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

Results 201 - 250 of 268
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00282
Type: Notice
Date: 2013-01-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2013-00281
Type: Notice
Date: 2013-01-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-00280
Type: Notice
Date: 2013-01-10
Agency: Department of Health and Human Services, National Institutes of Health
Health and Human Services Acquisition Regulation
Document Number: 2012-31490
Type: Proposed Rule
Date: 2013-01-10
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) is proposing to amend its Federal Acquisition Regulation (FAR) Supplementthe HHS Acquisition Regulation (HHSAR)to add two clauses, ``Patent Rights Exceptional Circumstances'' and ``Rights in DataExceptional Circumstances,'' and their prescriptions.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-00176
Type: Notice
Date: 2013-01-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-00175
Type: Notice
Date: 2013-01-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2013-00174
Type: Notice
Date: 2013-01-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00173
Type: Notice
Date: 2013-01-09
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-00172
Type: Notice
Date: 2013-01-09
Agency: Department of Health and Human Services, National Institutes of Health
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-00136
Type: Notice
Date: 2013-01-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2013-00127
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, Administration for Children and Families
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-00089
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00088
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-00087
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support
Document Number: 2013-00086
Type: Proposed Rule
Date: 2013-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
On its own initiative, based on new information, the Food and Drug Administration (FDA) is proposing to reclassify membrane lung devices for long-term pulmonary support, a preamendments class III device, into class II (special controls) for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because circuit components used with the oxygenator are to be subject to the same regulatory controls, all of the device components used in an ECMO procedure are being considered in the scope of this proposed order, and the title and identification of the regulation will be revised accordingly to include extracorporeal circuit and accessories for long- term pulmonary/cardiac support.
Cardiovascular Devices; Reclassification of External Cardiac Compressor
Document Number: 2013-00085
Type: Proposed Rule
Date: 2013-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify the external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III devices into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00065
Type: Notice
Date: 2013-01-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-00031
Type: Notice
Date: 2013-01-08
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 Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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.
Proposed Information Collection Activity; Comment Request
Document Number: 2012-31714
Type: Notice
Date: 2013-01-08
Agency: Department of Health and Human Services, Administration for Children and Families
Regulatory Agenda
Document Number: 2012-31671
Type: Unknown
Date: 2013-01-08
Agency: Department of Health and Human Services, Department of Homeland Security, Office of the Secretary
The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.
Semiannual Regulatory Agenda
Document Number: 2012-31497
Type: Unknown
Date: 2013-01-08
Agency: Department of Energy, Department of Health and Human Services
The Department of Energy (DOE) has prepared and is making available its portion of the semiannual Unified Agenda of Federal Regulatory and Deregulatory Actions (Agenda), including its Regulatory Plan (Plan), pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' and the Regulatory Flexibility Act.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-00033
Type: Notice
Date: 2013-01-07
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 Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2013-00032
Type: Notice
Date: 2013-01-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-00030
Type: Notice
Date: 2013-01-07
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 Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-00029
Type: Notice
Date: 2013-01-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: HRSA Environmental Information and Documentation (EID) (OMB No. 0915-0324)Revision
Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2013-00028
Type: Notice
Date: 2013-01-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
Document Number: 2013-00027
Type: Notice
Date: 2013-01-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Committee on Vital and Health Statistics: Meeting Standards Subcommittee
Document Number: 2013-00011
Type: Notice
Date: 2013-01-07
Agency: Department of Health and Human Services
Findings of Research Misconduct
Document Number: 2013-00010
Type: Notice
Date: 2013-01-07
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Paul J. Muchowski, Ph.D., The J. David Gladstone Institutes: Based on the report of an investigation conducted by The J. David Gladstone Institutes (Gladstone) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Paul J. Muchowski, former Senior Investigator, Gladstone Institute of Neurological Disease, Gladstone, engaged in research misconduct in research supported by National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS054753-06A1. ORI found that the Respondent engaged in research misconduct by falsifying and fabricating data that was included in one (1) funded NIH grant R01 NS054753-06A1 and two (2) submitted NIH grant applications R01 NS054753-06 and R01 NS047237-06. Specifically, ORI finds that the Respondent knowingly and intentionally: Falsely reported research experiments when the results did not exist at the time the grant applications were submitted. Specifically: [rtrif] in Figures 19-21 and related text of grant application R01 NS047237-06, the Respondent claimed he had successfully transduced human neuroblastoma SH-SY5Y cells expressing [alpha]-synuclein ([alpha]Syn) with lentiviruses containing small hairpin RNAs (shRNAs) that targeted Cog6, Stx7, Vps52, or Vps33a. The Respondent reported lentiviral expressed Cog6 significantly exacerbated [alpha]-Syn toxicity in SH-SY5Y cells, when only plasmid shRNAs were generated and utilized at the time the grant application was submitted. [rtrif] in Figure 5 and the accompanying text of grant R01 NS054753-06A1, the Respondent described the insertion of toxic and inert mutant huntingtin (htt) fragments into maltose binding protein- Htt-Cerulean constructs with a nonpathogenic (25Q) or pathogenic (46Q) polyQ repeat, with and without Cerulean. The modified proteins were claimed to have been purified, when the constructs had not been made at the time the grant was submitted. [rtrif] in Figures 5 and 6 and the accompanying text of grant R01 NS054753-06A1, the Respondent claimed to have cloned toxic and inert mutant htt fragments into lentiviral constructs and generated lentiviruses, when the constructs were not made. [rtrif] in Figure 6 and related text in grant R01 NS054753-06A1, the Respondent claimed to have tested immunoblots of lysates from primary neurons with an antibody against mutant htt, which demonstrated that levels of htt expression in transduced cells were roughly equivalent to levels in normal neurons, when the experiment was not conducted. Falsified Figure 3 of grant application R01 NS054753-06 by labeling the Western blot images for the expression of mutant htt in lentiviral-transduced primary neurons as `Cortex' (left panel) and `Striatum' (right panel), when the results were actually from the microglial cell lines N9 and BV2, respectively. Dr. Muchowski has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of two (2) years, beginning on December 10, 2012: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for PHS support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; and (2) to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal
Document Number: 2013-00009
Type: Notice
Date: 2013-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
This document withdraws a Food and Drug Administration (FDA) notice that published in the Federal Register of December 11, 2012 (77 FR 73662).
Office for State, Tribal, Local and Territorial Support (OSTLTS)
Document Number: 2013-00007
Type: Notice
Date: 2013-01-07
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2013-00004
Type: Notice
Date: 2013-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments
Document Number: 2013-00003
Type: Notice
Date: 2013-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Accessible Standardized Medical Device Labeling.'' The purpose of this public workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-31592
Type: Notice
Date: 2013-01-07
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: ``Pilot Test of the Proposed Value and Efficiency Surveys and Communicating About Value Checklist.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-31591
Type: Notice
Date: 2013-01-07
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: ``Using Health Information Technology in Practice Redesign: Impact of Health Information Technology on Workflow.'' 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 October 31st, 2012 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.
Prospective Grant of Exclusive License: The Development of Gene Expression Signatures of Neoplasm Responsiveness to mTOR and HDAC Inhibitor Combination Therapy
Document Number: 2012-31743
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Empire Genomics LLC of an exclusive patent license to practice the inventions embodied in US Provisional Patent Application 61/558,402 entitled, ``Gene Expression Signatures of Neoplasm Responsiveness to Therapy'' [HHS Ref. E-013-2012/0-US-01], and all continuing applications and foreign counterparts. The patent rights in this invention have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:
Clinical Center; Notice of Meeting
Document Number: 2012-31741
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-31740
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-31739
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-31738
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-31737
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2012-31692
Type: Notice
Date: 2013-01-04
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: 2012-31689
Type: Notice
Date: 2013-01-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2012-31685
Type: Notice
Date: 2013-01-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Imaging Drugs Advisory Committee; Notice of Meeting
Document Number: 2012-31676
Type: Notice
Date: 2013-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
Advisory Committee for Reproductive Health Drugs; Notice of Meeting
Document Number: 2012-31675
Type: Notice
Date: 2013-01-04
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-31631
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-31630
Type: Notice
Date: 2013-01-04
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
Document Number: 2012-31535
Type: Notice
Date: 2013-01-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.