Protection of Human Subjects and Institutional Review Boards

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
IRB Waiver FRIA -- 11-27-23.docx	Supplementary Document	Uploaded 2023-11-27	Available
Minimal Risk Final Rule SSA Fall 2023 RIN AH52 CLEAN.docx	Supporting Statement A	Uploaded 2023-11-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5743	Recordkeeping associated with 21 CFR parts 50 and 56		Unchanged
263686	FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation		New
258027	Requests for Discretionary Certificates of Confidntiality	Other-Statutory Authority	Unchanged
239100	Reporting associated with 21 CFR parts 50 and 56		Unchanged
239099	Disclosures associated with 21 CFR parts 50 and 56		Unchanged

ICR Details

OMB Control No: 0910-0130	ICR Reference No: 202311-0910-012
Status: Active	Previous ICR Reference No: 202301-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Protection of Human Subjects and Institutional Review Boards
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/26/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/27/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2026	36 Months From Approved	03/31/2026
Responses	347,930	0	346,828
Time Burden (Hours)	1,627,905	0	1,626,803
Cost Burden (Dollars)	0	0	0

---

Abstract: The information collection supports implementation of statutory and regulatory requirements pertaining to the rights and welfare of human subjects involved in FDA-regulated research, and applicable to Institutional Review Boards that oversee such research.

---

Authorizing Statute(s): US Code: 21 USC 301 et. seq. Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 241; 289 Name of Law: Public Health and Welfare; Institutional Review Boards
  

Citations for New Statutory Requirements: PL: Pub.L. 114 - 255 3024 Name of Law: 21st Century Cures Act

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH52	Final or interim final rulemaking	88 FR 88228	12/21/2023

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 57378	11/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 57378	11/15/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 5

table that charts list of burden

IC Title	Form No.	Form Name
Disclosures associated with 21 CFR parts 50 and 56
FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation
Recordkeeping associated with 21 CFR parts 50 and 56
Reporting associated with 21 CFR parts 50 and 56
Requests for Discretionary Certificates of Confidntiality

---

ICR Summary of Burden

table that charts list 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	347,930	346,828	0	0	1,102	0
Annual Time Burden (Hours)	1,627,905	1,626,803	0	0	1,102	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: We estimate the rulemaking will result in an annual burden increase of 1,102 responses and 1,102 hours from recordkeeping and disclosure activity relating to the revised regulations in 21 CFR parts 50 and 56.

---

Annual Cost to Federal Government: $8,750,000

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? No

---

Common Form ICR:  No

---

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: 11/27/2023

---