Department of Health and Human Services November 27, 2013 – Federal Register Recent Federal Regulation Documents

Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-28454
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Pantex Plant in Amarillo, Texas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-28453
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Feed Materials Production Center (FMPC) in Fernald, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-28452
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Feed Materials Production Center (FMPC) in Fernald, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Submission for OMB Review; Comment Request
Document Number: 2013-28448
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice
Document Number: 2013-28438
Type: Notice
Date: 2013-11-27
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 FDA's Importer's Entry Notice.
Risk Communications Advisory Committee; Notice of Meeting
Document Number: 2013-28435
Type: Notice
Date: 2013-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2013-28430
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services, Administration for Children and Families
Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period
Document Number: 2013-28394
Type: Notice
Date: 2013-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate'', published in the Federal Register of September 10, 2013 (78 FR 55263). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment period due to the inability of some commenters to submit comments through the www.regulations.gov Web site from November 4, 2013, through November 13, 2013, due to technical difficulties.
Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Reopening of the Comment Period
Document Number: 2013-28392
Type: Notice
Date: 2013-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in the Federal Register of September 10, 2013 (78 FR 55261). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment period due to the inability of some commenters to submit comments through the www.regulations.gov Web site from November 4, 2013, through November 13, 2013, due to technical difficulties.
Transport Format for the Submission of Regulatory Study Data; Notice of Pilot Project
Document Number: 2013-28391
Type: Notice
Date: 2013-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) are announcing a pilot project to evaluate the Clinical Data Interchange Standard Consortium (CDISC) Submission Data Standards (SDS) Extensible Markup Language (XML) transport format for the submission of regulatory study data. The current study data transport format supported by FDA is the SAS Transport (XPORT) version 5 file format. Although XPORT has been a reliable exchange format for many years, it is not an extensible modern technology. SDS XML is an extension of the CDISC Operational Data Model, which is a vendor neutral, platform-independent format for the exchange and archive of study data. FDA is announcing an invitation to sponsors to participate in this pilot project to evaluate the SDS XML transport format.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-28385
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number OS-0990-0323, scheduled to expire on 30 April 2014. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-28376
Type: Notice
Date: 2013-11-27
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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-28375
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent License: GMCSF-BclxL-Derived Chimeric Therapeutics for Use in Treatment of Cancer, Neutropenia, CNS Injury and Parkinson's Disease
Document Number: 2013-28374
Type: Notice
Date: 2013-11-27
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, indicates that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in technology family E-150-2005/0, including U.S. Patent application 11/991,692 [HHS Ref. E- 150-2005/0-US-07], PCT Application PCT/US06/35070 [HHS Ref. E-150-2005/ 0-PCT-02] and foreign equivalents thereof, entitled ``Methods and Compositions for Inhibiting Cell Death or Enhancing Cell Proliferation'', to Medicenna Therapeutics, Inc., located in Vancouver, Canada. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive patent license territory may be worldwide, and the field of use may be limited to: