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

Forms and Documents

Document Name	Status
Form 1 Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
Form 1 Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
Form 1 Call for Proposals to Support Development of Public Goods for Consortium for Cancer Implementation Science (CCIS) (NCI) Form and Instruction	Unchanged
Form 1 Call for Proposals to Support Development of Public Goods for Consortium for Cancer Implementation Science (CCIS) (NCI) Form and Instruction	Unchanged
Form 1 Specialized Program of Research Excellence (SPORE) Webpage Information and Instructions (NCI) Form	Unchanged
Form 1 Specialized Program of Research Excellence (SPORE) Webpage Information and Instructions (NCI) Form	Unchanged
Form 1 NIDCD 2022-2027 Strategic Plan: Idea Generation Template (NIDCD) Form	Unchanged
Form 1 NIDCD 2022-2027 Strategic Plan: Idea Generation Template (NIDCD) Form	Unchanged
Form 1 Environmental Health Language Collaborative Survey (NIEHS) Form	Unchanged
Form 1 Environmental Health Language Collaborative Survey (NIEHS) Form	Unchanged
Form 1 BPCA Framework Initiative Resource Collection (NICHD) Form and Instruction	Unchanged
Form 1 BPCA Framework Initiative Resource Collection (NICHD) Form and Instruction	Unchanged
Form 1 Cancer Moonshot Junior Investigators Nomination (NCI) Form	Unchanged
Form 1 Cancer Moonshot Junior Investigators Nomination (NCI) Form	Unchanged
Form 1 Nominations for Center for Cancer Training NCI Director's Outstanding Mentor Award (NCI) Form	Unchanged
Form 1 Nominations for Center for Cancer Training NCI Director's Outstanding Mentor Award (NCI) Form	Unchanged
Form 1 Nominations for Center for Cancer Training NCI Staff Scientists and Staff Clinicians Outstanding Mentor Award Programs (NCI) Form	Unchanged
Form 1 Nominations for Center for Cancer Training NCI Staff Scientists and Staff Clinicians Outstanding Mentor Award Programs (NCI) Form	Unchanged
Form 1 Survivorship Survey for Post-Transplant Interdisciplinary Providers (NCI) Form and Instruction	Unchanged
Form 1 Survivorship Survey for Post-Transplant Interdisciplinary Providers (NCI) Form and Instruction	Unchanged
Form 1 Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS) Form	Unchanged
Form 1 Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS) Form	Unchanged
Form 1 BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD) Form and Instruction	Unchanged
Form 1 BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD) Form and Instruction	Unchanged
Form 1 Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
Form 1 Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
Form 1 NIAID ClinRegs Country Specific SME Interest Form (NIAID) Form	Unchanged
Form 1 NIAID ClinRegs Country Specific SME Interest Form (NIAID) Form	Unchanged
Form 1 Common Data Elements (CDE) Project Request Form (NINDS) Form and Instruction	Unchanged
Form 1 Common Data Elements (CDE) Project Request Form (NINDS) Form and Instruction	Unchanged
Form 1 BPCA Stakeholder Contact Details (NICHD) Form and Instruction	Unchanged
Form 1 BPCA Stakeholder Contact Details (NICHD) Form and Instruction	Unchanged
Form 1 Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government)) Form and Instruction	Unchanged
Form 1 Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government)) Form and Instruction	Unchanged
Form 1 Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector) Form and Instruction	Unchanged
Form 1 Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector) Form and Instruction	Unchanged
Form 1 Professional Societies' Recommendations of Scientific Reviewers for NIH CSR Review Sections (CSR) Form	Unchanged
Form 1 Professional Societies' Recommendations of Scientific Reviewers for NIH CSR Review Sections (CSR) Form	Unchanged
0925-0766 OMB Change Request Memo.docx Justification for No Material/Nonsubstantive Change	2021-09-23
0925-0766 OMB Change Request Memo.docx Justification for No Material/Nonsubstantive Change	2021-09-23
Privacy Act Memo.pdf Supplementary Document	2020-03-23
Privacy Act Memo.pdf Supplementary Document	2020-03-23
pub 30day FRN2020-05104.pdf Supplementary Document	2020-03-13
pub 30day FRN2020-05104.pdf Supplementary Document	2020-03-13
Example Mini Supporting Statement for New generic.docx 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
new generic Template 2020.docx Supplementary Document	2020-03-13
0925-0766 SSA (2021-09-28).docx Supporting Statement A	2021-09-28
NIH New Generic SSA final.docx Supporting Statement A	2020-03-13

IC Document Collections

IC ID	Document Title	Status
249253	Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
249253	Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
248464	Call for Proposals to Support Development of Public Goods for Consortium for Cancer Implementation Science (CCIS) (NCI) Form and Instruction	Unchanged
248464	Call for Proposals to Support Development of Public Goods for Consortium for Cancer Implementation Science (CCIS) (NCI) Form and Instruction	Unchanged
248293	Specialized Program of Research Excellence (SPORE) Webpage Information and Instructions (NCI) Form	Unchanged
248293	Specialized Program of Research Excellence (SPORE) Webpage Information and Instructions (NCI) Form	Unchanged
247966	NIDCD 2022-2027 Strategic Plan: Idea Generation Template (NIDCD) Form	Unchanged
247966	NIDCD 2022-2027 Strategic Plan: Idea Generation Template (NIDCD) Form	Unchanged
247553	Environmental Health Language Collaborative Survey (NIEHS) Form	Unchanged
247553	Environmental Health Language Collaborative Survey (NIEHS) Form	Unchanged
246512	BPCA Framework Initiative Resource Collection (NICHD) Form and Instruction	Unchanged
246512	BPCA Framework Initiative Resource Collection (NICHD) Form and Instruction	Unchanged
246489	Cancer Moonshot Junior Investigators Nomination (NCI) Form	Unchanged
246489	Cancer Moonshot Junior Investigators Nomination (NCI) Form	Unchanged
245548	Nominations for Center for Cancer Training NCI Director's Outstanding Mentor Award (NCI) Form	Unchanged
245548	Nominations for Center for Cancer Training NCI Director's Outstanding Mentor Award (NCI) Form	Unchanged
245527	Nominations for Center for Cancer Training NCI Staff Scientists and Staff Clinicians Outstanding Mentor Award Programs (NCI) Form	Unchanged
245527	Nominations for Center for Cancer Training NCI Staff Scientists and Staff Clinicians Outstanding Mentor Award Programs (NCI) Form	Unchanged
245206	Survivorship Survey for Post-Transplant Interdisciplinary Providers (NCI) Form and Instruction	Unchanged
245206	Survivorship Survey for Post-Transplant Interdisciplinary Providers (NCI) Form and Instruction	Unchanged
244584	Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS) Form	Unchanged
244584	Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS) Form	Unchanged
244423	BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD) Form and Instruction	Unchanged
244423	BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD) Form and Instruction	Unchanged
244169	Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
244169	Rachel Pearline Award Nominations (NCI) Form and Instruction	Unchanged
243478	NIAID ClinRegs Country Specific SME Interest Form (NIAID) Form	Unchanged
243478	NIAID ClinRegs Country Specific SME Interest Form (NIAID) Form	Unchanged
242507	Common Data Elements (CDE) Project Request Form (NINDS) Form and Instruction	Unchanged
242507	Common Data Elements (CDE) Project Request Form (NINDS) Form and Instruction	Unchanged
241871	BPCA Stakeholder Contact Details (NICHD) Form and Instruction	Unchanged
241871	BPCA Stakeholder Contact Details (NICHD) Form and Instruction	Unchanged
241710	Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government)) Form and Instruction	Unchanged
241710	Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government)) Form and Instruction	Unchanged
241709	Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector) Form and Instruction	Unchanged
241709	Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector) Form and Instruction	Unchanged
241535	Professional Societies' Recommendations of Scientific Reviewers for NIH CSR Review Sections (CSR) Form	Unchanged
241535	Professional Societies' Recommendations of Scientific Reviewers for NIH CSR Review Sections (CSR) Form	Unchanged

ICR Details

OMB Control No: 0925-0766	ICR Reference No: 202109-0925-004
Status: Active	Previous ICR Reference No: 202003-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (OD)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/28/2021
	Date Received in OIRA: 09/23/2021
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	04/30/2023	04/30/2023
Responses	122,000	0	122,000
Time Burden (Hours)	18,584	0	18,584
Cost Burden (Dollars)	466,044	0	466,044

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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): PL: Pub.L. 114 - 329 402 Name of Law: American Innovation and Competitiveness Act
   US Code: 42 USC 285 Name of Law: Public Health Service 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: 19

IC Title	Form No.	Form Name
Cancer Moonshot Junior Investigators Nomination (NCI)	1	Cancer Moonshot Junior Investigators Nomination form
BPCA Framework Initiative Resource Collection (NICHD)	1	BPCA Framework survey
BPCA Prioritization – Identification of Knowledge Gaps in Pediatric Drug Development (NICHD)	1	Substudy NICHD BPCA Prioritization Survey
BPCA Stakeholder Contact Details (NICHD)	1	BPCA survey
Call for Proposals to Support Development of Public Goods for Consortium for Cancer Implementation Science (CCIS) (NCI)	1	CCIS Awards Program Submission Form
Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Private Sector)	1	Blueprint Handout
Chronic obstructive pulmonary disease National Action Plan Tracking System - Preliminary Model (Federal Government))	1	Blueprint Handout
Common Data Elements (CDE) Project Request Form (NINDS)	1	NINDS CDE Project form
Environmental Health Language Collaborative Survey (NIEHS)	1, 2	Use cases survey ,   Community survey
NIAID ClinRegs Country Specific SME Interest Form (NIAID)	1	SME Interest form
NIDCD 2022-2027 Strategic Plan: Idea Generation Template (NIDCD)	1	Idea Generation feedback screenshot
Nominate to NTP and NTP Tox21 Assay Nomination Forms (NIEHS)	1, 2	Nominate to NTP 2020 ,   Tox21 Assay Nomination 2020
Nominations for Center for Cancer Training NCI Director's Outstanding Mentor Award (NCI)	1	Nomination form NCI Director Award
Nominations for Center for Cancer Training NCI Staff Scientists and Staff Clinicians Outstanding Mentor Award Programs (NCI)	1, 2	SSSC Nomination form ,   SSSC Nomination Upload website
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
Rachel Pearline Award Nominations (NCI)	1	2022 Rachel Pearline Award nomination
Specialized Program of Research Excellence (SPORE) Webpage Information and Instructions (NCI)	1	SPORE webpage screenshot
Survivorship Survey for Post-Transplant Interdisciplinary Providers (NCI)	1	Survey Survivorship Transplant

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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	122,000	0	0	0	0
Annual Time Burden (Hours)	18,584	18,584	0	0	0	0
Annual Cost Burden (Dollars)	466,044	466,044	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: 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? No

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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: 09/23/2021

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