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

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Document Number: 2014-24880
Type: Notice
Date: 2014-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-24879
Type: Notice
Date: 2014-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-24872
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Document Number: 2014-24870
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Document Number: 2014-24868
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act of 1974, HRSA is deleting an obsolete system of records titled the Information Center (IC) Integrated Clearinghouse System (ICS), HRSA 09- 15-0067, established in 2007 at 72 FR 34018 and 72 FR 44846.
Document Number: 2014-24862
Type: Notice
Date: 2014-10-20
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: 2014-24850
Type: Notice
Date: 2014-10-20
Agency: Department of Agriculture, Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S. Department of Agriculture (USDA), is hereby giving notice that a meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held and will be open to the public by Internet access only.
Document Number: 2014-24838
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations of individuals to serve as non-federal public members on the Interagency Autism Coordinating Committee. The Office of the Secretary has directed the Office of Autism Research Coordination (OARC) of the National Institute of Mental Health, National Institutes of Health to assist the Department in conducting an open and transparent nomination process.
Document Number: 2014-24827
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the General Atomics facility in La Jolla, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 25, 2014, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Document Number: 2014-24814
Type: Notice
Date: 2014-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Kelvin Soto from providing services in any capacity to a person that has an approved or pending drug product application for a period of 6 years. We base this order on a finding that Mr. Soto was convicted of four felony counts under Federal law for conduct involving health care fraud and conspiracy to commit health care fraud and that this pattern of conduct is sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Mr. Soto was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Soto failed to request a hearing. Mr. Soto's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Document Number: 2014-24797
Type: Notice
Date: 2014-10-20
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 requirements relating to FDA's regulation of current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donor testing, donor notification, and ``lookback.''
Document Number: 2014-24796
Type: Notice
Date: 2014-10-20
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 (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.'' The purpose of this document is to provide recommendations to sponsors submitting CMC data submissions. For review efficiency, the Center for Veterinary Medicine (CVM) prefers that CMC information be submitted in a single technical section. However, there may be instances when a two-phased technical submission process is more beneficial to improve the overall time to drug approval. Sponsors may submit the phased CMC technical section as a single technical section or a two-phased technical section. This guidance describes the use of the two-phased technical section submission process.
Document Number: 2014-24793
Type: Notice
Date: 2014-10-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-24792
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24789
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24788
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24787
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24786
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24785
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24784
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24783
Type: Notice
Date: 2014-10-20
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public as indicated below, and registration is requested for both attendance and oral comment and required to access the webcast. Parts of the meeting will be closed as indicated on the agenda. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
Document Number: 2014-24791
Type: Notice
Date: 2014-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24790
Type: Notice
Date: 2014-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24755
Type: Notice
Date: 2014-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the spring meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2015. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and hospital outpatient therapeutic services supervision issues.
Document Number: 2014-24714
Type: Notice
Date: 2014-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (``FDA Recognized Consensus Standards''). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 037'' (``Recognition List Number: 037''), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Document Number: 2014-24663
Type: Rule
Date: 2014-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of Inspector General
This document announces the continuation of effectiveness of an interim final rule and the extension of the timeline for publication of the final rule. This document is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.
Document Number: 2014-24639
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) was created in order to achieve several important objectives: to reduce the fragmentation that currently exists in Federal programs addressing the community living service and support needs of both the aging and disability populations; to enhance access to quality health care and long-term services and supports for all individuals; to promote consistency in community living policy across other areas of the Federal government; and to complement the community infrastructure, as supported by both Medicaid and other Federal programs, in order to better respond to the full spectrum of needs of seniors and persons with disabilities. This reorganization will further advance these objectives by establishing a Center for Consumer Access and Self- Determination to serve as the locus for programs that assist older Americans and people with disabilities to access both health care services and long-term services and supports, as well as initiatives to expand the use of self-directed and person-center service models; and by establishing a Center for Policy and Evaluation to provide a strategic focal point for the development and implementation of policies to improve access to long-term services and supports and enhance opportunities for both populations to live in their communities.
Document Number: 2014-24607
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24606
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24605
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24604
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24603
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24602
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24601
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24600
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24599
Type: Notice
Date: 2014-10-16
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: 2014-24597
Type: Notice
Date: 2014-10-16
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 ``New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.'' This guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed- combination drug products (fixed combinations). As described in the guidance, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of ``new chemical entity,'' regardless of whether that drug substance is approved in a single-ingredient drug product or in certain fixed- combinations. This guidance finalizes the draft guidance issued in February 2014.
Document Number: 2014-24593
Type: Proposed Rule
Date: 2014-10-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Nutritional Products, proposing that the food additive regulations be amended to provide for the safe use of Schizochytrium sp. dried algae as a source of docosahexaenoic acid for use in standard pelleted foods for adult dogs.
Document Number: 2014-24555
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, Administration for Children and Families
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: ``Continuing Education for Comparative Effectiveness Research Survey.'' 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 August 4th, 2014 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-24538
Type: Notice
Date: 2014-10-16
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the establishment of a probability-based panel of tobacco users.
Document Number: 2014-24513
Type: Notice
Date: 2014-10-16
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: ``Care Coordination Quality Measure for Patients in the Primary Care Setting.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 30th, 2014 and allowed 60 days for public comment. AHRQ received and responded to comments from two members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-24502
Type: Notice
Date: 2014-10-16
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 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc., which is located in Los Angeles, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications:
Document Number: 2014-24501
Type: Notice
Date: 2014-10-16
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 an exclusive start-up option license to practice the inventions embodied in U.S. Patent Application 61/706,396 entitled ``Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/0-US-01], PCT Application PCT/US2013/059883 entitled ``Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/ 0-PCT-02], and all related continuing and foreign patents/patent applications for the technology family, to H2Bio, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive start-up option licensed territory may be worldwide, and the field of use may be limited to:
Document Number: 2014-24500
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24499
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24455
Type: Notice
Date: 2014-10-16
Agency: Department of Health and Human Services, National Institutes of Health
A conference to identify issues surrounding evidence-based decision making for vitamin D in primary care will be held December 2- 3, 2014, on the main campus of the National Institutes of Health (NIH) in Bethesda, Maryland. It will also be broadcast as a webinar. The conference discussions will serve to highlight research gaps as well as data and methodological needs relevant to reducing uncertainties surrounding vitamin D in primary care practice. All persons are invited to attend, especially clinical educators, those who develop clinical recommendations, health care providers and researchers. Persons wishing to attend are required to register in advance of the conference.
Document Number: 2014-24451
Type: Notice
Date: 2014-10-15
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-24446
Type: Notice
Date: 2014-10-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled, ``Distinguishing Medical Device Recalls From Medical Device Enhancements.'' This guidance is intended to clarify when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and explain reporting requirements.
Document Number: 2014-24445
Type: Notice
Date: 2014-10-15
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 for the labeling of natural rubber latex condoms.
Document Number: 2014-24444
Type: Notice
Date: 2014-10-15
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 ``Animal Drug User Fee Cover Sheet'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.