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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
0925-0590
ICR Reference No:
201107-0925-005
Status:
Historical Active
Previous ICR Reference No:
200802-0925-003
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
National Children's Study Formative Generic Clearance
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
09/01/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/30/2011
Terms of Clearance:
This generic clearance is approved for 3 years under the following conditions: (1) For individual "sub-studies" NIH shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template mutually agreed upon by OMB and NIH (including a statement of need, intended use of information, study design, description of respondents, data collection procedures, justification for any proposed incentive, and estimated burden); (b) the IRB protocol and approval; (c) recruitment materials and participant screeners, (d) instruments/moderator guides, and (e) consent forms. (2) NIH may submit up to three independent sub-studies in a single submission to OMB. (3) OMB will respond to NIH within 45 days, which allows 15 days per sub-study. (4) NIH will brief OMB on the schedule of upcoming sub-studies on a quarterly basis.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2014
36 Months From Approved
08/31/2011
Responses
63,000
0
3,150
Time Burden (Hours)
90,000
0
5,825
Cost Burden (Dollars)
0
0
0
Abstract:
The National Children's Study is a multi-center longitudinal study that will enroll a nationally representative sample of approximately 100,000 children born in the U.S. This is a request for programmatic clearance of formative research to help develop instruments, materials, and procedures for the NCS. These activities will be conducted to improve the efficiency of data collection and to decrease participant burden throughout the course of the Study.
Authorizing Statute(s):
PL:
Pub.L. 106 - 310 1004
Name of Law: Children's Health Act of 2000
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
76 FR 23603
04/27/2011
30-day Notice:
Federal Register Citation:
Citation Date:
76 FR 41508
07/14/2011
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Methods to Enhance Child Assent Practices (for Parents and Children)
1.1
Contact Information Form
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
63,000
3,150
0
0
59,850
0
Annual Time Burden (Hours)
90,000
5,825
0
0
84,175
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$300,000
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Saleda Perryman
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
07/29/2011
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