Department of Health and Human Services March 2017 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice
Document Number: 2017-06398
Type: Notice
Date: 2017-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Notice To Propose the Re-Designation of the Service Delivery Area for the Tolowa Dee-ni' Nation (Smith River Rancheria)
Document Number: 2017-06383
Type: Notice
Date: 2017-03-31
Agency: Department of Health and Human Services, Indian Health Service
This notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Service Delivery Area for the Tolowa Dee-ni' Nation (Tribe) previously known as the Smith River Rancheria of Smith River, California. The Tolowa Dee- ni's Tribal Headquarters is located three miles south of the California-Oregon border in Northern California. The entire State of California, excluding the counties of Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura, are designated a Purchased/Referred Care (PRC) Service Delivery Area, formerly referred to as a Contract Health Service Delivery Area, by statute. The current Service Delivery Area for the Tolowa Dee-ni' Nation Tribal members is the statutorily established California PRC Service Delivery Area. The expanded PRC Service Delivery Area for the Tolowa Dee-ni' Nation includes the statutorily established California PRC Service Delivery Area and Curry County in the State of Oregon.
Roadmap for Engaging With the Food and Drug Administration's Center for Drug Evaluation and Research; Public Workshop
Document Number: 2017-06370
Type: Notice
Date: 2017-03-31
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), is announcing the following public workshop entitled ``Roadmap for Engaging with FDA's Center for Drug Evaluation and Research (CDER).'' The purpose of this workshop is to help the public learn how to successfully engage with CDER.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-06331
Type: Notice
Date: 2017-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2017-06330
Type: Notice
Date: 2017-03-31
Agency: Department of Health and Human Services
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-06329
Type: Notice
Date: 2017-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2017-06250
Type: Notice
Date: 2017-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2017-06249
Type: Notice
Date: 2017-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-06248
Type: Notice
Date: 2017-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Supplemental Evidence and Data Request on Physiologic Predictors of the Need for Trauma Center Care: A Systematic Review
Document Number: 2017-06232
Type: Notice
Date: 2017-03-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Physiologic Predictors of the Need for Trauma Center Care: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Requirements To Submit Prior Notice of Imported Food; Technical Amendments
Document Number: 2017-06201
Type: Rule
Date: 2017-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the prior notice of imported food regulations to reflect a change in the electronic data interchange system and its expanded capabilities, to correct inaccurate number designations in section headings, and to reflect a change in an office's name. This action is ministerial or editorial in nature.
Request for Information for the Development of the Fiscal Year 2019 Trans-NIH Plan for HIV-Related Research
Document Number: 2017-06183
Type: Notice
Date: 2017-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), National Institutes of Health (NIH), invites feedback from investigators in academia, industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, community, and other interested constituents on the development of the fiscal year (FY) 2019 Trans-NIH Plan for HIV-Related Research (FY 2019 AIDS Research Plan). This plan is designed to identify and articulate future directions to maximize the NIH's investments in HIV/AIDS research.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-06168
Type: Notice
Date: 2017-03-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-06149
Type: Notice
Date: 2017-03-29
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2017-06148
Type: Notice
Date: 2017-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-06147
Type: Notice
Date: 2017-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 30-Day Public Comment Request, Grants.gov
Document Number: 2017-06142
Type: Notice
Date: 2017-03-29
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-06129
Type: Notice
Date: 2017-03-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; 30-Day Comment Request; Early Career Reviewer Program Application and Vetting System (EAVS) (Center for Scientific Review)
Document Number: 2017-06116
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 December 29, 2016, page 96020 (Vol. 81, No. 250) 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
Document Number: 2017-06078
Type: Notice
Date: 2017-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study on Warning Statements for Cigarette Graphic Health Warnings that is being conducted in support of the graphic label statement provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
National Library of Medicine; Notice of Meeting
Document Number: 2017-06045
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2017-06044
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2017-06043
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2017-06042
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2017-06041
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-06040
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-06039
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Closed Meeting
Document Number: 2017-06038
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License for Commercialization: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation
Document Number: 2017-06036
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in:
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2017-06033
Type: Notice
Date: 2017-03-28
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the next federal advisory committee meeting regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will advise the Secretary on the Healthy People 2030 mission, vision, framework, and organizational structure. The Committee will provide advice regarding criteria for identifying a more focused set of measurable, nationally representative objectives. The Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-06013
Type: Notice
Date: 2017-03-27
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Reconciliation Tool for the Teaching Health Center Graduate Medical Education Program
Document Number: 2017-05960
Type: Notice
Date: 2017-03-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast
Document Number: 2017-05952
Type: Notice
Date: 2017-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The HHS/CDC's Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, Agriculture Select Agent Services (AgSAS) are jointly charged with the regulation of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the webcast is to provide guidance and information related to the Federal Select Agent Program for interested individuals.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Information Collection Request Title: Ryan White HIV/AIDS Program: Allocation and Expenditure Forms, OMB No. 0915-0318-Revision
Document Number: 2017-05948
Type: Notice
Date: 2017-03-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Application and Other Forms Used by the National Health Service Corps (NHSC) Scholarship Program (SP), the NHSC Students To Service Loan Repayment Program (S2S LRP), and the Native Hawaiian Health Scholarship Program (NHHSP), OMB No. 0915-0146-Extension
Document Number: 2017-05946
Type: Notice
Date: 2017-03-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0915-0323-Extension
Document Number: 2017-05944
Type: Notice
Date: 2017-03-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-05933
Type: Notice
Date: 2017-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 information collection project titled ``Knowledge, Attitudes, and Practices related to a Domestic Readiness Initiative on Zika Virus Disease.'' This project consists of telephone interviews with participants in Puerto Rico and the domestic U.S.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-05932
Type: Notice
Date: 2017-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2017-05910
Type: Notice
Date: 2017-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-05909
Type: Notice
Date: 2017-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Effect of Stockpiling Conditions on the Performance of Medical N95 Respirators and High-Level Protective Surgical Gowns
Document Number: 2017-05896
Type: Notice
Date: 2017-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announces the request for information about facilities that stockpile N95 respirators and high-level protective surgical gowns.
Supplemental Evidence and Data Request on Telehealth for Acute and Chronic Care Consultations
Document Number: 2017-05840
Type: Notice
Date: 2017-03-24
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public to inform our review on Telehealth for Acute and Chronic Care Consultations, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to the Public Health Service Act.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-05839
Type: Notice
Date: 2017-03-24
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Generic Clearance for the Collection of Data Through ACTION III Field-Based Investigations to Improve Health Care Delivery.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 20, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments during this period. The purpose of this notice is to allow an additional 30 days for public comment.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-05838
Type: Notice
Date: 2017-03-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-05837
Type: Notice
Date: 2017-03-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Proposed Extension With Modifications of a Currently Approved Collection; National Survey of Older Americans Act Participants; Correction
Document Number: 2017-05827
Type: Notice
Date: 2017-03-24
Agency: Department of Health and Human Services
The Administration for Community Living published a proposed collection of information document in the Federal Register on March 13, 2017. (82 FR 13457 and 13458) The document title and summary incorrectly stated that no changes were proposed to the currently approved collection.
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Draft Guidance for Industry; Availability
Document Number: 2017-05818
Type: Notice
Date: 2017-03-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation.
Center for Devices and Radiological Health: Experiential Learning Program
Document Number: 2017-05763
Type: Notice
Date: 2017-03-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2017 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH's employees, or to contact CDRH for more information regarding the ELP.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-05752
Type: Notice
Date: 2017-03-23
Agency: Department of Health and Human Services