PROCESS ASSESSMENT REVIEW OF THE DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME (DAIDS) CRITICAL EVENTS POLICY IMPLEMENTATION (CEPI) PROGRAM (NIAID)

Forms and Documents

Document	Type	Status	Availability
Form 8 Focus group opening script and questions (ER/ES)	Form	Unchanged	Available
Form 8 Focus group opening script and questions (DAIDS Staff)	Form	Unchanged	Available
Form 7 Incentive distribution log for focus group participants	Form	Unchanged	Available
Form 6 Reminder email to T2 web-survey participants (ER/ES)	Form	Unchanged	Available
Form 4 Extramural Researcher External Stakeholder Survey screenshots	Form	Unchanged	Available
Form 3 Webpage Study Details and DAIDS staff Informed Consent Screenshots	Form and Instruction	Unchanged	Available
Form 2 DAIDS Staff Survey Screenshots	Form and Instruction	Unchanged	Repair queued
Form 1 Webpage Study Details and Informed Consent for Extramural Researchers, and External Stakeholders Screenshots	Form and Instruction	Unchanged	Repair queued
rev. 0925-0712 Change Request Memo Feb2016.doc	Supplementary Document	Uploaded 2016-02-18	Available
0925-0712 CEPI Supporting Statement B Track Changes Oct 2015.docx	Supplementary Document	Uploaded 2016-01-08	Available
0925-0712 Change Request Memo to OMB - FINAL 12 11 2015.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2016-01-08	Available
rev. 0925-0721 CEPI Supporting Statement B Feb2016.docx	Supporting Statement B	Uploaded 2016-02-18	Available
CEPI Supporting Statement A 952014.docx	Supporting Statement A	Uploaded 2016-01-08	Available
Attachment 15 Recruitment email to potential focus group participants.docx	Supplementary Document	Uploaded 2014-09-25	Available
Attachment 16 burden to respondents researcher salaries.xlsx	Supplementary Document	Uploaded 2014-09-25	Available
Attachment 17 burden to respondents BLS DoL wages 2013.pdf	Supplementary Document	Uploaded 2014-09-25	Available
Attachment 12 email invitation for T2 survey participants 09252014.docx	Supplementary Document	Uploaded 2014-09-25	Available
Attachment 11 Extramural Researchers External Stakeholders T1 survey reminder email.doc	Supplementary Document	Uploaded 2014-09-25	Repair queued
Attachment 10 DAIDS T1 survey reminder email.doc	Supplementary Document	Uploaded 2014-09-25	Repair queued
Attachment 8 Email with Unique Link to T1 Survey.docx	Supplementary Document	Uploaded 2014-09-25	Available
Attachment 4 Extramural Researchers External Stakeholders T1 survey initial email.doc	Supplementary Document	Uploaded 2014-09-24	Available
Attachment 3 DAIDS T1 survey initial email invitation final.doc	Supplementary Document	Uploaded 2014-09-24	Repair queued
Attachment 2 SSi IRB letter of approval.pdf	Supplementary Document	Uploaded 2014-09-24	Available
Attachment 1 NIH IRB response letter.pdf	Supplementary Document	Uploaded 2014-09-24	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
213304	Focus group opening script and questions (ER/ES)	Form	Unchanged
213303	Focus group opening script and questions (DAIDS Staff)	Form	Unchanged
213302	Incentive distribution log for focus group participants	Form	Unchanged
213301	Extramural researcher external stakeholders focus group consent form	Other-Consent Form	Unchanged
213300	DAIDS staff focus group consent form	Other-Consent Form	Unchanged
213299	Reminder email to T2 web-survey participants (ER/ES)	Form	Unchanged
213298	Reminder email to T2 web-survey participants (DAIDS Staff)	Instruction	Unchanged
213297	Extramural Researcher External Stakeholder Survey screenshots	Form	Unchanged
213286	Webpage Study Details and DAIDS staff Informed Consent Screenshots	Form and Instruction	Unchanged
213285	DAIDS Staff Survey Screenshots	Form and Instruction	Unchanged
213275	Webpage Study Details and Informed Consent for Extramural Researchers, and External Stakeholders Screenshots	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0925-0712	ICR Reference No: 201601-0925-001
Status: Historical Active	Previous ICR Reference No: 201501-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: PROCESS ASSESSMENT REVIEW OF THE DIVISION OF ACQUIRED IMMUNODEFICIENCY SYNDROME (DAIDS) CRITICAL EVENTS POLICY IMPLEMENTATION (CEPI) PROGRAM (NIAID)
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: 02/18/2016
	Date Received in OIRA: 01/11/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	03/31/2018	03/31/2018
Responses	1,725	0	1,725
Time Burden (Hours)	470	0	470
Cost Burden (Dollars)	0	0	0

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Abstract: The CEPI Program began in 2012, with the release of the Critical Events policy and manual. To optimize the delivery, dissemination and training of the policy documents, DAIDS would like to obtain feedback from DAIDS staff, extramural researchers and external stakeholders to determine if any improvements should be made to the CEPI Program. To guide this feedback, NIAID engaged a contractor (Social Solutions International, Inc.) to develop the web-based survey and focus group questions, and collect and analyze the data. NIAID has also identified an Advisor to review the data collection instruments and provide recommendations to CEPI based on the analyzed data.

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Authorizing Statute(s): US Code: 42 USC 285(f) Name of Law: Protection of Participants, Evaluation and Policy (ProPEP) Branch
  

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:
	79 FR 19633	04/09/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 56380	09/19/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Reminder email to T2 web-survey participants (ER/ES)	6	Reminder email to T2 web-survey participants
Webpage Study Details and Informed Consent for Extramural Researchers, and External Stakeholders Screenshots	1	Webpage Study Details and Informed Consent for Extramural Researchers, and External Stakeholders Screenshots
DAIDS staff focus group consent form
Extramural researcher external stakeholders focus group consent form
Focus group opening script and questions (ER/ES)	8	Focus group opening script and questions
Webpage Study Details and DAIDS staff Informed Consent Screenshots	3	Webpage Study Details and DAIDS staff Informed Consent Screenshots
DAIDS Staff Survey Screenshots	2	DAIDS Staff Survey Screenshots
Extramural Researcher External Stakeholder Survey screenshots	5, 4	Incentive Survey Distribution Screenshots ,   Extramural Researcher External Stakeholder Survey screenshots
Reminder email to T2 web-survey participants (DAIDS Staff)
Incentive distribution log for focus group participants	7	Incentive distribution log for focus group participants
Focus group opening script and questions (DAIDS Staff)	8	Focus group opening script and questions

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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	1,725	1,725	0	0	0	0
Annual Time Burden (Hours)	470	470	0	0	0	0
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: This is a new ICR.

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Annual Cost to Federal Government: $87,048

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: 01/11/2016

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