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

Results 51 - 100 of 234
Medicare Program; Public Meetings in Calendar Year 2017 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
Document Number: 2017-03557
Type: Notice
Date: 2017-02-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2017 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. As indicated in this notice, we are reorganizing public meeting content under two main headings: Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents, and Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and ``Other''.
Medicare and Medicaid Programs: Application From the Center for Improvement in Healthcare Quality for Continued Approval of Its Hospital Accreditation Program
Document Number: 2017-03556
Type: Notice
Date: 2017-02-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2016
Document Number: 2017-03559
Type: Notice
Date: 2017-02-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03531
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2017-03530
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2017-03529
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03528
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Revision of a Currently Approved Information Collection (ICR-REV); Centers for Independent Living Annual Performance Report (CILPPR)
Document Number: 2017-03486
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information necessary to determining grantee compliance with Title VII of the Rehabilitation Act of 1973, As Amended by the Workforce Innovation and Opportunity Act of 2014. 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 of an existing collection of information, and to allow 60 days for public comment in response to the proposed action. This notice solicits comments on a proposed revision to an existing data collection related to the Centers for Independent Living Program Performance Report (CIL PPR, formerly the Section 704 Part II Report).
Agency Information Collection Activities; Proposed Collection; Comment Request; Data Collection Materials for the Evaluation of the Administration for Community Living's American Indian, Alaska Natives and Native Hawaiian Programs (OAA Title VI)
Document Number: 2017-03485
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information the agency proposes to collect related to an evaluation of the American Indian, Alaska Natives and Native Hawaiian Programs. 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 relating to the evaluation of the Title VI of the Older Americans Act.
Center for Substance Abuse Prevention: Notice of Meeting
Document Number: 2017-03480
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: 2017-03477
Type: Notice
Date: 2017-02-23
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-03453
Type: Notice
Date: 2017-02-23
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: 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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-03452
Type: Notice
Date: 2017-02-23
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 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03463
Type: Notice
Date: 2017-02-22
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) to review again proposed information collection project: Pharmacy Survey on Patient Safety Culture Comparative Database.'' This proposed information collection was previously published in the Federal Register on November 18, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-03451
Type: Notice
Date: 2017-02-22
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 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Cancer Institute; Amended Notice of Meeting
Document Number: 2017-03448
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03447
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-03446
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Delay of Effective Date
Document Number: 2017-03416
Type: Rule
Date: 2017-02-22
Agency: Department of Health and Human Services
On January 19, 2017, the Department of Health and Human Services published in the Federal Register a final rule to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by revising the Vaccine Injury Table (Table). That final rule is scheduled to take effect on February 21, 2017. This document announces that the effective date is delayed until March 21, 2017.
Request for Public Comment; 60 Day Proposed Information Collection: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment
Document Number: 2017-03407
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the new information collection Office of Management and Budget (OMB) Control Number 0917-NEW, titled, ``Mashpee Wampanoag Community Health Assessment.'' The purpose of this notice is to allow 60 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID [IHS-2017-0001]).
Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE)
Document Number: 2017-03402
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to 3D Medicines (``3DMed'') located in Shanghai, China.
National Institute on Drug Abuse; Amended Notice of Meeting
Document Number: 2017-03389
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-03388
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2017-03387
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2017-03386
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-03385
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2017-03384
Type: Notice
Date: 2017-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03370
Type: Notice
Date: 2017-02-21
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 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: Submission for OMB Review; Comment Request
Document Number: 2017-03369
Type: Notice
Date: 2017-02-21
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 (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.
Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments
Document Number: 2017-03365
Type: Notice
Date: 2017-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments related to the pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between September 17, 2016, and February 24, 2017, on the FDA Web site, but will not be presented at the March 6-7, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2017-03364
Type: Notice
Date: 2017-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration
Document Number: 2017-03342
Type: Notice
Date: 2017-02-21
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; Information Collection Request Title: Nurse Faculty Loan Program-Revised Program Specific Data Form, OMB No. 0915-0378-Revision
Document Number: 2017-03339
Type: Notice
Date: 2017-02-21
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.
World Trade Center Health Program; Petition 014-Autoimmune Diseases; Finding of Insufficient Evidence
Document Number: 2017-03336
Type: Proposed Rule
Date: 2017-02-21
Agency: Department of Health and Human Services
On September 29, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition to add autoimmune diseases, including rheumatoid arthritis, to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 014 is not substantially different from Petitions 007, 008, 009, 011, and 013, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator has published responses to the five previous petitions in the Federal Register and has determined that Petition 014 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including rheumatoid arthritis. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The National Health Service Corps and NURSE Corps Interest Capture Form
Document Number: 2017-03335
Type: Notice
Date: 2017-02-21
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; Nurse Faculty Loan Program, Annual Performance Report Financial Data Form
Document Number: 2017-03316
Type: Notice
Date: 2017-02-21
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.
Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
Document Number: 2017-03311
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services
This notice announces the next two meeting dates for the Physician-Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') which will be held in Washington, DC. All meetings will be open to the public.
Q11 Development and Manufacture of Drug Substances-Questions and Answers (Regarding the Selection and Justification of Starting Materials); International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2017-03309
Type: Notice
Date: 2017-02-21
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 entitled ``Q11 Development and Manufacture of Drug SubstancesQuestions and Answers (regarding the selection and justification of starting materials).'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ``Q11 Development and Manufacture of Drug Substances''. The draft guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The question-and-answer (Q&A) draft guidance focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and/or Master Files to justify the starting materials.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-03306
Type: Notice
Date: 2017-02-21
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.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-03282
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03281
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2017-03280
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2017-03278
Type: Notice
Date: 2017-02-21
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: 2017-03277
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03276
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-03275
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2017-03274
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective Date
Document Number: 2017-03347
Type: Rule
Date: 2017-02-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review'', this action delays for 60 days from the date of the memorandum the effective date of the rule entitled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model'' published in the January 3, 2017 Federal Register (82 FR 180). That rule implements three new Medicare Parts A and B episode payment models and a Cardiac Rehabilitation (CR) Incentive Payment model, and implements changes to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act (the Act). Under the three new episode payment models, acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. Under the CR Incentive Payment model, acute care hospitals in certain selected geographic areas will receive retrospective incentive payments for beneficiary utilization of cardiac rehabilitation/intensive cardiac rehabilitation services during the 90 days following discharge from a hospitalization treatment of an acute myocardial infarction or coronary artery bypass graft surgery. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.
Meeting of the Advisory Committee on Minority Health
Document Number: 2017-03247
Type: Notice
Date: 2017-02-17
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email OMH-ACMH@hhs.gov.