Certification of Identity for Freedom of Information and Privacy Act Requests

Forms and Documents

Document Name	Status
Form FDA 3975 Certificate of Identity; Form FDA 3975 Form and Instruction	Modified
0832 Certificate of Identity for FOIA and Privacy Act Requests SSA 2020.pdf Supporting Statement A	2020-05-11

IC Document Collections

IC ID	Document Title	Status
226535	Certificate of Identity; Form FDA 3975 Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0832	ICR Reference No: 202005-0910-001
Status: Active	Previous ICR Reference No: 201704-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Certification of Identity for Freedom of Information and Privacy Act Requests
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 without change	Conclusion Date: 06/08/2020
	Date Received in OIRA: 05/11/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	50	0	60
Time Burden (Hours)	9	0	10
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports laws pertaining to the Freedom of Information Act (5 USC 552 (FOIA)) and the Privacy Act (5 USC 552a), as well as applicable FDA regulations at 21 CFR Part 20 and Part 21. In processing certain requests under the FOIA and the Privacy Act, the agency must confirm that the individual making the request is the same person to whom the records pertain and will be released.

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Authorizing Statute(s): US Code: 5 USC 552 Name of Law: Freedom of Information 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:
	84 FR 64539	11/22/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 18984	04/03/2020
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Certificate of Identity; Form FDA 3975	FDA 3975	Certification of Identify

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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	50	60	0	0	-10	0
Annual Time Burden (Hours)	9	10	0	0	-1	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: Based on agency data, we have received no more than 50 submissions since establishing the collection in 2017. We have therefore adjusted the number of respondents resulting in a decrease to the collection.

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Annual Cost to Federal Government: $0

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.     Yes

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.     Yes

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: 05/11/2020

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