Department of Health and Human Services March 20, 2013 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Chronic Disease Self-Management Education Program Standardized Data Collection
Document Number: 2013-06390
Type: Notice
Date: 2013-03-20
Agency: Department of Health and Human Services
The Administration on Aging (AoA), now part of the Administration for Community Living, is announcing that the proposed collection of information listed below 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
Document Number: 2013-06382
Type: Notice
Date: 2013-03-20
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 for Toxic Substances and Disease Registry Availability of Final Toxicological Profile
Document Number: 2013-06377
Type: Notice
Date: 2013-03-20
Agency: Department of Health and Human Services
This notice announces the availability of the final Toxicological Profile for Uranium prepared by ATSDR.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Correction
Document Number: 2013-06357
Type: Proposed Rule
Date: 2013-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is correcting the preamble to a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA proposed these standards as part of our implementation of the FDA Food Safety Modernization Act. The document published with several technical errors, including some errors in cross references, as well as several errors in reference numbers cited throughout the document. This document corrects those errors. We are also placing a corrected copy of the proposed rule in the docket.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Correction
Document Number: 2013-06356
Type: Proposed Rule
Date: 2013-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is correcting a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would amend our regulation for current good manufacturing practice in manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That proposed rule also would revise certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' We proposed these actions as part of our announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The document published with several typographical errors, stylistic errors (such as incorrect indentation of bulleted paragraphs and a gap in the sequential numbering of tables), and a mistake in the date of a reference. The document also published with an Appendix in which all references are numbered incorrectly. This document corrects those errors.
Public Hearing Before a Public Advisory Committee; Technical Amendments
Document Number: 2013-06354
Type: Rule
Date: 2013-03-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations regarding advisory committees to address minor technical changes and corrections to statutory citations. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs
Document Number: 2013-06351
Type: Notice
Date: 2013-03-20
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 solicits comments on the information collection contained in FDA's regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-06347
Type: Notice
Date: 2013-03-20
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 Meetings
Document Number: 2013-06339
Type: Notice
Date: 2013-03-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-06338
Type: Notice
Date: 2013-03-20
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2013-06326
Type: Notice
Date: 2013-03-20
Agency: Department of Health and Human Services, Administration for Children and Families
Meetings of the National Biodefense Science Board
Document Number: 2013-06308
Type: Notice
Date: 2013-03-20
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding public meetings on April 2 and April 3, 2013.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-06217
Type: Notice
Date: 2013-03-20
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey Insurance Component.'' 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 December 26th, 2012 and allowed 60 days for public comment. Two comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Patient Safety Organizations: Voluntary Relinquishment From Universal Safety Solution PSO
Document Number: 2013-06216
Type: Notice
Date: 2013-03-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from Universal Safety Solution PSO of its status as a PSO, and has delisted the PSO accordingly.
Patient Safety Organizations: Voluntary Relinquishment From QAISys, Inc.
Document Number: 2013-06215
Type: Notice
Date: 2013-03-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21 b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from QAISys, Inc. of its status as a PSO, and has delisted the PSO accordingly.