View Information Collection Request (ICR) Package
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Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
0925-0675
ICR Reference No:
201606-0925-002
Status:
Historical Active
Previous ICR Reference No:
201303-0925-001
Agency/Subagency:
HHS/NIH
Agency Tracking No:
18997
Title:
Generic Clearance for Methodological Studies in the Population Assessment of Tobacco and Health (PATH) Study (NIDA)
Type of Information Collection:
Reinstatement without change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
08/15/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/07/2016
Terms of Clearance:
NIH will submit individual collections under this generic clearance to OMB. OMB will strive to provide feedback on the individual collections within ten working days, whenever possible. Standard incentive amount is remuneration is $40.00; requests for higher levels must be justified (e.g., very difficult recruitments), two-hour focus groups, etc.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2019
36 Months From Approved
Responses
60,000
0
0
Time Burden (Hours)
89,250
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This is a reinstatement without change (of OMB number 0925-06764, expiration date 5/31/2016) for the Population Assessment of Tobacco and Health (PATH) Study to conduct methodological substudies to improve its methods for data and biospecimen collection. The PATH Study is collecting behavioral data and biospecimens among a national longitudinal cohort to assess within-person changes and between-person differences in tobacco-product use behaviors and related health conditions over time. Its longitudinal, population-based data will help to enhance the evidence base that informs FDA’s regulatory actions under the Family Smoking Prevention and Tobacco Control Act (TCA) to protect the Nation’s public health and reduce its burden of tobacco-related morbidity and mortality.
Authorizing Statute(s):
US Code:
42 USC 285o
Name of Law: NIDA in partnership with FDA
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:
81 FR 12913
03/11/2016
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 35369
06/02/2016
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
0
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
60,000
0
0
40,000
0
20,000
Annual Time Burden (Hours)
89,250
0
0
0
0
89,250
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:
$2,916,358
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:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
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:
06/07/2016
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