Department of Health and Human Services October 2013 – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 391
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-25058
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-25057
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-25056
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2013-25055
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-25054
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-25053
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2013-25052
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2013-25039
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders, Amended Notice of Meeting
Document Number: 2013-25038
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-25035
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-25034
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-25033
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-25032
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-25031
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-25030
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-25029
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-25028
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health Notice of Meeting
Document Number: 2013-25027
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs: Application From the Joint Commission for Continued Approval of Its Home Health Agency (HHA) Accreditation Program
Document Number: 2013-25010
Type: Notice
Date: 2013-10-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for Home Health Agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, CMS publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
Document Number: 2013-25008
Type: Notice
Date: 2013-10-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS for ``reasonable and necessary'' determinations under Medicare. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore, we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-24941
Type: Notice
Date: 2013-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; 30-Day Comment Request; Application for the Postdoctoral Research Associate Program
Document Number: 2013-24997
Type: Notice
Date: 2013-10-24
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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 23, 2013, pages 44135-44136, 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 General Medical Sciences (NIGMS), 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. Comments 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.
Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
Document Number: 2013-24940
Type: Notice
Date: 2013-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps, with recommendations for donor testing for West Nile Virus (WNV) using an FDA-licensed donor screening test. The guidance recommends the use of an FDA-licensed nucleic acid test (NAT) for testing donors of HCT/Ps for infection with WNV. The draft guidance replaces the draft guidance entitled ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated April 2008, with respect to HCT/ Ps. The testing recommendations in the guidance, when finalized, will supplement the donor screening recommendations for WNV (which will remain in place) that were made in the guidance entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-24912
Type: Notice
Date: 2013-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
Therapeutic Area Standards Initiative Project Plan; Availability
Document Number: 2013-24909
Type: Notice
Date: 2013-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the Therapeutic Area Standards Initiative Project Plan. This therapeutic area (TA) Project Plan will be the primary document for guiding all major aspects of FDA's multi-year initiative to develop and implement TA standards to support the regulatory review process for drugs and biologics. The TA Project Plan will be updated annually and made available for public comment.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-24908
Type: Notice
Date: 2013-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability
Document Number: 2013-24894
Type: Notice
Date: 2013-10-24
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 204 entitled ``Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals.'' This guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal drugs for use in companion animals. The intent of the guidance is to provide information to clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-24876
Type: Notice
Date: 2013-10-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-24875
Type: Notice
Date: 2013-10-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-24874
Type: Notice
Date: 2013-10-24
Agency: Department of Health and Human Services, National Institutes of Health
UPDATE-Meeting of the Community Preventive Services Task Force (Task Force)
Document Number: 2013-24928
Type: Notice
Date: 2013-10-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces an update to the meeting of the Community Preventive Services Task Force (Task Force). The in-person Task Force meeting is being replaced by an abbreviated conference call as a result of the lapse in the FY 2014 appropriation, which limited CDC's ability to complete the necessary scientific and logistical support for the meeting. The Task Force is an independent, nonfederal, and uncompensated 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. These recommendations provide evidence-based options from which decision makers in communities, companies, health departments, health plans and healthcare systems, non-governmental organizations, and at all levels of government can choose what best meets the needs, preferences, available resources, and constraints of their 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).
Announcing the Award of Four Single-Source Expansion Supplement Grants Under the Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV), Tribal Early Learning Initiative Program
Document Number: 2013-24863
Type: Notice
Date: 2013-10-23
Agency: Department of Health and Human Services, Administration for Children and Families
This announces the award of single-source program expansion supplement grants to the following Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) grantees to support their ongoing participation in the Tribal Early Learning Initiative, by the Office of Child Care, a program of the Administration for Children and Families.
Privacy Act of 1974; Report of an Altered CMS System of Records Notice
Document Number: 2013-24861
Type: Notice
Date: 2013-10-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS proposes several alterations to the existing system of records titled, ``Health Insurance Exchanges (HIX) Program'' (No. 09-70-0560), published at 78 FR 8538 (February 6, 2013) and amended and published at 78 FR 32256 (May 29, 2013). The alterations affect the ``Purposes of the System'', ``Categories of Individuals Covered by the System'', ``Categories of Records in the System'', ``Authority for Maintenance of the System'', ``System Location'', ``Retention and Disposal'', ``System Manager and Address'', ``Routine Uses of Records Maintained in the System'', and ``Record Source Categories'' sections of the accompanying System of Records Notice, as more fully explained in the Supplementary Information section.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-24854
Type: Notice
Date: 2013-10-23
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: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-24851
Type: Notice
Date: 2013-10-23
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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
GlaxoSmithKline LLC; Withdrawal of Approval of the Indication for Treatment of Patients With Relapsed or Refractory, Low Grade, Follicular, or Transformed CD20 Positive Non-Hodgkin's Lymphoma Who Have Not Received Prior Rituximab; BEXXAR
Document Number: 2013-24840
Type: Notice
Date: 2013-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of the indication for treatment of patients with relapsed or refractory, low grade, follicular, or transformed CD20 positive non- Hodgkin's lymphoma who have not received prior rituximab, for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection held by GlaxoSmithKline LLP, P.O. Box 5089, 1250 South Collegeville Rd., Collegeville, PA 19426 (Glaxo). Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing.
Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-24832
Type: Notice
Date: 2013-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-24824
Type: Notice
Date: 2013-10-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-24823
Type: Notice
Date: 2013-10-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-24822
Type: Notice
Date: 2013-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-24821
Type: Notice
Date: 2013-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-24819
Type: Notice
Date: 2013-10-23
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.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-24817
Type: Notice
Date: 2013-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-24805
Type: Notice
Date: 2013-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
Document Number: 2013-24804
Type: Notice
Date: 2013-10-23
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.
Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability
Document Number: 2013-24803
Type: Notice
Date: 2013-10-23
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 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this guidance is to assist sponsors or non-applicants with filling out Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report,'' in both paper and electronic format, as required by FDA regulations.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-24799
Type: Notice
Date: 2013-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2013-24798
Type: Notice
Date: 2013-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment; Availability
Document Number: 2013-24787
Type: Notice
Date: 2013-10-23
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 ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the development of new antibacterial drugs to treat acute bacterial skin and skin structure infections (ABSSSI). This guidance finalizes the revised draft guidance of the same name issued on August 27, 2010.