Department of Health and Human Services November 10, 2008 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300”
Document Number: E8-26828
Type: Notice
Date: 2008-11-10
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).
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
Document Number: E8-26825
Type: Rule
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.
Privacy Act of 1974; New OIG Privacy Act System of Records: Consolidated Data Repository
Document Number: E8-26725
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
The Privacy Act of 1974 (5 U.S.C. 552(e)(4)) requires that all agencies publish in the Federal Register a notice of the existence and character of their system of records. Notice is hereby given that OIG is adding a new system of records entitled ``Consolidated Data RepositoryHHS-OIG'' (09-90-1000).
Determination of Regulatory Review Period for Purposes of Patent Extension; TYKERB
Document Number: E8-26679
Type: Notice
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for TYKERB and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; IXEMPRA
Document Number: E8-26678
Type: Notice
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for IXEMPRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: E8-26638
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: E8-26637
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
The Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-26635
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009 (NCI)
Document Number: E8-26633
Type: Notice
Date: 2008-11-10
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 Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2008 (Volume 73, No. 164, p. 49685) 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. Proposed Collection: Title: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009. Type of Information Collection Request: New. Need and Use of Information Collection: The NCI has sponsored four Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a fifth to be administered in 2009. CHIS is a telephone survey that collects population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in 2007 to 48,150 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2009, the fifth bi-annual survey, is planned for administration to 55,000 adult Californians. This study will allow NCI to examine patterns and trends in cancer screening and follow-up, as well as to study other cancer-related topics such as tobacco control, diet, physical activity, and obesity. Additionally, CHIS is designed to be comparable to the National Health Interview Survey (NHIS) data in order to conduct comparative analyses. CHIS provides enhanced estimates for cancer risk factors and screening among racial/ethnic minority populations. Frequency of Response: Once. Affected public: Individuals or households. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 3,436.93 (see Table A). The annualized cost to respondents is estimated at: $57,825. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.