Department of Health and Human Services June 14, 2013 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Collection; Comment Request: Palliative Care: Conversations Matter Evaluation
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 Institute of Nursing Research (NINR), 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 on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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 obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0256, or Email your request, including your address to: adrienne.burroughs@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.
Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination; Availability
The FDA is announcing the availability of a guidance for industry entitled ``Codevelopment of Two or More New Investigational Drugs for Use in Combination.'' This guidance is intended to assist sponsors in the codevelopment of two or more investigational drugs that have not been previously developed for any indication (i.e., ``new investigational drugs'') to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during codevelopment of two or more new investigational drugs. It is not intended to apply to development of combinations of already approved drugs or to development of a single new investigational drug to be used in combination with an already approved drug or drugs. The guidance is not intended to apply to biological products regulated by the Center for Biologics Evaluation and Research or medical devices.
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices in order to maintain information confidentiality, integrity, and availability. This draft guidance is not final nor is it in effect at this time.
National Institute for Occupational Health (NIOSH)-Certified B Readers; Training and Testing
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC, is requesting information from stakeholders and the general public to identify and prioritize competencies currently needed by B Readers. The information obtained will be used in the development of the new digital B Reader program, including training and examinations.
Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document was initially issued in draft on November 10, 2011, and was developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. The guidance was also intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions. This guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to specify certain situations in which FDA cannot disapprove an IDE. This draft guidance is not final nor is it in effect at this time.
National Institute on Minority Health and Health Disparities Research Endowments
The National Institutes of Health (NIH) proposes to issue regulations governing National Institute on Minority Health and Health Disparities (NIMHD) endowment grants awarded to section 736 and section 464z-4 Centers of Excellence to facilitate minority health disparities research and other health disparities research.
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