Federal-State Regulatory Program Standards

Forms and Documents

Document Name	Status
0760 Fed-State Regulatory Program Standards SSA 2021 09.28.21 clean.pdf Supporting Statement A	2021-09-28

IC Document Collections

IC ID	Document Title	Status
248483	State Egg Regulatory Standards Program Other-Egg Regulatory Program Standards	New
209610	State Feed Regulatory Programs Other-Animal Feed Regulatory Program Standards	Modified

ICR Details

OMB Control No: 0910-0760	ICR Reference No: 202107-0910-016
Status: Received in OIRA	Previous ICR Reference No: 201911-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Federal-State Regulatory Program Standards
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/04/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2023
Responses	134	34
Time Burden (Hours)	24,346	19,346
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports implementation of FDA's Animal Feed and Egg Regulatory Standards Programs. Respondents to the information collection are State agencies that conduct feed or egg inspections and want to participate in implementing the standards.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 201 Name of Law: Food Safety Modernization Act
   PL: Pub.L. 111 - 353 205(c)(1) Name of Law: FSMA
  

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:
	86 FR 26528	05/14/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 54454	10/01/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
State Egg Regulatory Standards Program
State Feed Regulatory Programs

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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	134	34	0	100	0	0
Annual Time Burden (Hours)	24,346	19,346	0	5,000	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 information collection request reflects a program change revision. The total estimated burden of this collection has increased by 5,000 burden hours, from 19,346 to 24,346 burden hours. Based on our experience with similar information collection, we estimate an initial 10 respondents will participate in the Egg Regulatory Program Standards (ERPS), and assume an average of 50 burden hours per response is necessary for the attendant recordkeeping and submission of data elements to FDA. We expect participation in the ERPS to increase. Finally, upon submission of the Information Collection Request, we are correcting an inadvertent calculation error in the total burden hours as displayed on page 26530, in Table 1, in our 60-day notice in the Federal Register of May 14, 2021 (86 FR 26528).

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Annual Cost to Federal Government: $300,000

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: 10/04/2021

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