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

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Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-27942
Type: Notice
Date: 2013-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-27928
Type: Notice
Date: 2013-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
Document Number: 2013-27927
Type: Notice
Date: 2013-11-21
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 a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: http:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2013-27926
Type: Notice
Date: 2013-11-21
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 a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place via webinar. This webinar meeting will be open to the public. The webinar will include public comment session(s). Registration is required in advance for both public participants and comment. Any individual who wishes to participate in the public meeting and/or in the public comment session should register at www.blsmeetings.net/CFSACdec2013/.
Determination That BANZEL (Rufinamide) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2013-27874
Type: Notice
Date: 2013-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that BANZEL (rufinamide) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for rufinamide tablet, 100 mg, if all other legal and regulatory requirements are met.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2013-27859
Type: Notice
Date: 2013-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2013-27857
Type: Notice
Date: 2013-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2013-27856
Type: Notice
Date: 2013-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-27840
Type: Notice
Date: 2013-11-20
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-27836
Type: Notice
Date: 2013-11-20
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; OAA Title III-E Evaluation
Document Number: 2013-27822
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity to 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 Older Americans Act (OAA) Title III-E Evaluation.
Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
Document Number: 2013-27811
Type: Notice
Date: 2013-11-20
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 provisions of our regulations mandating the application of hazard analysis and critical control point (HAACP) principles to the processing of fruit and vegetable juices.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-27808
Type: Notice
Date: 2013-11-20
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-27802
Type: Notice
Date: 2013-11-20
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2013-27798
Type: Notice
Date: 2013-11-20
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.
National Advisory Council on Migrant Health; Notice of Meeting
Document Number: 2013-27790
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 2013-27789
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods
Document Number: 2013-27784
Type: Proposed Rule
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR 3504), entitled ``Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption'' and for its information collection provisions.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
Document Number: 2013-27783
Type: Proposed Rule
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR 3646), entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food'' and its information collection provisions.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables
Document Number: 2013-27782
Type: Notice
Date: 2013-11-20
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 invites comments on the information collection provisions in the guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
Document Number: 2013-27775
Type: Notice
Date: 2013-11-20
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.
Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Availability
Document Number: 2013-27774
Type: Notice
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation'' dated November 2013. The draft guidance document provides recommendations to submitters and FDA reviewers in preparing and reviewing 510(k) submissions for nucleic acid-based HLA test kits used for matching of donors and recipients in transfusion and transplantation. The guidance provides detailed information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s.
Amendments to General Regulations of the Food and Drug Administration; Technical Amendments
Document Number: 2013-27773
Type: Rule
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) published a final rule in the Federal Register on November 30, 2010, amending certain regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule inadvertently deleted an authority citation and language related to the definition of ``package.'' We are restoring the inadvertent deletions and making a corresponding technical change.
Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True Patient-Centric Value in Innovation; Public Workshop
Document Number: 2013-27771
Type: Notice
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation.'' FDA is cosponsoring the workshop with the American Gastroenterological Association (AGA). The purpose of the workshop is to facilitate discussion between FDA, AGA, and other interested parties of the development of medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches for the regulation and reimbursement of minimally invasive procedures. The public workshop is being rescheduled due to the government shutdown. The title of the workshop has also been changed.
Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability
Document Number: 2013-27770
Type: Notice
Date: 2013-11-20
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 entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.'' When finalized, the draft guidance will replace the guidance of the same title issued January 25, 2012. The draft guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human drugs, including biological drug products, and prescription animal drugs and articulates the circumstances under which FDA intends to exercise enforcement discretion.
Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period
Document Number: 2013-27769
Type: Notice
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The draft guidance document provides sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products. In the notice, we requested comments on the draft guidance. We are taking this action to allow interested persons additional time to submit comments and to allow for public discussion at the February 25-26, 2014, Cellular, Tissue, and Gene Therapies Advisory Committee meeting, where FDA will present the draft guidance document for review.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-27741
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-27740
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-27739
Type: Notice
Date: 2013-11-20
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.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2013-27717
Type: Notice
Date: 2013-11-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Infectious Diseases: Notice of Charter Renewal
Document Number: 2013-27716
Type: Notice
Date: 2013-11-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Public Health Preparedness and Response: Notice of Charter Renewal
Document Number: 2013-27715
Type: Notice
Date: 2013-11-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-27714
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-27713
Type: Notice
Date: 2013-11-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Injury Prevention and Control: Notice of Charter Renewal
Document Number: 2013-27712
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-27692
Type: Notice
Date: 2013-11-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2013-27663
Type: Notice
Date: 2013-11-20
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Extension of Comment Periods
Document Number: 2013-27645
Type: Proposed Rule
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals'' that appeared in the Federal Register of July 29, 2013. We are taking this action in response to requests for an extension to allow interested persons an opportunity to consider the interrelationship between this proposed rule and the proposed rule announced in October 2013 entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications; Extension of Comment Periods
Document Number: 2013-27644
Type: Proposed Rule
Date: 2013-11-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule entitled ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications'' that appeared in the Federal Register of July 29, 2013. We are taking this action in response to requests for an extension to allow interested persons an opportunity to consider the interrelationship between this proposed rule and the proposed rule announced in October 2013 entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.'' We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-27653
Type: Notice
Date: 2013-11-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Patient Protection and Affordable Care Act; Exchanges and Qualified Health Plans, Quality Rating System (QRS), Framework Measures and Methodology
Document Number: 2013-27649
Type: Notice
Date: 2013-11-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice with comment describes the overall Quality Rating System (QRS) framework for rating Qualified Health Plans (QHPs) offered through an Exchange. The purpose of this notice is to solicit comments on the list of proposed QRS quality measures that QHP issuers would be required to collect and report, the hierarchical structure of the measure sets and the elements of the QRS rating methodology. In addition, this notice solicits comments on ways to ensure the integrity of QRS ratings, and on priority areas for future QRS measure enhancement and development.
Prospective Grant of Exclusive License: The Development of Modified T-cells for the Treatment of Multiple Myeloma
Document Number: 2013-27601
Type: Notice
Date: 2013-11-19
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 to Thirsty Brook Bioscience, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following US Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/ 622,6008 entitled, ``Chimeric Antigen Receptors Targeting B-cell Maturation Antigen'' [HHS Ref. E-040-2012/0-US-01]. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide, and the field of use may be limited to:
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-27600
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences Amended; Notice of Meeting
Document Number: 2013-27599
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Cancellation of Meeting
Document Number: 2013-27598
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2013-27597
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-27596
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-27595
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-27594
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-27593
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health