[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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of     Responses per     Hours per      Annual hour
       Recruitment  strategy                   Activity             Type of respondent      respondents     respondent       response         burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                           Provider-based: 10 Study LocProjected for Stage 1 (July 2010-December 2010)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     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
                                                                                         ---------------------------------------------------------------
                                          Total--Stage 1........  ......................          12,188  ..............  ..............           3,671
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Enhanced Household: 10 Study LProjected for Stage 1 (July 2010-December 2010)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     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
                                                                                         ---------------------------------------------------------------
                                          Total--Stage 1........  ......................         188,695  ..............  ..............          65,653
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Two Tier (Low): 10 Study Locations AcProjected for Stage 1 (July 2010-December 2010)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     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.
                                                                                         ---------------------------------------------------------------
                                          Total--Stage 1........  ......................          97,598  ..............  ..............          37,709
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Two Tier (High): 10 Study Locations AProjected for Stage 1 (July 2010-December 2010)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     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
                                                                                         ---------------------------------------------------------------
                                          Total--Stage 1........  ......................          35,826  ..............  ..............          21,006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grand Total, Recruitment Substudy...............................  ......................         334,308  ..............  ..............         128,039
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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