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

Results 101 - 150 of 451
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Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of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
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-27592
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: 2013-27591
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Amended; Notice of Meeting
Document Number: 2013-27590
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: 2013-27589
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)
Document Number: 2013-27556
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2013, Vol. 78, P. 52204 and allowed 60-days for public comment. There were no public comments received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI)
Document Number: 2013-27554
Type: Notice
Date: 2013-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 30, 2013, Vol. 78, p. 53763 and allowed 60-days for public comment. There have been no public comments. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Development of Inward Leakage Standards for Half-Mask Air-Purifying Particulate Respirators
Document Number: 2013-27445
Type: Proposed Rule
Date: 2013-11-19
Agency: Department of Health and Human Services
On September 17, 2013, the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) held a public meeting concerning inward leakage performance requirements for the class of NIOSH-certified non-powered air-purifying particulate respirators approved as half-facepiece respirators for protection from particulate-only hazards. The purpose of this meeting was to share information and to seek stakeholder feedback, in identified topic areas, concerning the development of inward leakage performance standards. Questions concerning the identified topics of specific interest were included in the meeting notice published in the Federal Register on September 4, 2013. Written comments were to be received by October 18, 2013. HHS/CDC received a request from a stakeholder for additional time to comment on this notice. In consideration of this request HHS/CDC is reopening the public comment period through December 31, 2013.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers; Extension of Comment Period
Document Number: 2013-27537
Type: Notice
Date: 2013-11-18
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 information collection entitled ``Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers'' that appeared in the Federal Register of September 18, 2013 (78 FR 57391). In the notice requesting comment on the proposed information collection, we requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments on the proposed information collection.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2013-27536
Type: Notice
Date: 2013-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
Document Number: 2013-27503
Type: Notice
Date: 2013-11-18
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 in the guidance for industry on special protocol assessment.
Performance Review Board Members
Document Number: 2013-27501
Type: Notice
Date: 2013-11-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2013.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-27485
Type: Notice
Date: 2013-11-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Period
Document Number: 2013-27479
Type: Proposed Rule
Date: 2013-11-18
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 ``Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of August 19, 2013. We are taking this action to allow interested persons an opportunity to provide comment on the scope of issues the Agency should include in the Environmental Impact Statement (EIS), including their significance, as part of the scoping process for the EIS.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-27455
Type: Notice
Date: 2013-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-27447
Type: Notice
Date: 2013-11-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Performance Review Board Members
Document Number: 2013-27423
Type: Notice
Date: 2013-11-18
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-27176
Type: Notice
Date: 2013-11-18
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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database.'' 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 August 14th, 2013 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-27410
Type: Notice
Date: 2013-11-15
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstating the use of the approved information collection assigned OMB control number 0990-0317, which expired on October 31, 2013. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.