Electronic Records: Electronic Signatures

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0303 Elec Sigs 21 CFR part 11 SSA 2023 REV.docx	Supporting Statement A	Uploaded 2024-01-22	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5871	General Requirements - 11.100		Modified
213244	Controls for Identification Codes/Passwords - 11.300		Modified
213243	Signature Manifestation - 11.50		Modified
213242	Closed for Open Systems - 11.30		Unchanged
213241	Controls for Closed Systems - 11.10		Unchanged

ICR Details

OMB Control No: 0910-0303	ICR Reference No: 202312-0910-007
Status: Active	Previous ICR Reference No: 202011-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Electronic Records: Electronic Signatures
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: 03/26/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/22/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2027	36 Months From Approved	03/31/2024
Responses	20,000	0	18,500
Time Burden (Hours)	305,000	0	284,500
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports Food and Drug Administration (FDA) regulations. Specifically, the regulations found at 21 CFR Part 11: Electronic Records; Electronic Signatures provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures serving to legally bind subsequent electronic submissions and verify electronic records. Under the regulations, records and reports may be submitted to FDA electronically, with certain provisions.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food Drug and Cosmetic 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:
	88 FR 64441	09/19/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 1921	01/11/2024
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Closed for Open Systems - 11.30
Controls for Closed Systems - 11.10
Controls for Identification Codes/Passwords - 11.300
General Requirements - 11.100
Signature Manifestation - 11.50

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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	20,000	18,500	0	0	1,500	0
Annual Time Burden (Hours)	305,000	284,500	0	0	20,500	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 have revised the collection consistent with a technical amendment changing the agency’s address as referenced in the applicable regulations and to allow for electronic submission of information. We have also adjusted our estimate of burden upward by 1,500 responses and 20,500 hours annually.

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Annual Cost to Federal Government: $200,538

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

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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: 01/22/2024

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