Generic Clearance for the Research Domain Criteria (RDoC) Initiative (NIMH)

Forms and Documents

Document Name	Status
Form 1 Environment and Development in RDoC Survey (NIMH) Form	New
Form 1 RDoC Training Meeting Survey Form and Instruction	New
30-day FRN2018-07859.pdf Supplementary Document	2018-04-18
Attachment 4 - RDoC Sample Survey Questions.FINAL.04.17.2018.docx Supplementary Document	2018-04-18
Attachment 5 - Example Mini Supporting Statement.docx Supplementary Document	2018-04-18
RDoC.Attachment 3 - HHS PIA - NIH NIMH Internet and Intranet Web Sites_2018.docx Supplementary Document	2018-04-18
RDoC.Attachment 2 - HHS PIA - NIH NIMH Headquarters Network System_2018.docx Supplementary Document	2018-04-17
Attachment 1 - HHS Terms of Service Agreements.pdf Supplementary Document	2018-04-17
RDoC.SSA.FINAL.07_12_2018 (2nd revised).docx Supporting Statement A	2018-07-12

IC Document Collections

IC ID	Document Title	Status
235591	Environment and Development in RDoC Survey (NIMH) Form	New
233399	RDoC Training Meeting Survey Form and Instruction	New

ICR Details

OMB Control No: 0925-0756	ICR Reference No: 201804-0925-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Generic Clearance for the Research Domain Criteria (RDoC) Initiative (NIMH)
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: 07/13/2018
	Date Received in OIRA: 04/18/2018
Terms of Clearance: OMB approves this collection for a period of three years. To request approval of information collections under this generic approval, the agency must do the following: 1) Unless an agency is using multiple modes of collection (e.g., paper forms and electronic submissions), provide a Generic Clearance Submission Template for each Instrument; 2) If the agency is using multiple modes of collection (e.g., paper forms and electronic submissions), the same Generic Clearance Submission Template may be used for both instruments; 3) each Generic Clearance Submission Template must be uploaded as a Supplementary document using a naming convention that allows the public to identify the associated instrument; 4) submit no more than five Generic Submission Templates with each request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2021	36 Months From Approved
Responses	270	0	0
Time Burden (Hours)	490	0	0
Cost Burden (Dollars)	19,705	0	0

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Abstract: NIMH developed a research framework for new ways of studying mental disorders known as RDoC through a series of workshops (https://www.nimh.nih.gov/research-priorities/rdoc/development-of-the-rdoc-framework.shtml). The framework integrates many levels of information (from genomics to self-report) to better understand basic dimensions of functioning underlying the full range of human behavior from normal to abnormal. This effort resulted in the creation of a matrix of units of analysis (from molecules to self-report) for several domains (cognitive, positive valence, negative valence, social processes, arousal and regulatory systems)—all examined in a context emphasizing developmental trajectories and individual’s interactions with their environment. The RDoC matrix has become a framework for organizing our research efforts, with the aim to guide research that begins with disruptions in neurobiological and behavioral mechanisms, and then works across systems to clarify connections among such disruptions and clinical symptoms; it is a flexible entity that can be updated as new research emerges that could influence the understanding of psychopathology.

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Authorizing Statute(s): US Code: 42 USC 285(p) and Section 401(a) 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:
	83 FR 4062	01/29/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 16378	04/16/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Environment and Development in RDoC Survey (NIMH)	1	RDoC Environment and Development Pre-Workshop Survey Questions
RDoC Training Meeting Survey	1	RDoC Training Meeting Survey

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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	270	0	0	270	0	0
Annual Time Burden (Hours)	490	0	0	490	0	0
Annual Cost Burden (Dollars)	19,705	0	0	19,705	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: This is a new Generic

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Annual Cost to Federal Government: $14,450

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: 04/18/2018

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