Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics and Federally Qualified Health Centers
This proposed rule would establish location requirements including exception criteria for rural health clinics (RHCs). It would also require RHCs to establish a quality assessment and performance improvement (QAPI) program. In addition, it would: Clarify our policies on ``commingling'' of an RHC with another entity; revise the RHC and Federally Qualified Health Centers (FQHC) payment methodology and exceptions to the per-visit payment limit to implement statutory requirements; revise RHC and FQHC payment requirements for services furnished to skilled nursing facility (SNF) patients; allow RHCs to contract with RHC nonphysician providers under certain circumstances; and update the regulations pertaining to waivers to the staffing requirements. This proposed rule would also add requirements for RHCs and FQHCs to maintain and document an infection control process and to post RHC or FQHC hours of clinical services. In addition, this proposed rule would update the requirements under the emergency services standard and patient health records condition for certification (CfC) to reflect advancements in technology and treatment. Finally, this proposed rule solicits comments on payment for high cost drugs and the appropriateness of a mental health specialty clinic as an exception to the location requirements.
Medicare and Medicaid Programs; Hospital Conditions of Participation: Laboratory Services
This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2008
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2008 through March 2008, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities
The Office of Global Health Affairs within the U.S. Department of Health and Human Services (HHS) is reopening the period to submit comments on the proposed rule, published in the Federal Register of April 17, 2008. The proposed rule describes the separation that must exist between a recipient of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), Public Law No. 108-25 (May 27, 2003), and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking, as required under section 301(f) of the Leadership Act.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine
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.
Public Consultation on a Proposed Framework for Oversight of Dual Use Life Sciences Research
The Federal Government is sponsoring a public consultation to engage the scientific community and research organizations in a discussion of a framework for the oversight of dual use life sciences research proposed by the National Science Advisory Board for Biosecurity (NSABB), which is an advisory committee to the Federal Government. In its report, the NSABB posed a series of questions on which the Board encouraged the Federal Government to solicit public comment. These questions concerned such matters as the clarity of the criteria proposed by the Board for identifying dual use research of concern, institutional oversight responsibilities, who should make determinations regarding dual use research of concern, and how to balance appropriate controls with academic freedom and scientific exchange. This public consultation is an opportunity for members of the scientific community and general public to provide input on these important issues.
Proposed Collection; Comment Request; Simulations for Drug Related Science Education
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), 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. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module ArchieMD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforces or instills negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre- and post-test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
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