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

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Document Number: 2016-15029
Type: Notice
Date: 2016-06-24
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Document Number: 2016-15021
Type: Notice
Date: 2016-06-24
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 a 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: 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.
Document Number: 2016-15016
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on July 6-7, 2016. The subject of the meeting will be the ``Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies.'' The meeting is open to the public.
Document Number: 2016-15010
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2016-14981
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of Planning, Research and Evaluation (OPRE). This reorganization creates a new Division of Data and Improvement. It will transfer the state systems assessment function and the project management and oversight for Public Assistance Reporting Information System (PARIS) from the Office of Administration, Office of Financial Services, to the new Division of Data and Improvement.
Document Number: 2016-14980
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to the Preventing Sex Trafficking and Strengthening Families Act of 2014, Public Law 113-183, notice is hereby given of an opportunity to submit a Statement of Interest for the National Advisory Committee on Trafficking of Children and Youth in the United States (Committee). The purpose of the Committee is to advise the Secretary and the Attorney General on practical and general policies concerning improvements to the Nation's response to the sex trafficking of children and youth in the United States. The Committee will be composed of not more than 21 members whose diverse experience and background enable them to provide balanced points of view with regard to carrying out the duties of the Committee.
Document Number: 2016-14960
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
Document Number: 2016-14958
Type: Notice
Date: 2016-06-24
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 (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.
Document Number: 2016-14957
Type: Notice
Date: 2016-06-24
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 the ``Older Adult Safe Mobility Assessment Tool Impact Evaluation and Developing a Dissemination Plan'' extension for the previously approved information collection designed to evaluate whether the Mobility Planning Tool is effective for promoting readiness to adopt mobility-protective behaviors in older adults.
Document Number: 2016-14956
Type: Notice
Date: 2016-06-24
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 the proposed generic information collection entitled CDC Fellowship Programs Assessments. CDC is requesting Office of Management and Budget approval for a new generic clearance for data collection associated with quality improvement for the CDC fellowship programs that develop the current, emerging, and future public health workforce.
Document Number: 2016-14952
Type: Notice
Date: 2016-06-24
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 (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.
Document Number: 2016-14951
Type: Notice
Date: 2016-06-24
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 (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.
Document Number: 2016-14945
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2016-14923
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14922
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14921
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14920
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14919
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14918
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14917
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14916
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14915
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14914
Type: Notice
Date: 2016-06-24
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Document Number: 2016-14874
Type: Notice
Date: 2016-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) Account Management function. Participation will be needed from a small group of Filers, Importers of Record, and Consignees, who will use the new ITACS Account Management function and provide feedback to FDA. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email.
Document Number: 2016-14845
Type: Notice
Date: 2016-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled ``FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines'' supplements the ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation GuideData Elements and Message Specification'' final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.
Document Number: 2016-14827
Type: Notice
Date: 2016-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of June 16, 2016. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.
Document Number: 2016-14531
Type: Rule
Date: 2016-06-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which significantly revises the Medicare payment system for clinical diagnostic laboratory tests. This final rule also announces an implementation date of January 1, 2018 for the private payor rate-based fee schedule required by PAMA.
Document Number: 2016-14825
Type: Notice
Date: 2016-06-22
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 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 April 15, 2016, page 22289 and allowed 60 days for public comment. There were no comments received. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Document Number: 2016-14802
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, Office of the Secretary
Document Number: 2016-14788
Type: Notice
Date: 2016-06-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-14787
Type: Notice
Date: 2016-06-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-14778
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14777
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14740
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services
The National Institute of Mental Health (NIMH) seeks information about the availability of data and existing biological specimens (plasma and cerebrospinal fluid (CSF)) obtained from healthy controls and clinically well-characterized individuals with mental illnesses (bipolar disorder, major depressive disorder, post-traumatic stress disorder, schizophrenia). This information will be used to identify biobanks of existing samples that could potentially be sourced to assess the technical performance of a panel of inflammation-related proteins, and to identify gaps in the availability of samples for the mental illnesses listed above.
Document Number: 2016-14739
Type: Notice
Date: 2016-06-22
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 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, September 28, 2015, pages 58270-58271, and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of General Medical Sciences (NIGMS), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Document Number: 2016-14738
Type: Notice
Date: 2016-06-22
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 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 March 10, 2016, page 12744, 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Document Number: 2016-14727
Type: Notice
Date: 2016-06-22
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 Using the Standardized National Hypothesis Generating Questionnaire during Multistate Investigations of Foodborne Disease Clusters and Outbreaks.
Document Number: 2016-14726
Type: Notice
Date: 2016-06-22
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 the proposed information collection entitled ``Poison Center Collaborations for Public Health Emergencies.'' The goal for this new information collection is to create a timely generic clearance mechanism to allow a network of U.S. poison centers, in collaboration with CDC, to obtain critical exposure and health information during public health emergencies. CDC will collect follow-up information not captured during poison center callers' initial calls.
Document Number: 2016-14725
Type: Notice
Date: 2016-06-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-14724
Type: Notice
Date: 2016-06-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2016-14722
Type: Notice
Date: 2016-06-22
Agency: Food and Drug Administration, Department of Health and Human Services
This document withdraws a Food and Drug Administration (FDA) notice that published in the Federal Register of June 2, 2016 (81 FR 35367).
Document Number: 2016-14721
Type: Rule
Date: 2016-06-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.
Document Number: 2016-14711
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2016-14710
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2016-14693
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14692
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14691
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14690
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14689
Type: Notice
Date: 2016-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-14658
Type: Notice
Date: 2016-06-22
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 (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.
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