Approved consistent with the follow two terms: 1) In advance of adding biological and environmental sampling for the participants in the provider-based sampling arm of the Vanguard study, NIH will consult with the IRB amount whether the time between written consent for biosampling and the actual implementation of this activity warrents written re-consent.
2) NIH agrees to brief OMB/OIRA on the results of this test, particularly the measures in Table A.16 in advance of finalizing the design for the main study of the NCS.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
08/31/2014
36 Months From Approved
07/31/2013
55,748
0
455,206
22,791
0
159,966
0
0
0
The National Children's Study is an integrated system of activities that includes a Vanguard (Pilot) Study for operations and methods development, and an NCS Main Study to collect data on exposure and response. The Vanguard (Pilot) Study, which includes the Initial Vanguard Study, the Alternate Recruitment Substudy (Phases 1 and 2), and the Provider-Based Sampling Feasibility Study (proposed in this information collection request), is currently underway. The Main Study is expected to follow within the next year. This request for revision includes (1) the addition of a Provider-Based Sampling Feasibility Study, and (2) supplemental measures for the Alternate Recruitment Substudy involving revised study visit assessments, physical measurements, and additional biospecimen collections. These information collections, revisions of instruments, physical measure implementation, and biospecimen collections will evaluate the feasibility, acceptability, and cost of study design elements to inform the Main Study.
This section describes program changes that are the result of deliberate Federal government action.
As noted in Supporting Statement A.1 and A.2, the NCS halted ARS recruitment (Provider-Based Recruitment, Enhanced Household-Based Recruitment, Two-Tier Recruitment) in February 2012, eliminating the need for further screening and preconception data collection, which comprised the bulk of respondent burden in the Vanguard (Pilot) Study. This resulted in significantly decreased burden to the public. Currently, the NCS is approved for 159,966 annualized burden hours. In this information collection request, the total annualized hour burden for the ARS is 22,031.
This request for revision proposes the addition of a Provider-Based Sampling Feasibility Study component of the Vanguard (Pilot) Study, supplemental measures involving Study Visit assessments, supplemental measures involving physical measurements, and supplemental collections involving biospecimens. These information collections, revisions of instruments, physical measure implementation, and biospecimen collections will evaluate the feasibility, acceptability, and cost of study design elements to inform the Main Study.
The NCS intends to use a modular approach for Study Visit assessments. The Core Questionnaire (described in A.2) is intended to be administered at multiple study visits, and will be piloted at the 30-month visit. A modular approach will also be instituted for the informed consent process (described in B.2.1.) and the Tracing Interview (described in A.2). In the long term, we anticipate that the modular approach mentioned above will result in reduced administrative burden as well as the potential for reduced participant burden.
To date, child physical measures have not yet been collected into the Vanguard (Pilot) Study. This collection will impose a relatively small amount of burden on the public. In addition, the re-introduction of child biospecimen collection into the Vanguard (Pilot) Study will also represent a relatively small amount of burden on the public.
To accommodate Department of Health and Human Services data standards for the Affordable Care Act Measures, the NCS has proposed a plan to incorporate questions on ethnicity, race, sex, primary language / language spoken, and disability status into existing Study Visit assessments that are asked of mothers, fathers, children, and primary caregivers, and range from before the child is born until 5 years of age. Upon finalization of this plan, this will result in a minimal public burden increase.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)