Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents
Results 701 - 750 of 3,398
Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket
The Food and Drug Administration (FDA) is announcing the Web location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA is establishing a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates; Correction
This document corrects technical errors that appeared in the final rule with comment period entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates'' that appeared in the August 22, 2007 Federal Register.
New Animal Drugs; Florfenicol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect conditional approval of an application for conditional approval of a new animal drug intended for a minor species filed by Schering-Plough Animal Health Corp. The application seeks conditional approval of the use of florfenicol by veterinary feed directive for the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Jon Sudb[oslash], D.D.S., Norwegian Radium Hospital: Based on the findings of an investigation conducted by the Investigation Commission appointed by Norwegian Radium Hospital (NRH) and the University of Oslo, the respondent's own admission, and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Jon Sudb[oslash], D.D.S., former doctoral student and faculty member, University of Oslo, and former physician in the Department of Medical Oncology and Radiotherapy, NRH, engaged in scientific misconduct by reporting fabricated and/or falsified research in grant application 1 P01 CA106451-01 submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH), and its first-year progress report. Specifically, PHS found that Dr. Sudb[oslash] engaged in scientific misconduct by falsifying and fabricating research that served as the rationale for Project 1, ``Oral Cancer Prevention with Molecular Targeting Therapy,'' with Dr. Jon Sudb[oslash], as project leader, in the grant application, and by falsifying a progress report for the awarded grant. In particular, in Figure 1 of the Background and Significance section of the grant application, Dr. Sudb[oslash] reported fabricated/falsified results for the effects of lesion ploidy upon survival in patients with oral pre-malignant lesions. In the Preliminary Data section of the grant application, Dr. Sudb[oslash] reported several events intended to demonstrate his experience in the research field that the Investigation Commission stated ``appear as pure fiction.'' Also, in the first yearly progress report for the funded grant, Dr. Sudb[oslash] falsified the number of patients that had been screened for admission to the study. In addition to three publications for which Dr. Sudb[oslash] admitted falsifying and/or fabricating data, the Investigation Commission found at least twelve other publications that warranted retraction because they could not be considered valid. The research reported in these publications was not supported by PHS funds. However, the publications address the same general research area as that addressed in the grant application and demonstrate a pervasive pattern of falsification/fabrication in research reporting on the part of Dr. Sudb[oslash]. The falsified/fabricated data presented in the grant application purport to demonstrate the feasibility of preventing cancer in a high risk population with nontoxic oral agents. Dr. Sudb[oslash] has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, beginning on August 31, 2007: (1) To exclude himself permanently from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as delineated in the OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR Part 376, et seq.; Dr. Sudb[oslash] agrees that he will not petition HHS to reverse or reduce the scope of the permanent voluntary exclusion or other administrative actions that are the subject of this Agreement; and (2) To exclude himself permanently from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant or contractor to PHS.
Announcement of Anticipated Availability of Funds for Family Planning Services Grants
The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Monday, June 11, 2007 announcing the anticipated availability of funds for family planning services grants. On July 13, 2007, the Notice was corrected to reflect the availability of Arizona, Navajo Nation for competition. Since that time, an additional State/population/area to be served has become available for competition. This Notice reflects the availability of Illinois, Chicago area for competition.
Notice of a Cooperative Agreement with Meharry Medical College
The Office of Minority Health (OMH), Office of Public Health and Science, announces that it will enter into a cooperative agreement with Meharry Medical College (MMC). This cooperative agreement is an umbrella cooperative agreement and will establish the programmatic framework in which specific projects can be supported by various agencies during the project period. The purpose of this cooperative agreement is to strengthen the nation's capacity to prepare health professionals from disadvantaged backgrounds to serve minority populations and to develop a national model for improving health care delivery to indigent and underserved citizens. The ultimate goal is to improve the health status of minorities and disadvantaged people and increase the diversity of the health-related workforce.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines and Publication of Final Program Eligibility Guidelines
A notice was published in the Federal Register on April 9, 2007 (72 FR 17564). The purpose of this notice was to solicit comments on the eligibility criteria that were proposed by HRSA concerning the Reimbursement of Travel and Subsistence Expenses Grant Program.
New Animal Drugs; Ractopamine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter, a revision to bacterial pathogen nomenclature, and an increase in liver tolerance.
Implantation or Injectable Dosage Form New Animal Drugs; Polysulfated Glycosaminoglycan
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for a revised food safety warning on labeling for an injectable solution of polysulfated glycosaminoglycan used in horses.
Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year 2008
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2008 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2008, the inpatient hospital deductible will be $1024. The daily coinsurance amounts for CY 2008 will be: (a) $256 for the 61st through 90th day of hospitalization in a benefit period; (b) $512 for lifetime reserve days; and (c) $128 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2008
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2008. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2008 are $192.70 for aged enrollees and $209.70 for disabled enrollees. The standard monthly Part B premium rate for 2008 is $96.40, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2007 standard premium rate was $93.50.) The Part B deductible for 2008 is $135.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they may have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage, by the end of the 3-year transition period. However, for 2008, the beneficiary is only responsible for 67 percent of any applicable income-related monthly adjustment amount. (For 2007, the beneficiary was responsible for 33 percent of the applicable amount.)
Medicare Program; Part A Premium for Calendar Year 2008 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2008. This premium is to be paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2008 for these individuals will be $423. The reduced premium for certain other individuals as described in this notice will be $233.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally Qualified Health Centers Arrangements Under the Anti-Kickback Statute
In accordance with section 431 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), this final rule sets forth a safe harbor under the anti-kickback statute to protect certain arrangements involving goods, items, services, donations, and loans provided by individuals and entities to certain health centers funded under section 330 of the Public Health Service Act. The goods, items, services, donations, or loans must contribute to the health center's ability to maintain or increase the availability, or enhance the quality, of services available to a medically underserved population.
Proposed Consolidated Vaccine Information Materials for Multiple Infant Vaccines
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on a proposed new vaccine information statement that consolidates the six vaccine information statements for the following childhood vaccines: DTaP, Haemophilus influenzae type b, inactivated polio vaccine, pneumococcal conjugate vaccine, hepatitis B, and rotavirus. This consolidated Vaccine Information Statement would be available to be used by vaccination providers as an alternative to providing the six individual Vaccine Information Statements for the same vaccines.
Notice of Public Meeting and Availability for Public Comment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting and request for public input regarding a proposed survey of U.S. truck driver safety and health. The goal of the survey is to collect information on truck driver health, sleep disorders, fatigue, working conditions, and non-fatal injuries. Further information on the proposed survey may be found at: https://www.cdc.gov/ niosh/review/public/110. Public Comment Period: From date of publication of this notice until January 2, 2008. Public Meeting Date and Time: Thursday, November 1, 2007, 8:30 a.m.-4:30 p.m., CST. Place: Westin O'Hare Hotel, 6100 North River Road, Rosemont, Illinois 60018, telephone (888) 627-8517. Purpose of the Meeting: To obtain public comment on the content and conduct of a nationally representative survey of truck drivers' safety and health. Special emphasis will be placed on discussion of the following: (1) Content of the survey. (2) Appropriate methods of conducting such a survey. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room will accommodate approximately 70 people. Interested parties should make hotel reservations directly with the Westin O'Hare Hotel by calling (888) 627-8517 or via the Web site at https://www.starwoodmeeting.com/Book/westatOc before the cut-off date of 5 p.m. CST October 10, 2007. A special group rate of $205.00 per night (or prevailing government rate) plus tax per night for meeting guests has been negotiated for this meeting. In order to receive the special room rate, you will need to indicate that you will be attending the NIOSH meeting. Interested parties should confirm their attendance to this meeting by contacting Ms. Mary K. Dingwall, meeting coordinator, at (301) 738- 3583 or MaryDingwall@Westat.com by October 19, 2007. Oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting or by submitting them to the NIOSH Docket Office. Contact Person for Technical Information: Karl Sieber, NIOSH/CDC, Robert A. Taft Laboratories, 4676 Columbia Pkwy. MS R-17, Cincinnati, OH 45226, telephone (513) 841-4231, or Stephanie Pratt, NIOSH/CDC, 1095 Willowdale Road, MS 1808, Morgantown, WV 26505, telephone (304) 285- 5992. Contact Person for Submitting Comments: Comments on the topics presented in this notice and at the meeting should be mailed to: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone (513) 533-8450, fax (513) 533-8285. Comments may also be submitted by e-mail to nioshdocket@cdc.gov or at https://www.cdc.gov/niosh/review/public/110/. E-mail attachments should be formatted in Microsoft Word. All comments should be received by January 2, 2008 and should reference the Docket Number (NIOSH-110) in the subject heading. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226 and at https:// www.cdc.gov/niosh/docket/default.html.
Fees for Sanitation Inspections of Cruise Ships
This notice announces fees for vessel sanitation inspections for fiscal year 2008 (October 1, 2007, through September 30, 2008).
Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls
The Food and Drug Administration (FDA) is proposing to amend the classification regulation for the electrocardiograph electrode device to establish special controls and to exempt the device from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the act). The agency is taking this action on its own initiative. 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 for the device if the rule is finalized. The agency believes that special controls, when followed and combined with the general controls, will provide reasonable assurance of the safety and effectiveness of these devices, if this proposal becomes final.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The draft guidance describes a means by which the electrocardiograph electrode 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 that would designate this draft guidance as the special control for this device and would exempt the device from premarket notification requirements, subject to specific limitations, if the device addresses the issues identified in the guidance by following its recommendations. The draft guidance document is not final, nor is it being implemented at this time.
Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza; Availability
The Food and Drug Administration (FDA) is announcing the opening of a docket to receive information and comments from manufacturers of vaccines and other interested persons concerning the development of safety and effectiveness assessments of vaccines used for pandemic influenza. FDA is interested in obtaining comments and information to aid in the development of programs for adverse events surveillance following administration of pandemic influenza vaccines, and in the development of protocols to study effectiveness of influenza vaccines in pre-pandemic and pandemic situations.
Dean Foods Co.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Dean Foods Co. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 as a nutrient supplement in soy-based food products.
Guidance for Industry and Food and Drug Administration Staff; Biological Indicator Premarket Notification Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Biological Indicator (BI) Premarket Notification (510(k)) Submissions.'' The agency is issuing this guidance document to provide information that will help manufacturers prepare premarket notification submissions for these devices. The document provides guidance regarding performance characteristics for biological indicator devices, which are intended to monitor the effectiveness of sterilizers used in healthcare facilities.
Behind the Counter Availability of Certain Drugs; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to obtain comments regarding behind-the-counter (BTC) availability of drugs. Currently, drugs are available as prescription and non-prescription. Generally, non-prescription products are available in an ``over-the-counter'' (OTC) manner. The FDA is interested in obtaining public comment as it explores the public health benefit of certain drugs being available without a prescription but only after intervention by a pharmacist. The purpose of the meeting is to solicit information and views from interested persons on specific issues associated with BTC availability, including the impact on patient access to safe and effective drug products. Dates and Times: The public meeting will be held on November 14, 2007, from 8 a.m. to 5 p.m. Location: The public meeting will be held at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594.
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