Department of Health and Human Services August 25, 2010 – Federal Register Recent Federal Regulation Documents

The National Center for Complementary and Alternative Medicine (NCCAM) is developing its third strategic plan and invites the public to provide comments on a draft. The draft will be publicly available through the NCCAM Web site at https://nccam.nih.gov from on or about August 30 through September 30, 2010. The public is invited to provide comments through the NCCAM Web site.

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 four class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; female condom; and transilluminator for breast evaluation. 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.

The National Conversation on Public Health and Chemical Exposures is a collaborative initiative through which many organizations and individuals are helping develop an action agenda for strengthening the nation's approach to protecting the public's health from harmful chemical exposures. This notice announces the availability of draft National Conversation work group reports for public review and comment. CDC/ATSDR has partnered with RESOLVE, a non-profit independent consensus-building organization, to manage aspects of the National Conversation project. RESOLVE is convening the National Conversation Leadership Council and facilitating the work group process.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 16, 2010 (75 FR 34146) and allowed 60-days for public comment. One public comment was received on 7/16/2010 from a business informing us that they are able to provide a time-saving ``batch processing service'' to

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010.'' Section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act) requires certain chain restaurants and similar retail food establishments with 20 or more locations (hereinafter ``chain retail food establishments'') to provide calorie information, and other nutrition information, for standard menu items, food on display, and self-service food. Section 4205 also requires vending machine operators who own or operate 20 or more machines (hereinafter ``chain vending machine operators'') to disclose calories for articles of food. Restaurants and similar retail food establishments with fewer than 20 locations and vending machine operators with fewer than 20 machines may elect to be subject to these Federal requirements by registering every other year with the FDA.

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: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.