Department of Health and Human Services December 12, 2008 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007
Document Number: E8-29459
Type: Notice
Date: 2008-12-12
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.
Submission for OMB Review; Comment Request; The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL)
Document Number: E8-29427
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on October 3, 2008, page 57634, and allowed 60 days for public comment. One comment was 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. Proposed Collection: Title: Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL). Type of Information Collection Request: New Collection. Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the US, are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six- and-a-half year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 30,401; Estimated Number of Responses per Respondent: 2.234; Average Burden Hours Per Response: 0.7178; and Estimated Total Annual Burden Hours Requested: 48,755. The annualized cost to respondents is estimated at $756,412, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability
Document Number: E8-29413
Type: Notice
Date: 2008-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.'' This draft guidance document updates and clarifies the procedures for reviewing premarket notification submissions (510(k)s) for devices labeled as sterile, particularly with respect to sterilization technologies FDA considers novel, and the information that should be included in 510(k)s for devices labeled as sterile.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-29402
Type: Notice
Date: 2008-12-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-29399
Type: Notice
Date: 2008-12-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-29391
Type: Notice
Date: 2008-12-12
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 Connecticut Aircraft Nuclear Engine Laboratory in Middletown, Connecticut, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 24, 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 at the Connecticut Aircraft Nuclear Engine Laboratory in Middletown, CT, from January 1, 1958 through December 31, 1965 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 November 23, 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.
Withdrawal of Certain Proposed Rules and Other Proposed Actions
Document Number: E8-29331
Type: Proposed Rule
Date: 2008-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of a certain advance notice of proposed rulemaking (ANPRM) and proposed rules (NPRMs) that published in the Federal Register more than 5 years ago. These proposals are no longer considered viable candidates for final action at this time.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-29290
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E8-29288
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: E8-29287
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: E8-29286
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-29284
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-29274
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-29149
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: E8-29148
Type: Notice
Date: 2008-12-12
Agency: Department of Health and Human Services, National Institutes of Health
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