Proposed Collection; Comment Request; ActiGraph Accelerometer Validation Study, 29653-29654 [E6-7857]

Download as PDF 29653 Federal Register / Vol. 71, No. 99 / Tuesday, May 23, 2006 / Notices prone to develop certain neutrophil antibodies. The results from testing HLA positive donors for neutrophil antibodies in this primary study could be used to develop an optimal testing strategy for large number of donors using the stored repository samples. These dat will provide the basis for calculating donor loss in the event that a TRALI prevention strategy is implemented that includes deferring donors with a history of transfusion or pregnancy or those with HLA or neutrophil antibodies. The second major goal of this study is to develop a repository of blood samples from well characterized blood donors whose detailed transfusion and pregnancy histories are known. Repository samples will be stored indefinitely. Although future research on repository samples is yet to be determined, they may be tested for studies designed to help transfusion safety and transfusion biology. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 7,900; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.17; and Estimated Total Annual Burden Hours Requested: 1343. The annualized cost to respondents is estimated at: $24,174 (based on $18 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Adult Blood Donors .......................................................................................... rmajette on PROD1PC67 with NOTICES Type of respondents 7,900 1 0.17 1343 Request for Comments: Written comments and/or suggestions from the public and affected agencies should address 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 the assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information 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. George Nemo, Project Officer, NHLBI, Two Rockledge Center, Suite 361, 6700 Rockledge Drive, Bethesda, MD 20892, or call non-toll free number 301–435– 0075, or e-mail your request, including your address to nemog@nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if VerDate Aug<31>2005 15:14 May 22, 2006 Jkt 208001 received within 30 days of the date of this publication. Dated: May 12, 2006. Charles M. Peterson, Director, DBDR, National Institutes of Health. [FR Doc. 06–4790 Filed 5–22–06; 8:45 am] 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 fourfold 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 E:\FR\FM\23MYN1.SGM 23MYN1 29654 Federal Register / Vol. 71, No. 99 / Tuesday, May 23, 2006 / Notices 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 crossvalidation study comparing the two ActiGraph accelerometer models under different circumstances of walking or Number of participants Data Collection Task rmajette on PROD1PC67 with NOTICES Screener ..................................................................... Height and weight ...................................................... Accelerometer fitting .................................................. Walking track ............................................................. 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 VerDate Aug<31>2005 15:14 May 22, 2006 Jkt 208001 Frequency of response 144 120 120 120 Average time per response 1 1 1 1 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 301435–6822, 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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. Annual hour burden Hourly wage rate 12 10 20 20 62 $18.00 18.00 18.00 18.00 .................... 0.25 0.25 0.5 0.5 0.66 Cost to respond $216 180 360 360 1116 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 https://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 nondiscrimination legislation and the work of the two interagency work groups monitoring claims made by companies advertising genetic tests on the Internet E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 71, Number 99 (Tuesday, May 23, 2006)]
[Notices]
[Pages 29653-29654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7857]

-----------------------------------------------------------------------

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

[[Page 29654]]

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.

----------------------------------------------------------------------------------------------------------------
Average
Data Collection Task Number of Frequency time per Annual hour Hourly wage Cost to
participants of response response burden rate 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 20 18.00 360
0.66 62 ........... 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

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