Department of Health and Human Services August 18, 2011 – Federal Register Recent Federal Regulation Documents

Meeting of the National Biodefense Science Board
Document Number: 2011-21163
Type: Notice
Date: 2011-08-18
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2011-21155
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2011-21150
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2011-21146
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended Notice of Meeting
Document Number: 2011-21137
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-21135
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health Notice of Meeting
Document Number: 2011-21134
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health Notice of Meeting
Document Number: 2011-21133
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2011-21131
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2011-21130
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2011-21128
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting
Document Number: 2011-21126
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2011-21107
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2011-21092
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
Direct Discovery of HLA Associated Influenza Epitopes Isolated From Human Cells for Vaccine and Therapeutic Evaluation and Development (U01)
Document Number: 2011-21043
Type: Notice
Date: 2011-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a sole source cooperative agreement with the University of Oklahoma Health Sciences Center. The goal of the FDA, Center for Drug Evaluation and Research, Office of Chief Scientist, is to develop technology to molecularly characterize peptide epitopes that are processed and presented on soluble HLA (human leucocyte antigen) expressed by human cells. Initial studies will examine and characterize influenza peptides isolated from several different soluble Class I HLAs produced from influenza infected human lung cell lines. There is a growing interest in developing universal vaccines for influenza by targeting conserved internal proteins to stimulate cross-protective CTLs (cytolytic T lymphocyte) to provide long-lasting immunity. It is therefore critically important to identify which viral epitopes are generated by antigen processing in influenza infected lung cells, the target cells of cell mediated immune response to respiratory viruses. FDA seeks a collaboration to develop this technology for this purpose which can then be applied to identifying and characterizing other HLA-presented epitopes in viral infections, cancer, and immune toxicities.
Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials
Document Number: 2011-21042
Type: Notice
Date: 2011-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Document Number: 2011-21041
Type: Notice
Date: 2011-08-18
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations
Document Number: 2011-21040
Type: Notice
Date: 2011-08-18
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications
Document Number: 2011-21039
Type: Notice
Date: 2011-08-18
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.
Supplemental Awards to Seven Unaccompanied Alien Shelter Care Providers
Document Number: 2011-21032
Type: Notice
Date: 2011-08-18
Agency: Department of Health and Human Services, Office of Refugee Resettlement
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of single-source expansion supplement grants to seven unaccompanied alien shelter care providers for a total of $5,016,218. The additional funding provided by the awards will support services to refugees through September 30, 2011. These grants will support the expansion of bed capacity to meet the number of unaccompanied alien children referrals from the Department of Homeland Security (DHS). The funding program is mandated by Section 462 of the Homeland Security Act to ensure appropriate placement of all referrals from the DHS. ORR's ability to meet this mandate is often a challenge since the program is completely tied to DHS apprehension strategies and the sporadic number of border crossers. The program has specific requirements for the provision of services. Existing grantees are the only entities with the infrastructure, licensing, experience and appropriate level of trained staff to meet the service requirements and the urgent need for expansion. The program's ability to avoid a backlog of children waiting in border patrol stations for placement can only be accommodated through the expansion of existing programs through this supplemental award process. The single-source expansion supplement recipients are:
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2012 Rates; Hospitals' FTE Resident Caps for Graduate Medical Education Payment
Document Number: 2011-19719
Type: Rule
Date: 2011-08-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. We are updating the payment policy and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implementing certain statutory changes made by the Affordable Care Act. In addition, we are finalizing an interim final rule with comment period that implements section 203 of the Medicare and Medicaid Extenders Act of 2010 relating to the treatment of teaching hospitals that are members of the same Medicare graduate medical education affiliated groups for the purpose of determining possible full-time equivalent (FTE) resident cap reductions.
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