Department of Health and Human Services October 2015 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 354
Announcement of Requirements and Registration for the Open Science Prize
The National Institutes of Health (NIH) Office of the Associate Director for Data Science (ADDS) announces a collaboration with the Wellcome Trust (WT) and the Howard Hughes Medical Institute (HHMI) to launch the ``Open Science Prize'' (the ``Challenge'') to encourage and support the prototyping and development of services, tools and/or platforms that enable open contentincluding publications, datasets, code and other research outputsto be discovered, accessed and re-used in ways that will advance research, spark innovation, and generate new societal benefits. The Challenge is necessary to accelerate the field of ``open'' biomedical research beyond what current funding mechanisms can achieve. For the NIH, this Challenge is being launched under the America COMPETES Reauthorization Act of 2010.
Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill six vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
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 Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
The Food and Drug Administration (FDA or we) 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 procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
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 guidance on reagents for detection of specific novel influenza A viruses.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
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 information collection for administrative detention and banned medical devices.
Office of Women's Health General Update on Strategic Priorities and Initiatives
The Food and Drug Administration (FDA) is announcing the following meeting: Office of Women's Health General Update on Strategic Priorities and Initiatives. FDA staff will provide updates on strategic priorities, educational outreach, and research initiatives of interest to national organizations focused on the health of women.
Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #229 entitled ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle.'' The purpose of this document is to provide recommendations to industry relating to study design and describe criteria the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of new animal drugs that are intended to reduce pathogenic Shiga toxin- producing E. coli (STEC) in cattle.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reclassification Petitions for Medical Devices
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Reclassification Petitions for Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Office of Women's Health Update on Strategic Priorities and Initiatives for Nurses
The Food and Drug Administration (FDA) is announcing the following meeting: Office of Women's Health Update on Strategic Priorities and Initiatives. FDA staff will provide updates on strategic priorities, educational outreach, and research initiatives of interest to national organizations for nursing professionals and students.
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.
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.
Proposed Collection; 60-day Comment Request; Media-Smart Youth Leaders Program (NICHD)
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), will issue a funding announcement for the Media-Smart Youth Leaders Program 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: Whether the proposed collection of information is necessary for the proper selection of facilitators to serve as local health educators, using the Media-Smart Youth curriculum; the accuracy of the agency's estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and 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: Dr. Sarah Glavin, Acting Director, Office of Science Policy, Analysis, and Communications, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Dr., Bldg. 31, Rm. 2A28, Bethesda, MD 20892, or call non-toll-free number (301) 496-7898, or email your request, including your address to: glavins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Application for Consideration for the Media- Smart Youth Leaders Program (A Local Health Education Program and Leadership Opportunity): 0925New, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: Media-Smart Youth: Eat, Think, and Be Active![supreg] is an interactive program designed to teach youth ages 11-13 about how media can affect their health. Developed by the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the program includes 10 lessons on media analysis, nutrition, and physical activity, plus a final capstone project. The Media-Smart Youth[supreg] Leaders Program is designed for teens and adults, ages 15 years and up, who are interested in bringing the Media-Smart Youth program to their community. In return for recruiting youth participants, teaching the 10 lessons, and leading the final project, Media-Smart Youth Leaders will receive leadership experience, community service hours, and recognition from the NICHD. To help Leaders succeed, the NICHD will provide training, ongoing assistance, and a small funding amount for program expenses. The purpose of this information collection is to solicit information from applicants about their qualifications that would make them effective Leaders, their reason for wanting to pursue this opportunity, and the details of their proposed program (including, but not limited to, location, community partner(s), and proposed budget). This information will help NICHD staff select the candidates for the program who are most likely to succeed in implementing the full curriculum and teaching youth effective lessons about nutrition, physical activity, and media. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 800.
Proposed Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
The NIH seeks public comment on its proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to incorporate the recommendations of the Institute of Medicine (IOM) regarding human gene transfer clinical research protocols. The NIH proposes amendments to the following: (A) The criteria for selecting protocols for in-depth review and public discussion by the NIH Recombinant DNA Advisory Committee (RAC), (B) the process by which human gene transfer protocols are reviewed and registered with the NIH, and (C) the streamlining of the NIH protocol registration submission requirements under Appendix M-I-A of the NIH Guidelines.
Draft Recommendations for the Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Conference on Harmonisation; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for a new permitted daily exposure (PDE) for the residual solvent triethylamine and a revised PDE for the residual solvent methylisobutylketone, according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The draft recommendations were prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of the patient.
Availability of Draft Toxicological Profile; Set 27 Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of Set 27 Toxicological Profiles for review and comment. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3), (42 U.S.C. 9604(i)(3)), directs the ATSDR Administrator to prepare Toxicological Profiles of Priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile. Comments can include additional information or reports on studies about the health effects of Set 27 substances. Although ATSDR considered key studies for each of these substances during the profile development process, the Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology; Public Meeting
Under the auspices of the National Science and Technology Council, the Food and Drug Administration (FDA or the Agency), along with the Office of Science and Technology Policy (OSTP), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), is announcing a public meeting, to be held on October 30, 2015, to discuss the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' issued by the Executive Office of the President (EOP) in July 2015. The purpose of the meeting is to inform the public about the activities described in the July 2015 memorandum; invite oral comments from interested parties; and provide information about how to submit written comments, data, or other information to the docket.
2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications
This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or ``2015 Edition'') and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.
Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017
This final rule with comment period specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. In addition, it changes the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. This final rule with comment period also removes reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR Incentive Programs. In addition, this final rule with comment period establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. The final rule with comment period continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs.
Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry.'' The draft guidance provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early-phase clinical trials. MVGTs meet the regulatory definition of ``biological product'', when such products are applicable to the prevention, treatment, or cure of a disease or condition of human beings. The draft guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The draft guidance, when finalized, will supplement the guidance entitled, ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008 (April 2008 Guidance).
Submission for OMB Review; 30-Day Comment Request Population Assessment of Tobacco and Health (PATH) Study (NIDA)
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 June 30, 2015, pages 37276-37277 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 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.
Proposed Revised Vaccine Information Materials for Meningococcal ACWY and Serogroup B Meningococcal Vaccines
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for meningococcal ACWY and serogroup B meningococcal vaccines.
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 Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
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 Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0166, scheduled to expire on October 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``General Considerations for Animal Studies for Medical Devices.'' FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption (IDE) application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. This draft guidance is not final nor is it in effect at this time.
Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information; Amended Notice
This notice amends Federal Register notice 80 FR 60692, published October 7, 2015, requesting information on nominations to the Report on Carcinogens and Office of Health Assessment and Translation. The correct CASRN for vinylidene chloride is 75-35-4. All other information in the original notice has not changed. Information on nominations is available at https://ntp.niehs.nih.gov/go/rocnom and https://ntp.niehs.nih.gov/go/763346.
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