Imports and Electronic Import Entries

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 5054 New Inquiry Form CDER Import Compliance Branch	Form and Instruction	Unchanged	Repair queued
Form FDA 5054 FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch	Form and Instruction	Unchanged	Repair queued
Form FDA 766 APPLICATION FOR AUTHORIZATION TO RELABEL OR RECONDITION NON-COMPLIANT ARTICLES	Form and Instruction	Unchanged	Repair queued
Form FDA 766 APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTS	Form and Instruction	Unchanged	Available
Form FDA 766 Application for authorization to relabel and recondition	Form and Instruction	Unchanged	Repair queued
ACE NPRM SSA FINAL.docx	Supporting Statement A	Uploaded 2024-08-20	Repair queued
ACE NPRM SSA FINAL.docx	Supporting Statement A	Uploaded 2024-08-19	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5700	Importers submission of data elements		Unchanged
270219	Proposed rule: ONGOING gathering and entering STN into filer's internal database		New
270218	Proposed rule: ONE-TIME gathering and entering STN into filer's internal database		New
259086	FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch	Form and Instruction	Unchanged	New Inquiry Form CDER Import Compliance Branch
259086	FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch	Form and Instruction	Unchanged
241015	Application for authorization to relabel and recondition	Form and Instruction	Unchanged	APPLICATION FOR AUTHORIZATION TO RELABEL OR RECONDITION NON-COMPLIANT ARTICLES
241015	Application for authorization to relabel and recondition	Form and Instruction	Unchanged	APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTS
241015	Application for authorization to relabel and recondition	Form and Instruction	Unchanged
224932	PLAIR Submissions		Unchanged
224931	ITACS; creation of new account		Unchanged
224557	WEF participants		Unchanged
210811	Entry filers (applies to unique lines only)	Other-list of examples	Unchanged

ICR Details

OMB Control No: 0910-0046	ICR Reference No: 202408-0910-004
Status: Historical Inactive	Previous ICR Reference No: 202303-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Imports and Electronic Import Entries
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 03/17/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/19/2024
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	08/31/2026
Responses	45,625,880	0	45,625,880
Time Burden (Hours)	2,053,803	0	2,053,803
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA import operations and regulations in 21 CFR part 1, subparts D & E. The regulations describe reporting elements that must be submitted for FDA-regulated products being imported into the United States, and related recordkeeping.

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Authorizing Statute(s): US Code: 21 USC 801 Name of Law: FFDCA
   PL: Pub.L. 111 - 31 801 Name of Law: Tobacco Control Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI64	Proposed rulemaking	89 FR 66647	08/16/2024

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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: 9

table that charts list of burden

IC Title	Form No.	Form Name
Application for authorization to relabel and recondition	FDA 766, FDA 766	APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTS ,   APPLICATION FOR AUTHORIZATION TO RELABEL OR RECONDITION NON-COMPLIANT ARTICLES
Entry filers (applies to unique lines only)
FDA Form 5054: New Inquiry Form/CDER Import Compliance Branch	FDA 5054	New Inquiry Form CDER Import Compliance Branch
ITACS; creation of new account
Importers submission of data elements
PLAIR Submissions
Proposed rule: ONE-TIME gathering and entering STN into filer's internal database
Proposed rule: ONGOING gathering and entering STN into filer's internal database
WEF participants

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This a revision to the current information collection. If this proposed rule is finalized, we estimate that Tobacco Product Importers gathering and submitting the required STN will increase the burden by 371 hours (355 first year burden hours + 16 burden hours for subsequent years). This revision, when added to current burden for 0910-0046 results in total burden of 45,629,939 responses and 2,053,937 hours. These totals include, as instructed by HHS, the ONE-TIME burden for the No. of Responses per Respondent, Total Annual Responses and Total Hours divided by three.

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Annual Cost to Federal Government: $38,753,148

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.     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: 08/19/2024

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