Department of Health and Human Services May 2017 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 277
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 (CJR); Delay of Effective Date
This final rule finalizes May 20, 2017 as the effective date of the final rule titled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)'' originally published in the January 3, 2017 Federal Register. This final rule also finalizes a delay of the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to January 1, 2018 and delays the effective date of the specific CJR regulations listed in the DATES section from July 1, 2017 to January 1, 2018.
Agency Information Collection Activities: Proposed Collection; Comment Request
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
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.
Medicare and Medicaid Programs: Application From the Joint Commission for Continued CMS-Approval of Its Critical Access Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.
Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research Training and Medical Education at the NIH Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center)
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 March 9, 2017, 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.
Government-Owned Inventions; Availability for Licensing
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.
Prospective Grant of an Exclusive Patent License: Manufacturing and Testing of PVSRIPO in the Treatment of Solid, Non-lymphoid Tumors Expressing Poliovirus Receptor CD155
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 Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Istari Oncology Incorporated located in North Carolina, U.S.A.
Prospective Grant of Exclusive Patent License: The Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers
The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to AbPro, located in Woburn, Massachusetts, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Prospective Grant of Exclusive Patent License: Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines
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 U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to PathoVax, LLC located in Baltimore, MD.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 titled ``Who's at Risk: From Hazards to CommunitiesAn Approach for Operationalizing CDC Guidelines to Determine Risks, and Define, Locate and Reach At-Risk Populations in Public Health Emergencies.'' The data collection will include invitations to subject matter experts for public health and medical emergency planning. The data collection efforts will include a focus group format and also investigate at-risk population needs through an anonymous survey.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Common Formats for Reporting on Health Care Quality and Patient Safety
As authorized by the Secretary of HHS, AHRQ coordinates the development of sets of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the release of the Common Formats for Event ReportingHospital Version 2.0.
Supplemental Evidence and Data Request on Noninvasive, Nonpharmacological Treatment for Chronic Pain
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 Noninvasive, Nonpharmacological Treatment for Chronic Pain, 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``TeamSTEPPS 2.0 Online Master Trainer Course.''
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``The AHRQ Safety Program for Enhancing Surgical Care and Recovery.''
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Part F Dental Services Report, OMB No. 0915-0151-Extension
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: Assessing Client Factors Associated With Detectable HIV Viral Loads and Models of Care and the Ryan White HIV/AIDS Program
In compliance with the requirement for opportunity for public comment on proposed data collection projects 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: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation-New
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.
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments; Extension of Comment Period
In the Federal Register of January 9, 2017, the Food and Drug Administration (FDA or the Agency) issued a final rule entitled ``Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' '' (Final Rule). On March 20, 2017, FDA published a document in the Federal Register (Final Rule Extension) to delay the effective date of the Final Rule until March 19, 2018, and requested comments on particular issues raised in a petition for reconsideration and stay of action of the Final Rule. The petition for reconsideration raised questions about the amendments to the regulations regarding ``intended uses'' that are set forth in the Final Rule. In the Final Rule Extension FDA also requested comments regarding any aspect of the Final Rule, or with respect to issues relating to ``intended uses'' generally, and on whether the delay in the effective date should be modified or revoked. FDA is now issuing this document to extend the comment period. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site. The guidances identified in this notice were developed using the process described in that guidance.
Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by May 30, 2017. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the Web site for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH Web site under the heading About OMH.
Solicitation of Public Comments on the Draft Federal Pain Research Strategy
The Federal Pain Research Strategy is an effort of the Interagency Pain Research Coordinating Committee (IPRCC) and the NINDS Office of Pain Policy to oversee development of a long-term strategic plan for pain research. A diverse and balanced group of scientific experts, patient advocates, and federal representatives identified and prioritized research recommendations as a basis for a long-term strategic plan to coordinate and advance the federal research agenda. The key areas of prevention of acute and chronic pain, acute pain and acute pain management, the transition from acute to chronic pain, chronic pain and chronic pain management, and disparities in pain and pain care will provide a framework for development of the strategy upon which important cross-cutting elements will be addressed. Meeting Location: William H. Natcher Conference Center, Auditorium, National Institutes of Health, Bethesda, MD 20892. Webcast Live: https://videocast.nih.gov/. Contact Person: Linda L. Porter, Ph.D., Director, Office of Pain Policy, Officer of the Director, National Institute of Neurological Disorders and Stroke, NIH, 31 Center Drive, Room 8A31, Bethesda, MD 20892, Phone: (301) 451-4460, Email: Linda.Porter@nih.gov. The meeting is open to the public and is free. More information can be found at https://iprcc.nih.gov/. Individuals who participate in person or by videocast and who need special assistance, such as captioning of the call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least seven days prior to the meeting. Information about the IPRCC and the Federal Pain Research Strategy is available on the Web site at https://iprcc.nih.gov/.
Request for Comments on National Institute of Dental and Craniofacial Research's 2030 Strategic Visioning Initiative
The National Institute of Dental and Craniofacial Research (NIDCR) is pleased to launch NIDCR 2030, a strategic visioning initiative designed to advance dental, oral, and craniofacial research over the next 15 years. The purpose of this Request for Comments (RFC) is to seek input on how best to ensure that dental, oral, and craniofacial health and disease are understood in the context of the whole body, and that research transforms how we promote health, treat disease, and overcome health disparities. Visit the NIDCR 2030 Web site to submit your research ideas and vote and comment on the ideas of others: https:// nidcr2030.ideascale.com/. We'll use your ideas and comments to plan future workshops and identify themes for potential funding opportunities.
Request for Comments on Food and Drug Administration Accreditation Scheme for Conformity Assessment Pilot Program
The Food and Drug Administration (FDA or the Agency), Center for Devices and Radiological Health (CDRH), is establishing a public docket to request comments related to the FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The purpose is to gain insight regarding the development and overall design/approach of the ASCA pilot program including program goals, pilot standards, design concepts, and overall program approach. The Agency is interested in gathering additional information to increase the efficiency of the ASCA Program.
Government-Owned Invention; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government.
Government-Owned Invention; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
