Establishing and Maintaining Lists of U.S.Product Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products

Forms and Documents

Document Name	Status
0509 HFP Food MFR export list SSA 2025 EXT.docx Supporting Statement A	2025-08-26

IC Document Collections

IC ID	Document Title	Status
46483	Occasional Update of Information	Unchanged
46482	Biennial Update of Infomation	Unchanged
37675	New Written Request to be Placed on the List Other-E-form Screenshots	Modified
236914	Third-Party Certification Information (including updates)	Unchanged

ICR Details

OMB Control No: 0910-0509	ICR Reference No: 202411-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202206-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Establishing and Maintaining Lists of U.S.Product Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products
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: 08/26/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2025
Responses	1,769	1,769
Time Burden (Hours)	7,451	7,451
Cost Burden (Dollars)	0	0

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Abstract: This ICR supports agency programs by which respondents who satisfy specified criteria may voluntarily be included on established lists of those wanting to export FDA-regulated products (foods) to foreign countries. Respondents who wish to be included on the list will voluntarily send information to FDA, including the name and address of the firm and the manufacturing plant, a list of products presently shipped and expected to be shipped in the future, and identities of agencies that inspect the plant, plant number and copy of last inspection.

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Authorizing Statute(s): US Code: 21 USC 301 et. seq.; 801 Name of Law: FFDCA; Imports and Exports
  

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:
	90 FR 18688	05/01/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 41077	08/22/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Biennial Update of Infomation
New Written Request to be Placed on the List	3972	Online Application for Export List
Occasional Update of Information
Third-Party Certification Information (including updates)

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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	1,769	1,769	0	0	0	0
Annual Time Burden (Hours)	7,451	7,451	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: $24,360

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: 08/26/2025

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