Department of Health and Human Services December 23, 2010 – Federal Register Recent Federal Regulation Documents

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 National Cancer Institute (NCI), 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.

On Wednesday, April 8, 2009 [74 FR 15985], the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announced in the Federal Register plans to evaluate the scientific data on carbon nanotubes and to issue its findings on the potential health risks. A draft Current Intelligence Bulletin entitled ``Occupational Exposure to Carbon Nanotubes and Nanofibers'' has been developed which contains an assessment of the toxicological data and provides recommendations for the safe handling of these materials. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. The draft document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/docket/review/docket161A/ default.html. This guidance publication does not have the force or effect of the law. Public Comment Period: Comments must be received by February 18, 2011. Public Meeting Time and Date: 9 a.m.-4 p.m., February 3, 2011. Place: Millennium Hotel Cincinnati, Grand Ballroom A, 150 West 5th Street, Cincinnati, OH 45202. Purpose of Meeting: To discuss and obtain comments on the draft document, ``Occupational Exposure to Carbon Nanotubes and Nanofibers''. Special emphasis will be placed on discussion of the following: (1) Whether the hazard identification, risk estimation, and discussion of health effects for carbon nanotubes and nanofibers are a reasonable reflection of the current understanding of the evidence in the scientific literature; (2) Workplaces and occupations where exposure to carbon nanotubes and nanofibers occur; (3) Current strategies for controlling occupational exposure to carbon nanotubes and nanofibers (e.g., engineering controls, work practices, personal protective equipment; (4) Current exposure measurement methods and challenges in measuring workplace exposures to carbon nanotubes and nanofibers; (5) Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies). Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room accommodates 100 people. Interested parties should contact the NIOSH Docket Office at nioshdocket@cdc.gov, (513) 533-8611, or fax (513) 533-8285, for information about how to register for the meeting. Due to limited space, notification of intent to attend the meeting must be made to the NIOSH Docket Office no later than January 28, 2011. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come basis. Persons wanting to provide oral comments will be permitted 15 minutes. If additional time becomes available, presenters will be notified. All requests to present should contain the name, address, telephone number, and relevant business affiliations of the presenter, topic of the presentation, and the approximate time requested for the presentation. Oral comments made at the public meeting must also be submitted to the NIOSH Docket Office in writing in order to be considered by the Agency. Request for Information: NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible health risks of occupational exposure to carbon nanotubes and nanofibers. Examples of requested information include, but are not to be limited to: (1) Identification of industries or occupations in which exposures to carbon nanotubes and nanofibers can occur; (2) Trends in the production and use of carbon nanotubes and nanofibers; (3) Exposure measurement data; (4) Case reports or other health information demonstrating possible health effects in workers exposed to carbon nanotubes or nanofibers; (5) Reports of experimental in vivo and in vitro studies that provide evidence of a dose-relationship between exposure to carbon nanotubes and nanofibers and biological activity; (6) Reports of experimental data on the airborne characteristics of carbon nanotubes or nanofibers, including information on the amounts that are inhalable and respirable; (7) Criteria and rationale for including workers in a medical surveillance and screening program; (8) Description of work practices and engineering controls used to reduce or prevent workplace exposure to carbon nanotubes and nanofibers; and (9) Educational materials for worker safety and training on the safe handling of carbon nanotubes and nanofibers.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

This advance notice of proposed rulemaking announces the intention of CMS to solicit comment on the need to publish a proposed rule to address two policies related to the Emergency Medical Treatment and Labor Act (EMTALA). Specifically, this document serves as a request for comments regarding our need to revisit the policies articulated in the September 9, 2003 Federal Register (68 FR 53243) and the August 19, 2008 Federal Register (73 FR 48656) concerning the applicability of EMTALA to hospital inpatients and the responsibilities of hospitals with specialized capabilities, respectively.

The Food and Drug Administration (FDA) is announcing the availability of draft ``Compliance Policy Guide Sec. 510.800 BeveragesServing Size Labeling'' (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on FDA's exercise of enforcement discretion related to serving size labeling for certain beverages that are packaged in containers larger than 20 fluid ounces and that display calories per 12 fluid ounce serving on the front of the container.

The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 527.300 Dairy Products Microbial Contaminants and Alkaline Phosphatase Activity (the CPG). The CPG provides guidance for FDA staff on its enforcement policies for pathogens and other indicators of inadequate pasteurization or post-pasteurization contamination of dairy products.

This document contains proposed regulations implementing the rules for health insurance issuers regarding the disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The proposed rule would establish a rate review program to ensure that all rate increases that meet or exceed an established threshold are reviewed by a State or HHS to determine whether the rate increases are unreasonable.