Department of Health and Human Services April 6, 2011 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; Comment Request; Short Follow-Up Questionnaire for the National Institutes of Health (NIH)-AARP Diet and Health Study (NCI)
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 February 4, 2011 (76 FR 6485) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Short Follow-Up Questionnaire for the National Institutes of Health (NIH)-AARP Diet and Health Study (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The purpose of this short 2-page questionnaire is to obtain information on 18 different medical conditions, several medical procedures, and lifestyle characteristics from 485,909 participants of the NIH-AARP Diet and Health Study. The questionnaire will support the ongoing examination between cancer and nutritional exposures. A pilot mailing to 1,600 randomly selected NIH-AARP Diet and Health study participants confirmed the feasibility of the methodology and willingness of respondents to participate in this data collection effort. This questionnaire adheres to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50-85). The annual reporting burden is displayed in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Medicare Programs: Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment
This interim final rule with comment will revise the end-stage renal disease (ESRD) transition budget-neutrality adjustment finalized in the CY 2011 ESRD Prospective Payment System (PPS) final rule for renal dialysis services provided on April 1, 2011 through December 31, 2011. We are revising the transition budget-neutrality adjustment to reflect the actual election decision to receive payment under the ESRD PPS for renal dialysis services furnished on or after January 1, 2011 made by ESRD facilities, rather than projected elections using the same methodology as described in the ESRD PPS proposed and final rules. This results in a zero percent adjustment for renal dialysis services furnished April 1, 2011 through December 31, 2011.
Maria Carmen Palazzo: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Maria Carmen Palazzo, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Palazzo was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product or otherwise relating to the regulation of any drug product under the FD&C Act. Dr. Palazzo was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Palazzo failed to respond. Dr. Palazzo's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for a Nonvoting Industry Representative on an FDA Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Allergenic Products Advisory Committee notify FDA in writing. A nominee may either be self- nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
To implement the vending machine labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), the Food and Drug Administration (FDA) is proposing requirements for providing calorie information for certain articles of food sold from vending machines. The Affordable Care Act, in part, amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to, among other things, require that for an article of food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase, and is operated by a person engaged in the business of owning or operating 20 or more vending machines, the vending machine operator must disclose the number of calories for the article of food. Vending machine operators not subject to the requirements of the Affordable Care Act may elect to be subject to the Federal requirements by registering with FDA. Providing calorie disclosures for food sold from vending machines would assist consumers in making healthier dietary choices.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
To implement the menu labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), the Food and Drug Administration (FDA) is proposing requirements for providing certain nutrition information for standard menu items in certain chain restaurants and similar retail food establishments. The Affordable Care Act, in part, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the Affordable Care Act, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to the Federal requirements by registering every other year with the FDA. Providing calorie and other nutrition information in restaurants and similar retail food establishments would assist consumers in making healthier dietary choices.
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