Seeking Public Comment on Two Draft Chapters of the National Health Security Strategy Biennial Implementation Plan
To help the Nation achieve national health security and to implement the first quadrennial National Health Security Strategy (NHSS) of the United States of America (2009) and build upon the NHSS Interim Implementation Guide for the National Health Security Strategy of the United States of America (2009) the U.S. Government has drafted a NHSS Biennial Implementation Plan (BIP). This document is intended to describe the priority activities to occur during fiscal years 2011 and 2012 of implementation so that all sectors and segments of the Nation are working collectively and leveraging resources to achieve the same outcomes. The activities include responsible entities. The target audience for the BIP is the Nation (individuals, families, communities including all sectors and governments, states and the Federal Government). Two chapters (and respective appendices) of the draft BIP document which address (1) Strategic Objective 4, Foster Integrated, Scalable Health Care Delivery Systems; and (2) Strategic Objective 6, Promote and Effective Countermeasures Enterprise are submitted for public consideration and comment for a period of 14 calendar days at https:// www.phe.gov/nhss. These chapters are the final two to be provided for public consideration and comment; others were available in July 2010. The Office of the Assistant Secretary of Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) is submitting this document for public consideration as the lead agency in a broad interagency process to draft the implementation plan.
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent for Emergency Research; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research.'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in the development, conduct, and oversight of research involving FDA-regulated products (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed consent requirements is requested under the Code of Federal Regulations (CFR). FDA determined that guidance is needed in interpreting and complying with these regulations, particularly in the areas of planning and conducting community consultation and public disclosure activities, and the establishment of informed consent procedures to be used when feasible. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2006.
Marilyn A. Mehlmauer: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Marilyn Mehlmauer, MD for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Mehlmauer was convicted of a misdemeanor under Federal Law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Mehlmauer was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Mehlmauer failed to respond. Dr. Mehlmauer's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Maja S. Ruetschi: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Maja S. Ruetschi, MD for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Ruetschi was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Ruetschi was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Ruetschi failed to respond. Dr. Ruetschi's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Reopening of the Comment Period
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
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
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.
Request for Public Comment on Proposed Funding Opportunity Announcement for Special Initiative Concerning the Assets for Independence Program
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
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.