Department of Health and Human Services July 1, 2008 – Federal Register Recent Federal Regulation Documents

Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs
Document Number: E8-14917
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments from affected entities and individuals about (a) Whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research, or (b) whether HHS should develop a regulation requiring the implementation of such training and education programs. This request for information and comment stems from the 1998 report from the HHS Office of Inspector General (OIG) recommending that Federal requirements be enacted to help ensure that investigators and institutional review board (IRB) members be adequately educated about, and sensitized to, human subjects protections. More recently, the Secretary's Advisory Committee on Human Research Protections (SACHRP) recommended that OHRP require institutions to ensure that initial and continuing training is provided for IRB members and staff, investigators, and certain institutional officials. The implementation of such training and education programs might help to ensure that individuals involved in the conduct or review of human subjects research at institutions holding OHRP-approved Federalwide Assurances (FWAs) understand and meet their regulatory responsibilities for protecting human subjects.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension of Certification on Maintenance of Effort for the Title III and Certification of Long-Term Care Ombudsman Program Expenditures
Document Number: E8-14898
Type: Notice
Date: 2008-07-01
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-14896
Type: Notice
Date: 2008-07-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities-Survey
Document Number: E8-14888
Type: Notice
Date: 2008-07-01
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices
Document Number: E8-14887
Type: Notice
Date: 2008-07-01
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed study entitled ``Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
Document Number: E8-14882
Type: Notice
Date: 2008-07-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Designation as Country not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Innovative Food Defense Projects; New Limited Competition Cooperative Agreement U13; Request for Application Number: RFA-FDA-08-010
Document Number: E8-14876
Type: Notice
Date: 2008-07-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) is announcing the availability of grant funds for the support of innovative food defense projects. These grants are available to State, local, and tribal levels and must have national implication or application that can enhance Federal, State, and local food regulatory programs and are likely to impact preparedness, response and/or recovery. FDA anticipates providing approximately $240,000 in direct plus indirect costs in support of this program in fiscal year 2008. It is anticipated that 6 awards will be made for up to $40,000 per award/per year for up to 1 year.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-14839
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-14837
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-14827
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Nuclear Materials and Equipment Corporation (NUMEC) facility, Parks Township, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-14826
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Horizons Inc. facility, Cleveland, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-14824
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Hanford Nuclear Reservation in Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC: All employees of the Department of Energy (DOE), its predecessor agencies, and DOE contractors or subcontractors who worked from: 1. September 1, 1946 through December 31, 1961 in the 300 area; or 2. January 1, 1949 through December 31, 1968 in the 200 areas (East and West) at the Hanford Nuclear Reservation in Richland, Washington, for a number of work days aggregating at least 250 work days occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort. This designation will become effective on June 29, 2008, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-14822
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at SAM (Special Alloyed or Substitute Alloy Materials) Laboratories of Columbia University, in New York City, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-14821
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Kellex/Pierpont facility in Jersey City, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC:
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