Generic Clearance to Conduct Formative Research (NIAID)

Forms and Documents

Document Name	Status
Form 1 U.S.-Russia Collaborative Research Program in HIV/AIDS and Comorbidities [A Partnership between NIH and the Russian Foundation for Basic Research (RFBR)] (OAR/OD) Form and Instruction	New
NIAID Generic Clearance to Conduct Formative Research.pdf Supplementary Document	2018-01-09
30-day FRN2017-26538.pdf Supplementary Document	2017-12-11
Appendix -1 Substudy application for Generic Clearance to Conduct Formative Research (NIAID) (2).docx Supplementary Document	2017-12-05
SSB - Generic Clearance to Conduct Formative Research (NIAID) - v2.doc Supporting Statement B	2017-12-05
SSA - Generic Clearance to Conduct Formative Research (NIAID)- update final.docx Supporting Statement A	2018-03-07

IC Document Collections

IC ID	Document Title	Status
244719	U.S.-Russia Collaborative Research Program in HIV/AIDS and Comorbidities [A Partnership between NIH and the Russian Foundation for Basic Research (RFBR)] (OAR/OD) Form and Instruction	New

ICR Details

OMB Control No: 0925-0755	ICR Reference No: 201712-0925-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Generic Clearance to Conduct Formative Research (NIAID)
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: 03/12/2018
	Date Received in OIRA: 12/11/2017
Terms of Clearance: Approved consistent with the understanding that outcomes will not be employed to influence or directly inform significant policy or determination/allocation of grant funding. Outcomes are primarily intended for internal agency use in the further development of materials, resources, and projects. A full supporting statement part A and B, along with all accompanying instruments and documentation will be submitted for each information collection (IC) submitted under this generic. Any use of incentives will include a justification for the specific value proposed and its necessity in conducting the collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	36 Months From Approved
Responses	35,550	0	0
Time Burden (Hours)	34,575	0	0
Cost Burden (Dollars)	1,187,647	0	0

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Abstract: NIAID is requesting OMB approval for information collections to improve research approaches and final product development to identify emergent infectious disease threats and comorbidities related to the needs of diverse audiences. The National Institute of Allergy and Infectious Diseases is charged with the conduct and support of research, training, health information dissemination, and other programs with respect to allergic and immunologic diseases and disorders. The Evaluation Section of the Strategic Planning and Evaluation Branch (SPEB) at NIAID conducts various types of research, analyses, and assessments to identify and learn about target audience programmatic needs, and gaps. The activities conducted by the Evaluation Section of SPEB helps to ensure that NIAID communicates, educates, and disseminates appropriate, useful and effective resources. The information to be collected as part of this generic clearance will allow the agency to make appropriate adjustments in content and methods used in developmental and testing stages, including peer-review, in order to improve research approaches and final product development.

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Authorizing Statute(s): US Code: 42 USC 285f Name of Law: National Institute of Allergy and Infectious Diseases (NIAID)
  

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:
	82 FR 44631	09/25/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 58213	12/11/2017
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	35,550	0	0	35,550	0	0
Annual Time Burden (Hours)	34,575	0	0	34,575	0	0
Annual Cost Burden (Dollars)	1,187,647	0	0	1,187,647	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 Generic

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Annual Cost to Federal Government: $1,025,112

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 12/11/2017

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