Department of Health and Human Services October 2007 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 338
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.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Rocky Flats Plant, Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 6, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Rocky Flats Plant, Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 6, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Y-12 Facility, Oak Ridge, TN, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Y-12 facility, Oak Ridge, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Y-12. Location: Oak Ridge, Tennessee. Job Titles and/or Job Duties: All workers. Period of Employment: March 1, 1943 through December 31, 1947.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Mound Plant, Miamisburg, OH, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Mound Plant, Miamisburg, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mound Plant. Location: Miamisburg, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: February 1, 1949 through the present.
Notice of Availability of Draft Policy Document for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of BPHC programs, including the FQHC Look-Alike Program. Therefore, we are requesting comments on the PIN referenced above. After review and consideration of all comments received, the PIN may be amended to incorporate certain recommendations from the public. Once the PIN is finalized, it will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' That document will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments do not result in a revision to the PIN, explanations will be provided. Background: HRSA has received numerous requests for clarification regarding the program guidelines, requirements, and application process for the FQHC Look-Alike program. The purpose of the FQHC Look-Alike PIN is to respond to these requests for clarification and to make the application process more consistent with section 330 grant programs. The Omnibus Budget Reconciliation Acts of 1989, 1990, and 1993 amended section 1905 of the Social Security Act to create a new category of facility under Medicaid and Medicare known as Federally Qualified Health Centers (FQHCs). The Social Security Act Sec. 1905(l)(2)(B) definition of an FQHC included an entity which, based on the recommendation of HRSA, is determined to meet the requirements of the section 330 grant program but does not receive the grant. This category of health centers has been labeled FQHC Look-Alikes. To ensure that there are appropriate numbers of health centers to serve the millions of uninsured and underinsured populations throughout the country, FQHC Look-Alike status was made available to those entities that do not receive funding under section 330 but operate and provide services similar to grant-funded programs. As such, FQHC Look- Alikes are expected to demonstrate a commitment to serve all populations residing in their respective medically underserved communities regardless of their ability to pay and to satisfy all of the administrative, management, governance and service-related requirements that apply to section 330 funded health centers. Benefits of obtaining FQHC Look-Alike status include eligibility for enhanced Medicaid and Medicare reimbursement, participation in the 340(b) Federal Drug Pricing Program, and automatic Health Professional Shortage Area designation. HRSA is responsible for managing the FQHC Look-Alike program and submitting recommendations to the Centers for Medicare and Medicaid Services (CMS) for designation as FQHCs; however, CMS has the final authority to designate applicants as FQHCs. The organizations are recertified annually to assure they are in compliance with these regulations.
Electronic Nonclinical Study Data Submission; Notice of Pilot Project
The Center for Drug Evaluation and Research (CDER) is seeking sponsors interested in participating in a pilot project to test, in a regulatory setting, the electronic submission of nonclinical study data using the Standard for Exchange of Nonclinical Data (SEND). The purpose of this pilot is to test the ability of a new electronic data format to support nonclinical review activity. The pilot also will involve a collaboration of FDA, available pilot participants, and the SEND Consortium to update and create a new draft SEND implementation guide. FDA anticipates that a successful pilot will enable CDER to routinely accept nonclinical study data electronically in SEND format, instead of paper or portable document format (PDF), in investigational new drug applications (INDs), new drug applications (NDAs), and biologics licensing applications (BLAs).
National Institutes of Health Submission for OMB Review; Comment Request; Second National Survey To Evaluate the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Program
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), Office of Extramural Research (OER) Office of Extramural Programs (OEP), National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 15, 2007, pages 7442-7443 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
National Toxicology Program (NTP); Host Susceptibility Program (HSP); Genetic Variation and the Basis for Individual Susceptibility to Environmental Toxicant Associated Disease: Request for Information
The NTP is developing the Host Susceptibility Program (HSP), a new research program, to identify and functionally validate genes associated with environmental exposure. This program will make available NTP expertise and resources to investigate the genetic basis for population-level differences in susceptibility to environmental toxicants and/or disease based upon gene and environment interactions. This research will be designed to ultimately lead to a better understanding of why some individuals are more susceptible than others to exposure to an environmental toxicant resulting in disease and morbidity. Asthma, cardiovascular disease, cancer, diabetes, and obesity are examples of diseases associated with multiple interacting genes that are influenced by exposure to environmental agents. Through this Request for Information, extramural and intramural scientists are invited and encouraged to provide information and comment relevant to this proposed programmatic research approach in order to help guide further development and refinement of the goals of the NTP HSP. Information on this initiative can be submitted electronically through the HSP Request for Information Web site at: (https://ntp.niehs.nih.gov/ go/32130 ) or by contacting Dr. John E. French (see FOR FURTHER INFORMATION CONTACT below).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Human Tissue Intended for Transplantation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Human Tissue Intended for Transplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form Food and Drug Administration 3356; Eligibility Determination for Donors; and Current Good Tissue Practice
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Nominations for Membership on the Board of Directors of the Reagan-Udall Foundation From Consumer Advocacy Groups, Professional Scientific and Medical Societies, and Industry Trade Organizations
The Food and Drug Administration (FDA) is announcing the opportunity for patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations to nominate candidates to serve on the Board of Directors (the Board) of a new non-profit foundation, the Reagan-Udall Foundation for the Food and Drug Administration (the Foundation). The Foundation will be dedicated to modernizing medical, veterinary, food, food ingredient, and cosmetic product development, accelerating innovation, and enhancing product safety.
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