Department of Health and Human Services January 28, 2013 – Federal Register Recent Federal Regulation Documents

Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-01663
Type: Notice
Date: 2013-01-28
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-01660
Type: Notice
Date: 2013-01-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2013-01649
Type: Notice
Date: 2013-01-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
New Animal Drugs; Cefpodoxime; Meloxicam
Document Number: 2013-01647
Type: Rule
Date: 2013-01-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Electronic Study Data Submission; Data Standard Support End Date
Document Number: 2013-01641
Type: Notice
Date: 2013-01-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) are announcing the end of support for the 3.1.1. version of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Implementation Guide (SDTM IG 3.1.1.). SDTM IG 3.1.2, which has been available since October 2009, is the newer standard supported by FDA. Support for SDTM IG 3.1.1 will end on January 28, 2015.
Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It?; Public Conference; Request for Comments
Document Number: 2013-01640
Type: Notice
Date: 2013-01-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public conference entitled ``Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It?'' This conference will be cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. Its purpose is to discuss, debate, and build consensus among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose.
2013 Assuring Radiation Protection
Document Number: 2013-01639
Type: Notice
Date: 2013-01-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Devices and Radiological Health (CDRH) radiation protection program. The goal of the 2013 Assuring Radiation Protection will be to coordinate Federal, State, and Tribal activities to achieve effective solutions to present and future radiation control problems. The recipient of this cooperative agreement award will be expected to obtain the States' cooperation and participation on committees and working groups established to deal with individual problems. The recipient will also plan and facilitate an annual meeting and develop and offer educational activities to demonstrate mutually beneficial techniques, procedures, and systems relevant to the mission of assuring radiation protection. The recipient will establish committees, in accordance with Federal statutes and regulations, to address, evaluate, and propose solutions for a wide range of radiation health and protection issues. Examples of relevant areas already identified to be of interest include, but are not limited to: (1) The application of x-rays to the healing arts; (2) the application of non-medical ionizing radiation and medical/non- medical non-ionizing radiation; and (3) the control and mitigation of radiation exposure from all sources.
Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling; Availability
Document Number: 2013-01638
Type: Notice
Date: 2013-01-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling.'' This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug's pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The guidance provides recommendations on when and how genomic principles should be considered and applied in early-phase clinical studies to address questions arising during drug development and regulatory review.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-01622
Type: Notice
Date: 2013-01-28
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), 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 extending the use of the approved information collection assigned OMB control number 4040-0001, which expires on March 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-01621
Type: Notice
Date: 2013-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-01620
Type: Notice
Date: 2013-01-28
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. 207 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.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-01618
Type: Notice
Date: 2013-01-28
Agency: Department of Health and Human Services, Administration for Children and Families
AHRQ Standing Workgroup for Quality Indicator Measure Specification
Document Number: 2013-01348
Type: Notice
Date: 2013-01-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for both a time-limited work group and a standing work group to be convened by an AHRQ contractor. The work groups shall be comprised of individuals with knowledge of the AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues. The overarching goals of each group are to provide feedback to AHRQ regarding refinements to the Qls. The time- limited workgroup is more restricted to specific clinical or methodological issues, while the standing workgroup addresses broader issues related to the measurement cycle.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-01345
Type: Notice
Date: 2013-01-28
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: ``Applying Novel Methods To Better Understand the Relationship Between Health IT and Ambulatory Care Workflow Redesign.'' 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: 2013-01342
Type: Notice
Date: 2013-01-28
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: ``Evaluating the Knowledge and Educational Needs of Students of Health Professions on Patient-Centered Outcomes Research.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.