Department of Health and Human Services June 2014 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 338
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.
Ninety-Day Waiting Period Limitation
These final regulations clarify the maximum allowed length of any reasonable and bona fide employment-based orientation period, consistent with the 90-day waiting period limitation set forth in section 2708 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act (Affordable Care Act), as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.'' FDA is issuing this document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health. In this document, FDA is also proposing changes to its guidance entitled ``Mobile Medical Applications,'' issued on September 25, 2013, to conform to the proposed policy discussed in this draft guidance document. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations
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; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
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.
Cooperative Agreement to Support the World Trade Organization's Standards and Trade Development Facility
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2014 (FY14) to the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF).
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the July meeting, the Advisory Council will review and discuss its recommendations on informal caregiving, hear presentations on statistics about caregivers and existing programs to provide them with help, and hear presentations from the four subcommittees (Research, Clinical Care, Long-Term Services and Supports, and Ethics). The Advisory Council will also discuss the G7 Dementia Summit that was held on June 19th, 2014 in the UK.
Office of Health Assessment and Translation Webinar on Lessons Learned in Application of the OHAT Framework for Systematic Review and Evidence Integration to Case Studies; Notice of Public Webinar and Registration Information
The National Toxicology Program (NTP) announces a public webinar, ``Lessons Learned in Application of the Office of Health Assessment and Translation (OHAT) Framework for Systematic Review and Evidence Integration to Case Studies.'' The OHAT, Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) will host the web-based meeting and the public can register to participate at https://ntp.niehs.nih.gov/go/41629.
Adverse Outcome Pathways: From Research to Regulation Workshop; Notice of Public Meeting and Registration Information
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces a workshop on ``Adverse Outcome Pathways: From Research to Regulation.'' The workshop proposes to initiate stakeholder interaction and collaboration to enhance scientific development of the Adverse Outcome Pathway (AOP) concept with the goal of improving regulatory assessment of chemical toxicity. Registration is requested for attendance and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/ 41374.
National Center for Advancing Translational Sciences (NCATS): Cooperative Research and Development Agreement (CRADA) and Licensing Opportunity for Small Molecule Inhibitors of the Human USP1/UAF1 Complex(1) for the Treatment of Cancer
The National Center for Advancing Translational Sciences (NCATS) and its collaborator, the University of Delaware, are seeking Cooperative Research and Development Agreement (CRADA) partners to collaborate in the final stages of lead optimization, evaluation and preclinical development of a novel series of selective and potent small-molecule inhibitors of the human USP1/UAF1 complex(1) for the treatment of cancer. Interested potential CRADA partners will receive detailed information about the project after signing a confidential disclosure agreement (CDA) with NCATS and University of Delaware.
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.
Notification of Charter Renewal: National Preparedness and Response Science Board (Previously Known as the National Biodefense Science Board)
The Secretary of the Department of Health and Human Services has renewed the charter of the National Preparedness and Response Science Board (NPRSB), previously known as the National Biodefense Science Board, for an additional two-year period through July 3, 2016.
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for a proposed rule that appeared in the Federal Register of April 25, 2014. In the proposed rule, FDA requested comments, including comments on FDA's proposed options for regulation of cigars, regulatory approach to electronic cigarettes and other non- combustible tobacco products, pathways to market for proposed deemed tobacco products, and compliance dates for certain provisions, among other issues. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Melanie Cokonis, Southern Research Institute: Based on the report of an investigation conducted by Southern Research Institute (SRI) and additional analysis conducted by ORI in its oversight review, ORI found that Ms. Melanie Cokonis, former Research Technician, SRI, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), contracts N01-AI-30047 (HHSN2722011000009C) and N01-AI-70042 (HHSN272200700042C), and National Human Genome Research Institute (NHGRI), NIH, grant U54 HG005034. ORI found that the Respondent engaged in research misconduct by falsifying assay data that were submitted in reports to NIH. Specifically, ORI found that Respondent knowingly falsified data for cytoprotection assays with antiviral compounds and provided the false data for inclusion in reports submitted to NIH for contracts N01-AI- 30047 and N01-AI-70042 and grant U54 HG005034. Respondent transferred raw data from 8X12 SoftmaxPro matrix files into spreadsheets and then falsified the numbers for cell control, virus control, drug cytotoxicity, drug only, and/or cells+ virus+ drug wells to make 206 assays appear to have been successfully performed when they were not. Ms. Cokonis has voluntarily agreed for a period of three (3) years, beginning on May 29, 2014: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq) of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) To exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Novel Influenza A (H7N9) Virus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Arbor Vita Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
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 for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.