Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments
To assist the Food and Drug Administration (FDA or Agency) in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages.
Current Traumatic Brain Injury State Implementation Partnership Grantees; Non-Competitive One-Year Extension Funds
The Health Resources and Services Administration (HRSA) will issue funding for a non-competitive one-year extension for the State Implementation Partnerships (H21) awards to current grantees whose awards are scheduled to end in fiscal year (FY) 2013. Up to $250,000 per grantee will be awarded over a one-year extended project period. The HRSA TBI Program was initially authorized by the Traumatic Brain Injury Act of 1996 (Pub. L. 104-166) and was most recently reauthorized by the Traumatic Brain Injury Act of 2008 (Pub. L. 110- 206). Under this authority, the HRSA TBI Program is charged with improving access to rehabilitation and other services for individuals with traumatic brain injury and their families. The TBI State Implementation Partnership Grants support activities that complement existing state infrastructure to provide needed services following TBI. Through comprehensive and periodic needs and resources assessments, activities supported by grant funds are aligned with the highest priority areas as determined by providers, individuals with TBI and their families, advocates, and other stakeholders. Recipients of grant funds are expected to modify infrastructure in such a way that improvements in service delivery will be sustained beyond the grant period. As part of this charge, grantees must specifically have or develop the following four core components: (1) A Statewide Advisory Board consisting of members of the community, and representatives of other state agencies with an interest in TBI, such as State Departments of Health, Rehabilitation, Human Services, Education, Transportation, or Labor. This board should also have strong representation from individuals with TBI and/or family members; and also organizations that serve individuals with TBI; and other service providers, medical and non-medical; (2) A designated state agency that takes responsibility for carrying out activities of the grant; (3) A statewide needs and resources assessment; and (4) A comprehensive Statewide Action Plan for assisting individuals with TBI and their families to increase access to needed services and supports.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Program Report
The Administration for Community Living (ACL) 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 Title III and VII State Program Report.
Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by establishing a user fee for filovirus testing of all nonhuman primates that die during the HHS/CDC-required 31-day quarantine period for any reason other than trauma. We are amending the regulations to establish a filovirus testing service at HHS/CDC, because testing is no longer being offered by the only private, commercial laboratory that previously performed these tests. This testing service will be funded through user fees.