Department of Health and Human Services January 26, 2007 – 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. Proposed Collection: Title: Phase II of A Prospective Cohort Study of Diet and Cancer in Members of the American Association of Retired Persons. Type of Information Collection Request: New. Need and Use of Information Collection: The specific objectives of the current study are to: (1) Examine prospectively the relation between diet and major cancers (especially those of the breast, colorectal, prostate, and non- Hodgkin's lymphoma; (2) in a series of pilot studies, evaluate the quality and completeness of dietary data collected from automated web- based dietary assessment instruments, individually and collectively, in a large cohort, and; (3) in a calibration substudy, compare energy expenditure (measured by doubly labeled water) and protein and potassium intakes (measured by 24-hour urinary nitrogen and potassium excretion) with intakes of energy, protein, and potassium as reported on web-based, automated 24-Hour Dietary Record (24HR), an automated Diet History Questionnaire (DHQ), and an automated DHQ adjusted by automated 7-Day Food Lists (7DFLs) to assess measurement error structure in the instruments. The proposed study will build on the existing Prospective Study of Diet and Cancer in members of the American Association of Retired Persons by updating exposure information in the existing cohort and allowing for continued tracking and follow-up; (2) expanding the cohort by recruiting additional participants and surveying their diet and other exposures. In addition to the 566,403 persons from the original cohort, a new cohort of 2.5 million 50-59 year olds from the same states as the original AARP cohort, and 4 million 50-69 year olds from 8 new states will be contacted as part of the recruitment and data collection effort. Phase II will apply the latest technology to use web-based data collection instruments for economical and efficient assessment of dietary exposures of study participants. This uniquely designed cohort study has a capacity greater than that of any previous study for evaluating connections between dietary factors and major cancers. Frequency of Response: The frequency of response is dependent on the instrument and the portion of the study that the respondent is participating in (pilot, main study, and/or calibration substudy), as described in the table below. Affected Public: Individuals. Type of Respondents: U.S. adults (person ages 50-85). The annual reporting burden is as follows:

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 FDA's collection of information from local, State, and tribal governmental agencies concerning their adoption of, or plans to adopt, all or portions of the FDA Food Code or its equivalent by regulation, law, or ordinance.

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 requirements for FDA regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP).

This notice announces the renewal and name change of the Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence Development Coverage Advisory Committee (MedCAC). It also requests nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MedCAC).

This document corrects a technical error that appeared in the wage index table in the September 1, 2006 Federal Register, entitled ``Hospice Wage Index for Fiscal Year 2007.''