Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; Report of New System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to establish a new system of records (SOR) titled ``One Program Integrity Data Repository (ODR),'' System No. 09- 70-0568. Section 1893 of the Social Security Act (the Act) established the ``Medicare Integrity Program'' that requires CMS to contract with eligible entities to ``review activities of providers of services or other individuals and entities furnishing items and services for which payment may be made under this title'' by utilizing equipment and software technologies. Likewise, section 1893 of the Act requires CMS to establish the Medicare Medicaid Data Match Program (Medi-Medi) in which data from both the Medicare and Medicaid programs are analyzed together to better detect fraud, waste, and abuse existent in these programs. In order to comply with these requirements and enhance our ability to detect fraud, waste, and abuse in Medicare and Medicaid, CMS is proposing to construct the ODR. CMS maintains numerous systems housing Medicare beneficiary Parts A, B, C, and D entitlement, enrollment, and utilization information. Additionally, CMS maintains data on physicians, providers, employer plans, Medicaid recipients and Medicare secondary payers. There are a large number of data sources, extraction tools, and access mechanisms. Users of the data often experience inconsistent, untimely, or duplicated information. The ODR will be an enterprise resource that will provide an integrated view of the data to all of CMS and its partners providing a single authoritative source of information and providing quality and timely data. The ODR will provide an organized structure for reaching the data through a consistent application of access policies, processes and procedures, common services, governance, and framework. The ODR will integrate and load data from various CMS systems consisting of Medicare Parts A, B, C, and D, Medicaid and Retiree Drug Subsidy entitlement, enrollment and utilization data. The ODR will also contain demographic information on Medicaid beneficiaries, Medicare providers and physicians, and employer plans that are receiving a subsidy from CMS for providing creditable drug coverage to their retirees. It is through the integration of this Medicare data with other data; e.g., historic data, Part A and Part B data, and Medicaid data sets provided by state agencies that CMS fraud, waste, and abuse, quality improvement, research, and other analytic activities are maximized. The data collected and maintained in this system are retrieved from the following databases: Medicare Drug Data Processing System, System No. 09-70-0553 (70 FR 58436 (October 6, 2005)); Medicare Beneficiary Database, System No. 09-70-0536 (66 FR 63392 (December 6, 2001)); Medicare Advantage Prescription Drug System, System No. 09-70-4001 (70 FR 60530 (October 18, 2005)); Medicaid Statistical Information System, System No. 09-70-6001 (67 FR 48906 (July 26, 2002)); Retiree Drug Subsidy Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); Common Working File, System No. 09-70-0526 (67 FR 3210 (January 23, 2002)); National Claims History, System No. 09-70-0005 (67 FR 57015 (September 6, 2002)); Enrollment Database, System No. 09-70-0502 (67 FR 3203 (January 23, 2002)); Carrier Medicare Claims Record, System No. 09-70-0501 (67 FR 54428 (August 22, 2002)); Intermediary Medicare Claims Record, System No. 09- 70-0503 (67 FR 65982 (October 29, 2002)); Unique Physician/Provider Identification Number, System No. 09-70-0525, (69 FR 75316 (December 16, 2004)); Medicare Supplier Identification File, System No. 09-70- 0530 (67 FR 48184 (July 23, 2002)); and the Medicaid data sets provided by participating state agencies. The primary purpose of this system is to establish an enterprise resource that will provide a single source of information for all CMS fraud, waste, and abuse activities. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or State agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) support Quality Improvement Organizations (QIO); (4) assist other insurers for processing individual insurance claims; (5) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (6) support litigation involving the agency; and (7) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See Effective Date section for comment period.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Evaluation of Drug Usage Under the Staff Time and Resource Intensity Verification Study (STRIVE), System No. 09-70-0595.'' Section 1888(e)(G) of the Social Security Act (the Act) authorizes the Secretary of HHS to provide for payment adjustments to the skilled nursing facility (SNF) prospective payment system (PPS) through a resident classification system established by the Secretary that accounts for the relative resource utilization of different patient types. The case mix adjustment shall be based on resident assessment data and other data the Secretary considers appropriate. To accomplish this task, CMS is currently undertaking a national nursing home time study known as STRIVE, of which this data will be a part. The purpose of this system is to collect and maintain during the STRIVE time study individually identifiable information on selected beneficiaries' medication utilization while in a nursing home, skilled nursing facility or swing bed hospital. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Date section for comment period.
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567
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 related to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Forms FDA 356h and 2567.
Implantation or Injectable Dosage Form New Animal Drugs; Glycopyrrolate
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of glycopyrrolate solution as an injectable preanesthetic agent in dogs and cats.
Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).'' The guidance explains, using a question and answer format, FDA's current thinking on a number of issues related to the regulation of food allergens, including implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs
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 an information collection to meet specified requirements for submitting adequate and well-controlled studies to provide substantial evidence of effectiveness for a new animal drug.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Request for Information (RFI): Improving Health and Accelerating Personalized Health Care Through Health Information Technology and Genomic Information in Population- and Community-Based Health Care Delivery Systems
Advances in medicine, biomedical science, and technology present opportunities for enabling health care practices to be increasingly patient-specific by taking into account individual differences in health states, disease processes, and outcomes from interventions. Often referred to as personalized health care, the desired impact of these types of health practices is improved effectiveness and safety of medical practices. These health benefits may be manifested through new approaches for predicting disease risk at an early time point, enabling preemption of disease processes prior to full manifestation of symptoms, analyzing the effectiveness of different interventions in specific populations based on their genetic makeup, and preventing the progression of disease and the related complications. For the purpose of achieving a broader understanding of rapid changes occurring in the health care setting that may have an impact on the future of personalized health care, the Department of Health and Human Services (HHS) requests input from the public and private sectors on plans for developing and using resources involving health information technology (IT) and genetic and molecular medicine, with specific reference to incorporating these capacities in evidence-based clinical practice, health outcomes evaluations, and research.
Marketed Unapproved Drugs; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. This will be a 1-day workshop involving FDA staff and representatives from businesses currently marketing unapproved drugs. The purpose of the workshop is to provide clarification and direction to businesses on how to seek approval to legally market drugs through the new drug application (NDA) and abbreviated new drug application (ANDA) processes and how to legally market drugs through compliance with the over-the-counter (OTC) monographs.
General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
The Food and Drug Administration (FDA) is proposing to reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Absorbable Hemostatic Device.'' The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). This draft guidance is not final, nor is it being implemented at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological 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 Forms FDA 3486 and 3486A.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Public Meeting; Extension of Comment Period
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed changes to the National Drug Code (NDC) system contained in the agency's proposed rule governing drug establishment registration and drug listing. The proposed rule appeared in the Federal Register of August 29, 2006 (71 FR 51276). In addition, in response to requests for an extension, FDA is extending to January 26, 2007, the comment period for the proposed rule to provide interested parties additional time to submit comments.
Meeting of the President's Council on Physical Fitness and Sports
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Physical Fitness and Sports will hold a meeting. This meeting is open to the public. A description of the Council's functions is included with this notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infectious Disease Issues in Xenotransplantation
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; Investigational Device Exemptions Reports and Records
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; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
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 proposed collection of information that will permit an applicant to certify that it qualifies as a ``small business'' within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
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.
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the eleventh meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Public Meeting of the President's Council on Bioethics on November 16-17, 2006
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-seventh meeting, at which it will (1) Hear an update on stem cell research; (2) hear presentations on and discuss issues in clinical applications of advancements in genetics, as well as genetics policy and ethics; (3) discuss policy options in organ procurement, transplantation, and allocation; and (4) hear a presentation on and discuss issues in the ethics of health care. Agenda items one through three are continuations of previous Council discussions; the fourth agenda item is a new area of potential inquiry for the Council. Subjects discussed at past Council meetings (although not on the agenda for the November 2006 meeting) include: human dignity, therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, and lifespan- extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).
Draft Guidance for Industry; Blue Bird Medicated Feed Labels; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (181) entitled ``Draft Guidance for Industry: Blue Bird Medicated Feed Labels.'' This draft guidance is intended to provide new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's (CVM's) current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Guidance for Industry on Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components,'' dated October 2006. The guidance document provides blood establishments that collect blood and blood components intended for transfusion or for further manufacture with advice on reporting to FDA a manufacturing change consisting of the implementation of a standardized full-length donor history questionnaire and accompanying materials (DHQ documents). The guidance document addresses which DHQ documents are acceptable, and establishes the process for FDA to recognize other DHQ documents in the future. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components'' dated April 2004.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
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 procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act.
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-December 13, 2006
This notice announces a public meeting of the Medicare Coverage Advisory Committee (``MCAC'' or ``the Committee''). MCAC provides guidance and advice to CMS on specific clinical topics under review for Medicare coverage. This meeting concerns reconsideration of the Medicare clinical trial policy. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare and Medicaid Programs; Reapproval of Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations
This notice announces our proposal to reapprove Medicare Advantage Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for health maintenance organizations and local preferred provider organizations for a term of 6 years. This new term of approval begins July 12, 2006, and ends July 11, 2012. This notice also announces a 30-day period for public comments on renewal of the application.
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