[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Notices]
[Pages 35042-35044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14969]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development;
Revision to Proposed Collection; Comment Request; The National
Children's Study (NCS), Vanguard (Pilot) Study
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Child Health and Human
Development (NICHD), 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 March 22, 2010, pages 14165-14168, and allowed 60 days for
public comment. One comment was received. The comment questioned the
value and utility of the proposed data collection, stating that this
type of research is not needed. 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: Pilot Study for the National Children's
Study, Type of Information Collection Request: Revision, Affected
entities: Households and individuals. Types of respondents: People
potentially affected by this action are pregnant women, women age 18-49
years of age, their husbands or partners, and their children who live
in selected areas within National Children's Study sites. Health care
professionals, community leaders, and child care personnel are also
potentially affected. Frequency of Response: On occasion. See burden
table for estimated number of annual responses for each respondent.
Need and use of information collection: The purpose of the proposed
methodological study is to evaluate the feasibility, acceptability, and
cost of three separate recruitment strategies for enrollment of women
into a prospective, national longitudinal study of child health and
development. This Recruitment Substudy is a component of the Vanguard
Phase of the National Children's Study (NCS). In combination, the
studies in the Vanguard Phase will be used to inform the design of the
Main Study of the National Children's Study.
This data collection will evaluate the feasibility, acceptability
and cost of three separate recruitment strategies for enrollment of
women into the NCS. Up to 30 additional sites will be added to the NCS
Vanguard Cohort, as reflected in the burden table, in order to ensure
an adequate cohort size. These additional sites will be chosen from
among those already identified for the Main Study of the NCS. Across
these additional sites, three alternate recruitment strategies will be
assessed:
An enhanced household enumeration strategy that builds on
the lessons learned in the existing Vanguard Study by enhancing
enumeration techniques and employing a more streamlined recruitment
process;
A provider based recruitment strategy that relies on
health care providers for assistance in participant identification and
recruitment; and
A two-tiered recruitment strategy that relies on larger
secondary sampling units to increase the number of geographically-
eligible women in a given area, and allows for both higher-intensity
and lower-intensity forms of data collection.
The feasibility (technical performance), acceptability (respondent
tolerance and impact on study infrastructure), and cost (operations,
time, and effort) of each of these three strategies will be evaluated
using pre-determined measures. The findings will be assessed and used
to inform the strategies, or combinations of strategies, that might be
used in the Main Study of the NCS. Further details pertaining to the
NCS background and planning can be found at: http://www.nationalchildrensstudy.gov.
Burden statement: The public burden for this study will vary
depending on the eligibility and pregnancy status of potential
participants at the time of household screening and the method of
recruitment. The table below provides an annualized average burden per
person for each stage of the Recruitment Substudy.
Table A.2--Estimated Hour Burden and Cost for Recruitment Substudy Respondents--Stage 1
[July 2010 to December 2010]
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Number of Responses per Hours per Annual hour
Recruitment strategy Activity Type of respondent respondents respondent response burden
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Provider-based: 10 Study LocProjected for Stage 1 (July 2010-December 2010)
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Screening Activities
Address Look-Up......... Age-Eligible Women.... 7,500 1 0.1 750
[[Page 35043]]
Pregnancy Screening..... Age-Eligible Women.... 1,500 1 0.42 630
Preconception Activities
Pre-Pregnancy Interview. Age-Eligible Women.... 123 1 0.75 92
Pregnancy Probability Age-Eligible Women.... 123 6 0.1 74
Group Follow Up Script.
Pregnancy Activities
Women's Informed Consent Pregnant Women........ 1,500 1 0.67 1,005
Form.
Pregnancy Visit 1 Pregnant Women........ 572 1 1 572
Interview.
Pregnancy Visit 2 Pregnant Women........ 572 1 0.75 429
Interview.
Birth-Related Activities
Birth Visit Interview... Mother/Baby........... 299 1 0.4 120
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Total--Stage 1........ ...................... 12,188 .............. .............. 3,671
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Enhanced Household: 10 Study LProjected for Stage 1 (July 2010-December 2010)
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Screening Activities
Household Enumeration HH reporters.......... 120,000 1 0.33 39,600
Script.
Pregnancy Screening..... Age-Eligible Women.... 51,198 1 0.42 21,503
Neighbor Report......... Neighbors............. 12,000 1 0.05 600
Preconception Activities
Pre-Pregnancy Interview. Age-Eligible Women.... 211 1 0.75 158
Pregnancy Probability Age-Eligible Women.... 211 6 0.1 127
Group Follow Up Script.
Pregnancy Activities
Women's Informed Consent Pregnant Women........ 2,586 1 0.67 1,733
Form.
Pregnancy Visit 1 Pregnant Women........ 986 1 1 986
Interview.
Pregnancy Visit 2 Pregnant Women........ 986 1 0.75 740
Interview.
Birth-Related Activities
Birth Visit Interview... Mother/Baby........... 516 1 0.4 206
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Total--Stage 1........ ...................... 188,695 .............. .............. 65,653
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Two Tier (Low): 10 Study Locations AcProjected for Stage 1 (July 2010-December 2010)
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Screening Activities
Low-intensity CATI Preg. Age-Eligible Women.... 48,000 1 0.35 16,800
Screener.
Low-Intensity Consent Age-Eligible Women.... 28,800 1 0.33 9,504
Script.
Preconception Activities
Low-intensity CATI Age-Eligible Women.... 10,057 1 0.5 5,028
Questionnaire.
Pregnancy Probability Age-Eligible Women.... 10,057 6 0.1 6,034
Group Follow Up Script.
Pregnancy Activities
Low-intensity CATI Pregnant Women........ 518 1 0.5 259
Questionnaire.
Birth-Related Activities
Low-intensity CATI Mother/Baby........... 166 1 0.5 83
Questionnaire.
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Total--Stage 1........ ...................... 97,598 .............. .............. 37,709
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Two Tier (High): 10 Study Locations AProjected for Stage 1 (July 2010-December 2010)
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Screening Activities
Pregnancy Screening..... Age-Eligible Women.... 15,840 1 0.42 6,653
Preconception Activities
Pre-Pregnancy Interview. Age-Eligible Women.... 761 1 0.75 571
[[Page 35044]]
Pregnancy Probability Age-Eligible Women.... 761 6 0.1 456
Group Follow Up Script.
Pregnancy Activities
Women's Informed Consent Pregnant Women........ 9,504 1 0.67 6,368
Form.
Pregnancy Visit 1 Pregnant Women........ 3,552 1 1 3,552
Interview.
Pregnancy Visit 2 Pregnant Women........ 3,552 1 0.75 2,664
Interview.
Birth-Related Activities
Birth Visit Interview... Mother/Baby........... 1,857 1 0.4 743
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Total--Stage 1........ ...................... 35,826 .............. .............. 21,006
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Grand Total, Recruitment Substudy............................... ...................... 334,308 .............. .............. 128,039
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The estimated annualized cost to respondents is $1,782,053 based on
the differential hourly rate estimates in the above table. 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.
FOR FURTHER INFORMATION CONTACT: 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: Jamelle E. Banks, M.P.H., National Institute
of Child Health and Human Development, 31 Center Drive, Room 2A18,
Bethesda, Maryland, 20892, or call non-toll free number (301) 443-7210,
or e-mail your request, including your address to [email protected].
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: June 15, 2010.
Jamelle E. Banks,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-14969 Filed 6-18-10; 8:45 am]
BILLING CODE 4140-01-P