Notices. DEPARTMENT OF HEALTH AND HUMAN SERVICES
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/register/2006/05/23/06-4772A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; ActiGraph Accelerometer Validation Study *Summary:* 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 for review and approval of the information collection listed below. This proposed information collection was previously published in the **Federal Register** on January 23, 2006, page 3312 and allowed 60-days for public comment. One public comment was 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:* Actigraph Accelerometer Validation Study *Type of Information Collection Request:* New. *Need and Use of Information Collection:* The NCI is collaborating with other NIH Institutes on a proposed longitudinal study of Hispanic subpopulations in the United States referred to as the Hispanic Community Health Study. The Hispanic population is now the largest minority population in the U.S. with a projected three-fold growth by 2050. Hispanic subgroups are influenced by a number of chronic disease risk factors associated with immigration from different cultural settings and environments. These factors include diet, physical activity, community support, working conditions, and access to health care. Hispanic groups have higher rates of obesity and diabetes than non-Hispanic groups, but have lower coronary disease and cancer (all sites) mortality. There are also observed differences in health outcomes between Hispanic subgroups. For example, Puerto Ricans have a four-fold higher asthma prevalence than Mexican-Americans. Hispanic populations are understudied with respect to many diseases and risk factors. Their projected population growth underscores the need for accurate evaluation of their disease burden and risk. A vast amount of research suggests that the level of physical activity influences many of the chronic diseases and conditions of interest, including obesity, diabetes, cardiovascular disease, and cancer. To better understand the relationship between physical activity and chronic disease, and to make specific activity prescriptions, it is necessary to be able to accurately assess levels and types of activity. In particular, better methods are needed to improve the validity and reliability of physical activity assessment instruments to better assess the frequency, duration, and intensity of physical activity. For that reason, NCI plans to evaluate the use of a new type of accelerometer, a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time. This new accelerometer will be used in the Hispanic Community Health Study and will allow examination of levels as well as patterns of activity. Physical activity was measured with accelerometers in the nationally representative 2003-2006 National Health and Nutrition Examination Survey (NHANES) (OMB#: 0920-0237, October 15, 2004, Vol 69, pp. 61253-61254). NHANES provides estimates for Mexican-American, but not other Hispanic subgroups. Between the time of the NHANES and the Hispanic Community Health Study, there has been a change in the technology of the accelerometer used in NHANES. To allow comparison of the physical activity data that will be collected from the four Hispanic subgroups in the Hispanic Community Study to the data collected with the previous technology used in NHANES, a cross-validation study is needed. The proposed study, the ActiGraph Accelerometer Validation Study, will serve this purpose. It is a cross-validation study comparing the two ActiGraph accelerometer models under different circumstances of walking or jogging in differing age groups and for both genders. *Frequency of response:* One-time study. *Affected Public:* Individuals. *Type of Respondents:* Healthy adults between the ages of 18-74 years. The annual reporting burden is as follows: *Estimated Number of Respondents: 144; Estimated Number of Responses per Respondent:* 1.14; *Average Burden Hours Per Response: 0.66; and Estimated Total Annual Burden Hours Requested:* 62. The annualized cost to respondents is estimated at: $1116. Data Collection Task Number of participants Frequency of response Average time per response Annual hour burden Hourly wage rate Cost to respond Screener 144 1 0.25 12 $18.00 $216 Height and weight 120 1 0.25 10 18.00 180 Accelerometer fitting 120 1 0.5 20 18.00 360 Walking track 120 1 0.5 0.66 20 62 18.00 360 1116 There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:
(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility,
(2)The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used,
(3)Ways to enhance the quality, utility and clarity of the information to be collected; and
(4)Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Direct Comments to OMB:* Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Richard Troiano, CDR, U.S. Public Health Service, Risk Factor Monitoring and Methods Branch, Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, EPN 4005, 6130 Executive Blvd, MSC 7344, Bethesda, MD 20892-7344, or call non-toll-free number 301-435-6822, or FAX your request to
(301)435-3710, or E-mail your request, including your address, to: *troianor@mail.nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. Dated: May 16, 2006. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E6-7857 Filed 5-22-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Meeting: Secretary's Advisory Committee on Genetics, Health, and Society Pursuant to Public Law 92-463, notice is hereby given of the tenth meeting of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), U.S. Public Health Service. The meeting will be held from 8:30 a.m. to approximately 5 p.m. on Monday, June 26, 2006 and 8:30 a.m. to approximately 5 p.m. on Tuesday, June 27, 2006, at the National Institutes of Health, Building 31, C Wing, Conference Room 6, 31 Center Drive, Bethesda, MD 20892. The meeting will be open to the public with attendance limited to space available. The meeting also will be Webcast. The first day of the meeting will include a review of the Committee's draft report and recommendations on pharmacogenomics, and a briefing on FDA's Critical Path Initiative. The Committee will also hear from the Centers for Medicare & Medicaid Services ont he status of a proposal to add a genetics specialty to the regulations implementing the Clinical Laboratory Improvement Act Amendments. In addition, the Committee will discuss the status of its solicitation of public comments on the Committee's draft report “Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease” (posted at *http://www4.od.nih.gov/oba/sacghs/public_comments.htm* ). Issues to be discussed on the second day will include several presentations intended to provide the Committee with a better understanding of the impact of gene patents and licensing practices on access to genetic tests and services as well as deliberations about the Committee's next steps on this issue. The Committee will also be updated about the status of Federal genetic non-discrimination legislation and the work of the two interagency work groups monitoring claims made by companies advertising genetic tests on the Internet and evaluating the public health impact of DTC marketing of genetic tests. Time will be provided each day for public comments. The Committee would welcome hearing from anyone wishing to provide public comment on any issue related to genetics, health and society. Individuals who would like to provide public comment should notify the SACGHS Executive Secretary, Ms. Sarah Carr, by telephone at 301-496-9838 or E-mail at *sc112c@nih.gov.* The SACGHS office is located at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892. Anyone planning to attend the meeting who is in need of special assistance, such as sign language interpretation or other reasonable accommodations, is also asked to contact the Executive Secretary. Under authority of 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established SACGHS to serve as a public forum for deliberations on the broad range of human health and societal issues raised by the development and use of genetic technologies and, as warranted, to provide advice on these issues. The draft meeting agenda and other information about SACGHS, including information about access to the Webcast, will be available at the following Web site: *http://www4.od.nih.gov/oba/sacghs.htm.* Dated: May 15, 2006. Anna Snouffer, Acting Director, NIH Office of Federal Advisory Committee Policy. [FR Doc. 06-4772 Filed 5-22-06; 8:45 am]
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- Pub. L. 92-463
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