Importer's Entry Notice

Forms and Documents

Document Name	Status
Form FDA 766 Application for authorization to relabel and recondition Form and Instruction	New
0046 Imports SSA REV 2020.pdf Supporting Statement A	2020-04-26

IC Document Collections

IC ID	Document Title	Status
5700	Importers submission of data elements	Modified
241015	Application for authorization to relabel and recondition Form and Instruction	New
224932	PLAIR Submissions	Modified
224931	ITACS; creation of new account	Modified
224557	WEF participants	Modified
210811	Entry filers (applies to unique lines only) Other-list of examples	Modified

ICR Details

OMB Control No: 0910-0046	ICR Reference No: 202003-0910-011
Status: Historical Active	Previous ICR Reference No: 201706-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Importer's Entry Notice
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/02/2020
	Date Received in OIRA: 04/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	42,558,387	0	82,669,422
Time Burden (Hours)	1,916,084	0	1,785,512
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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 318	01/03/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 23048	04/24/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Application for authorization to relabel and recondition	FDA 766	APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTS
Importers submission of data elements
Entry filers (applies to unique lines only)
WEF participants
ITACS; creation of new account
PLAIR Submissions

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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	42,558,387	82,669,422	0	0	-40,111,035	0
Annual Time Burden (Hours)	1,916,084	1,785,512	0	0	130,572	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: The information collection reflects program changes as well as adjustments. Cumulatively, these changes and revisions result in 40,111,035 fewer annual responses and 130,572 less burden hours to the information collection. This is discussed more fully in Questions 1 and 15 of our Supporting Statement.

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Annual Cost to Federal Government: $38,750,000

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.     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: 04/27/2020

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