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

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Document Number: 2015-07118
Type: Notice
Date: 2015-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is publishing this Notice to inform the public of the criteria CDC considers for requesting federal travel restrictions for public health purposes, including for use of the Do Not Board (DNB) list and Public Health Border Lookout records. Individuals with communicable diseases that pose a public health threat to travelers can be placed on this list to restrict them from boarding commercial aircraft arriving into, departing from, or traveling within the United States. This notice further describes the factors that HHS/CDC will consider in evaluating whether to request that an individual who may have been exposed to a hemorrhagic fever virus be placed on the DNB list, which is administered by the Department of Homeland Security (DHS). It also contains information for individuals who have been placed on this list to respond to this decision in writing, if they believe the decision was made in error. This notice is effective immediately.
Document Number: 2015-07115
Type: Notice
Date: 2015-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AOA/HFAP meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AOA/HFAP deeming authority for a period of 6 years.
Document Number: 2015-07113
Type: Notice
Date: 2015-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that laboratories located in and licensed by the State of New York that possess a valid permit under New York State Public Health Law Article 5, Title V, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years.
Document Number: 2015-07111
Type: Notice
Date: 2015-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of the College of American Pathologists (CAP) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the CAP meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant CAP deeming authority for a period of 6 years.
Document Number: 2015-07108
Type: Notice
Date: 2015-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice updates the Healthcare Common Procedure Coding System (HCPCS) codes on the Durable Medical Equipment (DME) List of Specified Covered Items that require a face-to-face encounter and a written order prior to delivery.
Document Number: 2015-07105
Type: Notice
Date: 2015-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
Document Number: 2015-07039
Type: Notice
Date: 2015-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention requests withdrawal from publication the 30-Day Federal Register Notice (FRN) 15-15GD concerning the Emergency Self Escape for Coal Miners ([FR Doc. 2015-06655 Filed 3-23-15; 8:45 a.m.]), which was submitted on March 19, 2015 for public inspection in the Federal Register. CDC published the notice as a Proposed Data Collections Submitted for Public Comment and Recommendations, when, in fact, the notice should have received publication as Agency Forms Undergoing Paperwork Reduction Act Review.
Document Number: 2015-07038
Type: Notice
Date: 2015-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Workplace Violence Prevention Programs in New Jersey Healthcare Facilities (OMB No. 0920-0914, expires 02/29/2016). The National Institute for Occupational Safety and Health (NIOSH) is requesting a two year extension in order to complete nursing home interviews.
Document Number: 2015-07037
Type: Notice
Date: 2015-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 ``Continuing and New International and U.S. Data Collections from the 2014 CDC Ebola Virus Disease Emergency Response''. Under the current 60-day Federal Register Notice, the CDC is announcing its intention to seek three-year OMB approval to continue several Ebola-related information collections beyond their current emergency expiration dates and to conduct newly proposed information collections within international borders of Ebola- affected West African countries and within the domestic borders of State, Territorial and Local (STL) public health authorities in the U.S. These existing ``source'' information collections and new information collection requests (ICRs) will be submitted under four ``destination'' ICRs for Office of Management and Budget (OMB) approval.
Document Number: 2015-07036
Type: Notice
Date: 2015-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 newly proposed information collection activities for enhanced surveillance of Coccidioidomycosis in low- and non-endemic states.
Document Number: 2015-07035
Type: Notice
Date: 2015-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-07034
Type: Notice
Date: 2015-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-07018
Type: Proposed Rule
Date: 2015-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency's regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.
Document Number: 2015-07010
Type: Rule
Date: 2015-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the brain injury adjunctive interpretive electroencephalograph assessment aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the brain injury adjunctive interpretive electroencephalograph assessment aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Document Number: 2015-07009
Type: Notice
Date: 2015-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
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 the collection of information concerning the establishment and operation of clinical trial data monitoring committees.
Document Number: 2015-07008
Type: Notice
Date: 2015-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
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 the information collection requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the Agency.
Document Number: 2015-06999
Type: Notice
Date: 2015-03-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold its annual meeting. The meeting will be open to the public.
Document Number: 2015-06974
Type: Notice
Date: 2015-03-27
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, Department of Health and Human Services, is contemplating the grant of a start-up exclusive commercial patent license agreement to practice the inventions embodied in U.S. provisional patent application no. 61/909,414 (NIH Ref. No. E- 011-2014/0-US-01) filed November 27, 2013; International PCT application no. PCT/US2014/066680 (NIH Ref. No. E-011-2014/0-PCT-02) filed November 20, 2014; Taiwanese patent application no. 103141004 (NIH Ref. No. E-011-2014/0-TW-03) filed November 26, 2014; and U.S. provisional patent application no. 62/011,462 (NIH Ref. No. E-161-2014/ 0-US-01) filed June 12, 2014; all entitled, ``Heterocyclic Compounds and Methods of Use Thereof;'' and all continuing applications and foreign counterparts to Virotas Biopharmaceuticals, LLC, a company having a place of business in California. The patent rights in these inventions have (a) been assigned to the United States of America, as represented by the Secretary, Department of Health and Human Services who has delegated authority for the licensing of inventions to the National Institutes of Health or (b) been exclusively licensed to the National Institutes of Health. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to the following: ``Prevention and treatment of Hepatitis C Virus infection.''
Document Number: 2015-06929
Type: Notice
Date: 2015-03-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06915
Type: Notice
Date: 2015-03-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2015-06884
Type: Notice
Date: 2015-03-25
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: 2015-06850
Type: Notice
Date: 2015-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06849
Type: Notice
Date: 2015-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06845
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services, National Institutes of Health
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.
Document Number: 2015-06844
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-06843
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-06842
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-06841
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-06840
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-06801
Type: Notice
Date: 2015-03-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06786
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Argonne National Laboratory- West in Scoville, Idaho, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Document Number: 2015-06784
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Hanford site in Richland, Washington, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Document Number: 2015-06773
Type: Notice
Date: 2015-03-25
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 (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 December 30, 2014 page 43609 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 Nursing Research, 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.
Document Number: 2015-06703
Type: Notice
Date: 2015-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment in response to the notice. This notice invites comments on the reporting and recordkeeping requirements of our regulations implementing the Federal Import Milk Act (FIMA).
Document Number: 2015-06702
Type: Notice
Date: 2015-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Ninth Annual DIA/FDA Statistics Forum2015''. The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. A primary focus for this meeting will be to establish an ongoing dialogue regarding FDA's ``Critical Path'' initiative emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trial data and measuring the progress being made in designing and implementing innovative solutions.
Document Number: 2015-06699
Type: Notice
Date: 2015-03-25
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-06698
Type: Notice
Date: 2015-03-24
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-06686
Type: Notice
Date: 2015-03-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry'' dated March 2015. The guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA) or a supplement to a BLA (BLA supplement), with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products (GTVVs). The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2014.
Document Number: 2015-06662
Type: Notice
Date: 2015-03-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS), announces the award of a single-source grant in the amount of $144,000 to Compass Family and Community Services of Youngstown, OH, under the Basic Center Program.
Document Number: 2015-06656
Type: Notice
Date: 2015-03-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to obtain comments that will inform our development of FDA Food Safety Modernization Act (FSMA) implementation work plans. FDA is also announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.'' At the public meeting, we will share our current thinking on our operational strategy for implementation work plans. We will also provide interested persons an opportunity to provide input on this operational strategy and the risk- based industry oversight framework that is at the core of FSMA.
Document Number: 2015-06655
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06654
Type: Notice
Date: 2015-03-24
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers.
Document Number: 2015-06653
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06652
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06651
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06650
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06649
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06648
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-06647
Type: Notice
Date: 2015-03-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This document corrects a notice that was published in the Federal Register on March 12, 2015 (Volume 80, Number 48, Page 13008. The time and date should read as follows: Time and Date: 8:30 a.m.-12:00 p.m., Panel 1; and 1:30 p.m.-5:30 p.m., Panel 2, April 1, 2015 (Closed).
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