Department of Health and Human Services January 13, 2011 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-685
Type: Notice
Date: 2011-01-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Meeting of the National Biodefense Science Board
Document Number: 2011-684
Type: Notice
Date: 2011-01-13
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Federal Agency Responses to Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Recommendations on Two Nonradioactive Versions of the Murine Local Lymph Node Assay (LLNA) for Assessing Allergic Contact Dermatitis (ACD) Hazard Potential of Chemicals and Products, and Expanded Uses of the LLNA for Pesticide Formulations and Other Products; Notice of Availability
Document Number: 2011-669
Type: Notice
Date: 2011-01-13
Agency: Department of Health and Human Services
U.S. Federal agency responses to ICCVAM test method recommendations on two nonradioactive versions of the LLNA for assessing the ACD hazard potential of chemicals and products and for expanded uses of the LLNA for pesticide formulations and other products are now available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/immunotox/llna.htm. ICCVAM recommended the nonradioactive LLNA: 5-bromo-2-deoxyuridine-enzyme-linked immunosorbent assay (BrdU-ELISA) and LLNA: Daicel Adenosine Triphosphate (DA), and expanded uses for the LLNA. In accordance with the ICCVAM Authorization Act (42 U.S.C. 285l-3(e)(4)), ICCVAM forwarded recommendations to Federal agencies and made these recommendations available to the public (75 FR 37443). Agencies have now notified ICCVAM in writing of their findings and ICCVAM is making these responses available to the public.
Submission for OMB Review; Comment Request; California Health Interview Survey Cancer Control Module (CHIS-CCM) 2011 (NCI)
Document Number: 2011-661
Type: Notice
Date: 2011-01-13
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 November 15, 2010 (75 FR 69681) 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) 2011. Type of Information Collection Request: Revision. 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 sixth to be administered in 2011. 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 2011 is planned for continual administration to 48,000 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, obesity, and human papillomavirus. 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. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 2,177 (see Table 1). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Proposed HHS Recommendation for Fluoride Concentration in Drinking Water for Prevention of Dental Caries
Document Number: 2011-637
Type: Notice
Date: 2011-01-13
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) seeks public comment on proposed new guidance which will update and replace the 1962 U.S. Public Health Service Drinking Water Standards related to recommendations for fluoride concentrations in drinking water. The U.S. Public Health Service recommendations for optimal fluoride concentrations were based on ambient air temperature of geographic areas and ranged from 0.7-1.2 mg/L. HHS proposes that community water systems adjust the amount of fluoride to 0.7 mg/L to achieve an optimal fluoride level. For the purpose of this guidance, the optimal concentration of fluoride in drinking water is that concentration that provides the best balance of protection from dental caries while limiting the risk of dental fluorosis. Community water fluoridation is the adjusting and monitoring of fluoride in drinking water to reach the optimal concentration (Truman BI, et al, 2002). This updated guidance is intended to apply to community water systems that are currently fluoridating or will initiate fluoridation.\1\ This guidance is based on several considerations that include:
Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2011-635
Type: Notice
Date: 2011-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2011-634
Type: Notice
Date: 2011-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-629
Type: Notice
Date: 2011-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2011-628
Type: Notice
Date: 2011-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
Document Number: 2011-592
Type: Notice
Date: 2011-01-13
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions of FDA's recordkeeping and records access requirements for food facilities.
Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
Document Number: 2011-532
Type: Notice
Date: 2011-01-13
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on voluntary customer satisfaction service surveys to implement Executive Order 12862.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-470
Type: Notice
Date: 2011-01-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Hospital Inpatient Value-Based Purchasing Program
Document Number: 2011-454
Type: Proposed Rule
Date: 2011-01-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In this proposed rule, we are proposing to implement a Hospital Value-Based Purchasing program (``Hospital VBP program'' or ``the program'') under section 1886(o) of the Social Security Act (``Act''), under which value-based incentive payments will be made in a fiscal year to hospitals that meet performance standards with respect to a performance period for the fiscal year involved. The program will apply to payments for discharges occurring on or after October 1, 2012, in accordance with section 1886(o) of the Social Security Act (as added by section 3001(a) of the Patient Protection and Affordable Care Act (Pub. L. 111-148), enacted on March 23, 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), enacted on March 30, 2010 (collectively known as the Affordable Care Act)). The measures we are proposing to initially adopt for the program are a subset of the measures that we have already adopted for the existing Medicare Hospital Inpatient Quality Reporting Program (Hospital IQR program), formerly known as the Reporting Hospital Quality Data for the Annual Payment Update Program (RHQDAPU), and we are proposing, based on whether a hospital meets or exceeds the performance standards that we are proposing to establish with respect to the measures, to reward the hospital based on its actual performance, rather than simply its reporting of data for those measures.
Proposed Information Collection Activity; Comment Request
Document Number: 2011-412
Type: Notice
Date: 2011-01-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-408
Type: Notice
Date: 2011-01-13
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Connecting Primary Care Practices with Hard-to-Reach Adolescent Populations.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
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