human-research-subjects

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TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
Protection of Human SubjectsRule2017-1973709/18/2017CONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionOn January 19, 2017, the Federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the Common Rule) published a final rule amending the Common Rule. The Consumer Produc … On January 19, 2017, the Federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the Common Rule) published a final rule amending the Common Rule. The Consumer Product Safety Commission (CPSC or Commission) adopts the Common Rule.protection-of-human-subjectsFR-Doc-2017-19737
Open Licensing Requirement for Competitive Grant ProgramsRule2017-0572303/21/2017DEPARTMENT OF EDUCATIONEducation DepartmentIn accordance with a directive from the memorandum entitled ``Regulatory Freeze Pending Review,'' published in the Federal Register on January 24, 2017 (Memorandum), the Secretary further delays until May 22, 2017, the effectiv … In accordance with a directive from the memorandum entitled ``Regulatory Freeze Pending Review,'' published in the Federal Register on January 24, 2017 (Memorandum), the Secretary further delays until May 22, 2017, the effective date of the final regulations entitled Open Licensing Requirement for Competitive Grant Programs (Open Licensing), published in the Federal Register on January 19, 2017 (82 FR 7376). The current effective date is March 21, 2017. The additional delay will allow the Department the opportunity for further review of the final regulations.open-licensing-requirement-for-competitive-grant-programsFR-Doc-2017-05723
Elementary and Secondary Education Act of 1965, as Amended by the Every Student Succeeds Act-Accountability and State Plans; Open Licensing Requirement for Competitive Grant Programs; Family Educational Rights and Privacy ActRule2017-0205601/30/2017DEPARTMENT OF EDUCATIONEducation DepartmentIn accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' published in the Federal Register on January 24, 2017, the Department delays … In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' published in the Federal Register on January 24, 2017, the Department delays the effective dates of the following regulations until March 21, 2017: Elementary and Secondary Education Act of 1965, as Amended by the Every Student Succeeds Act-- Accountability and State Plans (ESSA Accountability and State Plans), RIN 1810-AB27; Open Licensing Requirement for Competitive Grant Programs (Open Licensing), RIN 1894-AA07; and Family Educational Rights and Privacy Act.elementary-and-secondary-education-act-of-1965-as-amended-by-the-every-student-succeedsFR-Doc-2017-02056
Federal Policy for the Protection of Human SubjectsRule2017-0105801/19/2017DEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentThe departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. … The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.federal-policy-for-the-protection-of-human-subjectsFR-Doc-2017-01058
Open Licensing Requirement for Competitive Grant ProgramsRule2017-0091001/19/2017DEPARTMENT OF EDUCATIONEducation DepartmentThe Secretary amends the regulations of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in order to require, subject to certain categorical exceptions and case-by-case exceptio … The Secretary amends the regulations of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in order to require, subject to certain categorical exceptions and case-by-case exceptions, that Department grantees awarded competitive grant funds openly license to the public copyrightable grant deliverables created with Department grant funds.open-licensing-requirement-for-competitive-grant-programsFR-Doc-2017-00910
National Policy Requirements: General Award Terms and ConditionsProposed Rule2016-2570011/07/2016DEPARTMENT OF DEFENSEDefense DepartmentThis notice of proposed rulemaking (NPRM) is the fourth of a sequence of six NPRM documents in this issue of the Federal Register. This NPRM proposes to add a new Department of Defense Grant and Agreement Regulations (DoDGARs) … This notice of proposed rulemaking (NPRM) is the fourth of a sequence of six NPRM documents in this issue of the Federal Register. This NPRM proposes to add a new Department of Defense Grant and Agreement Regulations (DoDGARs) part to establish a consistent way for DoD Components to organize the portion of their general terms and conditions covering national policy requirements in areas such as nondiscrimination, environmental protection, and live organisms. The new part also provides standard wording of terms and conditions for national policy requirements that apply generally to DoD programs and awards.national-policy-requirements-general-award-terms-and-conditionsFR-Doc-2016-25700
Clinical Trials Registration and Results Information SubmissionRule2016-2212909/21/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThis final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device produc … This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.clinical-trials-registration-and-results-information-submissionFR-Doc-2016-22129
Administrative Actions for Noncompliance; Lesser Administrative ActionsRule2016-0752304/04/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clar … The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.administrative-actions-for-noncompliance-lesser-administrative-actionsFR-Doc-2016-07523
Federal Agency Final Regulations Implementing Executive Order 13559: Fundamental Principles and Policymaking Criteria for Partnerships With Faith-Based and Other Neighborhood OrganizationsRule2016-0733904/04/2016DEPARTMENT OF EDUCATIONEducation DepartmentThe Agencies publishing this final rule amend or establish their regulations to implement Executive Order 13279, as amended by Executive Order 13559. Executive Order 13279 established fundamental principles to guide the policies … The Agencies publishing this final rule amend or establish their regulations to implement Executive Order 13279, as amended by Executive Order 13559. Executive Order 13279 established fundamental principles to guide the policies of Federal agencies regarding the participation of faith-based and other community organizations in programs that the Federal agencies administer. Executive Order 13559 amended Executive Order 13279 to clarify those principles and add certain protections for beneficiaries of Federal social service programs.federal-agency-final-regulations-implementing-executive-order-13559-fundamental-principles-andFR-Doc-2016-07339
Administrative Actions for Noncompliance; Lesser Administrative ActionsProposed Rule2016-0752404/04/2016DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We … The Food and Drug Administration (FDA) is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions, until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.administrative-actions-for-noncompliance-lesser-administrative-actionsFR-Doc-2016-07524
Open Licensing Requirement for Direct Grant ProgramsProposed Rule2015-2793011/03/2015DEPARTMENT OF EDUCATIONEducation DepartmentThe Secretary proposes to amend the regulations regarding the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in order to require that all Department grantees awarded direct competitive … The Secretary proposes to amend the regulations regarding the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in order to require that all Department grantees awarded direct competitive grant funds openly license to the public all copyrightable intellectual property created with Department grant funds. These proposed changes would increase the Department's ability to be more strategic with limited resources, broadening the impact of its investments by allowing stakeholders, such as local educational agencies (LEAs), State educational agencies (SEAs), institutions of higher education (IHEs), and other entities, to benefit from these investments, even if they are not themselves recipients of Department funds. An open licensing requirement would also allow the Department to sustain innovations beyond the grant period by encouraging subject matter experts and users to adapt, update, and build upon grant products, stimulating quality and innovation in the development of educational resources. Finally, the proposed requirement would promote equity and access to Department-funded technology and materials and increase transparency and accountability for the Department and its grantees.open-licensing-requirement-for-direct-grant-programsFR-Doc-2015-27930
Adoption of Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; States and Tribal Mitigation Planning Regulations ChangeRule2015-2458410/02/2015DEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentOn December 19, 2014, all Federal award-making agencies, including the Department of Homeland Security (DHS) and its component, the Federal Emergency Management Agency (FEMA), published a joint interim final rule implementing the Offic … On December 19, 2014, all Federal award-making agencies, including the Department of Homeland Security (DHS) and its component, the Federal Emergency Management Agency (FEMA), published a joint interim final rule implementing the Office of Management and Budget (OMB)'s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. DHS and FEMA now adopt, with one change, the interim final rule as final. The change restores language in the FEMA State and Tribal mitigation planning regulations that was inadvertently removed by the interim final rule.adoption-of-uniform-administrative-requirements-cost-principles-and-audit-requirements-for-federalFR-Doc-2015-24584
Federal Policy for the Protection of Human SubjectsProposed Rule2015-2483110/01/2015DEPARTMENT OF HOUSING AND URBAN DEVELOPMENTHousing and Urban Development DepartmentOn September 8, 2015, 16 Federal departments and agencies published a proposed rule pertaining to Federal Policy for the Protection of Human Subjects. Due to certain statutory prepublication requirements applicable to HUD rules, HUD … On September 8, 2015, 16 Federal departments and agencies published a proposed rule pertaining to Federal Policy for the Protection of Human Subjects. Due to certain statutory prepublication requirements applicable to HUD rules, HUD was unable to be a signatory to the September 8, 2015, proposed rule. Through this HUD proposed rule, HUD adopts the September 8, 2015, proposal and solicits public comment on the proposal.federal-policy-for-the-protection-of-human-subjectsFR-Doc-2015-24831
Protection of Human SubjectsProposed Rule2015-2424709/24/2015CONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionOn September 8, 2015, the federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the ``Common Rule'') published a notice of proposed rulemaking (``NPR'') amendi … On September 8, 2015, the federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the ``Common Rule'') published a notice of proposed rulemaking (``NPR'') amending the Common Rule. Through this proposed rule, the Consumer Product Safety Commission (``CPSC'' or ``Commission'') proposes to adopt the Common Rule NPR and solicits public comment on the proposal.protection-of-human-subjectsFR-Doc-2015-24247
Federal Policy for the Protection of Human SubjectsProposed Rule2015-2175609/08/2015DEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentThe departments and agencies listed in this document propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NP … The departments and agencies listed in this document propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. The participating departments and agencies propose these revisions to the human subjects regulations because they believe these changes would strengthen protections for research subjects while facilitating important research.federal-policy-for-the-protection-of-human-subjectsFR-Doc-2015-21756
Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal AwardsRule2014-2869712/19/2014EXECUTIVE OFFICE OF THE PRESIDENTExecutive Office of the PresidentThis joint interim final rule implements for all Federal award-making agencies the final guidance Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) published by the Offic … This joint interim final rule implements for all Federal award-making agencies the final guidance Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) published by the Office of Management and Budget (OMB) on December 26, 2013. This rule is necessary in order to incorporate into regulation and thus bring into effect the Uniform Guidance as required by OMB. Implementation of this guidance will reduce administrative burden and risk of waste, fraud, and abuse for the approximately $600 billion per year awarded in Federal financial assistance. The result will be more Federal dollars reprogrammed to support the mission, new entities able to compete and win awards, and ultimately a stronger framework to provide key services to American citizens and support the basic research that underpins the United States economy.federal-awarding-agency-regulatory-implementation-of-office-of-management-and-budgets-uniformFR-Doc-2014-28697
Clinical Trials Registration and Results SubmissionProposed Rule2014-2619711/21/2014DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThis Notice of Proposed Rulemaking proposes requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devic … This Notice of Proposed Rulemaking proposes requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM). This proposed rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials. The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drugs (including biological products) and devices that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device that are ordered by FDA.clinical-trials-registration-and-results-submissionFR-Doc-2014-26197
Removal of Redundant RegulationsRule2013-2947512/16/2013NATIONAL AERONAUTICS AND SPACE ADMINISTRATIONNational Aeronautics and Space AdministrationThis direct final rule makes nonsubstantive changes by removing redundant regulatory language that is already captured in statues that govern NASA activities related to delegation of authority of certain civil rights functions, … This direct final rule makes nonsubstantive changes by removing redundant regulatory language that is already captured in statues that govern NASA activities related to delegation of authority of certain civil rights functions, protection of human subjects, and care and use of animals in the conduct of NASA activities. Therefore, NASA regulations will be streamlined to make reference to those statutes.removal-of-redundant-regulationsFR-Doc-2013-29475
Institutional Review Boards; Correcting AmendmentsRule2013-0603003/15/2013DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending its regulations regarding institutional review boards to address a minor correction to the regulatory text and to update contact information. This action is editorial in nature and is … The Food and Drug Administration (FDA) is amending its regulations regarding institutional review boards to address a minor correction to the regulatory text and to update contact information. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.institutional-review-boards-correcting-amendmentsFR-Doc-2013-06030
Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated ProductsRule2013-0438702/26/2013DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to b … The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.additional-safeguards-for-children-in-clinical-investigations-of-food-and-drugFR-Doc-2013-04387
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