Section 232 National Security Adjustments to Imports of Pharmaceuticals

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0694-0147 Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020 of April 2, 2026	Form and Instruction	New	Available
Form 0694-0147 Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020 of April 2, 2026	Form and Instruction	New	Available
0694-0147 Supporting Statement for Adjustments to Imports of Pharma.docx	Supporting Statement A	Uploaded 2026-05-13	Available
0694-0147 Supporting Statement for Adjustments to Imports of Pharma.docx	Supporting Statement A	Uploaded 2026-05-13	Available
PRA Emergency OMB Letter Pharma Onshoring from BIS DAS JC.pdf	Supplementary Document	Uploaded 2026-05-12	Available
PRA Emergency OMB Letter Pharma Onshoring from BIS DAS JC.pdf	Supplementary Document	Uploaded 2026-05-12	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
280389	Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020	Form and Instruction	New	Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020 of April 2, 2026
280389	Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020	Form and Instruction	New	Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020 of April 2, 2026

ICR Details

OMB Control No: 0694-0147	ICR Reference No: 202605-0694-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: DOC/BIS	Agency Tracking No:
Title: Section 232 National Security Adjustments to Imports of Pharmaceuticals
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 05/13/2026
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/18/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/13/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2026	6 Months From Approved
Responses	450	0	0
Time Burden (Hours)	3,600	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The collection of information is essential to the mission of the Department, in particular to allow companies seeking to obtain tariff adjustments from the ad valorem tariff by submitting onshoring agreements to effectuate the terms outlined by Proclamation 11020. These collection requirements include detailed onshoring plans across product portfolios, percentage of U.S. sales that are made in the United States, investment and production milestones, and other information required to substantiate the applications for reduced tariff treatment under Section 232.

Emergency Justfication: Public harm is reasonably likely to result if BIS were to follow the normal clearance procedures before issuing this information collection. BIS needs time to get onshoring agreements in place before September 29, 2026, when the Section 232 tariffs for most companies will become effective. This information collection allows companies to apply for onshoring agreements to increase domestic manufacturing of pharmaceutical products and their ingredients, which will increase the stability of the industry. A delay in Commerce’s ability to begin immediate information collection from companies seeking an onshoring agreement and inability to issue decisions before the 100 percent tariff rate is in effect could lead to companies delaying decisions to increase domestic manufacturing of pharmaceuticals, which would further import dependence that the Presidential Proclamation is seeking to reduce.

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Authorizing Statute(s): EO: EO 11020 Name/Subject of EO: Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States
  

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

Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020	0694-0147	Implementing Company-Specific Onshoring Agreements for Tariff Adjustments of Certain Pharmaceuticals and Pharmaceutical Ingredients Under Presidential Proclamation 11020 of April 2, 2026

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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	450	0	0	450	0	0
Annual Time Burden (Hours)	3,600	0	0	3,600	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection based on Presidential Proclamation 11020.

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Annual Cost to Federal Government: $2,380,000

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

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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: 05/13/2026

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