Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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 the information collection requirements relating to the blood establishment registration and product listing requirements in the agency's regulations and Form FDA 2830.
Submission for OMB Review; Comment Request; The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors
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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 29, 2008, pages 30951-30952 and allowed 60 days for public comment. 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 current valid OMB control number. Proposed Collection: Title: The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors. Type of Information Collection Request: New. Need and Use of Information Collection: Establishing and monitoring viral prevalence and incidence rates, and identifying risk behaviors for HIV incidence among blood donors, are critical to assessing and reducing risk of HIV transmission through blood transfusion. Identifying donation samples from donors with recent HIV infection is particularly critical as it enables characterization of the viral subtypes currently transmitted within the screened population and hence most likely to ``break-through'' routine screening measures (i.e., peri-seroconversion window period donations). Molecular surveillance of incident HIV infections in blood donors not only characterizes genotypes of recently infected donors for purposes of blood safety, but also enables documentation of the rates of primary transmission of anti-viral drug resistant strains in the community, serving a public health role in identifying new HIV infections for anti-retroviral treatment. Both a prospective surveillance and a case- control design are proposed to enroll all eligible HIV seropositives detected at three blood centers in Brazil (Sao Paulo, Belo Horizante, and Rec[iacute]fe) plus a satellite center in Rio de Janeiro. A comparison of epidemiological risk profiles will be made between the seropositive donors and a group of randomly selected seronegative donors. There are three study aims. Laboratory studies (LS-EIA testing and sequencing of pol region) on linked specimens from all enrolled HIV cases, will allow for estimation of HIV prevalence and incidence relative to genotype and putative route of infection. Data derived from molecular genotyping, including drug resistant genotypes, will be provided, along with counseling, to all enrolled HIV positive donors to facilitate their clinical care via referral to the Brazilian national HIV treatment system. Our findings will be compared to trends in prevalence, incidence and molecular variants from studies of the general population and high risk populations in Brazil, thus allowing for broad monitoring of the HIV epidemic in Brazil and assessment of the impact of donor selection criteria on these parameters. Finally, HIV cases and a group of controls, through responses to a questionnaire, will provide data on HIV risk behaviors among prospective blood donors. This HIV risk behavior data will be used as covariates in the molecular surveillance analyses described above, as well as aid in assessing whether modifications may be needed to Brazil's routine blood center operational donor screening questionnaire. The study participants will return to their local blood center for the administration of an informed consent form, explaining the confidential nature of the research study as well as the risks and benefits to their participation. Once enrolled, they will be asked to complete the self-administered risk factor questionnaire. In addition, a small blood sample will be collected from each HIV seropositive participant to be used for the genotyping and drug resistance testing. The results of the drug resistance testing will be communicated back to the seropositive participants during an in-person counseling session at the blood center. Defining prevalence and incidence in blood donors and residual risk of HIV transmission by transfusions may lead to new regulations and blood safety initiatives in Brazil. The data can be used to project the yield, safety impact and cost effectiveness of implementing enhanced testing strategies such as combination antigen-antibody assays and/or NAT. Determination of HIV risk factors in donors (first time versus repeat donor status; volunteer versus replacement status; demographics and risk behaviors) will support policy discussions over strategies to recruit the safest possible donors in Brazil. The findings from this project will also complement similar monitoring of HIV prevalence, incidence, transfusion risk and molecular variants in the U.S. and other funded international REDS-II sites, thus allowing direct comparisons of these parameters on a global level. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 2,000; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.40 (including administration of the informed consent form and questionnaire completion instructions); and Estimated Total Annual Burden Hours Requested: 800. The annualized cost to respondents is estimated at: $5,200 (based on $6.50 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Proposed Matching Requirements for Specific SAMHSA Discretionary Grant Funding Opportunities
In fiscal year 2009, the Substance Abuse and Mental Health Services Administration (SAMHSA) plans to require matching funds for some discretionary grant funding opportunities within the Programs of Regional and National Significance as described in the President's Fiscal Year (FY) 2009 Budget Request. This notice describes the specific FY 2009 funding opportunities for which matching is proposed. We understand that some grantees could experience initial difficulty with the matching requirements. The goal of this solicitation is to seek comment so that we can design these activities to assist grantees in lessening these challenges over time.
Solicitation for Written Comments on the Development of Healthy People 2020
The Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science (OPHS), U.S. Department of Health and Human Services (HHS), is soliciting written comments on key elements of Healthy People 2020, including the vision, mission, overarching goals and framework. Every 10 years, through the Healthy People initiative, HHS leverages scientific insights and lessons from the past decade, along with the new knowledge of current data, trends, and innovations to develop the next iteration of national health promotion and disease prevention objectives. Healthy People provides science-based, 10-year national objectives for promoting health and preventing disease. Since 1979, Healthy People has set and monitored national health objectives to meet a broad range of health needs, encourage collaborations across sectors, guide individuals toward making informed health decisions, and measure the impact of our prevention and health promotion activities. Healthy People 2020 will reflect assessments of major risks to health and wellness, changing public health priorities, and emerging issues related to our nation's health preparedness and prevention. Background: The Healthy People process is inclusive: its strength is directly tied to collaboration. The development process strives to maximize transparency, public input and stakeholder dialogue to ensure that Healthy People 2020 is relevant to diverse public health needs and seizes opportunities to achieve its goals. Since its inception, Healthy People has become a broad-based, public engagement initiative with thousands of citizens helping to shape it at every step along the way. Drawing on the expertise of a Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 and public input, Healthy People will organize and establish a framework to address risk factors and determinants of health and the diseases and disorders that are affecting our communities. Public participation will shape Healthy People 2020, its purpose, goals, organization, and action plans. HHS has sought input from communities and stakeholders across the nation through six regional meetings and is soliciting written public comments on the development of Healthy People 2020 through an online public comment database. As a national initiative, Healthy People's success depends on a coordinated commitment to improve the health of the nation. Individuals may subscribe to the listserv at: http://www.healthypeople.gov/Contact for the latest information on Healthy People 2020 and to receive email notices of related Healthy People 2020. Healthy People 2020 will be released in two-phases. The vision, mission, overarching goals, and organizing framework will be released in late 2008-early 2009. A year later, in January 2010, the specific Healthy People 2020 objectives with baselines and targets will be released.
Food Labeling; Current Trends in the Use of Allergen Advisory Labeling: Its Use, Effectiveness, and Consumer Perception; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a public hearing on the use of advisory labeling of allergens in foods. FDA is developing a long-term strategy to assist manufacturers in using allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs food-allergic consumers and their caregivers. To that end, FDA is soliciting comments and information to assist the agency in determining how manufacturers currently use advisory labeling, how consumers interpret different advisory labeling statements, and what wording is likely to be most effective in communicating to consumers the likelihood that an allergen may be present in a food. The agency is also interested in receiving comments about whether consumers find advisory labeling helpful for making food purchasing decisions. This public hearing is the first step in closing existing knowledge gaps in developing our long-term strategy.
Temporary Assistance for Needy Families (TANF) Program, Elimination of Enhanced Caseload Reduction Credit for Excess Maintenance-of-Effort Expenditures
The Administration for Children and Families proposes to revise the TANF regulations to eliminate the provision that allows a State to receive additional caseload reduction credit for maintenance- of-effort (MOE) expenditures in excess of its required MOE spending. This provision is no longer necessary and not consistent with Congressional direction in the Deficit Reduction Act of 2005.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2009
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2009. It also discusses our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification (STRIVE) project. Finally, this final rule makes technical corrections in the regulations text with respect to Medicare bad debt payments to SNFs and the reference to the definition of urban and rural as applied to SNFs.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2009
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2009 (for discharges occurring on or after October 1, 2008 and on or before September 30, 2009) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are revising existing policies regarding the PPS within the authority granted under section 1886(j) of the Act.
Medicare Program; Hospice Wage Index for Fiscal Year 2009
This final rule sets forth the hospice wage index for fiscal year 2009. In addition, this final rule finalizes the policy to phase out the Medicare hospice budget neutrality adjustment factor, and clarifies two wage index issues pertaining to the definition of rural and urban areas and multi-campus hospital facilities.
Consideration of FDA-Regulated Products That May Contain Nanoscale Materials; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting and a request for comments including available data to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report (the Report) relating to the development of agency guidances. The Report's recommendations covered foods (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices. In addition to requesting comments in response to the questions in this notice and those that will be discussed at the public meeting, FDA is announcing a request for available data and information on the effects of nanoscale materials on quality, safety, and, where relevant, effectiveness of products subject to FDA oversight.
New Animal Drugs For Use in Animal Feeds; Oxytetracycline
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Phibro Animal Health. The supplemental NADA provides for use of oxytetracycline dihydrate in Type C medicated feeds for the control of mortality in freshwater-reared salmonids due to coldwater disease and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease.