Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption

Forms and Documents

Document Name	Status
TITLE 42 – The Public Health and Welfare.docx Supplementary Document	2018-03-16
0990-0263Attachment 2.docx Supplementary Document	2018-03-16
0990-0263 Supporting Statement_Optional 310 Form.doc Supporting Statement A	2018-03-16

IC Document Collections

IC ID	Document Title	Status
10393	Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption Other-form	Modified

ICR Details

OMB Control No: 0990-0263	ICR Reference No: 201801-0990-001
Status: Active	Previous ICR Reference No: 201411-0990-003
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/11/2018
	Date Received in OIRA: 03/16/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	36 Months From Approved	04/30/2018
Responses	28,000	0	24,000
Time Burden (Hours)	14,000	0	12,000
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this Form is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the requirements of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this collection are institutions engaged in research involving human subjects where the research is supported by HHS. Institutional use of the form is also relied upon by other federal departments and agencies that have codified or follow the Federal Policy for the Protection of Human Subjects (Common Rule) which is identical to 45 CFR part 46, subpart A.

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Authorizing Statute(s): PL: Pub.L. 99 - 158 491 Name of Law: Health Research Extension 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:
	82 FR 58212	12/11/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 9745	03/07/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption

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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	28,000	24,000	0	0	4,000	0
Annual Time Burden (Hours)	14,000	12,000	0	0	2,000	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: The annual burden will increase by from 12,000 hours to 14,000 hours and from $480,000 to $560,000. The increase in number of burden hours and burden dollars is due to the increase in the number of respondents.

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Annual Cost to Federal Government: $467,000

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.     No

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.     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: 03/16/2018

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