[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6478-6483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 November 15, 2010, pages 69680-69681, 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 continue the Vanguard phase of the National 
Children's Study (NCS) to evaluate the feasibility, acceptability, and 
cost of recruitment strategies and study design elements for a 
prospective, national longitudinal study of child health and 
development. In combination, the sub-studies encompassed by the 
Vanguard Phase will be used to inform the design of the Main Study of 
the National Children's Study.
    We propose to continue data collection among the 37 Vanguard Study 
locations up to and including the visit planned to take place when the 
sample children have reached 24 months of age. This would align study 
visits approved for the initial 7 Vanguard Study locations (which 
extend past the birth visit to include a 3-, 6-, 9-, 12-, 18- and 24-
month visit) with the study visits approved for the 30 additional 
Vanguard Study locations (which were initially proposed and approved up 
to and including the birth visit). Extending the data collection of the 
30 additional Vanguard Study locations to 24 months of age would 
support rigorous, empirical evaluation of participant retention as it 
may relate to recruitment strategy. A strong understanding of how to 
encourage retention of study participants, particularly during the 
infancy and early childhood years, will be essential to planning the 
Main Study. Additionally, continuing data collection post-birth among 
the alternate recruitment strategy study locations allows us to 
generate additional data to inform the development of study visit 
procedures, both for future Vanguard Study efforts and the Main Study.
    We also propose reintroduction of a limited set of study visit 
measures to all 37 of the Vanguard Study locations engaged in data 
collection. Recall that extensive measures, including biospecimens, 
were previously approved for use in the initial 7 Vanguard Study 
locations. When the additional 30 locations were added, we streamlined 
data collection to allow focus on improving recruitment rates. Now that 
we have the training for those new locations (and retraining for the 
initial locations) completed, it is an opportune time to reintroduce 
selected measures that have the benefit of field experience. That field 
experience has been used to improve their scientific robustness, 
burden, and cost. These improved measures now require field testing to 
best inform their suitability for the Main Study. Specifically, we 
would like to reincorporate a father interview; maternal blood and 
urine collection; infant cord blood collection; home tap water and dust 
collection; a pregnancy health care log; and an infant and child health 
care log. In addition to supporting further testing of refined items, 
including these measures in the Recruitment Substudy would result in a 
data collection scope more closely mirroring the anticipated scope of 
the Main Study, thereby allowing better gauge of data collection scope 
and

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resources and the relationship with retention and study logistics over 
time.
    We will evaluate the feasibility (technical performance), 
acceptability (respondent tolerance and impact on study 
infrastructure), and cost (operations, time, and effort) of each 
recruitment and retention strategy using pre-determined measures. We 
will compare these findings and use them as a basis 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 additional public burden for this study will 
vary depending on the method of recruitment. The table below provides 
the annualized average burden per person over the two-year data 
collection period for all three alternate recruitment strategies.
    The additional annualized cost to respondents over the two-year 
data collection period for the 30 locations engaged in the alternate 
recruitment strategies to extend data collection from birth to age 2 is 
estimated at $82,000 (based on $10 per hour) and the differential time 
estimates in Table A.2.e, below. To reintroduce the proposed measures 
into the 30 locations engaged in the alternate recruitment strategies, 
the annualized cost to respondents over the same period is estimated at 
an additional $79,000 (based on $10 per hour) and the differential time 
estimates in Table A.2.e, below. There are no Capital Costs to report. 
There are no Operating or Maintenance Costs to report.
BILLING CODE 4140-01-P

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BILLING CODE 4140-01-C
    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: January 28, 2011.
Jamelle E. Banks,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-2539 Filed 2-3-11; 8:45 am]
BILLING CODE 4140-01-P