Department of Health and Human Services March 28, 2016 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in cosponsorship with the Critical Path Institute (C-Path), is announcing a public scientific workshop to discuss the impact of safety biomarkers on drug development. The purpose of the workshop is to discuss the following issues: Application of toxicometrics as a translational safety strategy that integrates nonclinical and clinical safety approaches; uses of rodent and non- rodent nonclinical species in biomarker qualification; and assay validation aspects during biomarker development and qualification.

The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.

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 Cancer Institute, 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: 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; 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; The quality, utility, and clarity of the information to be collected; and 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*: Michele M. Doody, Radiation Epidemiology Branch, National Cancer Institute, 9609 Medical Center Drive, Room 7E566, Rockville, MD 20850, or call non-toll-free at 301-414-0308. Or Email your request, including your address to: doodym@mail.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: US Nuclear Medicine Technologists Study, 0925- 0656, Expiration Date 04/30/2015REINSTATEMENT WITH CHANGE, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: We propose to collect, from U.S. nuclear medicine technologists (USNMT) certified after 1980, historical information about nuclear medicine procedures performed, radioisotopes used, related work and safety practices, and places of employment. The primary objectives of the current feasibility effort are: (a) To identify a cohort of nuclear medicine technologists certified after 1980 by the American Registry of Radiologic Technologists (ARRT) and/or the Nuclear Medicine Technologist Certification Board (NMTCB); and (b) to characterize individual organ- specific occupational radiation doses from radioisotope procedures. More recently certified technologists, who specialized in nuclear medicine, are expected to have greater exposures to radioisotopes than the general radiologic technologists in the U.S. Radiologic Technologist (USRT) cohort owing to performing such procedures with greater frequency. The proposed USNMT study would be a direct follow-on to the USRT Study to assess health risks associated with occupational exposure to these much higher-energy radiopharmaceuticals. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 125.