State Enforcement Notifications

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0275 State enforcement notifications SSA 2024 Ext.docx	Supporting Statement A	Uploaded 2024-06-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5842	State Enforcement Notifications		Unchanged

ICR Details

OMB Control No: 0910-0275	ICR Reference No: 202406-0910-004
Status: Active	Previous ICR Reference No: 202105-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: State Enforcement Notifications
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: 07/22/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/18/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	07/31/2024
Responses	1	0	1
Time Burden (Hours)	10	0	10
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports section 310(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 337(b)). Agency implementing regulations in 100.2(d) (21 CFR 100.2 (d)) set forth information that a State must provide to FDA in a letter of notification when it intends to take enforcement action under the FFDCA against a particular food located in the State.

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Authorizing Statute(s): US Code: 21 USC 337 Name of Law: FFDCA
  

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:
	89 FR 4315	01/23/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 51533	06/18/2024
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
State Enforcement Notifications

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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	1	1	0	0	0	0
Annual Time Burden (Hours)	10	10	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: $4,521

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: 06/18/2024

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