Materials to Support NIH IRBs Serving As the Public Health Emergency Research Review Board (PHERRB) or as an IRB of Record for Outside Institutions

Forms and Documents

Document Name	Status
Form 3 CRLCW Form	New
Form 2 IRLCW Form	New
Form 1 APR Form	New
PTMS_PIA_2012.pdf Supplementary Document	2017-01-26
Privacy Act Memo.pdf Supplementary Document	2017-01-26
30-day FRN2016-28140.pdf Supplementary Document	2016-11-22
Supporting Statement A_20161121.docx Supporting Statement A	2016-11-22
Attachment 1 PHERRB Terms of Reference , October 2012.doc Supplementary Document	2016-11-21

IC Document Collections

IC ID	Document Title	Status
224494	CRLCW Form	New
224493	IRLCW Form	New
224491	APR Form	New

ICR Details

OMB Control No: 0925-0751	ICR Reference No: 201611-0925-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Materials to Support NIH IRBs Serving As the Public Health Emergency Research Review Board (PHERRB) or as an IRB of Record for Outside Institutions
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: 02/01/2017
	Date Received in OIRA: 11/23/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved
Responses	520	0	0
Time Burden (Hours)	790	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The NIH and HHS have recently established the Public Health Emergency Research Review Board (PHERRB) mechanism for human subject protections review of certain, typically multisite, public health emergency research studies. Any of the 12 NIH intramural IRBs can be designated to serve as the PHERRB for review of a public health emergency research protocol. Additionally, the NIH Human Research Protections Program (HRPP) is preparing to implement the recent “NIH Policy on the Use of a Single Institutional Review Board (sIRB) of Record for Multi-Site Research,” which requires the use of a single IRB of record for human subject protections review of certain multisite studies. To meet all of these needs, researchers at outside institutions will need to provide information to the NIH HRPP, which includes the NIH intramural IRBs. To facilitate and systematize collection of the necessary information, NIH has developed a set of required materials. These include the Application for PHERRB Review (APR); the Initial Review Local Context Worksheet (IRLCW); and the Continuing Review Local Context Worksheet (CRLCW). These materials are intended to provide the NIH HRPP and the NIH IRBs with information necessary for NIH to maintain regulatory compliance in its conduct of human subject protections review when an NIH IRB serves an IRB of record for multisite research.

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Authorizing Statute(s): US Code: 42 USC sections 301,307, 465, and 478 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: US Code: 42 USC 241 Name of Law: Public Health Service Act

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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:
	81 FR 56668	08/22/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 83855	11/22/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
CRLCW	3	Continuing Review Local Context Worksheet (CRLCW)
APR	1	Application for PHERB Review
IRLCW	2	Initial Review Local Context Worksheet (IRLCW)

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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	520	0	0	520	0	0
Annual Time Burden (Hours)	790	0	0	790	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: $23,450

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

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: 11/23/2016

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