Department of Health and Human Services September 5, 2013 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

ASPR requires collaboration with local health departments and officials to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems. This project aims to improve collaboration between ASPR and the local health departments (LHDs) to enhance national health security, foster community health resilience, and strengthen health care, public health, and emergency management systems. One of the overarching goals of both the National Health Security Strategy (2009) and the ASPR Strategic Plan 2011-2015 is to build community health resilience. ASPR seeks to partner with LHDs and health officials which play a critical role in building community health resilience by employing and evaluating localized public health strategies, such as preparing local communities to withstand and recover from public health emergencies and disasters, and engaging local health departments and health care organizations to build healthcare coalitions. The project will foster better approaches for building community health resilience. LHDs and health officials are intimately familiar with the communities and populations that they serve and are an essential partner in carrying out the mission of ASPR. ASPR seeks to engage LHDs and health officials as well as other appropriate local stakeholders in bi-directional communications to evaluate the effectiveness of, and ensure that, ASPR's strategies, policies, and programmatic activities are informed by and support the needs of local communities. The project will foster collaboration with local health officials to achieve, for example, national health security and strengthen local emergency preparedness, response, and recovery systems and capabilities, and build well-functioning healthcare coalitions, among other activities. ASPR seeks to partner with LHDs and local communities which frequently prepare for, respond to, and recover from localized emergency incidents and to identify valuable lessons and promising practices to collect and share these practices with other LHDs and communities. This project will capture lessons learned and promising practices from local communities and share them more widely. Justification: The National Association of County and City Health Officials (NACCHO) is the national nonprofit organization representing all local and tribal health officials from across the country. Members are elected by their peers, and include ex officio members representing the National Association of Counties, of which NACCHO is an affiliate, and the U.S. Conference of Mayors. NACCHO advocates on the behalf of county and city health departments by providing Congressional testimony, submitting letters to the Administration, and endorsing proposed legislation. NACCHO has demonstrated experience establishing partnerships with both traditional and non-traditional organizations to impact both county and city public health departments and the broader public health system. NACCHO's existing network of health officials will provide ASPR with the unique ability to collaborate on federal programs and actions that could impact the preparation for, response to or recovery from emergencies and disasters impacting public health and health care. Additional Information: The agency program contact is Lisa Kaplowitz, who can be contacted by phone at (202) 202-2882 or via email at Lisa.Kaplowitz@hhs.gov.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled ``Tobacco Retailer Training Programs.'' The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) does not require retailers to implement retailer training programs. However, the Tobacco Control Act does provide for lower civil money penalties for violations of sale and distribution, including youth access, advertising, and promotion restrictions issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed by FDA for such programs. FDA intends to issue regulations establishing standards for approved retailer training programs. In the interim, this guidance document is intended to assist tobacco retailers who wish to implement training programs for employees.