Department of Health and Human Services October 2016 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 301
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-25819
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-25818
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25817
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25816
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25815
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Final FY 2014 and Preliminary FY 2016 Disproportionate Share Hospital Allotments, and Final FY 2014 and Preliminary FY 2016 Institutions for Mental Diseases Disproportionate Share Hospital Limits
Document Number: 2016-25813
Type: Notice
Date: 2016-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2014 and the preliminary federal share DSH allotments for FY 2016, and corresponding limitations on aggregate state DSH payments to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
Medicare Program; Listening Session Regarding the Implementation of Certain Medicare Part D Provisions in the Comprehensive Addiction and Recovery Act of 2016 (CARA)
Document Number: 2016-25806
Type: Proposed Rule
Date: 2016-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces a listening session to solicit input from stakeholders regarding our implementation of section 704 of the Comprehensive Addiction and Recovery Act of 2016 (CARA), which includes provisions to permit Part D sponsors to establish drug management programs for at-risk beneficiaries under which Part D sponsors may limit such beneficiaries' access to frequently abused drugs to certain prescribers and pharmacies. Medicare beneficiaries with Part A or Part B, advocacy groups representing Medicare beneficiaries, physicians, pharmacists, and other clinicians (particularly other lawful prescribers of controlled substances), retail pharmacies, plan sponsors, entities delegated by plan sponsors (such as pharmacy benefit managers), biopharmaceutical manufacturers, and other interested parties are invited to participate. The Listening Session will be held via teleconference and is open to the public.
Guidelines Stating Principles for Working With Federally Recognized Indian Tribes
Document Number: 2016-25794
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF), is issuing guidelines stating principles for working with federally recognized Indian tribes.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
Document Number: 2016-25793
Type: Notice
Date: 2016-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2016-25788
Type: Notice
Date: 2016-10-26
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 ``Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/ or arousal in women. Specifically, this guidance addresses FDA's current thinking regarding the overall clinical development program, with a focus on phase 3 trial designs, to support an indication for the treatment of these conditions.
Submission for OMB Review; Comment Request
Document Number: 2016-25787
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-25671
Type: Notice
Date: 2016-10-24
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 information collection project entitled ``Assessment of Targeted Training and Technical Assistance (TTA) Efforts on the Implementation of Comprehensive Cancer Control''. CDC is requesting to collect information about TTA offered under two different cooperative agreements using case studies, a web-based survey, and in-depth interviews in order to document how TTA was provided and identify elements of TTA administered across both cooperative agreements that could inform the development of a viable TTA model for enhancing future tobacco and cancer prevention and control efforts.
Program for Parallel Review of Medical Devices
Document Number: 2016-25659
Type: Notice
Date: 2016-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Food and Drug Administration
The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) (the Agencies) are informing the public that the Parallel Review of medical devices pilot program will be fully implemented and extended indefinitely. The Agencies are soliciting nominations from manufacturers of innovative medical devices to participate in the ``Program for Parallel Review of Medical Devices.'' The Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA's granting of a de novo request and Medicare coverage decisions through CMS's National Coverage Determination (NCD) process. This program is intended to ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2016-25650
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Evaluation of the Maternal and Child Health Bureau's Autism CARES Act Initiative
Document Number: 2016-25618
Type: Notice
Date: 2016-10-24
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 pursuant to 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Document Number: 2016-25606
Type: Notice
Date: 2016-10-24
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 (the PRA).
Generic Drug User Fees; Notice of Public Meeting; Request for Comments; Extension of Comment Period; Correction
Document Number: 2016-25603
Type: Notice
Date: 2016-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the extension of the comment period and correcting a notice that appeared in the Federal Register of Monday, September 26, 2016 (81 FR 66035). The document announced a public meeting entitled ``Generic Drug User Fees; Public Meeting; Request for Comments.'' In that Federal Register notice, FDA requested comments on the draft recommendations related to the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The Agency is taking this action to allow interested persons the statutorily required 30 days to submit comments. Also, the document was published with an error in the SUPPLEMENTARY INFORMATION section. This document corrects that error.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
Document Number: 2016-25602
Type: Rule
Date: 2016-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the Eustachian tube balloon dilation system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-25601
Type: Notice
Date: 2016-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2016-25588
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25587
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25586
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-25579
Type: Notice
Date: 2016-10-24
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 effort 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 revision to the ``World Trade Center Health Program Enrollment, Treatment, Appeals & Reimbursement'' information collection approved under OMB Control Number 0920-0891, which allows the collection of information from Program members and affiliated medical providers for the purpose of determining eligibility and providing treatment services in accordance with the James Zadroga 9/11 Health and Compensation Act of 2010.
Specifications for Medical Examinations of Coal Miners
Document Number: 2016-24405
Type: Rule
Date: 2016-10-24
Agency: Department of Health and Human Services
With this action, the Department of Health and Human Services (HHS), in accordance with recent rulemaking by the Department of Labor's Mine Safety and Health Administration (MSHA), finalizes amendments to Coal Workers' Health Surveillance Program regulations to establish standards for the approval of facilities to conduct spirometry and requires that all coal mine operators submit a plan for the provision of spirometry testing and X-ray examinations to all surface and underground coal miners.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-25547
Type: Notice
Date: 2016-10-21
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.
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
Document Number: 2016-25522
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee.
Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee
Document Number: 2016-25497
Type: Notice
Date: 2016-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee (the Committee), Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Announcement of the Award of 38 Single-Source Low-Cost Extension Supplement Grants Under the Refugee School Impact Grant Program
Document Number: 2016-25496
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR announces the award of 38 single-source low-cost extension supplement grants for a total of 2,500,000 under the Refugee School Impact Grant Program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet
Document Number: 2016-25482
Type: Notice
Date: 2016-10-21
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements of the Animal Drug User Fee cover sheet.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
Document Number: 2016-25481
Type: Notice
Date: 2016-10-21
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 (the PRA).
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-25474
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2016-25473
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2016-25472
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2016-25471
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-25470
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25469
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Availability of License; Mutant IHD1 Inhibitors Useful for Treating Cancer
Document Number: 2016-25468
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, National Institutes of Health
The invention Mutant IHD1 Inhibitors Useful for Treating Cancer is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S.
Notice of Interest Rate on Overdue Debts
Document Number: 2016-25459
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services, Office of the Secretary
Meeting Announcement for the Technical Advisory Panel on Medicare Trustee Reports
Document Number: 2016-25458
Type: Notice
Date: 2016-10-21
Agency: Department of Health and Human Services
This notice announces the meeting dates for the Technical Advisory Panel on Medicare Trustee Reports on Monday, October 31, 2016 and Tuesday, November 1, 2016 in Washington, DC.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)
Document Number: 2016-25453
Type: Notice
Date: 2016-10-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Comments on the Proposed Measures and 2020 Targets for the National Action Plan for Adverse Drug Event Prevention: Inpatient and Outpatient Measures for Reduction of Adverse Drug Events From Anticoagulants, Diabetes Agents, and Opioid Analgesics
Document Number: 2016-25424
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services
The Office of Disease Prevention and Health Promotion (ODPHP), on behalf of the U.S. Department of Health and Human Services (HHS) Federal Interagency Steering Committee for Adverse Drug Events, proposes new measures and targets for adverse drug events (ADEs) from anticoagulants, diabetes agents, and opioid analgesics for the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based on input from the Federal Interagency Workgroups for Adverse Drug Events, six national measures and targets for the reduction of ADEs are being proposed. Each drug class highlighted in the ADE Action Plan (anticoagulants, diabetes agents, and opioid analgesics) includes a proposed inpatient and outpatient measure to track national progress in reduction of ADEs from these drug classes. The proposed targets will reflect improvement efforts over a four to six year period since the release of the ADE Action Plan in August 2014. As such, HHS is proposing a baseline year of 2014 for five of the measures and 2016 for one measure. All targets are to be achieved by 2020. HHS invites interested public and private professionals, organizations, and consumer representatives to submit written comments on the proposed 2020 ADE targets, found at https://health.gov/hcq/ade-measures.asp.
Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions
Document Number: 2016-25418
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Process Evaluation of the Long Term Care Ombudsman Program
Document Number: 2016-25416
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services
The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the continuation of collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Evaluation of the Elderly Nutritional Services Program
Document Number: 2016-25414
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services
The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the continuation of collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pre-Submission Program for Medical Devices
Document Number: 2016-25359
Type: Notice
Date: 2016-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Government-Owned Invention; Availability for Licensing
Document Number: 2016-25343
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is 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.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-25342
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2016-25341
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-25340
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-25339
Type: Notice
Date: 2016-10-20
Agency: Department of Health and Human Services, National Institutes of Health