Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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Document Number: 2014-22502
Type: Notice
Date: 2014-09-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. Task Force recommendations provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Document Number: 2014-22461
Type: Notice
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 (PRA).
Document Number: 2014-22460
Type: Notice
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public scientific workshop to discuss the roadmap for applying regulatory science to neonates. This public scientific workshop is being co- sponsored with the FDA, the Critical Path Institute (C-Path) and the Burroughs Welcome Fund (BWF). The purpose of the public scientific workshop is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public to determine whether there is sufficient interest on the part of stakeholders to develop a neonatal consortium and to discuss potential working groups dedicated to the regulatory science required to develop neonatal therapeutics.
Document Number: 2014-22456
Type: Notice
Date: 2014-09-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22455
Type: Notice
Date: 2014-09-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22454
Type: Notice
Date: 2014-09-22
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Food and Drug Administration, an agency within the Department of Health and Human Services, through the National Institutes of Health Office of Technology Transfer is contemplating the grant of an exclusive worldwide license to practice the inventions embodied in HHS Ref. No. E-258-2011/0, ``Direct Impact Corona Ionization (DICI) Mass Spectrometry;'' U.S. Patent 8,704,169, to Vivione Biosciences, Inc., a corporation incorporated under the laws of the State of Arkansas, having a principle place of business at 515 W. Matthews Ave., Jonesboro, AR 72401. The United States of America is the assignee of the patent rights pertaining to this invention. The exclusivity period of the contemplated license may be granted for no more than seven (7) years, may be territorially limited to the United States and may be limited to a field of use directed to direct impact corona ionization mass spectrometry pattern recognition devices and systems for detection of small molecules and microbiological agents.
Document Number: 2014-22453
Type: Proposed Rule
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify iontophoresis devices intended for any other purposes, a preamendments class III device, into class II (special controls), and to amend the device identification. FDA is proposing this reclassification on its own initiative based on new information. This action implements certain statutory requirements.
Document Number: 2014-22452
Type: Notice
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-22450
Type: Notice
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Draft Guidance on Estradiol.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal cream. This draft guidance is a revised version of a previously issued draft guidance of the same subject.
Document Number: 2014-22444
Type: Notice
Date: 2014-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-22240
Type: Notice
Date: 2014-09-22
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on May 14th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-22214
Type: Notice
Date: 2014-09-22
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, AHRQ [has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This proposed information collection was previously published in the Federal Register on June 4th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-22379
Type: Notice
Date: 2014-09-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Document Number: 2014-22308
Type: Notice
Date: 2014-09-19
Agency: Department of Health and Human Services, National Institutes of Health
The National Library of Medicine (NLM) invites pharmaceutical manufacturers, re-packagers, wholesalers, and retail and institutional pharmacies to submit prescription drug products for imaging as part of its Computational Photography Project for Pill Identification (C3PI). The NLM is developing the C3PI oral solid dosage formulations (OSDFs) collection as part of an initiative to build a reliable and high- quality image catalog of all OSDF prescription products marketed in the United States. Such a resource can support a number of public safety initiatives, such as in poison control, emergency response, and reduction of medication errors.
Document Number: 2014-22306
Type: Notice
Date: 2014-09-19
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, 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 April 9, 2013, page 19633 and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), 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, OIRAsubmission@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.
Document Number: 2014-22296
Type: Notice
Date: 2014-09-19
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22295
Type: Notice
Date: 2014-09-19
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22320
Type: Notice
Date: 2014-09-18
Agency: Department of Education, Department of Health and Human Services
On August 18, 2014, the Departments of Education and Health and Human Services published in the Federal Register (79 FR 48874) a notice inviting applications for new awards for fiscal year 2014 for the Preschool Development GrantsExpansion Grants program. This notice corrects the Executive Summary Selection Criterion (A)(7)(b).
Document Number: 2014-22298
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22297
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22275
Type: Notice
Date: 2014-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014.''
Document Number: 2014-22255
Type: Proposed Rule
Date: 2014-09-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes will provide a reasonable assurance of safety and effectiveness of the device. The Agency is proposing to rename the device ``electrical salivary stimulatory system.''
Document Number: 2014-22254
Type: Rule
Date: 2014-09-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Document Number: 2014-22253
Type: Notice
Date: 2014-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The HHS Centers for Disease Control and Prevention's Division of Select Agents and Toxins (DSAT) and the USDA Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) are jointly charged with the oversight of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the Webcast is to provide guidance related to the Federal Select Agent Program for interested individuals.
Document Number: 2014-22213
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22212
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22211
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22210
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications:
Document Number: 2014-22192
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Makoto Suzuki, M.D., University of Texas Southwestern Medical Center: Based on the report of an investigation conducted by the University of Texas Southwestern Medical Center (UT Southwestern) and analysis conducted by ORI in its oversight review, ORI found that Dr. Makoto Suzuki, currently a Professor in the Department of Thoracic Surgery, Kumamoto University Hospital, Kumamoto, Japan, and formerly a Visiting Scientist in the Hamon Center for Therapeutic Oncology Research, UT Southwestern, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants P50 CA070907 and U01 CA084971. ORI found that Respondent knowingly, intentionally, and recklessly falsified data reported in six (6) publications:
Document Number: 2014-22191
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Takao Takahashi, M.D., Ph.D., University of Texas Southwestern Medical Center: Based on the report of an investigation conducted by the University of Texas Southwestern Medical Center (UT Southwestern) and analysis conducted by ORI in its oversight review, ORI found that Dr. Takao Takahashi, currently a faculty member in the Department of Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu, Japan, and formerly a Visiting Scientist in the Hamon Center for Therapeutic Oncology Research, UT Southwestern, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant U01 CA084971. ORI found that Respondent knowingly, intentionally, and recklessly falsified data reported in four (4) publications:
Document Number: 2014-22185
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source cooperative agreement in the amount of $75,000 to the Gerontology Institute, University of Massachusetts Boston (UMass Boston) to support and stimulate the expansion of work already underway by UMass Boston in providing pension counseling services to residents of the State of Illinois.
Document Number: 2014-22184
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services
The Administration on Aging (AoA), Administration for Community Living (ACL), is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Document Number: 2014-22135
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22134
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22133
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22132
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22131
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22130
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22129
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22128
Type: Notice
Date: 2014-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-22123
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Threshold of Regulation for Substances Used in Food-Contact Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2014-22122
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-22110
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsRefuse to Receive for Lack of Proper Justification of Impurity Limits.'' This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements) for which the applicant is seeking approval of a new strength of the drug product. The draft guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA.
Document Number: 2014-22089
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Exception From General Requirements for Informed Consent'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Document Number: 2014-22088
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Document Number: 2014-22086
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
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 Ebola Zaire virus (detected in the West Africa outbreak in 2014). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Department of Defense (DoD). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola 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.
Document Number: 2014-22071
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-22068
Type: Notice
Date: 2014-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``ANDA Submissions Refuse-to-Receive Standards.'' It finalizes the draft guidance with the same name that published on October 1, 2013. This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements for new strengths). The guidance represents the FDA's current thinking regarding the types of serious deficiencies that may cause FDA to refuse-to-receive the submission.
Document Number: 2014-22051
Type: Rule
Date: 2014-09-16
Agency: Department of Health and Human Services
This document provides interim guidance on the implementation of section 301(f) of the Leadership Act in light of the Supreme Court's decision in Agency for Int'l Dev. v. Alliance for Open Soc'y Int'l, Inc., 133 S. Ct. 2321 (2013) (``AOSI decision''). While HHS awarding agencies have implemented the AOSI decision since its issuance, this document serves to clarify HHS policy. HHS is also currently developing an amendment to its regulations listed under ``Organizational Integrity of Entities Implementing Programs and Activities under the Leadership Act'' to ensure consistency with the decision. HHS has been coordinating its implementation activities with the Department of State, Office of the Global AIDS Coordinator (OGAC) and with the United States Agency for International Development (USAID). While issued through OGA, this guidance represents the views of the various agencies within HHS that issue awards with Leadership Act HIV/AIDS funds, namely, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Health Resources and Services Administration.