Proposed Collection; Comment Request-Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study, 13647-13648 [2011-5800]

Download as PDF 13647 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices the exercise of this authority prior to the effective date of this delegation. This delegation is effective upon date of signature. Dated: March 4, 2011. Kathleen Sebelius, Secretary. [FR Doc. 2011–5808 Filed 3–11–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request—Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study Summary: 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: Interactive Diet and Activity Tracking in AARP (iDATA): Biomarker Based Validation Study. Type of Information Collection Request: New. Need and Use of Information Collection: The AARP-based study is one component of a multi-center biomarker validation study project involving two other large cohorts in the United States. The iDATA study involves large cohorts and provides the necessary sample size to evaluate the measurement error structure of the diet and physical activity assessment instruments and the heterogeneity of the measurement error structure across multiple and diverse study populations. The iDATA study will include 1,500 participants from the NIH–AARP Diet and Health Study and current AARP membership. The data collection instruments adhere to The Public Health Service Act, which provides authority to the Risk Factor Monitoring and Methods Branch in the Division of Cancer Control and Population Sciences and the Division of Cancer Epidemiology and Genetics. Both divisions work to reduce cancer in the U.S. population by establishing and supporting programs for the detection, diagnosis, prevention and treatment of cancer; and by collecting, identifying, analyzing and disseminating information on cancer research, diagnosis, prevention and treatment. Dietary and physical activity data will be gathered using the instruments as detailed below. In addition, biospecimen and clinic data will be also gathered. Frequency of Response: Monthly. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50–74). The annual reporting burden is provided for each study component as shown in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. TABLE 1 ESTIMATES OF ANNUAL BURDEN HOURS [Type of respondents for all instruments: Adult participants, 50–74 years of age] Number of respondents Frequency of response Average time per response (minutes/hour) Annual burden hours Pre-Screening Telephone Interview (Attachment 1) ... Clinic Eligibility Screening Interview (Attachment 3) ... NHANES III Anthropometry (Attachment 13) .............. Resting Metabolic Rate—Main (Attachment 7) ........... Resting Metabolic Rate—Subsample (Attachment 7) Fasting Blood Protocol and Form (Attachment 5) ...... Fitness test Protocol and Form (Attachment 10) ........ Physical Activity Readiness Questionnaires—PAR–Q or PARmed-X (Attachments 11A–11B). Doubly Labelled Water—Main (Attachment 6) ............ Doubly Labelled Water—Subsample (Attachment 6) Automated Self-Administered 24-hour Dietary Recall (ASA24) (Attachment 32). 4-Day Food Record (Attachment 17) .......................... Diet History Questionnaire (DHQ*Web-II) (Attachment 33). 7-Day Food Checklist (Attachment 16) ....................... Activities Completed over Time in 24 Hours (ACT24) (Attachment 34). Community Healthy Activities Model Program for Seniors (CHAMPS) (Attachment 19). Harvard Lifestyle Validation Study Physical Activity Questionnaire (Attachment 18). Sedentary Behaviors Questionnaire (Attachment 21) Stanford physical activity Survey (Attachment 22) ..... NIH–AARP physical activity questions (Attachment 20). 24 Hour Urine Collection Log (Attachment 14) ........... Saliva Protocol and Form (Attachment 15) ................. Heart Rate Monitor Log (Attachment 8) ...................... Physical Activity Monitor Log (Accelerometer/Inclinometer) (Attachment 12). 1,334 742 742 742 34 742 742 742 1 1 3 1 1 2 1 1 15/60 (.25) 10/60 (.167) 10/60 (.167) 30/60 (.50) 30/60 (.50) 10/60 (.167) 15/60 (.25) 5/60 (.083) 334 124 371 371 17 247 186 62 742 34 742 1 1 6 40/60 (.667) 40/60 (.667) 30/60 (.50) 495 23 2,227 742 742 2 2 60/60 (1.0) 45/60 (.75) 1,485 1,114 742 742 2 6 60/60 (1.0) 30/60 (.50) 1,485 2,227 742 2 15/60 (.25) 371 742 2 10/60 (.167) 247 742 742 742 2 2 2 20/60 (.33) 8/60 (.133) 10/60 (.167) 495 198 247 742 742 34 742 2 3 1 2 60/60 (1.0) 10/60 (.167) 35/60 (.583) 35/60 (.583) 1,485 371 20 866 ...................................................................................... .................... .................... ........................ 15,060 Study component Instrument Screening ........................... Clinical Components .......... Dietary Questionnaires ...... Physical Activity Questionnaires. mstockstill on DSKH9S0YB1PROD with NOTICES Home Collections .............. Total ............................ VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1 13648 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 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) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Heather Bowles, Risk Factor Monitoring and Methods Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, 6130 Executive Blvd MSC 7344, Bethesda, MD 20892–7335 or call non-toll-free number 301–496–7344 or e-mail your request, including your address to: bowleshr@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: March 8, 2011. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2011–5800 Filed 3–11–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Process Evaluation of the NIH Roadmap Epigenomics Program Summary: 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 Institute of Drug Abuse (NIDA), 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: Process Evaluation of the NIH Roadmap Epigenomics Program. Type of Information Collection Request: New. Need and Use of Information Collection: The proposed information collection is essential to the process evaluation of the NIH Roadmap Epigenomics Program. The process evaluation is a requirement of each awardee funded under the NIH Roadmap Epigenomics Program. This participation requirement is stated in the program’s Requests for Applications. This evaluation study, a mixedmethods study which uses secondary source documentation and information from tracking and monitoring systems along with primary data to assess program process and progress, is nonexperimental. The assessment is based on secondary source information, with primary source information collection added to augment the reliability and internal validity. The primary data collection uses information categories that genuinely tap added distinctions and opinions that relate to it to build the weight of evidence from first-hand sources and substantiate the initial hypotheses about the program phenomenon and its differences from a typical research portfolio of individual and insular projects. The synthesized results across primary and secondary data sources will provide critical insights on transformativeness of high-impact, trans-NIH programs and contribute important information about the synergies and collaborations in multicomponent scientific research. It will also identify areas for program improvement and lessons learned that might be useful to other research programs of the Agency. To reduce response bias and to make the survey as accessible as possible to busy principal investigators, the survey will be Web-based. Frequency of Response: Once. Affected Public: Principal Investigators of the program at not-forprofit institutions. Type of Respondents: Principal Investigators. The annual reporting burden is as follows: Estimated number of Respondents: 53. Estimated Number of Responses per Respondent: 1. Average Burden Hours Per Response: 0.33. Estimated Total Annual Burden Hours Requested: 17.49. The annualized cost to respondents is estimated at: $891.99. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Frequency of responses per respondent Average burden hours per response Annual burden hours requested 53 1 0.33 (20 minutes) ....... 17.49 mstockstill on DSKH9S0YB1PROD with NOTICES Principal Investigators ......................................................................... 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 VerDate Mar<15>2010 16:20 Mar 11, 2011 Jkt 223001 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 collection techniques or other forms of information technology. For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Genevieve deAlmeida-Morris, PhD, M.P.H., Project Officer, Office of Science Policy and Communications, NIH/NIDA, NSC— Neuroscience Center, 5229, 6001 E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13647-13648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5800]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment Request--Interactive Diet and
Activity Tracking in AARP (iDATA): Biomarker Based Validation Study

Summary: 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: Interactive Diet and Activity Tracking
in AARP (iDATA): Biomarker Based Validation Study.
Type of Information Collection Request: New.
Need and Use of Information Collection: The AARP-based study is one
component of a multi-center biomarker validation study project
involving two other large cohorts in the United States. The iDATA study
involves large cohorts and provides the necessary sample size to
evaluate the measurement error structure of the diet and physical
activity assessment instruments and the heterogeneity of the
measurement error structure across multiple and diverse study
populations. The iDATA study will include 1,500 participants from the
NIH-AARP Diet and Health Study and current AARP membership. The data
collection instruments adhere to The Public Health Service Act, which
provides authority to the Risk Factor Monitoring and Methods Branch in
the Division of Cancer Control and Population Sciences and the Division
of Cancer Epidemiology and Genetics. Both divisions work to reduce
cancer in the U.S. population by establishing and supporting programs
for the detection, diagnosis, prevention and treatment of cancer; and
by collecting, identifying, analyzing and disseminating information on
cancer research, diagnosis, prevention and treatment. Dietary and
physical activity data will be gathered using the instruments as
detailed below. In addition, biospecimen and clinic data will be also
gathered.
Frequency of Response: Monthly.
Affected Public: Individuals.
Type of Respondents: U.S. adults (persons aged 50-74).
The annual reporting burden is provided for each study component as
shown in the table below. There are no Capital Costs, Operating Costs,
and/or Maintenance Costs to report.

Table 1 Estimates of Annual Burden Hours
[Type of respondents for all instruments: Adult participants, 50-74 years of age]
----------------------------------------------------------------------------------------------------------------
Average time Annual
Study component Instrument Number of Frequency per response burden
respondents of response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Screening....................... Pre-Screening Telephone 1,334 1 15/60 (.25) 334
Interview (Attachment
1).
Clinic Eligibility 742 1 10/60 (.167) 124
Screening Interview
(Attachment 3).
Clinical Components............. NHANES III 742 3 10/60 (.167) 371
Anthropometry
(Attachment 13).
Resting Metabolic Rate-- 742 1 30/60 (.50) 371
Main (Attachment 7).
Resting Metabolic Rate-- 34 1 30/60 (.50) 17
Subsample (Attachment
7).
Fasting Blood Protocol 742 2 10/60 (.167) 247
and Form (Attachment
5).
Fitness test Protocol 742 1 15/60 (.25) 186
and Form (Attachment
10).
Physical Activity 742 1 5/60 (.083) 62
Readiness
Questionnaires--PAR-Q
or PARmed-X
(Attachments 11A-11B).
Doubly Labelled Water-- 742 1 40/60 (.667) 495
Main (Attachment 6).
Doubly Labelled Water-- 34 1 40/60 (.667) 23
Subsample (Attachment
6).
Dietary Questionnaires.......... Automated Self- 742 6 30/60 (.50) 2,227
Administered 24-hour
Dietary Recall (ASA24)
(Attachment 32).
4-Day Food Record 742 2 60/60 (1.0) 1,485
(Attachment 17).
Diet History 742 2 45/60 (.75) 1,114
Questionnaire (DHQ*Web-
II) (Attachment 33).
7-Day Food Checklist 742 2 60/60 (1.0) 1,485
(Attachment 16).
Physical Activity Questionnaires Activities Completed 742 6 30/60 (.50) 2,227
over Time in 24 Hours
(ACT24) (Attachment
34).
Community Healthy 742 2 15/60 (.25) 371
Activities Model
Program for Seniors
(CHAMPS) (Attachment
19).
Harvard Lifestyle 742 2 10/60 (.167) 247
Validation Study
Physical Activity
Questionnaire
(Attachment 18).
Sedentary Behaviors 742 2 20/60 (.33) 495
Questionnaire
(Attachment 21).
Stanford physical 742 2 8/60 (.133) 198
activity Survey
(Attachment 22).
NIH-AARP physical 742 2 10/60 (.167) 247
activity questions
(Attachment 20).
Home Collections................ 24 Hour Urine 742 2 60/60 (1.0) 1,485
Collection Log
(Attachment 14).
Saliva Protocol and 742 3 10/60 (.167) 371
Form (Attachment 15).
Heart Rate Monitor Log 34 1 35/60 (.583) 20
(Attachment 8).
Physical Activity 742 2 35/60 (.583) 866
Monitor Log
(Accelerometer/
Inclinometer)
(Attachment 12).
------------------------------------------------------
Total....................... ....................... ........... ........... .............. 15,060
----------------------------------------------------------------------------------------------------------------

[[Page 13648]]

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) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Heather Bowles, Risk Factor Monitoring and Methods
Branch, Division of Cancer Control and Population Sciences, National
Cancer Institute, 6130 Executive Blvd MSC 7344, Bethesda, MD 20892-7335
or call non-toll-free number 301-496-7344 or e-mail your request,
including your address to: bowleshr@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.

Dated: March 8, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-5800 Filed 3-11-11; 8:45 am]
BILLING CODE 4140-01-P

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