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

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Document Number: 2015-12577
Type: Notice
Date: 2015-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for STIVARGA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Document Number: 2015-12542
Type: Notice
Date: 2015-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-12527
Type: Notice
Date: 2015-05-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the summer 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: 2015-12524
Type: Notice
Date: 2015-05-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare Conditions of Participation (CoPs).
Document Number: 2015-12512
Type: Notice
Date: 2015-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2015-12498
Type: Notice
Date: 2015-05-22
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 (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.
Document Number: 2015-12497
Type: Notice
Date: 2015-05-22
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: 2015-12479
Type: Notice
Date: 2015-05-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-12404
Type: Notice
Date: 2015-05-22
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, ``Substances Prohibited From Use in Animal Food or Feed'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2015-12403
Type: Notice
Date: 2015-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2015-12402
Type: Notice
Date: 2015-05-22
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.
Document Number: 2015-12401
Type: Notice
Date: 2015-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 18, 2015, expiration date.
Document Number: 2015-12400
Type: Notice
Date: 2015-05-22
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, ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2015-12399
Type: Notice
Date: 2015-05-22
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 ``Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2015-12398
Type: Notice
Date: 2015-05-22
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.
Document Number: 2015-12397
Type: Notice
Date: 2015-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for FLUCELVAX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Document Number: 2015-12396
Type: Notice
Date: 2015-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Document Number: 2015-12392
Type: Notice
Date: 2015-05-22
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-12389
Type: Notice
Date: 2015-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-12228
Type: Rule
Date: 2015-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.
Document Number: 2015-12087
Type: Rule
Date: 2015-05-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the survey, certification, and enforcement procedures related to CMS oversight of national accrediting organizations (AOs). The revisions implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The revisions also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the statute. The rule also extends some provisions, which are applicable to Medicare-participating providers, to Medicare-participating suppliers subject to certification requirements, and clarifies the definition of ``immediate jeopardy.''
Document Number: 2015-12418
Type: Notice
Date: 2015-05-21
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of a single-source cooperative agreement in the amount of $1,200,000 for each of 3 years to the American Public Human Services Association for its affiliate the Association of Administrators of the Interstate Compact on the Placement of Children (AAICPC), Washington, DC, for the national expansion of the NEICE to improve the administrative efficiency in the interstate process of the ICPC nationally. The ICPC establishes uniform legal and administrative procedures governing the interstate placement of children for the purposes of foster care, adoption and residential placement in all 52 member jurisdictions of the ICPC. Award funds will support the development of the NEICE beyond the original six pilot sites to include all 50 states, the District of Columbia and the U.S. Virgin Islands. The NEICE system was previously developed as a pilot project through the Partnership Fund for Program Integrity Innovation with funding directed through The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF). Implementation of a national inter-jurisdictional Interstate Compact on the Placement of Children (ICPC) electronic system is intended to improve the administrative efficiency in the interstate process via the ICPC. The AAICPC as an affiliate of the APHSA is uniquely positioned to scale up this project due to their governance of the placement of children across state lines for purposes of foster care, adoption and residential placements.
Document Number: 2015-12312
Type: Notice
Date: 2015-05-21
Agency: Department of Health and Human Services
In 2012, ACL, in partnership with the Centers for Medicare & Medicaid Services (CMS) and the Veterans Health Administration (VHA), issued a special funding opportunity known as the ``Part A: The Enhanced ADRC Options Counseling Program'' (Part A). The Part A grants were awarded to eight states (CT, MA, MD, NH, OR, VT, WI and WA) to develop a NWD System in their state so the federal partners could leverage the experience and models emerging in these states to serve as the basis for the development of national standards. The one year extension will enable the 8 Part A state grantees to continue their work with ACL, CMS and VHA specifically to further refine the tools, metrics and key elements of a NWD System and pilot the Person Centered Counseling training program.
Document Number: 2015-12308
Type: Notice
Date: 2015-05-21
Agency: Department of Health and Human Services
The Administrator of the Administration for Community Living announces a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, we announce a priority for an RRTC on Outcomes Measurement for Home and Community Based Services. The Administrator of the Administration for Community Living may use this priority for competitions in fiscal year (FY) 2015 and later years. We take this action to focus research attention on an area of national need. We intend for this priority to contribute to improved home and community based services for individuals with disabilities.
Document Number: 2015-12274
Type: Notice
Date: 2015-05-21
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Document Number: 2015-12251
Type: Notice
Date: 2015-05-21
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-12242
Type: Notice
Date: 2015-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-12241
Type: Notice
Date: 2015-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-12240
Type: Notice
Date: 2015-05-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for inactivated and live attenuated influenza vaccines.
Document Number: 2015-12239
Type: Notice
Date: 2015-05-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statement for pneumococcal conjugate vaccine (PCV13).
Document Number: 2015-12236
Type: Notice
Date: 2015-05-20
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: 2015-12229
Type: Notice
Date: 2015-05-20
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Document Number: 2015-12170
Type: Notice
Date: 2015-05-20
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 information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.
Document Number: 2015-12126
Type: Notice
Date: 2015-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-12125
Type: Notice
Date: 2015-05-20
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-12124
Type: Notice
Date: 2015-05-20
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: 2015-12081
Type: Proposed Rule
Date: 2015-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Animal Drug User Fee Amendments of 2008 (ADUFA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, and further requires FDA to publish annual summary reports of the data it receives from sponsors. At this time, FDA is issuing proposed regulations for the administrative practices and procedures for animal drug sponsors who must report under this law. This proposal also includes an additional reporting provision intended to enhance FDA's understanding of antimicrobial animal drug sales intended for use in specific food- producing animal species.
Document Number: 2015-12106
Type: Notice
Date: 2015-05-19
Agency: Department of Health and Human Services
Document Number: 2015-12104
Type: Notice
Date: 2015-05-19
Agency: Department of Health and Human Services
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that two meetings are scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meetings will be open to the public. Information about the Advisory Group and the agendas for these meetings can be obtained by accessing the following Web site: http:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html.
Document Number: 2015-12096
Type: Notice
Date: 2015-05-19
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-12095
Type: Notice
Date: 2015-05-19
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 a proposed revision to the approved information collection project entitled ``The National Intimate Partner and Sexual Violence Survey (NISVS)''. This project collects information about individual's experiences of sexual violence, stalking and intimate partner violence.
Document Number: 2015-12094
Type: Notice
Date: 2015-05-19
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 the proposed information collection entitled CDC Burden of Canine Brucellosis Information Collection. This information collection will help to estimate canine brucellosis disease burden in dogs, which will aid in the determination of the public health importance of human B. canis infections, and the potential for zoonotic transmission.
Document Number: 2015-12078
Type: Notice
Date: 2015-05-19
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, ``Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Document Number: 2015-12061
Type: Notice
Date: 2015-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2015-12059
Type: Notice
Date: 2015-05-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-12058
Type: Notice
Date: 2015-05-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-12057
Type: Notice
Date: 2015-05-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-12056
Type: Notice
Date: 2015-05-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-12055
Type: Notice
Date: 2015-05-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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