Department of Health and Human Services October 2005 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), 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. The proposed information collection below was previously published in the Federal Register on May 18, 2005, page 28544-28545 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 after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: 5 A Day Customized Survey. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of the 5 A Day Customized Survey is to further the development of standardized measures of consumer knowledge, attitudes, and behaviors regarding the consumption of fruits and vegetables. Specifically, the Customized Survey will allow for validation of the new ``cup'' portion sizes (consistent with the 2005 Dietary Guidelines) and identify the most efficacious short screener methods of fruit and vegetable intake. In addition, the Customized Survey will measure established predictors of fruit and vegetable consumption at the national level and explore new predictors and constructs not previously examined for fruit and vegetable consumption. The sample will be drawn from a consumer opinion panel methodology using balancing techniques to mirror the U.S. general population on a set of key demographic variables. A separate sample of African Americans will be drawn from the panel. Prior to fielding the Customized Survey, two pilot studies will be completed as the first phase of this research. Pilot respondents will be drawn from the same consumer panel and have similar demographics as respondents in the main study. A brief description of the two pilot studies follows. In pilot study 1, respondents will initially complete a brief screener questionnaire, three 24-hour dietary recalls over the phone, followed by the Customized Survey by mail. To account for diversity in eating habits, dietary recalls will be obtained for 2 weekdays and 1 weekend per respondent. The recalls will be conducted via phone by trained interviewers using the University of Minnesota's Nutrition Data System (NDS). After completing the dietary recalls pilot respondents will be mailed the Customized Survey within 2 weeks. Fruit and vegetable consumption as assessed by the average of the three 24- hour recalls will be compared with the fruit and vegetable consumption measures from the Customized Survey. In pilot study 2, respondents will complete the Customized Survey by mail at two points in time, six to eight weeks apart. The analysis in pilot study 2 will focus on a rigorous evaluation of the psychometric properties of the Customized Survey instrument to ensure that item-level and instrument-level reliability and validity has been achieved before proceeding to the main data collection phase of the study. Based on the findings of the pilot studies, minor modifications may be made to the Customized Survey prior to the implementation of the main study. Frequency of response: Main study, one time response (5 A Day Customized Survey). Pilot study 1, five times (screener, three 24-hour dietary recalls, 5 A Day Customized Survey). Pilot study 2, two times (5 A Day Customized Survey at two points in time). Affected Public: Individuals. Type of Respondents: U.S. adults. The annual reporting burden is as follows: Estimated Number of Respondents: 5,875; Estimated Number of Responses per Respondent: 1, 2 or 5; Average Burden Hours per Response: .416; and Estimated Total Annual Burden Hours Requested: 2,467.90. The annualized cost to respondents is estimated at: $46,384.28. The annual reporting burden is summarized in exhibit 1 below. There are no Operating or Maintenance Costs to report.

The NTP invites public comments on an updated list of nominations proposed for review in the 12th RoC and the nomination of scientists who have expertise and/or knowledge relevant to the evaluation of carcinogenicity for these nominations (see SUPPLEMENTARY INFORMATION). Information on the nominations under consideration for the RoC can be obtained at the NTP Web site https://ntp.niehs.nih.gov (select ``Report on Carcinogens'') or by contacting Dr. C.W. Jameson at the address provided below.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Ames Laboratory, on the Iowa State University Campus, Ames, Iowa, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

Title 5, U.S. Code, Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that appointment of Performance Review Board members be published in the Federal Register.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Fluoro-Deoxy Glucose (FDG) Positron Emission Tomography (PET) for Dementia and Neurodegenerative Diseases (DND) (PET DND), HHS/CMS/OCSQ, System No. 09-70-0561.'' National Coverage Determinations are determinations by the Secretary (HHS) with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act (the Act) section 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained in Part A or Part B, and must not be otherwise excluded from coverage. In our review of DND indications, we found sufficient evidence to determine that PET scans are no longer experimental. However, the evidence was insufficient to reach a conclusion that FDG PET is reasonable and necessary in all instances. A sufficient inference of benefit, however, can be drawn to support limited coverage if certain safeguards for patients are provided. This inference is based on both the physiological basis for FDG PET usefulness in a differential diagnosis of fronto-temporal dementia (FTD) and Alzheimer's disease (AD), as well as, evidence of a positive benefit of PET for patients with several other dementing neurodegenerative diseases for which there is evidence of sufficient quality to warrant coverage. The purpose of this system is to collect and maintain information on Medicare beneficiaries receiving FDG PET scans for indications for DND when there is not sufficient evidence to reach a firm conclusion that the scan is reasonable and necessary unless they are enrolled in an approved study. Information retrieved from this system will be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Date section for comment period.