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

Statement of Organization, Functions and Delegations of Authority
Document Number: 2016-06971
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
American Indians Into Nursing; Nursing Program
Document Number: 2016-06969
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, Indian Health Service
Submission for OMB Review; 30-Day Comment Request; Investigating Factors That Influence Career Choice Among Neuroscience Trainees (NINDS)
Document Number: 2016-06961
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on Tuesday, January 12, 2016 on pages 1436-1437 and allowed 60-days for public comment. (No public comments were received.) The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-06922
Type: Notice
Date: 2016-03-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Submission for OMB Review; Comment Request
Document Number: 2016-06915
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, Administration for Children and Families
Seventh Annual Predictive Safety Testing Consortium/Food and Drug Administration Scientific Workshop; Public Workshop
Document Number: 2016-06889
Type: Notice
Date: 2016-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Diagnosis of Zika Virus Infection; Availability
Document Number: 2016-06888
Type: Notice
Date: 2016-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for diagnosis of Zika virus infection in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the HHS Secretary declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment
Document Number: 2016-06886
Type: Rule
Date: 2016-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-06885
Type: Notice
Date: 2016-03-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-06884
Type: Notice
Date: 2016-03-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2016-06882
Type: Notice
Date: 2016-03-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
National Institute of Mental Health; Notice of Meeting
Document Number: 2016-06873
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-06872
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-06871
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2016-06870
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-06869
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-06868
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; U.S. Nuclear Medicine Technologists Study (NCI)
Document Number: 2016-06867
Type: Notice
Date: 2016-03-28
Agency: Department of Health and Human Services, National Institutes of Health
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.