Reporting and Recordkeeping Requirements for Reportable Food

Forms and Documents

Document Name	Status
SS-0910-0643 #3.doc Supporting Statement A	2011-03-22

IC Document Collections

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

ICR Details

OMB Control No: 0910-0643	ICR Reference No: 201103-0910-009
Status: Historical Active	Previous ICR Reference No: 200906-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Reporting and Recordkeeping Requirements for Reportable Food
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/22/2011
	Date Received in OIRA: 03/26/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2014	36 Months From Approved
Responses	6,600	0	0
Time Burden (Hours)	3,330	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 1005 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), among other things. Section 417 of the act defines "reportable food" as an "article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." (Section 417(a)(2) of the act). Section 417 of the act requires FDA to establish an electronic portal (the Reportable Food electronic portal) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. FDA made the decision that the most efficient and cost effective means to implement the requirements of section 417 of the act relating to the Registry was to utilize the business enterprise system currently under development within the agency: the MedWatchPlus Portal. In addition, Section 1005(f) of FDAAA required FDA to issue guidance to industry about submitting reports through the electronic portal of instances of reportable food and providing notifications to other persons in the supply chain of such article of food. FDA is issuing guidance containing questions and answers relating to the requirements under section 417 of the act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

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Authorizing Statute(s): US Code: 21 USC 350f 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:
	74 FR 53746	10/20/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 8960	02/26/2010
Did the Agency receive public comments on this ICR? Yes

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

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

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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	6,600	0	0	600	0	6,000
Annual Time Burden (Hours)	3,330	0	0	150	0	3,180
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There was a program change for recordkeeping requirenments (increase) of 150 hours due to maintainance of records for voluntary reports.

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Annual Cost to Federal Government: $350

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

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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: 03/26/2011

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