[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32474-32476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13705]



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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, Recruitment Substudy 

Phase 1



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



[[Page 32475]]



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 1--Estimated Hour Burden and Cost for Recruitment Substudy Respondents--Stage 1

                                          [July 2010 to December 2010]

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

                                     Type of         Number of     Responses per     Hours per      Annual hour

 Recruitment strategy/activity     respondent       respondents     respondent       response         burden

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

               Provider-based: 10 Study Locations--Projected for Stage 1 (July 2010-December 2010)

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

Screening Activities

    Address Look-Up...........  Age-Eligible               7,500               1            0.1              750

                                 Women.

    Pregnancy Screening.......  Age-Eligible               1,500               1            0.42             630

                                 Women.

Preconception Activities

    Pre-Pregnancy Interview...  Age-Eligible                 123               1            0.75              92

                                 Women.

    PPG Follow Up Script......  Age-Eligible                 123               6            0.1               74

                                 Women.

Pregnancy Activities

    Women's Informed Consent    Pregnant Women..           1,500               1            0.67           1,005

     Form.

    First Pregnancy Interview.  Pregnant Women..             572               1            1                572

    Second Pregnancy Interview  Pregnant Women..             572               1            0.75             429

Birth-Related Activities

    Birth Visit Interview.....  Mother/Baby.....             299               1            0.4              120

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

        Total--Stage 1........  ................          12,188  ..............  ..............           3,671

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

             Enhanced Household: 10 Study Locations--Projected 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              51,198               1            0.42          21,503

                                 Women.

    Neighbor Report...........  Neighbors.......          12,000               1            0.05             600

Preconception Activities

    Pre-Pregnancy Interview...  Age-Eligible                 211               1            0.75             158

                                 Women.

    PPG Follow Up Script......  Age-Eligible                 211               6            0.1              127

                                 Women.

Pregnancy Activities

    Women's Informed Consent    Pregnant Women..           2,586               1            0.67           1,733

     Form.

    First Pregnancy Interview.  Pregnant Women..             986               1            1                986

    Second Pregnancy Interview  Pregnant Women..             986               1            0.75             740

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 Across Both Tiers--Projected for Stage 1 (July 2010-December 2010)

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

Screening Activities

    Low-intensity CATI Preg.    Age-Eligible              48,000               1            0.35          16,800

     Screener.                   Women.

    Low Intensity Consent       Age-Eligible              28,800               1            0.33           9,504

     Script.                     Women.

Preconception Activities



[[Page 32476]]



 

    Low-intensity CATI          Age-Eligible              10,057               1            0.5            5,028

     Questionnaire.              Women.

    PPG Follow Up Script......  Age-Eligible              10,057               6            0.1            6,034

                                 Women.

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 Across Both Tiers--Projected for Stage 1 (July 2010-December 2010)

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

Screening Activities

    Pregnancy Screening.......  Age-Eligible              15,840               1            0.42           6,653

                                 Women.

Preconception Activities

    Pre-Pregnancy Interview...  Age-Eligible                 761               1            0.75             571

                                 Women.

    PPG Follow Up Script......  Age-Eligible                 761               6            0.1              456

                                 Women.

Pregnancy Activities

    Women's Informed Consent    Pregnant Women..           9,504               1            0.67           6,368

     Form.

    First Pregnancy Interview.  Pregnant Women..           3,552               1            1              3,552

    Second Pregnancy Interview  Pregnant Women..           3,552               1            0.75           2,664

Birth-Related Activities

    Birth Visit Interview.....  Mother/Baby.....           1,857               1            0.4              743

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

        Total--Stage 1........  ................          35,826  ..............  ..............          21,006

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

            Grand Total,        ................         334,308  ..............  ..............         176,876

             Recruitment

             Substudy.

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



    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: Sarah L. Glavin, Ph.D., National Institute of 

Child Health and Human Development, 31 Center Drive, Room 2A18, 

Bethesda, Maryland, 20892, or call non-toll free number (301) 496-1877, 

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 2, 2010.

Sarah L. Glavin,

NICHD Project Clearance Liaison, National Institutes of Health.

[FR Doc. 2010-13705 Filed 6-7-10; 8:45 am]

BILLING CODE 4140-01-P