Department of Health and Human Services March 10, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Proposed Collection; 60-Day Comment Request: NEXT Generation Health Study
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 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 and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Denise L. Haynie, Ph.D., MPH, Staff Scientist, Division of Population Intramural Research, 6100 Executive Blvd. Rm. 7B13, Bethesda, MD 20892, or call non-toll-free number (301)-435-6933 or Email your request, including your address to: Denise_Haynie@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: 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: NEXT Generation Health Study, 0925-0610, Expiration Date 04/30/2016, EXTENSION, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: The goal of this research is to obtain data on health and health behaviors annually for seven years beginning in the 2009-2010 school-year from a national probability sample of adolescents. The transition from high school to post high school years is a critical period for changes in health risk behaviors. This information will enable the improvement of health services and programs for youth. The study will provide needed information about the health of U.S. adolescents and young adults and influences on their health. The study has collected information on adolescent health behaviors and social and environmental contexts for these behaviors annually for six years beginning in the 2009-2010 school year. This study will collect this information in 2016, the last planned data collection. Self-report of health status, health behaviors, and health attitudes will be collected by online surveys. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1385.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; OPSUMIT
The Food and Drug Administration (FDA) has determined the regulatory review period for OPSUMIT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Center for Devices and Radiological Health: Experiential Learning Program
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2016 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to request to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the ELP.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records
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.
Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
The Food and Drug Administration (FDA or Agency) is proposing to classify posterior cervical screw systems into class II (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a prescription device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term ``posterior cervical screw systems'' is used to distinguish these devices from currently classified pedicle screw spinal systems cleared for use in other spinal regions.
Agency Information Collection Activities; Comment Request; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
The Food and Drug Administration (FDA) 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 solicits comments on the information collection associated with the guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible.
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