Generic Clearance for Methodological Studies in the Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Forms and Documents

Document Name	Status
Revised_1Examples of Methodological Studies.docx Supplementary Document	2016-08-15
Revised_Generic Methodological Studies SSA.docx Supporting Statement A	2016-08-15
Attach5. Privacy Impact Assessment.pdf Supplementary Document	2016-06-06
Attach4.NIH Privacy Act and System of Records Notice.pdf Supplementary Document	2016-06-06
Attach3.Certificate of Confidentiality.pdf Supplementary Document	2016-06-06
Attach2.List of consultants.pdf Supplementary Document	2016-06-06
Attach1.Examples of methodological studies to inform the PATH Study.pdf Supplementary Document	2016-06-06
30-day FRN - Generic - Methodology Studies.pdf Supplementary Document	2016-06-06
Revised_Generic Methodological Studies SSB.docx Supporting Statement B	2016-08-15

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0925-0675	ICR Reference No: 201606-0925-002
Status: 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
	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

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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.

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Authorizing Statute(s): US Code: 42 USC 285o Name of Law: NIDA in partnership with FDA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 0

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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:

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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

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Common Form ICR:  No

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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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