Department of Health and Human Services December 30, 2013 – Federal Register Recent Federal Regulation Documents

Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation
Document Number: 2013-31218
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non- cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for IABPs when indicated for septic shock or pulsatile flow generation.
Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
Document Number: 2013-31217
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device ``temporary mandibular condyle reconstruction plate.'' FDA is also issuing the special controls guideline entitled ``Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline'' that sets forth the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.
Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses
Document Number: 2013-31216
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti- anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations
Document Number: 2013-31215
Type: Notice
Date: 2013-12-30
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.
Strategies To Address Hemolytic Complications of Immune Globulin Infusions; Public Workshop
Document Number: 2013-31213
Type: Notice
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Tapentadol; Tramadol; Ketamine; gamma-Butyrolactone; 22 Additional Substances; Request for Comments
Document Number: 2013-31212
Type: Notice
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 26 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA).
New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction
Document Number: 2013-31184
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a document that appeared in the Federal Register of December 16, 2013 (78 FR 76059). The document amended the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for which free- choice, loose-mineral medicated feeds containing bambermycins are approved. The document was published with an incorrect docket number. This document corrects that error.
Discretionary Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2013-31161
Type: Notice
Date: 2013-12-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Findings of Research Misconduct
Document Number: 2013-31160
Type: Notice
Date: 2013-12-30
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: Baoyan Xu, M.D., Ph.D., National Heart, Lung, and Blood Institute, National Institutes of Health: Based on allegations made by readers of a published paper,\1\ additional review by the National Institutes of Health (NIH) and ORI, and a limited admission by the Respondent that ``some better looking strips were repeatedly used as representatives for several times [sic],'' ORI found that Dr. Baoyan Xu, formerly a Postdoctoral Fellow, Hematology Branch, Systems Biology Center, National Heart, Lung, and Blood Institute (NHLBI), NIH, and currently at the Institute of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chonqing, China, engaged in research misconduct in research supported by intramural research at NHLBI, NIH.
Proposed Collection; 60-Day Comment Request: Generic Clearance To Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development
Document Number: 2013-31159
Type: Notice
Date: 2013-12-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-1877 or Email your request, including your address to glavins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-31158
Type: Notice
Date: 2013-12-30
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.