Department of Health and Human Services January 18, 2013 – Federal Register Recent Federal Regulation Documents

Medicare Program; Request for Information on Hospital and Vendor Readiness for Electronic Health Records Hospital Inpatient Quality Data Reporting; Extension of Comment Period
Document Number: 2013-01142
Type: Notice
Date: 2013-01-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice extends the comment period for a request for information (RFI) which was published in the January 3, 2013 Federal Register (78 FR 308). The RFI requests that hospitals, electronic health record (EHR) vendors, and other interested parties respond to questions regarding their readiness to conduct electronic reporting of certain patient-level data under the Hospital Inpatient Quality Reporting (IQR) Program using the Quality Reporting Document Architecture (QRDA) Category I. The comment period for the RFI, which would have ended on January 22, 2013, is extended to February 1, 2013.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Document Number: 2013-01032
Type: Notice
Date: 2013-01-18
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 invites comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
Document Number: 2013-01031
Type: Notice
Date: 2013-01-18
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. 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 invites comments on the information collection provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify us that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-01022
Type: Notice
Date: 2013-01-18
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 Assistant Secretary for Health (OASH), 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, OASH seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Document Number: 2013-01006
Type: Proposed Rule
Date: 2013-01-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.
Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance
Document Number: 2013-00994
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) seeks comment on the types of hazard identification and risk management research that should be considered for updating the NIOSH FY2013-FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan 2013-2016) can be found in Docket CDC-2013-0001 at http://www.regulations.gov.
Notice of Development of Set 26 Toxicological Profiles
Document Number: 2013-00991
Type: Notice
Date: 2013-01-18
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the development of Set 26 Toxicological Profiles, which will consist of three updated profiles and two new profiles. Draft for Public Comment versions of these profiles will be available to the public on or about October 17, 2013. Electronic access to these documents will be available at the ATSDR Web site: http:// www.atsdr.cdc.gov/toxprofiles/index.asp.
Office for State, Tribal, Local and Territorial Support (OSTLTS) Meeting; Correction
Document Number: 2013-00989
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This document corrects a notice that was published in the Federal Register on January 7, 2013 (78 FR 949-950). The 10th Biannual Tribal Consultation session has been postponed to coincide with the summer 2013 meetings; the dates will be announced once they are determined. The Tribal Advisory Committee Meeting will be extended and held February 5, 6, and 7, 2013, from 8:00 a.m.-4:30 p.m.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-00988
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-00987
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the National Vaccine Advisory Committee
Document Number: 2013-00950
Type: Notice
Date: 2013-01-18
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at http://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.