Department of Health and Human Services June 5, 2014 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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.
Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements
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.
Privacy Act of 1974; Report of New System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new SOR titled, ``Open Payments,'' System No. 09-70-0507, to implement the requirements in Section 6002 of the Patient Protection and Affordable Care Act of 2010 (ACA) (Pub. L. 111- 148), which added section 1128G to the Social Security Act (the Act). The Open Payments program requires applicable manufacturers and applicable Group Purchasing Organizations (GPOs) to report payments and other transfers of value to covered physician recipients as defined by 42 CFR 403.902, as well as certain ownership or investment interests held by physicians and/or their immediate family members in such applicable manufacturers and/or applicable GPOs. CMS is required to publish the data submitted by applicable manufacturers or GPOs on a public Web site.
Discretionary Grant Program
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.
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