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.
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.
Form 26.1 30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)
PBS-SDM 2012-05 Provider Substitution Guidelines.docx
NCS-FS_PBS Provider Substitution Form_2012-07-06.pdf
Appendix 1 - Methods for Sampling Women within Selected Providers.xlsx
Provider Based Sampling Provider List Revision Letter.doc
30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)