Department of Health and Human Services March 2007 – Federal Register Recent Federal Regulation Documents
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Notice of Availability of Final Policy Guidance
HRSA is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2007-09) to describe and clarify HRSA's current policy and process for resolving issues and conflicts related to health center service area overlap. The PIN, ``Service Area Overlap: Policy and Process,'' and the Agency's ``Response to Public Comments'' are available on the Internet at https://bphc.hrsa.gov/chc/sao.htm.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to the Wage Index; Corrections
This document corrects wage index values and a relative weighting factor error that appeared in the correction notice published in the Federal Register on January 5, 2007 entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to Wage Index; Corrections''.
Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees'' dated March 2007. This draft guidance describes the factors and analyses that should be used in considering whether an advisory committee member has a potential conflict of interest and whether participation in a meeting is appropriate. This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA policy in applying the applicable statutory and regulatory requirements. This draft guidance, when finalized, will replace the guidance document entitled ``FDA Waiver Criteria 2000.''
Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relations (Phase II); Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule
This notice announces the continuation of effectiveness of a Medicare interim final rule and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.
Medicaid Program; Health Care-Related Taxes
This proposed rule would revise the threshold under the indirect guarantee hold harmless arrangement test to reflect the provisions of the Tax Relief and Health Care Act of 2006, Public Law 109-432, by providing that, when determining whether there is an indirect guarantee under the 2-prong test for any part of a fiscal year on or after January 1, 2008 through September 30, 2011, the allowable amount that can be collected from a health care-related tax is reduced from 6 to 5.5 percent of net patient revenues received by the taxpayers. This proposed rule would also clarify the standard for determining the existence of a hold harmless arrangement under the positive correlation test, Medicaid payment test, and the guarantee test (with conforming changes to parallel provisions concerning hold harmless arrangements with respect to provider-related donations); codify descriptions for two classes of health care services permissible under Federal statute for purposes of taxes on health care providers; and, remove obsolete transition period regulatory language.
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention Announces the Following: Implementation of New Record Schedule
NIOSH is implementing a new record schedule governing the retention of records transferred to the agency by employers pursuant to the regulations of the Occupational Safety and Health Administration (OSHA). Pursuant to this schedule, NIOSH will review these records to determine if they document exposures or medical conditions as required under the OSHA regulations and have research value. Those records that NIOSH determines meet the OSHA regulations and have a research value will be retained for 30 years. Those records that do not document exposure or medical condition and treatment or have no research value will not be retained.
A Public meeting to provide input regarding the draft document, “Long-Term Field Evaluation (LTFE) Program Concept”
The National Institute for Occupational Safety and Health (NIOSH) announces the availability of opportunity for the public to provide input regarding the draft document, ``Long-Term Field Evaluation (LTFE) Program Concept.'' The public meeting will be held on March 22, 2007 at the DoubleTree Pittsburgh Airport Hotel, 8402 University Blvd., Moon Township, PA 15108. NIOSH is the Federal agency responsible for conducting research and making recommendations for the approval for self-contained, self- rescuer (SCSR) closed circuit escape respirators, Title 42, Code of Federal Regulations (CFR), Part 84. The LTFE program for self-contained self-rescuers (SCSRs) for miners was initiated more than 20 years ago by the U.S. Bureau of Mines. The objective for the LTFE program is to obtain data to determine the expected performance characteristics of SCSRs used in the mining industry. LTFE program results based on scientific principles can provide useful information to monitor expected SCSR performance and assess possible degradation due to the physical stresses of in-mine use. Of utmost concern is the successful performance of any SCSR that passes its inspection criteria specified by the manufacturer. It is such an apparatus that must be relied upon in an emergency. A copy of the draft document can be found at: https://www.cdc.gov/ niosh/review/public/NPPTL-LTFE/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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 Food and Drug Administration Rapid Response Surveys
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 use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
Request for Nominations for Voting Members on Public Advisory Committees
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory Committee, Transmissible Spongiform Encephalopathies Advisory Committee, and the Vaccines and Related Biological Products Advisory Committee in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will or may occur through January 31, 2008. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees, and therefore, encourages nominations of qualified candidates from these groups.
Office of the Assistant Secretary for Preparedness and Response; HHS Public Health Emergency Medical Countermeasures Enterprise Strategy for Chemical, Biological, Radiological and Nuclear Threats
The United States faces serious public health threats from the deliberate use of weapons of mass destruction (WMD)chemical, biological, radiological, or nuclear (CBRN)by hostile States or terrorists, and from naturally emerging infectious diseases that have a potential to cause illness on a scale that could adversely impact national security. Effective strategies to prevent, mitigate, and treat the consequences of CBRN threats is an integral component of our national security strategy. To that end, the United States must be able to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the American people. This HHS Public Health Emergency Medical Countermeasures Enterprise Strategy (HHS PHEMCE Strategy) establishes the goals and objectives that HHS will employ to ensure that medical countermeasures are available for effective use against the highest priority CBRN threats facing the Nation. The HHS PHEMCE Strategy considers the full spectrum of medical countermeasures- related activities, including research, development, acquisition, storage/maintenance, deployment, and utilization. The HHS PHEMCE Strategy is consistent with the President's Biodefense for the 21st Century and aligned with the National Strategy for Medical Countermeasures against Weapons of Mass Destruction.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information That They Provide to Pregnant Women
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 Health Assessments and Health Consultations Completed October 2006-December 2006
This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from October 1, 2006, through December 31, 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.
National Institute for Occupational Safety and Health; Notice of Public Input Opportunity
The National Institute for Occupational Safety and Health (NIOSH) announces the following availability of opportunity for the public to provide input regarding the draft document, ``Long-Term Field Evaluation (LTFE) Program Concept.'' NIOSH is the Federal agency responsible for conducting research and making recommendations for the approval for self-contained, self- rescuer (SCSR) closed circuit escape respirators, Title 42, Code of Federal Regulations (CFR), Part 84. The LTFE program for self-contained self-rescuers (SCSRs) for miners was initiated more than 20 years ago by the U.S. Bureau of Mines. The objective for the LTFE program is to obtain data to determine the expected performance characteristics of SCSRs used in the mining industry. LTFE program results based on scientific principles can provide useful information to monitor expected SCSR performance and assess possible degradation due to the physical stresses of in-mine use. Of utmost concern is the successful performance of any SCSR that passes its inspection criteria specified by the manufacturer. It is such apparatus that must be relied upon in an emergency. A copy of the draft document can be found at https://www.cdc.gov/ niosh/review/public/NPPTL-LTFE/.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to change the location of a section in an over-the-counter (OTC) drug monograph. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Privacy Act of 1974: Report of Modified System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify a SOR titled, ``Long Term Care-Minimum Data Set'' (MDS), System No. 09-70-1517, most recently modified at 67 FR 6714 (February 13, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new identifying number for this system should read: System No. 09-70-0528. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We also propose to modify existing routine use number 3 that permits disclosure to Peer Review Organizations (PRO). The name of PROs has been changed to read: ``Quality Improvement Organizations (QIO).'' QIOs will continue work to implement quality improvement programs, provide consultation to CMS, its contractors, and to state agencies. The modified routine use will remain as routine use number 3. We will delete routine use number 6 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system is to aid in the administration of the survey and certification, and payment of Medicare Long Term Care services, which include skilled nursing facilities (SNFs), nursing facilities (NFs) SNFs/NFs, and hospital swing beds, and to study the effectiveness and quality of care given in those facilities. Information in this system will also be used to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor or consultant; (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; (7) assist national accrediting organizations; and (8) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the modified 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 Dates'' section for comment period.
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