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

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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.

The Food and Drug Administration (FDA or we) 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 invites comments on reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.

The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

HRSA will be issuing a 1-year non-competitive continuation budget period beyond the planned 3-year project period for the Autism Intervention Research Network on Behavioral Health (AIR-B Network) and the Autism Intervention Research Network on Physical Health (AIR-P Network) programs. Approximately $1,500,000 in funding will be made available in the form of a cooperative agreement to the University of California Los Angeles (UCLA), Cooperative Agreement Number UA3MC11055, during the budget period of September 1, 2014, through August 31, 2015. Approximately $3,000,000 in funding will be made available in the form of a cooperative agreement to the Massachusetts General Hospital (MGH), Cooperative Agreement Number UA3MC11054, during the budget period of September 1, 2014, through August 31, 2015. The AIR-B Network (UA3MC 11055) and the AIR-P Network (UA3MC11054) programs, CFDA No. 93.110, are authorized by the Public Health Service Act, Sec. 399BB(f) (42 U.S.C. 280i-1(f)), as amended by the Combating Autism Reauthorization Act of 2011 (Pub. L. 112-32), which is scheduled to sunset on September 30, 2014. The AIR-B Network is an interdisciplinary, multi-site network of researchers working together with communities to provide national leadership in research to improve the behavioral, mental, social, and/ or cognitive health and wellbeing of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities. The AIR-B Network conducts protocol-based research to advance effective intervention strategies aimed at improving social and behavioral health and well-being among underserved children and adolescents with ASD, in both home and school settings; provides a research environment that is supportive of the professional development of emerging researchers interested in autism intervention research; disseminates critical information on its research findings to inform researchers, care providers, policymakers, other stakeholders in the field, and the public, including families with children and adolescents with ASD; and promotes the translation of network findings into practice settings and communities that will result in improved care. The AIR-P Network is an interdisciplinary, multi-site research network of clinicians and researchers that provides national leadership in research to improve the physical health and well-being of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities. The AIR-P Network conducts protocol-based research to advance effective treatment strategies; develops and updates evidence-based guidelines and validates tools for interventions; provides a research environment that supports the professional development of emerging researchers interested in autism intervention research; disseminates critical information on its research findings to inform researchers, care providers, policymakers, other stakeholders in the field, and the public, including families with children and adolescents with ASD; and promotes the translation of findings into practice settings and communities that will result in improved care.

HRSA will be issuing non-competitive awards under the F2F HIC program. Approximately $5 million will be made available in the form of a grant to current grantees (see below) covering the period of 6/1/ 2014-5/31/2015. This will provide for an extension of the program, as provided for in Section 1203 of the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) and Section 207 of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93) with the least disruption to the states, communities, and constituencies that currently receive assistance and services from these grantees.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, AHRQ has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA).