Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (OD)

Forms and Documents

Document Name	Status
Form 1 Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS) Form	New
Form 1 BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD) Form and Instruction	New
Form 1 Rachel Pearline Award Nominations (NCI) Form and Instruction	New
Form 1 NIAID ClinRegs Country Specific SME Interest Form (NIAID) Form	New
Form 1 Common Data Elements (CDE) Project Request Form (NINDS) Form and Instruction	New
Form 1 BPCA Stakeholder Contact Details (NICHD) Form and Instruction	New
Form 1 Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government)) Form and Instruction	New
Form 1 Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector) Form and Instruction	New
Form 1 Professional Societies' Recommendations of Scientific Reviewers for NIH CSR Review Sections (CSR) Form	New
Privacy Act Memo.pdf Supplementary Document	2020-03-23
pub 30day FRN2020-05104.pdf Supplementary Document	2020-03-13
Example Mini Supporting Statement for New generic.docx Supplementary Document	2020-03-13
new generic Template 2020.docx Supplementary Document	2020-03-13
NIH New Generic SSA final.docx Supporting Statement A	2020-03-13

IC Document Collections

IC ID	Document Title	Status
244584	Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS) Form	New
244423	BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD) Form and Instruction	New
244169	Rachel Pearline Award Nominations (NCI) Form and Instruction	New
243478	NIAID ClinRegs Country Specific SME Interest Form (NIAID) Form	New
242507	Common Data Elements (CDE) Project Request Form (NINDS) Form and Instruction	New
241871	BPCA Stakeholder Contact Details (NICHD) Form and Instruction	New
241710	Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government)) Form and Instruction	New
241709	Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector) Form and Instruction	New
241535	Professional Societies' Recommendations of Scientific Reviewers for NIH CSR Review Sections (CSR) Form	New

ICR Details

OMB Control No: 0925-0766	ICR Reference No: 202003-0925-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (OD)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/14/2020
	Date Received in OIRA: 03/13/2020
Terms of Clearance: The agency will submit individual collections under this generic clearance to OMB. These submissions will include the actual study instruments along with a completed template and mini SSA describing the specific study goal, the study design, any incentives to be used, and the sampling and analysis plans.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2023	36 Months From Approved
Responses	122,000	0	0
Time Burden (Hours)	18,584	0	0
Cost Burden (Dollars)	466,044	0	0

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Abstract: This is a new generic collection titled, “Generic Clearance for NIH Citizen Science and Crowdsourcing Projects.” Projects under this generic clearance will allow Agency researchers and program staff to test ideas more quickly, respond to the project’s needs as they evolve, and incorporate feedback from participants for flexible, innovative research methods. Any collection under this umbrella is expected to be low in burden.

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Authorizing Statute(s): US Code: 42 USC 285 Name of Law: Public Health Service Act
   PL: Pub.L. 114 - 329 402 Name of Law: American Innovation and Competitiveness Act
  

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:
	84 FR 53162	10/04/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 14689	03/13/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
BPCA Stakeholder Contact Details (NICHD)	1	BPCA survey
Professional Societies' Recommendations of Scientific Reviewers for NIH CSR Review Sections (CSR)	1	Screenshot of Society Recommendation Webpage
Rachel Pearline Award Nominations (NCI)	1	Nomination form
Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector)	1	Blueprint Handout
Common Data Elements (CDE) Project Request Form (NINDS)	1	NINDS CDE Project form
Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government))	1	Blueprint Handout
NIAID ClinRegs Country Specific SME Interest Form (NIAID)	1	SME Interest form
BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD)	1	Substudy NICHD BPCA Prioritization Survey
Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS)	1, 2	Nominate to NTP 2020 ,   Tox21 Assay Nomination 2020

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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	122,000	0	0	122,000	0	0
Annual Time Burden (Hours)	18,584	0	0	18,584	0	0
Annual Cost Burden (Dollars)	466,044	0	0	466,044	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: New submission

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Annual Cost to Federal Government: $11,977

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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: 03/13/2020

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