Department of Health and Human Services March 13, 2009 – Federal Register Recent Federal Regulation Documents
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Public Consultation on Personnel Reliability Issues
The National Science Advisory Board for Biosecurity (NSABB), an advisory committee of the Federal Government, is hosting a public consultation to engage the scientific community and general public in a discussion of personnel reliability, with a focus on optimal characteristics of individuals with access to Select Agents. This public consultation is an opportunity for members of the scientific community and general public to provide input on these important issues.
Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, 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 of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 30, 2008, page 79889- 79890 and allowed 60-days for public comment. One comment was received and appropriate response was made. 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: Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: REVISION: OMB No. 0925-0414, Expiration date: 05/31/2009. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals and physicians. Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is as follows:
Request for Public Comment Concerning Requirements for Transferring Children From the Placement and Care Responsibility of a State Title IV-E Agency to a Tribal Title IV-E Agency and Tribal Share of Title IV-E Administration and Training Expenditures
Effective October 1, 2009, Public Law 110-351 provides Indian Tribes with the option to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Social Security Act (the Act). The Federal government would share in the costs of Tribes operating an ACF-approved title IV-E program. Public Law 110-351 requires that ACF develop interim final rules after consulting with Tribes and affected States on the implementation of the Tribal plan requirements in section 479B of the Act and other amendments made by the Tribal provisions in section 301 of Public Law 110-351. The law requires that such regulations include: (1) Procedures to ensure that a transfer of State responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E or title XIX Medicaid and such services or payments; and, (2) the in-kind expenditures from third- party sources permitted for the Tribal share of administration and training expenditures under title IV-E. This notice is designed to provide a written opportunity for comment to all interested persons, and specifically the affected States and to notify Tribal leaders of in-person opportunities to consult with the Children's Bureau on the development of these regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting
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.
Memorandum of Understanding With Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute for the FDA-ANH Nanotechnology Initiative
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with The Alliance for NanoHealth (ANH), a collaboration among: Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute. This MOU identifies the terms of collaboration between FDA and ANH in the area of nanotechnology. Specifically, this MOU establishes the FDA-ANH Nanotechnology Initiative (FANTI), a public- private partnership dedicated to the identification of scientific and translational gaps in moving nanoengineered medical products from the preclinical stages of development through clinical stages and then to commercialization, all with immediate benefit to public health. The activities are aligned with the mutual interests and respective missions of the Parties, including the FDA's Critical Path Initiative which seeks to modernize the product development and regulatory sciences needed to reduce uncertainties about product performance throughout the product life cycle. Thus, a key goal for the Parties is to improve the safety and efficacy of nanoengineered products and speed their delivery to the patients who need them and the consumers who use them.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-May 6, 2009
This notice announces that a public meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, May 6, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. The Committee may also review and evaluate medical literature and make recommendations concerning items and services that may be eligible for Medicare coverage. This meeting will focus on the requirements for evidence to determine if the use of screening genetic testing of beneficiaries without signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
State Median Income Estimate for a Four-Person Family: Notice of the Federal Fiscal Year (FFY) 2010 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) (Catalog of Federal Domestic Assistance Number 93.568) Administered by the U.S. Department of Health and Human Services (HHS), Administration for Children and Families, Office of Community Services, Division of Energy Assistance
This notice announces to LIHEAP grantees the estimated median income of four-person families in each State and the District of Columbia for FFY 2010 (October 1, 2009, to September 30, 2010). LIHEAP grantees that choose to base their income eligibility criteria on these State median income estimates may adopt these estimates (up to 60 percent) on the estimates' date of publication in the Federal Register or on a later date as discussed below. This enables these grantees to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2009, or the beginning of the grantees' fiscal years, whichever is later, these grantees must adjust their income eligibility criteria so that such criteria are in accord with the FFY 2010 State median income estimates. This listing of 60 percent of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.
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