Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed new information collection request entitled ``Mining Industry Surveillance System''.

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.

The Food and Drug Administration (FDA) is announcing the termination of the Medical Device ISO Voluntary Audit Report Pilot Program. This program allowed the submission of ISO audit reports performed by third parties, along with audit reports from the preceding 2 years, to determine if the owner or operator of the medical device establishment could be removed from FDA's routine inspection work plan for 1 year. FDA is also announcing its participation in the operational phase of the Medical Device Single Audit Program (MDSAP), which will allow third parties recognized by the MDSAP consortium to submit audit reports that FDA will utilize for routine inspections.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Safety Assessment for IND Safety Reporting.'' The draft guidance provides recommendations to sponsors on developing a systematic approach to investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND. This draft guidance is a follow-on to the guidance for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/ BE Studies'' that provides recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators, including a recommendation that sponsors develop a safety assessment committee.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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 Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), including the Intramural Research and Training Award (IRTA) and Superfund Research Program (SRP) within NIEHS, National Institute of General Medical Science (NIGMS), and National Cancer Institute (NCI), 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: Dr. Rachel Sturke, Evaluation Officer, Division of Science Policy, Planning, and Evaluation, FIC, NIH, 16 Center Drive, Bethesda, MD 20892 or call non-toll-free number (301)-480-6025 or Email your request, including your address to: rachel.sturke@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: CareerTrac, 0925-0568, Expiration Date: 02/29/ 2016REVISION, Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), National Institute of General Medical Science (NIGMS), National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This data collection system is being developed to track, evaluate and report short and long-term outputs, outcomes and impacts of trainees involved in health research training programsspecifically tracking this for at least ten years following training by having Principal Investigators enter data after trainees have completed the program. The data collection system provides a streamlined, web-based application permitting principal investigators to record career achievement progress by trainee on a voluntary basis. FIC, NLM, NIEHS, NCI and NIGMS management will use this data to monitor, evaluate and adjust grants to ensure desired outcomes are achieved, comply with OMB Part requirements, respond to congressional inquiries, and as a guide to inform future strategic and management decisions regarding the grant program. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 8,714.

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 Clinical Center, 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. To Submit Comments and for Further Information: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance 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 request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Robert M. Lembo, MD, Office of Clinical Research Training and Medical Education, NIH Clinical Center, National Institutes of Health, 10 Center Drive, Room 1N252C, Bethesda, MD 20892- 1158, or call non-toll-free number (301) 496-2636, or Email your request, including your address to: robert.lembo@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research, Revision OMB#0925-0602 Expiration Date: 3/31/16, Clinical Center (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The information collected will allow continued assessment of the value of the training provided by the Office of Clinical Research Training and Medical Education (OCRTME) at the NIH Clinical Center and the extent to which this training promotes (a) patient safety; (b) research productivity and independence; and (c) future career development within clinical, translational, and academic research settings. The information received from respondents is presented to, evaluated by, and incorporated into the ongoing operational improvement efforts of the Director of the Office of Clinical Research Training and Education, and the Clinical Center Director. This information will enable the ongoing operational improvement efforts of the OCRTME and its commitment to providing clinical research training and medical education of the highest quality to each trainee. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours: 320.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This draft guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.'' The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA's process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness.

The Food and Drug Administration (FDA) has determined the regulatory review period for VIZAMYL 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.

The Food and Drug Administration (FDA) has determined the regulatory review period for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM 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 medical device.

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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.