Department of Health and Human Services June 6, 2014 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To submit comments in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact Elizabeth M. Ginexi, Ph.D., Tobacco Control Research Branch, Behavioral Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Room 3E564 MSC 9761, Bethesda, Maryland 20892- 9761 or call non-toll-free number 240-276-6765 or Email your request, including your address to: LGinexi@mail.nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: State and Community Tobacco Control Research Initiative Evaluation (SCTC), 0925, NEW submission, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute State and Community Tobacco Control Research Initiative is a program within the Tobacco Control Research Branch in the Behavioral Research Program of the Division of Cancer Control and Population Sciences. The program targets 4 high-priority tobacco control research areas at the state and community level in the United States: (1) Secondhand smoke policies, (2) Tobacco tax and pricing policies, (3) Mass media countermeasures and community and social norms, and (4) Tobacco industry practices. The initiative supports innovative research to yield rapid and actionable findings for state and community tobacco control programs. The purpose of the evaluation is to assess the dissemination, implementation, and community collaboration processes of the grantees and their respective state and community partners and stakeholders. The evaluation will utilize archival grant project data and archival data collected from the scientists in the first two years of the initiative. The evaluation also will collect new data to: (1) Determine relationships, interactions, and connectedness among different network partnerships over time and with policy makers; (2) assess the utility of research tools, interventions, products, and findings from the perspective of key tobacco control stakeholders; and (3) determine key indicators for broad adoption of research products. Results will address research-to-practice gaps by providing a critical window into the process of disseminating evidence-based research tools, products, and science findings in community public health settings. Intended audiences include staff at NIH Institutes and Centers interested in supporting translation/dissemination and implementation science. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 112.

The Food and Drug Administration (FDA) is confirming the effective date of June 18, 2014, for the direct final rule that appeared in the Federal Register of February 3, 2014. The direct final rule revises the regulations to update the table to adjust the preceding maximum civil penalty amounts for inflation as prescribed by the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). The direct final rule also revises the regulations to amend the process for initiating certain civil money penalty (CMP) administrative actions. This document confirms the effective date of the direct final rule.

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. 209 and 37 CFR Part 404 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.