Department of Health and Human Services September 24, 2008 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program
Document Number: E8-22440
Type: Notice
Date: 2008-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the PRA).
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-22437
Type: Notice
Date: 2008-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Document Number: E8-22435
Type: Notice
Date: 2008-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Product Tracing Systems for Fresh Produce; Public Meetings
Document Number: E8-22430
Type: Notice
Date: 2008-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing two public meetings regarding product tracing systems for fresh produce. The purpose of the meetings is to stimulate and focus a discussion about mechanisms to enhance product tracing systems for fresh produce and to improve FDA's ability to use the information in such systems to identify the source of contamination associated with fresh produce- related outbreaks of foodborne illness. This discussion will help FDA determine what short and long term steps we should take to enhance the current tracing system.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306
Document Number: E8-22359
Type: Notice
Date: 2008-09-24
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-0028, ``IHS Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306. Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0028, ``IHS Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306. Form Number: OPM-306. Forms: Declaration for Federal Employment. Need and Use of Information Collection: This is a request for approval of collection information required by Section 408 of the Indian Child Protection and Family Violence Prevention Act, Public Law 101-630, 104 Stat. 4544, and 25 U.S.C. 3201-3211. The IHS is required to compile a list of all authorized positions within the IRS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. Section 3207(b) of the Indian Child Protection and Family Violence Prevention Act was amended by Section 814 of U.S.C. 3031, the Native American Laws Technical Corrections Act of 2000, which requires that the regulations prescribing the minimum standards of character ensure that none of the individuals appointed to positions involving regular contact with, or control over Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution; crimes against persons; or offenses committed against children. In addition, 42 U.S.C. 13041 requires each agency of the Federal Government, and every facility operated by the Federal Government (or operated under contract with the Federal Government), that hires (or contracts for hire) individuals involved with children under the age of 18 or child care services to assure that all existing and newly hired employees undergo a criminal history background check. The background is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal Government, or for a facility or program operated by (or through contract with) the Federal Government, in positions involved with the provision to children under the age of 18 or child care services, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
Document Number: E8-22346
Type: Notice
Date: 2008-09-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH)
Document Number: E8-22344
Type: Notice
Date: 2008-09-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Public Comment on Section 635 [42 U.S.C. 9801]-The 2007 Head Start School Readiness Act, Sub-Section 649(k)(1)(A-D)-“Indian Head Start Study”
Document Number: E8-22335
Type: Notice
Date: 2008-09-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The following Notice of Public Comment is in response to section 649(k) Sub-Section (3) of the 2007 Head Start School Readiness Act that requires the Secretary no later than 9 months after the effective date of this Sub-Section, publish in the Federal Register a plan of how the Secretary will carry out section 649 Sub-Section (k) Sub-Paragraph (1) and shall provide a period for public comment.
Office of Community Services
Document Number: E8-22319
Type: Notice
Date: 2008-09-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This supplement would enhance the ability for the CAP to find new ways to address training and technical assistance needs. After gathering information from the Community Action Network, the applicant will provide a report to the Office of Community Services (OCS) containing recommendations about creative approaches and strategies for providing technical assistance and training to Community Action Agencies (CAAs). The applicant will compile information gathered thru: Brainstorming sessions with members of the Community Action Network and the Virtual CAP. The report to OCS will include sections on major recommendations and a strategy for implementation. These will be supported by summaries of the ideas presented at the sessions and input compiled by Virtual CAP.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2009
Document Number: E8-22314
Type: Notice
Date: 2008-09-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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, 2009. 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 2009 are $192.70 for aged enrollees and $224.20 for disabled enrollees. The standard monthly Part B premium rate for 2009 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 2008 standard premium rate was also $96.40.) The Part B deductible for 2009 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.
Medicare Program; Part A Premium for Calendar Year 2009 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: E8-22312
Type: Notice
Date: 2008-09-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2009. 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, 2009 for these individuals will be $443. The reduced premium for certain other individuals as described in this notice will be $244.
Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year 2009
Document Number: E8-22310
Type: Notice
Date: 2008-09-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2009 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2009, the inpatient hospital deductible will be $1068. The daily coinsurance amounts for CY 2009 will be: (a) $267 for the 61st through 90th day of hospitalization in a benefit period; (b) $534 for lifetime reserve days; and (c) $133.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Submission for OMB Review; Comment Request
Document Number: E8-22152
Type: Notice
Date: 2008-09-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-22151
Type: Notice
Date: 2008-09-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice of Meetings
Document Number: E8-22132
Type: Notice
Date: 2008-09-24
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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