Department of Health and Human Services April 1, 2011 – Federal Register Recent Federal Regulation Documents

National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2011-7819
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-7818
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-7817
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2011-7816
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Council for the Elimination of Tuberculosis; Notice of Charter Renewal
Document Number: 2011-7754
Type: Notice
Date: 2011-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2011-7752
Type: Notice
Date: 2011-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)
Document Number: 2011-7749
Type: Notice
Date: 2011-04-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-7747
Type: Notice
Date: 2011-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-7746
Type: Notice
Date: 2011-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-7742
Type: Notice
Date: 2011-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Reopening of the Comment Period
Document Number: 2011-7708
Type: Notice
Date: 2011-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening until May 2, 2011, the comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published in the Federal Register of February 7, 2011 (76 FR 6623). In the notice, FDA requested public comment regarding the March 8 and 9, 2011, meeting of the panel to discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims. FDA is reopening the comment period to update comments and to receive any new information.
Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2011-7707
Type: Notice
Date: 2011-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Studies and Clinical TrialsImplementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain postmarketing studies and clinical trials for prescription drugs approved under the FD&C Act and biological products approved under the Public Health Service Act (the PHS Act). This guidance provides information on the implementation of the new provisions and a description of the types of postmarketing studies and clinical trials that will generally be required under the new legislation (postmarketing requirements (PMRs)) and the types that will generally be agreed-upon commitments (postmarketing commitments (PMCs)) because they do not meet the new statutory criteria for required postmarketing studies and clinical trials.
Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
Document Number: 2011-7673
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) hereby announces the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2011. The BPCA seeks to improve the level of informationin scientific publications and on the labelabout pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations and publish a list of drugs/needs in pediatric therapeutics. This notice fulfills the requirement to publish that list.
Proposed Information Collection Activity; Comment Request
Document Number: 2011-7667
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, Administration for Children and Families
Request for Public Comment on Proposed Funding Opportunity Announcement for Special Initiative Concerning the Assets for Independence Program
Document Number: 2011-7649
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, Administration for Children and Families
In FY 2011, the Office of Community Services (OCS) will coordinate with the Administration on Native Americans (ANA) to implement the Native Asset Building Initiative, through which the two offices will support Tribes and Native organizations in planning and implementing comprehensive asset-building projects. The initiative will feature special grants through the Assets for Independence (AFI) program. These grants will be in addition to the annual AFI grants that OCS will award in FY 2011. In contrast to the annual awards, though, the eligibility criteria to be listed for these AFI grants in the ``Native Asset Building Initiative'' will vary from the annual AFI awards' eligibility criteria. This is because the criteria used to determine eligibility for these special initiative awards will be more consistent with those used to determine eligibility in the ANA grant program with which OCS is coordinating. Consequently, the eligibility for the special AFI grants will be limited to Native 501(c)(3) non- profits serving Native Americans; Federally recognized Tribal governments or Alaska Native Villages, as defined in the Alaska Native Claims Settlement Act, that are joint applicants with a 501(c)(3) Native non-profit organization; and Native non-profit organizations designated by the Secretary of the Treasury as Community Development Financial Institutions and Native non-profit credit unions designated by the National Credit Union Administration as low-income credit unions that demonstrate a collaborative relationship with a local community based organization whose activities are designed to address poverty and the needs of community members for economic independence and stability. Other entities will not be eligible for awards under this initiative, but will continue to be eligible for awards under the annual AFI funding opportunity announcement that was published issued for FY 2011 through FY 2013 on February 24, 2011 on https://www.acf.hhs.gov/grants/ open/foa/view/HHS-2011-ACF-OCS-EI-0137. It is estimated that OCS will award up to 10 AFI program grants under Native Asset Building Initiative, with overall funding of approximately $2,500,000 toward the initiative. It is anticipated that each recipient of these special AFI grants will also receive a separate ANA award for their project. In addition to these special AFI awards, we estimate that $15,000,000 in grants will be awarded in FY 2011 under the annual AFI funding opportunity announcement published on February 24, 2011.
Announcement of Award
Document Number: 2011-7648
Type: Notice
Date: 2011-04-01
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source program expansion supplement grant to the Regents of the University of Michigan at Anne Arbor, MI, Quality Improvement Center on the Representation of Children in the Child Welfare System (QIC-ChildRep), to support additional and enhanced evaluation of the QIC-ChildRep research and demonstration projects. The Regents of the University of Michigan was awarded a cooperative agreement in FY 2009 as the result of a competition to establish the QIC-ChildRep. The purpose of the QIC-ChildRep is to improve the quality of legal representation for children and youth in child welfare cases so that States and Tribes achieve the best safety, permanency and well- being outcomes for children and youth. Under the cooperative agreement, the QIC-ChildRep develops knowledge about effective strategies to provide competent and effective representation for children and youth in child welfare cases, promotes the certification of lawyers as specialist is child welfare, develops and implements child representation research and demonstration projects to promote evidence- based, evidence-informed practice improvements and effective child representation, establishes and maintains a national information sharing network to disseminate information on promising practices; evaluates the impact of selected projects implementing the child representation models on outcomes for children and families who have competent and effective child representation, and identifies barriers and recommends need changes in laws, policies, procedures and/or practice. The supplemental funds will be used to provide additional training, technical assistance, and support to each research and demonstration site to fully implement and maintain rigorous on-site and cross-site evaluation plans.
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