Electronic Records: Electronic Signatures

Forms and Documents

Document Name	Status
0303 Elec Sigs 21 CFR part 11 SSA 2021 EXT.docx Supporting Statement A	2021-01-12

IC Document Collections

IC ID	Document Title	Status
5871	General Requirements - 11.100	Unchanged
213244	Controls for Identification Codes/Passwords - 11.300	Unchanged
213243	Signature Manifestation - 11.50	Unchanged
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: 202011-0910-011
Status: Received in OIRA	Previous ICR Reference No: 201711-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Electronic Records: Electronic Signatures
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/12/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2021
Responses	18,500	18,500
Time Burden (Hours)	284,500	284,500
Cost Burden (Dollars)	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:
	85 FR 49381	08/13/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 77219	12/01/2020
Did the Agency receive public comments on this ICR? Yes

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

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

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ICR Summary of Burden

	Total Request	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	18,500	18,500	0	0	0	0
Annual Time Burden (Hours)	284,500	284,500	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:

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Annual Cost to Federal Government: $161,112

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: 01/12/2021

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