Department of Health and Human Services April 2015 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 315
Government-Owned Inventions; Availability for Licensing
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. 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
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.
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 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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
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.
Medicaid and Children's Health Insurance Programs; Mental Health Parity and Addiction Equity Act of 2008; the Application of Mental Health Parity Requirements to Coverage Offered by Medicaid Managed Care Organizations, the Children's Health Insurance Program (CHIP), and Alternative Benefit Plans
This proposed rule would address application of certain requirements set forth in the Public Health Service Act, as amended by the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, to coverage offered by Medicaid managed care organizations, Medicaid Alternative Benefit Plans, and Children's Health Insurance Programs.
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: ``Assessing the Impact of the National Implementation of TeamSTEPPS Master Training Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Proposed Collection; 60-Day Comment Request: United States and Global Human Influenza Surveillance in at-Risk Settings
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Agency Forms Undergoing Paperwork Reduction Act Review; Withdrawal
Due to an information collection request oversight, the Centers for Disease Control and Prevention (CDC) requests immediate publication withdrawal of the 30-Day Federal Register Notice (FRN) entitled ``Agency Forms Undergoing Paperwork Reduction Act Review'' concerning the Public Health Associate Program (PHAP) Alumni Assessment.
Amendments to Registration of Food Facilities
The Food and Drug Administration (FDA or we) is proposing to amend its regulation for registration of food facilities that requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This proposed rule would amend and update FDA's registration regulations and is part of our implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. Moreover, a number of provisions in FSMA apply only to facilities required to register, including hazard analysis and risk-based preventive controls and mandatory recall authority. The proposed amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.
Solicitation of Written Comments on the Scientific Report of the 2015 Dietary Guidelines Advisory Committee; Extension of Comment Period
A notice was published in the Federal Register on Monday, February 23, 2015, Vol. 80, No. 35, pages 9465-9466 to announce the availability of the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (Advisory Report) and to solicit written comments on the Advisory Report (among other things). In the notice dated February 23, 2015, it was announced that the due date for providing comments was April 8, 2015. This notice is to announce the extension of the solicitation period to allow for additional time for written comments to be submitted for consideration.
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 information collection request for reinstatement with change of the collection previously approved under OMB control number 0920-1005``Conduct an Older Adult Mobility Assessment Tool Impact Evaluation and Develop a Dissemination Plan''. This collection will help evaluate whether the Mobility Planning Tool is effective for promoting readiness to adopt mobility-protective behaviors in older adults.
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 procedures to conduct interviews with Age Friendly Initiative, Senior Village, and local health department staff, as well as surveys of older adults.
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 Enhancing Mine Workers' Abilities to Identify Hazards at Sand, Stone, and Gravel (SSG) Mines. The objective of this project is to characterize SSG mine workers ability to recognize worksite hazards, to understand how this ability relates to perceived and measured risk as well as to other factors internal and external to the SSG mine worker.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations.
Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a fomepizole injectable solution used as an antidote for ethylene glycol poisoning in dogs. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.
Center for Devices and Radiological Health: Experiential Learning Program
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH or Center) is announcing the 2015 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to apply to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the ELP.
Proposed Collection; 60-Day Comment Request
In compliance with the requirement of Section 3506(c) (2) (A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, or Email your request, including your address to: glynnsa@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that CHOLBAM (cholic acid), manufactured by Asklepion Pharmaceuticals, LLC, meets the criteria for a priority review voucher.
Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Risk Evaluation and Mitigation Strategies: Modifications and Revisions.'' This guidance provides information on how FDA will define and process submissions for modifications and revisions to risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS. There are different procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA review and action of such changes. In addition, this guidance provides information on how REMS modifications and revisions should be submitted to FDA and how FDA intends to review and act on these submissions. The definitions of REMS modifications and revisions apply to all types of REMS.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that UNITUXIN (dinutuximab), manufactured by United Therapeutics Corporation, meets the criteria for a priority review voucher.
Proposed Collection; 60-day Comment Request: Identifying Experts in Prevention Science Methods To Include on NIH Review Panels (OD)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, regarding the opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH), Office of Disease Prevention (ODP) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Paris Watson, Senior Advisor, NIH Office of Disease Prevention, 6100 Executive Blvd., Room 2B03, Bethesda, MD 20892 or call (301) 496-1508 or email your request, including your address to prevention@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation
ACF and HRSA announce the renewal of the Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation to provide advice to the Secretary of Health and Human Services (``the Secretary'') on the design, plan, progress, and findings of the evaluation required under the Act.
Tribal Consultation Meetings
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of three 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
Privacy Act of 1974; Report of an Altered System of Records
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), the Health Resources and Services Administration (HRSA) is publishing notice of a proposed alteration of the system of records entitled and numbered ``Public Health and National Health Service Corps Scholarship Program (NHSC SP), National Health Service Corps Loan Repayment Program (NHSC LRP), Students to Service, (S2S), NHSC Student/Resident Experiences and Rotations in Community Health (SEARCH), NURSE Corps Loan Repayment Program (NURSE Corps LRP) formerly the Nursing Education Loan Repayment Program (NELRP), NURSE Corps Scholarship Program (NURSE Corps SP) formerly the Nursing Scholarship Program (NSP), Native Hawaiian Health Scholarship Program (NHHSP), and Faculty Loan Repayment Program (FLRP), Applicants and/or Participants Records System, HHS/HRSA/BHW,'' No. 09-15-0037. The proposed alterations affect the system name, system location, categories of records, purposes, routine uses, safeguards, records retention and disposal, system manager title and address, as well as minor editorial corrections and clarifications.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Ryousuke Fujita, Ph.D., Columbia University: Based on the report of an investigation conducted by Columbia University (CU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Ryousuke Fujita, former Postdoctoral Scientist, Taub Institute for the Aging Brain, Departments of Pathology and Cell Biology and Neurology, CU Medical Center, engaged in research misconduct in research supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS064433 and National Institute of Aging (NIA), NIH, grant R01 AG042317. ORI found that Respondent engaged in research misconduct by falsifying and fabricating data for specific protein expressions in human-induced neuronal (hiN) cells derived skin fibroblasts of Alzheimer's disease patients and unaffected individuals in seventy-four (74) panels included in figures in the following two (2) publications and one (1) unpublished manuscript: Cell 146:359-371, 2011 (hereafter referred to as ``Cell 2011''). Nature 500:45-53, 2013 (hereafter referred to as ``Nature 2013''). ``Human induced neuron models of APOE4-associated Alzheimer's disease display altered APP endocytosis and processing.'' Unpublished manuscript. ORI found that Respondent engaged in research misconduct by knowingly and intentionally fabricating and falsifying research in seventy-four (74) panels included in figures in Cell 2011, Nature 2013, and the unpublished manuscript. Respondent inflated sample numbers and data, fabricated numbers for data sets, manipulated enzyme-linked immunosorbent assay (ELISA) analysis, mislabelled immunoflourescent confocal images, and manipulated and reused Western blot images.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Teresita L. Briones, Ph.D., Wayne State University: Based on the report of an inquiry conducted by Wayne State University (WSU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Teresita L. Briones, former Associate Professor, College of Nursing, WSU, engaged in research misconduct in research supported by National Institute of Nursing Research (NINR), National Institutes of Health (NIH), grants P30 NR009014, R01 NR005260, and R01 NR007666. ORI found that Respondent intentionally, knowingly, and recklessly engaged in research misconduct by falsifying and/or fabricating data that were included in five (5) publications and three (3) grant applications submitted to NINR, NIH:
Submission for OMB Review; 30-Day Comment Request; Evaluation of the NHLBI Proteomics Centers Program: Qualitative Interviews (NHLBI)
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 1/27/2015 page 4,291 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 National Heart, Lung and Blood Institute (NHLBI), 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.
Meeting of the National Advisory Committee on Children and Disasters
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.
Submission for OMB Review; 30-day Comment Request; National Institute of Health Neurobiobank Tissue Access Request
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 February 13, 2014, page 8723 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 National Institute of Mental Health (NIMH), 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.
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