Reporting and Recordkeeping Requirements for Reportable Food

Forms and Documents

Document	Type	Status	Availability
0643 ss 9-29-2017.docx	Supporting Statement A	Uploaded 2017-09-29	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
197085	Recordkeeping: FDAA- Section 417(g)- Maintainence of Reportable Food Records ( Voluntary Reports)	Other-Guidance- Questions and Answers	Modified
197084	Recordkeeping- FDAAA- Section 417(g)- Maintainence of Reportable Food Records (Mandatory )	Other-Guidance- Questions and Answers	Modified
197083	Disclosure: FDAAA - Section 417 ( d)((7)( C )( ii ) Immediate Notification of The Subquent Recipient of The Article of Food.	Other-Guidance - Questions and Answers	Removed
197082	Disclosure- FDAA - Section 417(d)(7)( C )( i )- Immediate Notification of Previous Source of The Article of Food.	Other-Guidance-Questions and Answers	Removed
189627	Disclosure- FDAA- Section 417(d)(6)(B)(ii)- Immediate Notification of Subsquent Recipient of The Article of Food	Other-Guidance - Questions and Answers	Removed
189626	Disclosure - FDAA-Section 417 - Immediate Notification	Other-Guidance - Questions and Answers	Modified

ICR Details

OMB Control No: 0910-0643	ICR Reference No: 201708-0910-014
Status: Historical Active	Previous ICR Reference No: 201408-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Reporting and Recordkeeping Requirements for Reportable Food
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: 10/30/2017
	Date Received in OIRA: 09/29/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	36 Months From Approved	10/31/2017
Responses	2,404	0	6,600
Time Burden (Hours)	3,181	0	3,330
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection supports agency regulations to ensure the safety of the U.S. Food Supply.

---

Authorizing Statute(s): US Code: 21 USC 301 et. seq. Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 26489	06/07/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 44422	09/22/2017
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Disclosure- FDAA- Section 417(d)(6)(B)(ii)- Immediate Notification of Subsquent Recipient of The Article of Food
Disclosure- FDAA - Section 417(d)(7)( C )( i )- Immediate Notification of Previous Source of The Article of Food.
Disclosure: FDAAA - Section 417 ( d)((7)( C )( ii ) Immediate Notification of The Subquent Recipient of The Article of Food.
Recordkeeping: FDAA- Section 417(g)- Maintainence of Reportable Food Records ( Voluntary Reports)
Disclosure - FDAA-Section 417 - Immediate Notification
Recordkeeping- FDAAA- Section 417(g)- Maintainence of Reportable Food Records (Mandatory )

---

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	2,404	6,600	0	0	-4,196	0
Annual Time Burden (Hours)	3,181	3,330	0	0	-149	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 agency adjustments. Specifically we have decreased our recordkeeping estimate by 149 hours, with a corresponding [decrease in responses by 596 responses]. Because we expect fewer records to be maintained, we have adjusted our estimate accordingly. Also, in ROCIS, we have consolidated the third-party disclosure ICs into one element from four in this collection while we have listed the recordkeeping elements individually (i.e., we consolidated the total number for ICs from six to three). Therefore, for this submission of extension, this ICR now has three ICs in ROCIS, but the information collection activities and the burden associated with each IC remain broken down into six ICs in Item 12 of this supporting statement.

---

Annual Cost to Federal Government: $382

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? Uncollected

---

Common Form ICR:  No

---

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: 09/29/2017

---